FDA recently awarded three grants to help to stimulate the development of pediatric medical devices. Development of medical devices for children lags up to a decade behind similar devices intended for use in adults. Children differ in size, growth and body chemistry, and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children.
This is a new grant program originating from legislation passed in 2007, and although the program is administered by the Office of Orphan Product Development, this program encompasses devices used in all pediatric diseases, not just rare diseases.
The recipients and grant amounts are:
• James Geiger, M.D., and the Michigan Pediatric Device Consortium for $1 million
• Pedro DelNido, MD., and the Pediatric Cardiovascular Device Consortium, for $500,000
• Michael Harrison, MD., and the University of California at San Francisco Pediatric Device Consortium for $500,000
The grant recipients will use the funding to:
• Encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers
• Mentor and manage pediatric device projects through their development including prototype design and marketing
• Connect innovators and physicians to existing federal and non-federal resources
• Assess the scientific and medical merit of the proposed pediatric projects and provide assistance and advice on business development, training, prototype development, and post-marketing needs
The grant recipients will coordinate their research among the FDA, device companies and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.