Assisted by a congressional mandate, the FDA has taken a new approach to helping clinical innovators overcome barriers to moving pediatric medical devices from the research stage to commercialization. So says Linda Ulrich, MD, director of the Pediatric Device Consortia Grant Program at the FDA’s Office of Orphan Products Development, who recently spoke at an Innovators’ Forum cosponsored by her office and Boston Children’s Hospital’s Innovation Acceleration Program.

Regulation and reimbursement are the largest barriers to medical device innovation. “The time it takes to develop a medical device and get it to the U.S. market can take a range from 18 months to 10 years,” says Ulrich.

The stages of device development are concept, prototype, preclinical and clinical testing, manufacturing and marketing—only for the device to become obsolete within as little as 18 months after commercialization. Inventors need to consider the return on investment after their products receive regulatory approval, given the time and funding it takes to get them to market, says Ulrich. …