Webinar Webinar

Breakthrough Devices Program: Where’s the value?

November 7, 2023

11:00 AM - 11:45 AM


Almost a decade into the FDA’s Breakthrough Devices Program (previously the Expedited Access Pathway) and there have been 839 Breakthrough Device designations granted, as of June 30 this year. While that seems a significant number, the FDA also reports that only 81 marketing authorizations have been approved. 

Parexel’s MedTech Regulatory Strategy and Health Advances MedTech consulting teams have conducted research on the challenges and benefits of the designation and are excited to share those learnings with others in the medical device industry. 

In this webinar, a panel of regulatory experts and MedTech executives will discuss the motivation for seeking Breakthrough Device designation, experiences working with regulatory consultants and the FDA on the process, and challenges and benefits along the way.

Hear firsthand experience from medical device innovators who have been through the process. If you would like to find out more about the Breakthrough Devices Program and its potential value for your organization.

Please join our panel Darcy Krzynowek, Vice President, Health Advances (Moderator), Trisha Eustaquio, PhD, Vice President, Technical, Parexel Regulatory Strategy, John Konsin, Co-Founder & CEO, Prapela, Sean Robert Huff, MD, Vice President of Global Business Development, AI Medical Service, Satabhisa Mukhopadhyay, PhD, Founder & Chief Scientist, 4D Path,  and Sinead E. Miller, PhD, Co-Founder & CEO, PATH EX.

Meet our experts