Technology and Innovation Volume 19, Number 1

Volume 19, Number 1

ISSN 1949-8241 • E-ISSN 1949-825X

Fostering Innovation and Entrepreneurship University-Based Technology Accelerators

349

Adapting Stage-Gate to MTM

363

Event Analytics for Innovation

397

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EDITORS-IN-CHIEF PAUL R. SANBERG University of South Florida Tampa, FL

ERIC R. FOSSUM Dartmouth College Hanover, NH

SENIOR EDITORS HOWARD J. FEDEROFF University of California, Irvine Irvine, CA

NASSER ARSHADI University of Missouri – Saint Louis St. Louis, MO

EDITORIAL STAFF Kimberly Macuare, Associate Editor

EDITORIAL BOARD Shantikumar Nair, Amrita University, India Sethuraman Panchanathan, Arizona State University David Winwood, Association of University Technology Managers

Jarett Rieger, H. Lee Moffitt Cancer Center & Research Institute Shinn-Zong (John) Lin, Hualien Tzu Chi Hospital Christopher Fasel, Idaho State University

Jay Gogue, Auburn University

Sharon Heise, Institute for Human & Machine Cognition

Rivka Carmi, Ben-Gurion University of the Negev, Israel

Cama McNamara, Inventor’s Digest

Ernest B. Izevbigie, Benson Idahosa University, Nigeria

Kamal S. Ali, Jackson State University

Mark Rudin, Boise State University

Christy Wyskiel, Johns Hopkins University

Gloria Waters, Boston University

Solomon H. Snyder, Johns Hopkins University

Farnam Jahanian, Carnegie Mellon University

Mary Rezac, Kansas State University

Joseph Jankowski, Case Western Reserve University

Norman R. Augustine, Lockheed Martin Corporation

Todd Headley, Colorado State University

Kalliat T. Valsaraj, Louisiana State University

Scot Hamilton, Columbia University

Richard Kordal, Louisiana Tech University

Alice Li, Cornell University

Robert S. Langer, Massachusetts Institute of Technology

Donna M. DeCarolis, Drexel University Marti Van Scott, East Carolina University

Mariesa L. Crow, Missouri University of Science and Technology

Todd Sherer, Emory University

Rebecca Mahurin, Montana State University

Daniel C. Flynn, Florida Atlantic University

Vimal Chaitanya, New Mexico State University

Tachung (T.C.) Yih, Florida Gulf Coast University

Kurt H. Becker, New York University

Tristan J. Fiedler, Florida Institute of Technology

Gerald Blazey, Northern Illinois University

Andres G. Gil, Florida International University

James G. Conley, Northwestern University

Lawrence O. Gostin, Georgetown University Law Center

Arlene A. Garrison, Oak Ridge Associated Universities

Steven J. Kubisen, The George Washington University

Lonnie G. Thompson, The Ohio State University

John J. Kopchick, Ohio University

Karen J.L. Burg, University of Georgia

Steven Price, Oklahoma State University

Derek E. Eberhart, University of Georgia

Neil A. Sharkey, The Pennsylvania State University

Richard C. Willson, University of Houston

Curtis R. Carlson, The Practice of Innovation

Lesley Millar-Nicholson, University of Illinois at Urbana-Champaign

Kenneth J. Blank, Rowan University S. David Kimball, Rutgers, The State University of New Jersey Kenneth A. Olliff, Saint Louis University Arthur Daemmrich, Smithsonian Lemelson Center Arthur Molella, Smithsonian Lemelson Center Arthur J. Tipton, Southern Research Institute

Taunya Phillips Walker, University of Kentucky Mary Shire, University of Limerick, Ireland William M. Pierce, Jr., University of Louisville Patrick O’Shea, University of Maryland Louis A. Carpino, University of Massachusetts – Amherst

Christos Christodoulatos, Stevens Institute of Technology

James P. McNamara, University of Massachusetts Medical School

Robert V. Duncan, Texas Tech University

Kenneth J. Nisbet, University of Michigan

Stephen Klasko, Thomas Jefferson University Richard A. Houghten, Torrey Pines Institute for Molecular Studies

Henry C. Foley, University of Missouri – Columbia Lawrence Dreyfus, University of Missouri – Kansas City

Woody Maggard, University at Buffalo – State University of New York

Steve Goddard, University of Nebraska-Lincoln

Stephen Z. Cheng, The University of Akron

Kumi Nagamoto-Combs, The University of North Dakota

Richard P. Swatloski, The University of Alabama

Zachary Miles, The University of Nevada, Las Vegas

John Kantner, University of North Florida

Richard B. Marchase, The University of Alabama at Birmingham

Thomas McCoy, University of North Texas

Frederic Zenhausern, The University of Arizona

James H. Bratton, The University of Oklahoma

Jim Rankin, University of Arkansas

Lynne U. Chronister, The University of South Alabama

Gloria D. Hayes, University of California, Davis

Judy Genshaft, University of South Florida

Tom O’Neal, University of Central Florida

Gordon C. Cannon, University of Southern Mississippi

Patrick A. Limbach, University of Cincinnati

T. Taylor Eighmy, The University of Tennessee, Knoxville

Inge Wefes, University of Colorado – Denver/AMC

Cynthia M. Furse, The University of Utah

Jeff Seemann, University of Connecticut

John Biondi, University of Wisconsin – Madison

Mathew Willenbrink, University of Dayton

H. Holden Thorp, Washington University in St. Louis

David S. Weir, University of Delaware

Anthony J. Vizzini, Wichita State University

Jennifer Graban, University of Evansville David P. Norton, University of Florida

Robert E. W. Fyffe, Wright State University T. Kyle Vanderlick, Yale University

National Academy of Inventors. Technology and Innovation, University of South Florida Research Park, 3702 Spectrum Boulevard, Suite 165, Tampa, FL 33612-9445 USA. Tel: +1-813-974-1347; Fax: +1-813-974-4962; tijournal@academyofinventors.org; www. academyofinventors.org.

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Copyright © 2017 National Academy of Inventors® Printed in the USA Cover Photo: An adidas Futurecraft 4D midsole printing on a Carbon M-series printer. Notice how the midsole has different lattice structures in the heel and forefoot, to account for different cushioning needs for these parts of the foot while running. (photo courtesy of adidas)

Volume 19, Number 1, 2017

Pages 345-452

ISSN 1949-8241 E-ISSN 1949-825X

CONTENTS SPECIAL TOPIC ISSUE: FOSTERING INNOVATION AND ENTREPRENEURSHIP Fostering Innovation and Entrepreneurship

Rathindra DasGupta

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University Technology Accelerators: Design Considerations and Emerging Best Practices

Julia Byrd, Orin Herskowitz, Jim Aloise, Andrea Nye, Satish Rao,

and Katherine Reuther

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Adapting the Industrial Stage-Gate® Process to Create a Novel Master’s Degree Innovation Curriculum 363

Angelika Domschke and John A. Blaho The PhD Innovation Program at the Thayer School of Engineering at Dartmouth

Eric R. Fossum, Carolyn E. Fraser, and Joseph J. Helble

381

University-Based Makerspaces: A Source of Innovation

Shane Farritor

389

Event Analytics for Innovation Trajectories: Understanding Inputs and Outcomes for Entrepreneurial Success

C. Scott Dempwolf and Ben Shneiderman

397

Maximize Collisions, Minimize Friction : Applying Platform Strategies to Accelerate University Research Commercialization

Vinit Nijhawan

415

SM

Transportation and Energy: The Push for Leadership and Innovation

James E. Smith

425

REGULAR FEATURES From the USPTO - Innovation Saving Lives: 2016 Patents for Humanity Awards

Philippa Olsen and Edward Elliott

437

The NAI Fellow Profile: An Interview with Dr. Joseph M. DeSimone

Joseph M. DeSimone and Kimberly A. Macuare

441

Innovation in Action

449

T&I Book Review

Charles E. Hutchinson

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Aims and Scopes

i

Preparation of Manuscripts

i

Ethics Statement

ii www.technologyandinnovation.org

Technology and Innovation, Vol. 19, pp. 345-348, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.345 www.technologyandinnovation.org

FOSTERING INNOVATION AND ENTREPRENEURSHIP Rathindra DasGupta Manitowoc, WI, USA

To many, innovation and entrepreneurship (I&E) are two closely related words; however, they do not mean the same thing. Too often, they are used interchangeably with little to no knowledge of the key difference between the two.

Innovation involves “the design, invention, development and/or implementation of new or altered products, services, processes, systems, organizational structures, or business models for the purpose of creating new value for customers and financial returns for the firm” (1). On the other hand, entrepreneurship is the process of designing, launching, and running a new business (2). That is, “[t]he entrepreneur chooses/ develops a business model, acquires the human and other required resources, and is fully responsible for its success or failure” (2). Simply stated, entrepreneurs use their creativity to bring ideas and/or concepts to life by building businesses and taking risks.

Innovation is critical to the success of any business. For a business to accelerate innovation, thereby stimulating the economy, it must have an “innovation strategy” as well as a culture for innovation. Fostering such a culture requires an organization to emphasize team building, brainstorming and sharing ideas, and empowering its people to be creative and to have fun. Creating an environment for innovation, however, also requires an understanding of the “Valley of Death” (3): the time gap between the initial scientific discovery and the development and introduction of

products and/or processes to the market, since such “time gaps” can be long and expensive.

The responsibility to drive economic growth through creation and implementation of new ideas that generate “value” for public use falls not just on corporations but also on universities. Consequently, in recent years, many universities have played an important role in helping drive the impact of innovation by offering faculty and students an innovation ecosystem that nurtures I&E. Examples include the University of Michigan (http://cfe.umich.edu/), Stanford University (https://www.gsb.stanford.edu/ faculty-research/centers-initiatives/ces), the University of Maryland (http://innovation.umd.edu/), and many others.

An approach frequently employed to allow for innovation to thrive is design thinking, a multi-step (iterative) process that allows for bringing ideas to life (4). In recent years, Lean Startup methodology (LSM) has grown in popularity as a tool employed for sustaining and disruptive innovation (5). LSM, first proposed in 2008 by Eric Ries, was initially focused on high-tech start-up companies; however, the methodology is now being applied to any individual, team, or company looking to introduce new products or services into the market (6). LSM has played an important role in creating and introducing new initiatives and programs. One such program is the National Science Foundation (NSF) Innovation

_____________________ Accepted April 15, 2017.

Address correspondence to Rathindra DasGupta, 1030 S. 39th St., Apt. D, Manitowoc, WI 54220, USA. Tel: +1 (703) 307-3652; E-mail: babu.dasgupta@gmail.com

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Corps Teams (I-Corps™) curriculum, which is designed to help NSF-funded researchers accelerate innovation (from discoveries resulting from their fundamental research) and to maximize the potential for their new business ideas (7).

To appreciate the importance of I&E in driving economic growth and the role of universities in advancing entrepreneurship, I urge the readers to read the small list of sources below. These articles are self-explanatory, and I sincerely hope you enjoy reading them as much as I did • http://www.investopedia.com/articles/ personal-finance/101414/why-entrepreneurs-are-important-economy.asp • http://www.smithsonianmag.com/innovation/ how-are-universities-grooming-next-greatinnovators-180955792/ • https://fuse.wustl.edu/innovation-entrepreneurship-higher-education/ • https://www.uk-cpi.com/news/the-innovation-process/ • https://hbr.org/2013/05/why-the-lean-start-upchanges-everything • https://venturebeat.com/2017/03/08/the-noexcuses-culture/ Finally, having been involved in I&E programs and initiatives for many years, I want to share a few of my thoughts on what an individual must possess/ exhibit to be an entrepreneur (8): 1. HAVE THE MINDSET TO FOLLOW THROUGH 2. BE RESILIENT, PATIENT, AND PERSISTENT 3. NOT BE AFRAID OF FAILURE (NOT RISK AVERSE) 4. BELIEVE IN EVIDENCE-BASED ENTREPRENEURSHIP 5. BE WILLING TO GET OUT OF THE BUILDING AND INTERVIEW POTENTIAL CUSTOMERS 6. BE ABLE TO INFER KEY INSIGHTS FROM CONVERSATIONS WITH POTENTIAL CUSTOMERS 7. BE WILLING TO PIVOT 8. BE A TEAM PLAYER

Given the importance of I&E and the university’s ever-increasing role in these areas, this special issue of Technology and Innovation offers important insights into university-based business accelerators, novel educational programs and courses designed to support innovative and entrepreneurial activities, and innovation tools and models, among others.

Focusing on lessons learned in Columbia University’s five years of managing or co-managing accelerators in the medical, energy, and media sectors, Byrd et al. compare and contrast the university’s experiences in these disparate areas, including similarities and differences in objectives, strategies, tactics, and organizational structure. Based on these experiences and lessons, the authors identify key points of consideration and best practices methods for universities looking to enter the accelerator arena.

Domschke and Blaho detail an innovative master’s degree curriculum created at the City University of New York that is based on the industrial Stage-Gate® process. The Stage-Gate process is a well-known tool developed to help companies manage complex and often-difficult product development processes for things like medical devices and drugs. By taking Stage-Gate out of the business schools where it is currently taught and incorporating it into the translational medicine master’s degree, they are able to equip engineers and scientists with the necessary skills to carry out the key tasks of product development, which, in turn, both lowers costs and boosts adoption of new products.

Fossum et al. weigh in on the innovative education discussion as well, focusing on Dartmouth’s PhD Innovation Program at the Thayer School of Engineering. Because the program and the area are new, they start off by offering some context as to why the program was created and to what end. In addition, they draw some important conclusions about how to best prepare engineering students to actively participate in technology transfer activities and thus make a positive economic and technological impact nationally and globally, something they argue that this program has been successful in doing.

In addition to curricular considerations, there are other elements in the university that contribute to students’ innovative output. Shane Farritor focuses on the importance of providing makerspaces for students in order to promote innovation outside of

FOSTERING INNOVATION AND ENTREPRENEURSHIP the classroom setting. Touching on physical layout, proximity to key areas, opportunities for engagement, the groups of people sharing the space, and more, Farritor offers a blueprint that cannot guarantee innovation but will certainly give faculty and administrators a starting place for considering the key characteristics their makerspaces should have in order to promote innovation output.

New analysis tools are expanding the options for innovation researchers. While previous researchers often speculated on the relationship between inputs, such as patents or funding, and outcomes, such as product releases or initial public offerings, new software tools enable researchers to analyze innovation event data more efficiently. Tools such as EventFlow make it possible to rapidly scan visual displays, algorithmically search for patterns, and study an aggregated view that shows common and rare patterns. This paper presents initial examples, using data from 34,331 drugs or medical devices, of how event analytic software tools such as EventFlow could be applied to innovation research.

Vinit Nijhawan discusses the great benefits that universities can achieve in the tech transfer arena by applying platform strategies, strategies which have propelled the success of companies such as Uber and Airbnb. As he notes, these new strategies are necessary because the majority of universities engaging in these commercialization activities do not generate enough to cover costs despite the encouragement provided by the Bayh-Dole Act of 1980. By employing platform strategies, which focus on connecting people, organizations, and resources in an interactive ecosystem, Nijhawan shows the real results that Boston University was able to achieve, including significantly accelerated research and intellectual property commercialization.

James Smith’s contribution takes a wide view of innovation history, focusing on the centrality of innovation to our society’s economic and social success.

Specifically, he argues that energy and the transportation afforded by that energy has allowed us to advance as a society. Starting from the origins of the Industrial Revolution in the United States, he traces the progression of innovation and the concomitant development of the U.S. as a global powerhouse, highlighting the interdependent relationship between the two. After his historical review, Smith addresses

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the future and recognizes that the gains we have made can only be sustained and surpassed if our national and global leadership continue to make economic and social improvements and advancements a priority.

T&I’s regular features include the United States Patent and Trademark Office’s commentary, which focuses on their Patents for Humanity awards.

This is their top honor for innovators who bring life-changing technologies to those in need. This issue’s NAI Fellow Profile features professor, inventor, and serial entrepreneur Dr. Joseph DeSimone, who discusses how his company Carbon is revolutionizing the Maker Movement, why we shouldn’t be pessimistic about the impact that 3D printing and other technologies will have on jobs, and what really makes innovative teams successful. The T&I book review assesses Paul Swamidass’s book Engineering Entrepreneurship, From Idea to Business Plan. Finally, T&I is pleased to present a new feature in this issue, Innovation in Action, which focuses on exciting new technologies, drugs, and processes being developed at universities across the country and around the world.

The various papers in this issue have been written by individuals who are known innovators and/or entrepreneurs. I sincerely thank these authors for their contributions to this issue and their perspicacious observations about I&E, especially what makes it successful in a university setting. This issue provides substantive (and new) information, including meaningful examples, that furthers the understanding of I&E. I thank the reviewers for their helpful comments and criticisms of the manuscripts.

Finally, I am indebted to Kimberly Macuare for her guidance, patience, and numerous suggestions to help make this issue possible.

REFERENCES 1.

2.

Advisory Committee on Measuring Innovation in 21st Century Economy. Innovation measurement: tracking the state of innovation in the American economy. Washington (DC): Department of Commerce; 2008.

Wikipedia contributors. Entrepreneurship.

Wikipedia, The Free Encyclopedia. 2017 May 22 [accessed 2017 May 15]. https://en.wikipedia. org/wiki/Entrepreneurship.

348 3.

4.

5.

DASGUPTA Markham SK, Ward SJ, Aiman-Smith L, Kingon AI. The valley of death as context for role theory in product innovation. J Prod Innov Manag.

27:402-417; 2010. [accessed 2017 May 20]. http:// onlinelibrary.wiley.com/doi/10.1111/j.15405885.2010.00724.x/pdf.

Dam RF, Siang TY. 5 stages in the Design Thinking process. Aarhus (DK): The Interaction Design Foundation; c2017 [accessed 2017 May 20]. https://www.interaction-design.org/ literature/article/5-stages-in-the-design-thinking-process.

Gaffney S, Lin S, Miller K, Nilsson H, Ravala S, Unnikrishnan M. Lean Startup Methodology for enterprises [white paper]. Berkeley (CA): Engineering Leadership Professional Program;

6.

7.

8.

201. [accessed 2017 May 20]. https://ikhlaqsidhu. files.wordpress.com/2014/08/elpp-project-1lean-startup-for-enterprises-final-3.pdf.

Wikipedia contributors. Lean startup. Wikipedia, The Free Encyclopedia. 2017 May 15 [accessed 2017 May 20]. https://en.wikipedia.org/wiki/ Lean_startup.

NSF I-Corps. Program Solicitation. Arlington (VA): National Science Foundation; c2017. [accessed 2017 May 20]. https://www.nsf.gov/ pubs/2017/nsf17559/nsf17559.pdf.

DasGupta R. The entrepreneur’s journey. WSPE eNews. Mar 2017. [accessed 2017 May 20]. http:// www.wspe.org/enews/2017/2017%20March%20 eNews%20WSPE.pdf.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.349 www.technologyandinnovation.org

Technology and Innovation, Vol. 19, pp. 349-362, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

UNIVERSITY TECHNOLOGY ACCELERATORS: DESIGN CONSIDERATIONS AND EMERGING BEST PRACTICES Julia Byrd1, Orin Herskowitz1,2,3, Jim Aloise1,2, Andrea Nye4,5, Satish Rao2,3, and Katherine Reuther4,5 1 PowerBridgeNY, New York, NY, USA Columbia Technology Ventures, Columbia University, New York, NY, USA 3 NYC Media Lab Combine, New York, NY, USA 4 Department of Biomedical Engineering, Columbia University, New York, NY, USA 5 Columbia-Coulter Translational Research Partnership, New York, NY, USA 2

This article reviews some of the lessons learned by Columbia University in five years of managing or co-managing proof-of-concept center accelerators for grant-funded technologies in three industries: medical devices, diagnostics, and imaging; clean energy; and media. Each of these accelerators is described in terms of objectives, strategies, tactics, and organizational structure, with the commonalities and differences across the accelerators discussed in some detail. Based on these commonalities, the article identifies some common key decision points to be addressed and “best practices” to be employed by other universities looking to launch accelerators of their own. Given the increasing proliferation of such accelerators at other institutions, the authors propose establishing a forum for ongoing discussion and best practice sharing in the future.

Key words: Accelerators; Entrepreneurship; Technology commercialization; Proof-of-concept; Valley of Death

commercialization of university-originated intellectual property (IP). By applying similar strategies and tactics to different fields, each fledgling program was able to modify previous models to meet the needs of another industry, with ensuing lessons flowing back to the other programs in a positive feedback loop.

As the suite of Columbia programs grew, we began to recognize that there are both common elements of technology accelerators as well as elements that need to be adapted to best fit the specific dynamics within different industries. For example, NYC Media Lab

INTRODUCTION: WHY WRITE THIS ARTICLE? Over the past five years, Columbia University has launched accelerator and proof-of-concept center programs, which bridge the gap between discovery and technology development, in diverse industries: medical technologies (Columbia-Coulter Translational Research Partnership), clean technology & energy (PowerBridgeNY), digital media (NYC Media Lab Combine), and now in therapeutics as well. Each has built on the lessons and successes of the other programs, with the end goal of accelerating the _____________________

Accepted April 15, 2017.

Address correspondence to Orin Herskowitz, Executive Director, Columbia Technology Ventures, 80 Claremont Ave. 4th Floor, New York, NY 10027, USA. Tel: +1 (212) 854-1242; E-mail: orin-herskowitz@columbia.edu

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Combine (Combine) works with media technologies that tend to be leaner and faster moving, and hence instituted an abbreviated application and awardee process compared with the energy or medical device programs. In the case of Combine, a new format was molded using many but not all of the fundamental elements in PowerBridgeNY and Columbia-Coulter Translational Research Partnership. We are now in the process of taking the lessons learned from these first three accelerators to launch a new program specific to therapeutics and are finding that building off an existing base is much easier than starting from scratch. We are also combining many of the shared administrative and infrastructural elements from each of these programs into a centrally-staffed virtual core facility, called the Columbia Accelerator Network, to better leverage these best practices and increase efficiency and effectiveness across the programs.

The authors hope that by sharing lessons learned from these accelerators, as well as collecting and disseminating similar lessons from accelerators at other research institutions, best practices will continue to evolve to benefit everyone involved in moving early-stage technologies out of labs and into the market for the good of society. To that end, Columbia University has begun to keep a public repository of observations and materials from our existing accelerator programs, including lessons learned, application and review materials, award terms and conditions, and public outreach materials. Other universities will be able to access these resources while also uploading their own, thus initiating a conversation across the national research community. If your institution would like to participate, please email the authors at techventures@columbia.edu with “Accelerators” in the subject line.

Until the repository is fully established, our hope is that this article will start the dialogue and begin sharing what we have learned about both the key elements of an accelerator program and how the surrounding components can be tweaked in order to meet industry needs. Ultimately, the authors hope readers will be empowered by this information and take steps toward starting their own programs or, if they already have programs, share their experiences with others.

BACKGROUND: WHY ARE THESE PROGRAMS NEEDED IN THE FIRST PLACE? It is well established that high-potential early-stage scientific innovations often fall into what is commonly known as the “Valley of Death” (Figure 1).

This “valley” exists when fundamental basic research that indicates potential opportunities for commercialization has been completed in the academic lab but stalls without the expertise, knowledge, and resources to bring these technologies to market. In many cases, this results in a tremendous net loss to society—fewer new products or services, fewer new jobs, loss of exports and taxes, and lower chances for fundamental breakthroughs.

Why does this valley exist? Federal research grants primarily fund basic academic research, but the resulting projects are often still too risky for industry to simply in-license or for traditional venture capital investment. Academic researchers often lack the business skills, experience, and network to navigate the early stages of company formation. These projects do not benefit from early and frequent industry and investor input reflecting the real-time needs of the marketplace or are developed in ways that cannot scale effectively to serve those needs. Even those products that make it to market may not have been tested, proven, and deployed enough to appeal to clients or consumers, particularly enterprise customers who may need to demonstrate high reliability and cost-effectiveness.

As a result, early-stage start-ups leveraging grant or angel capital have become increasingly critical for getting high-promise but not-yet-validated university IP to a more mature stage, after which the large industry players can obtain access to the technology either through an IP license, company acquisition, or by purchasing the start-up’s product or service.

Technology commercialization in general, but specifically via start-ups, also fulfills other objectives for universities, including local and regional economic development, supporting entrepreneurial students and faculty, increasing connections to local communities, and employing postdocs and graduate students.

However, commercializing a technology through a license or a start-up presents problems beyond solely the dearth of financial resources. It is fairly

UNIVERSITY-BASED TECHNOLOGY ACCELERATORS

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Figure 1. Valley of Death for innovations.

rare for faculty inventors in an academic setting to have previous entrepreneurial experience. Likewise, students who invent a technology during their studies and want to commercialize it often lack the entrepreneurial skills and market knowledge needed to succeed. Thus, accelerators can provide participants with needed skills and the means to obtain market knowledge while also supplying some of the validation and prototype funding required. When it works, the result is a system capable of getting more and better technologies out of the lab at a faster rate.

CONTEXT: HOW DID THESE SPECIFIC PROGRAMS COME ABOUT, AND WHAT HAVE THEY ACCOMPLISHED? Columbia’s biomedical accelerator program, Columbia-Coulter Translational Research Partnership (Columbia-Coulter), was established in 2011 through a generous five-year, $5 million grant from the Wallace H. Coulter Foundation, with the ultimate goal of developing health care solutions that address unmet or underserved clinical needs and lead to improvements in patient care. This is accomplished by supporting interdisciplinary, cross-departmental

teams as they work to bridge the Valley of Death and move promising medical technologies from the lab to patient use.

The Coulter Foundation was established in 1998 after its namesake, Wallace H. Coulter. Wallace was the founder of Coulter Corporation, a leading global diagnostics company, and a prolific inventor and entrepreneur whose inventions led to significant breakthroughs in science and medicine. In addition to the program at Columbia, the Coulter Foundation has funded over 20 similar programs and initiatives at universities across the country, helping to support education, mentoring, project management, and funding for promising translational projects. By fostering collaboration between biomedical engineers and clinicians while focusing specifically on the commercialization of medical devices and diagnostics and health care information technology, Coulter Foundation programs have served as an effective catalyst in the development and validation of biomedical technologies.

Now entering its sixth year, the Columbia-Coulter program has provided education and in-kind resources to over 95 clinician-engineer-led teams

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at Columbia and direct funding of over $4 million to 35 projects. Of these funded projects, six have spun out of the university into start-ups, raising $9 million to date, and five have been licensed to established companies in industry, with one already FDA approved and in use for both clinical practice and research. In addition, funded projects have secured an additional $49 million in government and foundation grants to further support translational research efforts on these projects within the University.

Having seen the success of Columbia’s biomedical accelerator program, in 2013, Columbia Technology Ventures (CTV), which is Columbia’s technology transfer office, applied for a grant from the New York State Energy Research and Development Authority to establish a proof-of-concept center for clean energy technologies using a comparable model. Columbia partnered with Brookhaven National Lab, Cornell NYC Tech, and Stony Brook University and won one of the three awards. Concurrently, New York University (NYU) partnered with the City University of New York and won another of the awards.

Since Columbia, NYU, and the other institutions are all co-located in downstate New York and have a history of successful collaborations, the institutions formed one joint center called PowerBridgeNY (PBNY). Together, the institutions are able to share resources and responsibilities rather than duplicate or compete for applicants, mentors, judges, sponsors, investors, events, and so forth. As a result, PBNY has $10 million in funding to spend across the six partner institutions over the five-year period.

The goals of PBNY are similar to those of the Columbia-Coulter program. First, the program seeks to move clean energy technologies developed at the universities out of the lab and into the market, ideally as start-ups based in New York State. The program provides translational funding for prototypes as well as an education in entrepreneurship, mentorship, marketing, and other support mechanisms. Another goal is to enhance the clean technology ecosystem in the New York City (NYC) area, primarily by hosting events, aggregating resources, and engaging external organizations and individuals in the program as advisors, mentors, and judges.

Over the last three years, PowerBridgeNY has received nearly a hundred applications from across

the six partner schools, with twenty-two teams ultimately selected as awardees. As a result of the PBNY funding, there have already been sixteen new inventions disclosed to the universities, eleven prototypes completed, eight new start-ups incorporated, and four license agreements signed. Teams have also raised nearly $3 million in additional grant funding, including five Small Business Innovation Research (SBIR) grants, with several more applications in the pipeline.

Additionally, one team from the first cycle recently closed a $9 million Series A investment. To assist the teams, the program has a pool of over a hundred advisors and mentors, as well as a panel of fifteen industry and venture capital judges, who provide feedback during the application process.

The successes of Columbia-Coulter and PBNY in pushing university technologies to the market inspired the concept for Combine, a program launched by the NYC Media Lab. The program offers design and operation support from NYU and CTV and is funded by the New York City Economic Development Corporation and the NYC Mayor’s Office for Media and Entertainment. Combine accelerates NYC university teams working on digital media-related technologies through a program similar to that offered by PBNY and Columbia-Coulter while leveraging the Media Lab’s well-established consortium of 20+ media corporations and nine NYC universities.

Combine pushes teams to find product-market fit, pivot the prototype based on intense customer discovery, regularly interact with the media industry, and construct a “story” for the final pitch. The ultimate goal is to have teams exit the program with a clearly identified business, a skeleton prototype, and significant leads with industry partners and investors.

Combine has completed its first cycle, for which over 60 applications were received from nine NYC universities, with nine applications accepted. During the course of the four-month program, teams conducted more than 1,000 customer interviews combined and regularly interacted with mentors from several media corporations and investment firms. Since the first cohort graduated this past spring, seven teams have been incorporated as start-ups, three were accepted into later-stage privately funded start-up accelerators, and two have already executed their first commercial agreements with industry partners.

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BEST PRACTICES: WHAT MAKES A GOOD PROGRAM? The Columbia programs have a combined nine years of experience running accelerator programs.

Below, we share what we believe to be successful approaches to core elements of the accelerator programs: program oversight, outreach and application development, selection process, educational elements, and awardee process. Naturally, these are not the only ways to approach these steps, nor are they necessarily the best. However, we share them here in the hopes of starting the conversation. Columbia has developed many of the template materials for activities below, which we can share with interested institutions upon request.

Program Oversight Because an accelerator involves much more than simply soliciting applications and awarding funds, when setting up a new initiative, it is essential that dedicated staff be available to oversee the many activities in order to ensure that a quality program is created and nurtured. This includes a focus on the programmatic efforts necessary to attract project applications, the creation or honing of educational programs capable of supporting teams, and the creation of vital external collaborations and partnerships. Because of the many stakeholders involved (applicant teams, awardee teams, mentors, judges, teaching teams, and others), as well as the various phases taking place concurrently (e.g., project applications from new teams, project management of existing teams, educational programs), we found that setting up an accelerator requires, at a minimum, one full-time equivalent (FTE) or more if resources allow. Our Columbia-Coulter medical technology accelerator is run with 1.5 FTEs, while a multi-institutional program such as PowerBridgeNY requires at least 2 FTEs but ideally more. Once a program is fully established and systems are in place, and/or there are multiple accelerators that can share core resources, it could be possible to scale back the number of staff dedicated to any one program, but the initiation of a successful program will require a focused and dedicated staff.

The skill set of the administrative team can vary depending on the goals of the program. In most cases,

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knowledge of the technological area is a plus but not required; it is most important for the administrators to be familiar with technology commercialization and entrepreneurship overall. The full-time administrator needs to be self-organized and comfortable working on a small team where resources are limited.

Many programs may also be able to rely on available resources from within the technology transfer office or elsewhere at the university to fill in gaps as needed.

Outreach and Application Development During the initial years of a new program, it can be challenging to spread the word to potential applicants. Accelerators can increase their outreach and application development through the following: • Engage with technology transfer offices and campus entrepreneurship organizations to advertise the program via newsletters, events, referrals, and direct contact with researchers via presentations at departmental meetings and new faculty orientations.

• Target researchers with relevant grant awards or submitted grant applications by coordinating with the sponsored projects office or sourcing them from publicly available grant agency awardee lists.

• Leverage accelerator alumni teams for referrals to their scientific colleagues.

• Circulate advertising print material, such as flyers and handouts, to relevant departments.

• Host multiple information sessions on campus: ◉ Invite researchers as well as technology transfer officers and entrepreneurship directors to discuss the specifics of the program. ◉ Present a simple, accessible document containing eligibility requirements, important dates, requirements for awardees, and benefits of participating, including specific examples of success if possible.

• Assemble a steering committee of key stakeholders within the university community (research faculty, entrepreneurship educators, technology transfer officers, department chairs and/or deans) to champion the program by helping to shape policies, provide feedback, and spread the word across campus.

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In addition to soliciting team and project applications, it is also important to put thought into who will review applications and serve in mentorship roles to guide and assist teams. Depending on the strength of the local ecosystem, recruiting an initial set of mentors and judges could be challenging. Some ideas for maximizing the chances of finding top-tier advisors include: • Direct outreach to personal contacts and alumni.

The steering committee originally put together to mold the structure of the program will likely have an impressive combined contact list. Accelerator administrators can help jog memories by looking through the LinkedIn contacts of the steering committee to suggest candidates.

• Solicit referrals from existing reviewers and mentors. Even people who decline to serve due to time constraints may be willing to suggest other candidates.

• Solicit referrals from local business plan competitions, incubators, business organizations, chambers of commerce, and entrepreneurship organizations.

• Attend and recruit at local events relevant for the industry.

• Create a ready-made guidebook for mentors and judges that includes what you expect of them, forms required for signature, and commonly asked questions.

Selection Process Applicants move through selection processes that are unique to each program but share common key elements: • External judges are selected from a mix of industry, venture investors, entrepreneurs, and technical experts, who collectively lend credibility and real-world experience to the program. ◉ Judges can be subdivided into approximately equal groups based on expertise, with certain applications assigned to each group. We recommend having enough reviewers so that each judging group gets no more than ten applications assigned to it to limit fatigue. It is also to be expected that some judges will drop out or become unresponsive, so adding in a few more judges than you expect to need may be useful.

• A phased application process for applicant teams with increasing commitment required for each incremental step is used. A multi-stage process provides the chance for teams to get additional feedback and allows judges to get a sense of each team’s “coachability.” For more rigorous programs, stages might include: ◉ Idea Grants: After hearing about the concept through another institution, PBNY instituted an easy but optional element of the application process to encourage more initial submissions, with nominal prizes attached. The so-called “Idea Grant” submission form is short and informal, asking respondents to simply name their team members (no biographies needed), describe their technologies in one paragraph, and describe why they want to apply to the program in another paragraph. If the program is industry-specific, a question about how the technology fits into the industry can be added. Applicants will also have to select a 30-minute time slot to interview with the program managers, which is a time both for the program managers to assess the team and technology as well as for the team to ask questions to determine if the program is a good fit. After the interview, the program managers send a follow-up email to each team indicating whether or not they are encouraged to submit a pre-proposal. Those that ultimately do submit a pre-proposal receive a nominally-valued Visa gift card for their lab’s use. Applicants can only receive one Idea Grant per submission, so reapplications are not permitted. ◉ Pre-Proposal: A short (one- to two-page) written proposal and/or self-made video to provide a basic overview of the proposed project is required. Judges can use this material to assess the inherent feasibility and applicability of a given project, primarily in order to screen out teams early on before requiring too much effort by the team.

Keeping this short can encourage more researchers to apply and minimize effort in case they do not proceed. Videos are also excellent recruiting tools for mentors who might not want to wade through long

UNIVERSITY-BASED TECHNOLOGY ACCELERATORS written applications to get a sense of which teams are of interest. A sample format might include the following sections: the problem or unmet need, market size, team introductions and the envisioned solution. ◉ Full Proposal: A full proposal expands on the aspects first introduced in the pre-proposals and allows teams to update their responses based on feedback from reviewers during the pre-proposal phase. In addition to providing a more in-depth market analysis, teams are asked to discuss competitors, intellectual property position, project budget, and detailed technical milestones. To help teams dive deeper into their initial markets, a business mentor is assigned (see below) to each team. For our energy and biomedical accelerators, given the centrality of intellectual property protection, an external law firm is enlisted to perform cursory IP reviews, which have proved extremely helpful. For a few thousand dollars per team, the IP review can provide judges with an independent, objective lay summary of the core technology, including prior art landscape. ◉ Live Pitch: Well in advance of pitch day, teams are provided with a structured format for their materials, including guidelines on content to be covered, length of each section, time and location of their pitch, and a list of the judges. Teams continue to work with their mentors to finalize their pitches and practice delivery in order to give the best impression to the judges. Sample pitch guidelines might include a general overview of how to draft a compelling story, specific slides to include (e.g., IP, competitive landscape), a list of questions that should be answered, and/or a list of common mistakes to avoid. In addition to these guidelines, program administrators run a pitch practice session (see below) to assist teams in refining their stories and sharpening their presentation skills.

• Communication of scores and comments to the teams. ◉ Allow reviewers two to three weeks to review written proposals. Pre-scores and comments are due from the judges at least two business

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day in advance of the review meeting. ◉ An online review and scoring platform is helpful to efficiently collect and manage judges’ feedback in advance of and during the proposal rounds. FluidReview©, for example, is a commercially-available tool that we have found useful for this task. ◉ During review sessions, the scores of all the teams are pre-loaded and teams ranked from lowest to highest based on that scoring.

Review discussions are focused towards the teams in the middle rather than discussing the consensus on the “winners” and “losers” in depth.

■ An introduction at the beginning of the meeting is important to establish the goals of the program with the judges.

■ Show both average scores as well as the scores of individual judges. To keep vocal judges from monopolizing the conversation, use the individual scores to guide the discussion and draw out quieter judges.

■ Judges can change their individual scores (and thus the overall average score of the team) at any time.

■ At the end, display the final ranking of teams and estimate where the cutoff will be.

Ask the reviewers if they agree with which teams will be moving forward or if they would like to change their scores.

■ Have a dedicated notetaker capture anonymized verbal comments to be given directly to teams along with the de-identified comments from the reviewers themselves. Provide teams with the unfiltered (but aggregated and anonymized) feedback from the reviewers regardless of whether they move forward in the competition or not. This allows teams to see the judges’ perception of their material so that they can improve for future rounds or subsequent submissions.

■ Once awards are made, keep judges updated on their progress. The structure of the updates can vary from formal periodic reviews to informal invitations to pitch or demo days that highlight how awardees are progressing.

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The above list enumerates the common elements that most if not all accelerators and proof-of-concept centers should consider. However, the Columbia programs have built upon the common core elements to suit the needs of each specific program. For example, the processes for the energy and medical technology accelerators are largely similar based on both industries being capital intensive with long development timelines, while the media program was adapted to fit the faster-moving media industry in particular. For example, start-ups in the media space often go through faster development cycles, require less money to launch, and, with typically software-based products, depend more upon speed-to-market than bulletproof patents. Accordingly, the Combine program adopted a single-step application process and solicited brief IP reviews from technology transfer offices rather than full IP reviews from outside counsel.

Educational Elements While many teams initially apply for the promise of funding, they often acknowledge that the educational experiences were actually equally or more valuable. Educational elements, which are extremely customizable in timing and execution, could include any combination of the following: • Methodology: The existing Columbia accelerators offer educational “boot camps” grounded in characterizing an unmet need and assessing how well a proposed solution fits that need. While one uses a variation on the BioDesign program and the other two utilize the Lean LaunchPad approach, the most critical aspect is to select a methodology (ideally an existing approach with a successful track record), get trained in how to teach it, customize a curriculum for one’s specific needs, and then modify it for future cohorts as needed. Assigning readings and videos (e.g., customer discovery interview examples) can reinforce teachings. Both BioDesign and Lean LaunchPad have extensive and modular resources available online for teachers and students, the use of which can avoid huge amounts of work and expense when launching an accelerator.

• Group Learning and Feedback: As much as possible, there is an emphasis on and effort towards in-person sessions for peer-to-peer

learning. Teams should be required to speak with potential customers in order to assess the market problem and determine how effective their technology is as a solution, which allows teams to pivot their solutions in response to market feedback. Presenting live each session forces teams to dedicate the time required to complete assignments and learn the methodology. In-person sessions also allow teams to meet each other, fostering a sense of community among participants.

Even for teams whose proposals do not move forward, this kind of educational experience can be leveraged for future entrepreneurial pursuits.

• Mentors: Assigning business mentors to work closely with teams for an extended period of time can fill basic business knowledge gaps, inject domain expertise, provide an impartial observer, and potentially open doors to target industries.

A “dating period” during the pairing process allows teams and mentors to gain familiarity with each other before committing to work together throughout the program. Program administrators ensure there is an onboarding and check-in process for the mentors. Mentors are given an overview of the methodology and tasks teams are working on and are invited to educational events.

Administrators periodically meet with both teams and mentors to ensure the relationship is working and that they are collaborating on a regular basis. Feedback can be formally or informally collected from the teams to ensure that the best mentors are invited back for future rounds.

• Pitch Prep Event: Presenting a business pitch (vs. giving a scientific presentation) will most likely be new for most teams, so an event to acclimate them to the format and to prepare them for potential questions can dramatically improve their final products. Some programs choose to assemble a volunteer panel of mock judges consisting of mentors, investors, and other local experts in the field. Other programs hire professional pitch and presentation coaches for a few days to work with the teams on content as well as presentation style. The Columbia programs generally allocate a significant amount of time to teams for practicing pitches, including receiving iterative feedback from instructors, mentors, and judges.

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• Other Educational and Networking Events: The chosen educational methodology may not include important elements in start-up creation, especially targeted content relevant to an industry vertical. Accordingly, the program managers host a significant number of one-off lectures or office hours with experts on specific topics relevant to the field. These include lectures on intellectual property, company formation, SBIR/Small Business Technology Transfer (STTR) funding, selling into industryspecific channels, understanding relevant regulatory issues, and immigration and visa challenges. To help teams network with industry professionals, periodic showcases and demo days are also encouraged. These activities are often shared across the accelerator programs and/or university ecosystem since they are applicable to many kinds of ventures.

in addition to customer discovery, there are many details of the health care system, as well as regulatory and reimbursement processes, that teams need to understand before they move forward. This means that more time is spent on these issues, hence a longer course. On the other hand, given Combine’s focus on media technologies, the customer discovery process is in many cases far more critical compared to further technical development. Accordingly, all of the instruction and training around customer discovery need to happen up front before the bulk of the award is given.

The requirements for commercializing a technology within a given industry drive the timing and structure of the curriculum. As an example of how the above elements can be customized, all three of Columbia’s accelerators host educational sessions, but each takes a different approach to how these sessions are implemented. PowerBridgeNY’s program requires a two-day session for applicants, a one-day program for awardees, and monthly assignments during the award period. In contrast, the Columbia-Coulter medical technology accelerator hosts an optional, but highly recommended, 12-week course for applicants, and Combine hosts a required 10-week boot camp for awardees.

This diversity of approaches derives from the goals and operating conditions of each program.

For example, clean technology projects are typically technically involved, have long development timelines, and require more advanced prototypes prior to in-depth customer outreach. Hence, for PBNY, most of the customer discovery efforts that would normally be front-loaded are completed after the award in parallel to when teams are doing their prototype development. The abbreviated two-day boot camp during the application process largely serves as a teaser to engage the teams in thinking about the marketplace and to test how receptive they are to coaching and feedback. In medical technology,

• Award Setup: Since teams may receive feedback from reviewers at each stage, a team may need to change the milestones and/or budget from those presented in their initial proposal. Reviewers may require changes that teams must agree to in order to get funding. Scheduling a post-award notification meeting to discuss the general terms and conditions of the award, the specific details of the milestones, associated deliverables, and approved budget items allows program managers to set expectations and ensure everyone is on the same page.

• Tranches: In most cases, funding is released in tranches based on both business and technical milestones, not solely the progression of time or the incurrence of cost. Doing so allows program administrators to retain enough influence to keep teams on track and ensure that award funding is used to advance the technology towards the marketplace. The balance of business and technical milestones helps to keep teams thinking about their end goal of university exit versus solely building a prototype. Business milestones can include customer discovery, IP review, market assessment, competitive landscape analysis, business plan creation, incorporating a company, creating a cap table, executing an IP agreement, attending an industry conference, and creating

Post-Award Process The final format of the post-award process will depend heavily on the particular industry, amount of funding, availability of the program managers, and other factors. Accelerators could include any combination of the following components:

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marketing materials. While technical milestones and deliverables may change as the project progresses, we recommend that the customer discovery and business milestones be firmly maintained.

• Check-Ins: Having teams report back regularly on progress allows program managers to intervene early if there are problems. During these in-person meetings, which can happen weekly, monthly, or quarterly, teams are asked to get out of their comfort zone and discuss their business progress in addition to technical progress. The administrators reserve time at the end of the meeting for a quick overview of the technical progress or to schedule a separate meeting to do a lab tour. Administrators send out a written summary of what was discussed as well as the clearly articulated agreed-upon business and technical next steps to be completed prior to the next meeting. These check-ins are meant to be an opportunity for two-way communication, so inquiring about what teams are struggling with and how the program could be helpful can lead to unexpected requests and the opportunity for the program to be even more impactful. Always schedule the next meeting before adjourning, and always begin each meeting with a review of the action items from the prior ones.

• Reports: As a precondition to receiving further tranches, awardees are required to submit quarterly reports based on a provided template to collect important metrics both during the awardee process and up to two years after graduation (if feasible). Having metrics reported regularly and in a common format allows program administrators to easily aggregate the numbers and update marketing materials and/or reports to funders as appropriate. The chosen metrics may change depending on the program, but some key metrics include additional grant funding received, number of faculty and students involved in the project, number of commercial prototypes developed, number of in-field tests completed, number of start-ups incorporated, number of FTEs, number of license agreements signed, and total number of awardees and graduates. Traditional economic development

metrics such as number of jobs created and revenue earned can be tracked as well, but, depending on the industry vertical, these metrics are likely to take quite a few years to become significant.

• Subsidized Resources: If a program has sufficient funding, there are supplementary resources that teams have found particularly useful. For instance, we have found that external SBIR/STTR consultants have been very helpful to teams, as SBIR grants are often the next funding sources for the emerging start-ups. Teams might also need specialized consultants with experience in clinical trials or insurance reimbursement. The accelerator may determine that a few thousand dollars spent on early intervention can mean the difference between success and failure. For other resources that are not team-specific, consider hosting group workshops to lower per-team costs. For instance, we provide joint group sessions on pitch training for all of our accelerators. It may be possible to secure free lectures or sponsorship funding from local law firms or other service providers to subsidize expenses.

Furthermore, there may be other organizations in the entrepreneurship ecosystem that offer valuable training classes.

The question of project funding is an important one. How much validation funding is required, and is it really necessary? While funding attracts teams, we have found that awards do not need to be huge nor do full awards have to be given to every team.

For example, Combine found that a single lump-sum $25,000 award to be spent primarily on customer discovery and “minimum viable product” development is enough to attract quality applicants in the media space given that the majority of the envisioned products are software-based. On the other hand, given Columbia-Coulter’s focus on medical devices, funding is tranched, with amounts ranging from $5,000 to $180,000 per team based on need. In some cases, teams are awarded less than their initial ask if it is determined that they can progress with less than their full proposed budget.

CURRENT CHALLENGES While the Columbia programs have done well thus far, we face challenges that others are likely facing.

UNIVERSITY-BASED TECHNOLOGY ACCELERATORS In this section, we outline a few of these challenges as well as some potential solutions we have tried. We look forward to hearing about how other programs have addressed these challenges in the ongoing conversation that we hope this paper and the creation of the public repository of resources will initiate.

Metrics Funders of translational accelerator programs may have varying objectives and metrics. For example, our medical technology program, funded by a private foundation, is most interested in patient impact through successful product commercialization. The PowerBridgeNY and Combine programs, which are funded all or in part by governmental agencies, have significant economic development objectives, with metrics that include job creation, company revenue, products sales, etc. However, given the early-stage nature of the technology, the typical outcome metrics for any program will likely be negligible for several years regardless of how well the program is set up.

There will also be questions regarding whether teams would have become successful even without the intervention. Conversely, even technologies that do not advance in a particular program can lead to future successes outside the program, as a team may learn valuable lessons that will help make their next venture successful. In fact, an underlying mentality of the educational curricula is to accelerate teams to a potential failure or pivot point so that they can instead allocate their time, energy, and resources to future projects. How can metrics capture this?

The Columbia programs have all wrestled with the above problems in deciding what metrics to track and report. Once accelerator graduates have been operating their companies for three or more years, the quantitative business metrics may become more substantial, thus allowing accelerators to better demonstrate their value to potential sponsors, applicants, mentors, and other interested parties. However, quantitative metrics still cannot adequately capture the true impact of the programs.

While moving current technologies out of the lab is an immediate goal, we also seek to affect cultural change within the university to encourage entrepreneurial efforts and increase long-term commercialization figures. The Columbia programs provide connections and training to individual

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student and faculty entrepreneurs, which may end up helping them on their next ventures. Culture change is difficult to measure, but anecdotal evidence from participating teams about how the program has changed their grant application approaches, how they work with their advisees, and how they behave in job interviews can help demonstrate a program’s impact.

Some programs do before-and-after videos of each team, for instance, to emphasize the team’s growth during the program. However, programs would also be wise to not start solely believing their own storytelling at the expense of continuous and rigorous self-analysis and improvement.

Sustainability Our current accelerator programs have been awarded multi-year grants, with the expectation that the programs will secure additional funding to continue beyond the contract period. This situation is fairly common, as the governmental or philanthropic sources that typically fund such programs often have finite funding timelines and view their resources as “seed corn” for larger third-party investments. The hypothesis is that, after several years, these programs will demonstrate their effectiveness and attract investments externally and/or from resources within the universities.

Unfortunately, securing follow-on funding is often extremely challenging regardless of the industry area or program success rates. The universities in which these programs are housed have many competing demands for each funding dollar, with commercial translational accelerators often being lower on the list compared to basic research, student financial aid, and classrooms. While the participating industry and venture partners may benefit from the increased and improved deal flow, their own financial structures may limit their ability to significantly fund not-forprofit programs.

As the initial funding source wanes, programs may consider limiting the number of awards made each year or reducing the amount of each award in order to stretch the funding. Another option is for the program to continue to offer the educational elements (boot camps, mentoring, etc.) and eliminate the large proof-of-concept awards altogether. As mentioned earlier, graduates of the program often report that, while the funding is helpful, the education is far more

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valuable, as the skills and knowledge they learn allows them to succeed on future projects as well. With this model, the university would still be able to generate positive press for supporting entrepreneurship and foster cultural change in the academic community toward a focus on commercialization. Nonetheless, removing the project funding would likely have a severe impact on application volume and engaged participation by busy faculty and students.

Awardee Team Leadership Even with educational offerings and mentorship, accelerator teams often struggle due to a lack of full-time business leadership with relevant industry experience. While graduate students theoretically can make the transition into the CEO role, they also have STEM degrees from top universities, leading them to frequently get recruited by the very companies that they meet through the accelerator. While this is a good outcome from an ecosystem perspective, it can leave the technology stranded without a path to market.

This is not evidence that the programs in their current incarnations are ineffective. There have been many technologies that have exited the university and are being sold on the market today, including some by start-ups led by former graduate students.

However, with additional team-building support, there would likely be even more success stories.

To address this, the Columbia programs try to pair serial entrepreneurs and/or MBA students with participating teams. MBA students can be a great resource while they are in school, but, with their busy schedules and lucrative internships and job offers, it can be difficult to secure enough of their time.

Experienced serial entrepreneurs are clearly ideal but can be hard to find depending on your region. So far, our programs have not found a perfect solution to the CEO challenge.

Leveraging Scale As mentioned, one of the benefits of running concurrent accelerator programs in multiple industries is that each program can learn from the experiences of the others. Now that our programs are relatively stable, we are exploring ways to gain further efficiencies from scale across the programs. For instance, the

program managers spend a significant amount of time doing fairly routine, repetitive administrative duties, such as tracking and communicating with mentors, maintaining a web and social media presence, hiring external service providers to support the teams, managing sponsored project paperwork, and collating metrics for sponsors (Figure 2). At Columbia, we are exploring the creation of a shared core facility (the Columbia Accelator Network) to provide many of these administrative functions across the multiple accelerators while retaining industry-experienced program managers within each separate program.

Our hope is that the accelerator core will allow for greater efficiency and effectiveness; coordinated scheduling to leverage physical presence of judges, advisors, and vendors; and increased branding for the university. We also hope that the core facility will allow us to more quickly and effectively launch new accelerators in more industries (such as Columbia’s new therapeutics accelerator) when such opportunities arise. Any input from our peers would be appreciated.

CONCLUSIONS: ADVICE FOR THOSE SEEKING TO START THEIR OWN PROGRAMS Collectively, our medical technology, clean technology, and media technology accelerator programs have discovered a core model and evolved it to fit their needs, resulting in more university-based technology being developed and ultimately commercialized.

Over the past five years, participants of the three programs have earned $51.2 million in grant funding, including SBIR/STTRs, and $18.2 million in venture investment, with two of those companies already generating revenue. In addition to the ten IP agreements signed with the university spin-outs, five more technologies have been licensed to industry.

We conclude that, by employing a few key lessons, a viable commercialization program that includes entrepreneurship training in tandem with project support has great potential to accelerate inventions to market and can be established for various technology sectors.

1) Use other programs as templates and customize where needed to reduce start-up time and cost.

Universities looking to create a program would not need to copy the exact models presented in this article.

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Figure 2. Common elements, synergies, and support.

Core pieces, such as mentorship and educational elements focused on market validation, can and should be adapted as needed. Physical documentation, such as descriptions of the benefits, applications, review forms, terms and conditions, and even outreach emails, can be borrowed from similar organizations and tweaked as well. To that end, Columbia is happy to share our forms and templates upon request.

Starting with the backbone of a model and templates for many of the materials can dramatically shorten the timeline to launch. For example, following the core elements of PowerBridgeNY and Columbia-Coulter and adapting boot camp materials from classes at a local university, Combine was able to go from ideation to launch in six months. The Columbia programs recognize that the access to high-caliber researchers, flexibility of funding sources, and access to industry representatives and mentors through the NYC area could be considered unique advantages that

have helped the Columbia accelerators launch and grow quickly. However, even in smaller cities, tapping into the local ecosystem is a key component in building any successful commercialization program.

2) Results will not be immediately or objectively measurable; team testimonials can help.

The timeline to scaling up and thus creating jobs for early-stage start-ups is long, which hinders the ability of an accelerator or proof-of-concept center to convey its importance in terms of near-term economic development. Many of the immediate successes are intangibles, such as a shift in perspective or even learning from a failed project. Quantifiable metrics will improve with time, while intangible metrics may forever remain unquantifiable. However, testimonials from participating teams can elucidate the true impact of the program as well as opportunities for improvement. Checking the pulse of teams

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through surveys or openly soliciting feedback and endorsements can supplement quantitative metrics.

3) Project funding is often largely a carrot, while the real value lies in the education and other resources provided.

While funding is an incentive for teams to apply, programs do not necessarily need to offer financial awards in order to deliver value. Providing funding for technology de-risking is, of course, ideal.

However, for programs that do not have a budget for awards, it is still possible to remove a number of commercialization barriers through low-cost education programs, the creation of mentor networks, and connections to existing local resources. Instead of funds, a program could highlight the opportunity to have an increased chance of receiving funds from other programs, such as SBIR/STTR, since teams will better understand their markets and initial target customers. Thus, even without funding, programs could still generate many of the benefits, such as support for entrepreneurship, press for the university, increased collaboration internally and externally, and more. Applicant numbers may be low to start, but as faculty come through the program, they will hopefully see the benefits and spread the word to their colleagues.

4) A supportive ecosystem for start-ups is equally important as launching the start-ups.

Start-ups do not develop in a vacuum. In addition to funding and education, they need connections to others within the local and national start-up and industry ecosystems in order to smoothly transition

out of the accelerator. Universities and other local institutions have ample resources to help teams get funding, meet mentors and industry experts, apply to incubators, and more. However, these resources are often in silos that can be challenging to navigate.

Accelerator programs can work to bring together previously unconnected resources and foster collaboration within and outside of the university. Engaging internal resources first and then combining them with external resources makes the cooperating programs collectively stronger and can yield more satisfied participants. Collaborating rather than duplicating or competing also reduces the administrative burden, freeing up valuable time and funding to build even more beneficial relationships.

5) Challenges always emerge. Look to other programs to exchange solutions and discuss how to collectively be more effective.

The Columbia programs have not solved all of their challenges, but they have looked to each other as well as to other models for ideas and feedback. To make information sharing easier and to facilitate conversations around common problems and solutions, we would like to create a network of similar programs that can share materials, experiences, lessons learned, and best practices in order to create a broad ecosystem capable of better supporting and catalyzing the movement of university technologies from the lab to the market for the benefit of society. We invite you to continue the conversation by emailing us at techventures@columbia.edu with “Accelerators� in the subject line.

Technology and Innovation, Vol. 19, pp. 363-379, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.363 www.technologyandinnovation.org

ADAPTING THE INDUSTRIAL STAGE-GATE® PROCESS TO CREATE A NOVEL MASTER’S DEGREE INNOVATION CURRICULUM Angelika Domschke1 and John A. Blaho2 2

1 Domschke Consulting, LLC, Duluth, GA, USA NYC Regional Innovation Node, New York, NY, USA

This article describes the creation of a novel product-driven master’s degree curriculum in translational medicine based on the industrial Stage-Gate® process. Stage-Gate is an essential tool used by top industrial companies to successfully manage complex development processes for products like medical devices and drugs. Intimate knowledge of this tool is key in the translation of a brilliant concept to a successful product. Currently, Stage-Gate is predominantly taught to high-level executive leadership personnel or in business-related graduate programs.

Unfortunately, this “top-down approach” does not leverage the full workforce that is involved in the process. A skilled workforce on all levels, including graduate-level technical experts, is desired by industry to reduce costly ramp-up resources and to boost the attrition rate of successful new products.

We adapted the Stage-Gate process to a new and exceptionally visionary master’s degree program in translational medicine. A vertically integrated strategy was utilized to implement Stage-Gate. Industry expert lecturers were assigned to teach Stage-Gate in the context of small and large company environments. The Stage-Gate process itself was integrated into the curriculum schedule to allow continued hands-on practice from a company perspective. Courses were aligned and supplemented to adequately deepen key aspects of the Stage-Gate tool and seamlessly integrate the multidisciplinary curriculum that combines comprehensive core competency in medicine, engineering, and business. Finally, students were required to undergo a formal Stage-Gate review at the completion of each Stage-Gate step. The results illustrate the effectiveness of this adaptation to teach the Stage-Gate tool in a pilot cohort.

Key words: Novel master’s degree program curriculum; Translational medicine; Stage-Gate® process; Entrepreneurship; Product–driven; Industry-driven

INTRODUCTION When considering the application of the biomedical industrial Stage-Gate Process® (1) to a graduate-level educational situation, it is important to take a moment to reflect on a healthy trend that is emerging in new graduate programs, particularly those in the life sciences and biomedical engineering.

This new movement promotes the close alignment

of education and business in preparing students for seamless integration into business careers. In life science, this trend is in response to the critical need for increasing the rate of successful medical products, which falls significantly behind the considerably higher industrial and governmental research spending (2). A primary driver of this incongruity is believed to be the lack of a skilled workforce (3) in

_____________________ Accepted April 15, 2017.

Address correspondence to John A. Blaho, Ph.D., NYC Regional Innovation Node, 555 West 57th Street, Suite 1407, New York, NY 10019, USA. Tel: +1 (646) 664-3578. E-mail: jblaho@cuny.edu or Angelika Domschke, Ph.D., 3379 Ennfield Way, Duluth, GA 30096, USA. E-mail: Angel.Domschke@yahoo.com

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small university start-ups and large industrial companies alike.

University programs, particularly conventional master’s degree programs in translational medicine or science, typically provide an excellent education in technologies. There remains, however, a gap between the acquired education of students and their true workplace readiness as it pertains to education in the practical knowledge of the multidisciplinary product development process, key skill sets, standards, and norms needed to manage complex processes while mastering translational hurdles. This gap often hampers the successful development of brilliant scientific discoveries that incubate within university start-up hubs.

A similar situation exists in industry, where a skilled workforce that is capable of mastering complex product development processes is key. Medical products are generally highly technically advanced; therefore, expert industrial engineers and scientists often carry much of the responsibility for the design and development of these products. In many cases, these technical experts are recruited at the graduate level to ensure a competitive edge in the rapid-growing technical environment. This leads to costly ramp-up periods and the high risk of incorrect decisions, which may impede the successful development of a bright idea through the complex hurdles to the final product.

A growing number of university programs are responding to this demand by offering multidisciplinary course materials that relate to the early stages of the product development process. This trend, however, comes with a unique challenge of its own: the efficient linkage and management of complex course materials and high-quality teaching standards. An example of such a multidisciplinary Master of Translational Medicine (MTM) program is the joint program between University of California, San Francisco, and University of California, Berkeley, which was funded by a gift from Andrew S. Grove (http://uctranslationalmedicine.org). Similarly, Grove approached the leadership of the City College of New York (CCNY) of the City University of New York (CUNY) to develop another innovative MTM training program focusing on industrial key skill sets and best practices as well as entrepreneurship. The CCNY executive team, under the lead of the dean

of the Grove School of Engineering, Professor Gilda Barabino, recruited author Domschke as the CCNY MTM industrial consultant. Domschke served as the program’s acting director to help with design and implementation, with a specific focus on industrial best practices and tools such as Stage-Gate. Author Blaho developed the program’s entrepreneurship components. Together, the authors collaborated on the creation of the novel industrial Stage-Gate- and entrepreneurship-driven aspects of this new MTM program.

The new CCNY MTM separates itself from conventional programs in translational medicine or science through its far-reaching goal of seamlessly fusing contemporary translational medicine with core knowledge in all of the multiple disciplines that play key roles in the successful development of medical products. For example, the multidisciplinary CCNY MTM program comprises biomedical engineering capstone projects, business management with a particular focus on entrepreneurship, finance, regulations and standards, intellectual property, and quality assurance. This program aims to establish a new standard, one that facilitates the translation of brilliant ideas to successful medical products.

METHODS The Stage-Gate Process History Stage-Gate is an important management tool that provides the roadmap for conceiving, developing, and launching new products. The general concept is believed to have its origin back in the 1940s (4).

It has since been refined by many well-known pioneering institutions and companies, such as the National Aeronautics and Space Administration, ExxonMobil, DuPont, Royal Bank, and Procter & Gamble (5). According to an AC Nielsen study in 2010 (6), a rigorous stage-and-gate system increases company sales performance from new products by a factor of 6.5 times. By the year 2000, almost 75% of product developers in the U.S. were using this stage-and-gate system (6). In recent years, thought leaders such as Robert G. Cooper have taken on further refinements of this process to meet the needs of increasingly complex product processes (6). Particular emphasis is placed on the quality of the ideas that

ADAPTING STAGE-GATE TO MTM CURRICULUM enter the Stage-Gate system. Elements such as voice of the customer (VOC) research, spiral or iterative development, sharp definition of the value proposition, and open innovation or design thinking have been integrated into the modern Stage-Gate systems (7).

The Stage-Gate process is of great value in particular for the medical industry (8). The medical product development process has become progressively complex in recent years. The arrival of new technology concepts, stricter regulatory requirements, and the ever-increasing importance of reimbursement decisions for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes.

Study results suggest that Stage-Gate processes are the predominant development model used in the medical device industry (8).

Application of the Stage-Gate Process When applying Stage-Gate, complex medical product development is viewed as a process, which is separated into small well-defined and manageable

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steps called “stages.� The process begins with a discovery stage and ends with the post-launch review.

Typical stages in this process are as follows: 0) Discovery/ideation: Dedicated to the project initiation and idea screening 1) Scoping: Opportunity and risk analysis 2) Feasibility: Technical feasibility and business case 3) Full development: Design verification and validation 4) Scale-up and launch preparation: Final validation to product launch preparation 5) Launch: Product launch and post-launch assessment Each stage is designed to gather information to reduce key project uncertainties and risks. Each stage typically costs more than the preceding one.

The process is one of incremental commitments and a series of increasing investments. But, with each stage and step-increase in project cost, the unknowns and uncertainties are driven down so that risk is effectively managed (1). A cross-functional and multidisciplinary team is assigned to each stage, resulting in a highly co-operative process (Figure 1).

CROSS-FUNCTIONAL TEAMS TYPICALLY INVOLVED IN THE PRODUCT DEVELOPMENT PROCESS Discovery /Ideation

DISCOVERY Small team of Pioneers

STAGE 1

STAGE 2

STAGE 3

STAGE 4

STAGE 5

Feasibility Gate Gate Gate Gate Scale-up Gate Full & 1 2 3 4 5 Scoping Launch & Launch Business Development Prep.

Case

STAGE 1 Medical Engineering Legal Regulatory

STAGE 2 Medical Engineering Legal Regulatory Quality Finance Business Management

Figure 1. Schematic reprsentation of the Stage-Gate process.

STAGE 3 R&D Legal Regulatory Quality Finance Business Management Sales Marketing Production Sourcing

STAGE 4 R&D Production Sourcing Legal Regulatory Quality Finance Business Management Sales Marketing

STAGE 5 Production Sourcing Legal Regulatory Quality Business Management Sales Marketing

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In the Stage-Gate process, each stage is followed by a decision gate, at which point activities and information available at the time of the previous stage (such as the project progress, business case, risk analysis, etc.) are presented by the multidisciplinary team. The carefully compiled information (deliverable) is reviewed by the stakeholders and executive committee of the company (the gatekeepers) in specifically assigned board meetings (gate meetings). The gatekeepers may arrive at the decision to move the project forward and invest in the next defined stage (go decision). Alternatively, if the results of the previous stage are not favorable, the gatekeepers may decide to redo parts of the previous stage or stop the program completely (kill or no go decision).

Curriculum Adaptation of Stage-Gate The Stage-Gate tool for the CCNY MTM program was designed to closely resemble the Stage-Gate process of a biomedical company, as it applies in the early product development stages of a medical device.

It was implemented into the curriculum according to the following strategies: i) introduction to StageGate, ii) integration of the Stage-Gate process into the curriculum schedule, and iii) alignment and supplementation of the course material. i) Introduction to Stage-Gate: In preparation for the launch of the MTM program, student input sessions were held with the intention to round out the lecture content with topics that are of particular interest for the trainees. The feedback indicated a high interest in several topics related to industrial aspects.

Students were most interested in learning the most up-to-date information about industry tools applied in the process of moving an idea toward a successful product and which processes are most relevant to start-ups and top companies alike. Students also wanted to gain an understanding of specific company needs related to their product development processes in the context of different sized company environments (small, midsize, large) and company life-cycles. Finally, students wanted insight into the work environments of different sized companies (e.g., the responsibilities of a chief technology officer (CTO) in a start-up company versus a top 500 company, etc.)

To address student needs, sector experts were recruited as lecturers and guest lecturers to provide effective introductions to and answer questions about these topics of high interest within the first semesters. A set of special lectures and individual student mentor sessions were created to build on the broad expertise of Domschke in bringing a product to market in different sized company environments.

Preceding the Engineering Entrepreneurship course, Blaho created an introductory lecture with the purpose of familiarizing students with the terms of the business canvas model that would be the central aspect of their later course work. Finally, prior to the actual MTM program initiation, a kick-off event was held to introduce this new CCNY program and its unique product-driven approach to students and university faculty. The following brief summaries describe examples of the lecture topics and content covered in the first semesters of the curriculum schedule to introduce the Stage-Gate process. • Integrating Industry Tools and Expertise: Part of the kickoff program included an introductory lecture from Domschke on her role as acting director and industry consultant. This lecture gave an overview of the program concept along with an introduction to Stage-Gate and its integration into the curriculum schedule. Finally, an overview of program curriculum was given. • Building the Stage-Gate Tool for MTM: This second lecture by Domschke reviewed the typical stage activities and gates deliverables in the development of a medical product, including an overview of the simulated stages and gates as they pertain to the MTM Program, a review of required student assignments (i.e., deliverables) for the first gate meeting, and an overview of the flow of the first gate meeting and its required presentations. • Strategic Focus in Different Sized Company Environments: This lecture, taught by Domschke, introduced prevalent company cultures, organizational life cycles, and the relationship between company size and strategic focus. Large, midsize, and small company environments, as well as particular dynamics of start-up environments, were investigated in case studies. The process of

ADAPTING STAGE-GATE TO MTM CURRICULUM company growth and the different needs in each growth phase, which create different work environments and career opportunities, were discussed.

Additional topics included product life cycles and the creation of short-, mid-, and long-term product portfolios.

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tion of customer needs (techniques and methods), VOC in the Stage-Gate process, and the anatomy of a concept.

• Navigating the Complex Product Development Process: The Stage-Gate Paradigm: Creel’s second lecture covered organizational considerations, investment decisions, the Stage-Gate process, the “front end” of innovation, and evolved Stage-Gate.

• Individual Student Mentor Sessions: Domschke’s one-on-one student mentor sessions were held each month throughout the program to help students explore their own talents and true interests. In these sessions, students defined their preferred work environments and company fits so that they might take charge of their own career choices and plan the next steps toward the realization of their goals. Homework was assigned during each session, including the creation of a career canvas that adopted the principles of the career help book What Color Is Your Parachute by Richard Boles (9). The canvas categories included a mission statement, favorite knowledge, transferable skills, working conditions, responsibilities, people, and geography.

ii) Integration of the Stage Gate process into the curriculum schedule: The Stage-Gate process itself was integrated into the curriculum schedule with the objective of fostering a deeper understanding from a business or company perspective, offering hands-on working knowledge of the actual product development process, and providing ample training in industry-relevant multidisciplinary communication skills. An effective integration of stages and gates into the curriculum was achieved by having Stages 1 to 3 coincide with the three semesters of the program, with each semester ending with a gate meeting (Figure 2).

• Getting to Market: It Takes People, Process, and the Promise of Profits: Two lectures were given by Kip Creel on the Stage-Gate process.

Creel is the founder and president of Stand Point, an Atlanta-based agency specializing in VOC studies that trains top-200 companies in the development of a successful Stage-Gate process. The “Getting to Market” lecture covered cognitive styles, innovation team interactions, sources of ideas, identification and valida-

• Creation of a Fictional Company: As an educational paradigm, a fictional company was created as part of the Stage-Gate integration. The capstone engineering project served as core technology for the fictional company. The capstone project itself was conceived in close collaboration with biomedical sponsors. In the case of the first cohort, students were to develop a technically advanced device to measure joint movement. The fictional company for the first cohort

INTEGRATED STAGE-GATE PROCESS SEMESTER 1 STAGE 1 Scoping

Gate 2

SEMESTER 2

SEMESTER 3

STAGE 2

STAGE 3

Feasibility & Business Case

Gate 3

Development

Figure 2. Schematic showing the integration of the Stage-Gate process into the curriculum schedule.

Gate 4

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was named ELBONIX and was theoretically envisioned to rank amongst the top 200 biggest companies. This fictional company setting offered students the opportunity to work with the Stage-Gate tool in the role of junior leadership who presented at company board meetings (gate meetings). College faculty and industry partners assumed the roles of multidisciplinary stakeholders (gatekeepers) of the company. Students were encouraged to take ownership of and lead the gate meetings. They presented and discussed gate deliverables relevant to their fictional company. Emphasis was placed on the presentation of knowledge gained during their analyses from a business perspective and their ability to link together the multidisciplinary MTM course material from a business management viewpoint. iii) Alignment and supplementation of courses: The objective of this final phase of the program was to create a transparent structure for the complex

multidisciplinary course material in the context of a real-life, early-stage medical product development process. Stage-Gate provides a clear structure defined by the stage activities and gate deliverables assigned to each discipline, which form the basis for the communication and discussions in subsequent gate meetings.

The typical disciplines in the early stages (1 and 2), stage activities, and gate deliverables of a medical device product are shown in Figure 3.

The main difference between Stages 1 and 2 is that in Stage 1, the deliverables are preliminary estimates, whereas, in Stage 2, those estimates are replaced with evidence-based final assessments. The disciplines of quality, business management, and finance are of particular interest in Stage 2. In recent years, quality and business management with an emphasis on entrepreneurship have been progressively moved into earlier stages in order to proactively comply with regulatory demands and improve risk management.

The alignment of the curriculum with the stages of the medical device development process was

THE MEDICAL DEVICE PRODUCT DEVELOPMENT PROCESS TYPICAL STAGE 1 AND 2 DISCIPLINES

ACTIVITIES

DELIVERABLES

MEDICAL RESEARCH

Define strategic focus

Disease analysis Gap analysis Problem / need statement

BIOMEDICAL ENGINEERING

Assess technical feasibility

Product concept & Product success criteria

LEGAL (IP)

Assess IP strategy

IP / Patent strategy

REGULATORY

Assess regulatory strategy

Regulatory plan

QUALITY

Implement Quality plan

Quality management

Business Management / Entrepreneurship

Assess customer insights Create business model

Customer insights Business Case

FINANCE

Assess financial justifiability

Cost / Value analysis

Program Management

Cross-functional communication Pull it all together

Solid plan for the next stages

Figure 3. Table showing the activities and deliverables of Stages 1 and 2.

ADAPTING STAGE-GATE TO MTM CURRICULUM introduced in a lecture entitled “Building the StageGate Tool for MTM Fictional Company: ELBONIX.” This lecture included a review of the MTM stage activities and gate deliverables as well as the gate meeting process. In preparation for the first and second gate meetings, students received guidelines for the preparation of the gate deliverables as well as templates for the slide presentation.

Figure 4 depicts the alignment of these disciplines with the MTM program curriculum. Stage 3 of the medical device product development process relates to the full development. The following two key aspects of Stage 3 are part of the Semester 3 curriculum.

• Prototype Development: The goal in Stage 3 is prototype development and ultimately testing with patients following an institutional review board approved protocol. However, the successful design of a concept does not only depend on technical expertise. Other factors, such as knowledge of the patent landscape surrounding

the technology, are equally important to assure intellectual property (IP) rights and financial success for the company. Thus, securing IP rights and patent filing were also goals. Technical experts, capable of exploring IP landscape and design and with smart patenting know-how, are a great asset. Expert guest lecturers were recruited to teach this important skill set.

• Intellectual Property, Regulations, and Quality Assurance: This course is of particular interest from an industry perspective because it teaches the knowledge to design and navigate the most effective path. It proactively addresses translational hurdles that make a significant difference in the development time (years) and determines if the process will become a success or failure.

Domschke created and assisted in the execution of this course, leveraging her extensive and nationally recognized expertise in industry research leadership and medical product devel-

THE MEDICAL DEVICE PRODUCT DEVELOPMENT PROCESS CCNY’S MTM CURRICULUM OVERVIEW ALIGNED WITH THE TYPICAL STAGES 1 AND 2 OF A MEDICAL DEVICE DEVELOPMENT PROCESS

DISCIPLINES MEDICAL RESEARCH

BIOMEDICAL ENGINEERING

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COURSE CONTENT • Translational Challenges in Medicine • Translational Challenges in Diagnostics, Devices, and Therapeutics • Biomed. Ethics • Transl. Research Design Prototype engineering of medical device (in collaboration with med. Institutions)

DELIVERABLES Strategic focus: Disease analysis Gap analysis Problem / need statement Product concept & Product success criteria

LEGAL (IP)

• Intellectual property / Patenting basics • Smart patent search / Smart Patenting

IP / Patent strategy

REGULATORY

• Regulatory basics (FDA, international) • Device & drug regulations and filing

Regulatory plan

QUALITY

• Quality systems & regulations

Quality management

Business Management / Entrepreneurship

• Entrepreneurship & business leadership

Customer insights Business Case

FINANCE

• Cost analysis, the business of translation

Cost / Value analysis

Figure 4. Table showing the alignment of Stage-Gate disciplines with the MTM curriculum.

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DOMSCHKE & BLAHO opment from conception to launch. The industry subject matter expert Dr. Abhishek Datta, who is employed as CTO at a medical device start-up company, was recruited as course director. ◉ Regulatory topics covered were the latest regulatory developments presented at the 2015 conference Food and Drug Administration (FDA) Small Business Regulatory Education for Industry (REdI). These topics included the FDA and its regulations, establishment registration, medical device listing, medical device tracking, drug establishment registration, drug listings, and an overview of basic regulatory requirements. Details of the FDA approval process were given, including device classification, predicate devices, the de novo classification process, humanitarian device exemption, product codes and regulation numbers, drug regulation, orange book, types of drug filings, drug product exclusivity, and Hatch-Waxman regulations. Regulatory pathways for medical devices were described, including 510(k), 513(g), and premarket approval filings. Regulatory pathways for drugs included new drug applications, abbreviated new drug applications, and 505(b)(2) filings.

Students were assigned medical devices or licensed drugs for which they researched the regulatory pathway that led to its approval.

Further topics included strategies for interactions with the FDA, clinical trial basics, and select international regulations (European Union, Canada, etc.). ◉ IP discussions began with an overview of patents. Topics included patent definition, content, terms, and acquisition. Students were walked through a patent example that included a description of all its aspects (methods, ranges, etc.). Other topics included requirements for patentability, freedom to operate, inventorship and proof of invention, trademarks and copyrights, provisional and non-provisional applications, U.S. filing, international patent coverage and filing, patent examination, notice of allowance, patent maintenance, licensing, the university IP process, nondisclosure agreements, patent enforcement basics, burden of

proof, trials in the U.S., trials outside U.S., infringement, infringement opinions, validity opinions, and damages and injunctions. Students performed initial searches of the United States Patent and Trademark Office website for patents related to their planned projects.

The goal was to enable them to integrate the IP sequencing timeline into the product development pathway. ◉ In addition to the comprehensive course mateial described above, the basics of smart patent searching and smart patenting were taught by University Research Commercialization Manager Neeti Mitra at the CUNY Technology Commercialization Office. This workshop enabled the students to find, understand, and evaluate patents related to their products as well as enabled communication with legal experts to create successful patents. Topics included novelty and prior art searches as well as understanding the background and purpose of the invention. Students were taught how to identify the key areas of invention, develop search strategies to identify similar patents, and find relevant key word, international patent classification, and structure data in relevant patent databases. Students were encouraged to create a final search set for analysis and to identify prior art. Smart patenting topics included IP management, patent commercialization, strategies of defensive and offensive patenting, cross-licensing, inlicensing, out-licensing, fields of use, territories, and time frames. ◉ Quality assurance (QA) is an essential part of Stage 3. The MTM program includes comprehensive quality assurance classes and an expert guest lecture. Classes in QA were taught in the first semester. Continued QA “refresher” lectures—to be placed throughout the whole curriculum—are envisioned for future cohorts. QA was covered in a series of guest lectures. Topics included FDA quality system regulation, quality policy, a quality manual, and subsystems of a quality system (i.e., management using six systems: design controls, material controls, record controls,

ADAPTING STAGE-GATE TO MTM CURRICULUM equipment and facility controls, production and process controls, corrective and preventive action (CAPA)). The topic of organizational structure and responsibilities included management control subsystems, quality policy, audits, reviews, training, inputs, outputs, verification, validation, transfer, change, risk management, and technical files. The topic of production and process control covered how manufactured products meet specifications, including process control, validation, monitoring, purchasing, acceptance, sampling, calibration, vendor assessment, identification, storage, labeling, installation, and servicing. The area of non-conformities and CAPA focused on quality policy that strives for continuous improvement. Topics included collecting and analyzing data; identifying and investigating product and quality problems; root cause analysis; identifying and implementing corrective and preventive actions; verifying and validating; providing information for management review; differences between correction, corrective action, and preventive action; and customer feedback. Finally, the topic of medical device reporting included reporting, recall and vigilance systems (European Union and Canada), customer complaints, risk management, internal audit, external audit, management review, International Organization for Standardization (ISO) 13485, and differences among U.S. FDA, good manufacturing practice, and ISO. Guest lectures given

by Susan Littlefield, manager for Quality Systems & Regulatory Affairs at the Georgia Eye Bank, focused on the real-life company approach to quality: how to build quality into the process, separate the department for quality, and introduce quality systems. ◉ ISO standards, which are important standards related to medical devices and drugs, were an integral part of the MTM I6100 Intellectual Property, Regulation, and Quality Assurance course material. Relevant standards were discussed in great detail, including the history of the ISO standards and other norms.

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Engineering Entrepreneurship Using the Lean LaunchPad Methodology In 2011, the National Science Foundation (NSF) adopted the Lean LaunchPad methodology of entrepreneurial immersion, hypothesis-driven customer discovery, and business model validation (10,11) via the creation of the NSF Innovation Corps (NSF I-CorpsTM) program. The New York City Regional Innovation Node (NYCRIN), the third I-Corps node created through support from the NSF, is led by CUNY in partnership with Columbia University and New York University and includes a network of over 25 regional institutions (12). Previously, NYCRIN successfully adapted the NSF I-Corps program for undergraduate engineering entrepreneurship training (13).

The NSF I-Corps boot camp is seven weeks long and is taught by seasoned commercialization experts, including serial entrepreneurs, investors, and directors of innovation. Each cohort consists of 21 to 24 teams of three: an NSF-funded principal investigator, an entrepreneurial lead who is typically a graduate student or postdoc familiar with the technology, and an industry mentor. These three-person teams are required to develop business model hypotheses about their technology’s value proposition and customer segments, which together create a product/market fit, along with the remainder of the Business Model Canvas (BMC). The team must test their hypotheses by “getting out of the building” and interviewing at least 100 potential customers during the seven-week course. Learning the customer pain points leads to insights that can either validate or invalidate the teams’ hypotheses. The methodology favors experimentation over elaborate planning, customer feedback over intuition, and iterative design over traditional “big design up front” development (14).

The course is a modified flipped classroom, in which the pedagogical learning is assigned through videos in the Udacity series How to Build a Startup to be watched outside of class time. Class sessions are used for the teams to present their weekly insights with feedback from the teaching team followed by a discussion of the video and corresponding assigned text, which covers one block of the BMC each week.

After sufficient data is gathered, the team can pivot as a result of a pattern of invalidations and must continue their customer discovery process to reach a go

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or no go conclusion by the end of the course. Simply put, the NSF I-Corps program enables academic researchers to quickly determine the technology’s readiness in the marketplace.

The challenges we met in adapting this process to the new CCNY MTM program included the small number of students in the class and the fact that the program focused on a single technology solution.

Accordingly, the Engineering Entrepreneurship course began with three weeks of introduction (how the course fits into the Stage-Gate process), ideation, and brainstorming. We “promoted” each student to the level of division head and charged them with identifying which indication their division would investigate by customer discovery for the semester.

We then proceeded through the usual Lean LaunchPad inverted classroom model for the remainder of the course. Students were expected to create a final lessons learned video and make a final lessons learned presentation. Results in Figure 5 indicate that the students learned a significant amount about aspects related to the creation of a business model. The left panel of Figure 5 shows the students’ level of understanding prior to the course, and it is mixed. However, upon completion of the course (right panel), the students indicate that they understood a great deal about all of the aspects of a business model. These results suggest that incorporating the Lean LaunchPad methodology into a Stage-Gate-driven program can successfully teach entrepreneurship concepts.

RESULTS Whenever a new teaching paradigm is launched, it is imperative that an accurate assessment process is also developed alongside to determine the overall impact of the teaching process. For example, the Engineering Entrepreneurship course described above leveraged its already existing assessment procedure (13). Instructors successfully captured the key learning milestones that the students accomplished (Figure 5). A similar rigorous assessment plan was also developed for the CCNY MTM program, and the results were as follows.

Mentoring Sessions Provide Real-Time, Longitudinal Assessments As described in the Methods section above, Domschke regularly met with the students in defined sessions to assist students in the pursuit of their career

paths and to learn first-hand how their learning was progressing. Students were asked for feedback, which was shared in a timely manner with the program advisory board for review and possible program modification. It was concluded that these timely feedback sessions assisted in keeping the evolving program on track.

Stage-Gate Meetings Enable Group Faculty Assessments At the end of each stage (semester), the students were required to give formal Stage-Gate presentations to their company executives (the faculty). Thus, all students presented the multidisciplinary course material they had learned in a coherent manner and from a business perspective in front of all faculty in one single session. During the immediate subsequent executive review session, the faculty were able to have an honest, data-driven discussion about the progress of the students through the program. It was concluded that these sessions functioned as an important, nonbiased quality control step for the program, as all faculty reviewed the students’ progress through their colleagues’ courses.

Semester 1 Student Feedback Empowered the Students Following the first gate meeting, the students were asked to fill out a very short feedback survey with two questions: 1) How would you rate the efficacy of the MTM program to develop your professional skills? and 2) How would you rate the helpfulness of the mentor session to develop a more focused picture of your career aspiration and steps toward achieving it? Both of these open-ended questions were rated on a scale of 0 to 10 (0= not helpful at all, 10= extremely helpful), and the students were asked to support their rankings with a short written response. As expected, these surveys enabled the tracking of the professional progress of the students.

An important conclusion from this activity was that it served as a method for reinforcing to the students that the faculty are interested in their development as professionals as well as their learning as students.

A Detailed, Final Survey Documented the Impact of the Program After the completion of the second Stage-Gate meeting (during the third and final stage), the

Figure 5. Results related to students’ understanding of topics related to the development of a business model. The difference in the percentages reflects a difference in the number of students who completed the survey before and after completion of the Engineering Entrepreneurship course.

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students were required to complete a detailed survey that covered topics extending back to the beginning of the program. Results from this survey may be summarized as follows.

• Students acquired knowledge related to the Stage-Gate process. Stage-Gate is a tool to manage complex medical product development.

It views product development as a process with a series of stages, and it was integrated into the CCNY MTM program plan. After the students completed the early stages (Stages 1 and 2), they were asked to indicate how knowledgeable they were about the tool (Figure 6). For all students, there was a significant amount of learning about what the process is and what its stages are. Based on these findings, it was concluded that the Stage-Gate tool can, indeed, be adapted to graduate student training.

• Students acquired skills related to product development. Following the second gate meeting, three-quarters of the students felt that they had learned how to apply the Stage-Gate process (Figure 7). When reviewing how much they knew before MTM compared with after, the stu-

students gained a significant amount of knowledge in moving a project into the next developmental stage (go or no go) based on the gate deliverables. They also learned how to propose next steps and activities for the subsequent development stage as well as how to communicate well with the multidisciplinary teams within the gate meetings using appropriate technical terms.

• Students acquired skills related to applying the Stage-Gate tool. Following the second gate meeting, three-quarters of the students felt that they had learned the product development process (Figure 8). When comparing how much they knew before MTM with after, the students gained a significant amount of knowledge in defining key product activities and gate deliverables.

• Students felt that lectures provided relevant course content. Students were asked how they rated invited lectures, including “Introduction to Stage-Gate (Kickoff),” “Getting to Market: It Takes People, Process, & the Promise of Profits,” and “Building the Stage-Gate Tool for ELBONIX Lectures.” In all cases, the students felt to a

Figure 6. Representation of learning by students about the Stage-Gate process acquired after the MTM program.

Figure 7. Comparison of skills related to product development by students acquired after the MTM program.

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Figure 8. Comparison of skills related to applying the Stage-Gate process acquired after the MTM program.

large or moderate extent that these lectures were relevant to them. Based on these results, it was concluded that supplementary guest lectures are a valuable mechanism for providing additional course content. • The multidisciplinary course material gave students confidence in their own skills. Students felt to a large extent that they had acquired skills in i) drafting a translational path (milestones and timelines) within a product development process, ii) drafting a translational path for regulatory, intellectual property, and quality, iii) conceiving translational hurdles in the multidisciplinary course material, iv) communicating these translational hurdles from a business relevant perspective, and v) comprehending and articulating how the disciplines of the MTM program work together in the early stages of the product development process.

in connection with the fictional company inspired them to create ideas that could be developed into successful products. In addition, it allowed them to practice the Stage-Gate process and increase their confidence so that they could apply their knowledge to other product ideas. Similarly, the students felt that they had gained knowledge regarding i) the concept of a company life cycle, ii) the process of company growth and the different needs in each growth phase, which create different work environments and career opportunities, iii) the concept of product life-cycles and product portfolio management, iv) the idea that management of a short-, mid-, and longterm portfolio creates a need for different talent, v) the fact that organizations and companies have different cultures impacting the work environment, and vi) their preferred company environments.

• Students agreed that the fictional company and Stage-Gate process provided value. Students were asked directly if they felt that the introduction of a fictional company into the lesson plan helped them in practicing the Stage-Gate tool.

They strongly agreed that the knowledge learned

• Mentor sessions empowered students to pursue career opportunities. Students strongly felt that the mentor sessions i) defined their talents and true interests, ii) better defined their preferred work environments, and iii) encouraged them to actively pursue the next steps toward their career

ADAPTING STAGE-GATE TO MTM CURRICULUM goals, explore their talents and true interests, take charge of their career choices, and address hurdles on the path toward their career objectives.

DISCUSSION AND CONCLUSIONS The implementation of the industrial Stage-Gate process over a full 12-month graduate-level master’s degree program is a novel teaching paradigm.

Combining the Stage-Gate process with the Lean LaunchPad methodology enables students to gain industrial expertise that is relevant to career options in both start-up and mature companies. In addition to standard didactic teaching, the CCNY MTM program involves personal mentorship, experiential learning, and team building exercises so that the students become well-rounded and better positioned for their next career steps.

Based on our findings, we conclude the following: • Adaptation of the industrial Stage-Gate process as a pedagogical tool is feasible in a graduatelevel product-driven master’s degree program.

• Coordination of the teaching of industrial concepts with canonical academic graduate courses provides necessary real-life context to the students. The unanticipated consequence of this pairing was that the students become fully aware of the risks and challenges involved in commercializing their prototype devices.

• Participation in the Stage-Gate review process at the end of each semester by all course faculty of record helped the development of an integrated prototype device, as input from all experts was shared and discussed as a team.

While the students who are fortunate enough to participate in this program benefit in many ways, delivering such an ambitious program is not easy.

Recruitment of instructors is a particular challenge since most university faculty simply do not have the necessary industrial experience to deliver the needed content that a hybrid Stage-Gate/Lean LaunchPad program demands. It is very important that the course coordinators and directors for courses with industry-relevant content are the appropriate industry experts. Unfortunately, instructors with broad knowledge and industrial experience who can commit to a

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full 15-week course are a challenge to identify. While guest lecturers can suffice for specific defined topics, coordinating schedules with such speakers can be difficult, so course agendas need to be flexible to accommodate this.

Another area that can present challenges is the recruitment of appropriate students for such a multidisciplinary program. As it is anticipated that students with diverse educational backgrounds will apply for this program, the curriculum must be flexible enough to embrace all students equally. The success of the inaugural year was due in part to the fact that the original students completely bought into the process and were fully integrated into the program, even providing suggestions for industrial topic areas that they wanted covered in the course material. Looking ahead as the program scales, it will become more and more important to maintain such student input and integration so that the program content remains current and relevant.

In conclusion, while offering such an in-depth industry-based graduate student training program may be challenging, the rewards to the student are innumerable. It is hoped that this Stage-Gate-inspired program will help to better prepare students for long, fulfilling industrial careers.

ACKNOWLEDGMENTS The authors wish to dedicate this article to the memory of Andrew S. Grove, CCNY Class of 1960.

Without his vision and desire, this curriculum would not have been developed. Dr. Blaho acknowledges the National Science Foundation for a large center grant (NSF1305023) that partially supported programming, especially related to the development and delivery of the innovative entrepreneurship component of the MTM program. Dr. Domschke wishes to honor with this article a great visionary and a remarkable woman, Dean Gilda Barabino of the Grove School of Engineering. Her guidance, patience, and unwavering commitment to this program were the drivers that made the creation and successful implementation of this program happen in an unusually short period of time. Domschke wishes further to extend her gratitude to Ashiwel Undieh (Associate Provost for Research CCNY and Medical Professor) for his consistent superior support and insightful inspiration. Very special thanks shall be extended

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to the course directors Dr. Abhishek Datta (CTO Soterix Medical) and Joan Dorn (Chair, Department of Community Health and Social Medicine, Sophie Davis School of Biomedical Science). Their dedication and joy in creating this pioneering program resulted in greatly enjoyable course material of the highest standard. The authors gratefully acknowledge guest lecturers Neeti Mitra, Kip Creel, and Susan Littlefield for their devoted commitment in the creation of the valuable industry guest lectures for the class of 2015. Special thanks should be given to Warren Grundfest (Professor of Biomedical Engineering, Electrical Engineering, and Surgery at UCLA and initial External Advisory Board member for CCNY’s MTM program) for his professional guidance, valuable support, and constructive recommendations on the program implementation. Further thanks are extended to the faculty and the staff of the office of the Dean of the Grove School of Engineering who participated in and supported the implementation of this program with the insightful discussion and administrative help that shaped this unique program, in particular Mitch Schaffler (Chairman, Department of Biomedical Engineering), Maribel Vazquez (Associate Professor of Biomedical Engineering), Sihong Wang (Associate Professor of Biomedical Engineering), Lola Brown (Assistant Dean for Academic Initiatives), Annette Pineda (Director of External Relations), and Yulisa Aquino (Special Projects Coordinator). The authors wish to thank Philip Lowe, Christina Pellicane, and Kyle O’Brien for their assistance with the Engineering Entrepreneurship course. Finally, we thank the students of the first cohort for their patience and committed feedback and wish those great talents a bright future. The syllabi and related course materials may be requested from the authors.

REFERENCES 1.

2.

3.

4.

5.

6.

7.

8.

Cooper RG. Doing it right: winning with new products. Product Innovation Best Practices Series; Jul/Aug 2000 [accessed 2016 Aug 28]; Reference Paper #10. http://www.stage-gate.net/ downloads/working_papers/wp_10.pdf.

Lewis-Burke Associates LLC. Analysis of the FY 2016 Omnibus Appropriations Bill.

Washington (DC): Lewis-Burke Associates LLC; 2015 [accessed 2016 Sep 2]. https://gcr. uoregon.edu/sites/gcr2.uoregon.edu/files/ lewis-burke_analysis_of_the_fy_2016_omnibus_appropriations_bill.pdf.

International Labour Office, Geneva. A skilled workforce for strong, sustainable and balanced growth: a G20 training strategy. Geneva (Switzerland): International Labour Organization; 2011 [accessed 2016 Sep 2]. https://www.oecd. org/g20/summits/toronto/G20-Skills-Strategy. pdf.

Wikipedia contributors. History: phase–gate model. Wikipedia, The Free Encyclopedia; 2016 Nov 2 [accessed 2016 Sep 2]. https://en.wikipedia.org/wiki/Phase%E2%80%93gate_model.

Ajamian GM, Koen PA. Technology Stage-Gate™: a structured process for managing high-risk new technology projects. In: Belliveau P, Griffin A, Somermeyer S, editors. The PDMA toolbook for new product development, v. 1. New York (NY): John Wiley & Sons; 2002. p. 267-295.

Cooper RG, Edgett SJ. Best practices in the idea-to-launch process and its governance. Res Technol Manage. 55(2):43-54; 2012 [accessed 2016 Sep 2]. http://www.prod-dev.com/downloads/wp/wp_45.pdf.

Fuerst P. Stage-Gate – the origin, status quo, and future [blog]. Sopheon. [accessed 2016 Sep 2]. https://www.sopheon.com/stage-gate-the-origin-status-quo-and-its-future/.

Pietzsch JB, Shluzas LA, Paté-Cornell ME, Yock PG, Linehan JH. Stage-Gate process for the development of medical devices. J Med Devices.

3(2); 2009 [accessed 2016 Sep 2]. http://medicaldevices.asmedigitalcollection.asme.org/article. aspx?articleid=1473887.

ADAPTING STAGE-GATE TO MTM CURRICULUM 9.

10.

11.

12.

13.

14.

Boles R. What color is your parachute 2015: a practical manual for job-hunters and career-changers. New York (NY): Ten Speed Press; 2014.

Osterwalder A, Pigneur Y. Business model generation: a handbook for visionaries, game changers, and challengers. New York (NY): John Wiley & Sons, Inc.; 2010.

Blank S, Dorf B. The startup owner’s manual.

Pescadero (CA): K&S Ranch; 2012.

Pellicane C, Blaho J. Establishment of the NYC Regional Innovation Network. NCIIA Open 2014. Proceedings of Open 2014; 2014 Mar 21-22; San Jose. Hadley (MA): VentureWell; 2014. http://venturewell.org/open2014/wp-content/uploads/2013/10/BLAHO.pdf.

Pellicane C, Blaho J. Lessons learned from adapting the NSF I-Corps curriculum to undergraduate engineering student entrepreneurship training. NCIIA Open 2015. Proceedings of Open 2015; 2015 Mar 20-21; Washington DC. Hadley (MA): VentureWell; 2015. http://venturewell. org/open2015/wp-content/uploads/2013/10/ PELLICANE.pdf.

Blank S. Why the lean start-up changes everything. Harvard Business Review. [May 2013; 2016 Sep 2]. https://hbr.org/2013/05/ why-the-lean-start-up-changes-everything.

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ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.381 www.technologyandinnovation.org

Technology and Innovation, Vol. 19, pp. 381-388, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

THE PHD INNOVATION PROGRAM AT THE THAYER SCHOOL OF ENGINEERING AT DARTMOUTH Eric R. Fossum, Carolyn E. Fraser, and Joseph J. Helble Thayer School of Engineering at Dartmouth, Hanover, NH, USA

Dartmouth’s PhD Innovation Program at the Thayer School of Engineering is described. The rationale, structure, and results to date for the program are discussed. Despite the program’s youth and small size, significant success in better preparing engineering Ph.D. recipients to engage in technology commercialization and enterprise building has been demonstrated and a contribution to the nation’s technological and economic leadership established.

Key words: Engineering; Innovation; Enterprise; Entrepreneur; Ph.D.; Dartmouth

INTRODUCTION In 2005, Innovate America, a report from the National Innovation Summit, was released by the Council on Competitiveness (1). This report, authored by individuals drawn from the corporate world, academia, and government, argued that for the U.S. to maintain technological and economic leadership, a substantial investment in the development of a technically competent workforce was required. As the report articulates, nations that can provide conditions favorable to innovation and entrepreneurship, including a strong technically-trained workforce, stable government, culture that accepts and rewards risk taking, and the availability of early-stage capital, are those most likely to claim positions of leadership in the 21st century.

While this report and others appearing at that time (2,3) described the need for developing more engineering talent within the U.S. and demonstrated an

overall need for changes in engineering education to incorporate more open-ended problem-based learning and foster skills needed for innovation and entrepreneurship, their emphasis was generally on undergraduate science and engineering education.

Discussion of graduate programs focused primarily on the need for increased research and fellowship funding to encourage greater numbers of domestic students to pursue advanced degrees in engineering and science, yet a similar national need exists for Ph.D.-level students to develop skills in technology innovation and enterprise creation.

Engineering Ph.D. programs focus, appropriately, on helping students develop the skills needed to conduct original research. Their structure, emphasizing advanced coursework and publishable research, differs little from Ph.D. programs in the sciences. Similarly, some might argue that for many programs, “success” can be defined as placing top

_____________________ Accepted April 15, 2017.

Address correspondence to Eric R. Fossum, Ph.D., Thayer School of Engineering at Dartmouth, 14 Engineering Drive, Hanover, NH 03894, USA. Tel: +1 (603) 646-3486

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doctoral students in academic positions at peer institutions. While this is one important outcome for Ph.D. engineering students, we estimate, based on the number of engineering assistant professors in the United States and the number of Ph.D. degrees granted in engineering each year, that only approximately 10% of graduates obtain tenure-track faculty positions even after post-doctoral appointments (4).

Most engineering Ph.D. recipients pursue careers in industry, often in industrial research and development, where their deep technical knowledge is of immediate application. In both paths, however, the educational program focuses entirely on the students’ technical education. Little attention is paid to the potential benefits associated with helping engineering Ph.D. students develop, as part of their Ph.D. program, the business and organizational skills needed for technology entrepreneurship. Programs designed to help students explore commercialization of their research, often in collaboration with business schools, do exist at many universities, but there are not many programs that focus on helping Ph.D. students develop the knowledge and understanding necessary for technology entrepreneurship as a core part of their Ph.D. education.

To address this, in 2007-2008, the faculty of the Thayer School of Engineering at Dartmouth College developed a specific Innovation Program with the objective of providing a much more structured approach to developing the skills needed to be a Ph.D.-level technology entrepreneur. In our program, in the context of new technology generation, innovation is defined as the process of translating and transforming a discovery or invention into a form suitable for commercialization. Innovation is thus the bridge of directed research between pure research and advanced development. The program was structured with the goals of providing introductory exposure to the relevant business curricula, providing practical experience through a mandatory internship in a start-up company late in a student’s Ph.D. program, providing mentorship from successful entrepreneurs and venture capitalists, and building an understanding of the process of turning complex research into commercializable technology.

The program is designed to teach students to recognize the skills needed to bring about successful innovation and associated new enterprise and to

provide the opportunity to take risks, possibly fail, and ultimately learn from the experience in a structured environment. In addition to these educational outcomes, the program aimed to prove that acquisition and practice of these skills in the context of an engineering Ph.D. program can lead to increased national technological and economic leadership through an increase in intellectual property generation and enterprise formation by its students over their professional lifetimes.

PROGRAM OVERVIEW Curriculum The PhD Innovation Program shares a large common core with Thayer’s Ph.D. program, which comprises applied math and engineering coursework, a multi-year research project, professional skill-building, an oral qualifying examination, and a Ph.D. thesis defense. The PhD Innovation Program includes coursework from the Tuck School of Business (adjoining the engineering school on the Dartmouth campus), Thayer innovation coursework, and an internship, preferably in a start-up, which, under some circumstances, could be the student’s own venture. Internships in larger established corporations can also be instructive if the student has no prior work experience. Entrepreneurial courses are taught by full-time tenure-track faculty, but guests are often invited in the advanced coursework to provide supplemental information and experiences. Several faculty are experienced entrepreneurs. The required course load at Dartmouth for completing the PhD Innovation Program is only a few courses larger in total than the regular Ph.D. program since some of the required innovation courses supplant required courses in technical breadth. Upon successful completion and conferral of the Ph.D., an innovation certificate is granted. Innovation Program coursework includes corporate finance, a course in law for technology and entrepreneurship, an elective such as accounting, and Thayer School’s unique Introduction to Innovation course. The Introduction to Innovation capstone course, taught by a faculty member and entrepreneur, is specially designed for the program and provides instruction and practice in commercialization of new technologies over a several-term period. Thayer is able to deliver a rich experience in

DARTMOUTH PHD INNOVATION PROGRAM this regard due to a long history of integrating the practical aspects of market analysis and business planning into interdisciplinary engineering design project coursework at the undergraduate level. Guest lectures are presented by visiting entrepreneurs, venture capitalists, and inventors. An enterprise plan based on the development and commercialization of novel technology research is developed and presented to a panel of experts for a grade. Students report on their projects both orally and in written form and are graded on a pass-fail basis.

Financial Constructs and Administration The program director oversees the program with guidance from the dean of the engineering school and assistance from the assistant dean for academic and student affairs. In most cases, five full years of funding support the student through the completion of the Ph.D. in engineering, advance the adviser’s research agenda, and support the student’s innovation training and personal research agenda. PhD Innovation Program students are supported by graduate research assistantships for the first two years of the program, which are funded via adviser-secured grants or fellowships. In this period of the program, coursework and professional skill-building is emphasized as adviser-directed research ramps up, and the student is part of a thriving research lab while nurturing their own novel research ideas. In the third year, research focus shifts from being adviser-directed to being candidate-directed, and fellowship funding is provided through Thayer School in support of the candidate’s research agenda. In addition, in years three through five, the school makes up to $10,000 in supplies and equipment funding available per year per student for research activity that is divergent from their adviser’s own research and which furthers their innovation and enterprise-building endeavors.

Funding to start the program was raised through philanthropy. Grants and fellowships that align with the program’s objectives have been employed as funding sources. For example, a Luce Foundation grant has been employed to support development of women through the program, and a National Science Foundation Partnerships for Innovation grant funded student collaboration with existing small business enterprises. Thayer’s Energy Challenge Initiative has supported students in the field of energy,

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and Holekamp and Crump Funds have supported additional PhD Innovation Program students.

Recruiting A core requirement for students selected for our program is the same as the regular Ph.D. program— strong promise for academic success in coursework and research. The overlay emphasis on business and entrepreneurship coursework and activities must not come at the expense of rigor in advanced engineering sciences coursework and performance in the adviser’s lab, whether on the adviser’s or the student’s own research. While the core requirements are the same, the challenge in recruiting is finding students who have characteristics and interests that go beyond the core. The way we look at this has changed in a subtle manner over the first few years of the program as students come into and successfully complete the program. Initially, the assumption was that a percentage of the Ph.D. candidate population either has a strong interest in entrepreneurship or a research idea they want to develop, and this type of student was the main target for the program. Our program is the only one that combines research and entrepreneurship in such an integrated fashion, and finding ideal candidates has been challenging. In addition, because the program is unique and very selective, prospective students can be intimidated by the program description and requirements.

We have noted that many of our own faculty entrepreneurs are what one might call “adventitious entrepreneurs” who did not necessarily pre-meditate an entrepreneurial role, and that, perhaps, is the more common story for engineers with advanced degrees. Recognizing this, we expanded the target and messaging beyond speaking to students ready for entrepreneurship or bent on commercialization to include those that are interested in preparing for this opportunity down the road and broadening their future options. This change supports what we always knew: All engineers will benefit from additional training in business and entrepreneurship. To cast the net more widely, we have employed highly targeted tactics such as recruiting through alumni and faculty networks and from within our own pool of existing students, but also broader tactics such as posters and Facebook ads to reach Ph.D. prospects at

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both domestic and international universities. We’ve also experimented with positioning the opportunity as a program versus a fellowship opportunity but have not yet made any conclusions about which presentation is more attractive to students. We continue to refine these approaches in the program.

Admissions Candidates submit the same core application materials as for the regular engineering Ph.D. program, including GRE/TOEFL scores, intent essays, letters of recommendation, and transcripts. Additional materials required are a two-page essay elaborating on their interest in innovation and providing an example of creativity in arriving at a solution, a sample funding proposal for a technology development project, and a C.V. Applications are due at the same time as our regular Ph.D. program applications, and the screening process begins in a similar way but is performed by a dedicated faculty panel focused on innovation requirements and fit. Students who are chosen for consideration are invited to a panel interview. The panel further confirms the interest and aptitudes of the candidate and provides the candidate an opportunity to demonstrate fundamental knowledge, critical thinking, and presentation skills around their technology interest area. Each student offered admission into the program must have an established faculty sponsor who will be their adviser and who may provide financial support during the student’s first two years.

Brief History To Date The program began in July 2008 with a goal of enrolling up to five students a year based on interest and match. As of Fall 2017, thirty-six students (twenty-six men and ten women) will have entered the program. Of the fourteen who have received Ph.D. degrees, six founded start-ups, two became postdocs in the medical field, and the rest are involved with start-ups. None of them have gone on to academic teaching positions. Two have withdrawn, and twenty are currently in the program. The curriculum has remained consistent during this period, with modest changes to innovation coursework content and approach. Internships have taken a variety of forms, but most involve early-stage enterprises: the student’s own venture, early- and later-stage start-ups, technology incubators, and venture capital firms. Feedback

from students is strongly positive, and we continue to evolve the program and its features based on our assessment activities.

ASSESSMENT The program has joint goals of teaching skills for innovation and preparing students for generating intellectual property and forming or joining enterprises that bring intellectual property to fruition. In addition to assessing outcomes in terms of intellectual property generated, technology enterprises formed or joined, and student feedback on courses targeting innovation skills, we have employed high-touch mechanisms such as student meetings and check-ins with the dean and the program faculty coordinator and an annual meeting with at least one member of the school’s Board of Overseers. In addition, a comprehensive assessment interview was conducted with all current and finishing participants in 2012, with another scheduled for 2017.

Assessment interviews indicated the need to enhance networking and informal events for the program participants. In response to this feedback, several events were planned on an annual or semi-annual basis to bring participants together to meet with inventors and entrepreneurs, network with each other and faculty, and connect with cross-campus student and alumni entrepreneur networks and programs. Students also gave feedback about courses, including the Introduction to Innovation course. Students have noted positive learning outcomes in the innovation skill and knowledge areas of intellectual property and law, marketing, finance and accounting, enterprise planning and formation, and the development and oral presentation of enterprise proposals. In the area of the internship, students asked for additional mentoring and support in order to be able to optimize the integration of their internships with other Ph.D. activities.

Since the program is entering its ninth year and has had thirteen participants who have completed a Ph.D., it is possible to begin looking at outcomes in terms of intellectual property generated and start-up enterprises formed or joined by participants. While looking at the number of patent filings can be misleading and ignores issues of quality vs. quantity, it is a convenient metric. The

DARTMOUTH PHD INNOVATION PROGRAM average number of patents filed per student by students over the life of the program is about twice that of the regular Ph.D. program students, and, similarly, the percentage of program students who have filed at least one patent is also about twice that of the regular program students. The involvement of program students in start-ups during or after graduation is substantially greater than regular program students. This is likely due in part to heightened awareness and training as well as self-selection of students entering the program.

We acknowledge that, due to the small size of the PhD Innovation Program, one cannot draw strong conclusions, but we feel it is still useful to report the data.

In Figure 1, a graph by year shows participation rates of students in formal intellectual property generation. It can be seen that generally the participation of innovation program students is higher than that of the regular Ph.D. program students.

But, it also shows an upward trend of participation by regular Ph.D. program students. This can be ascribed, in part perhaps, to a collateral effect of the PhD Innovation Program on the peer group of regular Ph.D. students.

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In Figure 2, pie charts illustrate where our regular Ph.D. program and PhD Innovation Program students go after graduation. To minimize the number of categories, we grouped students into one of five categories: 1) Postdoctoral and medical programs, 2) Entrepreneurial activity, which includes co-founded start-ups, other start-ups, and venture fund advisers, 3) Industry and/or Government non-entrepreneurial positions, 4) Academic teaching positions, and 5) Other. As can be readily observed, there is substantial difference in outcomes between the regular Ph.D. program students and the PhD Innovation Program students. Likely most of this may be ascribed to self-selection of the students in the PhD Innovation Program, but outcomes show the program is meeting its objectives of training new technical Ph.D.’s in entrepreneurial thinking and thereby helping to invigorate the U.S. economy.

As with all long-term investments, program success will need to be measured over a longer timescale, and assessment results and feedback addressed through program adjustments going forward.

Figure 1. Patent filing rates for regular Ph.D. program (RegPhD) and PhD Innovation Program (IPPhD) students at the Thayer School of Engineering at Dartmouth. Due to the small size of the program in the earlier years, the variance in the data is larger for the PhD Innovation Program. In 2015, 15 out of 94 Ph.D. students were in the PhD Innovation Program.

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Figure 2. Initial employment (jobs) outcomes for Ph.D. students in the regular and Innovation programs. See text for category descriptions.

area of innovation and enterprise goes far in overOTHER PROGRAMS coming the natural barriers engineering personalities In 2014, Dartmouth’s Thayer School of Engineering have with creating enterprises. In fact, it seems many was awarded the National Academy of Engineering’s engineers often find a lack of education in the area of Bernard M. Gordon Prize for Innovation in Engi- business a formidable psychological barrier to takneering and Technology Education “[f]or creating ing the leap to initiating a new enterprise. However, an integrated program in engineering innovation most Innovation Program PhD students, already wellfrom undergraduate through doctorate to prepare equipped with mathematical and analytical skills, students for engineering leadership.” Fundamentals find that core entrepreneurial business concepts (e.g., in innovation and entrepreneurship concepts are legal, intellectual property, accounting, business plans, perhaps something all engineering students should etc.) are relatively easy to learn. In a phrase, learning be exposed to at the undergraduate level (e.g., 5), and, entrepreneurial business mechanics is not rocket indeed, a multitude of programs at the undergraduate science. Of course, taking risks does not come easily and master’s degree level exist in the U.S. and else- to most engineers, and we can only diminish the where. However, we find few engineering programs perceived risk through preparation.

Another lesson learned is that training students in that carry the same philosophy to the Ph.D. program, although their number has grown in recent years. this area, as in research, requires one-on-one menUniversities that have specific innovation and entre- torship and coaching. In a program that is a small preneurship training for Ph.D. engineering students subset of just over 100 engineering Ph.D. candidates include Stanford, Yale, Brown, Massachusetts Institute school-wide, each student’s background, needs, and of Technology, and Duke, but not dozens more. We trajectories are rather different from one another. A find that our program is unique in its emphasis on one-program-fits-all approach does not work well the integration of research and enterprise planning and has been difficult to fashion. Instead, great flexin learning, skill-building, and practice in a doc- ibility is required to achieve the program objectives. toral program. While having a unique curriculum in The ability to offer such flexibility is a strength of a this area is good for attracting excellent engineering smaller institution. graduate students to Dartmouth, we would like to One area of concern among some of the partisee more programs in the U.S. and feel it is vital for cipating faculty is that the Innovation Fellows are national competitiveness. extraordinarily independent, especially once enabled by fellowship and research funding. These intellectuLESSONS LEARNED AND IMPROVEMENTS ally strong students may adjust or possibly abandon Perhaps one of the most important lessons learned the research path foreseen by the faculty member in this program is that a modicum of education in the or may be reluctant to accept their adviser’s advice.

DARTMOUTH PHD INNOVATION PROGRAM While ultimately the student’s dissertation must be examined and approved by the adviser and dissertation committee, the independence of some of the Innovation Fellows can be disruptive to normal lab culture and thus unnerving to the faculty adviser.

Like all faculty, Dartmouth’s engineering faculty are diverse in their opinions about most subjects except perhaps for the need for quality education for undergraduate and graduates alike in engineering. The PhD Innovation program, while still in its youth, has garnered a range of opinions from its faculty. While generally supportive, faculty who are highly focused on the academic track without much exposure to industry are less convinced of the need for such a program compared to those who have had some exposure to the commercial world. Some believe that all our engineering students should have some minimum training in innovation and enterprise, a view held by many junior faculty members interviewed at Dartmouth in the past few years and indicative of a possible change in thinking in the next generation of faculty. Engineering has always been associated with the invention and application of new technology for society in both public and private sectors and often calls for the creation of new enterprises. It is therefore important to communicate continuously the need and importance of such innovation and enterprise training for some of today’s Ph.D. students. This is an ongoing process, and our successful outcomes help cement the relevancy and importance of the program.

An area of improvement for Dartmouth is in creating a larger pool of well-qualified applicants for the program. Relative to most of its Ivy League and other peer institutions, Dartmouth is a modest-sized school, especially for graduate study, and the climate in northern New England is for those who relish strong seasonal variety. Thus, the pool of students that are cognizant of our program and apply to Dartmouth for graduate engineering study is growing but has not reached our targeted size. Our selectivity is currently about 15%. We need to better communicate our PhD Innovation Program to our feeder schools and develop new feed paths for our program.

We are also working on strategies to further engage women to grow our applicant pool and increase the percentage of women in the program nearer to the fifty percent level we have recently seen among our undergraduate engineering degree program students.

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CONCLUSIONS Having celebrated its eighth birthday, the PhD Innovation Program at Dartmouth’s Thayer School of Engineering has already been able to measure significant successful outcomes in terms of innovation and entrepreneurship skill development and intellectual property and new technology enterprise generation from a relatively small group of PhD Innovation Program students. We believe that such training in innovation and enterprise is an important step in sustaining and increasing technological and economic vibrancy in the U.S. and worldwide, and there is evidence that other institutions agree. While our program is young and continuously improving, we feel we are on the right path for leadership at the forefront of future engineering education.

REFERENCES 1.

2.

3.

4.

Council on Competitiveness. Innovate America: National Innovation Initiative summit and report. Washington (DC): Council on Competitiveness; 2005 [accessed 2016 Nov 20]. http:// www.compete.org/reports/all/202.

Committee on the Engineer of 2020, Phase II, Committee on Engineering Education, National Academy of Engineering. Educating the engineer of 2020: adapting engineering education to the new century. Washington (DC): National Academies Press; 2005 [accessed 2016 Nov 20]. https://www.nap.edu/catalog/11338/ educating-the-engineer-of-2020-adapting-engineering-education-to-the.

Committee on Prospering in the Global Economy of the 21st Century: An Agenda for American Science and Technology, National Academy of Sciences, National Academy of Engineering, Institute of Medicine. Rising above the gathering storm: energizing and employing America for a brighter economic future. Washington (DC): The National Academies Press; 2007.

Yoder BL. Engineering by the numbers.

Washington (DC): American Society for Engineering Education; 2015 [accessed 2016 Nov 20]. https://www.asee.org/papers-and-publications/ publications/college-profiles/15EngineeringbytheNumbersPart1.pdf. According to the 2015 statistics, there were 11,702 doctoral degrees

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FOSSUM ET AL. granted in engineering [this excludes computer engineering degrees granted outside of engineering]. The report also indicates a total of 6,269 Assistant Professors of engineering in Fall 2014.

Assuming an average 6-year tenure as Assistant Professor and a 1:1 replacement suggests 1,045

5.

replacement openings each year if the number of assistant professors is approximately constant.

These numbers led to the 10% estimate.

Byers T, Seelig T, Sheppard S, Weilerstein P. Entrepreneurship: its role in engineering education. Bridge Natl Acad Eng. 4(2):35–40; 2013.

Technology and Innovation, Vol. 19, pp. 389-395, 2017 Printed in the USA. All rights reserved.

Copyright Š 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.389 www.technologyandinnovation.org

UNIVERSITY-BASED MAKERSPACES: A SOURCE OF INNOVATION Shane Farritor Department of Mechanical and Materials Engineering, University of Nebraska, Lincoln, NE, USA

Makerspaces are becoming more common on university campuses, but there is great variation in what constitutes a makerspace. On some campuses, many departmental classroom laboratories are being renamed or repurposed as makerspaces. Alternatively, other colleges are creating college-wide makerspaces for their students, and a few universities are even creating makerspaces for their entire campuses or their entire communities.

This paper presents the idea that university makerspaces can be a great source of innovation if they are properly conceived. Makerspaces that seek to create innovation should have certain characteristics. However, many of these characteristics do not come naturally to university-based makerspaces. Instead, a deliberate effort must be made to help promote innovation from a makerspace. In fact, many makerspace models inadvertently and explicitly exclude characteristics that are important to innovation. For example, a makerspace that is created by an engineering college might be more innovative if it allowed the use of the space by students outside of engineering (e.g., art, history, business). Making this happen might require a different funding structure or a different physical location for the makerspace.

Of course, no direct recipe or checklist exists that will ensure innovation. However, this paper lists characteristics that should be considered when designing or operating a makerspace. It is suggested that these characteristics will lead to increased makerspace innovation. The goal of this paper is to make makerspace administrators and participants aware of characteristics of the space that may lead to increased innovation.

Key words: Makerspace; Making; Innovation; Hardware; Entrepreneurship

BACKGROUND Makerspaces are a growing trend across the world and are increasingly appearing on university campuses (1-5). The White House under President Obama established an initiative to encourage more making opportunities for university students (6).

A makerspace (sometimes referred to as a fab lab, hobby shop, or hackerspace) is a physical space where individuals can build and create. University-based

makerspaces often focus on encouraging creativity, interdisciplinary collaboration, entrepreneurship, and/or experiential education. There are many types of university makerspaces (3), ranging from teaching labs renamed as makerspaces to large multidisciplinary makerspaces, with Case Western’s Sears think[box] being an excellent example of the latter (7). This paper will focus on issues to be considered if the goal of the university makerspace is to promote innovation.

_____________________ Accepted April 15, 2017.

Address correspondence to Shane Farritor, David & Nancy Lederer Professor, W358 Nebraska Hall, Department of Mechanical and Materials Engineering, University of Nebraska, Lincoln, NE 68588-0656, USA. Tel: +1 (402) 472-5805; Fax +1 (402) 472-1465. Email: sfarritor@unl.edu

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A good makerspace has both a physical space and a community. The physical space contains specialized tools and equipment (e.g., 3D printers, laser cutters, computer controlled embroidery machines, machining centers) that allow students to create projects that they are passionate about. There are many models for governing access to the physical space, most of which are based on a membership. Typically, membership requires some safety training and a contribution to the space (e.g., membership fee, time commitment).

Some makerspaces have formal training and a formal staff to operate and maintain the space, while other makerspaces are completely self-organized and are operated by members. More information is available on the functioning of makerspaces, including for-profit makerspaces (1), makerspaces in libraries (8), and university makerspaces (5,9). These interactive makerspaces can also foster a community by creating other modes of interaction, such as classes or activities. Being part of such a community can expand and improve the student’s education through outside-of-the-classroom experiential learning.

This article distinguishes makerspaces from traditional classroom laboratories in that students participate in makerspaces of their own accord and are self-directed. Traditional classes often require students to attend lab sessions to perform predetermined work, and the students are assigned grades based on the outcomes of this activity. This type of activity is not here considered makerspace activity.

Here, activity in makerspaces is generally outside the traditional academic setting. In makerspaces, students are self-motivated rather than motivated by grades or degree requirements.

Campus recreational facilities are a better analogy for describing a makerspace than traditional classroom laboratories. Campus recreation is to fitness what a makerspace can be to creativity. Students can participate in a campus recreational facility and gain access to specialized equipment (e.g., weight room, gym, pool), collaborate with students with similar interests (e.g., pick-up basketball), and take non-degree classes (e.g., spinning classes, rock climbing classes). All of these activities are focused on enhancing students’ fitness. Students are not required to participate; they only come to campus recreational centers to pursue their passions and do things they love. They go to improve themselves. In the same way,

students participate in makerspaces to gain access to specialized equipment, collaborate with students with similar creative interests, and take non-degree classes.

This paper presents the idea that certain characteristics of a makerspace can promote innovation.

The following sections describe those characteristics.

The premise is twofold: Makerspaces can be strong sources of innovation, and makerspaces that have more of the characteristics outlined below will generate more innovative ideas and products.

IMPORTANT ELEMENTS FOR INNOVATIVE MAKERSPACES Two important basic elements that lead to more innovation in a makerspace are intrinsic motivation and unstructured activity, and these elements are distinct from much of the university experience for students.

Intrinsic Motivation Intrinsic motivation, as opposed to extrinsic motivation, refers to behavior that is driven by internal rewards rather than rewards coming from another source. In some ways, simply attending college requires intrinsic motivation, as the student does not need to attend college. However, in reality, the day to day activities and the specific actions taken by students are largely driven by external requirements and therefore are extrinsically motivated. Homework assignments, class times and attendance, and exams are requirements that aren’t generated by the student.

Furthermore, most degree programs have a very specific list of required courses. These required courses may have some flexibility, such as an engineering program requiring two to three humanities electives.

However, even these flexible electives often require students to choose from another list of approved courses to fulfill the requirement. The result is that most of a student’s academic energy is focused on satisfying the externally imposed requirements to obtain a degree.

However, it has been shown that intrinsic motivation is important for increased innovative thinking (10,11). When someone originates a project and/or is self-motivated to solve a problem, more innovative results are possible. Passion and excitement for the

UNIVERSITY-BASED MAKERSPACES problem will lead to different thinking. Pink points to several open source examples, such as Wikipedia, where every contribution is provided by users who are almost exclusively not paid for the work and where intrinsic motivation has led to better and more innovative results than a traditional approach (10). Users post on Wikipedia because they are passionate about the subject they are describing. Pink also points to 3M’s “15% time” and then later Google’s use of “20% time.” These companies allow their employees to work on their own projects about one day per week (i.e., 20% of their time). These employees pursue new projects that they are individually passionate about, and this has been the source of several important products for these companies. Pink outlines how intrinsic motivation is especially important for creative tasks.

The research on self-motivation suggests that university makerspaces that are interested in producing new innovations should focus on member-generated activities. They should not, for example, focus on supporting existing classroom activities where the outcomes are externally assigned grades.

Unstructured Activity A second intangible element of university makerspaces that are trying to produce innovation is unstructured activity (11). Again, most student activities are highly structured. Classes have lectures and laboratories where all activities are scripted. The student is given assignments to perform and then are told in lecture the way in which the problems are to be solved. As an example, consider most homework assignments in engineering education. These assignments are very structured. The student is told to do a few specific, well-defined problems, usually culled from a textbook, in a specified amount of time.

The problems are sorted by chapter so the student knows which techniques to apply. Each problem will generally have exactly one correct answer (e.g., P = 34.1 psi). Tests, lectures, and lab assignments are similarly structured. Some classes may have design assignments with more flexibility, but they are generally more defined (general subject area, time to completion, scope of the problem) than the challenges of innovation.

Innovation, by definition, is not structured. Innovation requires new approaches to problems that are

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different than previous approaches. Any pre-scripted solution to a problem cannot be an innovative solution to that problem. Working on unstructured problems allows the student to challenge assumptions, restructure the problem, and find new paths to a solution. This also ties to the unstructured time set aside for 3M and Google employees.

Because unscripted thinking is central to innovative thought, university makerspaces should have a significant amount of time for students to work on unstructured activity. They should not, for example, focus on structured classroom laboratory activities but should instead allow users to explore and tinker without a defined outcome.

ENCOURAGING INNOVATION IN A MAKERSPACE Substantial evidence suggests that the culture of an environment has a significant impact on the amount of innovation that is produced (12,13).

The history of innovation shows that certain locations and times—such as Florence, Italy, during the Renaissance, ancient Greece, Scotland in the late 17th and early 18th centuries, and Silicon Valley from the 1970s to present day—produce a significant amount of innovative ideas when compared to similar populations and similar environments (13). The question then becomes why these locations at these times are so much more innovative than other locations that would seemingly have similar characteristics.

The premise of this paper is that these innovation-promoting characteristics can be identified and implemented (although imperfectly) so as to increase the output of innovative ideas. This paper proposes five characteristics that are important for university makerspaces to establish and develop a creative and innovative culture. Certainly, not all of these characteristics are required, and having these characteristics does not lead directly to innovation.

Instead, it is suggested here that having more of these characteristics tends to bring about a more creative environment.

Diversity of Ideas Encouraging a diversity of ideas is important to creating a makerspace that encourages innovation.

A diversity of ideas is the necessary first step in

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producing innovation. Many psychologists suggest that creativity is about making new combinations of existing ideas (11,13,14). This would suggest it is important to have a large variety of ideas to increase the number of possible combinations. It is also important to have ideas from outside the discipline of the problem. For example, techniques and ideas from textiles and fashion design might provide new approaches to problems in the medical device industry. This is the antithesis to “groupthink,� where everyone begins to see a problem from only one perspective, often leading to a stagnation of innovation.

This need for diversity has also been compared to innovation in the biological evolutionary process (12), where genetic diversity is needed to produce adaptations that solve new problems facing species as ecosystems change.

The first consequence of this for makerspaces is that several different disciplines should be involved in the makerspace. This is not how universities generally function, as most disciplines are divided by departments and colleges and often further segregated by buildings and geography. These existing divisions can lead to difficulties in establishing diverse makerspaces. For example, many of these isolated departments and colleges might simply rename existing laboratories as makerspaces. Also, the funding or physical space for a makerspace may come from one department or from one college. These constraints provide a strong incentive to only allow students affiliated with certain departments or colleges to use these spaces.

This paper suggests that university makerspaces that want to create innovation should try to increase the diversity of ideas in the space. Rather than an engineering shop recast as a makerspace, which will likely not produce the desired range of ideas, makerspaces can achieve diversity in several different ways.

First, the membership of the makerspace should be diverse. Second, the physical space should be located so as to encourage students from many disciplines to use the space. Finally, the tools and equipment in the space should also encourage a variety of activities, including tools for fabric and art as well as precision machining. An increase in the diversity of ideas will tend to produce an increase in the innovative ideas produced in a makerspace.

Diversity can also come in other forms, as college

students can be a homogeneous demographic in many ways. For example, some university makerspaces are open to people outside the university. Such a policy can allow new ideas and new perspectives to come in through the community. A variety of perspectives can also be cultivated by including older members, younger members, or members from industry.

Density of Ideas The second characteristic important to an innovative makerspace is to have a density of ideas. This density has been cited as one reason why cities exist (15). Having many people living in close proximity allows for tight collaboration and for ideas to be shared and spread. It allows for ideas to build upon other ideas and for ideas to advance.

The consequence for makerspaces is that they need to bring diverse ideas together into one location. Again, it is tempting to link several existing labs together under a common makerspace name.

This is not ideal if innovation is a goal. The preferred approach is to get the diverse groups together where they must interact, thus making it more likely for ideas to come together to form new solutions. It is an open question as to whether this density can be emulated through virtual connections.

Mixing of Ideas A diversity and a density of ideas is not enough to create innovation. These ideas must be mixed to create the possibility for new connections (11-13).

The mixing of ideas is not natural since ideas (i.e., work departments or sections) are generally divided along disciplines. In many ways, a university campus is specifically guilty of not mixing ideas. A university campus usually contains a diverse group of ideas and a high density of these ideas; however, they are most often divided into academic units that study specific, non-overlapping fields. While engineering, history, art, medicine, business, and many other disciplines are all researched in the small area of only a few city blocks, academic programs often do not encourage a mixing of ideas among these diverse disciplines.

The concept that diverse ideas must mix to create innovation is highlighted by the observation that, historically, major innovation hubs most often occur at crossroads and trading centers (13). It is suggested here that a mixing of diverse ideas is critical to new

UNIVERSITY-BASED MAKERSPACES innovations, and this principle should be applied to university makerspaces seeking to be innovative.

Much research points to the role of “third spaces” in innovation as a place for mixing ideas (11-13).

A third space is defined as a place where people come together that is not work and is not home. The traditional example of a third space is a coffee shop— leading to the cliché that new inventions are created on the back of a napkin. In the case of students, the laboratory or lecture hall is the student’s work space, the dorm room might be the student’s home space, and a makerspace or shop can be a student’s third space even if all are on the same university campus.

Makerspaces have great potential to serve as a student’s third space, a space where ideas can mix. The mixing of ideas is one of the great advantages makerspaces offer students, who may rarely encounter students from other fields in their discipline-specific work spaces or home spaces.

The mixing of ideas can be encouraged in makerspaces in several ways. First, the architecture of the makerspace can be used to promote collaboration. This might be accomplished by constructing a common bench space in the center of the lab to encourage different members of the space to work side by side and increase the likelihood that they will discuss their individual projects. The layout of the space may also encourage mixing. For example, an electronics shop might be located next to an art studio, and these spaces may be designed so that work in one shop can be observed from the other.

Makerspaces often have dining or social or gaming areas that can be a third space inside the makerspace.

Finally, even minor program details, such as bulletin idea boards, can encourage mixing in a makerspace.

For example, some makerspaces have display spaces where members can show the work they have created in the space. These displays encourage mixing when other members observe the display space and are exposed to other ideas.

Mechanisms for Ideas to Connect An environment created to promote the mixing of dense groups of diverse ideas still requires those ideas to connect (12,13). Sometimes the connections are obvious and automatic and sometimes subtle. It is proposed that steps can be taken in a university

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makerspace to encourage new connections of fledgling ideas.

There are many methods and activities that can be used to make connections in a makerspace. For example, something as simple as a message board (physical or virtual) can be used to help members connect. Often a person working in one discipline seeks skills from another. The makerspace should simplify and encourage these connections. For example, a fashion design student who wanted to create a garment that could change shape using electronic actuators might need assistance from an electrical engineer. A message board could help make this connection.

Another method to encourage such connections is to have design competitions that focus on interdisciplinary design problems. This can also be used to get outside groups involved in the space. For example, a research university might bring professionals from the clinical health field to talk about problems in clinical medicine. This could be the source of design problems that are then tackled by interdisciplinary design groups made up of members of the makerspace.

Mechanisms for Ideas to Grow Start-up businesses (and ideas) can face what is referred to as the “Valley of Death” between a proofof-concept for a product and profitability (16,17).

A makerspace with the characteristics outlined above will likely produce proof-of-concept products that have the potential to become innovations.

Makerspaces that desire innovation should have mechanisms in place to help ideas to grow and cross the Valley of Death. (Note, innovation is difficult to define, and a proof-of-concept product can be viewed as an innovation or as the result of an innovation.

Either way, it can be an important part of the process.)

In a research environment, seed grants are often used to help ideas grow and to solidify the connection of diverse ideas (18). Sometimes the desired goal of a seed grant is to get the researchers to publish together to formally solidify the connection to a point where publishable work has been done. The research is then in a place where a proposal for more substantial funding is possible. Similarly, seed awards can be used in makerspaces, allowing members to create a quality

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proof-of-concept product that could then be used to pitch to investors and to secure more substantial funding.

A more in-depth approach would be for a makerspace to incorporate or partner with a start-up business accelerator. Start-up business accelerators can come in many forms, but they provide education and assistance in areas such as market research and customer validation. Some business accelerators use a “boot camp” period to move an idea forward quickly.

A partnership between a university makerspace and a business accelerator that focuses on hardware-based innovation would be a strong source of innovation for any community. One strong example of this type of collaboration is think[box] at Case Western Reserve University (9).

SUMMARY: THE PROMISE OF UNIVERSITYBASED MAKERSPACES AS SOURCES FOR INNOVATION This paper presents characteristics of a makerspace that should be considered if a goal of the makerspace is to produce innovation. Innovation is unpredictable, and the characteristics described in the previous section can build upon one another. These characteristics are in no way required to have a good makerspace, and they will not ensure innovation. However, it is proposed here that makerspaces with more of these characteristics will tend to produce more innovation.

First, it should be recognized that members should be intrinsically motivated to use the space. There should also be ample time provided in the space to allow students to build their own projects that they are passionate about. This work should also be unstructured—in that there is no formula or recipe that must be followed—allowing students to tinker and hack rather than being focused on completing an assignment.

Second, the design of the makerspace should also support innovation. The space should contain a diversity of ideas rather than ideas from just one discipline, age group, or demographic. All of these ideas should exist in the same location so there is a density of ideas as well. Then, this dense and diverse group of ideas should be mixed so that new combinations of ideas can be formed. The makerspace should have a density of diverse ideas that mix and churn. These goals

can be accomplished with the physical design and/ or location of the space. Policies and programmatic details should be examined with respect to how they impact the characteristics that support innovation.

Finally, mechanisms can be put in place to make new ideas come together and grow. For example, design competitions, hacker weekends, or message boards can be used to make ideas connect, while techniques such as seed grants or business accelerators can then help these fledgling ideas grow.

ACKNOWLEDGMENTS The author declares no conflicts of interest.

REFERENCES 1. Hatch M. The maker movement manifesto: rules for innovation in the new world of crafters, hackers, and tinkerers. 1st ed. New York (NY): McGraw-Hill Education; 2013.

2. Miller PN. Is ‘design thinking’ the new liberal arts? The Chronicle of Higher Education. 2015 Mar 26.

3. Byrne D, Davidson C. State of making report.

Pittsburgh (PA): MakeSchools Higher Education Alliance; 2015.

4. Forest CR, Moore RA, Jariwala AS, Fasse BB, Linsey J, Newstetter W, Ngo P, Quintero C. The Invention Studio: a university maker space and culture. Adv Eng Educ. 4(2); 2014.

5. Levy B, Morocz R, Nagel R, Newstetter W, Talley K, Forest C, Linsey J. University maker spaces: discovery, optimization and measurement of impacts. 122nd Annual Conference & Exposition of the American Society for Engineering Education, Seattle, WA, Jun 14-17, 2015.

6. Executive Office of the President. Building a nation of makers: universities and colleges pledge to expand opportunities to make. Washington (DC); 2014.

7. Freiman LS. Higher education: Sears Thinkbox, Case Western Reserve University. Cleveland Business Connects Magazine. Jun 2016.

8. Colegrove T. Editorial board thoughts: libraries as makerspace? ITAL. 32(1):2–5; 2013.

9. think[box]. Cleveland (OH): Case Western Reserve University; [accessed 2016 Nov 15]. http://thinkbox.case.edu/.

UNIVERSITY-BASED MAKERSPACES 10. Pink D. Drive: the surprising truth about what motivates us. New York (NY): Riverhead Books; 2011.

11. Sawyer K. Group Genius: the creative power of collaboration. 1st ed. New York (NY): Basic Books; 2008.

12. Johnson S. Where good ideas come from: the natural history of innovation. New York (NY): Riverhead Books; 2011.

13. Weiner E. The geography of genius: a search for the world’s most creative places from ancient Athens to Silicon Valley. New York (NY): Simon & Schuster; 2016.

14. Von Oech R. A whack on the side of the head.

25th Anniversary Edition. New York (NY): Grand

15.

16.

17.

18.

395

Central Publishing; 2008.

Diamond J. Guns, germs, and steel: the fates of human societies. 1st ed. New York (NY): W. W. Norton & Company; 1999.

Blank S. The four steps to the epiphany. 2nd ed.

Pescadero (CA): K&S Ranch; 2013.

Swanson JA, Baird ML. Engineering your start-up: a guide for the high-tech entrepreneur.

2nd ed. Belmont (CA): Professional Publications, Inc.; 2003.

Herber D, Mendez-Hinds J, Miner J, Sedam M, Wozniak K, McDevitt V, Sanberg P. University seed capital programs: benefits beyond the loan.

Technol Innov. 18(4):305-314; 2017.

Technology and Innovation, Vol. 19, pp. 397-413, 2017 Printed in the USA. All rights reserved.

Copyright Š 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.397 www.technologyandinnovation.org

EVENT ANALYTICS FOR INNOVATION TRAJECTORIES: UNDERSTANDING INPUTS AND OUTCOMES FOR ENTREPRENEURIAL SUCCESS C. Scott Dempwolf1 and Ben Shneiderman2 Department of Urban Studies and Planning, National Center for Smart Growth, University of Maryland, College Park, MD, USA 2 Department of Computer Science, University of Maryland Institute for Advanced Computer Science, University of Maryland, College Park, MD, USA 1

New analysis tools are expanding the options for innovation researchers. While previous researchers often speculated on the relationship between innovation inputs, such as patents or funding, and innovation outcomes, such as product releases or initial public offerings, new software tools enable researchers to analyze innovation event data more efficiently. Tools such as EventFlow make it possible to rapidly scan visual displays, algorithmically search for patterns, and study an aggregated view that shows common and rare patterns. This paper presents initial examples, using data from 34,331 drugs or medical devices, of how event analytic software tools, such as EventFlow, could be applied to innovation research.

Key words: Event analytics; EventFlow; Innovation metrics; STI; Visualization

INTRODUCTION: STI SYSTEMS AND PROCESSES Worldwide interest in promoting economic growth through innovation has grown dramatically.

As a result, there is increased effort by researchers in science policy and scientometrics to study and measure science, technology, and innovation (STI) to help understand the basis for success or failure.

They are concerned with understanding, describing, measuring, and visualizing the scope, organization, and structure of human knowledge as a dynamic collection of concepts (1).

Such concepts are connected to and acted upon by a network of scholars and inventors engaged in the discovery and creation of new knowledge and technologies. These discoverers and inventors, in turn, engage with networks of institutions, agencies, organizations, intermediaries, entrepreneurs, and investors who sponsor their activities and help translate the results into new products and services in the marketplace. Taken together, these networks, along with their embedded knowledge and resources, comprise what we have recently recognized as innovation ecosystems. Understanding, modeling, and measuring

_____________________ Accepted April 15, 2017.

Address correspondence to C. Scott Dempwolf, Assistant Research Professor, School of Architecture, Planning and Preservation, 3835 Campus Dr., College Park, MD 20742, USA. Tel: +1 (301) 405-6307; Fax: +1 (301) 314-9583. E-mail:dempy@umd.edu

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these dynamic and complex adaptive systems has become an important priority within science policy and scientometrics (2).

Our modeling of research and development activities enriches the prevailing network approach with event analytics by focusing on time-stamped point events, such as getting a patent, or interval events, such as the funding period covered by a grant or contract.

We see STI processes as comprising sequences of point and interval events that together result in the translation of knowledge and research into new products and services in the marketplace. (The phrases “products” or “products in the marketplace” are construed broadly throughout this paper to include all types of innovation and all types of “marketplaces,” including public domain.) Point events are associated with a single date and time (e.g., the date of a patent application), while interval events are associated with start and end dates and times. Research projects or research grants with start and end dates are examples of interval events. These events generally fall into one of several categories, including research, invention, proof, and several types of commercialization events.

(The order of activities here generally follows the linear model of innovation. This ordering is primarily a matter of convenience and should not be construed as proffering any particular model or theory of STI processes.) Each event is associated with a document or record that describes the event, the key people and organizations involved and what roles they played, when and where the event occurred, along with other attributes. The information from these records, especially dates, may be used to model event networks of people, organizations, places, and documents.

Events that contribute to the development of specific products and services may be associated with each other, creating product and service event sequences or trajectories. The trajectories may be connected through the networks of people, organizations, places, and documents involved and through their contributions to specific product and service event sequences. Conceptually, this dual modeling structure (innovation networks and innovation event trajectories) provides a linkage between STI as complex adaptive systems and STI as complex processes.

Why Innovation Is Hard to Measure and How Event Analytics Can Help A streamlined definition of innovation is the process of working on marketplace problems that prompts innovators to transform ideas and scientific knowledge into new products (broadly defined to include services). The innovation process connects marketplace problems with research events; however, each product follows a unique path involving different types of activities, including research, publication, invention, prototyping, proof-of-concept, and several commercialization events culminating in a new product launch. The trajectory a product takes may involve multiple events within any stage and may involve revisiting a prior stage if remedial work is required. Thus, the first difficulty in measuring innovation is the unique and variable nature of the innovation trajectory or sequence of events for each product.

A second difficulty is that early-stage research events are often undertaken for the purposes of knowledge creation and publication. In fact, the explicit innovation goal of a new product may not yet exist. There is a temptation to define the distinctions among science, technology, and innovation more rigidly, but this creates as many problems as it solves. The creative moment when the product is first envisioned involves a specific set of conditions that are a function of the sequence and characteristics of events up to that point. It is as if the innovation path suddenly appears midway through the journey.

Mathematically, this describes a Markov chain or Bayesian network model, in which each event in the sequence is influenced by the cumulative effect of everything that has happened up to that point. Neither the final destination nor the intermediate events can be known with certainty. They may, however, be estimated based on certain probability distributions.

Modeling and analyzing innovation event trajectories for successful products a posteriori establishes the basis for estimating those baseline probability distributions. This, in turn, allows the formulation and testing of more sophisticated hypotheses. It may also allow the development of predictive models or facilitate machine learning and the development of related big data applications. Finally, the goal would be prescriptive modeling that would enable policy

EVENT ANALYTICS FOR INNOVATION makers at funding agencies, investors, and entrepreneurs to make decisions that lead to more successful outcomes.

Current Innovation Metrics and the Need for New Measures of Innovation In 2011, the Committee on National Statistics and the Board on Science, Technology, and Economic Policy of the National Research Council convened the Panel on Developing Science, Technology, and Innovation Indicators for the Future and charged the members with assessing the current state of innovation metrics and preparing recommendations for future measures of STI. The panel’s 2014 report was detailed and extensive in both areas, drawing on both U.S. and international research (3). The report is intended to provide guidance to the National Center for Science and Engineering Statistics (NCSES) at the U.S. National Science Foundation (NSF), the study’s sponsor.

NCSES currently produces many statistical measures of innovation inputs, outputs, and longterm outcomes, including metrics for: research and development (R&D); national R&D expenditures and performance (by type of industry and source of funds); commercial outputs and outcomes; knowledge outputs; STEM education; STEM workforce/ talent; and organizations/institutions (3).

Traditionally, NCSES and its predecessors have used surveys, including the Business R&D and Innovation Survey, to trace the inputs and outputs of the innovation system. More recently, alternative data sources, including administrative and electronic transaction records, are increasingly available (3).

Along with these new data sources, widespread and low cost computing power has made the use of new analytic methods possible, such as network and temporal analysis. The availability of new tools, including NodeXL (NodeXL: Network Overview, Discovery and Exploration for Excel https://nodexl.codeplex. com/) for network analysis and EventFlow (EventFlow: Visual Analysis of Temporal Event Sequences http://hcil.umd.edu/eventflow/) for temporal analysis, can help innovation researchers develop new innovation metrics.

The panel was unequivocal on its recommendation that NCSES should develop new metrics of

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innovation, particularly innovation outputs. These metrics are needed, the panel concluded, “to assess the impact of federal, state, and local innovation policies, such as the amount and direction of federal R&D funding, support for STEM education at the graduate level, and regulation of new products and services. In addition, having good measures of innovation output facilitates comparison of the United States with other countries in a key area that promotes economic growth” (3). The report also listed a selection of real and relevant policy questions for which new metrics are required to formulate appropriate answers.

Visualization as a Tool for Exploration and Understanding Innovation researchers have used diverse visualizations to explore data, derive insights, and present results. Traditional visualizations include these data types with example applications from innovation research (examples in Figure 1): • Choropleth maps to show intensity of innovation activity by county, state, etc.

• Scatterplots and heat maps • Timelines and hierarchies to show intensity of innovation activity in patent taxonomies • Networks to show connections among university or venture capital firms and start-up companies The emergence of tools for new data types offers fresh opportunities for innovation researchers to understand event patterns that could guide interventions to increase the success of innovation efforts.

Current interest in event analytics has been triggered by the growth of electronic health records, which now provide online access to tens of millions of patient histories. These histories reveal patterns of medication compliance, links between treatments and side effects, and the relationship between interventions and outcomes (4,5).

Increasing availability of innovation histories could produce similar benefits by allowing researchers for the first time to study the relationships between events in start-up companies and the eventual success or failure of those companies. Event analytics is a new and growing topic within visual analytics that combines interactive exploration with statistical tools to find expected common trajectories and

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Figure 1. Clockwise from left (a) Choropleth map: biomedical – pharmaceutical hot spot analysis by county, 2009. Analysis by Zhi Li, University of Maryland. Data Source: StatsAmerica (http://www.statsamerica.org/); (b) Spatial hot spot analysis of job concentrations in professional, scientific and technical services in Maryland, 2014; (c) and (d) Spatial distribution and concentration of innovative companies in Howard County, MD Source: Analysis and graphics by Cole Greene (6); (e) Time evolution of the community structure of the network of citations between papers published in journals of the American Physical Society (APS). Time is divided into nine decades, from 1927 until 2006. In each decade, the most cited papers were selected (about 3,000). The communities are classified based on the APS journal where the largest relative fraction of papers in the community were published (indicated by the symbols).

While links between different decades usually involve consecutive periods, there are five links connecting well-separated scientific ages (thick edges in the figure) (1); (f) Network model of Regenerative Medicine Cluster in Howard County, MD 2010 – 2015 (6).

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unexpected anomalies. Patterns may be as simple as seeing how often patents lead to start-up companies getting founded or venture capital investments lead to acquisition of start-up companies, or they may be more complex.

Temporal event sequences consist of thousands or millions of events, which include the record ID (company name, ID#, etc.), a timestamp (could be by the year or day or to the second; e.g., 6-2-25), and an event category (patent, company launched, initial public offering, etc.). This information about single point events can be assembled into records with a dozen or a thousand events (Table 1).

Temporal event sequences also include interval events, such as a one-year Small Business Innovation Research (SBIR) grant or a research project or clinical trial, in which case the event will have a start and an end timestamp (Table 2).

Initial efforts usually focus on cleaning the data, which often contains incorrect, incomplete, redundant, mislabeled, or surprising inputs. Typical errors include blank fields, erroneous record ID, misspelled event category, incorrect timestamp, or a start date that is later than an end date. Visual displays amplify human abilities to spot errors such as outliers in a scatterplot, surprising spikes in a timeline, or missing links in a network diagram.

The second data challenge involves record matching and disambiguation across data sources. For example, this project involves matching data from U.S. Food and Drug Administration (FDA) approvals, clinical trials, patents, research grants, and other sources where EventFlow records correspond to individual products. While products are named in the FDA databases and often in clinical trial data, those names often do not appear in patent or research grant data. Federal agencies, including the National Institutes of Health (NIH) and the FDA, have produced some ad hoc databases that help with some of this matching—allowing us to present some preliminary results in this paper—but much of this work remains to be done.

Once data has been cleaned and matched, standard algorithms for identifying volatile or stable periods in timelines can be used to speed analyses. The combination of visual displays and statistical methods brings great power to analysts.

HOW LONG DOES INNOVATION TAKE? Innovation trajectories, or the paths or lines of development that innovation follows, describe the sequences of innovation activities that translate initial and intermediate inputs into intermediate outputs and final outcomes. Like physical trajectories,

Table 1. Sample Single-Point Events

Record ID

Event Category

Start Date

ALTOPREV

Patent

12/12/1997

docnum="5916595";Organization= "Andrx Pharmaceuticals, Inc"

ALTOPREV

Patent

12/12/1997

docnum="6485748";Organization= "Andrx Pharmaceuticals, Inc"

ALTOPREV

Patent

3/23/1998

docnum="6080778";Organization="CHILDREN'S HOSPITAL CORP"

ALTOPREV

FDA Approval

6/26/2002

docnum="N21316";Organization="COVIS PHARMA SARL"

AMYVID

Patent

3/26/2007

docnum="7687052";Organization="UNIVERSITY OF PENNSYLVANIA"

AMYVID

Patent

8/5/2008

docnum="8506929";Organization=“UNIVERSITY OF PENNSYLVANIA"

AMYVID

FDA Approval

4/6/2012

cnum="N202008";Organization="AVID RADIOPHARMACEUTICALS"

Attributes

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403

Table 2. Sample Span Events

Record ID

Event Category

Start Date

End Date

AMYVID

Research

7/1/2003

2/28/2013

docnum="R01AG022559";Organization= "UNIVERSITY OF PENNSYLVANIA"

ALTOPREV

Research

4/1/1996

2/29/2000

docnum="R01NS033325";Organization= "CHILDREN'S HOSPITAL BOSTON"

innovation trajectories are functions of innovation inputs as well as time.

Innovation inputs include knowledge, talent, and a product idea; intellectual property (IP); proof-ofconcept or proof-of-relevance; entrepreneurship; and capital. Each event in an innovation sequence uses innovation inputs and produces outputs or outcomes that, in turn, become intermediate inputs in later activities. Entrepreneurial success is the desired outcome and is defined herein as successful commercialization of a product resulting in the launch of a new product in the marketplace.

A useful empirical question is: How long do these innovation trajectories take? The answer to this question has implications for public and private investment in innovation as well as public policy.

For example, one open policy question is: Do innovation accelerators actually accelerate innovation and, if so, by how much? Policymakers considering the investment of public funds in accelerator programs want to know if such programs are effective before committing public funds (7).

New temporal metrics for innovation will help future researchers answer many policy questions, including those identified in the National Research Council’s 2014 report. Indeed, baseline measures may hold the key to developing a better class of metrics for innovation and its economic impacts. Realistic estimates of confidence intervals for the duration of innovation sequences could reduce certain types of investment risk, thus making more capital available for prototyping and commercialization activities.

Billions of dollars are invested in the commercialization of new products; however, most of that money increasingly favors later-stage investments, where there is greater certainty about the product’s potential success and how long investment capital will be tied up. The question of how to shrink the so-called “Valley of Death”—the stage where many

Attributes

ideas and start-ups die due to lack of funding—and get more investment capital flowing into earlier-stage investments has remained unanswered in business, economic development, and public policy circles for many years. Event analytics may help shed some light on this problem, catalyzing significant economic impacts in the process.

FOCUSING ON DRUGS AND MEDICAL DEVICES This paper demonstrates our analytic methods using drugs and medical devices, which is an important example for which data is readily available because they are regulated products. We model innovation trajectories as sequences of events leading to the launch of new products, which is the desired outcome for entrepreneurial success. Clinical trials and FDA approvals offer useful proxies for the commercialization process, where available data is often limited. Certain FDA approvals may also provide useful proxies for product launch dates.

EVENT ANALYTICS FOR INNOVATION TRAJECTORIES EventFlow produces several event analytics and different visualizations that can help users understand innovation trajectories in new ways. By grouping similar event sequence patterns together, EventFlow provides users with descriptive statistics and visualizations for groups of records with the same sequence pattern. These descriptive statistics and visualizations have several uses: Descriptive Statistics (Metrics or Measures): For most research projects, the production of descriptive statistics is not cause for much excitement. However, in the case of innovation, there are no clear metrics on how long innovation processes take.

Visualization and Exploration of Sequence Patterns: Understanding the compositions and frequencies of different sequence patterns may also yield

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new insights and frame better hypotheses. EventFlow provides tools for visually simplifying event sequences to reveal common and rare patterns (8,9).

Theory Formation (Modeling): A key goal for researchers is to develop and test theories so as to guide future activities. The well-established linear model of innovation (basic research leads to applied research, then product development, culminating in commercialization) has its followers, as well as many critics. Comparisons with alternative models such as the ABC principle (applied and basic combined) could advance understanding of what leads to more frequently successful outcomes (10). It is fairly common practice in articles and presentations to show the linear model because of its simplicity and then immediately state that, in practice, innovation rarely follows the linear model. The popular understanding of innovation might be improved by documenting the prevalence of the linear model and its alternatives.

Hypothesis Testing: Event analytics can be as simple as seeing if event type A occurs more frequently before or after event type B. For example, do patents precede or follow founding of companies?

Another simple question is: How soon after founding a company do companies release a product? A refined version of this question might examine the distribution of times between founding a company and releasing a product. There are more sophisticated questions that can also be posed in event analytic tools, such as: Do companies with three or more patents before product launches have more successful outcomes than companies with fewer patents?

MODELING AND MEASURING INNOVATION TRAJECTORIES: DATA AND EXAMPLES The following examples are based on a dataset comprising 34,331 records, each representing a specific drug or medical device. Each record contains the events—research, patents, clinical trials and FDA approvals—associated with that product. In total, the model includes 85,690 events. The list of event types and the count of each type is shown at the bottom of the left EventFlow panel shown in Figure 2.

As a practical matter, answering the question of how long innovation takes requires identifying start and end points. In our first example, we take the date of first patent application as the starting point and a reasonable proxy for the date that the initial

product idea was first conceived. Limiting our analysis to drugs and medical devices, we take the date of final FDA approval as the end date and a reasonable proxy for product launch date. Neither the dates that commercial ideas were originally conceived nor the actual product launch dates are reliably recorded or made publicly available, thus the need for proxies.

The datasets available for modeling STI processes (see Table 3) have several current limitations, and much of the work yet to be done under this study involves cleaning, matching, transforming, and linking existing datasets. We present two preliminary examples that demonstrate some of the event analytics capabilities of EventFlow (www.cs.umd.edu/ hcil/eventflow) and suggest the methods and kinds of final results we might expect when all of the data cleaning and matching is completed.

The first example models and analyzes the trajectories starting with clinical trials and ending with last FDA approval for 2,402 medical devices. Clinical trial success is typically a necessary input for final FDA approval. In certain cases, successful results in early-stage trials may be sufficient for provisional, temporary approval, allowing the drug or device to be deployed prior to completion of the full set of clinical trials. The preliminary results of this second analysis demonstrate EventFlow’s ability to simplify the visualization of the dataset in ways that suggest overarching patterns in the data and allow researchers to pose clear, simple questions for further investigation. In this case, the visualization shows two distinct groups in the data: one in which the FDA approval is received after clinical trials are completed and one in which FDA approval is received during the clinical trials (see Figures 3 and 4). The visualizations suggest several additional research questions, demonstrating EventFlow’s usefulness as a tool for data exploration.

The second example analyzes drug innovation trajectories from first patent to last FDA approval for 884 drugs, resulting in mean, median, and standard deviation metrics for these trajectories (see Figures 5 and 6).

Data Gathering for Innovation Trajectories We use the EventFlow software to model innovation trajectories in drugs and medical devices from multiple datasets (Table 3):

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Table 3. Data Sources for Temporal Analysis of STI

Drug & Medical Device Data Sources

Drugs / Devices

Notes

RePORTER PATENTS C ALL RePORTER CLINICAL STUDIES C ALL CTTI AACT Database FDA Orange Book

Drugs

Drugs@FDA Pre-Market Approvals (PMA)

Med Devices

Pending and Potential Data Sources SBIR/STTR

Pending

CrunchBase

Potential (Proprietary)

NSF

Pending / Potential

Supporting and Core Data Sources NIH RePORTER PatentsView USASpending STARMETRICS

A BRIEF INTRODUCTION TO EventFlow Based on work with 40+ case study projects, we find that point and interval events provide sufficient richness to describe the records in most applications.

Point events have a record ID, a categorical event name, and a timestamp. Interval events have a record ID, a categorical event name, a start time, and an end time. Each point or interval event can have attributes, such as a patent category or a clinical trial director’s name. Eventflow constructs a record by collecting all the events that have the same record ID. When a dataset is loaded, EventFlow shows the records in a timeline view, with time moving from left to right.

The records are shown in a scrolling timeline window (rightmost panel in Figure 2) sorted by record ID with the lowest value at the top. Within each record, point events are shown as triangles with a distinct color for each point event type. Interval events are shown as colored horizontal lines with bars on the ends.

The center panel aggregates individual records into a summary overview showing patterns in how events are related to one another within records. The aggregated display starts with the most common

first event at the top left. The records with the higher frequency of an event name will be grouped first and shown as a vertical bar whose height indicates the number of records with that sequence. The grouping by common event names continues from left to right until all events are shown. Point events are shown as a vertical bar, where the distance to adjoining vertical bars shows the average time between the events.

Interval events are shown by a rectangular region, whose width is the average duration of the intervals. Complete explanations are in the user manual, which includes many videos demonstrating the use of EventFlow (http://www.cs.umd.edu/hcil/eventflow/ manual/index.html).

EXAMPLE 1: MEDICAL DEVICE CLINICAL TRIALS AND FDA APPROVALS Figure 3 shows clinical trials and FDA approvals for 2,325 medical devices. The EventFlow overview panel reveals two common patterns. For just over half the records, FDA approval was received on average two years and eight months AFTER the end of clinical trials (upper cohort). In just under half the records, FDA approval was received DURING clinical trials.

Figure 2. The EventFlow user interface consists of three panels. The control panel on the left displays model information along with formatting and processing options. The timeline panel on the right displays event timelines for individual records, along with tabs for searching and filtering records based on events and attributes. In the center is the overview panel, which aggregates records based on event sequence patterns, providing a condensed graphical representation of those event patterns.

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Figure 3. Clinical trials to FDA approval for 2,325 medical devices. The EventFlow overview panel reveals two common patterns. For just over half the records, FDA approval was received on average 2 years 8 months AFTER the end of clinical trials (upper cohort). In just under half the records, FDA approval was received DURING clinical trials. Several EventFlow tools were used to clean up and simplify the visualization without altering the underlying data model.

EVENT ANALYTICS FOR INNOVATION 407

Figure 4. Clinical trials to FDA approval for 2,325 medical devices. With the same underlying model as depicted in Figure 3, this image shows the exploration of event distributions for two non-adjacent time points—the start of clinical trials to final FDA approval. While the overall duration for the upper cohort averages 6 years and 10 months, we can quickly see from the time scale bar that the duration from the start of clinical trials to FDA approval in the lower cohort is about two years shorter, while the overall duration of clinical trials is considerably longer in the lower cohort.

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Figure 5. First patent to FDA approval for 688 drugs. The overview panel reveals that there are 6 main sequence patterns between these two events. The predominant pattern, covering nearly half the records, involves a period of patenting for several years followed by a gap and then followed by FDA approval. Presumably clinical trials and other activities are taking place as well between first patent and final FDA approval. However, three-way data matching across FDA, clinical trials, and patent databases has yet to be done.

EVENT ANALYTICS FOR INNOVATION 409

Figure 6. First patent to FDA approval for 688 drugs. The question of how long it takes to get a new drug to market is most often answered by rules of thumb or anecdotal evidence.

This image is among the first to actually show statistics and a distribution, with average duration of 9 years and 4 months for two prevalent event sequence patterns. These results are preliminary. Additional cleaning and matching of the data, along with the augmentation of record attributes, may allow for useful confidence intervals to be generated by, for example, segmenting the sample according to drug class or other attributes.

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EVENT ANALYTICS FOR INNOVATION Several EventFlow tools were used to clean up and simplify the visualization without altering the underlying data model.

Figure 4 shows clinical trials and FDA approvals for 2,325 medical devices. With the same underlying model as depicted in Figure 3, this image shows the exploration of event distributions for two non-adjacent time points—the start of clinical trials to final FDA approval. While the overall duration for the upper cohort averages six years and ten months, we can quickly see from the time scale bar that the duration from the start of clinical trials to FDA approval in the lower cohort is about two years shorter. Overall duration of clinical trials is considerably longer in the lower cohort. These simple graphics immediately provoke and/or frame several research questions.

Our intent here is not to answer or even ask those questions but, rather, to demonstrate the power of event analytics in facilitating that process.

EXAMPLE 2: FROM FIRST PATENT APPLICATIONS TO FINAL FDA APPROVAL Figure 5 shows events from first patent and FDA approval for 688 drugs. The overview panel reveals that there are six main sequence patterns between these two events. The predominant pattern, covering nearly half the records, involves a period of patenting for several years, followed by a gap, followed by FDA approval. Presumably, clinical trials and other activities are taking place as well between first patent and final FDA approval. However, three-way data matching across FDA, clinical trials, and patent databases has yet to be done.

Figure 6 shows first patent to FDA approval for 688 drugs. The question of how long it takes to get a new drug to market is most often answered by rules of thumb or anecdotal evidence. This image is among the first to actually show statistics and a distribution, with an average duration of nine years and four months for two prevalent event sequence patterns. These results are preliminary. Additional cleaning and matching of the data, along with the augmentation of record attributes, may allow for useful confidence intervals to be generated by, for example, segmenting the sample according to drug class or other attributes.

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DISCUSSION AND FUTURE DIRECTIONS This paper presents a new tool and a novel approach for temporal analysis of innovation trajectories using examples and data from drug and medical device activities. While significant data processing work remains to match events from multiple datasets to product records, the brief examples shown in this paper suggest that temporal analysis of innovation trajectories with EventFlow can yield valuable information about the structure of innovation processes and new statistical metrics of how long these activities and processes take.

Innovation processes have social, spatial, technological, and temporal characteristics. Quantitative analyses using geospatial and social network methods have yielded many useful insights, and a variety of quantitative methods have been applied to understanding and visualizing the technological dimension of innovation. However, most temporal analyses have been less robust. The development of a new statistical temporal baseline and metrics helps solve this problem and facilitates many new types of analyses.

As the clinical trial and FDA approval example suggested, obtaining FDA approval during clinical trials appears to shorten time-to-market by about two years according to preliminary results (additional validation work in process). That same analysis raises obvious questions about the two types of processes.

Why is there a two- to three-year lag in the upper group between completion of the clinical trials and FDA approval? Are the FDA approvals in the lower group qualitatively different from those in the upper group? For example, are they “preliminary” or “fasttrack” approvals? Are the devices in the upper group qualitatively different from those in the lower group?

What are the implications for science and regulatory policy? Expanding product-based temporal analyses beyond drugs and medical devices will allow exploration of questions regarding how differences in the sequences of activities impact innovation outcomes across a range of different technologies.

Other seemingly simple questions where the metrics developed using EventFlow could help include: • Do innovation accelerators actually accelerate innovation? That is, do they shorten the duration of the innovation process from idea to market?

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• Do regions with higher innovation network density innovate faster? What network structures are associated with faster innovation?

Both are active research questions for the authors.

Regarding accelerators, a 2014 study of innovation accelerators for the U.S. Small Business Administration found no good metrics in the literature that answered the question of whether accelerators did indeed accelerate innovation (7). A subsequent network analysis comparing outcomes between 77 accelerator-affiliated start-ups and 77 non-accelerator-affiliated start-ups receiving angel funding found that the accelerator subnetwork was 8.5 times larger than the unaffiliated angel network and exhibited more opportunity for brokerage. Accelerators invested 33% less per start-up in angel funding ($100,000 vs. $150,000) and 50% less overall ($1.3 billion vs. $2.6 billion) than unaffiliated angels. Combined, their start-ups raised an additional $41 billion in subsequent funding rounds and acquisitions (7). While these results suggest that accelerator-affiliated startups may be more efficient, they do not answer the question of whether the accelerator-related start-ups achieved those results faster than non-accelerator start-ups. A pending EventFlow offers the potential to answer that question using the same dataset (CrunchBase) as the 2014 study.

The question of whether regions with higher network density innovate faster was recently embedded in a successful funding application for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) under the National Institute of Standards and Technology. The authors will use EventFlow and NodeXL to model the network structure and innovation outcomes of NIIMBL partners and others in multiple regions throughout the U.S. over the next five years to answer this and other related questions.

CURRENT DATA LIMITATIONS As promising as the preliminary results are, several data limitations are hindering broader application of this temporal analysis technology to understanding and measuring innovation processes: 1. Data is typically not collected or organized around products as the end result of innovation. Product data is available for drugs and

2.

3.

4.

5.

6.

7.

medical devices because they are regulated and tested by product name. Otherwise, products are typically not identified in STI data sources. One data source that associates product names with the firms that produce them is the UPC database. The dates associated with UPC records are the date the record was last updated rather than the date of product launch, but the source is worth further investigation.

STI data resides in multiple unlinked administrative databases, and data quality is variable. Data cleaning, matching, and disambiguation is a significant, time-consuming, and ongoing task. Records are not always complete, and augmentation may be necessary. Efforts to automate data preparation processes through machine learning and other algorithms are underway, but this will still take time.

Innovation processes comprise many different events, and those events may involve different networks of people and organizations.

Finding the relationships among events is not always easy.

Technology topics have not been standardized across the various types of events although there have been numerous advances in topical analysis and natural language processing.

Data remains incomplete.

FDA drug databases and medical device databases are structured differently and contain different information. For example, medical devices may be linked to clinical trials, but there are no linkages between drugs and clinical trials. Drugs may be linked to patents, but there are no linkages between medical devices and patents.

Applying this methodology to other critical industry sectors may be useful. Clean technology and energy, for example, share many similarities with medical devices in terms of inputs, outputs, innovation trajectories, regulations, and challenges. The Lab-to-Market initiative and the Department of Energy’s Office of Energy Efficiency and Renewable Energy may offer comparable data to help overcome the identified data challenges.

EVENT ANALYTICS FOR INNOVATION

CONCLUSIONS This preliminary exploration of using timestamped event data to understand innovation trajectories shows promising possibilities. Even basic descriptive data reporting can substantially advance the capacity for evidence-based decisions by policy makers, investors, and entrepreneurs. Key goals include a better understanding of which inputs produce more reliably successful outcomes.

While geospatial, multi-variate, time series, hierarchical, and network data analyses are widely used, event analytics analysis represents a fruitful new path for researchers. As reliable datasets with temporal event sequences become more widely available, these event analytic approaches seem likely to produce valuable results that could speed innovation trajectories and make successful outcomes more common.

ACKNOWLEDGMENTS This research was supported in part by the National Science Foundation, Award #1551041. The authors declare no conflicts of interest. Scott Dempwolf wishes to acknowledge ongoing research support from the U.S. Economic Development Administration’s University Center Program.

REFERENCES 1. Scharnhorst A, Börner K, van den Besselaar P, editors. Models of science dynamics: encounters between complexity theory and information sciences. New York (NY): Springer; 2012.

2. Börner K, Edmonds B, Stasa M, Scharnhorst AM. Simulating the processes of science, technology, and innovation. Scientometrics. 110(1):387-390; 2016.

3. Litan RE, Wyckoff AW, Fealing KH, editors.

Capturing change in science, technology, and innovation: improving indicators to inform policy. Washington (DC): The National Academies Press; 2014.

4.

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Carter EA, Burd RS, Monroe M, Plaisant C, Shneiderman B. Using eventflow to analyze task performance during trauma resuscitation.

Poster session presented at Workshop Interactive Systems in Healthcare, WISH2013; 2013 Nov 16; Washington DC. 5. Onukwugha E, Plaisant C, Shneiderman B. Data visualization tools for investigating health services utilization among cancer patients. In: Hesse BW, Ahern D, Beckjord E, editors. Oncology informatics. London (UK): Elsevier Inc.; 2016. p. 207-229.

6. Dempwolf CS, Allen T, Benoit E, Choudhry R, Farhan H, Franklin K, Greene C, Haller A, Johnson J, Mohamed A, Norman K, Prindle E, Rockwell Z, Schlie D. Innovation-led economic development in Howard County, Maryland: using cluster analysis, network analysis and spatial analysis to identify economic development strategies. College Park (MD): University of Maryland, College Park; 2015.

7. Dempwolf CS, Auer J, Dippolito M. Innovation accelerators: defining characteristics among startup assistance organizations. Washington (DC): Small Business Administration; 2014.

8. Milojević S. Principles of scientific research team formation and evolution. PNAS. 111(11):39843989; 2013.

9. Du F, Shneiderman B, Plaisant C, Malik S, Perer A. Coping with volume and variety in temporal event sequences: strategies for sharpening analytic focus. IEEE Trans. Vis. Comput. Graphics.

23(6):1636-1649; 2017.

10. Shneiderman B. The new abcs of research: achieving breakthrough collaborations. Oxford (UK): Oxford University Press; 2016.

Technology and Innovation, Vol. 19, pp. 415-423, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.415 www.technologyandinnovation.org

MAXIMIZE COLLISIONS, MINIMIZE FRICTION : APPLYING PLATFORM STRATEGIES TO ACCELERATE UNIVERSITY RESEARCH COMMERCIALIZATION SM

Vinit Nijhawan Strategy & Innovation Department, Questrom School of Business, Boston University, Boston, MA, USA Massachusetts Association of Technology Transfer Offices, The Massachusetts Technology Transfer Center, Boston, MA, USA National Academy of Inventors, Tampa, Florida, USA

The Bayh-Dole Act of 1980 unleashed universities to own and commercialize inventions arising from federally funded research. By self-reported measures, the results have been dramatic: 100% growth of licensing revenue from 2003 to 2013. However, much of the license royalty revenue growth is the result of a handful of blockbuster inventions originating from a handful of serial academic inventors working in a handful of research universities. The majority of research universities generate less license royalty income than the cost of their technology transfer units.

The power of the platform, a new business model that uses technology to connect people, organizations, and resources in an interactive ecosystem to create value, has led to companies such as Airbnb, Uber, and Alibaba (1) . We applied platform strategies to accelerate the two-sided market of faculty inventors (supply of innovative research and intellectual property (IP)) and industry (demand for innovation) at Boston University from 2010 to present, resulting in significantly accelerated research and IP commercialization. This paper describes how we arrived at the platform strategy, the activities we undertook, and the outcome of this new strategy.

Key words: Technology transfer; Patent; University invention; Platform

INTRODUCTION The American private research university model began with the founding of Johns Hopkins University in 1876. The model was a hybrid of German and British higher education institutions with an American twist (2). They combined undergraduate and graduate education with basic research. In parallel, the Morrill Act of 1862 provided funding to land-grant colleges that led to the formation of state public research universities. The model was given a substantial boost from enlightened science public policy captured in Vannevar Bush’s policy report Science, the Endless Frontier in 1945. Federal research institutions such

as the Defense Research Board (established in 1947), National Science Foundation (NSF) (established in 1950), and National Institutes of Health (NIH) (established in 1949) were founded to conduct basic research in federal institutions and in research universities. Federal funding for basic research increased annually to $33 billion, or 24% of the overall $138 billion research and development (R&D) budget, by FY 2016. $30 billion of R&D funding, or 22%, went to academic institutions (3).

Additional sources of research funding for universities and academic centers include industry, which increased modestly over the past decade to $4.6

_____________________ Accepted April 15, 2017.

Address correspondence to Vinit Nijhawan, 595 Commonwealth Avenue, Boston, MA 02215, USA. Tel: (978) 590-0400; E-mail: vinit@nijhawan.com

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NIJHAWAN

billion in 2013, and distributions from university endowment funds, which have accumulated to $466 billion (4) nationally, of which the largest category in 2012 was for facilities and programs at $10.8 billion followed by grants and scholarships at $3.5 billion (5).

In Science, The Endless Frontier, Bush coined the clever term “basic research” to appeal to both scientists who were seeking independence to pursue curiosity-based research and politicians who were seeking a social benefit. The atom bomb was an example of curiosity-based research that resulted in a practical aim, ending World War II. As we enter an era of scarce public funds, politicians are increasingly demanding nearer-term return on investment (ROI) rather than just being focused on Nobel prizes from research funding. The term basic research is slowly being replaced by a new term: “translational research.” However, as stated in Science the Endless Frontier, “Words alone cannot bridge the gap between the different interests of scientists and politicians in pursuing research: governments demand relevance; scientists desire freedom. The so-far futile search for a language that is relevant today both reflects and reinforces the unsettled nature of science policy” (6).

The Bayh-Dole Act of 1980 unleashed universities to own and commercialize inventions arising from federally funded research. By self-reported measures, the results have been dramatic: 100% growth of licensing revenue from 2003 to 2013 as reported in the Association of University Technology Managers Licensing Activity Survey FY2014. However, much of the license royalty revenue growth has come from: 1. A handful of blockbuster inventions 2. A handful of research universities, academic medical centers, and related institutions, such as the Massachusetts Institute of Technology (MIT), Stanford, Massachusetts General Hospital, and the Wisconsin Alumni Research Foundation 3. A handful of serial faculty inventors The majority of research universities generate less license royalty income than the cost of their technology transfer units. A survey of high-tech patenting showed university patents collectively earn a negative 3% rate of ROI (7). Stanford University obtained 65% of its $1.77 billion in royalty income earned over 30

years from just three licenses, the last being Google in 1996. Of 44,902 active industry licenses in the U.S., only 222 generated over $1 million annually in 2015.

Figure 1 shows the Stokes classification of scientific research. Faculty conducting research in “Pascal’s Quadrant” are more likely to discover and invent technology relevant to the market and to be licensed by industry to bring to consumers.

Considerations of Use? No Yes

Quest for basic understanding?

No

Pure Basic Research (Bohr)

Yes

Use-inspired Basic Research (Pascal) Pure Applied Research (Edison)

Figure 1. Stokes classification of scientific research.

However, university technology transfer offices (TTO) have to provide patenting and licensing services to all faculty regardless of whether it is in Pasteur’s or in Bohr’s quadrant. Furthermore, TTOs are compelled to treat every invention as a potential blockbuster to avoid embarrassment from “the one that got away.” Venture capitalists (VC) also fear passing on blockbuster opportunities but have an “it’s part of business” attitude (8).

BOSTON UNIVERSITY OFFICE OF TECHNOLOGY DEVELOPMENT Boston University (BU) was founded in 1839 as the Newbury Biblical Institute, and the school moved first to New Hampshire in 1847 and then to Boston in 1867. It was chartered as Boston University in 1869.

In 1873, BU merged with the New England Female Medical College (founded in 1848), becoming the first accredited coeducational medical school in the U.S. In 1875, BU professor Alexander Graham Bell received a year’s salary advance to pursue his research.

The following year, he invented the telephone in a BU lab. BU established its technology transfer unit in 1976 and began to offer the Ph.D. in engineering in 1992. Over the first 34 years, the BU Office of Technology Development (OTD), as it is now known, generated peak annual licensing royalty revenue of

UNIVERSITY RESEARCH COMMERCIALIZATION $1.7 million as reported to Association of University Technology Managers. Given the historical data available, it appears the cost of OTD operations has always been higher than license royalty revenue received by BU. In 2009, the management team at OTD reviewed OTD’s mission and operations. First, we established with university administration that the primary goal of the OTD was to “benefit society” and the secondary goal to generate license revenue. Second, we reviewed other universities similar in makeup to BU and their technology transfer strategies. Third, we conceived and implemented a new technology transfer model at BU. TECHNOLOGY TRANSFER PROCESS REVIEW In the review of BU and other similar universities, we found four core operational strategies that we felt could be improved: 1. Pipeline process of invention disclosures to licenses 2. Cradle-to-grave case management organizational structure 3. Passivity of TTOs 4. Operating as if every patent is a potential blockbuster (i.e., home run) We also made the following further observations: • In modeling the “data flow” of OTD (see Figure 2), we realized university technology transfer is especially data diverse and intensive. As a result, it is extremely difficult to “curate” this data to pinpoint the right company at the right time that might be interested in licensing.

• Universities have a significant deal of friction as a result of a risk-averse culture, conflict of interest imperatives, lack of hierarchical decision making, and fear of reputational damage.

• A few faculty operate in “Pascal’s Quadrant” and are adept at commercializing their research. It is important to service these prolific faculty inventors and to use their examples to encourage other faculty to commercialize their research.

• It is extremely difficult to “pick winners” from a short list of promising technologies. As a VC investing in all stages of the development cycle, the author remembers how difficult it was to predict product-market fit even after a company had early product revenues. University tech-

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nology is even earlier in the development cycle, and that makes it nearly impossible to predict which technologies will have ready markets in two (information technology), four (diagnostic), seven (medical device), or ten (therapeutic) years.

• Most university TTOs are focused on transaction processing and not on business development and marketing, and depend on industry to discover university-patented technology.

• Universities usually license IP to an existing company with resources and access to markets.

In many cases, there is no interest from companies, and starting a new venture becomes the only other option. However, VC-backed new venture spin-offs based on university patents are uncommon (9), as there are only a handful of VC firms with a science focus, and management with university spin-off experience is scarce.

• An invention is only as good as the inventor (i.e., faculty involvement in commercialization to transfer their knowledge to the licensee is crucial).

• The Boston ecosystem is rich with industry and new venture support. However, BU competes for attention with the other research institutions, particularly with MIT, Harvard, and Partners Healthcare.

• We felt the “MIT model” of patenting most invention disclosures would not work at BU or for that matter at most other U.S. research universities, as it is highly dependent (a) on faculty entrepreneurial drive, (b) on the unique position of MIT in the robust entrepreneurial ecosystem of greater Boston, and (c) on a large patent budget.

• Patents can be compared to inventory in manufacturing processes, and “inventory turns” is a key metric for efficient manufacturing. The same principle can be applied to patents, reducing the number of “fallow” patents that are unlicensed.

• TTOs should be in the business of playing football (team is successful when it carries the ball into the end zone) not tennis (hit the ball to the opponent and call it a good day). In other words, success is when IP is licensed and not the incremental steps leading to it.

• Research faculty are “Explorers” but have diff-

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Education

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Research Programs

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Business Outreach

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Development

HR

Professional Societies

Ignition Awards

Fraunhofer

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ITEC

Univ. Admin.

Investment Office

NCET2 VC

Networking

Licenses Launch Awards

LES

Industry

Incubation Entrepreneurs

Service Providers

BioSquare

Mentors

VP Research/ Provosts

Public Relations

Law Firms

Research Compliance

OSP

Consultants

OGC

Database subscriptions

Thickness of Line Indicates Level of Activity Figure 2. BU OTD “data flow” interface map (10).

culty understanding why “Exploiters” (industry, VCs, and entrepreneurs) capture most of the value from their inventions. Each side needs a better appreciation of the value added by the other.

We applied the above lessons to create a new platform-centric technology transfer process embodied by the motto Maximize Collisions, Minimize FrictionSM. PLATFORM BUSINESS MODELS Platforms of “facilitated business exchanges” have existed for a long time, but it is just recently, with the growth of the internet, that they have become significant growth engines of the economy. Industries as diverse as music, banking, transportation, health care, and energy are being transformed by new entrants leveraging platform business models.

Traditional services and products are built around pipelines with raw material coming in one end and consumer products going out the other. As mentioned above, most TTOs also operate on a pipeline funnel, with research funding-initiated invention

disclosures at the top and licenses to industry at the bottom. Platforms are upending pipeline businesses in many industries. For platforms, community (not products) is the primary driver, and institutions need to shift their focus from internal to external activities. Most TTOs operate by pushing inventions to potential industry licensees. In a TTO platform model, faculty inventions would be pulled by relevant industry innovation needs. Platforms scale by using network effects (11) to create value for the parties on the platform. Minimizing friction both for entry and in transactions can magnify platform network effects.

Platforms create value broadly using two methods (12): 1. Multi-sided marketplaces that are transaction oriented (13) (examples of such platforms are Amazon, Uber, Airbnb, eBay).

2. Innovation platforms that use open interfaces to attract an ecosystem (example of such platforms are Apple App Store, Windows, Salesforce).

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Encourage

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Gap analysis Plan for improvement iTeam Course

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Faculty Bootcamp

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Faculty startups Industry sponsored research support

Kindle Mentoring New Venture Accelerator

Agreement templates Incubator Business Outreach TDRR Terrier Tech

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Figure 3. OTD TTO platform processes.

Simply, successful platforms increase the quantity (Maximize Collisions) and quality (Minimize Friction) of interactions between producers and consumers. In 2006, of the top five publicly traded companies by market capitalization, Microsoft was the only platform company. By 2016, all of the top five were platform companies: Apple, Alphabet (parent of Google), Microsoft, Amazon, and Facebook.

TECHNOLOGY TRANSFER AS A PLATFORM Our technology commercialization platform model begins with the motto: Maximize Collisions, Minimize FrictionSM. The idea behind “Maximize Collisions” is to create as many “connections” between research (and researchers) at BU and industry as possible so that the “market” can inform researchers and the OTD about commercially promising technologies. The goal of “Minimize Friction” is to simplify and make transparent processes to improve transactions and make it a better experience for companies licensing BU inventions. From this motto, we developed the following mission statement: “Encourage, Educate and Enable BU community to realize the commercial potential of their ideas.” Figure 3 details processes of the OTD platform.

Beginning in early 2010, we began to implement the Maximize Collisions, Minimize Friction technology transfer platform at OTD, which involved the following steps:

1. Implementation of the organization into three distinct teams: a. Business Development (BD) team, whose goal is to encourage faculty to submit invention disclosures and to educate faculty on how to commercialize their inventions.

Additionally, BD’s goal was to create “collisions” between faculty and industry. BD consists of people (mostly with industry background) “who don’t like sitting in their chairs” but are motivated to spend time in research labs at BU and interacting with potential industry collaborators. b. Intellectual Property & Licensing (IPL) team, whose goal is to manage all transactions, including patent filings and agreements (i.e., the things that enable invention commercialization). Additionally, IPL’s goal was to minimize friction by improving transaction processing. IPL consists of people (mostly with a legal or patent background) “who like sitting in their chairs” and completing transactions. c. Operations (OPS) team, who managed finance, administration, and human resources, including post-license compliance and royalty distributions.

2. Implementation of a program to Maximize Collisions:

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NIJHAWAN a. Launched a marketing strategy to boost BU’s share of attention from industry and the local new venture ecosystem. Some activities included i) the July 2010 launch of an annual “Tech, Drugs and Rock ‘N Roll” showcase of BU research and inventions; ii) the creation of the Innovator of the Year award to select and celebrate a faculty inventor’s accomplishments the previous year; iii) the launching of the quarterly Terrier Tech newsletter; and iv) a streamlined OTD website for easier navigation. b. OTD already had a new ventures focus, but it had few VC-backed successes. We reorganized that focus into three functions: i. Start-up Accelerator: Support Principal Investigator (PI) new ventures by attracting professional management, preparing business plans and fundraising presentations, and identifying sources of funding, such as VC. ii. Gap Funding: Rationalized BU gap funding strategy to address capital needs of PI projects at key stages of development. For early-stage technology development, we offered grants via the Ignition Grant program. For mid-stage technology development for medical technology, we offered the Coulter Grant Funding program. For PI spinoffs into new ventures, we offered the Launch program (bridge financing that required matching funding from a source outside BU). Additional support provided to gap funding from Pfizer and Fraunhofer Alliance funded programs. iii. Kindle Mentoring Program: Modeled on MIT Venture Mentoring Service, our program recruited over 40 mentors to support faculty and student research commercialization. These mentors are successful chief executive officers (CEO) or industry executives, several of whom are BU alumni. They have a commitment to students and faculty and have put in countless numbers of hours, all on a volunteer basis.

c. Formed an external advisory board (EAB) to provide guidance, counsel, support, and business connectivity to the managing director to accomplish the OTD’s mission and invited high-profile academic and business leaders to join. d. We reviewed our entire licensed and unlicensed patent portfolio to ensure we were maximizing revenue both through license compliance and, if needed, enforcement. In enforcement, we focused on two commercially successful licenses and prevailed in both. In addition, to address patent expenses, we successfully streamlined the criteria for terminating patents that had little chance of licensing by creating the “sixyear rule.” (By examining historical BU inventions, we discovered if an invention has not been licensed within six years of patent filing, it is unlikely to garner future industry interest.)

3. Implementation of a program to Minimize Friction: a. Established a working group of the top new venture lawyers in Boston to develop the BU EZ Express Startup License with subsequent significant reduction in redlining. b. Implemented web-based electronic forms and electronic signatures for most agreements. c. Updated agreement templates and established processes to complete agreements. d. Developed a process for quick university decisions on the return of inventions to faculty. e. Increased provisional patent to utility patent conversion rate from 25 out of 50 (50%) in FY 2011 to 25 out of 29 (86%) in FY 2014.

4. Established a set of OTD Metrics: a. Leading Indicators: Collisions, Invention Disclosures b. Lagging Indicators: Patents, Follow-on Funding c. Outcome Indicators: Licensing Revenue, License Compliance Results from implementing the Maximize Collisions, Minimize Friction technology transfer platform at OTD:

UNIVERSITY RESEARCH COMMERCIALIZATION • Faculty Service: ◉ Outreach via electronic and personal means significantly increased research faculty interactions on both the engineering and medical campuses.

• Process improvement: ◉ By focusing on “fewer but better” inventions to add to the portfolio, we were able to free up a greater portion of the patent budget to invest in new inventions as opposed to maintaining unlicensed inventions. Additionally, we ensured greater and deeper attention to making the most promising ones successful. ◉ By applying Coulter-inspired, milestone-based Ignition awards, increased the number of commercializable projects (14). ◉ By requiring matching funding for Launch awards, increased the number that successfully garnered follow-on commercial funding.

• BU new venture spin-offs since 2010 (>$150 million in cumulative VC equity funding): ◉ Sample6 received $32 million in VC funding (PIs: Jim Collins, Michael Koeris, Timothy Wu): ■ Applying synthetic biology to pathogen detection in food processing ◉ ByteLight raised $3 million and was acquired

by Acuity (engineering students and PI: Tom Little): ■ Indoor position location using Light Emitting Diodes for both lighting and data communication ◉ RayVio raised $40 million in VC funding (PIs: Ted Moustakas, Yitao Liao): ■ Developing ultraviolet light-emitting diodes for disinfection and curing ◉ Enbiotix raised $3 million (PI: Jim Collins): ■ Developing novel anti-infective therapeutics ◉ Constant Therapy raised $2.8 million (PI: Swathi Kiran): ■ Cognitive rehabilitation app for stroke, traumatic brain injury, and other brain repair ◉ Synlogic raised $70 million in VC funding from Atlas Venture and New Enterprise Associates (PI: Jim Collins): ■ Developing microbiome-related therapeutics ◉ Allegro Diagnostics acquired by Veracyte for $21 million (PIs: Avi Spira, Jerome Brody).

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DISCUSSION AND CONCLUSION Research universities must accommodate the need for translational benefits from the taxpayers’ research funding. That doesn’t mean that scientific freedom is to be sacrificed; on the contrary, good science is the basis for commercialization. Furthermore, society needs to invest in commercialization. For example, in a December 2013 presentation at the TTS-Asia Conference in Singapore, A*STAR (Singapore’s science and economic agency) chairman Lim Chuan Poh stated that 5% of every dollar spent on research needs to be spent on commercialization. If we were to apply that rule to U.S. academic research funding, it would equate to $1.5 billion annually. In addition to universities’ investments in technology transfer, the federal government has launched a number of commercialization acceleration programs, such as NIH National Centers for Accelerated Innovations and Research Evaluation and Commercialization Hub and NSF Innovation Corps. The Small Business Innovation Research and the Small Business Technology Transfer programs are similarly increasing the federal government’s focus on commercialization.

There are still areas for improvement for a TTO platform: • We developed but did not fully implement an IT system to automate TTO workflow processes.

Existing TTO IT systems lean towards data management rather than platform process management.

• A key element in platform process management is to develop a technology benchmark that we call the Commercialization Readiness Level (CRL) (14). Figure 4 details such a process flow.

Simply, the goal of a university TTO would be to manage every research project by improving its CRL score while making “collisions” with the market until the market (industry, entrepreneurs, or financiers) is ready to license the underlying intellectual property.

• Develop an algorithm to match faculty research with industry interest for related innovation utilizing existing publicly accessible data sources.

Use the results from this search to encourage research faculty to engage with industry and to submit invention disclosures.

• An increasing portion of universities’ inventions

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Continuous Improvement ❑ Mentoring ❑ GAP Funding

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■

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Every invention is rated for Commercialization Readiness The goal of Tech Transfer Office is to improve the CRL score of every invention by collaborating and supporting faculty ■ Catalysts to mentor ■ GAP funding ■ Attract non-dilutive funding ■ Industry SRA ■ SBIR/STTR ■ Foundations

Dashboards create transparency ■

■

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Industry ■ As an invention’s CRL increases, industry will “pull” the invention in as a license New venture ecosystem ■ NV Accelerator to improve CRL and make collisions with entrepreneurs and venture capital

Figure 4: TTO process management utilizing a commercialization readiness level.

are jointly owned with other academic institutions. The complexity of licensing such inventions increases exponentially with the number of institutions involved. Develop a mechanism that expands on the Massachusetts Association of Technology Transfer Officers’ Joint Invention Innovation Agreement to accelerate licensing of jointly-owned patents (15).

3.

REFERENCES 1. Parker G, Van Alstyne M, Choudhary SP. Platform revolution. New York (NY): W.W. Norton & Company; 2016.

2. Cole J. The great American university. New York (NY): Public Affairs; 2009.

5.

4.

[NSF] National Science Foundation. Survey of federal funds for research and development fiscal years 2014–16. Arlington (VA): National Science Foundation. [accessed 2017 May 15]. https:// ncsesdata.nsf.gov/fedfunds/2014/.

[NCES] National Center for Education Statistics.

Endowments. Washington (DC): U.S. Department of Education. [accessed 2017 May 15]. https://nces.ed.gov/fastfacts/display.asp?id=73.

Sherlock MF, Gravelle JG, Crandall-Hollick ML, Stupack JM. College and university endowments: overview and tax policy options. Washington (DC): Congressional Research Service; 2017. [accessed 2017 May 15]. https://www.fas.org/ sgp/crs/misc/R44293.pdf.

UNIVERSITY RESEARCH COMMERCIALIZATION 6.

Pielke R Jr. In retrospect: science the endless frontier. Nature. 466:922–923; 2010.

7. Love BJ. Do university patents pay off? evidence from a survey of university inventors in computer science and electrical engineering. Yale J L & Tech. 16:285; 2014.

8. Bessemer Venture Partners. The anti-portfolio.

Boston (MA): Bessemer Venture Partners; c2017 [accessed 2017 May 15]. https://www.bvp.com/ portfolio/anti-portfolio.

9. Munari F, Toschi L. Are academic spinoffs able to attract VC financing? Evidence from the micro and nanotechnology sector in the UK. Paper presented at: Copenhagen Business School Summer Conference. 2009 Jun 17-19; Copenhagen, Denmark.

10. Stokes D. Pasteur’s quadrant. Washington (DC): Brookings Institute; 1997. p. 73.

11. Shapiro C, Varian HR. Information rules: a strategic guide to the network economy. Brighton (MA): Harvard Business Review Press; 1999.

12. Evans PC, Gawer A. The rise of the platform enterprise. New York (NY): The Center for Global Enterprise; 2016. [accessed 2017 May 15]. http:// www.thecge.net/wp-content/uploads/2016/01/

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PDF-WEB-Platform-Survey_01_12.pdf 13. Rochet JC, Tirole J. Platform competition in twosided markets. J Eur Econ Assoc. 1(4):990-1029; 2003.

14. Wikipedia contributors. The CRL is inspired

by Defense Department’s & NASA’s Technology Readiness Level. Wikipedia, The Free Encyclopedia; 2017 May 10 [2017 May 15]. https://en.wikipedia.org/wiki/Technology_ readiness_level. While there are other similar readiness level scales such as https://steveblank. com/2013/11/25/its-time-to-play-moneyballthe-investment-readiness-level/, the CRL was formulated to best capture the stage and evolution of university technologies until they leave the university as licensed IP (i.e., it captures both technology readiness and market readiness, as well the (unique) relevance to each university).

15. MATTO joint invention administration agreement format [template]. Boston (MA): Massachusetts Association of Technology Transfer Offices; 2007. [accessed 2017 May 15]. http://www.masstechtransfer.org/files/2008/01/ matto_jiaa_final.doc.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.425 www.technologyandinnovation.org

Technology and Innovation, Vol. 19, pp. 425-435, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

TRANSPORTATION AND ENERGY: THE PUSH FOR LEADERSHIP AND INNOVATION James E. Smith Mechanical and Aerospace Engineering Department, Statler College of Engineering and Mineral Resources, West Virginia University, Morgantown, WV, USA

Innovation has always been the driving force behind humanity’s success at conquering our environment and in advancing our social agendas. In that ongoing effort, it is the acquisition and utilization of energy and the transportation afforded by that energy that has allowed us to advance and create better and more fulfilling lifestyles. This paper looks at the genesis of innovation in the United States and how the U.S.’s progression to a global powerhouse occurred due to both the human and environmental resources created as a result of the survival instincts associated with innovation. If this nation, and those that are mirroring it, are going to continue to make economic and social improvements and advancements, then the leaders and innovators of the world are going to play a critical part in that effort, and energy will power those improvements.

Key words: Innovation; Leadership; Energy; Transportation

HISTORICAL NOTE The United States has always held a prominent place, globally, in fostering innovation, as is exemplified in the worldwide consumer acceptance of its technology and products. This innovation has also cultivated, attracted, and provided the incentives for a strong leadership core that has served the nation in the best and worst of economic times. Similarly, to many regions of this country, it was with the cultural diversity and open-market spirit, facilitated by the availability of natural resources, that the U.S.’s innovative vision was forged, providing the driving force for social, cultural, and economic change. To this day, it is the interplay of these attributes and resources that creates our dynamic cultural and social heritage

and provides a standard of living that has few global equals.

The nation initially benefited from its many unique geographic and resource-rich regions. It also benefited from the changing cultural and demographic attributes influenced by the growing and diverse population. The risk-takers, adventurers, and individuals looking for a better, more prosperous life all contributed to the changing landscape that became the U.S. Each brought their language and culture and, more importantly, a variety of trade skills and a willingness to learn, adapt, and work hard because there was a clear avenue to a fair financial exchange for their contributions and a sense of accomplishment for their efforts.

_____________________ Accepted April 15, 2017.

Address correspondence to James E. Smith, Ph.D., Mechanical and Aerospace Engineering Department, Statler College of Engineering and Mineral Resources, West Virginia University, 401 Evansdale Drive, PO Box 6070, Morgantown, West Virginia 26506-6070, USA. Tel: +1 (304) 293-3264; E-mail: james.smith@mail.wvu.edu

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The skill set requirements for each local industry and trade, along with the local environment, influenced the specific influx of families and their languages and cultures. This, in turn, provided natural population and cultural centers matched to the local intellectual and capital-rich environments. Many of these individuals were attracted by the opportunities created by these cultural and political dynamics, while others had the needed skills or a vision of what the future could provide, and they wanted to be a part of that change.

These highly productive regions, located throughout the country, started as natural offshoots from the geographic attributes and natural resources that were available. From the grass lands, that even now feed this nation, to the safe harbors that ring the coastline, including the Great Lakes, it was from these starting points that the nation got its initial foundations. These regions grew and prospered and with that growth came the need for better and faster transportation and the energy to drive it. This need for transportation was not just necessary for the required exchanges in commerce but also for the people who were attracted to the ever-growing and changing opportunities that this new landscape was providing. Even at the beginning, it was the movement of people, products, and information, along with the concomitant development of new sources of energy, that kept the wheels of industry and commerce moving, as it still does today.

Each region can claim, and often boast of, its place in the historical development of this country. Today, these regions continue to contribute, responding through changes in their work and living environments and often adjusting their roles in the constantly developing global marketplace. Now, energy plus the movement of people, products, and information is occurring on a larger, more profound scale and to compete in the worldwide marketplace requires a broader view and a global perspective. These new types of global dynamics, similar to the regional ones in the past, are fraught with complexities, discomfort, and personal insecurity, but, as in the past, there is an inevitableness to these changes that will require the population to adapt and learn to take on this next round of opportunities.

EMBRACING CHANGE It is in the embrace of change where innovative breakthroughs occur, and it was those earlier breakthroughs that propelled this country into the world leadership position it has held for so many decades.

While change can often feel undesirable, it is the natural, inevitable, and necessary order of the universe.

Maintaining the status quo may seem to make life easier, but, in reality, it allows competing forces to gain a foothold or to get ahead. When you are in the lead, everyone wants to contribute their intellectual energy and products; they want to come and make themselves part of the mix. When you lose your edge or get behind, that same innovation, and the leadership that spawned it, goes elsewhere.

When it comes to change, most everyone speaks to it as a necessity, as long as it doesn’t adversely affect them or what they do. Change comes in two major varieties: the revolutionary breakthroughs and the subtler evolutionary transformations that slowly infiltrate the workplace and living environment. The latter is all around us, with visible examples in the communications and medical industries. The same can be said for all sectors of the work environment, where these advancements are more dramatic for some sectors than the others. This transformation is a slowly evolving process that the nation has grown accustomed to, often to the point of not even seeing the change—or, worse, often missing the vision that is driving innovation—until it is well established.

This missed vision, particularly for breakthrough innovations, is not without its negatives, as exemplified with the loss of jobs, personal initiative, and, in general, a loss in the innovative spirit due to not seeing or anticipating future trends and needs, particularly on a global basis. Having at least a limited vision of the future is a pre-requisite if this country is to compete in a global marketplace. Fortunately, as a society, we entrust those few who we have identified as innovators with the power to shape a larger, more radical view of the future that lies ahead.

The innovative breakthroughs, or game changers, are the easiest to detect, as they usually affect large segments of the population and work environments. As is normally the case, these changes are often opposed by individuals and companies alike simply because they represent something different, such as a change from the current direction of their

TRANSPORTATION AND ENERGY organization that forces them out of their comfort zone. Resistance, in and of itself, isn’t necessarily bad because inertia provides the time to adjust and, more importantly, to become proactive as opposed to always being reactive. Whatever the process, change is inevitable, and this nation’s population has the choice of embracing that change, as our forefathers did, or letting the rest of the world adapt and accelerate those same changes to best fit their current needs and desires, often to our disadvantage.

THE NEXUS FOR GROWTH The northeastern portion of the United States is one of those uniquely positioned geographic regions on the globe that helped create the early foundation for this country. It became a change agent, the nexus of industrial and manufacturing growth for a major portion of the country for well over a century. The Northeast’s industries are based in geography and an abundance of natural resources, such as coal, lumber, minerals, and fresh water. For example, the 1800s saw an increased need for more manufactured goods for construction, agriculture, and transportation.

In those days, it was the mountainous region that provided ease of access to the raw materials, such as outcrops of iron ore, coal, and sand. Plus, there was an ample supply of wood, a sufficient elevation drop, and a large watershed to supply the running water that was essential for transportation and industrial processing.

When it was no longer practical and the demand became too great simply to float a year’s worth of iron ingot production by raft or barge out of the mountains during the spring floods, it became necessary to localize and provide year-round manufacturing capabilities. Locations in the region with navigable rivers and an abundance of raw natural resources became industrial centers. With the rivers came the railroads and then the over-the-road improvements, all delivering people, products, and raw materials. This became the nucleus of the processed metals industries in the Pittsburgh region. Through similar events, the chemical industry in Charleston and the manufacturing centers along the Great Lakes—Cleveland, Detroit, and Chicago—evolved. The development of these centers, spreading out in all directions, created the business and social support infrastructure for these regions.

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This growth in prosperity, due to the harvesting of natural resources coupled with the commercialization and mass production of a variety of finished products and pre-assembled components, created prosperity for the region, attracting an ever-increasing population with the needed social and support infrastructure to sustain them. Additionally, this increase in the economic base provided the investment capital to further add to the growth rates in new businesses as well as the growth of novel technology created by the newly attracted entrepreneurs and innovators.

With a supply of capital, new technology, and a public willingness to embrace novel ideas and concepts, technological breakthroughs became an expected and, at times, demanded outcome. This advancement also drove the need to formalize the educational process to provide the current and next generations with the tools and skill sets to move the new technologies and society forward. It also created the need for, as well as the formation and funding of, research-rich development centers matched to innovative business environments. Each of these centers, both individually and jointly, focused on the next great product or service and the intellectual energy needed to keep that industrial machinery moving forward.

The Northeast is rich with examples of innovation and the entrepreneurial spirit, such as the first steamboat tests; the first use of natural gas for a commercial process; the first synthetic fiber, nylon; the development of the alternating current synchronous motor; and then later the development of nuclear energy programs. The list should also include the ongoing work in the transportation sector for boats, trains, cars, and trucks and the all-important advancements in communications and medicine. These examples come from an exciting historical period, the Industrial Revolution, where innovation was embraced and expected, a time when the anticipated growing pains were the major concern of the day and not the more recent concerns over unemployment, health care, and quality of life.

If given the choice, the path should be clear.

Advancements and breakthroughs in technology will make this nation’s future more prosperous, and it is through these same innovative activities that the current financial shortfalls and infrastructure

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stagnation will be healed. Creating and propagating innovative strategies can start all of this. If history serves this nation well as a guide, then the major advancements and breakthroughs will be through the critical transportation and energy production sectors.

As with our nation’s forefathers, it was the need for self-sufficiency and a strong survival instinct that drove this country forward, and it will be through that same innovative spirit that we will again advance this country’s economic and cultural agendas.

and corporate stress by making current profitable technology products, processes, and the jobs that support them obsolete. These changes often affect our familiar and comfortable lifestyles and work environments, creating personal financial hardships and often upsetting local and/or regional economies. If history teaches anything, it is that these changes, when eventually adopted, improve the lot for everyone, at least for those that are willing to learn and adapt to the change.

A NATURAL ORDER FOR PROGRESS The driving force behind these past technological improvements, and those to come in the future, has been the obvious commercial value they represent, but it was and still is innovation that provided the stage for increasing, and often accelerating, societal growth. Each of the energy and transportation advancements has led to growth in our economy and enhanced the way the social and physical infrastructures are shaped and developed. Energy innovation has provided improvements in personal safety and long-term survivability, and, in most cases, it has also provided improvements in the quality of life for the masses.

This process of growth is particularly evident during the introduction of advanced technological breakthroughs. These unique, easily recognized moments in our history are often unexpected, but, after introduction, are heralded and embraced by the public. For example, consider the discovery of flight, electricity and electronics, antibiotics, and even the internet, each of which has had a dramatic impact on our lives. It is in these revolutionary innovations that true accelerated social and economic progress is accomplished. It is also with these breakthroughs that a new string of evolutionary innovations can start their cycle all over again but with a new focus and direction. The human species is always attempting to improve and innovate, which creates excitement for everyone, including the youth, who can see the need for advanced training and educational topics.

More importantly, innovation, along with the change that it marshals, is one of the most important survival traits. Change and the stress that accompanies it are essential. Stress in all forms, while uncomfortable, toughens us as a species and forces our social order to evolve and not to become stagnant.

These game changers can also create personal

THE INNOVATION PROCESS The innovation process is still at work today for the energy and transportation sectors, including improvements in how goods are manufactured, handled, moved, and distributed. Individuals are also moving more reliably in safer and more energy efficient vehicles. Some of the latest improvements in personal transportation not only provide movement, but they are also making vehicles active centers for communications and entertainment. These innovations are the natural evolutionary process for any technology. It is this cycle that provides the normal competitive impetus in commerce, in the way we conduct business relationships, and how we arrange our personal lives.

The way we conduct business and our lives will not necessarily provide the needed improvements for us to continue to evolve socially and economically, but the economic and social pressures resulting from evolutionary and revolutionary innovation will.

It is these changes and advancements that provide the framework for future success, which is often most notably demonstrated and recognized when employed in the transportation sector, which is by necessity supported by the energy sector.

THE TRANSPORTATION SECTOR History has shown that the key to progress, as well as survival, has been the ability to transport people and items of commerce. From the earliest references in literature, advancements in modes of travel were chronicled and embraced by the masses. This advancement is seen from the domestication of draft animals with the use of the wheel to improvements in shipping, railways, and, more recently, air travel.

These improvements allowed the economical movement of growing quantities of goods over greater

TRANSPORTATION AND ENERGY distances along with the critically important ability to provide modern society with an individualized and reliable means of personal transportation.

For these modes of transportation, the key to their continuing success was, and continues to be, their ability to innovate, improve their efficiency, and effectively become more economical. In all cases, we can see the following pattern. There is an initial breakthrough idea followed by continuous improvements in both the technology and the implementation and improvements in the infrastructure that support the use of the technology, all of which create the societal changes that occur as a part of the natural order of progress.

With these changes and improvements, the older, less reliable, and inefficient modes of transportation were set aside or relegated to curiosities to be featured in parades and exhibitions. Each older technology had its day and served to advance then-contemporary societal and personal transportation needs.

What came next was, in most cases, a breakthrough technology, often referred to as a game changer that advanced the ability to move individuals faster, farther, and more economically. It also allowed the movement of greater volumes of goods over greater distances, again more economically and reliably.

It is with transportation that we get the greatest movement in our economy and our societal developments. Currently, the transportation sector is evolving in almost every facet of this nation’s development. This process will continue in an almost immeasurable fashion with the goal being another breakthrough that will provide a strategic and financial advantage to one or more segments of the economy. This will again start the evolving process of constant improvements until the next innovative breakthrough.

PERSONAL TRANSPORTATION Even with highly developed public transportation, there is a need for personal transportation. This is particularly true for large landmasses where the population density may not economically warrant the creation of complex public transportation systems.

This is also evident in developing counties that need individualized modes of transportation prior to justifying the need for public transportation.

Most current personal transportation relies on motive force supplied through some stored energy

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supply. Most of this energy currently comes from fossil fuels. Even the small numbers of vehicles powered by batteries mostly receive their charge from a power plant that runs on coal or natural gas. The reality is that it is hard to match the energy capacity per volume and weight of petroleum-based fuels. The key then is to use these fuels in the most effective ways to cut down on waste, reduce cost, and minimize the environmental impact.

Consider the automobile, of which there are well over 1.2 billion in use in the world today, with the prediction that this number will exceed 2 billion by the year 2035 (1). Of this quantity, approximately 260 million are in use in the United States (2). The global total represents a significant worldwide use of carbon-based fuels with the associated economic costs and environmental impact, and those costs are more heavily weighted towards the countries and regions with little or no regulatory supervision and/or control over the efficient use of the fuel or the cleanup after its use.

An overwhelming majority of these vehicles use petroleum-based products, and, even with the anticipated increase in electric and hybrid vehicles, the U.S. Department of Energy estimates that petroleumbased fuel use will exceed 80% of the total mobility energy distribution in the United States through the year 2050 and even more for the rest of the world.

Looking at the numbers for the U.S., it is not until at least 2025 that there is even a measureable change from the current almost entirely dominant use (percentagewise) of petroleum-based fuels (Figure 1).

THE PERSONAL AUTOMOBILE The U.S., in the recent past, sent over $1 billion a day overseas for liquid energy sources, most of which is used in the transportation sector. Since the world seems to be destined, by necessity and not convenience, to continue the use of carbon-based fuels, at least for the next few decades, it would seem reasonable to consider and expect there to be a series of technological innovations and possible breakthroughs to gain further value from these fuels while reducing the cost per mile and the environmental impact. All of this, of course, is in conjunction with improving vehicle safety, convenience, drivability, and sustainability.

The U. S. Department of Energy has established the energy requirements for the average personal

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Figure 1. Fuel use by type projections (3).

Figure 2. Energy requirements for combined city/highway driving (4).

TRANSPORTATION AND ENERGY vehicle for its use during its lifetime. These energy requirements are best understood as they relate to the function and support of the vehicle and its normal use (4). These major vehicle systems fall into the following categories: drivetrain losses, power to wheels, parasitic losses, and engine losses (Figure 2).

The aforementioned energy use categories, excluding the engine losses, represent less than a third of the total energy used by the vehicle in carrying out its functions. Every automobile designer and manufacturer seeks to improve the efficiency of vehicles by reducing the fuel needed to support each of these systems. This includes reducing mechanical friction of the moving parts, the rolling resistance of the tires, and even the wind resistance due to frontal profile and body shape.

The reality is that the rest of the energy consumed is related to engine requirements. With combustion within the cylinders approaching their efficiency limits, other strategies need to be employed to improve the overall vehicle efficiency. In fact, small incremental improvements in all the other categories will not gain the needed fuel economy numbers required by consumers and regulatory agencies unless the engine’s energy requirements are addressed aggressively.

Note, each of the energy use categories will see continued innovative improvements, but it will take a sizeable decrease in engine energy requirements to meet the currently mandated and future anticipated Corporate Average Fuel Economy Standards for the U. S. and similar fuel economies and regulated emissions requirements in other countries (5). These new energy requirements will necessitate a breakthrough in how we utilize fuel for the power plants in our vehicles and will also most likely require the use of a variety of alternate versions of the fossil fuels that we currently extract, including natural gas.

THE ENERGY SECTOR The recent exploratory drilling of the Marcellus Shale finds, using innovative directional drilling and advanced hydro-fracturing techniques, has opened an opportunity to create an historic turning point, bringing the nation back to a solid financial footing and creating a new sense of self-sufficiency. In turn, this has created an opportunity to bring greater energy security that can serve as a model for the rest of the world.

The quantity and cost of this resource, natural gas,

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will provide the energy requirements for decades.

The growth in consumption globally will almost double in the next 30 years (Figure 3). The ultimate primary users of natural gas will most likely come from the power generation sector, but, as with all large commercial undertakings, it will take years, most likely decades, to convert and bring enough online generating capacity to fully utilize the size and scope of the currently estimated natural gas reserve.

Except for those current facilities that use natural gas for peaking requirements, the infrastructure, along with the experience and expertise of the work force, will also need to develop with the technology and the availability of the gas supplies.

This buildup and future demand for natural gas by the utility industry will initially provide an even greater opportunity for its use in the transportation sector. It is evident that the transportation sector will consume only a small percentage of the total natural gas needed for the region once the power generators convert to natural gas. Until then, the use in the transportation sector will create economic value for the region far surpassing the actual value of the gas commodity. Every regional quantity of gas that offsets the use of liquid petroleum in the transportation sector lessens the need for foreign oil (Figure 4). Since over half of our liquid energy comes from non-domestic and often politically volatile locations, any offset of that supply will mean real dollars left in the U.S. for use in creating jobs and improving the social infrastructure.

It is purported that the current use of non-domestic crude oil is a result of our inability, or unwillingness, to acquire and use the considerable reserves we have historically identified in the western part of the country. Whatever the reasons, the future anticipated increases in the price of foreign oil, plus the growing demand for that foreign oil by other industrialized nations, will eventually require us to either use our reserves or develop innovative energy alternatives, particularly for our transportation sector. Either way, this effort encourages us to take a proactive stance instead of continuing to be reactionary to the volatile world economic climate, where energy is the primary issue and the true source of monetary value.

Natural gas has a smaller carbon footprint than petroleum (40% larger than natural gas) and coal (78% larger than natural gas) and creates a lower cost

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Figure 3. World natural gas consumption (2012-40) (6).

Figure 4. World market energy consumption (2012-40) (6).

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Figure 5. Average retail fuel prices in the U.S. (7).

for emissions cleanup. As seen in the figure above (Figure 5), the cost of petroleum was higher than natural gas by about 7.5% in 2016. The general trend line for natural gas has been fairly constant in comparison to petroleum. Since natural gas comes from domestic sources in the United States, the price is consistent.

For petroleum, however, the price varies more often based on economic factors and outside influences because about 50% of U.S. oil is imported (8,9). For all the right reasons, natural gas is the preferred choice for a more secure and well-planned energy future, especially if the money that is spent for energy then remains at home.

In addition to offsetting petroleum and other energy imports, the production and transmission of our natural gas feedstock would then be financed and expedited locally through its use in the transportation sector long before it will be utilized effectively in the power-generating sector. The use of this fuel will also help to competitively regulate the global price of energy and create a better sense of national security than has been seen in the past few decades. The use of this fuel, in addition to cutting our carbon footprint, will create the need for new industry in support of the fueling and the conversion and maintenance infrastructure. It will also directly cost the consumer

less for their energy usage, thus providing more disposable cash for infusion into their regional economies for leisure and value-added products and services.

This economic value will then be complemented by the need to provide the materials and manufactured products necessary to support this new energy economy. More importantly, it will stimulate and attract the entrepreneurs and innovators, along with the decision-making leadership, who will accelerate economic growth in the nation.

As a result of this growth, there will be a need to adjust the nation’s social support infrastructure to accommodate an influx or redistribution of population. The added tax base can be used to benefit the people who live, contribute, and work in the region.

This effort will also provide healing and fiscal growth for more than just localized regions, leading the country to a better understanding of the true power of domestic energy and fostering the ability to rebuild self-sufficiency, encourage innovation, and determine the direction of the country’s collective future. In this process, there is underlying progress in the acquisition, transportation, use, and environmental management of the essential

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energy that is the backbone of the transportation industry. In fact, it is energy that is the driving force for everything that we do, from the food we eat to the way we move and communicate and essentially to the way we live and survive.

LEADERSHIP CREATION PROCESS Noting that the implementation of any energy strategy is a complex effort and that plans are only as good as the leadership and commitment of the participants, there is normally an improved correlation between the efforts of a cohesive and motivated team over the summary efforts of a group of discrete individuals or, in this case, companies and governing officials. Clearly, the acquisition and use of all forms of energy is here to stay, and the market will develop based on the normal economic pressures and influences that affect all new opportunities. All of this could be adversely affected by the continually changing world energy landscape, especially with Asia vying for increasingly larger percentages of the available crude oil and its by-products and the continuing unrest in many of the oil-producing regions of the world.

To be most effective and to take the best advantage of the current opportunities will require concerted efforts by individuals and organizations across all disciplines and market sectors in this region. Once a vision and strategic plan is recognized and implemented, it will be those different sectors that will create the policy elements and the needed strategy to ensure the maximum value to the region and thus the country.

Finally, noting that economic pressures will, as often as not, provide the needed motivation to advance an opportunity, the benefits that can be derived from cross-discipline and market sector cooperation are often surprisingly misunderstood.

Most large operations and organizations have cultivated a culture based on market success and identity, and, given the nature of competition, it is easy to become vertically integrated and isolated. While this may prove to be highly effective in the current market environment, a dramatic change or a unique opportunity like the current one might leave this

type of an organization unable to respond in a timely fashion. It is thus essential that individuals and the companies that employ them work together to take full advantage of this opportunity.

CONCLUSION The world has a lot to learn about how to minimize the cost of energy acquisition, including the costs to the users and the environmental impacts. We also have even more to learn about how to move people and things. These areas are poised for evolutionary innovation and hopefully some much-needed game changers. As in the past, we will learn to use and appreciate all that happens at the hands of the innovators and the leadership that drives them and to then expect to see even more.

For example, the natural gas liquids created as a by-product of refining natural gas represent a resource to reestablish our lagging chemical industry. Moreover, as the use of natural gas proliferates, we can expect to see an increase in the development of additional advanced technologies, which will add again to the growth of the region. All of this will reenergize the work force and provide future generations with a positive and predictive vision for the future, encouraging them to prepare themselves through education and training based on need and not hope or rhetoric.

It will also create the need for and spur the formation and funding of research-rich development centers matched to innovative business environments, providing locations for our investors and entrepreneurs to call home.

The need for advanced energy and transportation solutions is clear. It is for us to make the conscious decision to invest in our future by organizing and marshalling our historically proven resources to take full advantage of it. Taking the path of being proactive and visionary, in contrast to reacting only when needed, will encourage and stimulate our intellectual and financial resources. It is through strong visionary leadership that innovation has a chance, and it is innovation that challenges our youth to continue to push the envelope into a future that has yet to be defined.

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REFERENCES 1.

2.

3.

4.

5.

Voelcker J. 1.2 billion vehicles on world’s roads now, 2 billion by 2035: report. Green car reports. El Segundo (CA): Internet Brands Automotive Group; c2017 [accessed 2016 Aug 16]. http://www.greencarreports.com/ news/1093560_1-2-billion-vehicles-on-worldsroads-now-2-billion-by-2035-report.

National Transportation Statistics. Table 1-11: number of U.S. aricraft, vehicles, vessels, and other conveyances [table]. Washington (DC): U.S. Department of Transportation. [2016 Mar 2; 2016 Aug 16]. http://www.rita.dot. gov/bts/sites/rita.dot.gov.bts/files/publications/national_transportation_statistics/html/ table_01_11.html.

[NREL] National Renewable Energy Laboratory.

Transportation Energy Futures Project. Washington (DC): U.S. Department of Energy. [2016 Apr 25; 2016 Aug 16]. http://www.nrel.gov/ analysis/transportation_futures/.

ENERGY.GOV. Fact #709: January 9, 2012 engine energy use: where does the energy go? Washington (DC): Office of Energy Efficiency & Renewable Energy. [accessed 2016 Aug 16]. http://energy.gov/eere/vehicles/ fact-709-january-9-2012-engine-energy-usewhere-does-energy-go.

Transportation.gov. Corporate average fuel economy (CAFE) standards. Washington (DC): U.S. Department of Transportation. [2014 Aug 27;

6.

7.

8.

9.

2016 Aug 16]. https://www.transportation.gov/ mission/sustainability/corporate-average-fuel-economy-cafe-standards.

Conti J, Holtberg P, Diefenderfer J, LaRose A, Turnure JT, Westfall L, Doman LE, Arora V, Singer LE, Zaretskaya V, Jones A, Huetteman T, Bowman M, Slater-Thompson N, Hojjati B, Peterson D, Gross P, Otis P, Lynes M, Lindstrom P. International energy outlook 2016. Washington (DC): U.S. Department of Energy; 2016 [accessed 2016 Aug 16]. Report No.: DOE/EIA0484(2016). https://www.eia.gov/outlooks/ieo/ pdf/0484(2016).pdf.

Average retail fuel prices in the U.S. [image].

Washington (DC): U.S. Department of Energy.

[2017 18 May; 2017 May 21]. http://www.afdc. energy.gov/fuels/prices.html.

[EIA] U.S. Energy Information Administration.

Frequently asked questions: how much of the oil produced in the United States is consumed in the United States? Washington (DC): U.S. Department of Energy; 2016 [2016 Oct 6; 2016 Aug 16]. https://www.eia.gov/tools/faqs/faq. cfm?id=268&t=6.

[EIA] U.S. Energy Information Administration.

Frequently asked questions: how much petroleum does the United States import and export?

Washington (DC): U.S. Department of Energy; 2017 [2017 Apr 4; 2017 Apr 15]. http://www.eia. gov/tools/faqs/faq.cfm?id=727&t=6.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.437 www.technologyandinnovation.org

Technology and Innovation, Vol. 19, pp. 437-440, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

INNOVATION SAVING LIVES: 2016 PATENTS FOR HUMANITY AWARDS Philippa Olsen1 and Edward Elliott2 Office of the Chief Communications Officer, United States Patent and Trademark Office, Alexandria, VA, USA 2 Patents for Humanity Program, United States Patent and Trademark Office, Alexandria, VA, USA

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Patents for Humanity is the United States Patent and Trademark Office’s top honor for innovators who bring life-changing technologies to those in need. While the developed world has long benefited from advanced technology in areas such as medical care, sanitation, and living standards, solutions are needed that work in different environments, environments where resources are often scarce. This year’s winners found new ways to administer and provide health care solutions in some of the most disadvantaged regions, demonstrating how the power of innovation can change the world for the better.

Key words: Patents; Intellectual property; Patents for Humanity; Humanitarian; USPTO

INNOVATION SAVING LIVES: 2016 PATENTS FOR HUMANITY AWARDS Universities, government agencies, nonprofits, and businesses use game-changing technology to tackle global humanitarian challenges, such as diagnosing and treating diseases or delivering vaccines effectively in underserved regions of the world. Patents for Humanity is the United States Patent and Trademark Office’s (USPTO) top honor for innovators who bring life-changing technologies to those in need. The program recognizes these innovators while also spurring further work by the innovation community aimed at helping impoverished communities.

Each year of the program, we have published the Patents for Humanity winners in Technology & Innovation. The journal and the National Academy of Inventors continue to be important collaborators in

our ongoing effort to raise awareness of intellectual property rights and their integral function in the development of human technology and progress.

This year’s winners found new and innovative ways to administer and provide health care solutions in some of the most disadvantaged regions of the world. Winners receive public recognition as well as a voucher for accelerating certain matters before the USPTO. While the developed world has long benefited from advanced technology in areas such as medical care, sanitation, and living standards, we need new solutions that work in different environments, environments where resources are often scarce. The winners’ technologies and products show tomorrow’s scientists and engineers how the power of innovation can change the world for the better.

_____________________ Accepted April 15, 2017.

Address correspondence to Edward Elliott, U.S. Patent and Trademark Office, 600 Dulany Street, Alexandria, VA 22314, USA. E-mail: Edward.Elliott@uspto.gov

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Several of the 2016 winners profiled below are associated with academic institutions. Further details on the Patents for Humanity Program, as well as the complete list of current and past winners, are available at www.uspto.gov/patentsforhumanity.

Program Background The first Patents for Humanity competition launched in 2012 as a pilot program. Since then, it has attracted support from the White House and members of the Senate and has become an ongoing program. The third round of Patents for Humanity award recipients were announced in September 2016 and honored at an awards ceremony in November.

Applicants compete in five broad categories of humanitarian needs: • Medicine - any medical-related technology, such as medicines, vaccines, diagnostics, or medical devices • Nutrition - technologies that improve nutrition, such as higher-yield crops, more nutritious food sources, food preservation, storage, or preparation • Sanitation - improving lives by addressing environmental factors such as clean water, waste treatment, air pollution, and toxic substances • Household Energy - technologies providing power to energy-poor homes and communities for household needs, including lighting, cooking, and heating • Living Standards - technologies that raise living standards to empower people to escape poverty, such as literacy, education, communications, information delivery, access to markets, and microfinance In addition to public recognition, winners also receive a certificate for accelerated handling of select matters at USPTO (i.e., patent examination, ex parte reexamination, and examination appeals) for any one technology of their choosing.

2016 Awards The award recipients and honorable mentions for the 2016 competition notably include a university, a government agency, and two private companies, including a university spin-off. Read more about each

of the winners and their technologies below (1). You can read about previous winners in Technology and Innovation 16(2) and 17(3).

University-Affiliated Recipients Case Western Reserve University (CWRU) Accurately diagnosing malaria is a difficult problem, with an estimated half of global cases undiagnosed. The standard microscope test has low sensitivity with up to 30% false positives and 20% false negatives. This causes people infected with malaria to go untreated and people without malaria to receive anti-malarial drugs, contributing to drug resistance. Engineers and doctors at Case Western Reserve University (CWRU) designed a rapid, accurate, low-cost malaria diagnostic test to address this problem. The Magneto-Optical Detection (MOD) device uses lasers and magnets to diagnose malaria in a completely new way: by detecting iron-laden by-products of the parasite in the blood. This provides results in minutes with just a finger-prick blood sample. The device can be ten times cheaper per test than the current standard and can be run by ordinary caregivers with minimal training. CWRU has conducted field trials diagnosing malaria in the Amazon, India, and Kenya. Since receiving an honorable mention in the 2014 Patents for Humanity program, CWRU has begun working with manufacturers to produce the device at scale for wider user.

GestVision Preeclampsia (PE) is a pregnancy complication that is the leading cause of prenatal death for mothers and babies worldwide, mostly in low- and middle-income countries. Although most deaths are preventable, approximately 63,000 women die from PE annually. In developed countries, PE can be diagnosed by regular doctor visits and laboratory tests, allowing treatment before severe symptoms if caught in time. However, in developing regions without regular prenatal care, PE is often undiagnosed until serious complications such as seizure, stroke, or organ failure occur. Start-up company GestVision has developed a rapid, affordable urine test that caregivers can use to diagnose PE in lowresource settings. The test detects misfolded proteins in urine associated with PE, which may be shown by

INNOVATION SAVING LIVES a colored dot similar to a pregnancy test. GestVision’s test kits are currently being used in clinical studies around the world, including Bangladesh, Mexico, and South Africa under a grant to The Research Institute at Nationwide Children’s Hospital from Saving Lives at Birth, which is a collaboration of the United States Agency for International Development, the Gates Foundation, and others to seek groundbreaking prevention and treatment approaches for pregnant women and newborns in poor, hard-to-reach communities. Following initial research at Yale University, GestVision was created to further develop the technology. GestVision is working on a manufacturing process to produce the kits in larger volume.

Other Recipients U.S. Food & Drug Administration Meningitis A is a devastating disease afflicting 26 countries in Africa’s meningitis belt, which extends across sub-Saharan Africa. In the past, thousands of people would die or be disabled each year, such as the 1996-97 epidemic when 25,000 were killed and a quarter million afflicted. The disease primarily afflicts young adults and children, leaving many wage earners with permanent brain damage. The Meningitis Vaccine Program (MVP) was formed by the health nonprofit PATH, the Gates Foundation, and the World Health Organization to combat this epidemic.

Besides regulating the safety of food and health products, the U.S. Food & Drug Administration (FDA) also conducts research on human health issues. FDA scientists set out to create a better meningitis vaccine production method for the MVP. The new technology they came up with raised the vaccine production yield from 20% to 60% and enabled the vaccine to last up to four days without refrigeration, unlike previous vaccines. The FDA licensed the technology to the MVP and hosted production scientists from MVP’s Indian manufacturer to teach them how to use the vaccine production technology.

As a result, more than 235 million people in Africa’s meningitis belt have been immunized with MenAfriVac® since 2010. Only four cases of meningitis A were reported in 2013 in the immunized region, which covers 16 countries. In 2015, the World Health Organization (WHO) recommended that MenAfriVac®

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be introduced in routine immunization schedules in sub-Saharan Africa. This will ensure that infants are protected against meningitis and will maintain population-wide immunity.

Global Good Fund Delivering vaccines to off-grid regions is complicated by the need to keep them cold. The World Health Organization (WHO) estimates that 25% to 50% of global vaccines are wasted annually, much of this due to problems with maintaining a refrigeration “cold chain” during delivery. Researchers at Global Good designed the Arktek cooler to keep vaccines cold for over a month with no power required. The device combines an advanced design with high-efficiency insulation materials to prevent heat transfer.

The Global Good Fund managed by Intellectual Ventures is dedicated to inventing technology that improves lives in the developing world. They aim to develop sustainable commercialization models that ensure the technology is affordable, accessible, and appropriate for developing regions. Global Good donated 30 Arktek coolers to help the WHO deliver vaccines during the Ebola outbreak in 2014 and sent other units to Nepal to assist with vaccinations after the 2015 earthquake. They have also collaborated with the Clinton Health Access Initiative, PATH, the Gates Foundation, UNICEF, and other United Nations organizations to conduct field trials with over 50 devices in Ghana, Senegal, Ethiopia, and Nigeria. Arktek has been used to store vaccines for tuberculosis, polio, and the pentavalent vaccines covering influenza, whooping cough, tetanus, hepatitis B, and diphtheria. The technology has been licensed to a leading refrigeration manufacturer to produce the device at scale for an affordable price.

Honorable Mentions Honorable mentions are awarded to outstanding projects with promising accomplishments. Honorable mentions in 2016 included Alere Inc. for developing diagnostic assays for rapid and early HIV diagnosis at the point of care in low-resource settings and French pharmaceutical company Sanofi for researching new malaria drug candidates with shorter, simpler treatment regimens that can potentially counter the growing trend of drug resistance.

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Future Work Patents for Humanity applicants and awardees are delivering very tangible benefits to underserved regions while also inspiring others to use the power of innovation to tackle more of the world’s most pressing humanitarian challenges.

When available, submission information and deadlines for future rounds of the program will be posted on the Patents for Humanity website. The competition is open to all owners, licensees, and applicants of U.S. patents, including foreign entities. Applicants provide a short narrative description of their project, its purpose, and current status to demonstrate how their technology alleviates humanitarian issues around the world. Multiple organizations may team together to capture creative partnerships

working together to improve the world, such as universities conducting initial research, manufacturers producing an end product, and developing world businesses or non-profits providing in-country distribution.

For detailed information regarding Patents for Humanity, eligibility requirements, and selection process, please visit www.uspto.gov/patentsforhumanity.

REFERENCES 1. The USPTO 2016 Patents for Humanity award recipients. Alexandria (VA): USPTO; 2016 [2017 Apr 10; 2017 Apr 24]. https://www. uspto.gov/patent/initiatives/patents-humanity/2016-award-recipients.

Technology and Innovation, Vol. 19, pp. 441-448, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.441 www.technologyandinnovation.org

THE NAI FELLOW PROFILE: AN INTERVIEW WITH DR. JOSEPH M. DESIMONE Joseph M. DeSimone1,2 and Kimberly A. Macuare3 2

1 Carbon, Redwood City, CA, USA University of North Carolina at Chapel Hill, Chapel Hill, NC, USA 3 National Academy of Inventors, Tampa, FL, USA

In a recent interview with T&I, renowned professor, inventor, and serial entrepreneur Dr. Joseph M. DeSimone discusses how his company Carbon is revolutionizing the Maker Movement, why we shouldn’t be pessimistic about the impact that 3D printing and other technologies will have on jobs, and what really makes innovative teams successful.

INTRODUCTION Technology and Innovation (T&I) is pleased to present Dr. Joseph M. DeSimone—engineer, inventor, and entrepreneur—as the subject of this issue’s NAI Fellow Profile. DeSimone is the CEO and co-founder of Carbon and the Chancellor’s Eminent Professor of Chemistry at the University of North Carolina at Chapel Hill (UNC), the William R. Kenan, Jr. Professor of Chemical Engineering at North Carolina State University and of Chemistry at UNC, and an adjunct member at Memorial Sloan-Kettering Cancer Center.

DeSimone, a Phi Beta Kappa graduate of Ursinus College, received his Ph.D. in chemistry from Virginia Tech and started his appointment as an assistant professor at UNC directly upon graduation. From that point on, he has set a whirlwind pace, and his career has been characterized both by swift ascent and high productivity. He is the author of over 300 articles, inventor on an awe-inspiring 350 issued or

(photo courtesy of Joseph DeSimone)

_____________________ Accepted April 15, 2017.

Profiled Inventor: Joseph M. DeSimone, Ph.D., 1089 Mills Way, Redwood City, CA 94063, USA Corresponding Author: Kimberly A. Macuare, Associate Editor, Technology and Innovation, Journal of the National Academy of Inventors® at the USF Research Park, 3702 Spectrum Boulevard, Suite 165, Tampa, FL 33612, USA. Tel: +1 (813) 974-1347; E-mail: kmacuare@academyofinventors.org

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pending patents, and a successful serial entrepreneur.

His outstanding scientific work has earned him a place in that elite group of scholars who have been elected to the U.S. National Academies of Sciences, Engineering, and Medicine and selected as fellows of the National Academy of Inventors, the American Association for the Advancement of Science, and the American Academy of Arts and Sciences.

Moreover, he has also been recognized with major awards in other areas that are equally important to him, including innovation, technology transfer, and the promotion of diversity in science.

Trained as a chemist, DeSimone has focused his academic and entrepreneurial efforts on finding innovative solutions to major problems in a wide range of areas. Some of his key contributions have come in the area of medicine and include his co-founding a company to commercialize bioabsorbable drug-eluting stents as well as his creation of fabrication techniques to specifically tailor nanoparticles for medical applications such as vaccines and medicines. Most recently, he has turned his considerable creative powers to the manufacturing sector, where his invention of Continuous Liquid Interface Production (CLIP), a new 3D printing technology inspired by the Hollywood blockbuster Terminator 2, stands to revolutionize the manufacturing industry and affect sectors from automotive to medical. CLIP technology, a major advance in additive manufacturing, uses a novel photochemical process that exploits light and oxygen to quickly make high-quality parts from specialized liquid resins. By using an oxygenated layer of resin during fabrication, CLIP obviates the need to peel between layers of resin, a process that made previous 3D printing machines slower and thus not feasible for mass manufacturing applications.

Dr. DeSimone was kind enough to take time away from his hectic schedule at his new company, which is in full growth mode, to talk about how Carbon is revolutionizing the Maker Movement, why we shouldn’t be pessimistic about the impact that 3D printing and other manufacturing technologies will have on jobs, and what really makes innovative teams successful.

INTERVIEW T&I: Can you tell us a bit about the current projects you are working on at Carbon and if you still have work in progress at your lab at UNC? DeSimone: I began my leave from the University of North Carolina about three years ago. I still have seven students finishing up their doctoral dissertations, and the majority of them will be done by the end of this calendar year. After starting several companies as a faculty member and nurturing them while being a faculty member—as a board member or a consultant—and having taught entrepreneurship in the College of Arts and Sciences at Carolina, after 25 years, I’ve turned a new chapter, and I’m leading Carbon.

We have an amazing team of people here working at the intersection of hardware engineering, software engineering, and molecular science. We’re about 200 strong, and we have products in the marketplace that are doing fantastic. We’re trying to reinvent and disrupt the manufacturing sector. We believe strongly that although the digital revolution has impacted many different sectors of the economy—commerce and movies and media and getting a hotel room or a taxi—the digital revolution has not happened in manufacturing. And the only hope for where that could really happen is in additive manufacturing and 3D printing. Up until this point, 3D printing has been slow and uneconomical, and the parts have not had the quality to be final parts. Carbon changes all of that, and therefore we’re trying to usher in the digital revolution in manufacturing, reinventing the way people design, engineer, make, and distribute physical things.

T&I: You just mentioned that you have several products on the market that are doing really well right now. Which products are you most excited about?

DeSimone: We’ve invented a new way of doing 3D printing, and our machine—our hardware that we call M1—is an internet-connected device that uses light and oxygen to grow parts. We have amazing resins that have a wide range of mechanical properties for a host of applications, ranging from a variety of performance plastics used in automotive and aerospace to advanced materials for medical devices to

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amazing elastomers for athletic footwear all the way to high-temperature materials used in demanding applications in aerospace and medical that are rigid and sterilizable. Some even have flame retardancy for use in some really demanding application spaces.

So, at Carbon, it’s hardware, it’s software, it’s resins. The M1 itself is internet-connected and streams a lot of data back to us on an ongoing basis, which helps us constantly to improve how our technology works for our customers and partners. This ushers in a whole new frontier of how people make things with equipment that gets better with time. We push features to the printer itself, doing software upgrades every six or seven weeks, and, with those software upgrades, machine performance continues to get better. We can add new resins easily and give people the power to use new resins and new features.

We’re really a data-centric company, and this also shifts the whole concept of provenance associated with parts. The idea that when people make a part using our technology, we know all the born-on data, all the conditions of the printer when a given part was made—how it was printed, which lot, which resins, which specific machine, which processing equipment was used to bake it—this allows us to raise the bar on authenticity of parts and part quality. We think people and businesses around the world are really going to love having data to track parts that are serialized, all the way back to a part’s origin. From a product safety and liability point of view, it’s a pretty amazing shift that ushers in new business models. Just look at recent cases of companies not knowing which cars contain terrible, defective air impact bags. We’re talking about hundreds of thousands, even millions, of cars. What a mess that is! The idea that we can change this kind of scenario through digital and additive by having a unique identifier on every part—we’re going to open up new business models.

T&I: So, really, this technology is going to be a breeding ground for complementary technologies— hardware, software, materials etc.

DeSimone: Yes, it’s a zero to one innovation in the Peter Thiel vernacular, with a whole bunch of cascading inventions that pile up on top of it. It really opens up a new vista of opportunities.

Figure 1. Since the date of this interview with Dr. DeSimone (February 9, 2017), Carbon has released another printer, the M2 (pictured here), that builds on the M1’s capabilities. The M2 features twice the build volume as the M1, allowing for larger parts, higher throughput, and lower part cost. (photo courtesy of Carbon, Inc.)

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T&I: 3D printing has spurred the Maker Movement, a highly influential movement with which you have been often associated and even cited as a pioneer.

Looking ahead, what do you envision the long-term impact will be of this new culture of makers?

exponentially. I think some people now believe that dance has evolved more in the last three years than in the last 3,000 years. That kind of accelerated innovation, where you can have an open environment, is pretty powerful.

DeSimone: You know, I think what’s amazing is that you get to tap the ingenuity of a broad range of people who get exposed to what you’re doing. Generating a whole new platform for making things—where historically unmakeable things are now makeable— really opens up amazing amounts of innovation. I can’t tell you how many examples we’re seeing now where a part that did some function, whether it’s in a mixer or blender or a multi-part valve in a car or a component on a drone or a medical device, used to be an assembly of five or six or seven parts because each part was what was makeable but the assembly wasn’t. Now, it becomes one part, and it fundamentally looks different because it’s now complex and unmakeable by traditional manufacturing techniques.

We usher in that kind of ingenuity, and the parts become better. Pressure drop across a valve can go to zero, and circulating pumps for that fluid can be much lower rated and cheaper, for example. And, all of a sudden, you get cost savings that are dramatic, with performance going way up at the same time. So, it’s almost like a Moore’s law kind of thing, where cost goes down and performance goes up. In fact, I like that analogy a lot. Cost goes down and performance goes up; it’s got a Moore’s law kind of feel to it when you can start making complex things easily.

T&I: I hadn’t intended to ask this, but, in the wake of the 2016 election, the potential negative effects of these new technologies have been widely discussed, and some people are evincing concerns about how these technologies are affecting jobs, especially jobs such as those in the manufacturing sector. Do you think about that? What kinds of jobs do you think rise up to take the place of those traditional manufacturing jobs?

T&I: That puts a lot of power in the hands of individual innovators.

DeSimone: Yes, there was this really cool TED talk by the curator of TED [Chris Anderson] where he talked about crowd-accelerated innovation. His story was about the rapid evolution of dance through kids posting YouTube videos of themselves that others around the world would then view and try to top. So, a kid somewhere in Asia may post a video and then a kid in Africa would then say, “Hey, that’s a great dance, but I can beat that kid’s dance.” And with this happening across multiple continents in real-time, with thousands and thousands of people participating and putting their own videos up there, new skills are showcased, taught, learned, and invented so rapidly that it accelerates the evolution of dance

DeSimone: There’s a couple of ways to think about this. I’m a pretty optimistic person. I think the ability to make complex things has been in the hands of very few entities over the years, and it’s really been the rich and powerful corporations that have had the capacity and the wherewithal to make amazing things. This is because the traditional tooling to manufacture parts is incredibly expensive and cost prohibitive for most.

If, all of a sudden, complexity is now free and the ability to make complex things is more democratized, then many more people have the ability to produce parts—for example, by going to a local service bureau, which is sort of like the Kinko’s of 3D printing. With more people getting access to amazing tools that can turn ideas into physical objects that create value, and also having the provenance associated with those products and the authenticity traced back to the inventor—these are amazing sorts of things that can be really powerful. I think entire new business models are going to emerge that are going to benefit individuals and empower individuals to make their ideas worthy of investment and commerce.

T&I: Now that you have been leading Carbon for a while, have you had time to reflect on the relationship between the entrepreneurial path and the academic one? Are there different keys to success in each arena?

DeSimone: There’s nothing like sitting in your faculty office with the smell of books around you thinking deep thoughts—of course, that’s not actually the way things go! What I would say is there’s a lot of commonality—at least in the way we are leading Carbon.

There is a lot of commonality between leading in a university setting and leading in the private sector.

THE NAI PROFILE I think one of the key features for success in both is that people need to be inspired and they need to know why. There needs to be purpose. This is a purpose-led organization: reinventing the way people make things, design things, engineer things, and deliver things. A lot of it is directed to health care, lowering health care costs and changing the way people treat and cure diseases, making cars more fuel-efficient and safer—really, all sorts of purposes are embedded in what we do. Universities are similar.

I think the strong connection between the two is that they are purpose-led organizations.

I’m a big believer in research, especially academic research and how it can create new things that are better and can improve the health and well-being of society. This becomes a call to action. I think too many times academic research can lie dormant and never get outside the academy. There is a moral obligation to do that. If one of my colleagues invents a cure for AIDS or Ebola and if she publishes a paper before her university even files a patent, the $600 million of needed follow-on investment may never happen in order to convert that brilliant concept into a legitimate product. It is vital to foster openness, but that doesn’t mean it isn’t also vital for universities to protect inventions with patents. That is necessary if breakthrough research is going to have the significant societal impact that it can have. The ability for academic research to lead to transformative products depends on financing from commercial interests—financing that is not achievable without a strong patent.

I love the marketplace. The marketplace in a controlled way really elevates society. If you publish something, and it’s open, and it’s not patented first, commercial interests now lack incentive to invest significant money to develop a product and enable that research to achieve its true impact and improve people’s lives. It wouldn’t be uncommon to need to plow one billion dollars into a new drug to go through all the appropriate FDA approval studies on efficacy and safety. If that money doesn’t get invested, the product will never see the light of day. I think there’s a need—I think there’s a moral obligation—to patent breakthroughs in academic research. There are a lot of people who are waking up at 3:30 in the morning to go to work and making minimum wage and paying taxes that go to the National Science Foundation and the National Institutes of Health (NIH). People are

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expecting a return on those investments to improve their lot or the lot of their kids. I think one needs to be pursuing a strong balance of long-term research along with seeing how that research can benefit and improve the health and well-being of society.

T&I: Turning from the general to the more personal, I’d like to dig in a little on your own story. You are a serial entrepreneur, and it’s one thing to be an entrepreneur and another thing altogether to be a serial entrepreneur. Statistically, only one in ten adults engages in entrepreneurial activities in the U.S. and an even narrower subset (29% of the original one in ten) can be classified as serial entrepreneurs. What do you identify as the reason for your involvement in what is really such a rare activity?

DeSimone: I think it’s addicting. Once you start doing it, the challenge is that the highs can be really, really high and the lows can be really, really low. To try to do it with an even keel is important. I can tell you that, with one of my earlier endeavors before Carbon, when I was watching remotely when our first biodegradable stent was being implanted in a human in New Zealand, my knees were weak and I had goosebumps. It was unbelievable. Now, there are over 200,000 people around the world who have our stents.

When I go to the Midwest and talk to Chip Gear, who is a retired Navy Captain with a business that is changing the footprint in the Rust Belt of the U.S. and creating jobs and businesses and driving innovation, it’s pretty heartwarming and inspiring. It’s heady stuff going into some of these humble places and seeing that people are so damned fired up that a tech group out in this Silicon Valley is helping them change their businesses. That’s pretty heady. When they start talking about visions that are as big as your own vision and based on your technology, it is goosebumps time. That’s truly motivating for a science person, a polymer person; that’s pretty neat.

And it is addicting to see that your toolbox can be helpful to others. When I started doing medical-related research that involved NIH funding, it was a powerful experience. NIH often has patient advocates who go on peer review site visits, you know, cancer survivors who are scientists and engineers standing by a student’s poster trying to understand their approach for treating pancreatic cancer. Are you kidding? Talk about a high. That is so motivating,

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and so I think it is a great time to be a scientist and engineer when you’re trying to improve people’s lot in life and their health and well-being. It’s fun to be helpful.

T&I: Motivation has clearly been a part of your story.

I mean, you were already an assistant professor at the age of 25 and have set a breakneck pace in the years since then, racking up accomplishment after accomplishment. Where does that drive come from?

DeSimone: I would say that it’s recognizing the power of a team. I would think ultimately that my product, to speak in business vernacular, is the people I’ve been associated with. I can look around Carbon—I just had the VP of materials pop his head in this morning, who got his Ph.D. with me and has three or four former students of mine in his group. We were on the phone with one of our customers that we’re going to do something really amazing with in a few months, and they were talking about the significance of teams. I think that what I have figured out is that the volume and height of my legacy is directly related to the quality of people that I’ve had the good fortune to touch. I’m really good at staying the hell out of their way and just helping them see the potential in themselves and what they’re doing, and that’s been a lot of fun. That’s the key.

T&I: The team?

DeSimone: Yes, having people who are a hell of a lot smarter than you and who are motivated, and seeing the unbounded potential in that team. We are good at recruiting great people who are motivated to do something special.

T&I: Speaking of recruiting, I was quite taken with a quote you offered on the importance of diversity when building an innovation team: “There is no more fertile ground for innovation than a diversity of experience. And that diversity of experience arises from a difference of cultures, ethnicities, and life backgrounds. A successful scientific endeavor is one that attracts a diversity of experience, draws upon the breadth and depth of that experience, and cultivates those differences, acknowledging the creativity they spark.” What experiences brought you to that realization? How do you put that into practice with your research group and your company?

DeSimone: I had a pretty enlightening experience in my late 20s. My Ph.D. advisor couldn’t make some commitment, and he threw a bone to me to take his place on an innovation committee at a very large chemical company. I said sure, and I walked into this boardroom that was pretty sterile looking. And not only were there all white guys around the table, which I barely noticed at first because I’m often in those environments, but what was especially striking to me was that they all had graduated from the same two research groups. They all knew the same stuff.

I thought, “Man, this is the innovation committee?

They’re at a structural disadvantage.”

I don’t like hanging out with people who are like me when I think about brainstorming. I like to hang out with physicians and surgeons and people who own problems. I just feel like I’m a workman. I have a toolbox, but other people have problems that are people-facing, and I’m just sort of a handyman that can help in solving them. It dawned on me that organizational structure has a profound influence on innovation. A lot of people will talk about the role of disciplinary diversity and the theme of convergence.

I’ve chaired studies on convergence, including for the National Academies, and many folks will limit how they think about convergence to the definition MIT established a number of years ago, focused at the interface of the life sciences, physical sciences, and engineering for advances in medicine. Those fields are indeed pretty hard to straddle, but this definition leaves out the broader social sciences, the humanities, and even the performing arts. Joining ideas from the broadest range of fields to solve a pressing problem is how I think about convergence. Innovation and problem-solving processes to tackle significant societal challenges benefit greatly from the convergence of diverse people and diverse disciplines—this means human diversity in the broadest sense too, not just disciplinary diversity.

You realize from having been on a lot of different design teams how important diversity is. You recognize that how a young person contributes to a design team may be very different depending, for example, on whether they grew up with a lot of money or they didn’t. How someone looks at a problem is shaped by life experience; if you grow up without a lot of resources, your problem-solving approach will be shaped by that experience. The richness of

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ideas and perspectives drives innovation. To me, that’s really been why I appreciate diversity as a fundamental tenet of innovation—that recognition that we learn the most from those we have the least in common with. If you have a thirst for knowledge, the last thing you want to be doing is sitting next to someone who knows the things that you know and looks the way you do. It takes a bit of discomfort and confidence—confidence in what you know and what you don’t know—to have a conversation with someone who knows a lot about something that you don’t, or who has experienced something that you’ve never experienced. And it’s core.

whole lot of time to read. I’ve been forcing myself to take time for reading on the weekends. I just read an amazing book called The Obstacle Is the Way. The path for so many great things is really embedded in the obstacles that one faces.

T&I: You are also on the record as an ardent supporter of a liberal arts education. In a world that increasingly tries to place the liberal arts and the STEM fields in opposition, this seems like an important point to pursue. How did your early foundation in the liberal arts shape your path in science? Why are the liberal arts so necessary?

DeSimone: I’ve been using the phrase “Every moment counts” a lot lately. Thinking about the election, every moment counts, and every vote counts.

We got what we voted for. I think everyone has got to be accountable, and everyone has to recognize that if you don’t participate or engage, then you’re going to get a result that you perhaps didn’t want. Who said, “Life is 90% showing up?” I think Woody Allen said something like that. There is truth to it. A quote that I love by Goethe also comes to mind: “It is not enough to know; we must also apply. It is not enough to will; we must also do.” You have to show up and you have to engage and “do” because every moment counts.

This is especially important for those following an entrepreneurial path.

DeSimone: I went to a phenomenal residential liberal arts institution outside Philly called Ursinus College.

Our family couldn’t afford for me to be residential there, so I was a commuter and worked a couple of jobs while I went to school. It was a pretty neat environment. I probably hated being put on the spot so much to describe what I thought about a passage of literature or other work that I had to read the night before. There were only 12 kids in each class, and there was no hiding in the back! It was pretty uncomfortable at times, yet it became very clear to me that—and probably more in hindsight than when I was going through it—understanding what lifelong learning is all about, understanding what’s important, understanding the messages in great works of literature and philosophy, understanding principles from different fields like economics and psychology, and seeing how this understanding resonates in our world today is key. Just look at what’s happening around us. You can make many analogies to historically important themes. Having been prepared by reading all of these different things shapes my perspectives and even helps me to understand my own areas of expertise better, especially in identifying ways to apply specialized knowledge, for example in polymer chemistry, to have a meaningful impact in society. I still read a lot even though I don’t have a

T&I: Your career is notable as a teacher and mentor as well as a researcher and entrepreneur. Given the critical issues we face as a society, we need more students to think like you and to take up careers in the innovation sphere. What are we doing well in the area of encouraging students to follow that path?

What could we be doing better?

T&I: Do you think that universities, by and large, are doing a good job of getting students to engage?

DeSimone: I think they are. There are probably too many political pressures that universities face.

Universities, especially public institutions, are really challenged to do more and more and more with less and less, and it’s unfortunate that a fundamental ratio that points to educational quality—the studentfaculty ratio—is the same ratio that some lawmakers look at to gauge inefficiency. You can’t get around that math. It’s a simple ratio, and I think it’s challenging.

CONCLUSION One can’t help but be impressed when DeSimone, a man of conviction and ideals, speaks passionately not only of his work in the sense of its scientific impact but also in its adherence to his own beliefs, especially those concerning the centrality of diverse and creative

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teams to all individual successes, including his own.

Cognizant that many people believe that mentioning teamwork is something done by rote, he’s adamant in insisting on the veracity of this sentiment, noting that when you are really in the thick of any creative work, you cannot help but recognize the simple and central truth that your success is determined not by you but by the quality of the people around you. Key to that quality, in his estimation, is the range of perspectives that his group can bring to the table. When considering whether he feels that he has been successful at Carbon in assembling a team that reflects that commitment to diversity and a true sense of what he means by convergence, his response is unequivocal: “Oh yeah. We are the land of misfit toys here, and it’s pretty fun. Everybody’s cherished, everybody’s different; it’s pretty neat.” With that philosophy front and center, there is little doubt that Carbon will make good on the lofty objectives that DeSimone and his team have set.

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FURTHER READING 1.

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DeSimone JM, Mecham SJ, Farrell CL. Organic polymer chemistry in the context of novel processes. ACS Cent Sci. 2(9):588-597; 2016.

Janusziewicz R, Tumbleston J, Quintanilla AL, Mecham SJ, DeSimone JM. Layerless fabrication with continuous liquid interface production.

Proc Natl Acad Sci USA. 113(42):11703-11708; 2016.

Tumbleston JR, Shirvanyants D, Ermoshkin N, Janusziewicz R, Johnson AR, Kelly D, Chen K, Pinschmidt R, Rolland JP, Ermoshkin A, Samulski ET, DeSimone JM. Continuous liquid interface production of 3D objects. Science.

347(6228):1349-1352; 2015.

DeSimone JM, Farrell CL. Driving convergence with human diversity. Sci Transl Med. 6(238):238ed11; 2014.

DeSimone JM. The role of diversity in commercializing basic science. Res Technol Manage.

57(6):16-20; 2014.

Wong DH, Thelen JL, Fu Y, Devaux D, Pandya AA, Battaglia VS, Balsara NP, DeSimone JM. Nonflammable Perfluoropolyether-based

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electrolytes for lithium batteries. Proc Natl Acad Sci USA. 111(9):3327; 2014.

National Research Council. Convergence: facilitating transdisciplinary integration of life sciences, physical sciences, engineering, and beyond. Washington (DC): The National Academies Press; 2014 [accessed 2017 May 1]. http:// www.nap.edu/catalog.php?record_id=18722.

Xu J, Wong DHC, Byrne JD, Chen K, Bowerman C, DeSimone JM. Future of the Particle Replication in Nonwetting Templates (PRINT) Technology. Angew Chem Int Ed Engl.

52(26):6580-6589; 2013.

Perry JL, Herlihy KP, Napier ME, DeSimone JM. PRINT: a novel platform toward shape and size specific nanoparticle theranostics. Acc Chem Res. 44(10):990-998; 2011.

Gratton SEA, Ropp PA, Pohlhaus PD, Luft JC, Madden VJ, Napier ME, DeSimone JM. The effect of particle design on cellular internalization pathways. Proc Natl Acad Sci USA. 105(33):11613-11618; 2008.

Rolland JP, Maynor BW, Euliss LE, Exner AE, Denison GM, DeSimone JM. Direct fabrication and harvesting of monodisperse, shape specific nano-biomaterials. J Am Chem Soc. 127(28):10096-10100; 2005.

Rolland JP, Van Dam RM, Schorzman DA, Quake SR, DeSimone JM. Solvent resistant “liquid Teflon” for microfluidic device fabrication.

J Am Chem Soc. 126(8):2322-2323; 2004.

McClain JB, Londono D, Combes JR, Romack TJ, Canelas DA, Betts DE, Samulski ET, Wignall G, DeSimone JM. Design of non-ionic surfactants for supercritical carbon dioxide. Science.

274(5295) 2049; 1996.

DeSimone JM, Maury EE, Menceloglu YZ, Combes JR, McClain JB, Romack T. Dispersion polymerizations in supercritical carbon dioxide.

Science. 265(5170):356-359; 1994.

DeSimone JM, Guan Z, Elsbernd CS. Synthesis of fluoropolymers in supercritical carbon dioxide.

Science. 257(5072):945-947; 1992.

INNOVATION

HYBRID HEART VALVE TECHNOLOGY (HValve) S. Hamed Alavi and Arash Kheradvar Kheradvar Research Group (KLAB) University of California Irvine, Irvine CA

HValve is the first patient-specific hybrid tissue-engineered heart valve prosthesis with selfregenerative capacity, lifelong durability, and enhanced biocompatibility. A new technology is being developed that combines both mechanical and native valves’ characteristics by mimicking a native valve’s biocompatibility and hemodynamics, yet with a mechanical valve’s long-term durability. The hybrid valve’s leaflets are composed of an extra-thin superelastic Nitinol (or polymeric) mesh, which is tightly enclosed by multiple layers of smooth muscle, fibroblast/myofibroblast, and endothelial cells of the patient who will receive the valve. Since HValve’s technology can be incorporated into both surgical and transcatheter valves, it has a potential competitive cost structure to capture a significant portion of the ~$3 billion current annual worldwide heart valve replacement market. HValve is protected by two issued and multiple pending U.S. and international patents.

More information can be found at:

kheradvar.eng.uci.edu/research.php?cat=hybridvalve Technology and Innovation, Vol. 19, pp. 449-450, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

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ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.349 www.technologyandinnovation.org

INNOVATION Sean White Tyler Rice Bruce Yang

Laser Associated Sciences, Inc. Beckman Laser Institute University of California, Irvine

Approximately 12 million people in the U.S. suffer from a condition called peripheral artery disease (PAD), which is characterized by arteries in the legs becoming narrowed or blocked by plaque. This restricts blood flow to the feet and results in 70,000 major amputations in the U.S. each year at a cost of more than $10 billion.

Despite the severity, >50% of individuals with PAD go undiagnosed because early symptoms can be difficult to detect by patients and because current screening tests for PAD take too long for most primary care doctors to perform. In addition, approximately 25% of patients who undergo surgery to treat PAD require reintervention.

Laser Associated Sciences, a medical device start-up incubating at the Beckman Laser Institute, has developed light-based technology to accurately measure blood flow.

Their first device – the FlowMet – is clipped onto a toe and uses a low-power laser to instantly measure blood flow. Data collected using FlowMet suggests that it can not only diagnose PAD earlier and more accurately than current tests, but that it can also improve surgical outcomes by giving surgeons the first real-time measurement of blood flow. This tells clinicians which surgical techniques and tools are most effective for restoring limb-saving blood flow.

FlowMet blood flow measurement system

More information can be found at:

www.laserassociatedsciences.com

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ISSN 1949-8241 • E-ISSN 1949-825X http://dx.doi.org/10.21300/19.1.2017.451 www.technologyandinnovation.org

Technology and Innovation, Vol. 19, p. 451, 2017 Printed in the USA. All rights reserved.

Copyright © 2017 National Academy of Inventors.

T&I BOOK REVIEW Charles E. Hutchinson Thayer School of Engineering, Dartmouth College, Hanover, NH, USA

Engineering Entrepreneurship, From Idea to Business Plan Paul Swamidass Cambridge University Press, 2016 (254 pp.) $39.95 (ISBN 978-1107651647) www.engineer-entrepreneur-book.com/ According to the author, “This is a book for engineers and scientists who have the aptitude and education to create value through new products that become income-producing businesses for them as well as for potential investors.” The structure of the material is suggested for use in a ten-week one-term course, either with a teacher or for self-study. There is also a companion website that contains backup and additional material, which would be particularly useful if the reader chooses the self-study approach but would also be helpful in a classroom environment as well. The fundamental “construct” the author uses is a Seven Phase process: Pre-Startup (Phases 1-3) followed by Execution (Phases 4-7). This construct works well with the author’s thesis that engineers’ and scientists’ (his primary audience) primary contributions to the complete process of innovation are in the area of the pre-startup. However, in the judgment of this reviewer, although I can accept the author’s thesis, in my experience, it is the execution phases where the training for scientists and engineers is the weakest.

A particularly strong contribution the author makes is his attention to the importance of intellectual property, something often missing in the training of scientists, in particular. Not only does he do a good job of explaining the process of patenting, as

well as the structure of the United States Patent and Trademark Office and their processes, he spends time outlining the opportunity for pro se applicants.

This is often left out of texts of this type. The author clearly has experience in this latter approach.

The only major weakness I find in the text is there could have been more time spent on the concept of the “Business Model” and the “Business Plan.”

I realize these concepts are often left for “business school” types, but again, in my experience, the “idea” and “product” concepts are so central to the “value proposition” that the scientists and engineers who want to be innovators really need to have a strong appreciation for them and be able to provide input in this regard. It always takes a “team” for a start-up to be successful, of course, but the “product” after all is the “secret sauce.”

On balance, I consider Professor Swamidass’s book should be considered by any instructor as a candidate for acceptance as either the text, or at least a reference, for a course focused on scientists and/or engineers. That could be true for either graduate students or undergraduates based on the background of the instructor. His book is complete but a bit “terse.”

Therefore, as a self-study, I am not as confident as for course use. The website helps in this regard but may not be sufficient.

In 2014, Prof. Hutchinson received the NAE Bernard M. Gordon Prize with three others for the design and implemenetation of Dartmouth’s Engineering Entrepreneurship Program.

_____________________ Accepted April 15, 2017.

Corresponding Author: Charles E. Hutchinson, Dean Emeritus, Thayer School of Engineering, John H. Krehbiel Sr. Professor for Emerging Technologies, Emeritus, Dartmouth College, Hanover, NH, USA. Tel: +1 (603) 646-3802; E-mail: Charles.Hutchinson@Dartmouth.edu

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Aims and Scope

Patent Reviews: New patents of interest to the readers of T&I are included in this category.

The journal Technology and Innovation, Journal of the National Academy of Inventors (T&I) is a forum for presentation of information encompassing essentially the entire field of applied sciences, with a focus on transformative technology and academic innovation. Owing to the broad nature of the applied sciences, authors should be guided by the interest of the readers who are likely to be knowledgeable non-specialist scholars. Contributions containing the following information will be considered for publication:

Book Reviews on Innovation and Technology: Solicited or unsolicited short reviews of relevant books and issued patents are considered for publication in this category.

Preparation of Manuscripts Submissions to Technology and Innovation must be in English, in an editable Microsoft Word-compatible electronic file, typed, 12-point font, double-spaced, formatted for 22 × 28 cm (8.5 × 11 in) with a margin of 2.5-3 cm (1 in) at the top, sides, and bottom of each page. Tables should be placed on separate page(s) sequentially at the end of the manuscript (after the ‘Reference’ section). Figures should be submitted separately from text.

• Description of advances in transformative technology and translational science • Critical assessments of a segment of science, engi neering, medicine, or other technologies • Economics of a technology, governmental and policy action, and innovation as related to intellectual prop erty • Environmental (including human health) impact of various technologies • Articles on historical, societal, ethical, and related aspects of science,engineering, medicine, or technol ogy, provided they are written for the scientific com munity and in a style compatible with a scientific journal • Articles should have a discussion on the process of innovation and invention

Title page: Each paper should include a title page with the title of the paper, submission type, name(s) of author(s), and complete affiliation(s). Provide a short title to be used as running head. Indicate the author to whom correspondence and proofs should be addressed (i.e. ‘corresponding author’), and provide a complete physical mailing address, phone, fax, and email address.

Title: The title should be as short as possible but fully descriptive.

Submission Type: The author should indicate the type of submission that best describes their manuscript (Article, Commentary, Editorial, or Patent Review).

Because T&I serves a multidisciplinary audience, authors are urged to avoid writing for specialists. In particular, they are discouraged from using expressions that are understandable only to a select audience of specialists. For example, mathematical expressions should be explained in words to assure their appreciation by nonmathematicians. All contributions will be subjected to peer review and will be evaluated on the basis of their general usefulness for the readers, including scientific quality, originality, and compliance with the style and format of the journal. The following categories of contributions will be considered for publication:

Abstract and key words: The abstract should contain a summary of the article, including its results in 250 words or less. Because many abstracting services use the abstract without reference to the content, the authors are urged to succinctly provide the essence of the paper in the (up to) 250 words allocated. Additionally, provide 3 to 6 key words after the abstract.

Tables and figures: Tables and figures should be understandable without excessive reference to the text; particularly, units and quantities should be clearly identified. In general, material should be presented in tables or figures but not in both. Avoid very wide or long figures and tables that would not fit on a printed page. By default, tables and figures will appear in B&W. If color figures are necessary or desired, there is a charge for their reproduction. Figures should be submitted at the highest resolution possible, preferably 300dpi at 7 inches (width or height).

Low-resolution files that appear pixilated when printed will NOT be accepted for publication.

Articles: Most articles will be review format with no minimum or maximum length. The journal subscribes to the concept that the length of an article is determined by its content. However, a preference will be given for articles that are between 7 and 15 published pages.

Commentaries and Discussions: (Letters to the editor, editorials, and similar contributions also fall into this category.) These are subjected to peer review and are required to follow T&I format and style and must be consistent with the requirements of a scholarly journal. The discussion of contested areas of science where a consensus is lacking is included in this category. Commentaries are shorter than regular manuscripts and must contain information that is likely to invoke scientific discussion with the objective of promoting the development of a consensus.

Tables: Present each table on a separate page at the end of the manuscript (i.e., not within the body of the text). Provide a short title for each table. Cite all tables sequentially in the text and provide publishing staff with a cue for where they should approximately appear in the manuscript (e.g.,

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ii ‘INSERT TABLE 1’) when published. Tables should be in an editable format.

Figures: Figures should be submitted separately from the text. Cite all figures sequentially in the text and provide publishing staff with a cue for where they should approximately appear in the manuscript (e.g., ‘INSERT FIGURE 1’) when published. All figures must be high-quality art work in electronic format. Lettering should be large enough to be readable when reduced to fit page or column size. Avoid light lettering and gray shading. SPECIAL NOTE: Figures in accepted submissions are printed for free in black & white. If you wish to have your figures reproduced in color, there is an additional fee for this service. All legends for figures should be included on a separate page at the end of the manuscript.

Equations: All equations should be typewritten. Mathematical notations should be simple and suitable for a multidisciplinary audience. For example, fractions within fractions and subscripts within subscripts should be avoided. Where possible, incorporate equations into the text rather than as a separate figure.

Units, quantities, and abbreviations: Use SI (metric) units and international quantities and abbreviations. Equivalent values in other systems may be used, provided their metric equivalents are included in every case. Note that percent, ppm, and ppb are not metric units.

Footnotes: Avoid text footnotes. Footnote material should be incorporated into the text for the benefit of the readers, editors, and printers.

Financial Disclosure: The authors should indicate any financial or other relationships connected with the information in the article.

Acknowledgment: If an acknowledgment is included, it should not contain lengthy descriptions of the reason for the acknowledgement.

References: For references, please follow CSE citation-sequence style. Information about CSE citation format can be found at http://www.scientificstyleandformat.org/Tools/ SSF-Citation-Quick-Guide.html. If you have additional questions about references or other formatting issues, please contact T&I at tijournal@academyofinventors.org.

The designated corresponding author will receive a proof of their article in PDF format via email before publication.

The corresponding author should answer all queries at this time and carefully check all editorial changes within 48 hours of receipt. Corrections at this stage should be limited to printer’s errors and minor changes. No major changes or rewrites are allowed.

Open Access: To help authors reach maximum exposure for manuscripts published in Technology and Innovation, T&I utilizes Open Access publishing. Fees are billed when a manuscript is accepted for publication.

Open Access Fee Rates Standard Single Submission: ...................................$1,000 NAI Fellow Contributed Single Submission: ...........$800 If you are interested in publishing with T&I but believe you will be unable to meet the Open Access fees, please contact T&I at tijournal@academyofinventors.org or (813) 974-1347.

Copyright: If data from any source other than the authors is used in tables or figures, it is the responsibility of the authors to obtain permission to reproduce such material.

Editorial staff may ask authors to provide proof that permission has been granted from the original publisher and indicate the source when signing our copyright forms.

For any questions relating to the formatting or submitting of manuscripts, please contact T&I at tijournal@ academyofinventors.org or (813) 974-1347.

Ethics Statement The publishers and editorial board of Technology and Innovation have adopted the publication ethics and malpractice statements of the Committee on Publication Ethics (COPE) (http://publicationethics.org/resources/guidelines). These guidelines highlight what is expected of authors and what they can expect from the reviewers and editorial board in return. They also provide details of how problems will be handled. Briefly: Author Responsibilities: Authors listed on a manuscript must have made a significant contribution to the study and/ or writing of the manuscript. During revisions, authors cannot be removed without their permission and that of the other authors. All authors must also agree to the addition of new authors. It is the responsibility of the corresponding author to ensure that this occurs.

Financial support and conflicts of interest for all authors must be declared. Further information on this can be obtained from the International Committee for Medical Journal Editors (http://www.icmje.org/).

The reported research must be novel and authentic and the authors should confirm that the same data has not been and is not going to be submitted to another journal (unless already rejected). Statements made in the introduction and discussion should be supported by appropriate references, and sufficient experimental detail should be provided to allow for repetition of the study by another group.

iii Plagiarism of the text/data will not be tolerated and could result in retraction of an accepted article. Any text or figures reproduced for another source require the permission of the original copyright holders (normally the publishers).

Any manipulation of figures should be equally applied and described in the text (including pseudocoloring) and must not change the meaning of the figure.

When humans, animals, or tissue derived from them have been used, then mention of the appropriate ethical approval must be included in the manuscript.

Reviewer responsibilities: Reviewers are expected to not possess any conflicts of interest with the authors and research. They should review the science objectively and provide recommendations for improvements where necessary. When aware of relevant published work not being cited, the reviewers should recommend inclusion of these references. If the reviewer feels that they would be unable to repeat the study as described, then additional methodological details should be requested. Any unpublished information read by a reviewer should be treated as confidential.

Editorial responsibilities: The editors will select an appropriate number of reviewers for the manuscript so that they can make an informed decision about whether to reject/ accept a manuscript. Their decision must be based only on the paper’s importance, originality, clarity, and suitability for the journal. They must not have a conflict of interest with the authors or work described. The anonymity of the reviewers must be maintained.

Should problems come to light after acceptance, then the editors agree to promote the publication of corrections and/or retractions as deemed necessary.

Publishing responsibilities: The publisher agrees to ensure that, to the best of their abilities, the information that they publish is genuine and ethically sound. If publishing ethics issues come to light, not limited to accusations of fraudulent data or plagiarism, during or after the publication process, they will be investigated by the editorial board, including contact with the author’s institution if necessary so that a decision on the appropriate corrections, clarifications, or retractions can be made. The publisher agrees to publish this as necessary so as to maintain the integrity of the academic record.

Protection for Research Participants These policies are in accordance with the recommendations of The International Committee of Medical Journal Editors (ICMJE)

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Humans

1. If experiments or research reported in the article in volve human subjects, the authors must indicate if their procedures were approved by an Institutional Review Board, ethics committee, or similar reg ulatory oversight committee. If a review board or committee is not available, the authors should indicate that their procedures are in accor dance with the Helsinki Declaration as revised in 2013.

2. Manuscripts must be accompanied by a statement that the informed consent of research participants was obtained prior to participation or that documen tation of informed consent was waived by the Insti tutional Review Board, ethics committee, or similar regulatory oversight committee.

If images or other identifying information is included in the manuscript, explicit written informed consent of the individual/patient must be obtained and included with your submission. Measures to protect the confidentiality of the individual(s) should also be employed. If consent cannot be obtained, you are encouraged to contact the editor for further guidance. n

Animals

If experiments or research reported in the article involve animals, the authors must indicate if their procedures were performed in accordance with the U.S. Public Health Service’s (PHS) Policy on Human Care and Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals and were approved by appropriate institutional review committee(s).

Editors reserve the right to reject manuscripts if there is doubt that appropriate ethical standards have not been met in research involving human and animal subjects or if there is reason to suspect research misconduct.

THE INVENTION GENDER GAP Guest Editor: Florence Haseltine Technology and Innovation (T&I) is currently soliciting manuscripts for a special issue on the gender gap in the invention arena. Statistics show that women are named as inventors on fewer than one in five patents despite gains in the number of women entering STEM fields, and addressing this disparity will be critical to remaining competitive in the global innovation sphere. This special issue builds on earlier work on the invention gender gap published in T&I by our guest editor Florence Haseltine (T&I 18.4) and Philippa Olsen (T&I 17.4).

We seek articles and reviews addressing topics associated with gender-based differences in representation and outcomes for inventors. Relevant topics include but are not limited to:

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The differential representation of men and women as inventors Differences in outcomes for male vs. female inventors Contributing factors and hypotheses related to the gender gap in invention— systemic, environmental, etc.

Analyses of relevant data and statistics Proposals and solutions to close the gender gap in invention Effects of the persistence of the gender gap in invention on inventors and society at large Roles of universities, government agencies, and private enterprise in addressing the gender gap

Initial manuscripts should be submitted by September 1, 2017. Instructions for authors can be found at: http://academyofinventors.org/ti/resources.asp.

T&I is published by the National Academy of Inventors and presents information encompassing the entire field of applied sciences, with a focus on transformative technology and academic innovation, and welcomes manuscripts that meet the general criteria of significance and scientific excellence. We publish original articles in basic and applied research, critical reviews, surveys, opinions, commentaries, essays, and patent and book reviews of interest to our readers.

If you have questions or would like to submit a manuscript, please contact associate editor of T&I, Kimberly Macuare, at kmacuare@academyofinventors.org.

TECHNOLOGIES FOR DISABILITIES SPECIAL EDITORS

Sethuraman Panchanathan, Arizona State University, USA, panch@asu.edu Diane Cook, Washington State University, USA, cook@eecs.wsu.edu Forouzan Golshani, California State University, Long Beach, USA, forouzan.golshani@csulb.edu Troy McDaniel, Arizona State University, USA, troy.mcdaniel@asu.edu Shayok Chakraborty, Arizona State University, USA, shayok.chakraborty@asu.edu

Technology and Innovation (T&I) is currently soliciting manuscripts for a special issue on technologies for disabilities.

Rapid technological advancements and innovations continue to largely target the “able” population with little consideration to accessibility, leaving behind the 15 percent (1 billion) of the world’s population who has some form of disability. Individuals with disabilities often must adapt themselves (usually unsuccessfully) to available devices and software designed with accessibility as an afterthought rather than as an integral component from ideation to development. Ad hoc solutions are common in which disparate technologies are combined to circumvent accessibility issues, often with much struggle. There is therefore a pronounced need for research on innovative assistive and rehabilitative technologies spanning diverse disabilities, including sensory, physical, and cognitive impairment as a result of an injury, disease, disorder, and/or aging. We invite authors to submit articles representing cutting edge advances and outcomes in assistive and rehabilitative technology intended for use by: •

Individuals with sensory impairment, including visual (e.g., blindness, low vision) and/or hearing (e.g., deafness, hard-of-hearing)

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Individuals with motor impairment due to stroke, brain injury, spinal cord injury, Cerebral Palsy, other causes

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Individuals with cognitive impairment affecting speech, language, memory, attention, and/or learning

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Individuals with psychiatric disabilities (e.g., anxiety, mood disorders)

Initial manuscripts should be submitted by January 2, 2018. Instructions for authors, including journal policies, manuscript formatting information, and author forms, can be found at: http://academyofinventors.org/ti/resources.asp.

T&I is published by the National Academy of Inventors and presents information encompassing the entire field of applied sciences, with a focus on transformative technology and academic innovation, and welcomes manuscripts that meet the general criteria of significance and scientific excellence. We publish original articles in basic and applied research, critical reviews, surveys, opinions, commentaries, essays, and patent and book reviews of interest to our readers.

If you have questions or would like to submit a manuscript, please contact associate editor of T&I, Kimberly Macuare, at kmacuare@academyofinventors.org.

NOMINATIONS OPEN JULY 1 - OCTOBER 1 A CADEMYOF I NVENTORS . ORG / FELLOWS . ASP Nominees must be a named inventor on United States issued patent(s) and be affiliated with a university, non-profit research institute or other academic entity.

There are 757 Fellows worldwide representing more than 229 prestigious universities and governmental and non-profit research institutes. Collectively, the Fellows hold more than 26,000 issued U.S. patents, which have generated more than 8,500 licensed technologies and companies, and created more than 1.1 million jobs. In addition, over $100 billion in revenue has been generated based on NAI Fellow discoveries.

For more information call (813) 974-0820