Combination Product Industry News & Guidance

And then there were three…Former FDA Reviewers on the Suttons Creek Team

Suttons Creek’s recent hire, Courtney Evans, puts the company’s count for regulatory experts who came directly from the FDA’s Reviewer pool to three.  

“We are beyond happy to share the news that three of the FDA’s most talented Reviewers have taken next steps in their careers with Suttons Creek,” says Suttons Creek CEO and Founder, Steven Badelt, PhD. “Not only can we tap into their insider knowledge and regulatory expertise to set our internal processes and strategies for fastest-time-to-market compliance, but they can also be assigned directly to client projects.” 

Courtney has over eight years of experience in medical device and drug delivery development and regulation, four of which were spent at the FDA as a Reviewer and Team Leader of injection device combination products. They began their combination product career as a test/quality engineer, supporting medical device programs and process improvement initiatives and, while at the FDA, Courtney was actively involved in policy development of connected “smart” drug delivery devices, on-body delivery systems, emergency-use injectors, and implantable infusion pumps. 

They will be reporting directly to SCI’s Technical Director and former FDA colleague Carolyn Dorgan, Carolyn has over ten years of experience in the Medical Device and Combination Product industries, including 6 years at the FDA leading the Infusion Devices team. Carolyn is active in the international regulatory community through speaking engagements and has participated in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. 

Also on Carolyn’s consultant team is Principal Consultant Max Lerman, PhD, who spent over three years at the FDA as a member of the infusion devices team. Max has deep experience in developing and setting review practices for infusion, life-critical drug delivery, and electroporation systems from his time at the FDA, as well as his experience developing and maintaining electrocautery platforms at Medtronic and serving as a member of AAMI ID and IP infusion pump committees.  

Our company is excited about the regulatory strength these three former FDA Reviewers will bring to our clients. Visit https://suttonscreek.com/combination-product-experienced-specialists/ to learn more about our former FDA trio and our other combination product specialists. Contact us at [email protected] to tap into their expertise!