#333: Exploring Breakthrough Device Designation

Global Medical Device Podcast powered by Greenlight Guru

Aug 25 2023 • 35 mins


In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain.

Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.

Some of the highlights of this episode include:

  1. The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.
  2. Planning for FDA Submission, and how to align with FDA timelines.
  3. Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.
  4. Whether or not it's worth pursuing Breakthrough Designation.
  5. The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).


"Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you."

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