University of Michigan MPED & PMDI Ped Med Device Consortium

描述（由申请人提供）： 作为美国食品药品监督管理局最初的儿科器械联盟资助计划（P50）的一部分，成立了密歇根儿科器械联盟（M-PED），并在补充资金的支持下扩大了与儿科医疗器械研究所（PMDI）的合作。在不到18个月的时间里，M-PED-PMDI已经建立了一个强大的儿科器械项目，管理着40多个儿科项目。虽然已经取得了进展，但儿科设备商业化的挑战是巨大的，需要持续的长期努力。 这项研究的主要目标是加强和发展MPED-PMDI联盟，联合一套独特的资源，不仅了解和优化儿科器械创新的过程，而且创建一个可持续的计划，这将导致儿科健康的显著改善。 MPED-PMDI联盟将利用密歇根大学的生物医学发现以及医学创新中心和PMDI在商业化和产品开发方面的基础设施，关系和广泛的专业知识。MPED-PMDI联盟的综合资源将充分参与，以加速联盟的儿科器械组合进入下一阶段的产品开发。重点介绍了五个将积极管理和推进商业化的项目：1）使用牵引力来诱导小肠延长，2）用于新生儿的非血栓形成和生物膜抗性导管，3）无线加速度计来量化有脑瘫风险的婴儿的一般运动，4）用于儿童唇腭裂患者的智能快速腭扩展器和5）儿童肝移植和表征系统。联合体将实现以下具体目标：1）沿着整个产品生命周期发展和推进现有儿科医疗器械产品组合，2）确定对高潜力儿科器械的资金支持，3）利用儿科试验网络开展临床试验，收集MPED-PMDI产品组合的有效性数据，4）继续确定和优先考虑未满足的儿科需求，5）为具有创新意识的教师、临床医生、行业、学生和工作人员提供帮助和教育，同时制作有关儿科器械商业化的信息“资产”。

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.