The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices – FDA Watch
In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, and Associate Research Professor at Rutgers University; and Cori Maegley, Vice President of Partnerships Management at the National Evaluation System for health Technology (NEST), a Medical Device Innovation Consortium initiative. Together, they discuss how real-world evidence (RWE) applies to medical devices; where RWE for medical devices comes from; what CDRH can learn from CDER and CBER about using RWE and vice versa; examples of real-world application of real-world evidence in devices; how FDA’s approach to RWE compares to other countries; how companies determine how much they rely on RWE and how CDRH is collaborating to help companies make those decisions; what makes RWE reliable enough for regulatory use and the importance of data quality; how AI plays into RWE for devices; and much more.
This episode and the rest of our series do not include the usual Headlines segment.
About Our Guests
Dr. Mary Beth Ritchey
Mary Beth Ritchey is a part-time Associate Research Professor at PETS where she conducts pharmacoepidemiology research, teaches, and mentors students/fellows in pharmacoepidemiology methodology. Outside of PETS, she is the Principal and Owner of Med Tech Epi, LLC where she conducts strategic evidence generation planning and analysis of health care databases for regulatory decision-making under contract with pharmaceutical and medical device clients.
Dr. Ritchey is an innovative and dynamic epidemiologist with over 15 years “real-world evidence” observational research experience across government, industry, and academia in study design and implementation. She is adept with scientific, technical, and logistical aspects of conducting regulatory-grade feasibility, utilization, safety, and effectiveness studies of medical products. Dr. Ritchey is experienced leading international multi-stakeholder teams for research, strategic planning and coordination of scientific programming, agenda-setting, and decision-making. She has proficiency in garnering efficiency in a continuous learning environment, specifically medical product safety and real-world evidence, through review of research processes and clarification of stakeholder needs.
Dr. Ritchey is a Fellow of in the International Society of Pharmacoepidemiology (ISPE), Associate Editor for Pharmacoepidemiology and Drug Safety (PDS) and serves on the Executive Operations and Scientific Oversight Committees for the Medical Device Epidemiology Network (MDEpiNet) public private partnership with FDA.
Cori Maegley
Cori Maegley is currently the Vice President of Partnerships Management at the National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium. In this role, Cori leads development of the NEST Medical Device Real World Evidence Marketplace, manages the NEST Research Network, and drives additional essential strategic partnerships to further the mission of NEST and advance the adoption of real-world evidence (RWE) to improve medical device evaluation and regulatory decision-making.
Prior to joining NEST in the fall of 2023, Cori spent 25 years in the medical device industry in multiple companies ranging from early-stage startup to Fortune 500, and in a variety of roles including Product Development, Marketing, Sales, Business Development, Enterprise and Value-based Healthcare Partnerships, and Healthcare Consulting.
Cori is a veteran of the United States Air Force and holds a Bachelor of Science in Mechanical Engineering from Rensselaer Polytechnic Institute, a Master of Science in Mechanical Engineering from George Washington University, and a Master of Business Administration from The Wharton School at the University of Pennsylvania.
