UCSF-Stanford Pediatric Device Consortium

项目摘要 UCSF-斯坦福儿科器械联盟（PDC）将利用现有的器械创新人才 两所世界一流的大学和硅谷中心无与伦比的创业网络， 在发展的各个阶段，使儿科创新者能够将他们的创新转化为高价值， 商业上可行的产品。结合八年历史的FDA资助的 UCSF儿科器械联盟和历史悠久、享誉世界的斯坦福大学生物设计公司 计划，新的“UCSF斯坦福PDC”的特点是强调概念阶段的市场评估， 价值分析;内部产品开发、监管、专利申请和常驻代表（EIR） 一个亲自动手的商业化咨询委员会，以制定针对具体情况的进入市场战略; 以及一个由外部医疗技术顾问和产品开发资源组成的深厚而忠诚的网络， 世界创新之都。 加州大学旧金山分校设备创新专家Michael Harrison，医学博士（儿科外科）和Shuvo Roy，博士 （生物工程）加入了斯坦福大学的詹姆斯沃尔，医学博士（儿科外科），助理主任斯坦福大学的 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 开发部）、Michael Billig（法规事务部）、大卫莱文（知识产权部）、丹尼尔伯内特 （驻场企业家）和道格拉斯克劳福德（主席，商业化咨询委员会）将提供 主任级支持。UCSF-斯坦福PDC提供了丰富的专业知识，可以通过其 每周“开放式创新”会议、互动门户网站、全面咨询服务， 儿科设备加速器间距竞争，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器械项目。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 医疗设备孵化器Theranova（旧金山弗朗西斯科）和埃尔卡米诺的福格蒂创新研究所 医院（山景）。 自2009年成立以来，加州大学旧金山分校PDC已经推进了10个内部开发的儿科设备， 从概念阶段到首次人体试验，引导三种设备进入市场，并利用超过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 建立了国际公认的设备创新和开发模式，已推出46个 成功的创业公司，其技术现已惠及超过一百万患者。下一个PDC 赠款周期，这两个创新计划将联合收割机结合各自的优势和基础设施， 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.