From Academia to FDA Clearance (True Quality Roadshow - Boston)

September 14, 2023

GMDP Ep 336

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.

Listen now:

Like this episode? Subscribe today on iTunes or Spotify.

Some of the highlights of this episode include:

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


Memorable quote:

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

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...

Search Results for:
    Load More Results