Innovation Summer 2014: Medical Evolution by Industrial Designers Society of America

QUARTERLY OF THE INDUSTRIAL DESIGNERS SOCIETY OF AMERICA

Medical Evolution FATHER OF ID

SMART TO WISE

NEW DIRECTIVES

SUMMER 2014

AUTHENTIC INNOVATION Disposables Auto Injectors Drug Delivery Devices Robotic Surgical Systems Manual & Powered Instruments Home Healthcare Products Instructions for Use Packaging Design Bayer, Blood Glucose Meter & Finger Lancing Device

GUI Designs Wearables

Refractive Technologies, Lasik Surgery Microkeratome

Medtronic, IPC Surgical Console & M4 Microdebrider

research - ergonomics - design

www.metaphase.com

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QUARTERLY OF THE INDUSTRIAL DESIGNERS SOCIETY OF AMERICA

SUMMER 2014 速

Publisher IDSA 555 Grove St., Suite 200 Herndon, VA 20170 P: 703.707.6000 F: 703.787.8501 www.innovationjournal.org www.idsa.org

Executive Editor Mark Dziersk, FIDSA Managing Director LUNAR | Chicago mark@lunar.com

Sr. Creative Director Karen Berube IDSA 703.707.6000 x102 karenb@idsa.org

Advisory Council Gregg Davis, IDSA Alistair Hamilton, IDSA

Contributing Editor Jennifer Evans Yankopolus jennifer@wordcollaborative.com

Advertising Teresa Algie 703.273.6211 teresa.algie@verizon.net

Annual Subscriptions Within the US $70 Canada & Mexico $85 International $125

Subscriptions/Copies Jill Richardson 703.707.6000 x118 jillr@idsa.org

Single Copies Fall/Yearbook All others

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The quarterly publication of the Industrial Designers Society of America (IDSA), INNOVATION provides in-depth coverage of design issues and long-term trends while communicating the value of design to business and society at large.

$40+ S&H $20+ S&H

PATRONS OF INDUSTRIAL DESIGN EXCELLENCE

MEDICAL EVOLUTION 20 High-Stakes Design by Sean Hägen, IDSA, Guest Editor

FEATURES 52 Design for Enjoyable Moments

by Cheryl Zhenyu Qian, IDSA 22 Medical Devices: The Next Big Frontier in Industrial IN EVERY ISSUE Design by Fernd van Engelen, IDSA 4 IDSA HQ 25 Coloring Inside the Lines: by Daniel Martinage, CAE Design’s New Role within a 6 From the Editor Highly Regulated Market by Mark Dziersk, FIDSA by R. Reade Harpham 8 Business Concepts by Michael Westcott, IDSA 27 Functional Aesthetics by Philip Remedios, IDSA 10 Book Review by Scott Stropkay, IDSA 30 Hospital to Home: A Blend 12 Design Defined of the Consumer and by Dan Brown Medical Worlds by Stuart Karten, IDSA 14 Beautility by Tucker Viemeister, FIDSA 32 Wearable Medical Devices: 16 A Look Back A Field with Great Promise by Carroll Gantz, FIDSA by Kyle Jarger 56 Showcase 36 Design’s Connection with 64 ID+ME: Medical Device Users by Mary Beth Priviteria, IDSA Clair Samhammer, FIDSA

40 The Ballerina, the Surgeon and America’s Caregiving Conundrum by Carol Shillinglaw, A/IDSA

INVESTOR IDEO, Palo Alto, CA; Shanghai, China; Cambridge, MA; London, UK; San Francisco; Munich, Germany; Chicago; New York Newell Rubbermaid, Atlanta, GA Procter & Gamble, Cincinnati, OH Webb deVlam Chicago, Chicago, IL CULTIVATOR Cesaroni Design Associates Inc., Glenview, IL Crown Equipment, New Bremen, OH Dell, Round Rock, TX Eastman Chemical Co., Kingsport, TN Jerome Caruso Design Inc., Lake Forest, IL Lunar Design Inc., Palo Alto, CA Metaphase Design Group Inc., St. Louis, MO Smart Design, New York; San Francisco; Barcelona, Spain Stanley Black & Decker, New Britain, CT Teague, Seattle, WA Tupperware, Worldwide Charter Patrons indicated by color.

For more information about becoming a Patron and supporting IDSA’s communication and education outreach, please contact Katrina Kona at 703.707.6000 x100.

44 The Benefits of Applying Human Factors Engineering by Michael Wiklund and Stephen Wilcox, FIDSA

49 Working Toward Sustainable Medical Device Design by Seth GaleWyrick

QUARTERLY OF THE INDUSTRIAL DESIGNERS SOCIETY OF AMERICA INNOVATION MEDICAL EVOLUTION

Medical Evolution FATHER OF ID

SMART TO WISE

NEW DIRECTIVES

SUMMER 2014

Cover photo: iStockphoto

SUMMER 2014

INNOVATION is the quarterly journal of the Industrial Designers Society of America (IDSA), the professional organization serving the needs of US industrial designers. Reproduction in whole or in part—in any form—without the written permission of the publisher is prohibited. The opinions expressed in the bylined articles are those of the writers and not necessarily those of IDSA. IDSA reserves the right to decline any advertisement that is contrary to the mission, goals and guiding principles of the Society. The appearance of an ad does not constitute an endorsement by IDSA. All design and photo credits are listed as provided by the submitter. INNOVATION is printed on recycled paper with soy-based inks. The use of IDSA and FIDSA after a name is a registered collective membership mark. INNOVATION (ISSN No. 0731-2334 and USPS No. 0016-067) is published quarterly by the Industrial Designers Society of America (IDSA)/INNOVATION, 555 Grove St., Suite 200, Herndon, VA 20170. Periodical postage at Sterling, VA 20164 and at additional mailing offices. POSTMASTER: Send address changes to IDSA/INNOVATION, 555 Grove St., Suite 200, Herndon, VA 20170, USA. ©2014 Industrial Designers Society of America. Vol. 33, No. 2, 2014; Library of Congress Catalog No. 82-640971; ISSN No. 0731-2334; USPS 0016-067.

Advertisers’ Index 19 2014 IDSA Medical Design Conference 11 2014 IDSA International Conference 1 Luxion c4 LUNAR c2 Metaphase Design c3 Philips 9 Proto Labs

I D S A HQ

NEW DIRECTORS & NEW DIRECTIVES

ur spring board of directors meeting is traditionally the most important leadership meeting in IDSA’s annual line-up. The three-day event is held at the national office in Herndon, VA, and marks the official beginning of terms of IDSA’s newly elected directors. The meeting brings new and retiring directors together to help celebrate past contributions as well as plan for future service. It’s also an opportunity for IDSA leadership and staff to get to know each other better and to assess their collective strengths and challenges. This year the board gave a particularly warm send-off to veteran member George McCain, FIDSA, as he ended five years of service, including serving as chair and chair-emeritus. He will not be disappearing, however. He still has oneyear stints to complete on both the IDSA Design Foundation and as chair of the IDSA Nominations Committee. Vice President of Education Sooshin Choi, IDSA and Northeast District Vice President Stephan Clambaneva, IDSA also rotated off the board, replaced (respectively) by Ayse Birsel, IDSA and Jeremy Van Hill, IDSA. Choi and Clambaneva were also warmly recognized by their peers for outstanding service. Sean Hägen, IDSA took over responsibility for the Sections as Megan Neese, IDSA moved to the director at-large spot. This annual rotation of leadership is a critical component contributing to IDSA’s continued importance and the relevance of IDSA as the principal voice of the industrial design profession. One of the major initiatives coming out of the May board of directors meeting deals specifically with strengthening IDSA’s nominations and elections process. A Nominations and Governance Task Force will be appointed by Chair Charles Austin Angell, IDSA to assess ways that IDSA can proactively improve leadership recruitment and ongoing performance. Several outcomes of the meeting are especially noteworthy, including the creation of a Membership Committee headed by Kevin Shinn, IDSA and the adoption of a revised strategic planning graphic (above). This graphic is an important visualization showing how all IDSA resources—financial and people—align under four principal pillars: education, information, community and advocacy. Having a concise representation of IDSA’s mission and strategic focus serves

IDSA Strategic Plan

ADVOCACY Communicating the value of ID, connecting business to society as a whole

“We will be the go-to source for information.”

INFORM ATION Providing valuable content and data-rich information to members/public

EDUCATION Advancing th e profes sion of Industrial Design

COMMUNIT Y “We will create successful in-person events and virtual communities.”

“We will champion industrial design.”

Promoting continuous learning & development of members/potential members

“We will advance our members’ careers.”

Creating environments that foster engagement, networking & knowledge exchange

as a critical filter when allocating resources and setting direction. The board of directors will be updating IDSA’s strategic plan at the board meeting in February. The Membership Committee comes on the heels of an intensive membership needs assessment survey conducted late in 2013. The committee was formed, in part, to address the opportunities and threats identified by survey respondents. The white paper is available upon request. The committee is charged with developing strategies on the composition of membership, conducting outreach/needs assessments and adjusting the membership value proposition. The committee is still in formation but will report on its progress in member communications and at the August board of directors meeting. A task force was also endorsed by the board headed by Chapter Vice President Julie Heard, IDSA to develop a model to allow chapters and sections to become more innovative and entrepreneurial. Section Vice President Hägen will serve on the task force along with Treasurer Marianne Grisdale. Finally, a huge shout-out to everyone who helped make this year’s District Design Conferences a great success. The pictures capture the spirit and camaraderie at the five regional events. —Daniel Martinage, CAE, IDSA Executive Director danielm@idsa.org

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Left to right, top row: Sooshin Choi, IDSA reviews a portfolio; Jeevak Badve, IDSA welcomes the Central attendees; Charles Mauro, IDSA addresses the Northeast; and Midwest attendees share a drink. Middle row: Audience at the Southern District; SCADâ&#x20AC;&#x2122;s Dean Victor Ermoli welcomes attendees to Savannah; George McCain, FIDSA in Denver; and IDSA Chair Charles Austen Angell, IDSA and Eun Sook Kwon, IDSA at SCAD. Bottom row: Discussions continue outside at the Western District; Midwest Student Merit winners on display; and Stephan Clambaneva, IDSA and guest in the Northeast. Page 2: Professional practice workshop at the Southern District Design Conference.

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Embracing Design Empathy

AN APPLE A DAY W hen we think about the “why” of how we design products and services, our best work usually makes this planet a better place for all of us to live. Of course, not every product can make that claim, but with the design of medical products it’s almost built in. That said, especially with the constraints imposed by regulations, it’s easy in the design of medical environments, products and services to claim that our hands are tied and settle for a design compromise instead of looking for the best possible and most poetic answer. One day a hospital room will need to have the equivalently delightful experience of shopping in an Apple store. It’s coming soon. Hard to picture? Maybe so in the short term, but as we progress, patients no longer will be willing to accept a care system or the products within it that view them as passive recipients of treatment. Patient loyalty can mean the difference between success and failure for healthcare organizations. Gaining patient loyalty comes down to one core factor:

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the ability of healthcare organizations to consistently deliver positive patient experiences. Organizations that can do so will own the future of healthcare. The adoption of a patient-centered care model is becoming the main focus of innovative healthcare organizations as accountability for clinical patient satisfaction continues to grow. Positive patient experiences are no longer a nicety for healthcare systems; they are an absolute necessity. We are seeing an industry wide consciousness shift of this understanding with the steady increase of CXOs (customer experience officers) being appointed to C-suite positions across major healthcare organizations. It is the responsibility of the CXO to cultivate meaningful patient experiences for their organizations. That means that patients are met with positive interactions at every aspect of the incredibly complex healthcare delivery system. No easy task. To successfully deliver on such a multilayered operation, CXOs must examine their organizations through the lens of the patient. This, of course, is where design lives and

LUNAR

F RO M T HE E DI TOR

“Suppose instead of computers, Apple decided to make medical devices.

”

What would a medical device suite from Apple look like? More importantly, how would it feel?

plays the most important role possible in delivering empathy in the form of products, services and user interactions—in looking at the entire user experience at every touchpoint. As the chief experience and marketing officer of Beacon Health Systems in South Bend, IN, Diane Stover has delivered patient experience improvement by using a patient-centered strategy. Working toward improving the holistic patient experience, Stover gives organization-wide recommendations based on insight gained from every level of the facilities. In a highly perceptive approach to reviewing the obstetrics program, for example, Stover decided to speak to the team of people who have the last interaction with parents leaving the hospital with a newborn: the valet attendants. She asked them what they say to departing parents. Some said, “Drive safe, take care of that baby,” but one said, “See you in nine months.” No one had clearly defined this interaction, so the valet attendants made it up and often said the wrong thing. Beacon decided to write a script to ensure a positive final interaction with new parents. At first they came to “Take care of that beautiful baby”; however, a nurse pointed out that if the baby had a cleft palate it could be misconstrued as sarcasm. So they revised the script until they reached “Take care of that precious baby.” Taking this deep level of care and empathy in defining such a seemingly small detail not only empowered the valet attendants to understand how powerful their words can be, it illustrates an important lesson: that all interactions are a part of shaping the patient experience. Every interaction with people as well as products at all touchpoints of the patient-care life cycle creates the patient experience. To successfully curate the future of positive patient experiences, we must continue investing this deep level of empathy for creating positive human interactions as we do into designing medical devices. The future of healthcare will be won by those who put patients first, who think about patients as customers of

healthcare. Again, this core value— always put your users first—is long understood in the design community. A good way to think about it is to design these experiences looking through three lenses: beauty, ingenuity and charisma. While we may not often think of medical products as beautiful, there is no reason not to; their expression in form and detail have the power to inspire and comfort. Ingenuity solves for problems of use and manufacture, and charisma draws people to a product because of a true understanding of need. The trick is an uncompromising commitment to all three lenses in every solution and product designed. With the widespread consciousness shift seen in healthcare organizations toward understanding the importance of focusing on positive patient experience, I believe that this is incredibly exciting time for design leadership to be brought to the table. Let me pose a final question, hinted at in the first paragraph: Suppose instead of computers, Apple decided to make medical devices. What would a medical device suite from Apple look like? More importantly, how would it feel? What would it feel like to have the same emotional connection, excitement and curiosity toward a suite of medical devices as we do toward the Apple devices we know and love today? Isn’t it time that we demand rich emotional experiences from medical products, products that truly make a difference in our lives and well-being? These are the questions that we explore everyday as designers because we believe that meaningful designs possessing beauty, ingenuity and charisma hold an important role for our future healthcare system. INNOVATION would like to thank Sean Hägen of BlackHägen Design for his outstanding contribution of time and energy as guest editor for this issue. Sean, along with the extraordinary suite of authors he assembled, has produced an exceptional body of thought leadership around this important and timely topic that affects us all, always. —Mark Dziersk, FIDSA, INNOVATION executive editor mark@lunar.com

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BU S I NE SS CO NCE PTS

REDESIGNING HEALTHCARE

atient-centric. This is a mantra you hear frequently in healthcare and the pharmaceutical industries, but there is a big difference between marketing banter and meaningful behavior. I have spoken in the past about the importance of taking business personally and focusing not on software, components, products, services and transactions, or even experiences, but on relationships. Relationships are made up of all these touchpoints and, most especially, the peopwle involved in delivering value and deepening (or damaging) the connection. The entire healthcare establishment appears riddled with ongoing conflict and quite fragile. Every part seems to be protecting itself from every other part: insurance companies vs. doctors vs. hospitals vs. pharma vs. government vs. patients vs. bankruptcy. Pity the poor souls who have to go it alone trying to knit together the best course of action and practitioners for their needs. A Call for Creativity My current experience has me questioning the value of Western medicine in certain situations. Fear, money and lawsuits now encourage doctors to tow the company line when it comes to treatment and options. They only share what big

labs have tested and said they have the data for. They focus on narrowing specialties and rarely look outside their discipline at the whole patient and the whole body, never mind alternative treatments or ideas. Instead, many physicians do what is easiest: treating parts and symptoms with favored solutions with a noticeable lack of curiosity and creativity. Sure, the people that greet you can be quite accommodating and do their best to make you feel they care, but the reality is they are stuck in a broken system. Scrums vs. Appointments Healthcare should take a lesson from design thinking and lean technology development and put the user at the center of their scrum the way the Mayo Clinic does to get multiple points of view and a wider understanding of the potential problem and implications. The reason the Mayo Clinic maintains a great reputation for care is that it collaborates, rather than pontificates. Teams of specialists collectively build on each other’s ideas, rather than try to shoot them down. It’s the world of “yes, and…,” rather than the world of “that’s not the way we do it.” That sounds more like design thinking to me. The real opportunity for design is to move beyond the products and the equipment to help improve these experiences. —Michael Westcott, IDSA, president, DMI mwestcott@dmi.org

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BO O K RE V I E W

Acting and Leading with Wisdom

FROM SMART TO WISE

“W

ise Leaders Wanted” is the title of the first chapter of From Smart to Wise, and in it the leadership coaching team of Prasad Kaipa and Navi Radjou describe a latent need in the quality of leadership demonstrated in personal, business, community, and societal contexts. They argue that a change in personal leadership style is required if we want to maximize the good we do in life. Even if you’ve read your fill of leadership books, you should consider one more; their approach is personal, holistic and significantly influenced by Eastern religious and cultural traditions. They offer a way to define your goals and a way to create empowered teams to achieve them. Like other books reviewed in this column, From Smart to Wise was written for people from all walks of life who want to achieve their full potential. As designers on this mission, it is interesting to consider how we can apply this fresh view on leadership to better wield our specialized skills and methods to make our ideas even more influential. According to Kaipa and Radjou, the world is full of smart leaders but tragically lacking in wise leaders. They define critical differences in the techniques used by the two and demonstrate the positive influence and ultimate success of wise leadership. According to the authors, smart leaders apply their intellect toward personal growth and success. While they can accomplish much, smart leaders are unable to achieve their ultimate goals because they don’t fully appreciate the subtleties of key concepts like mindfulness, stewardship, discipline and grace. The authors divide smart leaders into two camps by the way the see and address the world. Business-smart leaders value drive, vision and risk-taking and inspire others to follow their vision by painting a picture of what could be. Functionally smart leaders, on the other hand, see the world through their background, expertise or discipline and lead from experiences that have worked before; they are more risk averse, valuing safety and security over risks for greater rewards. The authors suggest that we all lead people at some level, and we all tend toward either a business-smart or functionally smart orientation. And that’s not bad; it just is not good enough if we aspire to create anything great

and long lasting. This book respectfully and provocatively illustrates how our existing framework and methods for success need adjustment. But the book’s power comes in the form of a virtual roadmap to a wise you. The journey will require that you develop six capabilities. First is a shift in perspective so you are able to identify what truly matters to you—your personal North Star. Second is an action orientation in which integrity, Wisdom is our and a full view birthright. authenticity of situational context provide your headings. The third is the ability to understand the specific role you should play while achieving a state of “detached engagement.” The fourth capability is about decision logic and your ability to balance idealism and pragmatism while understanding the value of instinct, intuition and emotion. Using the somewhat confusing title of “flexible fortitude,” the authors describe the fifth capability as courage under fire and resilience when facing obstacles. And finally, the sixth capability is about motivation and the need to develop enlightened self-interest. It is about how the greatest leaders in the world achieve the highest levels of success by purposefully driving themselves to serve others on the mission. Wise leaders ultimately realize the fact that the world has become an interconnected system of systems. Like Steve Jobs and Bill Gates recognized, individual leadership isn’t enough; wise leaders must co-create value with other leaders within their organizations and with leaders of other organizations, even if they compete on some level. In From Smart to Wise, Prasad Kaipa and Navi Radjou provide us with a fresh and informed framework for leadership, a rough roadmap, and some of the critical tools we’ll need to achieve success on our individual and connected journeys to our lives’ most meaningful work.

“

”

—Scott Stropkay, IDSA scott@essential-design.com 10

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D E S I G N DE F I NE D

THE DESIGNERS’ ETHOS

hen I reflect on the definition of design, two discreet but related interpretations come to mind. There’s the big “D” of Design as a noun, and the small “d” of design as a verb. I prefer the small “d” design because that’s where the action is. The enduring power “to design” is a transformative action that distinguishes how designers create new value within all disciplines. Inspired design has created incredible value, while design lacking principle has at times pillaged without conscience. We design to solve problems, to create beauty, to optimize and to put our mark on this world. Design can evade rules, neglect the aesthetic, placate the unethical and powerfully exploit. It can serve the common good or self-interested opportunistic greed, and designers can inspire greatness or bring despair. The consequences of design can often reach well beyond our intent as we gaze reflectively upon our actions. To understand the definition of design, we must look into exceptional designers’ intrinsically motivated process. Designers seek truth in expression through designerly actions: reframing problems, building originality and seeking insights that are reflected in the designers’ ethos. While design empowers creative actions, it is the designer who creates the new experience. Good and bad, it’s all design, even if the results are not always perceived as intended. Regardless, the desire to always pursue the good though design should be a cornerstone of the designers’ ethos, the heart and soul of a designer’s philosophy.

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The designer is a team creator. It is the designers who redefine the experience each time the team ventures into the next challenge. It is the designers who satisfy user needs through empathic inquiry and creative expression through design. One can define design simply as creative problem-solving, but that definition falls far short of the aspirational potential for designers’ ability to insightfully reframe problems, identifying needs for creating value and advantage through change. As a designer, I personally identify with my design by the value I can create and the expression of self my design offers to the world. I prefer to let my designing speak for me, beyond the physical and through the essence embodied in my creation experience. When users experience design’s meaning, they are experiencing the designer’s epiphany in action. This epiphany has been spiritually transferred and expressed in the work for all to see, appreciate and experience its transcendent value, and it is rightfully judged as such. You do not need to be told that an Eames chair is an Eames chair; Charles and Ray Eames’ immortal design ethos is embodied in the iconic symbolism of their creations. I have never met them, but I feel very close to them through their designs. The exponential power of design is beyond anything else individuals can achieve. Think of Einstein and his thought experiments, which often arose from seemingly nothing but the designer’s inspiration—ideas reframed and transformed creatively, demonstrating that the seed of an

insight can be nurtured by design into a force infinite beyond its origin. In its value to business, design can create sustaining economic power and competitive advantage To differentiate by design is the essence of strategic “customer getting.” The absence of design appreciation or poor execution of design can condemn an organization, an entrepreneurial opportunity, a market or a natural resource to extinction by design long before anyone sees it coming. Design is an epiphany of theory built on a symphony of practice, a design ethos transcending form and function while not neglecting it. Design’s greatest expression arises when a solution’s complexity reflects itself in ingenuity. At its best it is recognized as such with a word never spoken, a shot never fired, a right never lost, or a natural resource never polluted. As your design touches all of humanity, in both its intended and unintended expression, it should never purposefully or recklessly devalue an interaction or create a victim in its path. Ethically motivated and morally just, the designer is uniquely empowered to serve mankind, leading by example and building a responsible culture through action. When designers communicate through design, their knowledge is laid bare for all to see design’s glory and shortcomings alike. Designers cannot hide, cannot walk away. Their designs reflect the essence of the designers’ ethos, thus holding them accountable through design in a world that is often unaccountable. Although we can disagree on what embodies good design and what reflects poor design, we can all agree that nature is the ultimate benchmark. Nature’s designs are inspirations in genius and sustainability, and, as such, they are the measure by which all design should be judged. To aspire to anything less would be the blindness of a designer’s lost vision. While we designers will never approach the design majesty of nature, the goals and aspirations of all designers

must be to lead by design, seeking perfection in the creative evolution in the sustainable practice of social, environmental, economic and business models. Enlightened sustainability—not simply environmental sustainability—is the ultimate expression of design capability, a sustainable design that is socially, economically, politically and environmentally complementary through a virtuous creative blending. This designers’ ethos is the essence of what differentiates the dedication of design from all the other disciplines. Designers see and frame problems distinctly in a quest for strategic differentiation: to add value and advantage to the world, to lead change, to promote collaboration and to utilize the empowerment of design to create sustainable prosperity through design. It is a daunting future; if designers do not arise and address the necessary solutions society seeks in both our practice and our politics, who will we turn to? Certainly not the opportunistic pundits, politicians, bureaucrats or business leaders. For humanity to experience a sustainable future, we must universally embrace this designerly ethos, fighting the corruptness that trades off sustainability for expediency. Paradoxically, if designers cannot collectively lead us in this vision, I fear that the opportunity will be forever lost. Our children’s future will be the victim of our own inability to change, mobilize and champion the enlightened value of a design ethos rooted in sustainability. As both designers and citizens of this planet, we must rise to meet the challenge soon, for our blind faith alone in the power of design to solve all problems will not be enough to save us. Thus what is my definition of design? To design is the intrinsic designers’ ethos, seeking change in action, actualizing value through all disciplines, being an evolving creator of enlightened solutions and a solver of wicked problems, and fighting to gain advantage ethically, honorably and sustainably by enlightened design. —Dan Brown, associate professor, Northwestern University, and Founder, Consult-Tech Concepts and Loggerhead Tools dpbemail@gmail.com

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BE A U T I LI TY

HARD MODEL TRUTH T

he first inclination of an industrial designer is always “Let’s make a better one!” It’s the challenge of solving puzzles and the competitive push to do it better. That’s why the IDEA juries are so much fun to be on. Having the entry in front of you, the product tells the designers how to improve it—each of us has a better idea. You go home from the jury juiced with new ideas. We need to try out our new ideas and we can (we have the shop tools and skills). The deep craving to make stuff is not only built into our DNA, it’s what makes our profession so essential. Hollywood is less than skin deep: seeing is believing. They put on fantastic shows in which magic trumps physics—giving audiences “experiences” of traveling at hyper-speed, swinging from buildings or running from dinosaurs. Thanks to tools like MakerBot and Kickstarter, we have entered into another magical land: DIY, where people believe that they can pump out their fantastic ideas using their extraordinary imaginations alone. The marketplace isn’t safe anymore with all the DUI—design under the influence. At the Maker Faire people are making bamboo bikes you can ride on or artisanal beer you can drink. Hard reality. For industrial designers, working in the real world means making is believing. I’m teaching a prototyping class at Parsons. I think my students thought I was going to teach them how to cast resin or sand MDF. Prototyping is bigger than that—it’s a concept. It’s a verb. The iterative design process is all about trying out ideas, over and over, failing fast, making smaller and smaller mistakes. Digital natives nowadays may be spearheading the maker revolution, but they seem reluctant to test their ideas. Maybe they’re missing the feedback gene—they think mental prototypes or 3D renderings do the trick. Like Mycroft Holms (Sherlock’s “smarter” brother whose sedentary problem-solving is seemingly based on no evidence and who, although he doesn’t require any physical verification, is tolerant of Sherlock doing the legwork

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and handling the practical details), students today solve the case from their Internet armchair and don’t need to see any real evidence from the scene of the crime. But creating something new is not solving a mystery; we commit a crime when we don’t try out our innovations in the real world. As they say at IDEO, “Demo or die.” I’ve tried to instill in the students the need to test things out before they go too far. “We set the dream that hardens into deed,” is a line we sang from the Episcopalian hymn “We Would Be Building” at the “Thanksgiving for Life” service for Horace Havemeyer, the founder of Metropolis magazine. So before posting those dreams on Etsy or casting that resin, remember the famous admonishment from the longtime Pratt professor Bruce Hannah: “Mock it up before you fock it up!” I understand their feelings: The rendering looks so real, the idea seems to make so much sense—why open up a discussion? Taking criticism is not easy—but asking for it is harder. A hard model speaks the truth. Taking that step from unproven dream across the membrane into the real world takes some guts. “Personality traits like tolerance of ambiguity and curiosity allow designers to embrace new territory in the learning and discovery stage of design,” as Brian Heidsiek pointed out in the last issue of INNOVATION. The problem with everyone (except industrial designers, of course) is that people come up with ideas that seem to make sense in their heads, then verify them in their own minds and then think they are done. (They forget Thomas Edison’s 90 percent perspiration rule includes actual work). Even a quick drawing can begin to demonstrate the worthiness of an idea. Changing media from brain to paper can reveal many inconsistencies. By transforming the sketch off the page as fast as possible—paper mock-up, cardboard model, mashed potatoes (see Close Encounters of the Third Kind), dramatization (bodystorming), even explaining

Andreas Feininger, Time Life Pictures/Getty Images

Pioneer geneticist biologist James Watson with molecular model of DNA, Cambridge, MA, 1957.

the idea to your roommate—is a really great reality check. Making models is the best tool for learning—you make an object that allows you to learn by matching up ideas with reality. Hard reality. It’s not call “objective” for no reason. These tests aren’t just for measuring physical stuff like ergonomics. It’s no coincidence that printers call their first copy the “proof.” INNOVATION is a mock-up—not in the sense that thousands of copies are printed, but it can be a test-bed, a platform for discussion. That’s what Scott Klinker, IDSA was doing with the Spring 2014 issue. He selected provocative, pioneering work that pushes the frontiers of our profession. He presented designers who were using their product design work to test essential cultural ethics, like Revital Cohen’s Life Support or modernist aesthetic standards when Andrea Branzi and Ettore Sottsass did Memphis in the ’80s. Maybe the issue was also experimenting with different ways to use captions. Some were more successful than others. The cover caption credited the photographer, but didn’t mention who the designer was or even what the thing is (luckily I recognized the Boom Boom Burst chandelier and knew it was designed by Lindsey Adelman). Isn’t the main point of IDSA and INNOVATION to promote designers? Crediting their work is the first order. It was hard to figure out what was going on with Elliot Earls’ editorial artwork (or even which ones were his illustrations). The

picture of the Epidermits by Karten Design is a case where a traditional museum-style caption with materials and size would be really informative, like the comprehensive captions with Louise Schouwenberg’s article. Other captions were buried in the text. One of my magazine friends, like Steven Holt or Randy McAusland (once publisher of ID magazine) or John Thackara (I can’t remember which), once told me that he wrote extensive captions because “designers are visual, they don’t read the article!”—hoping the “readers” read a caption here or there as they looked at the pictures. I hope someone read my essay to find out that the Rockwell Grill was designed by David Rockwell with me and Tristan Shaw at Rockwell Group and manufactured by Caliber. What we can learn from the prototypes is one thing; on the other hand, we might gain more from the process of making the models. Hacking things up (or together) allows for serendipity, and thinking with your hands leads to new insights. “Design doing” that Scott Henderson wrote about in INNOVATION is not just for designers. James Watson and Francis Crick built physical models of the DNA chemistry as they discovered how the structure of the molecule was able to transfer information to the next generation. Learning by doing. The best empirical knowledge is not only registered in your head; you feel it in your stomach. The real power of prototypes is that they give you new ideas you believe in. It’s not hard. —Tucker Viemeister, FIDSA www.tuckerviemeister.com ps: Either I wasn’t able to position myself as a product designer for the Cooper-Hewitt National Design Awards or the jury didn’t think I was better than LUNAR—who are great designers. I congratulate LUNAR on winning this great honor!

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The Founding of Industrial Design Education

DOHNER VS. KOSTELLOW

The problem with this statement and ho is the father of American the entire Dohner/Kostellow controversy, industrial design education? as it turns out, is that Kostellow’s entitleThe desire to honor someone ment to the title of father has never with the title of “father” for an important been substantiated. The earliest known contribution to a profession, an invention Kostellow attribution, and the place where or an activity is a common and admirable my statement originated, is from a photo human endeavor. Yet many of these descaption found in the history of the indusignations, if carefully examined, are given trial design profession, The American arbitrarily, and once bestowed, such attriDesign Adventure, 1940–19751 by Arthur butions are often repeated as fact without further scrutiny. The submission of a J. Pulos, FIDSA. Yet as design histosecond and more suitable candidate for rian Hampton C. Wayt points out, Pulos the same honor can lead to great controgives no explanation for why Kostellow versy despite factual documentation that deserves the honorary title. In fact, it is not would seem to bring any such debate even clear if Pulos believes the statement to rest. Such is the case of Alexander himself, crediting the acknowledgement J. Kostellow (1900–1954) and Donald to “many people”—which may or may Donald R. Dohner (1892–1943) R. Dohner (1892–1943) and the title of not include himself. A search by Wayt of Father of American Industrial Design Education. Pulos’ designer files—folders dedicated to specific designI was recently made painfully aware of this fact. There ers—housed at the Smithsonian’s Archives of American Art have been a number of complaints of late from students in Washington, DC, revealed little on Dohner or Kostellow to and scholars of pioneer industrial designer and design help clarify Pulos’ take on the situation. educator Donald Dohner about my IDSA biography on In complete contrast, the source of Dohner’s title Kostellow. This biography, as I have written it, begins, of father is quite clear. Industrial designer and educator “Regarded by many as the ‘father’ of [American] industrial Jim Lesko, L/IDSA who is a graduate of Carnegie Mellon design education.” Yet Dohner too has been named the University (formerly Carnegie Institute of Technology, or father. So knowing of this controversy and attempting to CIT), became aware that his alma mater hosted the first remain unbiased, I continued my Kostellow introduction degree-granting industrial design program in the United parenthetically with: “(Many also regard Donald Dohner States, initiated in 1934, exactly 80 years ago this year. as the father of [American] industrial design education Lesko, interested in learning its origins, proceeded to because he initiated design education at Carnegie Tech research its formation. His findings were published in 1997 and instructed Kostellow, then a painter, to teach industrial in the Journal of Design History in an essay titled “Industrial design in 1934).” Design at Carnegie Institute of Technology, 1934–1967.”2

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“What is clear from this controversy is that former students of great educators

”

in retrospect endow them with mystical and superlative qualities that only increase with time.

trial design program, is better remembered As described in Part I of my and, by default, often more highly revered INNOVATION article in Spring 2013, than these men.7 Lesko’s research, howLesko’s research, which included an interview with a student from the school’s ever, points out that although Lepper was first graduating industrial design class supportive of the program’s implementa(1936) among other documentation, tion at the school, he was not actually revealed that Dohner, who had been the part of the program’s “core” faculty and head of Westinghouse design for four therefore not one of its founders. He furyears (beginning in 1930) and who was ther argues that although Lepper’s legacy hailed as one of the 10 most important as an educator is immense, his mark in industrial designers in a 1934 Fortune the field of industrial design education magazine article—along with such disbegan some years later—certainly after tinguished names as Loewy, Dreyfuss, Dohner and Kostellow were no longer at Teague and Bel Geddes—developed the the institution.8 school’s industrial design curriculum and In 1935, Dohner was recruited by was the first chair of the program.3 Pratt Institute in Brooklyn to establish a three-year certificate-awarding program Dohner, as the only person with actual Alexander J. Kostellow (1900–1954) similar to the one he had started at mass manufacturing design experience Carnegie. Dohner’s departure left a vacancy for the chair at Carnegie, taught the other faculty about the new profesof CIT’s industrial design program. Kostellow, despite a sion of industrial design. They in turn provided him with the situation that on paper would seem to make him the heir support necessary for implementing the program. apparent, was not promoted into that vacancy. Instead, Among Dohner’s supporting faculty was Alexander Carnegie outsider Peter Müller-Munk (1904–1967), a trained Kostellow, who was an aspiring painter and art teacher silversmith who would eventually open his own successful but who, inspired by Dohner, quickly moved into the budindustrial design firm, was brought in. The passing over ding field.4 Next to Dohner, Kostellow was the person most of Kostellow for this position would seem to highlight his involved in the teaching of the program’s curriculum during secondary involvement in the program while simultaneously its first year—sometimes in conjunction with Dohner.5 The magnifying Dohner’s importance in its development. pair also opened an industrial design “research & service” A similar hierarchical relationship between Dohner and firm together in the spring of 1934, although little is known Kostellow occurred at Pratt when Kostellow joined the about the venture or their individual contributions to it.6 faculty in 1938.9 As before, Dohner chaired the industrial Also present was Robert Lepper (1906–1991), who due to living decades longer than Dohner and Kostellow as design program while Kostellow supported his efforts. It well as receiving equal billing as a founder of the CIT induswas not until Dohner’s 1943 departure from Pratt to start

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Donald Dohner, director of the art-engineering department at Westinghouse Electric & Manufacturing Company, paints the last of the tiny models in the miniature of his company’s exhibit at the “Century of Progress” Exposition.

his own design firm, Dohner & Lippincott (later J. Gordon Lippincott & Co. and eventually Lippincott & Margulies), that Kostellow finally became the head of an industrial design education program. Lesko’s essay concludes with the statement that Dohner deserved the title of father of American industrial design education. At the time this assertion was published in 1997, Pulos’ unsupported naming of Kostellow as the father in his book was in print and influencing opinions for nine years. Naturally, Lesko’s assertion conflicted greatly with those who believed the honor was Kostellow’s—especially his former students, who understandably embraced his having the title—giving rise to controversy. In 1998 Lesko led the successful effort to submit Dohner’s name for the IDSA Personal Recognition Award and citation as Father of American Industrial Design Education. IDSA based on Lesko’s research and the lack of any documentation supporting the Kostellow claim, combined with the belief that the Carnegie program was the birthplace of industrial design education in America,

decided that Dohner was the clear winner. IDSA’s official naming of Dohner as the “father” was done not only to recognize this unsung hero, but also to put the controversy to rest once and for all. Despite my attempt to be fair when writing the Kostellow biography, it has become apparent that acknowledging this past controversy and mentioning the erroneous Pulos accreditation is clearly keeping alive a controversy that was resolved long ago. And as it is the role of historians to present the facts of the matter regardless of personal feelings or politics, the statement suggesting that Kostellow is considered by “many” to be the “father” will be removed from his IDSA biography in the near future. Wayt, who owns Donald Dohner’s archive, has agreed as well to rewrite and footnote both the Kostellow and Dohner biographies based on unique primary source and other documentation in his possession. In conclusion, what is clear from this controversy is that former students of great educators in retrospect endow them with mystical and superlative qualities that only increase with time. Such heartfelt devotion is hard to discourage or deny, as both Kostellow at Pratt and Lepper at Carnegie Mellon continue to be highly regarded by their many surviving students—as they should be. If nothing else, such devotion on their part is the finest tribute that educators can receive. But the facts at present are clear: Donald R. Dohner invented what we know of as industrial design education at Carnegie Tech in 1934, including the fundamentals of studying industrial production methods at the manufacturing site and preparing three-dimensional study models as an initial step in the design process. Furthermore, IDSA has formally and conclusively bestowed Dohner with the title of Father of American Industrial Design Education. Unless documentation surfaces to prove otherwise, there should be no further controversy about who is the “father.” —Carroll Gantz, FIDSA, in collaboration with Hampton C. Wayt, MA (with thanks to Russell Flinchum, PhD, College of Design, NC State University); carrgantz@bellsouth.net

1 Arthur J. Pulos, The American Design Adventure, 1940–1975 (Cambridge: MIT, 1988), 165. 2 Jim Lesko, “Industrial Design at Carnegie Institute of Technology, 1934–1967,” Journal of Design History, 10:3 (1997), 269–292. 3 George Nelson (attr.), “Both Fish and Fowl,” Fortune, Feb. 1934, 40–43, 88, 90. 4 Alexander J. Kostellow, “Design and Structure Program,” Design May 1940, 5–9 5 Lesko, “Industrial Design at Carnegie,” 283. 6 Donald R. Dohner Archive, Collection of Hampton C. Wayt. 7 “Lepper Show Runs at Warhol,” Carnegie Mellon Magazine (Winter 2002), accessed May 5, 2014. (www.cmu.edu/magazine/02winter/newsbriefs.html). 8 Lesko “Industrial Design at Carnegie,” 281–285. 9 Yasuhiro Okuda, “Industrial Design at Pratt Institute” (folded poster), 1974. 18

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Doctors Orders

Save the date Nov. 6â&#x20AC;&#x201C;8, Tampa FL

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HIGH-STAKES DESIGN

ndustrial design impacts so many topical issues in the healthcare domain that dedicating an issue to it is a welcome challenge. How to address the problems and opportunities for designers is a complex proposition considering the depth and breadth of technology, culture, industry and ethics.

We all know that industrial designers add value to immensely diverse market domains, but the healthcare field is unique—it is arguably the most regulated (the aviation industry may contest). Some designers find the regulatory requirements too constraining, while others thrive in this high-stakes problem-solver’s playground. From government initiatives intended to reform a dysfunctional insurance, reimbursement and care-delivery system, to domestic and international agencies compelling a bureaucracy to ensure safe and effective medical devices, the healthcare domain is going through a paradigm shift (please pardon the ’90s cliché) or, as some designers are coining, a golden age for industrial design. During the planning stage of this issue, the Affordable Care Act was in the spotlight while the FDA dominated the trade media with issues concerning use-safety accountability, electronic health records and the efficacy of new technologies (such as combination drug delivery products, smartphone apps and 23&Me). These media threads, and many others focused on healthcare, impact designers in the industry daily at both a strategic and tactical level. A short list of examples: The Strategic Impact n The healthcare culture is being pushed from treating illness to delivering wellness through patient outcome accountability. n Trends in which leading-edge technology enables global accessibility to a higher standard of care are being paced by user experience and industrial design. n The US-led medical innovation ecosystem is being forced to evolve due to both domestic and global influences.

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The Tactical Impact n Establishing the appropriate aesthetic and product semantic, the cornerstone of industrial design, improves safety and sales. n The point of care must move from an expert user model toward a consumer user model. n Excelling under the regulated design process is an opportunity for the union of human factors engineering and industrial design to create a new hybrid discipline. The value proposition for industrial design in the medical design arena has never looked better. A manufacturer is required by law to demonstrate that its device design has minimized use-related hazards—usability is a must have, not a nice to have. Although it may seem like a farfetched logical fallacy, there is science behind the association of aesthetics with usability. Appropriate aesthetics, being integral in optimal usability, are therefore required by domestic and international regulations. This means industrial design is required to be at the stakeholders’ table. Granted, most C-suites may not understand this just yet. It also means that the responsibility of the industrial designer has to go beyond inspiration and exaltation, beyond business and sustainability. The industrial designer in the medical space is responsible for people’s lives! I hope this issue promotes an engaging and expansive conversation within our profession regarding the use-safety obligations of the medical product and user experience designer. Does the integration of industrial design and human factors engineering diminish the traditional role of industrial design? Furthermore, how might IDSA facilitate this professional decorum? Is a medical design certification the right direction? Is the usability designer the latest specialist?

By Sean Hägen, IDSA, Guest Editor sean@blackhagendesign.com Sean Hägen, the IDSA Section Vice President and Medical Section Chair Emeritus, is the founder of BlackHägen Design. His current focus is the management of the user research and synthesis phases of product development for Fortune 100 medical manufacturers. He is an authoring member of the Human Factors Engineering Committee in the Association for the Advancement of Medical Instrumentation (AAMI) that is responsible for much of the medical regulatory content on usability.

IDSA will host an opportunity to continue this conversation on November 6–8 in Tampa, FL, at the inaugural Medical Design Conference, the Usability Ecosystem. The conference will be held in a 90,000-square-foot virtual hospital dedicated to training and usability testing called the Center for Advanced Medical Learning and Simulation. This venue offers an exciting opportunity for workshops conducted in the context of a clinical environment with stateof-the-art simulators. The conference is aimed at delivering advanced content for those product development and usability specialists practicing in healthcare who are looking for opportunities to further develop their knowledge, skills and inspiration. I thank my colleagues who, on relatively short notice, committed to volunteering the diverse range of articles in this issue. Although we’ve highlighted only a small sample of the strategic and tactical topics that make industrial design in the medial design arena so exciting, I invite the design community to continue this dialog and expand upon these design paradigms. n

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Medical Devices

Artefact

THE NEXT BIG FRONTIER IN INDUSTRIAL DESIGN

The SonoSite X-Porte features a highly configurable, intuitive and approachable user interface that replaces traditional button arrays.

t the end of 2013, Misfit Wearables, the firm behind the activity monitor Shine, announced that it has successfully raised $15.2 million to create “new, yet to be launched” products. The company’s CEO Sonny Vu hinted that these might be medical products, making Misfit one of the

growing number of examples of companies that are blurring the boundaries between consumer electronics and medical devices. As an industrial designer who has worked on a range of medical devices—from diagnostic to therapeutic, disposable to reusable, as well as instruments and controllers—I see this as a challenge and an opportunity for medical device companies to learn from personal devices and for designers to help bridge the gap between the personal and medical.

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By Fernd van Engelen, IDSA fernd@artefactgroup.com

Twitter: @artefactgroup

Fernd van Engelen leads the industrial design practice for the award-winning technology product design company Artefact. His work has been honored with more than 50 design awards, including IDEA, ID magazine, Red Dot and iF.

Unlike technology, such as smartphones, where new versions offer incremental improvements over the previous iterations by being smaller, faster and lighter, medical devices always have a clear set of priorities. Most procedures, for example, involve multiple participants, so tools have to be optimized for proper use. In addition, patient safety is always a top priority. But while medical devices have clear and non-negotiable design needs, I have always believed that the role of the designer is about more than just solving the functional requirements. As devices get smarter, users more discerning, and boundaries between personal and medical devices less defined, innovative device manufacturers should rethink the role design can play in the success of their products. Get Smarter about User Interfaces In the past, many procedures relied mostly on the skill of the practitioner, but today the communication and collaboration between the practitioner and the device is coming to the fore. Medical devices are becoming more intelligent and capable and, therefore, inherently more complex. Devices perform complicated computations and analyses using multiple inputs, which introduces a design problem: How do you communicate the data to practitioners in a manner that they can easily understand and act on? This means the designer is increasingly responsible for effective user interfaces. The challenge, then, is to design devices, interfaces and interactions in a way that enhance the practitioner’s skills while performing most of the heavy lifting of computing and analysis. While digital interfaces are becoming more robust, physical interfaces are becoming simpler—yesterday’s “screen with many buttons” today is a touch screen. Take for example SonoSite’s X-Porte ultrasound console, which reinterprets the traditional hard-button approach onto a complete touch-screen experience. This reinforces what has become one of my firm beliefs: the need for much closer collaboration between industrial designers and user interface designers. Don’t Forget: The Patient Is Watching Consumers are savvy, and the multitude of easy-to-use, appealing consumer electronics definitely influences people’s expectations for medical devices. This includes new

Gap between Consumer Electronics & Healthcare Technology Experiences

Consumer electronics

Gap in the quality of experience

Medical devices Healthcare IT systems Care services

We have an emotional connection to the product or service because it is beautiful or because it supports our self-image

Desirability

Usability

Usefulness

We are able to use the product to an effective end, as it was intended We seek a product or service because it helps us accomplish our goals & objectives Artefact

precedents for interaction, capability, speed, performance, and level of fit and finish that both medical professionals and patients demand from medical devices. The increase in medical devices now targeted directly to patients has further intensified this demand. Customers also take important cues about the quality and reliability of the device from the way it looks, feels and behaves. A large, responsive touch screen, for instance, comes across as more advanced than a small low-res screen with a large bezel and a multitude of buttons. Size, weight, materials, and fit and finish similarly impact perception. Performance, functionality and efficacy are clearly the most important priorities and deserve the designer’s attention. However, failing to consider the appearance, behavior and design execution of the product can stand in the way of adoption, acceptance and ultimate success. AliveCor seems to be taking the right approach with its heart rate monitoring system that includes the monitoring device, an intuitive and appropriate user interface to turn a smartphone into an ECG device, and a clinician-facing interface that gives the doctor easy access to the ECG data. By contrast, other medical devices still look like science projects. At the same time, we need to balance this consumerization of medical devices with the reality that medical devices have a much longer life cycle than a consumer electronics device. While your phone may appear outdated after a year prompting you to upgrade, a medical practice will expect to use its imaging, monitoring, diagnostic and therapeutic equipment for many years. It is the role of the designer to separate the fashion trends from those with a timeless impact on utility and usefulness.

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Artefact

M E D I C A L DE SI G N

Artefact’s Dialog concept can be used discretely as a sticker or on the wrist.

AliveCor

biometric and environmenFinding the Right Form tal data that provide them for the Function with new insights about their In an area where safety, percondition. For example, a formance and efficacy are key simple double tap marks an drivers, it’s often difficult to talk aura, which often indicates about aesthetics. Aesthetics an oncoming seizure, allowing should never come at the AliveCor’s heart rate monitoring system the patient to time stamp the expense of safety and perfordata and review it over time to discover recurring patterns mance, but I would argue that accounting for the look and or triggers. feel of a device can improve the patient experience. Medical devices are used in emotionally charged situaThe Design Imperatives tions, and the appearance and behavior of devices can set The design of medical devices places severe requirements people at ease or make them tense. In recent research, on the designer in an inherently complex and high-stakes we reviewed a device that offers voice commands to guide subject matter. At a time when technology and context are paramedics during resuscitation. While well-intentioned, we imposing additional complexity on products, user expectalearned that users often disabled that feature because voice tions as to the quality of the physical object as well as the commands instructing a paramedic to speed up compresquality of its behavior are also steadily increasing. sions left bystanders (like a patient’s family member) with the Most medical device manufacturers already invest impression that the paramedic was “doing it wrong.” in design at some level. Yet there is an opportunity to do The appearance of the device impacts users’ permuch more. First, we must focus on all aspects of device ceptions: outdated or state-of-the-art, reliable or flimsy, functionality in all of its use cases. As devices become more approachable or restrictive, valuable or disposable. This capable and intelligent, the job of managing that complexity perception determines how users will interact with it, and to provide clarity of information and operation will become how much they trust the device or practitioner. Finding the even more important for design quality. Second, consumer right message and presenting the device and its manuelectronics devices continue to push expectations for facturer in the best possible light are important parts of the level of build quality, visual refinement and attention the designer’s job. to detail. Third, this high level of refinement and quality Dialog, our concept platform that helps people underincreasingly has to pervade throughout all touchpoints of stand and manage their condition better, features a flexible the product experience (hardware, software, service). For form factor that allows people to use the wearable module us as designers, these imperatives offer some of the most as a sticker under their clothes or as a bracelet, depending challenging questions I have seen in my career—as well as on how discrete they want to be. The interaction language a rich opportunity to test and extend our thinking. n helps them create easy and meaningful time stamps on

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harphamr@battelle.org

Twitter: @ReadeHarpham

By R. Reade Harpham www.linkedin.com/profile/view?id=741517

R. Reade Harpham leads Battelle’s human-centric design capability, a multidisciplinary team that leverages human-centric processes across the company’s consumer, industrial and medical markets. His eclectic team consists of industrial and user interface designers, behavioral scientists, cognitive psychologists, design researchers and rapid prototyping experts. They engage with clients across the development spectrum, from early contextual research and concept development to the design and execution of formative and summative usability studies, to meet FDA expectations.

Design’s New Role within a Highly Regulated Market

COLORING INSIDE THE LINES

esign is quickly heading down a path toward commoditization, spurred by its desire to be everything to everyone. As a result, the true value of design has become lost within the din of buzzwords and generic innovation processes. However, if designers are willing to step away from

the long-held belief that they must be unconstrained in order to be successful, opportunities await that might not only set the field in a new direction but, more importantly, have a positive impact on the health of millions. For some time, design has been a self-professed underdog, scratching and clawing its way into the mainstream, desperately seeking acknowledgement of its value and appreciation of its unique talents. Over the last 10 years, the field has finally garnered the visibility and success it has been yearning for, rising to the top of many companies’ strategic initiatives. Design’s self-proclaimed masters have graced the covers of magazines, and at least one has been knighted. However, this meteoric rise to mindshare has come with a heavy price: commoditization. The ubiquity design desired for so many years is ironically becoming its undoing. Core77 lists 5,600 individual design companies, each with a snappy value proposition and sexy product hero shot. Crowdsourcing sites like Quirky and 99Designs have automated design to where the actual act of design is in the background. Design is now a household word. (Congratulations?) An Opening to the Future At the same time design became the epicenter of cultural mainstream, another seismic shift was happening. In 2007, the International Organization for Standardization (ISO) released a document that formally tied the principles of design to the review of a medical device. ISO 14971:2007 defines a set of specific requirements that must be followed to execute and document risk-reduction activities during medical device development. The requirements are supplemented by guidelines that recognize the user as a significant contributor to the safety risk profile of a device and that must be considered with the same rigor as the mechanical, software or any other elements of the system.

Manufacturers can no longer hide behind user error as the cause for adverse events, and now must take accountability to assure that user inputs are properly incorporated from the beginning. Even the term “user error” has been replaced with “use error,” which places the responsibility for any errors a user might commit on the user interface and not on the actual users themselves. With manufacturers needing an intimate knowledge of the users, who better to do this than designers, the de facto voice of the user? Unfortunately, this is where the problem begins, but is also where the opportunity awaits. All designers should take pride in their unique ability to uncover a user’s unmet need, visualize a solution and bring it to life. This is the alchemy that makes the field so fulfilling, and designers’ innate empathy for users is the cornerstone of their value. In many cases, designers work side by side with marketing or development teams to support the market and deliver value through creativity and innovation. Users are studied, concepts are market tested, and innovative products are manufactured and ultimately end up on the store shelves. In medical device development, design is faced with a new set of users who are as unique and demanding as ever. These “new users”—regulatory and compliance teams—are responsible for assuring that all relevant standards have been followed. It is a world that is black and white, bound by an FDA-regulated quality system and focused solely on ensuring that the device is safe for the patient and effective in its defined performance. The regulators require quantifiable evidence: statistically significant data sets, validated spreadsheets and definitive proof for

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everything you hand them. They enforce standard operating procedures for almost every aspect of development, including how to create standard operating procedures. They require everything to be documented in a certain way, right down to the color and type of ink you can use. They are not interested in the ambiguity the Technicolor world of design provides. This is not because they undervalue design, but because design’s typical outputs are completely unusable to them. Aspirational mapping? Empowered user profiles? Reimagined user experience? Utterly useless. Don’t just take my word for it. When representatives from the FDA were asked what they look for when reviewing user documentation, they made their position very clear: “The intent of the FDA is not to measure user happiness … no more of this mushy stuff. You tell us what the reality is, we are not going to guess. We want to share your optimism—prove it to us.” The Easy-to-Use Myth The tools and techniques used to elicit and act on user feedback are easily transferable across many industries, and designers have become quite adept at leveraging them. Unfortunately, this is not exactly the case in medical device development. Oftentimes, the user “testing” happens only during market research activities when the focus is on user preferences or how users feel about a specific solution or attribute. This is to be expected; a user’s reaction to concepts and features is the best form of validation a designer can get. To meet the needs of regulatory and compliance, however, the real focus must be on performance. “The device must be easy to use” is often an outcome of early user research. Sadly, it also one that invariably causes regulatory and compliance teams much anxiety because the development teams must now design and execute testing in order to validate a vague requirement for “easy.” Easy for whom—a novice or a trained professional? To achieve what outcome—applying something to the skin or implanting a device? Under what circumstances—firstworld operating room or third-world village? This is the level of detail designers must provide to assure that hard-earned user insights are appropriately integrated into the development activities. These new users (and the FDA) are looking for quantifiable proof that design decisions were made based

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on user inputs and that the defined users can use the product safely and effectively as intended. In the past this was accomplished by market research studies, but this is no longer acceptable. Formative and summative usability activities are the required method to prove safe and effective use of a device. While many of you have probably participated in a user study, a smaller number of you have likely participated in an actual medical device formative or summative usability study that will be submitted to the FDA. And an even smaller number of you have been responsible for designing, statistical powering, executing and reporting the results. This is to be expected. Design’s role has traditionally been to champion the benefits of qualitative research. For such a level of expertise we need to turn to the field of human factors, which has been around as long, if not longer, than design. It consists of professionals whose focus is the scientific study of how humans interact with the world around them. In the medical device space, human factors is following a similar meteoric trajectory into the mainstream. As a result many people, regardless of background or experience, are claiming themselves capable of conducting human factors research for medical devices. Just because you have interfaced with users or conducted user research does not qualify you to offer human factors activities to reduce the potential risks of medical devices. Not only is doing so misleading, it can have deadly consequences. In the commercial world, a result of poor human factors could be loss of market share and annoyed customers. In medical devices, a result could be death, and sadly there are almost 100,000 examples every year. A Path Forward What has emerged from the medical device world is an unmet need for a shared approach to assuring that users are incorporated from the beginning of the design process. It is a model that integrates the dynamism of design with the pragmatism of human factors to present a unified, humancentric approach to medical device development. Design has the opportunity to impact every corner of healthcare, but it must be willing to recognize that it is only one piece of a very complicated, highly regulated business. If design can agree to color within the lines and admit it can’t be the only user advocate, it will be embraced by an entirely new set of users who will recognize the value of design involvement and champion the cause throughout the organization. n

By Philip Remedios, IDSA philip@blackhagendesign.com Philip Remedios has been involved in international design and product development for over 25 years, and is a graduate of the Art Center College of Design. He spent eight years in automotive design before transitioning into product design with a focus on medical devices. He has held executive management positions at several firms before joining BlackHägen Design in 2002 as a partner and director of design.

FUNCTIONAL AESTHETICS

s a discipline, industrial design is more than a century old, yet its role in medical R&D is often misunderstood by engineering and executive management who are historically focused on technology, safety and efficacy. The old stereotype that designers merely round off the edges of

an enclosure and apply racing stripes to sex up the aesthetics still lives on in some minds. The good news is that for some time now marketing and sales teams have come to understand the value of good design. So why is there this misunderstanding? At its core, industrial design seeks to satisfy intrinsic and often subjective qualities of a product, important attributes whose values can be difficult to quantify and associate with commercial success, a conundrum familiar in marketing but not necessarily engineering. However, a recent focus from the US Food and Drug Administration and the International Organization for Standardization (ISO) to mitigate use error in medical devices has driven manufacturers to pay particular attention to human factors and ease-of-use qualities. This change in focus has resulted in the proliferation of usability design methods to ensure that human-machine interfaces are as friendly and intuitive to use as possible across a broad spectrum of intended end users. The truth is, this new movement has been desperately needed for some time, especially with patient health being so dependent on the human-machine interface. Designers and human factors engineers have found themselves cast in a new light among their R&D brethren, playing key collaborative roles in the definition, conceptualization, implementation and validation of new designs—the latter two phases being the realm of engineering. But what about rounded edges and racing stripes? What role does aesthetics play in this brave new world, and why should it also be considered a critical virtue in medical devices?

The Value of Aesthetics in Design It is generally understood that a positive user experience with a product improves its value proposition and therefore people’s desire to purchase it. So it is obvious that the objective should be to maximize the buyer’s positive experience however possible. To achieve this goal, along with technical capability and cost, the device should feature easy-to-understand interfaces; tactile qualities; and pleasing forms, colors, materials and finishes. In the consumer world, outward appearance is instrumental in attracting the attention of the buyer, differentiating the product from its competitors and neighbors. This dynamic relies on what is known as affective behavioral processing and emotional decision-making to steer the decision. Nowhere is this truer than in the purchasing of lifestyle products such as cars, home goods and fashion. Emotional design takes this human behavior into consideration and can be subdivided into three levels of cognitive processing, following Don Norman’s Emotional Design: visceral, behavioral and reflective. Consider these principles applied to the familiar scenario of the selection and pur-

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Multiple touchpoints crowding a device should express their activation modality through shape and contrast to reduce visual clutter and user confusion.

Medical Device Design chase of an automobile. Visceral Attributes processing is the first and most Unlike the consumer sales model, in immediate human response, the healthcare space there is typically that love-at-first-sight feeling a disconnect between the user and when the vehicle is first seen. the purchasing decision. Selection Behavioral processing is the next and purchase decisions for clinical influencerâ&#x20AC;&#x201D;a real-time opinion devices are typically conducted by modifier as the user interacts with administrative personnel, with guidthe vehicle and considers ease of ance from clinical directors who are entry, seat comfort, fit and finish, not the ultimate end users. In other tactile qualities of materials, and words, the user is not the customer. touchpoints. Reflective processPrice, warranty and group-purchasing, the remaining modifier, is the Control design should clearly convey the direction in which ing contract fulfillment are normal lingering memory of the test drive force should be applied while supporting sound ergonomic criteria for purchase decisions. It is and of the entire experience. principles such as anatomical fit and traction. arguable whether optimized clinical All three levels of response function, let alone affective usability create a personâ&#x20AC;&#x2122;s affective reacattributes and sexy design, even plays a critical role. tion to the device, which builds an often overwhelming It has only really been the recent proliferation of elecopinion. While the latter two responses are manifested from tive therapies and home healthcare devices that have made multilevel qualities, the visceral attraction is entirely aesthetic patient and end-user preferences more important to home and, if powerful enough, may well influence judgment and medical-equipment suppliers. As a result, consumer-like overall outcome of the remaining evaluation. Extrapolating product attributes have become relevant. Home medical this process to patient-purchased devices, and assuming equipment manufacturers in particular are now looking to that choices are available for equally effective devices, it is optimize appearance, colors, textures and other hard-toeasy to grasp that the design that is more visually appealing measure qualities. (see sidebar: Hospital to Home on p. 30) will be selected.

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For medical device design, it is important to understand the context of use, in other words, where will the device be deployed, under what conditions and by whom? This ethnographic-centered approach defines how the device should work, be configured and look, and even what color palettes and labeling graphics are suitable so that it interacts well in its intended environment. Let’s apply this appropriate aesthetic sensibility to some medical device scenarios: In the operating room and emergency room, space is always at a premium; it is crowded with devices of all functions that are either in use or on standby. Stress levels are high, and there is an overload of visual, olfactory, haptic and auditory signals bombarding the users. Throw into the mix that an inconsistent cast of personalities have to work in concert with a disparate set of devices. Understanding the context can explain why the aesthetics of such a device should harmonize with the environment and not call too much attention to itself. Compact proportions and aesthetics that connote reliability and hygiene are also design drivers. Handheld devices can often have a complex user interface, including a multitude of functions depending on different features and function sets—oftentimes without the ability to see those features during use (such as in laparoscopic surgery). Subtle use of form development can communicate the proper orientation and operation of an infrequently used device just by the shapes, form transitions and topography alone. Remember, clinicians are just like anyone else: They do not like to read the instructions! In the intensive care unit, catheterization lab and imaging suites, patients are often conscious and aware of the devices that may be keeping them alive or providing therapy. A different set of aesthetics become important in these cases: The visceral message might be calming yet authoritative (as if to say, “Don’t worry, I won’t hurt you; I am taking care of you”); feminine, if appropriate; modern (connoting cutting-edge technology); and never threatening. Through simple forms, the behavioral message suggests uncomplicated function and minimized dirt traps that detract from clinical ideology. This is the opportune application of what are referred to as product semantics, where the form itself communicates far more than just its function, and colors and finishes help frame a subliminal message. In contrast, home healthcare devices require a completely different set of parameters in order to achieve the appropriate design language. Patients typically do not like to advertise their illnesses and prefer to disguise their devices to look like other consumer devices around their homes or worn on their person. Therefore, blood-glucose monitors and CPAP machines often look like something you might find at a big-box consumer electronics retailer.

Use of visual prompts such as lightpipes and dedicated connection shapes assist in reducing use error and ease-of-use during system setup, particularly in low-light conditions.

Global medical devices have an added complication: to be sensitive to cultural differences in all intended markets. Japan, for example, has highly developed cultural standards that can be in opposition to Western practices. Form, proportion, colors and graphics can be interpreted in alarmingly different ways. For example, it is perfectly appropriate to have a cute cartoon character as a graphic element in the user interface, a housing color that is cherry blossom pink and a form factor that is an abstraction of a human or animal (anthropomorphism). Western values may consider these aesthetics inappropriate and overly casual or playful. In contrast, a monolithic structure set within a glossy black housing may well be offensive in Japan. Lastly, medical devices usually have an extended life cycle and are expected to operate for 10 years or more. Therefore trendy aesthetics that date quickly should be avoided if the device has any chance of still looking somewhat modern and capable as it approaches the end of its intended life. Blending Aesthetics with Human Factors While industrial design is understandably concerned that the overall product is easy to use, manufacture, service and recycle and looks good, human factors engineering is predominantly concerned with optimizing the humanmachine interface and minimizing use error, and not particularly focused on other design objectives. Nicely integrated

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Hospital to Home: A Blend of the Consumer and Medical Worlds

his is an exciting time for healthcare. As the government is working to drive change from the top down, advancements in science, medicine and technology are simultaneously pushing the boundaries of what we thought was possible with groundbreaking knowledge, treatments, products, services and experiences. Amidst these changes stands one dominant theme that has already and will continue to play a significant role during this revolutionary time: hospital to homeâ&#x20AC;&#x201D;the idea that patients should be released as quickly as possible back to their homes yet still be treated with a high enough standard of care to avoid readmissions. Coupled with the notion that the Affordable Care Act has changed the way doctors and hospitals are reimbursed, there is now an economic incentive to create positive patient outcomes. Yet another key variable in this situation is that we are living longer, and as we live longer we become more susceptible to chronic conditions like heart disease, stroke, cancer and diabetes. In fact, seven out of 10 deaths among Americans each year are from chronic diseases, and $3 out of $4 of healthcare costs can be attributed to chronic conditions. Fortunately, lifestyle behavior changes like exercise and nutrition can have a positive effect on many chronic conditions. As this concept of preventive medicine is becoming more widely adopted, the management and treatment of disease is no longer in the hands of just physicians in hospi-

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tals but patients and caregivers in the home as well. However, at times lifestyle behavior changes are not enough, and when pure human motivation and willpower subside, the resulting effect is a lack of compliance, decline in health and heightened need for treatments in the hospital. To break this cycle and increase patient compliance and overall health, it is critical to create hospital-to-home products that consistently engage and delight all intended users throughout the entirety of their experience. I believe that this can be most successfully accomplished by blending thought processes, methods and principles from the consumer design world with the medical design world. Creating Engagement So what does this really mean? It means understanding that oftentimes a hospital-to-home device is not going to be used by one person, such as a physician, but rather by a diverse group of people, including physicians, nurses, technicians, givers and patients, to name a few. It means exploring the similarities and differences between the cognitive, dexterity and mobile limitations of each user and designing to those. It means understanding the span of the usersâ&#x20AC;&#x2122; education levels, and knowing that not everyone will be able to interact with the device in the same way, nor need to see all of the information, options and features all of the time.

It means understanding that there are new, more varied and more complicated scenarios for administering care that need to be understood as early in the design process as possible. To be successful, the devices need to blend easily with the users’ existing habits and ceremonies. It means understanding the numerous environments this device could live in. Home environments are varied and unpredictable. As designers, we need to account for everything from pets to children—no one wants their new blood pressure monitor to be eaten by the family dog or a device remote to find itself in the hands of a young child who might not understand the dire consequences of pushing a simple button. It means understanding people as human beings with emotions and developing empathy for them, their frustrations and their unmet needs to increase the chances of a device being embraced, not rejected. Evolving the Future We have already begun to see this line between consumer technology and medical products become blurred through the rise of wearable devices. However, even though the digital health sector is still young and evolving, we have yet to see a truly “sticky” wearable device—one that engages users emotionally time after time by providing them with valuable information and education (as opposed to pure entertainment) and that seamlessly blends with their everyday behaviors and ceremonies. The migration of healthcare and medical devices from hospital to home presents a tremendous opportunity for designers. Knowing how to harness users’ emotions to create desire, change behaviors and make interactions sticky through in-depth design research and informed user-centered design and engineering efforts will ultimately provide for better outcomes. To optimize the potential for success, medical devices need to evolve from being products people need to products that they actually want. n

controls that look tidy and interesting may not provide the best ergonomics, so the resulting solution is hopefully a graceful compromise by both disciplines. The designer’s job, after all, is to harmonize objectives between all R&D disciplines while preserving aesthetics and optimizing the user’s emotional experience. More recently, industrial designers and human factors engineers have become close allies in implementing usability standards. This partnership has been mutually beneficial since early involvement of human factors engineers during conceptual design results in a more thorough approach to the mitigation of use error. Building sound usability constructs into the conceptual model enables the team to achieve more optimized solutions than ever before, a true win for medical device design as a whole. Consider that in order to infer their function, intuitive controls should ideally look like they should be turned, pushed or toggled. However, understanding the cognitive and anthropometric limitations of the user is important to achieving ergonomic excellence. Human factors engineering brings scientific rigor to the design equation. In today’s heavily regulated world of medical device design, over-rationalizing the appearance or applying rigid developmental methodologies can risk diluting the emotional stimuli that affect the visceral response to an attractive design. Designers should also be conscious of developing a follow-on experience that maximizes the value of emotional design. It is important to remember that all users are human after all, whether they are clinicians, technicians or patients. They can be positively (and negatively) influenced by form, colors, materials and finishes, and beauty still provokes primal sensory responses. Wherever emotional response is involved in the purchase decision and safe use of a device, it is just good business to capitalize on human behavior to help drive commercial success. n

—Stuart Karten, IDSA, president, Karten Design stuart@kartendesign.com

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By Kyle Jarger kylej@farmpd.com Kyle Jarger, program manager at Farm Design, Inc., brings 20 years of experience to Farmâ&#x20AC;&#x2122;s systems engineering team. Prior to Farm, he worked with companies such as Sanmina-SCI, Codman & Shurtleff, Omnisonics and Zoll. He received a BEEE in electrical engineering, technology and society from the State University of New York at Stony Brook.

Wearable Medical Devices

A FIELD WITH GREAT PROMISE

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t’s an exciting time to be a medical device designer and engineer. The constant evolution of existing technologies and the emer-

gence of new ones continue to challenge us. The popularity of wearable health devices cannot be ignored since the consumer in all of us sees the positive effect they’re having on our healthcare system. According to a recent report, “Wearable Medical Devices Market,” published by Transparency Market Research, the global market for wearable medical devices was valued at $2 billion in 2012 and is expected to reach $5.8 billion in 2019. The market potential for the wearable medical device industry is real, but if you’re an engineer or a designer you may need some guidance navigating the development process. The following guidelines are an attempt to identify and clarify some of the various hardware-focused electrical and mechanical issues unique to wearable product development that should have a positive impact both on regulatory success and on a successful user experience. Some of the points mentioned here may even be useful considerations in more conventional development programs.

Wearable devices create significant new design challenges.

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M E D I C AL DE SI G N A pilot build phase can uncover critical issues for manufacturing.

dislodged and lost, and possibly render your device useless. If such a part is required for the functionality of the product, consider providing the healthcare professional or the user with spare parts as appropriate to allow the device to continue functioning.

Users Consider your intended user population. Is there a certain patient age, weight or size that represents your typical user? Ideally, your product could be designed so that one model of the device—perhaps with an adjustable feature— could work for your entire end-user population. Should it appear that two or more versions or sizes of the device are required to satisfy your user population, you’ll need to assess the possible negative impact of excluding users at the extremes of the target population against the complexity and the sales and tech support implications of releasing multiple devices. A program of usability testing of early prototypes can often reveal problems and help the product developer arrive at the most effective and efficient solution for the target end user. Another important consideration is the user’s ability to operate small electronic devices. Some patient populations may not have the experience, eyesight or hearing acuity required to operate small controls or react appropriately to status indicators or alarms. For wearable devices, giving the patient a simple user interface is always preferable. Leave the complex device setups and interactions to the medical professional who is caring for the patient. If the patient must use a smartphone, tablet computer or custom device to interact with the wearable device, despite your best attempts to avoid it, be sure that the user interface is clear, simple and intuitive. This is another aspect of product development that can benefit from usability testing. Avoid small easily-removable parts if possible. Your device will be exposed to all the activities and chaos of daily life. Any small parts that can intentionally or unintentionally become disconnected from your device will get

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Regulatory Biological evaluation of medical devices may be new to you if this is your first wearable product. The acceptability of materials intended for patient contact is classified based on the amount of time that the material is expected to remain in contact with the patient. Ideally, a material that has already been validated for biocompatibility by the manufacturer can be specified for use on the areas of the device that directly come into contact with the patient. If not, ISO 10993 requires the manufacturer of the device to perform biocompatibility testing on the material in question, generally using the services of a third-party vendor. Since the wearable device will be used in a patient’s home, two guidance documents apply: the IEC standard 60601-1-11:2010 and the U.S. Food and Drug Administration’s Design Considerations for Devices Intended for Home Use. These address many of the safety and usability requirements that a wearable device or a system that includes a wearable device will need to meet. Regarding electromagnetic compatibility, wearable medical devices fall into the same category as other devices intended for use at home and are generally subject to tighter electromagnetic compatibility regulations than equipment intended for use in a healthcare facility. The governing standard is IEC 60601-1-2:2014. If there is a particular IEC standard (IEC 60601-2-X) for the type of device you are planning, you may find that there are clauses that cannot be applied to a wearable version of the device. Be aware of these details before claiming that your device meets a particular standard. Discuss the implications with your marketing department if you find that you will be unable to claim compliance. Engineering and Usage If your company has already released nonwearable devices with functions and features similar to your planned wearable

device, take advantage of the product history and records available to you. You may find areas of that product where problems or failure modes will occur when the device becomes wearable. Similarly, opportunities may arise to further mitigate failures, improve performance or reduce costs. An example might be an electrode cable for an electrocardiogram (ECG) device. Much effort is spent ensuring acceptability of ECG cables for a particular application, such as flexibility, triboelectric effects and electromagnetic compatibility. If the ECG electrode can be integrated into the device itself—the ECG cable with its associated functional requirements—failure modes and costs no longer need to be considered. If at all possible, your wearable design should be wireless and self-contained within a single housing. Device components that are wired together to create a system when the device is worn will inevitably cause patient discomfort or disconnect when the wires tug on the device components or become tangled in the patient’s clothing. The connections between components also create possible failure points. Consider the environment in which your wearable device will be expected to operate, as well as environments where a failure to operate under a specific condition is acceptable. As a wearable product, the device will be regularly exposed to sweat, and perhaps to other bodily fluids or rain. It will constantly be squeezed, dropped and mechanically shocked. Where a failure to operate in a specific environment is found to be acceptable, ensure that the device fails in a safe manner. Also have a clear understanding of how the patient will be expected to deal with the wearable device during showering or bathing, and make sure that this information is clearly communicated to the patient. If necessary, assess how the wearable device will be cleaned by the patient or healthcare professional. In the event that the device or part of the device is to be washed, ensure that the instructions for use are clear regarding device preparation, water temperatures, detergent or cleaner types, and drying methods. Should disassembly and reassembly of the device be required, simplify these actions as much as possible.

Carefully analyze the scheme that will be used to provide power to the wearable device. To optimize your patient’s experience, evaluate how to best integrate the charging or replacing of batteries into the workflow, use requirements and allowable downtime of your particular device’s functionality. This information will help to optimize design trade-offs, such as device size and weight versus battery run time. Ideally, your familiarity with your target patient’s abilities or limitations, the requirements of the device, and the optimum use scenario will allow you to determine whether it’s better to design your device with the battery permanently enclosed or able to be replaced by the user. Consider the use of wireless charging methods as this technology has the potential to greatly simplify ease of use. Of course, battery safety and regulatory requirements must be strictly followed in all cases. Your wearable device may require active accessories to provide for data display, data storage, communications or recharging. Carefully assess how best to allow for the transfer of data or power between system components, while minimizing the quantity and complexity of the tasks the user is required to perform. Ideally these connections and the communication between system components should be implemented using wireless technology and occur automatically, with no patient involvement. Looking Ahead The medical device industry is entering a golden age in the area of wearable product development that is being supported by both regulatory progress and significant innovation in battery technology, materials science and wireless communication. Wearable technology can not only provide personalized healthcare solutions, lower costs and empower users to make better decisions related to their healthcare but will also impact how doctors share information, interact with and offer choices for their patients. There is no doubt that this field has great promise and will continue to evolve. By approaching wearable product design with a consumercentric approach while paying close attention to regulatory requirements, patients and physicians will have several safe and usable choices that will aid in providing successful healthcare outcomes. n

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By Mary Beth Privitera, IDSA marybeth.privitera@uc.edu Mary Beth Privitera is currently director of the Medical Device Engine at the University of Cincinnati Medical Center and associate professor of emergency edicine, biomedical engineering and industrial design. She also serves as faculty for and is a member of the AAMI Human Factors Committee and has authored several scientific journal articles regarding medical device design.

DESIGNâ&#x20AC;&#x2122;S CONNECTION WITH MEDICAL DEVICE USERS

n medical device design, due to government requirements, connecting with users is a mandatory activity. Largely, this keeps us, as

patients, safe. In this field, the user (a physician, patient, nurse, technician or caregiver) is often the driver of design. In fact, historically, the origins of all new medical devices were based on specific patient needs. An unmet need would motivate a physician to develop a new procedure or technique that would require a new device. Beyond the initial idea, the development was almost always completed in close collaboration with engineering. This approach makes sense. However, as markets become saturated, cost reduction pressures come from every angle (both on the side of medical care facilities and medical device manufacturers), it is increasingly challenging to work in close collaboration with users, especially throughout the design process. To do so requires navigating hospital politics, egos, regulations and red tape. It is not easy. For user studies, everyone in the room must consent to photography. Patient consent is most important and will stop any photography if not granted.

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The Process of Working with Users Hospitals influence the collaboration process by hindering access to users, stemming from their lack of understanding of the development process and the goal of product development teams. Ironically, while as designers we do our best to understand the process of care in order to do our jobs adequately, hospitals, being solely focused on patient care, have little understanding of design. Our processes and methods are not necessarily understood by the average nurse, physician or hospital administrator. However, once mutual understanding is established, doors open widely, but not necessarily freely. There is an associated cost. For product development entities, the process of connecting with and gaining access to users often relies on the client or the client’s relationships with its customers. In some instances, design firms have made it a priority to develop relationships with specific clinical institutions. The conundrum of using sales and marketing personnel to access users almost assuredly leads to a visit, a visit that increases the likelihood that the user will perceive it as a sales call rather than one focused on product development. In addition, sales representatives likely covet the relationship they have developed with the provider, and any negative comment on current devices or practices could impact their livelihoods. Conversely, it is those negative comments we strive to collect in our processes. The use of third-party recruiting is also done in an attempt to get better feedback from users in a blinded evaluation. A challenge to this approach is in the core communication with the medical staff and their decisions as to who the best people may be for your particular study. If not enough detail is provided, then the right users (according to the recruiter) may not be pooled together for maximum results. The use of inclusion and exclusion criteria helps defray some of this misalignment; however, they typically do not include attributes like “highly creative” and “open minded.” While fundamentally all people are creative, not all of us get along.

Users in the operating room, rarely look at their hands but rather are guided by images on a screen.

Yet another approach is to have a stable set of clinical consultants who are handpicked for their personalities. Or alternatively, advisory boards full of key opinion leaders. Ironically, key opinion leaders represent 5 percent of the users in any subspecialty. They have advanced skills, and are highly opinionated and influential, which poses a challenge for product development as it is in the product design’s best interest to be designed with the lowest skilled user in mind. Influences in Medical Practice At first glance, the protocol-driven practice of medicine based on our excellently detailed task analysis might yield step-by-step results; however very few will have the passion of a provider and a comprehensive view of their job. For example, consider these observations from an intensive care nurse at the University of Cincinnati Medical Center (UCMC): “The patient had endured multiple surgeries over several weeks, was delirious, confused and incontinent with an enormous (approximately 10 inches long and 2-3 inches deep) open abdominal wound and a smaller open wound in her groin. She was also resolving a small bowel obstruction so the surgeons wanted to keep her stools loose and flowing. With Medicare & Medicaid changing reimbursement to

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All physicians have a plan prior to any procedure. It’s helpful to review any patient-specific images prior to the start of a case, time wiling.

no longer cover “hospital acquired” infections, physicians are discontinuing invasive lines ASAP. While nurses certainly concur in removing unnecessary lines, unfortunately, too often the resulting incontinence leads to skin breakdown (also no longer reimbursed) and increases patients’ risk of falls. So, healthcare providers find themselves in a conundrum, damned if you do, damned if you don’t. For this particular lady, she had had multiple episodes of incontinence through the night and into my day shift, and despite vigilant nurse care, I suspect the risk that either or both open wounds had a high probability of being contaminated by stool and/or urine.” In this example, the user easily and readily assessed what is important clinically, but notes the cost of devices and the influence of business practices. This addition of costs is increasingly prevalent in communications with healthcare providers, reflecting the changing nature of healthcare practices wherein business implications are sometimes equally as important as functionality and usability. In fact, the overall cost of a device may often be more important, depending upon the institution. In addition, users are increasingly asked to prepare for credentialing reviews and inspections. Consider this observation from an emergency room physician at UCMC: “Our

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friends who govern credentialing agencies have made infectious disease, product sterilization as well as documentation thereof, and oversight of any piece of medical equipment that ever enters a patient’s orifice a high priority. This means our institution will be scrutinized colonoscopy-style during upcoming scheduled/random site reviews.” It’s no wonder we have challenges in collaborating freely; healthcare providers have much more to consider than providing care in their daily work lives. However, it’s not all bad news. Some providers are not content with the status quo and are tinkerers by nature. They welcome participating with product development entities. They have ideas and routinely combine devices together or modify devices to better meet their needs. Many times they do not have the luxury of facing a difficult problem and walking away to think about it for a while. Instead they have to quickly react to the clinical situation. These mitigations and potential opportunities go without follow-up. It’s not just the user’s opinion that matters; it’s also many other stakeholders’. As the previous quotes indicate, the practice of medicine is moving from a volume-based payment structure to a value-based payment structure. This has direct impact on device design as the entire system of healthcare delivery is becoming increasingly intertwined.

Device designers alongside package designers must consider everyone who touches the product as a stakeholder and influencer in the decision to purchase and use a device. Gone are the days that surgeons held the majority influence over purchases. Today those decisions are done by a committee in which one negative vote can kill the entire program. Despite being a committee, a high degree of personal judgment contributes to decisions that occur when devices are being considered for purchase. The moral of the story is that when you ask to work with a user, you might ask to observe and interview the tech who prepares the devices in question or the biomed who maintains the device, or take a visit to central processing. After all that work, it may be the lack of a billing health code or a subtle design detail that kills what we perceive as a perfectly designed product. In the Eyes of a Provider When we request to observe care, we are essentially asking the providers to enable us, a complete stranger, to enter their workplace and watch them perform what can be delicate, high-risk procedures on completely exposed patients. Consenting aside, we almost always request to film the visit and promise not to use any clips for interesting Facebook posts. Yet typically there is no contractual agreement in place that would prohibit us from doing so, merely a signature that affirms we understand HIPPA regulations. The lack of official contracts is rooted in our avoidance of being perceived as part of a clinical trial or the result of healthcare laws, for example the Sunshine Act, whereby physicians cannot get additional compensation while performing services under Medicare and Medicaid. Additionally, we are asking them to host us. A reality is that the job descriptions of healthcare providers do not include assisting product development. Patient care is a paid activity and as such occupies their time. In addition, due to patient safety, the majority of providers are risk adverse and do not take kindly to surprises. In the words of an operating room charge nurse, “I have to tell everyone who may come in contact with [industry] visitors, especially if they are wielding a camera!”

We ask questions that require foreign thinking. As alluded to above, the practice of medicine is about the here and now. Providers only have the tools currently stocked by the hospital. While there are those users who are highly creative or who perhaps trained as an engineer before medical school, the majority of providers have never envisioned beyond a magic wand to take the problem away in order to improve their work lives. Yet, in most of our protocols we ask the question, “If you can have anything you want to solve [insert clinical issue here], what would it be?” A typical response is “Oh….um…gee, I’ve not thought about it.” Even more common, “I do not see anything wrong with the current method; I’ve always done it this way.” And why should they? They have been highly trained to do procedures by the book and avoid being creative. This leads us to begin prompting based upon our observation or previous knowledge. While there is value in opening the door to innovative thinking and dreaming, there is no device that meets the needs of everyone: low cost, lightweight, small, with infinite battery life that cures a disease. Suggestions Being inside a clinical practice and part of the UC Health ecosystem has enlightened my experience as a medical device designer. The hurdles in paperwork (for example, ICD-9 vs. ICD-10), additional training required for recordkeeping and the ever-changing landscape of reimbursement cause me no wonder in why we have challenges working with our users. Here’s a list of suggestions for your next request to collaborate with healthcare users: n Expect adversity and respond with patience. They simply may not understand your goals. n Use their language and avoid using product development language. For example, they have no idea what contextual inquiry is, but they do understand quality improvement. n Know the rules, expectations and culture of the clinical environment you are entering. Try using Reptrax or another vendor credentialing service. Sure, you might appear to be a sales rep, however the hospital you are visiting will feel more comfortable with you there. n

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By Carol Shillinglaw, A/IDSA Carol.Shillinglaw@med.ge.com Carol Shillinglaw is the global director for the Growth Incubators team at GE Healthcare. She founded the team to develop big ideas and bring together disparate partners to help turn them into actionable business propositions. Most recently, she has been focused on the underdeveloped area of nonprofessional caregiving of the chronically ill and is an activist in the treatment of victims of Alzheimer’s disease and the family members who care for them.

THE BALLERINA, THE SURGEON AND

om was a ballerina. Dad was a pre-med student in the audience. In the middle of the performance

he noticed she had lost one slipper, then the other. He decided he had to meet her. Not long after, at a bowling alley in South Bend, IN, they had their first date. It was 1949. Of course, this story is about more than just my mom and dad. It’s about your mom and dad, too. Or your brother or your neighbor. Or your old friend from college. It’s about all of us. America is growing old. Every day some 10,000 baby boomers turn 65. That’s going to be the case for the next 25 years. The fastest-growing US demographic today is people 85 and over, a group whose numbers, currently at about 5.8 million, are expected to more than triple by 2050. Nearly half the adult US population has at least one chronic illness. Who will take care of them? And how? My design colleagues and I at GE Healthcare organized a small summit in New York in 2013 to tackle these questions. Because the issues touch so many people, in so many ways, we convened not only healthcare expert, but also spiritual leaders, consumer marketers, employers, government officials and creative thinkers to provide the broadest possible set of perspectives.

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AMERICA’S CAREGIVING CONUNDRUM Rather than treating this complex challenge as purely a policy or business matter, we asked them to treat it the way designers approach a creative challenge, with empathy. Our goal, and theirs, was to seek solutions that feel normal— that integrate seamlessly into everyday life but that also accommodate the distinctive aspects of caregiving. Gone also should be the stigma that goes with typical solutions for aging and chronically ill populations. We asked the group to apply design thinking to every part of the problem—new care and delivery models, integrated support networks, remote and digital solutions, home-health products, just to name a few. And when we asked them to take a “yes, and…” approach to the caregiving problem, this extraordinary group of experts and deep thinkers came up with some surprising answers. There are fewer than 1 million hospital beds in the US, and just another 1.7 million at nursing homes. That means nearly all the care elderly Americans will need in coming decades will be delivered at home, much of it by their families and closest friends. Already 66 million Americans, many with little or no training, have been called upon to help care for this surging population. So you see, we have a crisis brewing. The challenges and costs faced by the caregivers will be tremendous—economically, emotionally and otherwise. The strain of caregiving can take a toll on the mental and physical health of caregivers, not to mention create a drag on their workplace productivity or even cost them their jobs. And when caregivers suffer physically and financially, they put their elderly parents or loved ones at further risk. As one of my colleagues, Bob Schwartz, FIDSA, GE Healthcare general manager of global design and user experience, put it, “Every one of us has a story like this— and if you don’t, you will.”

They graduated in 1953: Dad as a surgeon, Mom as a nurse. They married. Then things got crazy. Nine kids! Mom was master of ceremonies, Dad the breadwinner. Fortunately, we lived on “The Land,” 30 acres of woods, fruit trees, and vegetable gardens, to help feed this small army. Modern American Life Complicates Caregiving People have been caring for their aging relatives for thousands of years, of course. But the particulars of modern life in the US make it especially challenging. More than half of married American couples, for example, rely on two incomes—leaving them less able to care for elderly relatives. And most of today’s ailing elderly don’t live near the family members who might be best qualified to care for them. Caregiving is also a drain on businesses in many forms, including slower workdays for distracted or sleep-deprived workers, increased absenteeism and higher risk of on-thejob accidents. But employers are frequently unaware when caregiving drains productivity. An estimated $17 billion to $33 billion in workplace productivity is lost every year due to

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Caregiving by the Numbers n n n n n n n n n

10,000 Americans are turning 65 each day 25 years is the expected length that rate will remain high 1 in 18 American households are multigenerational 5.8 million Americans are over 85 years old 19 million Americans will be over 85 by the year 2050 (est.) 6.6 percent of Americans over 65 are in nursing homes 5,415 new adult daycare centers are required to meet rising demand 42 million Americans served as regular caregivers in 2009 66 million Americans gave some care at some point that year

porate caregiving. Caregiving could be recognized as an occupation in the tax code. Licensing standards for caregivers could also be established. Dr. Aran Ron, president of Health Strategies Consultants, urged a shift from a position-centered model of healthcare— one that bases all its assumptions on whether a patient resides in, say, their own home, a senior-housing community or an elder-care facility—to a patient-centered model. For example, a program in Japan has nurses living in the same building as patients in order to reduce some of the unnatural institutional quality of elder care. This is the type of thinking we sought to foster at our summit. Rather than treating the complex challenge of caregiving as purely a policy or business matter, we asked the group to approach the problems the way designers would approach a creative project. Our goal, and theirs, was to seek solutions that integrate seamlessly into everyday life but that also accommodate the distinctive aspects of caregiving.

Sources: The Caregiving Conundrum, GE Healthcare and Pew Research Center, U.S. Census Bureau, U.S. Department of Health & Human Services Administration on Aging, Robert Wood Johnson Foundation Partners in Caregiving, AARP Public Policy Institute/ United Hospital Fund

Mom and Dad always celebrated their anniversary with a week’s long retreat at the cabin in Minocqua, WI. Then Mom developed mild cognitive impairment, a precursor to Alzheimer’s. Preparing for that retreat was becoming harder.

employees’ caregiving requirements, according to Sandra Timmermann, a former vice president at MetLife who spoke at the New York summit. One challenge is to get Americans to rethink attitudes about caregiving and destigmatize dependence, while maintaining as much of a sense of dignity and autonomy as possible for the recipients. Caregiving can be emotionally fraught because it diametrically reverses the parent-child dynamic. Additionally, government is an obvious realm for improvement. We need closer analysis of where regulations might burden the provision of care and where they might smooth its integration into public and private healthcare offerings—whether it’s offering simpler coverage for caregiving activities, enabling simpler proxy access to medical records or expanding concierge medical services to incor-

There Is No Silver Bullet The challenges ahead may be overwhelming unless we start thinking and talking now about possible solutions. The more than 40 experts from a range of fields who attended our conference aimed to do just that. (Tellingly, three of our attendees had to cancel because of their own caregiving conflicts.) A number of key points emerged. We can’t insure our way out of this. The nation’s private insurers will play a crucial role as we seek to pay for caregiving services. But insurance products will need to evolve—perhaps to cover the expenses of someone falling ill, faltering at work or even losing a job while tending to an ailing parent. Further complicating matters, the pricing for procedures varies wildly among insurance networks. Standardization and simplification of the nature and cost of these offerings could provide for the nimbler purchase, provision and delivery of care.

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New financial tools are needed. Banks and financial advisers will have to create investment vehicles to facilitate saving for caregiving. While some products already exist for potential recipients of care, few exist for those likely to provide that care. The new products will have to be flexible to allow for a wide variety of scenarios. Could health savings accounts be a model? Americans must be persuaded that caregiving is an eventuality. According to a recent poll conducted by the Associated Press and the NORC Center for Public Affairs, more than half of adults over 40 had already served as caregivers in some way, yet only a quarter thought that they themselves might need care someday. These expectations must be adjusted. A sustained government-funded creative marketing campaign, akin to those that helped change attitudes about littering and drunk driving, could be of considerable help. The current system is too hard on families. Children and other family members are the most obvious source for

caregiving, but most are frustrated by the current system. No products or policies exist to help them plan for the unequal burdens family members are likely to bear. Thereâ&#x20AC;&#x2122;s also a massive unmet need for mediators and advisers to help families organize and plan caregiving efforts. We spend years planning to go to college, buy a home and retire. We donâ&#x20AC;&#x2122;t plan nearly as well for caregiving. We are beginning to make changes, but we have a long way to go. This moment of need is a tremendous opportunity for policymakers, entrepreneurs and designers alike to provide solutions, ranging from the personal and spiritual to the bureaucratic and national. Mom is in a care facility full time now. Dad is there to feed her breakfast every morning and stays with her all day. One of us kids will usually come by to serve her dinner and play music for her. She rarely calls us by name. But when the music starts, Mom smiles. Her feet begin to move, and she moves my hand to the beat. The dancer is still in there. n

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By Michael Wiklund and Stephen Wilcox, FIDSA michael.wiklund@ul.com n sbw@dscience.com

THE BENEFITS OF APPLYING HUMAN FACTORS ENGINEERING

s the awakening over? Has the medical industry finally come to embrace the benefits of human factors engineering, arguably decades after the aviation, military and consumer product industries did so? Let’s give the medical industry the benefit of the doubt and say yes.

Although for many years now industrial designers have been included in the product development team for medical devices, as recently as the early 2000s only a small proportion of medical companies had really embraced human factors engineering. Those that had did so primarily to give them a competitive advantage in the market, as opposed to meeting safety goals, per se. Today, however, medical device manufacturers are doing a reasonable job of integrating human factors engineering into their design processes. A key motivating force has been FDA regulations calling for devices to meet users’ needs, as well as a slowly increasing level of agency oversight and enforcement. Regulatory agencies and surrogates (for example, notified bodies in the European Union) in many other nations have followed suit. However, an unintended consequence of this situation is that a large proportion of medical companies now seem to view human factors engineering primarily as a regulatory imperative tightly linked to risk management rather than to product development. They perform human factors engineering with the goal of controlling risk so that they have a safer device and can obtain regulatory clearance to put it on the market. This means that regulatory affairs and quality management, rather than product development professionals, often control the plans and budgets for human factors engineering, resulting in a disruption of what we take to be the natural state of affairs: the integration of human factors engineering with industrial design. Oddly, there appears to

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be little discussion about how human factors engineers can work with industrial designers to improve a device’s usability and competitiveness in the market, as well as to meet safety and regulatory goals. We propose that medical device manufacturers should now consider a return (or, we could call it a progressive step) toward a middle ground where human factors engineering in conjunction with industrial design is applied to address both regulatory and commercial imperatives. This is likely to be the place where companies can make strides toward increased user satisfaction and profit while maintaining protection against what can feel like a disaster: a regulator rejecting their product. The readers of INNOVATION are likely to be well informed about what constitutes good human factors engineering. If not, tutorial resources include the FDA’s own Human Factors Guidance to medical device manufacturers, standards published by the Association for the Advancement of Medical Instrumentation and the International Electrotechnical Commission (IEC), and multiple textbooks on the subject. So this article dispenses with further tutorial content except to summarize that good human factors engineering involves three imperatives: learning about users; establishing proper user-interface requirements and applying human factors engineering design principles to produce good user interfaces; and conducting iterative studies of users interacting with preliminary, refined and final designs to confirm their safety, effectiveness and usability. Oh, and may we add

Michael Wiklund is general manager of human factors engineering at UL–Wiklund. He is co-author of Usability Testing of Medical Devices and Designing Usability into Medical Devices. He teaches courses on human factors in medical technology and software user interface design at Tufts University. n Stephen Wilcox, FIDSA is a principal and the founder of Design Science, a 30-person firm in Philadelphia that specializes in optimizing the human interface of products, particularly medical devices. He was chair of the IDSA Human Factors Professional Interest Section for a number of years and is the other co-author of Designing Usability into Medical Devices.

a fourth: confirming that users can interact with a device in a satisfying manner. The fourth objective is the key to moving back toward a middle ground where commercial imperatives receive their due. Accordingly, the balance of this article discusses how manufacturers can fine-tune their human factors engineering processes so that they are not just about fulfilling the requirements of FDA’s guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 2011, or IEC’s broadly-applied human factors engineering standard ISO/IEC 62366:2007, Medical Devices – Application of Usability Engineering to Medical Devices. In our view, achieving design excellence for a medical device’s user interface requires gathering accurate information about users and how they might ideally interact with the given device. It also requires bringing users and evolving design solutions together on a sufficiently frequent basis to keep a device’s design moving in the right direction. Thus, for the remainder of this article we will discuss a couple of our pet topics—ethnographic research and usability testing—providing an update on how these well-established techniques are still having an impact on design. Companies that master these techniques and engage competent designers are sure to produce medical devices that rise above others, delivering on the promise of safety, effectiveness, usability and user satisfaction. Ethnographic Research The figure above provides a fairly abstract summary of where ethnographic research and usability testing (as well as the application of technical human factors information) fit into medical product development. We take the term contextual inquiry to be equivalent to ethnographic research and have used the former in the figure because it is what

tends to be used in the relevant standards and guidelines. The point of the figure is that the regulatory imperatives increase as the product development process advances toward completion. Moving from left to right, ethnographic research is not required, strictly speaking, but is encouraged by both the IEC standard 62366:2007 and by the FDA Guidance mentioned previously. Also, iterative formative testing is not strictly required. However, speaking from experience, a Design History File (documentation required by the FDA) that does not show evidence of formative testing raises a red flag among regulators. It suggests that the manufacturer has not applied human factors engineering in an appropriately comprehensive manner. Summative testing, on the other hand, is a hard requirement. The Role of Human Factors in Medical Device Development One consequence of placing disproportionate emphasis on the regulatory aspects of human factors engineering is a concomitant reduction of resources applied to ethnographic research in favor of more resources applied, particularly, to summative testing. We think this is a mistake. The purpose of ethnographic research (and its methodological cousins) is to create a foundation of information about the real world of product use. Without this foundation, the design team is at risk of doing a brilliant job of solving the wrong problems because of misconceptions regarding what ethnographic

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Information graphic applied to the use of a surgical kit

research is designed to illuminate: who the users are, what the environment of use is and what procedures a given device will be subjected to. In fact, this plays out later, vis-Ă -vis regulation, because the summative testing that is ultimately done will have to be defended to the notified bodies, including the FDA, as realisticâ&#x20AC;&#x201D;realistic in the choice of participants, realistic in the use environments that are simulated and realistic in the tasks that participants are given to perform. Without direct evidence of what goes on in the real world, it can be difficult to defend these choices. Another, sometimes overlooked, role of ethnographic research is to establish accord among the design team. Without a body of valid evidence to refer to, the team is vulnerable to the expert who has veto power over its ideas by virtue of the expert being the only one with knowledge of actual use. The team is also vulnerable to the gridlock

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that can result from staying in the realm of opinion rather than the realm of evidence. Without solid evidence about users, use environments and actual procedures to drive design decisions, the design process can be slowed by endless debates resulting from the fact that everyone, inevitably, has an opinion. Thus, good evidence can speed product development by providing a way out of this opinion-based gridlock. We do not have space here to go into great detail regarding the conduct of ethnographic research, but let us provide some advice regarding what we have found useful in the context of medical device development: n

Document the research using high-resolution multichannel video. The complexity typically associated with the use of medical devices and the need to capture the

details puts a particular premium on high-quality video. On the one hand, close-ups of clinical details are often important; on the other hand, it is usually necessary to understand what each member of a multiperson team is doing. It follows that the video system must be able to accurately capture fine details as well as multiple actors— the case for both high-resolution and multiple cameras. n

Analyze the video to achieve rigor for the research. The results of ethnographic research are typically reported in an anecdotal fashion. This approach may not be adequate for the life-and-death nature of medical device development. Video analysis can yield quantitative data crucial for a full understanding of the key issues, for example detailed timing of key events and frequency counts of errors or problems. Such data do not replace the user-centered insights that are the hallmark of ethnographic research, but can serve as an important supplement to them. Use information graphics to report the research. Given the complexity of the phenomena captured, graphic approaches to summarizing the information can be necessary to make that information accessible. Creating tools for visualizing information is another role that the designer can play in medical device development. The image on the left provides an example. Each row represents an actual use of a multipart surgical kit, with each item of the kit represented by a different color and the transition through the rainbow from yellow to purple (summarized at the top) representing “correct” use. Time is represented on the horizontal axis. Thus, at a glance, one can see that there is a good deal of variation in the timing of kit use and that there are several departures from the expected procedure—items of the kit are used in a variety or orders.

Use videoconferencing for home-healthcare projects. For example, for chronic diseases such as diabetes or renal failure (of increasing importance for medical device developers), it is not necessarily efficient to spend all day at a patient’s home waiting for the

periodic events of interest to occur. Setting up videoconferencing for indirect observation can, thus, be a reasonable compromise between relying solely on interviews and direct observation. In sum, ethnographic research is important for medical device development, and it requires tools and methods that may not typically be used for such research outside of the medical area. Usability Testing Is there anything new to be said about usability testing that is not covered—and then covered again and again—by the literature? We believe so. It is about conducting usability tests in a manner that covers the regulatory bases without forsaking product commercialization benefits, maintaining them as a tool for the design team, not just the regulatory professionals. We advise medical device manufacturers to design their formative usability tests—those conducted while a device is in the flexible development stage—to generate the maximum amount of insight possible about the user experience. We recommend strongly against making such tests just about safety issues and the basic ability of users to complete tasks. We offer the above advice because a safe and effective device might still be rejected by the market. After all, plenty of safe and effective devices are selling poorly; they would not be on the market if regulators had not deemed them so. They are probably selling poorly for many reasons (such as high price, poor service, missing features), but a crucial one might be poor usability compared to competitive offerings. Noting that usability is a high priority for medical device users, devices with poor usability certainly can languish. A properly designed formative usability test may be a company’s salvation. Here is a checklist to be sure that a formative test serves the multiple goals it can and should serve: n

Focus on frequent and critical user interactions with the device. Call upon users to perform tasks that will have a disproportionately large influence on their ability to use the device for its intended purpose, certainly in a safe and effective manner, but also with satisfaction. It

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A scene from a test conducted in UL,-Wiklund’s medical usability test lab.

is OK to ask users to perform tasks that are not safetyrelated. You are testing for your own company’s sake, not just to satisfy the regulators. n

Call upon test participants to state what they like most and least about the device and ask for detailed suggestions on how to improve the device. This is not biasing the test participant, and it fits right in with the goal of identifying opportunities for product improvement while there is still time. Remember that formative usability testing is not nearly as constrained as summative usability testing, which manufacturers perform to validate a design and support a regulatory submission. Go so far as to ask participants to compare the tested device to their vision of the ideal device, which might be quite similar or different from that presented. Also step back and ask them to compare the device to its contemporaries already on the market. You might learn that your device represents a great leap forward in usability, or that it is not much of a step forward and needs work.

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Consider conducting larger than usual formative usability tests if the user population is particularly heterogeneous such that you expect a wide range of user characteristics and manners of device use. Conventional wisdom and common practice suggests that eight to 12 test participants might be sufficient to gain deep insight into a device’s interactive performance. But a larger test might be the solution to gaining more nuanced and beneficial insights into how to optimize the device’s user interface. And, in what might seem antithetical to common practice, the greatest benefit from usability testing might occur at an earlier stage of design, when things can be changed for a reasonable cost. Alternatively, think about conducting many—perhaps a half dozen or more—small formative usability tests en route to the best possible user interface design and resulting user experience.

To be sure, we are not advocating a departure from using formative usability tests to achieve safe and effective design solutions, which is the most important among human factors engineering imperatives. However, there is every reason to derive broader benefit by also focusing on non-safety-related design matters. A Fuller Vision Our main point is that if you must do a rigorous job of human factors engineering to satisfy safety and regulatory requirements anyway, why not also apply human factors engineering in a manner that will lead to products that people love? We fear that the last few years have led to the partial or full displacement of human factors engineering from product development in favor of regulatory affairs and quality control. We certainly do not object to the new focus on medical device risk. But let’s get back to applying human factors engineering to enhance the user experience as well as make medical devices safer. This will afford greater opportunity for industrial designers and human factors engineers to work collaboratively to create great products that deliver great user experiences. n

By Seth GaleWyrick sgalewyrick@bresslergroup.com As a senior mechanical engineer and sustainable design specialist at Bresslergroup, Seth GaleWyrick applies his training in life cycle analysis and finite element analysis and optimization to guide clients toward strategies with impact. His projects have won numerous patents and awards, and he writes and presents regularly on sustainability issues in product development.

WORKING TOWARD SUSTAINABLE MEDICAL DEVICE DESIGN

“O

ur healthcare system is unsustainable.” When politicians say this, they’re usually speaking in terms of cost. But it’s just as true in terms of medical device design. Even as sustainable business practices have gained momentum in other sectors, with more

than half of Fortune 500 companies launching sustainability initiatives, the medical device industry has mostly sat on the sidelines, gauging sustainability as an unaffordable frill.

But it’s not. Sustainability is vital to the long-term health of our medical system, and the companies who lead the way will gain a substantial advantage over those who sit on the sidelines. Sustainability Is Catching On Efficacy, safety and cost are the classic triad of medical device design. At the moment, sustainability hovers just outside those well-established requirements. A client of ours conducted a survey that determined hospitals weren’t willing to pay a premium for more sustainable products. However, there are signs that this is changing. Another survey, this one commissioned by Johnson & Johnson in 2012, found that 54 percent of hospitals rate the environmental friendliness of a product as highly significant when making purchasing decisions and expect future requests for proposals to include green attributes. As consultants we’ve had success bringing on clients who are interested in sustainability but wary of damaging their business model by demonstrating how using less material or less energy in the manufacturing process will help their bottom line. The most persuasive argument

for medical device manufacturers is cost—we’ve brought along cautious adopters by telling them how much they’ll save. Once the design is complete, however, we’ve noticed they start to appreciate the broader picture. It’s hard not to get excited at the prospect of an improved brand image, customer loyalty, workforce satisfaction and reduced regulatory risk. The Potential and Promise of Product Design Companies typically start down the road to sustainability by analyzing the most tangible aspects of their operations: power consumption in offices, recycling and renewable energy. Compared to the impact of the products they manufacture, these adjustments are just a drop in the bucket. Sustainable product design is the real key to driving significant change. Since 60 to 80 percent of the environmental impact of a product is determined during spec development and concept generation, we recommend that our clients incorporate sustainable design principles and tools into their projects from the beginning. That way we can rely on

Above: Examples of medical devices that have incorporated sustainable design: the Welch Allyn EcoCuff, Hospira VisIV bag and Becton Dickinson Emerald syringe line.

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paring these two systems helped us understand how many times the reel would have to be reused before there was an environmental benefit. From an economic standpoint, the new reel pays for itself after four return trips, after which each reuse is essentially free. From an environmental standpoint, it needs to be used at least 14 times. With this in mind we gave it a design life of 36 uses, and it will likely last much longer.

A survey shows signs of change—hospitals are taking sustainability into account when making purchasing decisions.

an evolving life-cycle analysis that we update throughout the project to help inform decisions made along the way. For example, an industrial wire manufacturer was throwing away its bulky, wooden shipping reels after a single use because it was too expensive to return them to the factory. Our solution was a reel that easily dissembles and packs tightly for efficient return shipment. A life-cycle analysis com-

Examples of Sustainable Medical Device Design Similar savings can be had in the healthcare sector. The possibilities are made evident by devices that have already incorporated sustainable design. While we can’t disclose details about the medical devices we’ve designed, there are other strong examples out there to cite. After surgery almost everything that touches a patient is discarded, creating 7,000 tons of medical waste in the US. each day. Welch Allyn took steps to reduce this waste and in the process made a fairly generic product—its TrimLine blood pressure cuff—distinctive and desirable. The company began with the observation that the tube sets on the cuff could be reused since they don’t touch the patient. Detaching them from the disposable cuff both saved money and decreased the environmental impact. It also changed material from PVC, which can be toxic to manufacture and has associated health concerns, to polypropylene, which is more inert and easier to recycle. Welch Allyn now offers a 100 percent recyclable green cuff with detachable tubes. The cuff weighs 67 percent less and has a 60 percent lower environmental impact than its standard TrimLine cuff. Hospira’s VisIV IV bag is another example of sustainable medical device design. It’s made from a multilayer bag material that makes an overwrap redundant—resulting in 40 to 60 percent less waste than competitive IV bags.

Lessons in how to develop sustainable products can be found outside the medical sphere. We incorporated life-cycle analysis early in the process while designing this reusable shipping reel.

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At the moment, sustainability still sits outside the three pillars of medical device design: efficacy, safety and cost.

One more example is BD’s Emerald syringe line, which uses 30 percent less material than conventional syringes. A conservative back of the envelope calculation shows that if all the syringes BD sells were suddenly switched to the Emerald line it would save at least 8 million kilograms of plastic per year. That represents about 31 million kilograms of carbon dioxide equivalent emissions or the total emitted by about 6,100 automobiles in the US. Furthermore, through its Ecofinity Life Cycle program, those syringes can be collected, sterilized and recycled into new waste containers for sharps. This closed-loop system is a significant steppingstone toward the holy grail of sustainability: to create a product that can be endlessly recycled back into itself or reused. Turning Point Already, more companies and healthcare providers are beginning to realize that efficacy, safety and cost don’t capture the whole picture—sustainability is also important. Some of the biggest healthcare providers in the US have recently caught on. Kaiser Permanente, one of the nation’s largest healthcare providers, has made sustainability a centerpiece of its business philosophy. And President Obama’s executive order 13514 requires VA hospitals and other healthcare

facilities under the umbrella of the federal government to give preference to sustainable products. The order says that government agencies must “ensure 95% of all new contracts, including non-exempt contract modifications, require products and services that are energy-efficient, water-efficient, biobased, environmentally preferable, nonozone depleting, contain recycled-content, non-toxic or less-toxic alternatives.” But the dearth of sustainable medical devices has made this difficult—there aren’t that many medical device manufacturers making sustainable products. The government currently lists no medical device suppliers for many biomedical devices and supplies, from intravenous bags and tubing to dialysis equipment, in its Green Procurement “Where to Buy” list. And the government’s purchasing power will only grow along with US healthcare expenditures, expected to surpass $3 trillion in 2014 and reach $4.8 trillion in 2021. This increase will dovetail with sustainability’s growing foothold in the healthcare industry. No one who wants to stick around long term will be able to ignore their impact (positive or negative) for much longer. There is a huge gap in the market and a huge opportunity for medical device manufacturers to meet the demand with differentiated products reenvisioned through the lens of sustainability. n

Working Toward Sustainable Medical Device Design first appeared on Accelerator, Bresslergroup’s product innovation blog. http://accelerator.bresslergroup.com/2014/05/sustainable-medical-device-design/ http://accelerator.bresslergroup.com

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By Cheryl Zhenyu Qian, IDSA qianz@purdue.edu Cheryl Zhenyu Qian is an assistant professor at Purdue University. She and her students are boundary-crossers, looking for the harmonious integration of both physical and visual interactions in product design. From 2010 to 2013 she won six awards from IEEE VAST challenges. Her PhD dissertation on parametric design experience won the Dean of Graduate Studies Convocation Medal from Simon Fraser University in Canada. Special thanks to Paul Haney, Chris Bissig and Lou Lenzi from GE Appliances.

DESIGN FOR ENJOYABLE MOMENTS

verybody loves to wear fresh, clean clothes, but few love to spend hours doing laundry. The new generation of laundry machines are becoming increasingly intelligent and powerful, intending to accomplish washing and drying tasks in an effective way. For most families, however, laundry is

still a chore—for some, even a burden. Cooking is also a regular task in everybody’s life, but more often it can be full of enjoyment; some call it artistic expression. Is it possible for laundry to become so appreciated? In the fall of 2013, GE Appliances took a close look at this possibility and suggested a fresh and inspiring perspective to redesign this experience. Ten industrial design graduate students from Purdue University participated in this exploration. The project focused on detailed activities in the laundry process—before and after the clothes are washed and dried—instead of machine innovations. “At GE, we are about reimagining the home,” said Paul Haney, IDSA, chief designer for GE Appliances. “By collaborating with talented students at Purdue University, we looked beyond washers and dryers to the larger home laundry experience to find fresh ideas and designs that help make cleaning clothes less of a chore.” A Focus on the Minute Rooted in the Russian semiotic psychological theory pioneered by Lev Vygotsky in the 1960s, activity-centered design does not focus on user goals and preferences, but on the activity a user may perform with a given piece of technology. This approach does not intend to skip the analysis of detailed user requirements; instead it bridges the gap between the user and the social context through the mediating activity. When working with activity-centered design, designers use research to get user insights. Observations and interviews are typical approaches to learning more about user behavior. By mapping user activities and tasks, designers may consider and develop new tasks that will make activities easier to perform, enabling design solutions to accomplish them. Collector, a wall-mounted laundry container by Anqi Wang from Purdue University

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The students were introduced to the activitycentered-design approach and encouraged to focus their attention on one small laundryrelated “problem” activity, analyze its context and challenges, and redesign it as a more enjoyable moment in the laundry process. The 10 students paired up in two-member teams to observe, interview and analyze a user’s normal daily laundry experience. Their target users were people such as seniors who live independently, international students with limited dormitory space, young professionals who

“At GE, we are about

”

reimagining the home.

—Paul Haney, IDSA, chief designer for GE Appliances

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F RE S H I DE AS Easy Hanger by Shang Xu from Purdue University

need their office clothes carefully washed and ironed, and mothers who do the laundry for all their family members. These users are both specific and normal, representing different demands and capabilities in a real-life context. The general laundry experience was defined as a series of activities that includes collecting, sorting, loading, washing, transferring, drying and folding. The students using the activity-centered-design perspective had many issues to investigate and norms to challenge. In the simple task of collecting dirty clothes, for example, what kind of container is used, how often are they collected, what is the usual collection route, how it is determined if the clothes are dirty or clean, and have all the pockets been checked and emptied? Branching out from this general process are other activities: Sometimes a dress is worn only once and doesn’t need to be mixed with the dirty clothes for washing, nor with clean clothes. Or it may be more efficient to remove spots in a special area before putting the clothes in the washer. These occasional activities are also useful for consideration. Through observation and analysis, the students realized that opportunities exist to make laundry activities interesting and pleasant. It is natural to appreciate freshly washed clothes and to be proud of a well-organized closet that has a pleasant smell. The laundry tasks can also be combined with simple entertainment, such as listening to music or chatting with friends on the phone, to lessen the loneliness and boredom of the task. Participation by youngsters can also make the process more interesting and pleasurable. Students were motivated to seek potential improvements and innovations. After two rounds of brainstorming and sketching, students received advice not only from the instructor but also from professionals at GE Appliances. Several good ideas were selected for further development, and students quickly built functional prototypes to test the proposed

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ideas. Activity-centered design originates from the analysis of activities and should also be assessed and improved by real practices. Functional Feedback Sorting clothes is an essential process to ensure that certain colors or materials are grouped and washed properly. The students noted several major aspects of the sorting process: It requires space and is usually done by a person bending down, since the laundry basket is usually on the floor. Thus sorting a week’s accumulation of dirty clothes can be time-consuming, tiring and unpleasant. Collector is a container designed to streamline the sorting process. It can store multiple loads of laundry at one time. Mounted next to the washing machine, it has a vertical slit in the body, enabling almost all of the user’s dirty laundry to be clearly seen. While loading the laundry in the washer, the user can easily select the light-colored pieces, pull them out through the slit, and leave the dark and colored clothes for later loads. Creating a physical model helped students to eliminate some small design issues. With the Collector, for example, comparing two prototypes, a one-slit and a two-slit prototype, helped the student realize that one slit is enough. In prototyping, she also realized that adding a rubber liner inside the container protects the clothes from overstretching while they are being pulled out, and that a tilted base facilitates removing clothes and helps to show all pieces through the slit. Lastly, a zipper opening at the container’s bottom allows the leftover clothes to drop directly into a basket below, if desired. The new generation of detergents are powerful, for sure. But several kinds of stains, such as sauces, blood, juice, grass and paint, are difficult for regular detergents to remove in the washer, and the heat from the dryer can permanently set some stains. Not every washer has a

The Ripple Scrub Board on the washer (right) and as a prototype (below) by Amie Barnes from Purdue University

sink beside it to facilitate pretreating stains. The Ripple Scrub Board bridges the traditional washboard with the modern washing machine to produce a simple solution: a scrub board on top of the washer opening. Pretreated laundry can then be washed using a shorter cycle. This design invites the traditional hand-washing method to remedy the limits of the modern machine, also extending the machine toward the direction of sustainability. The student used a laser cutter to explore different designs for the board and hand-tested them to see which configurations work most effectively. As simple a concept as it is, it was a fresh idea to GE. The design details were crucial to the designâ&#x20AC;&#x2122;s success, such as the small drainage holes that allow excess cleaning liquid to flow into the washer and the molded plastic with an undulating texture for a firm yet flexible working surface. The One-Handed World study found that two-handed consumers spend 40 percent of their waking hours with one hand occupied. At the same time, they try to use products or open packages with the remaining hand, even though these items were never designed to be used as such. While collecting, sorting, loading and running machines can all be done with one hand, what about the activities that take place after drying clothes, such as hanging up clean laundry? Inspired by scissors, the Easy Hanger does just that. Itâ&#x20AC;&#x2122;s easy to use with only one hand and easy to store when folded. Simple and elegant, this design was also modified based on experimentation with several rounds of prototypes. The original design idea simulated the shape of a sparrowâ&#x20AC;&#x2122;s mouth. The sketches looked perfect. However, while practicing with the prototype using a soft piece of clothing, the student realized that two hands were required to balance and operate it. After exploring several different combinations, the one-handed hanger started to work, but it still could easily twist to the other side. Then the student added blue rubber bumpers on the two legs to stop the rotation. Students also proposed other design ideas, such as a tree-shaped sculptural rack for hanging clothes that have been used once and might soon be worn again and a scanner for laundry baskets that detects any metal and electronic items left in pockets.

Learnings Compared with previous projects, these designs appear rather simple. In a traditional design project the goal has been to design a product that can solve most or at least several problems identified by the research. In this project, however, the students were encouraged to focus on identifying and improving one small laundry-related activity and turn it into an enjoyable moment. Students learned that a series of simple and elegant activities can build a pleasant experience. When washing clothes, the user can skip the sorting process, remove the stains while loading, hang up the clothes with one hand, and be guaranteed clean laundry that smells fresh and pleasant. The improved process will be much more enjoyable than the one it replaces. During the presentations at GE Appliances, Purdue students received positive feedback, and GE funded further development of several designs. n

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S H O W CASE

WONDERS OF MODERN MEDICINE

+ MORE

“Translating the shape and natural motion

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of the surgeon’s hand into balanced and stress-free movement.

PERSONA Surgical Instruments for Total Knee Anthroplasty designed by Metaphase Design Group Inc. for Zimmer Inc.; www.metaphase.com

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“Using design and technology to assist with the prevention and treatment of pressure ulcers.

”

Isolibrium - Critical Care Support Surface designed by Stryker Medical and Twisthink for Stryker Medical; www.twisthink.com

“SunSprite is the first solar-powered personal sun exposure tracker.” SunSprite designed by Stream Product Development Inc. for Good Lux Technology; www.streampd.com

The submitters pay for the publishing to this unjuried showcase. I N N O V AT I O N S U M M E R 2 0 1 4

S H O W CASE

“Audio made visual.” JBL GX Series Mobile Speakers designed by LDA for Harman International; www.LDALLC.COM

“Scans esophageal tissues more deeply; displays the results more clearly.” NvsionVLE Imaging System designed by Farm Design Inc. for NinePoint Medical; www.farmpd.com

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“A fresh approach to

”

integrated refrigeration.

Integrated Refrigeration designed by Cesaroni Design Associates, Inc. for Sub-Zero Group Inc.; www.cesaroni.com

“A fabricated and painted steel rack never looked so powered-up for iPads.” PowerRack® for iPad 2 designed by Cesaroni Design Associates Inc. for Bretford Manufacturing Inc.; www.cesaroni.com

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S H O W CASE

â&#x20AC;&#x153;Advanced robotic leg brace enabling active lifestyles.â&#x20AC;? Active Lifestyle Brace designed by Adicep Technologies and Sundberg-Ferar; www. Sundbergferar.com

“Sleek and elegant remotes enhance the user experience with thoughtful touches and premium fit, finish and materials— a lifestyle accessory.

”

LiftMaster TX2EV, TX4EV, TX4UNI/ Chamberlain TX4RUNI/Merlin E950M Global Brands GDO Remote designed by The Chamberlain Group/Advanced Development USA; www.Chamberlain.eu; www.Liftmaster.eu

“The OR and the office become one.” Arkon Anesthesia Delivery System designed by Design Concepts Inc. for Spacelabs Healthcare; www.design-concepts.com

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S H O W CASE

“Easily add garage door opener control anywhere in your home with a wireless wall control. Simple installation and programming with an intuitive interface and contemporary design. ” LiftMaster 128EV/ Chamberlain 128RV/ Merlin E138M Global Brands GDO Wireless Wall Control designed by The Chamberlain Group/Advanced Development USA; www.Chamberlain.eu; www.Liftmaster.eu

“A global platform that harmonizes sophistication with contemporary smart design to accompany built-in myQ technology.

”

LiftMaster LM60, LM80, LM100/ Merlin MT100EVO Chamberlain ML1000EV, ML700EV Global Brands GDO Platform designed by The Chamberlain Group/ Advanced Development USA; www.Chamberlain.eu; www.Liftmaster.eu

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“Listen to your fetus’ heart sound. Share lovely words. Bless your baby. Anytime. Anyplace.” Grace designed by TAOTMS and BioSensor Lab; www.biosensorlab.com

“Easy, afforable at-home food safety appliance for children with Penguin’s amazing child-care spirits.” PENGUIN designed by TAOTMS and BioSensor Lab; www.biosensorlab.com

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ID+ME

TREASURE YOUR GIFT

headline in a recent designBytes email, “How to Be a Design Boss without Losing your Soul,” hit me too late to affect my decision to co-own and comanage a design office, Creative Design Center, Inc. Early in my career when I decided to put some distance between my family and the East by moving to California, the best boss I ever had said to me, “You are not suited to management, avoid it.” To Jim Balmer at Harley Earl, Inc. I had exhibited signs that my long-range success would not be what it could be if I tried to do something for which I had little or no talent, that my creativity as a designer was so important that to have to juggle my personal creativity and that of others at the same time was unwise. When I came to California and was active in IDSA regionally and locally, my love of design had no bounds. When I later decided to work for myself and a partner, I immediately became responsible for the work of others more than my own design contributions. What Jim Balmer had warned me to avoid became for me the reality of managing without an inherent aptitude for management. I put the gifted side of my design life on the shelf where it atrophied until my office of talented people resigned because of my un-gifted management. My partner, Bob Greene, also a fine designer but a gifted manager as well, had passed away unexpectedly, and I was a poor substitute. Of course, he too had sacrificed his personal design skills, but unlike me, he had an aptitude for management. When the reins fell upon my lack of inherent people and business skills, it didn’t take too long for the financial realities to exceed my shelved design dreams If you are interested in my recommendation from the perspective of a failed design office manager, listen to what Jim Balmer advised me: “Don’t even think of managing with design talents as significant as yours.” In other words, do not rise to the level of incompetence, as I did when I put the

gifts I had been given on the shelf and presumed to pick up and exercise gifts that I lacked. Because his design office had achieved so many admirable successes, I once asked Arnold Wolf, FIDSA what the difference was between becoming a corporate president and operating a productive design entity. He said that his job of managing the work of the talented designers in his design office made it appear to JBL, his client, that he was the key to the success of the designs. He was a key—one who didn’t exceed his management gifts. But as president of JBL, he became responsible primarily to the stockholders: to maximize their investment and income. As the financial half of Creative Design Center, I failed myself as a 50 percent stockholder. My partner had managed well enough. Only when I was the sole owner and stockholder did my lack of management skills serve no one well enough for the company to survive. Had I, instead, joined with someone with the managerial skills of Jim Balmer, and not had to abandon my inherent design gifts, I would have a different story to tell you. The lesson I learned: Avoid thinking that a person with a design gift needs to wear the hat of a person with a management gift and allow the design gift to remain in limbo till the financial ship comes in. I was wrong in thinking that a talented designer who lacked managerial skills could ignore reality. Some of you may think that a person who possesses both design and managerial gifts would finish well. You all know of Raymond Loewy, one such talent. What you probably don’t know is that in his later life, after all of his professional successes, he said to a personable designer friend who had worked in the New York and the Paris office’s: “Nobody calls, Tom.” Think about it. When your career has benefited from your gifts and the dregs of success have diminished and no one calls, you had better have strong faith and good friends—friends who would have called whether you had or hadn’t become a historical footnote. —Clair Samhammer, FIDSA csamhammer@att.net

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Turning insights into reality At Philips Design Healthcare we uncover the insights that lead to meaningful solutions and innovative user experiences. Our unique approach to design thinking and co-creation puts our designers at the center of the creation process â&#x20AC;&#x201C; from concept to prototype through to market launch. Our innovations make a positive difference to lives everywhere. We are recognized as one of the top design-awarded companies. And our employees benefit from growth opportunities at our design studios around the world.

See how we are creating the future of healthcare. Connect with us at www.usa.philips.com/about/design or www.usa.careers.philips.com.