[podcast] Exciting medical device pilot program with FDA and CMS

David Filmore is the Executive Editor at Informa. In this role, David works with reporters and editors to produce daily for ‘The Gray Sheet’ – a widely read publication in the medical device and diagnostics arena, published by IBI Pharma.

David Filmore - Informa

David Filmore – Executive Editor at Informa

In this podcast, I talk to David Filmore about a joint program between FDA and CMS. The program is in a pilot stage and involves parallel review of medical devices by FDA and CMS.

By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to patients.

FDA grants market clearance for medical device companies. CMS provides reimbursement codes for medical device products. Typically medical device companies have to get clearance / review from FDA then follow up with CMS before going to market.


And getting the go ahead from both FDA and CMS are vital to success for a medical device.

In the podcast, I ask David the following questions:

  • As you know, medical device companies are anxious to bring new products to market via FDA and get product reimbursement via CMS. I recently learned that FDA and CMS have been collaborating. Can you share some insights about this?
  • FDA / CMS parallel review program sounds very promising and seems to have potential to improve overall time to market. Are you aware of any case studies / examples of medical device companies who have gone through the parallel review?
  • Creo Quality works with medical device startups and smaller companies. Do you think this FDA / CMS parallel review program can benefit these types of companies?
  • It sometimes seem like pilot programs like FDA / CMS collaboration are temporary and seldom make it into the mainstream. What do you think will happen with this program?
  • Please take a few minutes to tell the audience a bit more about your work at Informa and how to connect with you.

Click to listen to the podcast below.




Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handle Design Controls. Because of this greenlight.guru was born. You can find him on Google+Twitter, and LinkedIn.  

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