Innovation and invention in medical devices
Subtitle: workshop summary
By: 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.
Contributors: Hanna, Kathi E.; Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.
Series: Compass series; Compass series (Washington, D.C.)
Publisher: National Academy Press
Published: 2001
Place of publication: Washington, D.C
Language: eng
Number of pages: 92
Subjects: Medical instruments and apparatus -- Congresses.; Medical innovations -- Congresses.; Equipment and Supplies -- congresses; Diffusion of Innovation -- congresses
Genres: Congresses.; congresses
Notes: Includes bibliographical references.
Support for this project was proveded by the U.S. Department of Health and Human Services and the Greenwall Foundation.
Table of contents: value: Machine generated contents note: 1 INTRODUCTORY OVERVIEW; value: Overview, 1; value: Challenges to Innovation, 2; value: Regulatory Issues, 3; value: Payment Issues, 4; value: Value and Consequences for Innovation, 7; value: Conclusions, 7; value: 2 KEYNOTE SESSION 9; value: Historical Perspective on IOM's Role in Providing a Forum for; value: Discussion, 9; value: A Regulatory Perspective, 13; value: An Industry Perspective: Challenges in the Development and; value: Regulation of Drug-Device Combination Products, 16; value: An Evaluator's Perspective, 20; value: Innovation and Invention in Medical Devices: Implantable; value: Defibrillators, 21; value: General Discussion of the Keynote Session, 25; value: 3 THE NATURE OF MEDICAL INNOVATION 31; value: The Innovative Process for Medical Devices: A NASA; value: Perspective, 31; value: Endovascular Devices, 36; value: Gene Arrays, 39; value: Inhaled Insulin, 40; value: Imaging the Microvasculature, 41; value: General Discussion of the Nature of Medical Innovation, 43; value: 4 SOURCES AND SUPPORT OF MEDICAL DEVICES INNOVATION 47; value: An Overview of Public and Private Factors Affecting Medical; value: Device Innovation, 47; value: The Federal Research Role, 49; value: The Federal Regulatory Role, 50; value: The Academic Role in Innovation, 51; value: The Academic Health Center Environment, 52; value: The Role of Small Medical Companies, 54; value: The Role of Large Medical Companies, 54; value: The Role of Public and Private Capital, 56; value: General Discussion of Sources and Support of Medical Device; value: Innovation, 57; value: 5 THE CHALLENGES AHEAD 61; value: Unmet Clinical Needs: Cardiovascular Disease, 61; value: Unmet Clinical Needs: Clinical Trials, 63; value: Barriers and Issues in Device Innovation: Reimbursement, 64; value: General Discussion of the Challenges Ahead, 65; value: 6 SUMMARY AND CONCLUSIONS 69; value: APPENDIXES; value: A Workshop Agenda, 71; value: B Speakers' Biographical Sketches, 77; value: C Registered Participants, 89.