#336: From Academia to FDA Clearance (True Quality Roadshow - Boston) - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers

from 2023-09-14T15:30

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Description:

In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.

Some of the highlights of this episode include:

  1. Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.
  2. Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.
  3. Building a quality-centric culture from day one to set the tone for long-term success in the MedTech space.
  4. How building a startup is akin to fixing a plane mid-flight – it's challenging but passion and clarity make it feasible.
  5. Tailoring communication, and how suiting it to the listener's background can be the game-changer in understanding and collaboration.

Quote:

"Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-Bensinger

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