workshop summary Hanna, Kathi E. Institute of Medicine (U.S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. text bibliography conference publication dcu Washington, D.C National Academy Press 2001 monographic eng spa

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xx, 92 p. : ill. ; 23 cm. 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. Kathi E. Hanna ... [et al.] editors ; based on a workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Board on Health Sciences Policy, Institute of Medicine. Includes bibliographical references. Support for this project was proveded by the U.S. Department of Health and Human Services and the Greenwall Foundation. Medical instruments and apparatus Congresses Medical innovations Congresses Equipment and Supplies congresses Diffusion of Innovation congresses R 856.4 I58 2001 681 0309082552 http://www.loc.gov/catdir/toc/fy031/2002265224.html http://www.loc.gov/catdir/toc/fy031/2002265224.html Compass series 020108 20230410143515.0 spa