Epidemiologic Studies of Medical Devices

With the technological transformation of healthcare, medical device epidemiology and outcomes research is becoming a hugely important scientific discipline. The diversity and complexity of medical devices and their impact on healthcare efficiency are hard to underestimate. This chapter focuses on global approaches to device regulation and recent methodologic developments. Diffusion of devices into practice and use in real-world settings led to recognition of “real-world evidence” as an important approach to device evaluation. Simultaneously, as most device performance concerns are related to long-term outcomes, there is an important focus on data linkages to create research networks leveraging real-world data. The chapter discusses the main challenges faced by device researchers, including device exposure assessment due to lack of unique device identifier implementation in practice; related population-level exposure uncertainty due to limitations of currently available datasets; and, when data are available, issues with comparative assessments and the need to develop advanced methodologies when working with imperfect data, including confounding in real-world settings, gaps in long-term outcome data, and sources of variations such as patient, device, and surgeon/interventionist. The chapter offers a framework and potential solutions to these challenges.