FDA and Children's National Team Up to Innovate Pediatric Medical Devices

Children's National Hospital has partnered with the FDA to tackle the long-standing challenges of developing medical devices specifically for pediatric patients, a market that lags behind adult-focused innovation by at least a decade. The collaboration will leverage de-identified clinical data, multimodal imaging, and machine learning to create open-source regulatory science tools, including in silico trials, to enhance the predictability of device performance and safety. This initiative is critical in addressing the limited datasets and lack of incentives that currently hinder pediatric device development, leading to widespread off-label use and safety concerns.

The partnership's initial focus will be on creating accurate pediatric brain tumor models to replace animal testing and improve neuromodulation and diagnostic tools, such as non-invasive methods to measure intracranial pressure. By improving clinical validation and reducing the dependence on large datasets, these tools will enable more efficient and confident transitions of devices from development to first-in-human use. This effort seeks to close the gap in pediatric device innovation and ensure safer, more effective treatment options for young patients.