Article | 10/1/2023

Where Is the Value in Breakthrough Designation?

Market Pathways
By Trisha Eustaquio, Parexel; Darcy Krzynowek, Health Advances; Russ Rapaport, Health Advances

The true impact of Breakthrough Device designation may not actually be from working more closely with the FDA. Experts from Health Advances and Parexel discuss a quantitative analysis and the experiences of several device companies with the Breakthrough process, highlighting benefits beyond a smoother regulatory path.

Read here.