Southwest National Pediatric Device Innovation Consortium (SWPDC)

西南国家儿科器械创新联盟 (SWPDC)

• 批准号: 10817574
• 负责人: Gwenyth A Fischer
• 金额: $ 148.33万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10817574
• 关键词: Southwest; National; Pediatric; Device; Innovation

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.

项目摘要/摘要： 目前迫切需要专门为儿童开发的医疗设备。 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创意与合格个人联系起来的既定机制， 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展。 国家儿科设备创新联盟 (SWPDC) 支持区域和国家儿科设备 凭借其现有的产品和技术加速服务以及业务加速服务的创新者 转化和商业化网络，帮助新型儿科医疗器械发展到 SWPDC 一直在通过促进合作伙伴关系来改善儿童的健康。 美国最大的儿童医院的教职员工、学生和资源之间，一个不断发展的中心和- 辐射儿童医院网络，并在主要大学建立学术工程项目， 并通过全面的儿科设备开发服务支持儿科设备创新者 与地方、区域和国家机构和创新合作伙伴一起创造新型儿科医疗设备。 该联盟还包括提供临床、科学、商业、金融、 监管、报销、工程、符合 ISO13485 的产品设计和制造，以及 该联盟还将努力确定美国西南部/中西部地区的知识产权专业知识。 并解决目前儿科设备开发和商业化的障碍，特别是 SWPDC 还将重点关注建立生产性需求驱动的新型儿科医疗器械产品线。 继续努力促进合作、多样性、公平和包容性，以创建一个全国网络 儿科设备的开发有利于所有儿科患者，包括那些服务不足的人群和 它利用美国儿童医院现有的专业知识和基础设施来支持加速 与公共和私营部门利益相关者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了持续的合作 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的关系 基金会资助的工程研究中心 PATHS-UP，旨在提供全面且可扩展的现实世界 数据/证据示范项目计划支持各个阶段的儿科设备创新 还促进多元化和包容性人群的包容、参与和参与。 创建国家儿科真实数据/证据项目服务中心，支持医疗 设备公司和初创公司为监管审批前/后、价值分析提供证据生成， 儿科标签扩展研究和市场采用。