ARTICLE SUMMARY:
Former leaders of CDRH want to take the thinking behind the device center's TAP program into the venture capital world. Longtime center director Jeff Shuren is joining former CDRH Chief Scientist Douglas Kelly and others to launch White Oak 66 Capital, seeking to combine medtech investing with a heavy focus on helping firms proactively address reimbursement and other post-FDA commercialization risks.
Jeff Shuren and several former colleagues at CDRH are co-founding a new medtech venture fund, aiming to leverage their expertise and contacts in the broader market access ecosystem to help firms avoid pitfalls that often arise following FDA authorization.
Shuren, the longtime device center director, is launching White Oak 66 Capital with Doug Kelly, who was CDRH deputy director and chief scientist, Ross (Rusty) Segan, who briefly ran the Office of Product Evaluation and Quality, and Joel Brill, a medtech reimbursement expert who consulted on the center’s TPLC Advisory Program (TAP) pilot. The firm was planning to publicize its launch April 8 at MedTech Innovator’s Radar Forum in Manhattan Beach, CA.
