UCSF-Stanford Pediatric Device Consortium

项目概要 加州大学旧金山分校-斯坦福儿科设备联盟 (PDC) 将利用现有的设备创新人才 两所世界一流大学和硅谷中心无与伦比的创业网络 为处于各个发展阶段的儿科创新者提供装备，将他们的创新转化为高价值、 商业上可行的产品。结合FDA资助八年的经验和资源 加州大学旧金山分校儿科设备联盟和历史悠久、世界知名的斯坦福生物设计公司 计划中，新的“加州大学旧金山分校-斯坦福 PDC”强调概念阶段的市场评估和 价值分析；内部产品开发、监管、专利申请和常驻企业家 (EIR) 服务；一个实践型商业化顾问委员会，根据具体情况制定上市策略； 以及由外部医疗技术顾问和产品开发资源组成的深厚而忠诚的网络 世界创新之都。 加州大学旧金山分校 (UCSF) 资深设备创新者 Michael Harrison 医学博士（儿科外科）和 Shuvo Roy 博士 （生物工程）由斯坦福大学的 James Wall 医学博士（小儿外科）、斯坦福大学助理主任加入 生物设计创新奖学金计划。高级医疗技术行业专业人士 Chris Jones（产品 开发）、Michael Billig（监管事务）、David Levine（知识产权）、Daniel Burnett （驻地企业家）和道格拉斯·克劳福德（商业化咨询委员会主席）将提供 总监级支持。加州大学旧金山分校-斯坦福 PDC 提供丰富的专业知识，可通过其轻松获取 每周一次的“开放式创新”会议、交互式门户网站、全面的咨询服务以及半年一次的会议 儿科设备加速器推介竞赛，提供专家咨询、商业化 指导和直接资金来推进具有强大市场潜力的儿科设备项目。除了 PDC 的内部服务、儿科创新者将受益于与受人尊敬的湾区的合作伙伴关系 医疗器械孵化器 Theranova（旧金山）和埃尔卡米诺福加蒂创新研究所 医院（山景城）。 自 2009 年成立以来，UCSF PDC 已推出 10 种内部开发的儿科设备 从概念阶段到首次人体试验，引导三种设备投入市场，并利用了超过 3000 万美元的资金 外部资金支持其技术的持续发展。斯坦福大学的生物设计项目 建立了国际公认的器械创新和开发模式，已推出 46 成功的初创公司，其技术现已惠及超过一百万患者。在下一个PDC中 在资助周期中，这两个创新计划将结合各自的优势和基础设施来创造 一个强大的计划，加速高影响力、基于价值的儿科设备解决方案的商业化 和患者的影响。

PROJECT SUMMARY The UCSF-Stanford Pediatric Device Consortium (PDC) will leverage the established device innovation talent of two world-class universities and an unsurpassed entrepreneurial network in the heart of Silicon Valley to equip pediatric innovators at all stages of development to translate their innovations into high-value, commercially viable products. Combining the experience and resources of the eight-year-old FDA-funded UCSF Pediatric Device Consortium and the long-established and world-renowned Stanford Biodesign program, the new “UCSF-Stanford PDC” features an emphasis on concept-stage market assessment and value analysis; in-house product development, regulatory, patenting, and entrepreneur-in-residence (EIR) services; a hands-on Commercialization Advisory Board to create situation-specific go-to-market strategies; and a deep and committed network of external medtech advisors and product development resources in the world's innovation capital. Veteran UCSF device innovators Michael Harrison, MD (Pediatric Surgery) and Shuvo Roy, PhD (Bioengineering) are joined by Stanford's James Wall, MD (Pediatric Surgery), Assistant Director of Stanford's Biodesign Innovation Fellowship Program. Senior medtech industry professionals Chris Jones (Product Development), Michael Billig (Regulatory Affairs), David Levine (Intellectual Property), Daniel Burnett (Entrepreneur-in-Residence), and Douglas Crawford (Chair, Commercialization Advisory Board) will provide director-level support. The UCSF-Stanford PDC offers a wealth of expertise that is easily accessed through its weekly `open innovation' meetings, interactive web portal, comprehensive advising services, and semiannual Pediatric Device Accelerator pitch competition, which provides expert consulting, commercialization mentorship, and direct funding to advance pediatric device projects with strong market potential. In addition to the PDC's in-house services, pediatric innovators will benefit from partnerships with esteemed Bay Area medical device incubators Theranova (San Francisco) and the Fogarty Institute for Innovation at El Camino Hospital (Mountain View). Since its founding in 2009, the UCSF PDC has advanced 10 internally developed pediatric devices from the concept stage to first-in-human trials, guided three devices to market availability, and leveraged over $30M in external funding to support continued development of its technologies. Stanford's Biodesign program has established an internationally recognized model for device innovation and development, having launched 46 successful startup companies whose technologies have now reached over a million patients. In the next PDC grant cycle, these two innovation programs will combine their respective strengths and infrastructures to create a powerhouse program accelerating high-impact, value-based pediatric device solutions to commercialization and patient impact.