BioVenture I Class Guide

ECCLES EXECUTIVE EDUCATION

BIOVENTURE: EARLY STAGE

BIOVENTURE: EARLY STAGE Overview Learn how to navigate the world of life science industry product development in this rigorous program. Through a blend of lecture-based learning, interactive case discussions, and first-hand accounts by experienced professionals who have successfully navigated the process, you will develop a deeper understanding of clinical problems, solution creation, and early-stage product development in the context of regulatory and stakeholder requirements. Explore business opportunities as you gain competency in a wide range of key issues, including the methodology of strategic clinical problem-solving and core elements of early product development. You’ll also learn to identify, assess, and address ethical issues associated with innovating clinical technologies.

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Clinical Immersion, Needs Finding and Ethnographic Research Disease State Fundamentals and Treatment Landscape Analysis Stakeholder and Market Analysis Opportunity and Financial Modeling Intellectual Property Fundamentals Design Processes and Prototype Development

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Regulatory Fundamentals, Hazard Analysis and Risk Management Bench Testing, Animal Studies, Clinical Trials and Ethics Human Factors and Usability Testing Advocacy and Promotion--Developing Key Opinion Leaders Healthcare Reimbursement Fundamentals

Employer Benefits

Employee Benefits

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Develop cross-functional leaders in your organization who are well-educated in all aspects of medical product innovation Gain valuable insights into the current business landscape and challenges facing your organization Avoid pitfalls encountered in real-world application of the clinical innovation process Anticipate challenges associated with the clinical introduction of new medical technologies, including issues with market analysis and business plan development Create opportunities to promote brands through word-of-mouth and referrals

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Gain competency in the methodology of strategic clinical problem solving Master the core elements of early product development through needs finding, ethnographic research, regulatory requirements, prototype design, concept generation and refinement, market opportunity and segmentation analysis Learn the intricacies and challenges of market analysis and business plan development involved in the clinical introduction of new medical technologies Experience a unique clinical shadowing opportunity and conduct a clinical observation under the guidance of a clinician from the University of Utah

Who Should Attend • • •

Managers and directors in any division of medical device companies Doctors who are interested in augmenting their career by applying their medical knowledge to business endeavors Entrepreneurs who have ideas for medical products or wish to break in to the industry

SHRM Recertification Provider Eccles Executive Education is recognized by SHRM to offer SHRM-CP and SHRM-SCP professional development credits (PDCs). This class is valid for 13 PDCs. For more information, please visit shrmcertification.org.

Sample Schedule Day 1

Day 4

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Clinical Immersion and Ethnographic Research Problem Identification and Validation Needs Statement Development Disease Statement Development Predevelopment Stakeholder and Market Analysis Treatment and Landscape Analysis

Day 2 • • • •

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Stakeholder Engagement, Advocacy, and Promotion Intellectual Property Basics TAC/VAC Reimbursement and Coding Advice Idea Maturation and Assistance

Day 5

ICH Normal Anatomy and Physiology ICH Abnormal Anatomy and Pathophysiology ICH Current Treatment Landscape and Shortfalls ICH Cycle of Care and Flow of Money Analysis

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Approaches to Innovation Project Development Strategy Human Factors and Usability Testing Team Project Presentations

Day 3 • • • • • •

Regulatory Fundamentals Design Controls and Design Review Risk Management and Hazard Analysis User-Centered Design and Design Thinking Prototyping and Bench Testing Regulatory Resources

Faculty Director | Dr. John Langell Dr. John Langell, MD, PhD, MPH, MBA is the Executive Director of the Center for Medical innovation and a minimally invasive gastrointestinal and endocrine surgeon at the University of Utah and Chief of General Surgery at the George E. Wahlen VA medical Center.

Doctor Langell completed hs surgical training at Stanford University Medical Center and completed advanced training in Space and Aerospace Medicine with NASA at the Johnson Space Center in Houston, Texas.

THE ECCLES DIFFERENCE The David Eccles School of Business enrolls about 6,000 students in its eight undergraduate majors, four MBAs, six other specialized graduate programs, one Ph.D. program, and executive education curricula. It is also home to seven institutes and centers that support an ecosystem of entrepreneurship, technology, and innovation, including the Lassonde Entrepreneur Institute, Ken C. Gardner Policy Institute, Sorenson Impact Center, and more.

Our faculty members boast impressive professional and educational backgrounds and hold Ph.D.s from esteemed universities including the University of Pennsylvania’s Wharton School, Northwestern University’s Kellogg School, Harvard Business School, Stanford Graduate School of Business, and University of California at Berkeley’s Haas School.

TAKE THE NEXT STEP Telephone: (801) 587-7273 Email: ExecEd@Utah.edu Website: Execed.Utah.Edu Registration: Eccles.Secure.Force.com/ExecEdApplication 1731 E Campus Center Drive Robert H. and Katharine B. Garff Building, GARFF 4340 Salt Lake City, Utah 84112