Managing the Medical Arms Race: Policy and Medical Device Innovation

Abstract

As the technology of health care has grown in significant amount and cost, its most publicly visible feature has been its machines and materials, called, in the language of regulation, medical devices. They are the subject of this volume. Susan Bartlett Foote has done fine work in presenting the story of how medical devices, developed through research funding and manufacture, are brought to the marketplace and regulated in use. She discusses the principal institutions behind these events: the National Institutes of Health, the medical device industry, and government agencies, such as the Food and Drug Administration, the Health Care Financing Administration, and the courts. The battle between the forces of innovation and regulation is played out on these pages. Described are the cases of computed tomographic scanners, pacemakers, intrauterine devices, heart valves, and so forth. The book then provides in one place a splendid source of brief histories of major