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.

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.

Equipment and Supplies.

Diffusion of Innovation.

Medical Subjects:

Equipment and Supplies.

Diffusion of Innovation.

Genre:

Conference papers and proceedings.

Physical Description:

xx, 92 pages : illustrations ; 23 cm.

Place of Publication:

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

Contents:

Challenges to Innovation 2

Regulatory Issues 3

Payment Issues 4

Value and Consequences for Innovation 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

Inhales 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.

Notes:

Includes bibliographical references.

ISBN:

0309082552

OCLC:

48528858