UCSF-Stanford Pediatric Device Consortium

项目总结 临床和商业上对专门设计的新型儿科设备的需求还未得到满足 为了满足孩子们的独特需求。加州大学旧金山分校-斯坦福大学儿科设备联盟(PDC)一直是一个关键参与者 自2009年成立以来，已成功支持了250多台儿科设备 在商业化和患者的道路上，许多临床专科和所有设备类别的创新 进入。在上一个为期5年的资助周期中，加州大学旧金山分校-斯坦福大学项目发展中心资助了128个研究项目， 开发和工程，67个试验台和动物试验项目，21个知识产权项目，55个 规上项目71个，商业化项目71个，支付和商业化项目30个 报销。这导致了超过1亿美元的集体后续资金，9种商业产品， 20,000多名儿童受到了这些技术的积极影响。加州大学旧金山分校-斯坦福大学PDC也为 成为第一个有效利用真实临床数据和真实世界证据实现成功监管的PDC 儿科使用的装置和标签扩展的净空。 加州大学旧金山分校-斯坦福PDC将出色的资源和独特的创新生态系统结合在一起 世界一流的大学和两家领先的儿童医院，拥有世界上无与伦比的创业网络 旧金山湾区的心脏地带，让儿科创新者在发展的所有阶段都能将他们的创新转化为 变成所有人都能接触到的高价值、商业上可行和公平的产品。PDC是 现在通过1)与世界级设备孵化器Fogarty合作，进一步扩大其范围和影响 创新，2)领导多样化，制定可操作的计划，促进多样性、公平和包容性 (Dei)设备开发，以及3)扩大真实世界证据(RWE)咨询和教育 通过合作的PDC服务中心以及与领先的莱茵公司Ation建立新的合作伙伴关系。 两位经验丰富的设备创新者，医学博士Hanmin Lee(儿科外科医生兼加州大学贝尼奥夫分校主任医师 儿童医院)和詹姆斯·沃尔医学博士(斯坦福大学儿科外科医生和生物设计负责人)将领导 PDC团队由具有临床、技术、监管和其他相关专业知识的设备专家组成。他们 将由资深医疗技术行业专业人士、多学科咨询委员会和多个 机构利益相关者(加州大学旧金山分校-斯坦福大学监管科学和创新卓越中心，临床 试验办公室和Dei Council)，将有希望的儿科设备创新转化为可行的商业产品。 通过坚定的领导、集体努力、巨大的资源和从以前的 赠款周期，加州大学旧金山分校-斯坦福PDC将能够实现提案中详细说明的目标，以加快 许多高影响力、基于价值的儿科设备解决方案，以商业化和对患者的影响。加州大学旧金山分校- 斯坦福PDC将继续发挥领导作用，与其他PDC一起，创建一个全国性的网络和 促进儿科设备创新的生态系统。

PROJECT SUMMARY There is a critical clinical and commercial unmet need for novel pediatric devices that are designed specifically for the unique needs of children. The UCSF-Stanford Pediatric Device Consortium (PDC) has been a key player in this space since its inception in 2009, with a successful history in supporting over 250 pediatric device innovations in many clinical specialties and in all device classes on their path to commercialization and patient access. In the previous 5-year grant cycle, the UCSF-Stanford PDC supported 128 projects in research, development, and engineering, 67 projects in bench and animal testing, 21 projects in intellectual property, 55 projects in regulation, 71 projects in business and commercialization, and 30 projects in payment and reimbursement. This has led to over $100M in collective follow-on funding, 9 commercially available products, and over 20,000 children positively impacted by these technologies. The UCSF-Stanford PDC is also proud to be the first PDC to effectively use real-world clinical data and real-world evidence for successful regulatory clearance of a device and label expansion for pediatric use. UCSF-Stanford PDC combines the outstanding resources and unique innovation ecosystems available in two world-class universities and two leading children’s hospitals with the unsurpassed entrepreneurial network in the heart of the Bay Area, to equip pediatric innovators at all stages of development to translate their innovations into high-value, commercially viable, and equitable products that are accessible to all populations. The PDC is now further expanding its scope and impact through 1) a partnership with world-class device incubator Fogarty Innovation, 2) the diversification of leadership with actionable plans to promote diversity, equity and inclusion (DEI) in device development, and 3) the expansion of real-world evidence (RWE) consulting and education through a collaborative PDC Service Center as well as a new partnership with a leading RWE firm, Aetion. Two seasoned device innovators, Hanmin Lee, MD (Pediatric Surgeon and Surgeon in Chief at UCSF Benioff Children’s Hospitals) and James Wall, MD (Pediatric Surgeon and Biodesign Lead, Stanford University) will lead the PDC team consisting of device experts with clinical, technical, regulatory, and other relevant expertise. They will be supported by senior medtech industry professionals, multidisciplinary advisory committees, and multiple institutional stakeholders (UCSF-Stanford Center of Excellence in Regulatory Science and Innovation, clinical trials offices, and DEI Council),to catalyze promising pediatric device innovations to viable commercial products. Through committed leadership, collective efforts, great resources, and the unique expertise gained from previous grant cycles, the UCSF-Stanford PDC will be able to achieve the objectives detailed in the proposal to accelerate many high-impact, value-based pediatric device solutions to commercialization and patient impact. The UCSF- Stanford PDC will continue to play a leadership role, along with other PDCs, in creating a national network and ecosystem to foster pediatric device innovations.