Doctor's Domain: Innovation and Regulation in the U.S. Medical Device Industry, 1950-2000

Abstract

This dissertation examines the role of physicians in shaping the development and regulation of medical technologies in the United States during the second half of the twentieth century. I argue that physicians became the dominant actors in the medical technology sector by using their preexisting professional prestige to assert the primacy of clinical knowledge and promote a culture of tinkering in private sector research and development. In contrast, the nascent profession of biomedical engineering could not effectively compete for status and influence. By analyzing the professional conflicts between physicians, biomedical engineers, and other stakeholders in the regulatory system for medical devices that emerged during and after Congress enacted the Medical Device Amendments of 1976, this dissertation explores the role of perceived expertise and scientific legitimacy in shaping regulatory policy, business organization, and other social structures that facilitate technological innovation.