EPISODE 102
John McCutcheon took one on the chin in 2008 when an FDA advisory board voted against recommending approval for a promising new bronchial valve being tested by his company, Emphasys Medical.
The rejection was the nadir of relations beween Medtech and the FDA, helping to drive even more investors out of the space.
But McCutcheon took the hit. He got up and took the top spot at Ceterix Orthopedix, a start-up that had a surer path through the FDA – 510(k) – but didn’t quite have the data to demonstrate why this early-stage company could change how the meniscus is being repaired.
Yet, McCutcheon got others to believe and today Ceterix is enjoying its third nod from the FDA.
In this podcast, McCutcheon recalls the low point and shares what it takes to get back up on top.
Podcast Guest
John G. McCutcheon
President & CEO
Ceterix Orthopaedics
John McCutcheon has worked in sales, marketing, and general management in the medical device industry for over thirty years. Prior to Ceterix, Mr. McCutcheon held President and CEO roles at Emphasys Medical and then Ventus Medical. As President and CEO, Mr. McCutcheon excels at fundraising; hiring, retaining, and motivating senior executives; setting and executing corporate strategy; driving product development; managing complex clinical trials; and launching products in the U.S. and internationally. Before becoming President and CEO, Mr. McCutcheon held a variety of roles with increasing levels of responsibility at Perclose (acquired by Abbott Labs), DVI (acquired by Guidant), and Bentley Labs, a division of Baxter International. Mr. McCutcheon has managed both U.S. and international sales and marketing. Mr. McCutcheon holds Bachelor of Arts Degrees in Economics and Psychology from the University of California at Los Angeles, and a Master’s Degree in Business Administration from the UCLA Anderson School of Management.
Meet Our Host
Geoff Pardo
Geoff has been in medtech for over two decades in both operational and investment roles. He is passionate about the industry potential and sharing stories from the front lines of innovation.