Appendix A
Workshop Agenda Roundtable on Research and Development of Drugs, Biologics, and Medical Devices

INNOVATION AND INVENTION IN MEDICAL DEVICES

17–18 FEBRUARY 2000

WYNDHAM CITY CENTER HOTEL

1143 NEW HAMPSHIRE AVENUE, N.W.

WASHINGTON, D.C.

AGENDA

Thursday, 17 February

7:30 a.m.

Continental Breakfast

Opening Session

8:00

Welcome and Opening Remarks

Kenneth I.Shine, M.D., President

Institute of Medicine

8:15

Statement of Objectives, Charge to Participants, Introductions

Ronald W.Estabrook, Ph.D., Roundtable Chair

Virginia Lazenby O’Hara Professor of Biochemistry

University of Texas Southwestern Medical Center

8:30

Opening Remarks

Kshitij Mohan, Ph.D., Workshop Chair

Corporate Vice President for Research and Technical Services

Baxter Health Care Corporation



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Innovation and Invention in Medical Devices: Workshop Summary Appendix A Workshop Agenda Roundtable on Research and Development of Drugs, Biologics, and Medical Devices INNOVATION AND INVENTION IN MEDICAL DEVICES 17–18 FEBRUARY 2000 WYNDHAM CITY CENTER HOTEL 1143 NEW HAMPSHIRE AVENUE, N.W. WASHINGTON, D.C. AGENDA Thursday, 17 February 7:30 a.m. Continental Breakfast Opening Session 8:00 Welcome and Opening Remarks Kenneth I.Shine, M.D., President Institute of Medicine 8:15 Statement of Objectives, Charge to Participants, Introductions Ronald W.Estabrook, Ph.D., Roundtable Chair Virginia Lazenby O’Hara Professor of Biochemistry University of Texas Southwestern Medical Center 8:30 Opening Remarks Kshitij Mohan, Ph.D., Workshop Chair Corporate Vice President for Research and Technical Services Baxter Health Care Corporation

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Innovation and Invention in Medical Devices: Workshop Summary 8:45 Plenary Speaker Harry M.Jansen Kraemer, Jr. Chairman and Chief Executive Officer Baxter International, Inc. Keynote Session Innovation and invention-related perspectives of key stakeholders (research, clinical practice, regulatory, industry, and consumer constituencies) in the area of medical devices. Past, present, and future directions in medical devices. Moderator: Ronald W.Estabrook, Ph.D., Roundtable Chair 9:30 Robert W.Mann, Sc.D. Whitaker Professor Emeritus of Biomedical Engineering Massachusetts Institute of Technology 9:50 David W.Feigal, M.D., M.P.H. Director, Center for Devices and Radiological Health Food and Drug Administration 10:30 Tobias Massa, Ph.D. Executive Director, Global Regulatory Affairs Lilly Research Laboratories 10:50 Jeffrey C.Lerner Ph.D. Vice President for Strategic Planning ECRI 11:10 Glen D.Nelson, M.D. Vice Chairman Medtronic, Inc. 11:30 Panel Discussion Period Session I: The Nature of Medical Innovation Presentations in this session will provide the status of innovation in medical devices since the late 1980s, address the invention and development process map for medical device technologies and products, present case studies that analyze the factors which have led to significant medical device innovations in the past 50 years, and discuss the factors that have supported significant ongoing and emerging technology innovations to reach the development and clinical stage. Moderator: Annetine C.Gelijns, Ph.D. Director, International Center for Health Outcomes and Innovation Research Columbia University

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Innovation and Invention in Medical Devices: Workshop Summary 1:30 p.m. Introductory Comments Annetine C.Gelijns, Ph.D. 1:50 The Innovation Process for Medical Devices: A NASA Perspective John Hines, M.S. Technology Development Manager Space Life Sciences Program, NASA 2:10 Case Studies of Significant Medical Device Innovation in the Past Thomas J.Fogarty, M.D. Professor of Surgery Stanford University School of Medicine 2:30 Case Studies of Significant Emerging Innovations Stephen P.A.Fodor, Ph.D. Chairman and Chief Executive Officer Affymetrix 3:10 Inhaled Insulin—A Case Study Robert B.Chess Chief Executive Officer Inhale Therapeutics 3:30 Case Studies of Significant Emerging Innovations Richard Nadeau, Ph.D. Chairman and Chief Executive Officer Cytometrics 3:50 Case Studies of Significant Emerging Innovations Dean Kamen President DEKA Research and Development Corporation 4:10 Panel Discussion Period 5:10 Adjournment Friday, 18 February 8:15 a.m. Opening Remarks Ronald Estabrook, Ph.D., Roundtable Chair Session II: Sources and Support of Medical Device Innovation Presentations in this session will analyze the sources and amount of resources available in the medical device innovation field; discuss the role of small, large, and multinational medical companies and identify the issues and

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Innovation and Invention in Medical Devices: Workshop Summary opportunities confronted by them in this field, as well as the role of standards and product applications; identify the role as well as the incentives and drivers of venture capital; and discuss the role of the legal system. Moderator: James S.Benson Executive Vice President, Technology and Regulatory Affairs Health Industry Manufacturers Association 8:30 An Overview of Public and Private Factors Affecting Medical Device Innovation Cliff Goodman, Ph.D. Senior Scientist The Lewin Group 8:55 The Federal Research Role John T.Watson, Ph.D. Acting Deputy Director, National Heart, Lung and Blood Institute, NIH 9:15 The Federal Regulatory Role Susan Alpert, M.D., Ph.D. Director, Center for Food Safety and Applied Nutrition Food and Drug Administration 9:35 The Academic Role in Innovation John A.Parrish, M.D. Center for Innovative Minimally Invasive Technology Massachusetts General Hospital 10:20 The Academic Role Robert W.Anderson, M.D. David C.Sabiston Professor and Chair Department of Surgery Duke University 10:40 Role of Small Medical Companies Thomas M.Loarie Chief Executive Officer Kera Vision, Inc. 11:00 Role of Large Medical Companies John P.Wareham Chief Executive Officer Beckman Coulter 11:20 Role of Public and Private Capital J.Casey McGlynn Partner—Wilson, Sonsini, Goodrich and Rosati

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Innovation and Invention in Medical Devices: Workshop Summary 11:40 Panel Discussion Period Session III: The Challenges Ahead Session III will examine the challenges that lie ahead for medical device innovation, such as identifying areas of clinical medicine where there are significant unmet clinical needs that may be addressed through innovation in medical technology and through training and education, as well as identifying new initiatives in interdisciplinary science for promoting new models for the conduct of research essential to the undergirding of future medical technology. This session will also discuss emerging discoveries and technologies that could serve as the basis for developing new medical devices, addressing the unmet clinical needs, or for improving costs or outcome of currently available devices, as well as identify the potential barriers for present and future technologies which are being applied to medical devices and identify the public perception of risk assessment. Moderator: Robert Califf, M.D., Roundtable Member Associate Vice Chancellor for Clinical Research Duke University 1:30 p.m. Unmet Clinical Needs Robert Califf, M.D. 1:55 Unmet Clinical Needs James E.Muller, M.D. Center for Innovative Minimally Invasive Therapy 2:20 Barriers and Issues in Device Innovation: Reimbursement Pamela G.Bailey President, Health Industry Manufacturers Association 2:45 Panel Discussion Period Summary and Conclusions 3:30 Summary and Conclusions Kshitij Mohan, Ph.D., Workshop Chair 4:00 Closing Remarks Ronald Estabrook, Ph.D., Roundtable Chair 4:20 Adjournment

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