Medical Device Epidemiology

‎1. Course Aim ‎
Medical devices are used extensively within both branches of healthcare: medicine and surgery. In surgery, ‎medical devices are used as instruments (e.g., cutters, staplers, catheters and sutures) or implants (e.g.,, ‎cardiovascular stents, hip or knee replacements). Increasingly, surgeries also use digital tools to guide, plan ‎and navigate procedures. Wearable digital medical devices may be used before and after surgeries to ‎improve patient outcomes and reduce healthcare utilization. Other examples of medical devices are ‎contact lenses, X-ray machines, pacemakers, and both traditional laboratory diagnostics (e.g., lateral ‎flow assays) and artificial intelligence-enhanced imaging readers.‎

The study of the safety and effectiveness of medical devices using real world data (RWD) and epidemiologic ‎methods is a rapidly expanding and developing field. Thus, studies of medical products using RWD are ‎gaining visibility outside of ISPE. Medical device epidemiology uses methodologies similar to those for ‎medicines. However, alternative strategies are often implemented due to the nature of the products, data ‎sources, and situational use. With the changing regulatory and reimbursement environments, it is more ‎important than ever for pharmacoepidemiologists to better understand the methods and practice of medical ‎device epidemiology, both for study of medical devices and combination products of ‎pharmaceuticals/biologics with medical devices. ‎

This course provides a foundation for medical device epidemiology and its current applications in actual ‎clinical practice. It will comprise a 3.5-hour, live session of didactic lectures and live discussion of current and ‎future issues. The instructors of the course have extensive experience in medical device epidemiology, ‎including work at the US FDA, industry and in academia. Information in the course will span entry-level and ‎intermediate topics in medical device epidemiology. Methods discussed will be applicable across therapeutic ‎products and provide deeper understanding of the current regulatory and clinical context of medical device ‎epidemiology.‎

‎2. Requisites Statement ‎
Entry level course. Topics covered will span entry-level, intermediate, and advanced topics in epidemiology.‎

‎3. Course Objectives‎

‎1.‎ Explore methodologic and data source considerations of research involving medical devices and ‎combination products ‎
‎2.‎ Recount real-world examples of medical device epidemiology, in the context of comparative ‎effectiveness research ‎
‎3.‎ Examine the dynamic regulatory environment for medical devices and how it differs from ‎medications ‎
‎4.‎ Discuss the science of patient input in medical device research
‎5.‎ Learn about real-world medical devices and combination products in an interactive forum ‎

‎4. Syllabus Outline‎

Topics:‎
‎1. Overview of medical device epidemiology study design and methods
Students will be introduced to the language and regulation of medical devices and combination products. ‎
Discussion will include conceptual methods and study designs applicable to medical device epidemiology, ‎including identification of exposures, comparators, and outcomes; assessing provider effects and learning ‎curves; and biases specific to epidemiology of medical devices. Emphasis will be placed on regulatory studies ‎related to the role of epidemiologists.‎

‎2. Examples in medical device epidemiology
Students will learn about the practicalities of designing studies, using RWE from diagnostics and patient-‎generated data, and implementing analyses in medical device epidemiology. Case examples will be ‎presented related to novel COVID-19 diagnostics, injury prevention, and orthopedic devices.‎

‎3. Recent advances in medical device real-world evidence methods
Students will be introduced to current challenges and recent enhancements to evaluating real-world ‎evidence and differences between the epidemiologic study of medicines and devices. Specific examples of ‎medical device surveillance and leveraging available data to better understand safety and effectiveness of ‎therapeutic and diagnostic medical devices will be provided.‎

‎4. Future of medical device epidemiology
Students will hear about cutting-edge study design and analysis needed to address safety and effectiveness ‎research questions related to state-of-the art novel medical devices (e.g., robotic surgery). Additionally, ‎students will learn about needs for the future and what epidemiologists should be learning today to be ‎successful medical device real-world evidence researchers tomorrow.‎

‎5. Design a study
Interactive group discussion of topics to be considered when designing a medical device epidemiology study.‎

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