The University of Michigan won a 2-year $2.2 million award from the FDA to support more than 40 ongoing projects aimed at developing medical devices for children.
"This award will give us a great opportunity to meet our vision of creating a long-term sustainable effort in pediatric device development under the umbrella of the U-M Medical Innovation Center," pediatric surgeon Dr. James Geiger said in prepared remarks. "We are humbled to receive this award."
Pediatric devices are a particular challenge for the industry and a focus of FDA efforts in recent years, according to the U. of Mich. press release.
Pediatric devices traditionally take a long time to reach the market, which is so small that it can be difficult to gather clinical data require for FDA approval. Pediatric devices lag about 10 years behind comparable adult devices.
While the market is estimated at around $90 billion, demand for the devices is small, giving little incentive for companies to invest in the research.
Physicians attempting to work around the problem by adapting adult devices to fit children risk using devices, like catheters or stents, that are simply too large, or facing battery depletion in pacemakers because children’s hearts beat faster, according to the university.
The FDA award will go toward three projects in particular: a device that induces intestinal lengthening without surgery for children with short bowel syndrome; a palatal expander for children with cleft palate; and a non-clotting catheter for use in newborns.
The grant was shared between the University’s Pediatric Device Consortium, which ties together business, engineering, dental and medical school resources to develop children-specific devices, and Virginia-based Pediatric Medical Device Institute, a consortium of children’s hospitals with the task of turning pediatric needs into clinical tools.