FDA has just awarded seven grants totaling more than $3.5 million to stimulate the development of pediatric medical devices through their “Pediatric Development Consortia Grant Program”. The funding was awarded to various pediatric device consortia to enable the seven consortia to obtain expertise needed in the areas of business, regulatory and legal issues, plus scientific and engineering knowledge, to improve clinical services for the pediatric community.
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 being administered by the Office of Orphan Products Development (OOPD), it is intended to encompass devices used in all pediatric diseases, not just rare diseases.
“The 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 develop that includes concept formation, prototyping, preclinical, clinical, manufacturing , marketing, and commercialization”, said Gayatri R Rao M.D, J.D., Director of OOPD.
The funding will be used to:
- Encourage innovation and connect qualified individuals with good pediatric device ideas with potential manufacturers
- Mentor and manage pediatric device projects through 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
The awards went to the University of Michigan Pediatric Device Consortium, Atlantic Pediatric Device Consortium, National Capital Consortium for Pediatric Device Innovation, New England Pediatric Device Consortium, Southern California Center for Technology and Innovation in Pediatrics, Philadelphia Regional Pediatric Medical Device Consortium, and Boston Pediatric Device Consortium.
Each of the grant recipients will coordinate activities with FDA, device companies, and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. The consortia will also work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations, and obtain agency guidance.