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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.

Contributor(s): Hanna, Kathi EMaterial type: TextTextSeries: Compass series (Washington, D.C.)Publication details: Washington, D.C. : National Academy Press, 2001. Description: 1 online resource (xx, 92 pages) : illustrationsContent type: text Media type: computer Carrier type: online resourceISBN: 030956588X; 9780309565882Subject(s): Medical instruments and apparatus -- Congresses | Medical innovations -- Congresses | Analytical, Diagnostic and Therapeutic Techniques and Equipment | Communication | Publication Formats | Publication Characteristics | Information Science | Equipment and Supplies | Diffusion of Innovation | Diffusion of Innovation | MEDICAL -- Allied Health Services -- Medical Technology | Medical innovations | Medical instruments and apparatusGenre/Form: Congress. | Electronic books. | Electronic resource. | Conference papers and proceedings. Additional physical formats: Print version:: Innovation and invention in medical devices.DDC classification: 681/.761 LOC classification: R856.4 | .I56 2001ebNLM classification: 2002 B-639 | WB 26Online resources: Click here to access online
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.
Action note: digitized 2010 committed to preserveSummary: 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.
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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.

Print version record.

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Electronic reproduction. [Place of publication not identified] : HathiTrust Digital Library, 2010. MiAaHDL

Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. MiAaHDL

http://purl.oclc.org/DLF/benchrepro0212

digitized 2010 HathiTrust Digital Library committed to preserve pda MiAaHDL

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.

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