The Regulation of Medical Device Representatives: A Question of Trust?

Abstract

The introduction of new technologies in medical treatment has led to innovation in medical devices that are highly technical in their application and operation. The medical technology landscape is changeable and healthcare providers often turn to the medical device representatives (MDRs), employed by device manufacturers to help navigate the shifts and uncertainties. While the relationship between MDRs and healthcare providers can be a positive one focusing on appropriate use, selection and safety of devices, it is one that has evolved over time and is not independently regulated. In addition, patients, for the most part, are usually unaware of the involvement of MDRs in their healthcare. It is this knowledge gap with regard to the role of MDRs that is the focus of this paper. We argue that trust is at the heart of healthcare relationships and explore the nature of trust alongside the models of regulation of the medical device industry. We argue that MDRs may currently present a threat to both the interpersonal and the institutional trust of patients, and that regulation and policy responses are appropriate ways to address this risk. We consider potential regulatory frameworks and identify transparency and communication as the crucial characteristics of an appropriate response. We recommend that the polycentric nature of Australian healthcare regulation be cultivated through a multilayered approach, and that a positive obligation to inform the patient of the role of MDRs in their clinical care be established.

Keywords

• medical devices
• medical device representatives
• healthcare
• trust
• regulation