The FDA awarded seven grants totaling more than $3.5 million to pediatric device consortia to help boost development and availability of pediatric medical devices, according to an agency press release.
Gayatri R. Rao
“These consortia are part of FDA’s commitment to medical product innovation in areas of unmet medical need and will support pediatric medical device progression through all stages of development — concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization,” said Gayatri R. Rao, MD, director of the FDA’s Office of Orphan Product Development. “At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device products.
The recipients are:
- James Geiger, MD, of the University of Michigan Pediatric Device Consortium;
- David Ku, MD, PhD, of the Atlantic Pediatric Device Consortium;
- Peter Kim, MD, of the National Capital Consortium for Pediatric Device Innovation;
- Rick Greenwald, PhD, of the New England Pediatric Device Consortium;
- Yaniv Bar-Cohen, MD, of the Southern California Center for Technology and Innovation in Pediatrics;
- Matthew Maltese, MS, PhD, of the Philadelphia Regional Pediatric Medical Device Consortium; and
- Pedro del Nido, MD, of the Boston Pediatric Device Consortium.
Device developers deal with many challenges, including variation of child size, growth and body chemistry. The program is intended to help develop devices for all pediatric diseases, according to the release.
Awardees will encourage development and lead qualified individuals to potential manufacturers; mentor and manage device projects through development; point innovators and physicians to existing resources, federal and non-federal; and assess medical and scientific merit of proposed devices.