Anita Nosratieh, Ph.D., participated in the Institute’s 2016 fellowship, part of the FDA/CDRH Innovation program where they learn about the unique challenges faced by startup companies in bringing devices to market. During her time at Fogarty, she was exposed to a variety of aspects of the medical device innovation ecosystem, including a robust educational component that allowed her to learn first-hand from startups.
“At the Institute, we were able to have these eye-opening interactions that helped us realize that few entrepreneurs have the same resources enjoyed by larger companies. It allowed us to ‘wear their hats,’ so to speak – to see all the pieces of the puzzle that we don’t have the opportunity to see from our offices and connect with the goal of bringing groundbreaking technologies to patients.”
Dr. Nosratieh returned from the two-week fellowship inspired and began engaging more frequently with the CDRH Innovation group, which she was later asked to join. Previously, Anita was a lead reviewer where she primarily oversaw mammography devices for breast cancer screening and diagnosis. It was in this field where she felt she had yet to see true innovation. She hopes her work at CDRH Innovation will enable more disruptive technologies to enter the U.S. market.
As the Fogarty Institute’s fellowship continues to gain traction and interest with the FDA/CDRH, Dr. Nosratieh hopes the momentum will keep building, allowing FDA/CDRH to integrate the lessons learned into meaningful education for other staff and reviewers with the ultimate goal of expediting patient access to safe, effective and innovative medical devices.