Early Feasibility Studies (EFS) Round Table

This MDIC webinar on EFS brought together a diverse group of stakeholders to discuss how the program is expanding into electrophysiology (EP) device development. Since its inception over a decade ago, the EFS program has successfully facilitated the development of innovative medical devices within the U.S., particularly in the structural heart space. This event marked an important step towards replicating that success in EP, and it underscored the value of collaboration across sectors. Representatives from the FDA, MDIC, clinical sites, and industry shared insights on best practices and challenges in the early stages of medical device trials, emphasizing the importance of early communication with the FDA and strategies for streamlining clinical trial processes.

The speakers also addressed ways to overcome logistical barriers, such as slow site approvals and budget constraints. Strategies included engaging startup specialists, processing approvals in parallel, and leveraging MDIC’s resources, like the EFS toolkit, to navigate the regulatory landscape. Looking forward, MDIC plans to continue supporting the EP field by expanding OUR Clinical Site Network to enhance site readiness and improve access to EFS resources.

This insightful webinar is a must-watch for anyone involved in medical device development or interested in learning about the practical aspects of bringing groundbreaking technology to patients. Catch up on the conversation to see how MDIC’s EFS initiative is paving the way for faster and more effective trials in the EP space.

Moderators: Pete Weiss, MD and Vivek Reddy

MD Panelists: Devi Nair, MD, Andrew Farb, MD, Hetal Odobasic, Olav Bergheim, and Eileen Mihas