FDA to Offer $2M in Pediatric Device Grants
BY LAUREN UZDIENSKI, MAY 18, 2009
The FDA is offering $2.0 million in grants to support the development of medical devices for pediatric patients. The aim of the grants is to encourage devices designed specifically for the "size, growth, development and body chemistry" characteristics of pediatric patients as well as to drive the adaptation of existing devices to suit the pediatric population.
According to the FDA, device development for children lags product development for adults by five to ten years. As we noted previously, pediatric populations create challenges for device developers in that they reflect a smaller market and heighten the necessity for durable, long-lasting implants that allow the patient to remain active. At the same time, with more aggressive sports activity possibly increasing injury rates and more frequent and more sensitive imaging, certain pediatric markets may be growing and exposing unique unmet clinical needs. One of the companies currently addressing this market is OrthoPediatrics, who manufacture trauma products for children.
Grant applicants must represent nonprofit organizations or institutions. The funds can be used to cover total costs per year for up to two years and will be distributed in up to four awards. Applications will be accepted through June 15, 2009, with funds to be distributed as early as September 2009.