Children’s National, FDA collaborate to advance pediatric device regulatory tools

In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) have signed a five-year research collaboration agreement to develop regulatory science tools (RSTs) intended to assist in the technical evaluation of pediatric and perinatal medical devices. 

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

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, helping innovators to design and test their devices more efficiently.

“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,” says 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.”

The collaboration builds on Children’s National’s extensive expertise, which includes over a decade of leadership in pediatric innovation and its robust network of physicians and researchers. “We are excited to contribute our expertise in research and innovation, particularly in data analytics, to support the development of these regulatory science tools,” Dr. Eskandanian says.

The initiative exemplifies the commitment of Children’s National to ensuring that children benefit from the latest advances in medical technology. This collaboration marks a major step forward in addressing the unmet needs of pediatric and perinatal populations, providing new hope for children in need of advanced medical care.