MDIC In the News: The Case for Real World Evidence Studies

Simon Mason, President of NEST (National Evaluation System for Health Technology), joins host Etienne Nichols on the Global Medical Device Podcast  to discuss the pivotal role of real-world evidence (RWE) in advancing medical device regulation.

During the conversation, Simon explains how NEST supports the integration of RWE into regulatory submissions, enabling MedTech companies to streamline approval processes, reduce costs, and expedite market entry. He highlights impactful examples, including pediatric devices and robotic surgery, illustrating the value of RWE in addressing post-market data and off-label use while fostering innovation and improving patient outcomes.

Simon also reflects on NEST’s evolution under the FDA’s MDUFA framework, emphasizing the organization’s collaborations with industry leaders like Johnson & Johnson and Intuitive Surgical to successfully utilize RWE in achieving FDA clearances.