Children’s National Hospital and the FDA have announced a five-year research collaboration to develop regulatory science tools (RSTs) for pediatric medical devices.
The collaboration aims to assist in the technical evaluation of pediatric and perinatal medical devices, addressing long-standing challenges in testing novel medical devices for these patient populations. Children’s National Hospital and the FDA’s Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) will share de-identified data and leverage advanced technologies like multimodal imaging and machine learning.
Using these technologies, the collaboration could generate data that may help inform the design and development of new pediatric and perinatal device-centered RSTs. Children’s National and the FDA are targeting the development of a toolset for describing characteristics of the pediatric brain and skull. That includes tissue-mimicking phantoms and a tissue properties database. The resources may serve as public benchmarks to help innovators design and test their devices more efficiently.
Children’s National said in a news release that the collaboration builds on its “extensive expertise” in pediatric innovation, along with its network of physicians and researchers.
“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, VP 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.”
