This article is an excerpt from a blog post originally published on biodesignalumni.com
In his role as president and CEO of the Medical Device Manufacturers Association (MDMA), Mark Leahey admits that he sometimes feels like the grim reaper.
However, the Washington, D.C. native said he is actually an optimist about the future of the medical device industry. One of the reasons for his optimism is a recent FDA effort of enhanced transparency and accountability led by Christy Foreman, Director of the Office of Device Evaluation (ODE) at the FDA.
Last month, Biodesign alumni sat down with Leahey and Foreman to discuass their work, challenges, and opportunities for help.
In this blog post, Leahey and Forman provide some critical advice for small companies looking to interact with the FDA, as well as addressing some of the mistakes industry has made regarding its dealings with the watchdog agency in the past.
Check out the full post on the Biodesign Alumni blog.
Pedram Afshar, MD PhD is a Senior Scientist with Medtronic’s Neuromodulation group, and was the 2009-2010 Biodesign Innovation Littlefield Fellow. He currently serves as CFO for the Stanford Biodesign Alumni Association.
