Research Catalog

Innovation and invention in medical devices : workshop summary / Kathi E. Hanna [and others] 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.

Title
Innovation and invention in medical devices : workshop summary / Kathi E. Hanna [and others] 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.
Publication
Washington, D.C. : National Academy Press, 2001.

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TextRequest in advance R856.4 .I56 2001Off-site
TextRequest in advance R856.4 .I56 2001Off-site

Holdings

Details

Additional Authors
  • Hanna, Kathi E.
  • Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. http://id.loc.gov/authorities/names/no99081645
Description
xx, 92 pages : illustrations; 23 cm.
Series Statement
Compass series
Uniform Title
Compass series (Washington, D.C.)
Subjects
Genre/Form
Congress.
Bibliography (note)
  • Includes bibliographical references.
Funding (note)
  • Support for this project was proveded by the U.S. Department of Health and Human Services and the Greenwall Foundation.
Contents
  • 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.
ISBN
0309082552
Owning Institutions
Columbia University Libraries