A former surgeon and the current president and chief executive officer of Children’s National Hospital shares with Stat why the development and commercialization of medical devices for children lags significantly behind that of adults, and what can be done about it.
The SHIP-MD initiative aims to close the gap in the development of medical devices for children by removing the risk for developers and manufacturers and by accelerating the process to get safe devices to the market.
I and others are looking to this work for reforms in three key areas of pediatric device development:
- Designate all pediatric devices as breakthrough devices, which would allow the FDA a flexible approach to expedite submission review.
- Create clinical trial networks that would reduce costs for trial sites and assist in the recruitment of patients.
- Build upon the FDA’s Pediatric Device Consortium by allowing SHIP-MD to serve as a pediatric-specific review team for medical devices, removing some of the risk for developers of the devices.
To “walk the walk,” Children’s National Hospital is elevating its commitment to innovation in pediatric medical devices with a phased opening of the nation’s first research and innovation campus dedicated to pediatrics.
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