Summary: Children’s National Hospital and the FDA are collaborating on a five-year initiative to develop regulatory science tools for pediatric and perinatal medical devices, aiming to advance innovation and improve healthcare outcomes.

Key Takeaways:

  • Innovative Collaboration: The partnership focuses on creating open-source tools, such as pediatric brain and skull datasets, to support medical device innovation.
  • Reducing Barriers: By providing shared resources and reducing R&D costs, the initiative seeks to accelerate the development of pediatric and perinatal medical devices.

Children’s National Hospital and the U.S. FDA’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.

Addressing Challenges in Pediatric and Perinatal Device Testing

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.

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Developing Comprehensive Pediatric Brain and Skull Toolsets

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,” said Kolaleh Eskandanian, PhD, MBA, 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.”

Building on Children’s National’s Expertise in Pediatric Innovation

The collaboration builds on Children’s National’s expertise, which includes over a decade of pediatric innovation and its extensive 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,” said Eskandanian.