03307cam a22003497a 4500 102959 102959 BJBSDDR 20230410143515.0 ta 020108s2001 dcua b 100 0 eng d 0309082552 Compass series spa DLC spa eng R 856.4 I58 2001 681 Innovation and invention in medical devices : workshop summary / 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. Washington, D.C. : National Academy Press, 2001. xx, 92 p. : ill. ; 23 cm. Includes bibliographical references. 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. 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 Hanna, Kathi E. 11486 Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Compass series (Washington, D.C.) Table of contents http://www.loc.gov/catdir/toc/fy031/2002265224.html lcc BK lmm 0 0 lcc 0 0 S BJB BJB A2P 2023-04-10 0 R 856.4 I58 2001 00000120472 2019-01-21 00:00:00 1 2019-01-21 bk