Southwest National Pediatric Device Consortium

西南国家儿科设备联盟

• 批准号: 10466837
• 负责人: MICHAEL JOHN HEFFERNAN
• 金额: $ 135万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10466837
• 关键词: Southwest; National; Pediatric; Device; Consortium

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

项目总监/首席研究员（最后、第一、中间）：Koh, Chester 项目摘要/摘要： 目前对专门为儿童设计的医疗设备存在着巨大的需求，而这一差距是最大的 可能是经济、临床、监管、报销和商业模式挑战以及缺乏的结果 将儿科设备创意与合格个人/项目联系起来的既定机制，以及 此外，能够有效协助开发和商业化工作的行业合作伙伴。 儿科医疗器械还需要适应儿科独特的病理生理学和解剖学 位于德克萨斯州儿童医院和贝勒学院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 区域和国家加速服务，目标是新型药物的商业化和临床应用 该联盟包括临床、科学、商业、金融、监管、 报销、工程、符合 ISO13485 的产品设计和制造、知识产权以及 休斯顿/美国西南部地区的学术合作伙伴，包括德克萨斯农工大学、莱斯大学、 休斯顿大学、当地设备开发公司以及美国西南部的其他儿童医院 该联盟通过协调内部资源来促进儿科医疗器械的发展。 该联盟承认其现有的转化和商业化框架。 项目可能需要在儿童医院/学术环境中延长生命周期，然后才能接触到 外部市场，各大儿童医院的师生和资源可以合作 在主要研究型大学建立了工程设计团队，以确定未满足的儿科设备需求， 组建临床教师和工程设计团队合作伙伴关系，然后开发和测试新的儿科 该联盟还将帮助开发可开发成可行的儿科医疗设备的设备原型。 提高人们对新型儿科医疗器械开发需求的认识，并识别和 特别关注解决当前儿科设备开发和商业化的障碍 建立一个生产性需求驱动的新型儿科医疗设备管道。 整个商业、投资、高等教育和慈善界的利益相关者 美国西南部地区旨在为儿科创新者提供全面的儿科设备开发 此外，该联盟的真实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、德克萨斯儿童医院和贝勒学院之间的合作 医学，以及国家科学基金会资助的工程研究中心，德克萨斯 A&M 的 PATHS-UP， 重点关注服务不足的儿科人群的糖尿病远程监测。 OMB 编号 0925-0001/0002（修订版 01/18 批准至 03/31/2020） 页面延续格式页面