Southwest National Pediatric Device Consortium

西南国家儿科设备联盟

• 批准号: 10247488
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247488
• 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

项目主任/首席调查员(最后、第一、中间)：切斯特 项目摘要/摘要： 目前对专门为儿童设计的医疗器械的需求很大，而这一缺口最大的是 可能是经济、临床、监管、报销和商业模式挑战以及缺乏 建立将儿科设备的想法与合格的个人/计划联系起来的机制，并 能够有效协助开发和商业化努力的行业合作伙伴。此外, 儿科医疗器械也需要适应儿科独特的病理生理学和解剖学 病人。总部设在德克萨斯州儿童医院和贝勒学院的西南儿科设备协会 医学通过产品和技术加速服务和业务支持儿科设备创新者 加速服务于区域和国家，目标是将新型药物商业化和临床应用 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ISO13485标准的产品设计和制造、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。 区域。该联盟通过协调以下方面的资源来促进儿科医疗器械的开发 其现有的翻译和商业化框架。该联盟承认该儿科设备 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，主要儿童医院的教职员工、学生和资源可以合作 在主要研究型大学建立工程设计团队，以确定未得到满足的儿科设备需求， 汇集临床教员和工程设计团队合作伙伴关系，然后开发和测试新的儿科 可以被开发成可行的儿科医疗设备的设备原型。该财团还将帮助 提高对开发新型儿科医疗器械的必要性的认识，并确定和 解决目前儿科设备开发和商业化的障碍，重点放在 建立以生产需求为导向的新型儿科医疗设备流水线。财团网络 它与整个商业、投资、高等教育和慈善团体的利益相关者 美国西南部地区，为儿科创新者提供全面的儿科设备开发 服务。此外，该财团的真实世界证据示范项目提案代表了 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 医学和国家科学基金会资助的工程研究中心，德克萨斯农工大学的路径， 将重点一致地放在服务不足的儿科人群中的糖尿病远程监测上。 OMB编号0925-0001/0002(01/18修订版批准至2020年3月31日)页面续格式页面