Southwest National Pediatric Device Innovation Consortium (SWPDC)

项目概要/摘要： 目前迫切需要专门为儿童开发的医疗设备。儿科障碍 器械开发包括经济、临床、监管、报销和商业模式挑战， 再加上缺乏将儿科设备想法与合格个人联系起来的既定机制， 计划和行业合作伙伴。与儿科器械相关的较小的人群和市场规模， 通过用于将成人器械商业化的基于市场的方法防止进展。西南 国家儿科器械创新联盟（SWPDC）支持区域和国家儿科器械 创新者提供产品和技术加速服务，以及业务加速服务， 转化和商业化网络，以帮助新型儿科医疗器械的发展， 商业化和临床应用。社发中心一直在通过促进伙伴关系改善儿童健康 在美国最大的儿童医院的教师、学生和资源之间，一个不断发展的中心， 发言的儿童医院网络，并建立了学术工程计划，在主要大学， 并通过全面的儿科器械开发服务支持儿科器械创新者， 与当地、地区和国家机构和创新合作伙伴一起开发新型儿科医疗器械。的 联盟还包括当地的设备开发公司，提供临床，科学，商业，金融， 法规、报销、工程、符合ISO 13485的产品设计和制造，以及 美国西南/中西部地区的知识产权专业知识。该财团还将努力确定 并解决当前儿科器械开发和商业化的障碍， 专注于建立一个以需求为导向的新型儿科医疗器械生产线。SWPDC还将 继续努力促进合作，多样性，公平和包容，以建立一个国家网络， 儿科器械开发，使所有儿科患者受益，包括服务不足的人群， 它利用美国儿童医院现有的专业知识和基础设施， 与公共和私营部门利益相关者合作开发创新的儿科器械。 此外，该联合会的真实的世界证据示范项目代表了持续的合作 大型儿童医院卫生系统和拥有国家科学院的大型工程大学之间的关系， 基金会资助的工程研究中心，PATHS-UP，用于全面和可扩展的现实世界 数据/证据演示项目计划，支持各个阶段的儿科器械创新， 还促进包容性，参与和参与的多样性和包容性的人口。这将有助于 建立一个全国服务中心，为儿科真实的文字数据/证据项目提供支持， 设备公司和初创公司，为监管批准前/后提供证据，价值分析， 儿科标签扩展研究和市场采用。

Project Summary / Abstract: An urgent need currently exists for medical devices developed specifically for children. Barriers to pediatric device development include economic, clinical, regulatory, reimbursement, and business model challenges, combined with a lack of established mechanisms for connecting pediatric device ideas with qualified individuals, programs, and industry partners. The smaller population and market sizes associated with pediatric devices can prevent progression through market-based approaches used to commercialize adult devices. The Southwest National Pediatric Device Innovation Consortium (SWPDC) supports regional and national pediatric device innovators with product and technology acceleration services and business acceleration services with its existing translational and commercialization network to help novel pediatric medical devices progress to commercialization and clinical use. SWPDC has been improving children’s health by facilitating partnerships between the faculty, students, and resources of the largest children’s hospital in the U.S., a growing hub-and- spoke network of children’s hospitals, and established academic engineering programs at major universities, as well as supporting pediatric device innovators with comprehensive pediatric device development services to create novel pediatric medical devices with local, regional, and national institutional and innovation partners. The consortium also includes local device development firms offering clinical, scientific, business, financial, regulatory, reimbursement, engineering, ISO13485-compliant product design and manufacturing, and intellectual property expertise in the Southwest/Midwest U.S. regions. The consortium will also work to 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. SWPDC will also continue its work to foster collaboration, diversity, equity, and inclusion toward creating a national network for pediatric device development that benefits all pediatric patients including those in underserved populations and which utilizes the existing expertise and infrastructure of U.S. children’s hospitals to support the accelerated development of innovative pediatric devices in partnership with public and private sector stakeholders. Furthermore, the consortium’s Real World Evidence demonstration projects represents a continued collaboration between a large children’s hospital health system and a large engineering university with its National Science Foundation-funded Engineering Research Center, PATHS-UP, for a comprehensive and scalable Real-World Data/Evidence demonstration projects program that support pediatric device innovation at various stages that also promotes inclusion, engagement, and participation of diverse and inclusive populations. This will contribute to the creation of a national service center for pediatric real word data/evidence projects that support medical device companies and startups with evidence generation towards pre/post regulatory approval, value analysis, pediatric labeling expansion studies, and market adoption.