Coverart for item
The Resource 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, (electronic resource)

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, (electronic resource)

Label
Innovation and invention in medical devices : workshop summary
Title
Innovation and invention in medical devices
Title remainder
workshop summary
Statement of responsibility
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
Contributor
Subject
Language
eng
Member of
Cataloging source
OUN
Dewey number
681/.761
NLM call number
  • 2002 B-639
  • WB 26
NLM item number
I58 2001
http://library.link/vocab/relatedWorkOrContributorName
  • Hanna, Kathi E
  • Institute of Medicine (U.S.)
Series statement
Compass series
http://library.link/vocab/subjectName
  • Equipment and Supplies
  • Diffusion of Innovation
Label
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, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references
Contents
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
Control code
OCM1bookssj0000179470
Dimensions
unknown
Isbn
9780309082556
Lccn
2002265224
Specific material designation
remote
System control number
(WaSeSS)bookssj0000179470
Label
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, (electronic resource)
Publication
Bibliography note
Includes bibliographical references
Contents
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
Control code
OCM1bookssj0000179470
Dimensions
unknown
Isbn
9780309082556
Lccn
2002265224
Specific material designation
remote
System control number
(WaSeSS)bookssj0000179470

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