Southwest National Pediatric Device Innovation Consortium (SWPDC)

项目摘要/摘要： 目前迫切需要专门为儿童开发的医疗器械。儿科的障碍 设备开发包括经济、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。与儿科设备相关的较小的人口和市场规模可以 通过用于将成人设备商业化的基于市场的方法来防止进步。西南地区 国家儿科器械创新联盟(SWPDC)支持地区性和全国性的儿科器械 创新者通过其现有的产品和技术加速服务和业务加速服务 翻译和商业化网络帮助新型儿科医疗设备向 商业化和临床应用。SWPDC一直通过促进伙伴关系来改善儿童的健康 在美国最大的儿童医院的教职员工、学生和资源之间，一个日益增长的中心和- 儿童医院网络，并在主要大学建立学术工程项目，如 并为儿科设备创新者提供全面的儿科设备开发服务，以 与地方、地区和国家机构和创新合作伙伴共同创造新型儿科医疗设备。这个 财团还包括当地设备开发公司，提供临床、科学、商业、金融、 法规、报销、工程、符合ISO13485的产品设计和制造，以及 美国西南部/中西部地区的知识产权专业知识。该财团还将致力于确定 并解决目前阻碍儿科设备开发和商业化的障碍，特别是 重点建立以生产需求为导向的新型儿科医疗器械流水线。SWPDC还将 继续努力促进合作、多样性、公平和包容，以创建一个国家网络 儿科设备的开发，使所有儿科患者受益，包括那些服务不足的人群和 它利用美国儿童医院的现有专业知识和基础设施来支持加速的 与公共和私营部门利益攸关方合作开发创新的儿科设备。 此外，该联盟的真实世界证据示范项目代表着一种持续的合作 在大型儿童医院卫生系统和拥有国家科学的大型工程大学之间 基金会资助的工程研究中心，为全面和可扩展的现实世界铺路 数据/证据示范项目计划，支持不同阶段的儿科设备创新， 还促进多样化和包容性人口的包容性、参与性和参与性。这将有助于 为支持医疗保健的儿科真实世界数据/证据项目创建国家服务中心 设备公司和初创企业，通过事前/事后监管审批、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.