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.

Format:

Book

Contributor:

Hanna, Kathi E.

Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.

Series:

Compass series (Washington, D.C.)

Compass series

Language:

English

Subjects (All):

Medical instruments and apparatus--Congresses.

Medical instruments and apparatus.

Medical innovations--Congresses.

Medical innovations.

Physical Description:

1 online resource (112 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 2001.

Language Note:

English

Summary:

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Contents:

""Innovation and Invention In Medical Devices""; ""Copyright""; ""Preface""; ""Contents""; ""1 Introductory Overview ""; ""OVERVIEW""; ""CHALLENGES TO INNOVATION""; ""REGULATORY ISSUES""; ""PAYMENT ISSUES""; ""VALUE AND CONSEQUENCES FOR INNOVATION""; ""CONCLUSIONS""; ""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""""GENERAL DISCUSSION OF THE KEYNOTE SESSION""; ""3 The Nature of Medical Innovation ""; ""THE INNOVATIVE PROCESS FOR MEDICAL DEVICES: A NASA PERSPECTIVE""; ""Medical Device Case Studies""; ""Cardiac Monitor""; ""Heart Imaging System""; ""Heart Assist Pump""; ""Telemedicine Instrumentation Pack""; ""Pill Telemetry Technologies""; ""Benefits of the NASA Process""; ""ENDOVASCULAR DEVICES""; ""GENE ARRAYS""; ""INHALED INSULIN""; ""IMAGING THE MICROVASCULATURE""; ""GENERAL DISCUSSION OF THE NATURE OF MEDICAL INNOVATION""

""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""; ""GENERAL DISCUSSION OF SOURCES AND SUPPORT OF MEDICAL DEVICE INNOVATION""; ""5 The Challenges Ahead ""; ""UNMET CLINICAL NEEDS: CARDIOVASCULAR DISEASE""

""UNMET CLINICAL NEEDS: CLINICAL TRIALS""""BARRIERS AND ISSUES IN DEVICE INNOVATION: REIMBURSEMENT""; ""GENERAL DISCUSSION OF THE CHALLENGES AHEAD""; ""6 Summary and Conclusions ""; ""Appendix A Workshop Agenda Roundtable on Research and Development of Drugs, Biologics, and Medical Devices""; ""AGENDA""; ""Opening Session""; ""Keynote Session""; ""Session I: The Nature of Medical Innovation""; ""Session II: Sources and Support of Medical Device Innovation""; ""Session III: The Challenges Ahead""; ""Summary and Conclusions""; ""Appendix B Speakers' Biographical Sketches ""

""Appendix C Registered Participants ""

Notes:

Description based upon print version of record.

Includes bibliographical references.

ISBN:

0-309-18320-0

1-280-18409-4

9786610184095

0-309-56588-X

OCLC:

748530719