Exploring Breakthrough Device Designation

August 25, 2023


In this episode of the Global Medical Device Podcast, 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.

Listen now to 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 understand the planning and considerations for success, and how innovation can thrive within regulation.

Listen now:

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Some of the highlights of this episode include:

  • The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.

  • Planning for FDA Submission, and how to align with FDA timelines.

  • Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.

  • Whether or not it's worth pursuing Breakthrough Designation.

  • The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).


Memorable quote:

"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."

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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