FDA officials have had a mandate for a while now to spur the creation of more medical devices designed for kids, and now the agency is once again putting some serious money behind the rhetoric. Regulators gave out $3.5 million in grants to 7 research consortia around the country to spark a greater development effort.
Each group will focus on spurring the creation of more pediatric-friendly devices that address unmet needs. They'll function in part as a resource to others. Among their tasks: determining if a proposed project offers any scientific and medical benefit and advising on business development, training and postmarketing issues. Need a mentor for your pediatric device project? The consortia will offer assistance on tasks such as prototype design and marketing.
Importantly, the consortia will connect entrepreneurs with good ideas to potential manufacturers. And each group will coordinate its work with the FDA, device companies, and the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate a product's approval or clearance process. The grants themselves come through the FDA's Office of Orphan Products Development.
It's not that device companies and researchers aren't developing products with a pediatric audience in mind. Novo Nordisk ($NVO), for example, recently won FDA clearance for a new child-friendly insulin injection pen. Cincinnati Children's Hospital Medical Center and Ben-Gurion University in Israel are developing new pediatric medical devices. Children's Healthcare of Atlanta and the Georgia Institute of Technology are also well underway with a $20 million effort to develop new pediatric devices and treatments. And there are others.
But some have complained that device companies aren't moving fast enough to develop products that factor in pediatric patients. It's an ongoing issue in medicine, because children have different sizes, growth spurts and body chemistry that can reduce the safety and effectiveness of everything from imaging equipment to implants that are designed with adult patients in mind.
The FDA said this is the third time since 2009 that it has issued consortia grants focused on pediatric medical devices.
The 7 consortia are the University of Michigan Pediatric Device Consortium, the Atlantic Pediatric Device Consortium, the National Capital Consortium for Pediatric Device Innovation, the New England Pediatric Device Consortium, the Southern California Center for Technology and Innovation in Pediatrics, the Philadelphia Regional Pediatric Medial Device Consortium and the Boston Pediatric Device Consortium.
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