Rarely are devices developed to directly meet a pediatric need. Pediatric practitioners frequently utilize devices that have never been approved for use and often not even studied specifically in children. Worse, devices intended for use in adults are modified to make them usable in children. Children would benefit from the development of innovations that are specifically targeted to meet unmet pediatric health needs. The barriers unique to commercialization of pediatric devices include the increased cost of clinical studies in children, liability risk for manufacturers, the size of the potential markets, and the fact that devices must be tailored to specific pediatric subpopulations, such as neonates or adolescents. In response to the FDA's RFA for the Pediatric Device Consortia Grant Program (P50) the investigators propose to establish the Michigan Pediatric Device Consortium (M-PED Consortium) to bring together a unique set of resources to not only understand and optimize the process of pediatric device innovation, but to create a sustainable program in pediatric device innovation that will make significant improvements in pediatric health. The M-PED Consortium will be operated under the umbrella of the existing Medical Innovation Center (MIC) at the University of Michigan. The investigators state they will leverage the MIC's existing infrastructure, relationships and processes but create new structure and relationships to specifically focus on pediatric device innovation. These resources will be fully engaged to actively manage and advance towards commercialization the proposed five projects of the consortium. 1) Use of distractive forces to induce small intestinal lengthening, 2) Nonthrombogenic antiseptic catheters for TPN for children, 3) A portable clinical reaction time measurement apparatus for pediatric use, 4) A micro optofluidic device for multiplexed point-of-care molecular diagnostics of pediatric sepsis and 5) 3D ultrasound for cerebral blood flow in neonates. In addition the M-PED Consortium will also accomplish the following specific aims: 1) Advance additional pediatric device projects beyond the five detailed in this application, 2) Transform a group of four postgraduates into pediatric innovators, 3) Identify, characterize and prioritize significant unmet pediatric needs, 4) Provide assistance and education to innovation-minded faculty, clinicians, students and staff 5) Produce information """"""""assets"""""""" on topics critical to pediatric device commercialization.
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