The US Food and Drug Administration’s (FDA) Office of Science and Engineering Laboratories (OSEL) has partnered with Children’s National Hospital to address what they describe as the “drastic innovation disparity” between adult and paediatric medical devices.
Past research by the FDA has found that more than 90% of medical devices the agency approved between 2008 and 2018 were intended for adults, with only 4% labelled specifically for paediatric use.
To address challenges associated with testing novel medical devices for children and perinatal care, the five-year research partnership will involve sharing de-identified clinical data and using technologies. These include multimodal imaging and machine learning (ML) to generate data and inform the design and development of new paediatric and perinatal device-specific regulatory science tools (RST).
A key target of the collaboration will be to develop a toolset for describing the characteristics of the paediatric brain and skull, including tissue-mimicking phantoms and a tissue properties database.
The FDA and Children’s National said this toolset is intended to help innovators design and test their devices more efficiently and that such resources may serve as a public benchmark.
Kolaleh Eskandanian, vice president and chief innovation officer at Children’s National, commented: “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.
“Our goal is to reduce the financial and R&D barriers to innovation in paediatric medical devices and to help develop regulatory science tools for a broader community of innovators and entrepreneurs.”
Last month, the Center for Devices and Radiological Health initiated a pilot centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.
Elsewhere in paediatrics, Wyoming became the first US state in September to include Cognoa’s FDA-approved Canvas Dx autism diagnostic under Medicaid. In the same month, Beacon Biosignals initiated the HEADFIRST clinical trial to assess the usability of home-based electroencephalogram (EEG) recordings in paediatric subjects with neurotypical controls and neurodevelopmental disorders.
