UNIVERSITY OF MICHIGAN PEDIATRIC DEVICE CONSORTIUM (M-PED)

描述(由申请人提供)： 作为FDA最初的儿科补助计划(P50)的一部分，密歇根儿科设备联盟(M-PED)成立了，并扩大到包括几个合作项目。在不到四年的时间里，M-PED建立了一个专注于支持儿科医疗设备评估、支持和商业化的计划，该计划管理着80多个联合协作项目。在儿科设备商业化领域，向大学和非大学(小型、中型、大型组织/公司)机构提供了支持和指导。这些努力导致了商业化技术、临床评估技术以及关键监管(HUD、HDE、IDE进步)和制造评估。主要目标是进一步发挥M-PED作为催化剂的作用，加快儿科医疗设备的商业供应和采用，最终改善儿童的健康。M-PED将利用密歇根大学和整个地区的生物医学发现，以及在需求识别、技术风险评估、设计和原型开发、业务开发、监管、知识产权(IP)、报销、制造和监管支持方面建立的基础设施、关系和专业知识，将儿科设备推进到整个项目生命周期(TPLC)的越来越高级的阶段。 M-PED建议利用FDA的2013年财团RFA赠款计划(P50)来进一步加强儿科设备创新的财团，从而加强支持、指导和领导，以加速儿科医疗设备的商业发展。 M-PED将汇集一系列资源，以增加和加速专门针对儿童需求的儿科设备创新进程。M-PED将成为儿科设备创新的可持续计划，不仅将儿科设备商业化，还将为其他儿科创新者提供资源，从而改善儿科健康。

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.