附註:Includes bibliographical references.
1. Introductory Overview -- 2. Keynote Session. Historical Perspective on IOM's Role in Providing a Forum for Discussion. A Regulatory Perspective. An Industry Perspective: Challenges in the Development and Regulation of Drug-Device Combination Products. An Evaluator's Perspective. Innovation and Invention in Medical Devices: Implantable Defibrillators -- 3. The Nature of Medical Innovation. The Innovative Process for Medical Devices: A NASA Perspective. Endovascular Devices. Gene Arrays. Inhaled Insulin. Imaging the Microvasculature -- 4. Sources and Support of Medical Devices Innovation. An Overview of Public and Private Factors Affecting Medical Device Innovation. The Federal Research Role. The Federal Regulatory Role. The Academic Role in Innovation. The Academic Health Center Environment. The Role of Small Medical Companies. The Role of Large Medical Companies. The Role of Public and Private Capital -- 5. The Challenges Ahead. Unmet Clinical Needs: Cardiovascular Disease. Unmet Clinical Needs: Clinical Trials. Barriers and Issues in Device Innovation: Reimbursement -- 6. Summary and Conclusions.
摘要:Material from a recent workshop is summarized here, examining the nature of innovation in the field and the social and economic infrastructure that supports innovation and invention in medical devices, identifying unmet clinical needs, and considering barriers to the application of new technologies to meet clinical needs.
