Southwest National Pediatric Device Consortium

项目负责人/主要研究者（最后，第一，中间）：Koh，Chester 项目概要/摘要： 目前对专门为儿童设计的医疗设备存在巨大需求，这一差距最大 可能是经济、临床、监管、报销和商业模式挑战以及缺乏 将儿科器械想法与合格的个人/项目联系起来的既定机制， 能够有效协助开发和商业化工作的行业合作伙伴。此外，本发明还提供了一种方法， 儿科医疗设备还需要适应儿科患者独特的病理生理学和解剖学 患者位于德克萨斯州儿童医院和贝勒大学的西南儿科设备联盟 Medicine通过产品和技术加速服务和业务支持儿科设备创新者 加速区域和国家的服务，目标是商业化和临床使用的新的 儿科医疗器械。该联盟包括临床，科学，商业，金融，监管， 报销、工程、符合ISO 13485标准的产品设计和制造、知识产权，以及 休斯顿/美国西南地区的学术合作伙伴，包括德克萨斯A&M大学，莱斯大学， 休斯顿大学、当地设备开发公司和美国西南部的其他儿童医院。 地区该联盟通过协调内部资源促进儿科医疗器械的开发， 其现有的翻译和商业化框架。联盟认识到， 项目可能需要在儿童医院/学术环境中延长生命周期， 外部市场，教师，学生和主要儿童医院的资源可以与 在主要研究型大学建立工程设计团队，以确定未满足的儿科器械需求， 召集临床教师和工程设计团队合作，然后开发和测试新的儿科 可以开发成可行的儿科医疗设备的设备原型。该财团还将帮助 提高对新型儿科医疗器械开发需求的认识，以及识别和 解决当前儿科器械开发和商业化的障碍，特别关注 建立以需求为导向的新型儿科医疗器械生产线。联盟网络 它的利益相关者与商业，投资，高等教育和慈善界在整个 美国西南地区，为儿科创新者提供全面的儿科器械开发 服务此外，该联合体的真实的世界证据示范项目提案代表了一个 大型儿童医院卫生系统、德克萨斯州儿童医院和贝勒大学之间的合作 医学，和国家科学基金会资助的工程研究中心，在得克萨斯州A&M的PATHS-UP， 其重点是对服务不足的儿科人群进行糖尿病的远程监测。 OMB编号0925-0001/0002（2018年1月批准至2020年3月31日修订版）页码续页格式页码

Program Director/Principal Investigator (Last, First, Middle): Koh, Chester Project Summary / Abstract: A great need currently exists for medical devices designed specifically for children, where this gap is most likely a result of economic, clinical, regulatory, reimbursement and business model challenges as well as a lack of established mechanisms for connecting pediatric device ideas with qualified individuals / programs and industry partners who can effectively assist in the development and commercialization efforts. In addition, pediatric medical devices also need to accommodate the unique pathophysiology and anatomy of pediatric patients. The Southwest Pediatric Device Consortium based at Texas Children’s Hospital and Baylor College of Medicine supports pediatric device innovators with product and technology acceleration services and business acceleration services both regionally and nationally, with the goal of commercialization and clinical use of novel pediatric medical devices. The consortium includes clinical, scientific, business, financial, regulatory, reimbursement, engineering, ISO13485 compliant product design & manufacturing, intellectual property, and academic partners in the Houston / Southwest U.S. region, including Texas A&M University, Rice University, University of Houston, local device development firms, and other children’s hospitals in the Southwest U.S. region. The consortium facilitates the development of pediatric medical devices by coordinating resources within its existing translational and commercialization framework. The consortium recognizes that pediatric device projects may need an extended life cycle in the children’s hospital / academic setting before exposure to the external market, where the faculty, students, and resources of major children's hospitals can partner with established engineering design teams at major research universities to identify unmet pediatric device needs, assemble clinical faculty and engineering design team partnerships, and then develop and test new pediatric device prototypes that can be developed into viable pediatric medical devices. The consortium will also help to increase awareness around the need for novel pediatric medical device development, as well as identify and address current barriers to the development and commercialization of pediatric devices with a particular focus on establishing a productive needs-driven pipeline of new pediatric medical devices. The consortium networks its stakeholders with the business, investment, higher education, and philanthropic communities in the entire Southwest U.S. region in order to provide pediatric innovators with comprehensive pediatric device development services. Furthermore, the consortium’s Real World Evidence demonstration project proposal represents a collaboration between a large children’s hospital health system, Texas Children’s Hospital and Baylor College of Medicine, and a National Science Foundation-funded Engineering Research Center, PATHS-UP at Texas A&M, with an aligned focus on remote monitoring for diabetes mellitus in underserved pediatric populations. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page