University of Michigan MPED & PMDI Ped Med Device Consortium

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): As part of the Food and Drug Administration's initial Pediatric Device Consortia Grant Program (P50), the Michigan Pediatric Device Consortium (M-PED) was established and with supplemental funding was expanded to include collaboration with the Pediatric Medical Device Institute (PMDI). In less than eighteen months, M-PED-PMDI has established a robust program in pediatric devices that is managing a portfolio of over forty pediatric projects. Although progress has been made, the challenges to commercializing pediatric devices are great and a sustained long-term effort will be required. The proposed primary goal of this research is to strengthen and grow the MPED-PMDI consortium uniting a unique set of resources to not only understand and optimize the process of pediatric device innovation, but create a sustainable program that will lead to significant improvements in pediatric health. The MPED-PMDI consortium will leverage the biomedical discovery of the University of Michigan as well as the established infrastructure, relationships and extensive expertise in commercialization and product development of the Medical Innovation Center and PMDI. The combined resources of the MPED-PMDI consortium will be fully engaged in order to accelerate the consortium's affiliated portfolio of pediatric devices to the next phases of product development. Five projects are highlighted which will actively be managed and advanced toward commercialization: 1) Use of distractive forces to induce small intestinal lengthening, 2) Nonthrombogenic and biofilm resistant catheters for use in neonates, 3) Wireless accelerometers to quantify general movements in infants at risk for cerebral palsy, 4) Smart rapid palatal expander for pediatric cleft lip and palate patients and 5) Pediatric liver transplantation and characterization system. The consortium will accomplish the following specific aims: 1) Grow and advance the existing pediatric medical device portfolio along the total product life-cycle, 2) Identify funding support for high potential pediatric devices, 3) Conduct a clinical trial to gather efficacy data on an MPED-PMDI portfolio product utilizing the Pediatric Trials Network, 4) Continue to identify and prioritize unmet pediatric needs, 5) Provide assistance and education to innovation-minded faculty, clinicians, industry, students and staff while producing information "assets" on pediatric device commercialization.