The U.S. Food and Drug Administration today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children. A panel of experts with experience in the clinical, business, and regulatory aspects of pediatric device development reviewed applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The grant recipients are:
- James Geiger, M.D., University of Michigan Pediatric Device Consortium
- David Ku, M.D., Ph.D., Atlantic Pediatric Device Consortium
- Peter Kim, M.D., National Capital Consortium for Pediatric Device Innovation
- Rick Greenwald, Ph.D., New England Pediatric Device Consortium
- Yaniv Bar-Cohen, M.D., Southern California Center for Technology and Innovation in Pediatrics
- Matthew Maltese, M.S., Ph.D., Philadelphia Regional Pediatric Medical Device Consortium
- Pedro del Nido, M.D., Boston Pediatric Device Consortium
“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, M.D., J.D., 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 projects.”
Children differ in terms of size, growth, and body chemistry and present unique challenges to device developers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the OOPD, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.
Medical device legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit consortia to help stimulate projects to promote the development and availability of pediatric devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012. Those receiving grants will:
- 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 proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.
This is the third time since 2009 that the FDA has awarded grants to consortia which advance the development of pediatric medical devices. This year’s awards have been granted to consortia that each bring together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide advisory resources to promote multiple projects. Each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.
Along the way, the consortia will work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.