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.