UNIVERSITY OF MICHIGAN PEDIATRIC DEVICE CONSORTIUM (M-PED)

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DESCRIPTION (provided by applicant): As part of the FDA's initial Pediatric Grant Program (P50), the Michigan Pediatric Device Consortium (M-PED) was established and was expanded to include several collaborations. In less than four years, M-PED has established a program focused on supporting pediatric medical device evaluation, support, and commercialization that has managed a portfolio of over 80 combined, collaborative projects. Support and guidance have been provided to both university and non-university (small, medium, large organizations/companies) settings in the area of pediatric device commercialization. These efforts have led to commercialized technology, clinically evaluated technology, and key regulatory (HUD, HDE, IDE advancement) and manufacturing assessments. The primary goal is to further M-PED's role as a catalyst to accelerate the commercial availability and adoption of pediatric medical devices to ultimately improve the health of children. M-PED will leverage biomedical discovery at the University of Michigan and throughout the region as well as established infrastructure, relationships, and expertise in need identification, technology risk assessment, design and prototype development, business development, regulatory, intellectual property (IP), reimbursement, manufacturing, and regulatory support to advance pediatric devices toward increasingly advanced stages of the total project life cycle (TPLC). M-PED proposes to leverage the FDA's 2013 RFA for Consortia Grant Program (P50) to further enhance the consortium for pediatric device innovation, thus strengthening support, mentorship, and leadership to accelerate the commercial development of pediatric medical devices. M-PED will bring together a set of resources to increase and accelerate the process of pediatric device innovation specifically targeting the needs of children. M-PED will become a sustainable program in pediatric device innovation that will make improvements in pediatric health by not only commercializing pediatric devices, but serving as a resource for other pediatric innovators.