"Frank Antagonism to Patterned Organization": Medical Technology, Professional Power, and the Development of US Medical Device Regulation, 1950-1976.

Abstract

New medical devices and diagnostic tools dramatically expanded the capabilities of modern medicine in the late twentieth century. Nevertheless, many contemporary commentators argue that American medical devices receive insufficient regulatory scrutiny and often pose significant safety risks. This article probes the foundations of US medical device regulation by analyzing the technoscientific practices of physicians and engineers who designed or regulated medical technologies. Studying this history through the lens of professional power dynamics reveals the medical profession as one of the primary power brokers in device ecosystems. Physicians used their collective status and influence as medical experts to shape the legislation governing medical technology and oppose policies threatening their professional autonomy. Situating conversations about device regulation in the historical and sociological literature on professionalization demonstrates the salience of physicians' professional power in creating the modern regulatory environment.