The University of Michigan Pediatric Device Consortium

密歇根大学儿科设备联盟

• 批准号: 7936804
• 负责人: JAMES D GEIGER
• 金额: $ 100万
• 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 2011-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936804
• 关键词: University; Michigan; Pediatric; Device; Consortium

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 开发的设备很少是直接满足小儿需求的。儿科从业者经常使用从未被批准使用的设备，甚至通常没有专门研究儿童。更糟糕的是，针对成人使用的设备被修改为使其可在儿童中使用。儿童将受益于专门针对未满足儿科健康需求的创新的发展。小儿设备商业化所独有的障碍包括儿童临床研究的增加，制造商的责任风险，潜在市场的规模以及必须针对特定的儿科亚群（例如新生儿或青少年）量身定制设备的事实。为了响应儿科设备财团赠款计划（P50）的FDA RFA，调查人员建议建立密歇根州儿科设备联盟（M-PED Consortium），以汇集一套独特的资源，以汇总一套独特的资源，不仅了解和优化儿童设备创新的过程，还可以在踏板上创建可持续的pedication neverications，以使其在pediation nevery interivation the Ped Intercration in ped Interict中，以使其在PediaTric Intercration方面进行重要的改进。 M-PED财团将在密歇根大学现有医疗创新中心（MIC）的保护下运营。调查人员指出，他们将利用麦克风现有的基础架构，关系和流程，但创造了新的结构和关系，以特别关注儿科设备创新。这些资源将充分参与积极管理和迈向商业化，拟议的五个财团项目。 1）使用分散力量诱导小肠道延长，2）儿童TPN的非紧密杀菌性杀菌性导管，3）用于使用小儿的小儿临床诊断，用于小儿分子诊断和5）3D URSTRASS 3D。此外，M-PED联盟还将完成以下具体目的：1）提高额外的儿科设备项目以外的五个详细信息，2）将四个研究生组成的一组转变为儿科创新者，3）识别，表征和优先考虑重要的未满足儿科需求，4）为创新的临床机构和临床人员提供的辅助和教育，以实现临床和教育，以造福于临床的学生和教师5），这是临床上的5），这是临床上的5），”商业化。