Children’s National, FDA Collaborate to Advance Pediatric Device Regulatory Tools

Children’s National Hospital and the U.S. FDA’s Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) have entered a five-year research collaboration agreement to develop regulatory science tools (RSTs) to assist in the technical evaluation of pediatric and perinatal medical devices.

“Through this initiative, our aim is to provide an unprecedented level of support for medical device developers by providing access to open source in silico models, datasets, and other essential resources,” said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National. “Our goal is to reduce the financial and R&D barriers to innovation in pediatric medical devices and to help develop regulatory science tools for a broader community of innovators and entrepreneurs.”

One key target for the collaboration is the development of a comprehensive toolset describing characteristics of the pediatric brain and skull, including tissue-mimicking phantoms and a tissue properties database. These resources may serve as public benchmarks to help innovators effectively design and test their devices.

This partnership aims to address long-standing challenges in testing novel medical devices for children and perinatal care. The collaboration will generate data that may help inform the design and development of new pediatric and perinatal device-centered RSTs by sharing de-identified clinical data and leveraging advanced technologies, such as multimodal imaging and machine learning.