Kathryn Capanna has over 20 years of experience in medical device innovation and evaluation. She serves as Associate Office Director for Strategic Development within FDA CDRH’s Office of Strategic Partnerships and Technology Innovation (OST). In that role, she is dedicated to building and sustaining productive partnerships and programs to drive more equitable and patientcentered MedTech innovation, evaluation, access, and care.

At FDA, Kathryn has led many cross-functional teams to design, build and operate a broad
portfolio of strategic programs to advance innovation and protect patient safety. This includes significantly expanding CDRH’s involvement in public-private consortia and other strategic partnerships tackling challenges facing the medtech ecosystem. While at FDA, she has led and supported strategic initiatives and policy development around Clinical Trials Innovation, advancing use of Real-World Evidence, and improving diversity in medical device clinical research and product development.

Prior to FDA she worked in MedTech industry and academic research environments. Kathryn’seducation includes biomedical engineering at the University of Pittsburgh, public health through Johns Hopkins, and a healthcare MBA from George Washington University.