| Contents |
Machine generated contents note: 1 INTRODUCTORY OVERVIEW -- Overview, 1 -- Challenges to Innovation, 2 -- Regulatory Issues, 3 -- Payment Issues, 4 -- Value and Consequences for Innovation, 7 -- Conclusions, 7 -- 2 KEYNOTE SESSION 9 -- Historical Perspective on IOM's Role in Providing a Forum for -- Discussion, 9 -- A Regulatory Perspective, 13 -- An Industry Perspective: Challenges in the Development and -- Regulation of Drug-Device Combination Products, 16 -- An Evaluator's Perspective, 20 -- Innovation and Invention in Medical Devices: Implantable -- Defibrillators, 21 -- General Discussion of the Keynote Session, 25 -- 3 THE NATURE OF MEDICAL INNOVATION 31 -- The Innovative Process for Medical Devices: A NASA -- Perspective, 31 -- Endovascular Devices, 36 -- Gene Arrays, 39 -- Inhaled Insulin, 40 -- Imaging the Microvasculature, 41 -- General Discussion of the Nature of Medical Innovation, 43 -- 4 SOURCES AND SUPPORT OF MEDICAL DEVICES INNOVATION 47 -- An Overview of Public and Private Factors Affecting Medical -- Device Innovation, 47 -- The Federal Research Role, 49 -- The Federal Regulatory Role, 50 -- The Academic Role in Innovation, 51 -- The Academic Health Center Environment, 52 -- The Role of Small Medical Companies, 54 -- The Role of Large Medical Companies, 54 -- The Role of Public and Private Capital, 56 -- General Discussion of Sources and Support of Medical Device -- Innovation, 57 -- 5 THE CHALLENGES AHEAD 61 -- Unmet Clinical Needs: Cardiovascular Disease, 61 -- Unmet Clinical Needs: Clinical Trials, 63 -- Barriers and Issues in Device Innovation: Reimbursement, 64 -- General Discussion of the Challenges Ahead, 65 -- 6 SUMMARY AND CONCLUSIONS 69 -- APPENDIXES -- A Workshop Agenda, 71 -- B Speakers' Biographical Sketches, 77 -- C Registered Participants, 89. |
