The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices

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. To subscribe or find out more information about our podcast, visit FDAWatch.net (http://www.fdawatch.net/) . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net (mailto:info@fdawatch.net) . Music by Dvir Silver (https://pixabay.com/users/sonican-389...) from Pixabay (https://pixabay.com/music/?utm_source...) .