UCSF-Stanford Pediatric Device Consortium

项目总结 加州大学旧金山分校-斯坦福大学儿科设备联盟(PDC)将利用现有的设备创新人才 位于硅谷中心的两所世界一流大学和无与伦比的创业网络 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高价值， 商业上可行的产品。结合成立八年的FDA资助的经验和资源 加州大学旧金山分校儿科设备联盟和久负盛名的斯坦福生物设计公司 计划，新的“加州大学旧金山分校-斯坦福PDC”的特点是强调概念阶段的市场评估和 价值分析；内部产品开发、监管、专利和入驻企业家(EIR) 服务；一个亲力亲为的商业化咨询委员会，以制定具体情况下的进入市场战略； 以及一个由外部医疗技术顾问和产品开发资源组成的深入而坚定的网络 世界创新之都。 加州大学旧金山分校资深设备创新者迈克尔·哈里森医学博士和舒沃·罗伊博士 (生物工程)斯坦福大学的詹姆斯·沃尔(儿科外科)医学博士，斯坦福大学助理主任 生物设计创新奖学金计划。资深医疗技术行业专业人士Chris Jones(产品 发展)、Michael Billig(监管事务)、David Levine(知识产权)、Daniel Burnett 和道格拉斯·克劳福德(商业化咨询委员会主席)将提供 董事级别的支持。加州大学旧金山分校-斯坦福大学PDC提供了丰富的专业知识，可以通过其 每周“开放创新”会议、互动式门户网站、综合咨询服务和半年一次 儿科设备加速器推介大赛，提供专家咨询、商业化 指导和直接资助，以推进具有强大市场潜力的儿科设备项目。除了……之外 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El Camino的Fogarty创新研究所 医院(山景城)。 自2009年成立以来，加州大学旧金山分校的PDC已经从 从概念阶段到第一次人体试验，指导了三种设备的上市，并利用 外部资金，以支持其技术的持续发展。斯坦福大学的生物设计项目 建立了国际公认的设备创新和发展模式，推出了46 成功的创业公司，他们的技术现在已经覆盖了100多万患者。在下一个PDC中 授予周期，这两个创新计划将结合各自的优势和基础设施创建 一项强大的计划，加速高影响力、基于价值的儿科设备解决方案商业化 和耐心的影响。

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.