Medical Device Epidemiology

Course Aim
Over the past few years, there has been increased focus on generating real-world evidence for medical products. Thus, observational studies of medical products 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. Methods discussed will be applicable across therapeutic products and provide deeper understanding of the current regulatory and clinical context of medical device epidemiology.

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.

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

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

Syllabus Outline
Topics:
Overview of medical device epidemiology study design and methods — Mary Beth Ritchey
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.

Examples in medical device epidemiology — Christina Mack & Mackenzie Herzog
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.

Recent advances in medical device real-world evidence — David Maislin
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 medical device safety and effectiveness will be provided.

Future of medical device epidemiology — Paul Coplan
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.

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