University of Michigan MPED & PMDI Ped Med Device Consortium

密歇根大学 MPED

• 批准号: 8265205
• 负责人: JAMES D GEIGER
• 金额: $ 110万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8265205
• 关键词: University; Michigan; MPED; PMDI; Ped

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.

描述（由申请人提供）： 作为食品药品监督管理局最初的儿科装置财团赠款计划（P50）的一部分，建立了密歇根州小儿装置联盟（M-PED），并扩大了补充资金，包括与儿科医疗设备研究所（PMDI）的合作。在不到18个月的时间里，M-PED-PMDI在儿科设备中建立了一个强大的计划，该计划正在管理40多个儿科项目的投资组合。尽管取得了进展，但商业化儿科设备的挑战是伟大的，需要持续的长期努力。 这项研究的拟议主要目标是加强和发展MPED-PMDI联盟，将一组独特的资源团结起来，不仅了解和优化了儿科设备创新的过程，而且还会创建一个可持续的计划，从而导致儿科健康的重大改善。 MPED-PMDI联盟将利用密歇根大学的生物医学发现以及建立的基础设施，关系和广泛的专业知识，在医疗创新中心和PMDI的商业化和产品开发方面。 MPED-PMDI财团的组合资源将充分参与，以便将财团的附属小儿设备组合加速到产品开发的下一个阶段。 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)小儿肝移植和表征系统。该财团将实现以下特定目的：1）沿着产品生命周期的总生命周期增长和推进现有的儿科医疗设备组合，2）确定对高潜在儿科设备的资金支持，3）进行一项临床试验，以收集临床功效数据，以在MPED-PMDI上进行临床效率数据，以便在MEDS-PMDI上进行启用，以便在5个辅助网络上使用Pediactiz and Prientize Inceed，4）具有创新的教师，临床医生，行业，学生和员工，同时生产有关儿科设备商业化的信息。