Opportunities and Gaps in Real-World Evidence for Medical Devices

While medical devices play a critical role in patient care, there remain critical gaps in our ability to evaluate their safety and effectiveness. In 2016, the National Evaluation System for health Technology Coordinating Center (NESTcc) was launched by MDIC through a grant from the U.S. Food and Drug Administration Centers for Devices and Radiological Health to tap into the growing availability of real-world data collected routinely across the healthcare system to support the use of real-world evidence to evaluate medical devices. NESTcc is compiling the first version of a “living” landscape analysis of best practices and promising methods to encourage the use of real-world data across the medical device ecosystem. This work builds on the past and ongoing work of FDA, the Planning Board, the Registry Taskforce, and many other stakeholders and experts, and is intended to evolve as methods and data improve.

Under a cooperative agreement with FDA, the Duke-Robert J. Margolis, MD, Center for Health Policy convened an expert workshop in order to solicit multiple stakeholders’ feedback on NESTcc’s ongoing landscape analysis regarding: 1) the background research process and planned next steps, including potential topic area expansion; 2) the use of real-world evidence throughout the total product lifecycle; 3) the current gaps in real-world evidence generation; and 4) the identification of key stakeholder priorities.

Funding for this conference was made possible in part by a cooperative agreement with the Food and Drug Administration, Center for Drug Evaluation and Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.