UC San Francisco Pediatric Device Consortium

描述（由申请人提供）： 弗朗西斯科加州大学儿科器械联盟的使命是为寻求通过设计和开发新型医疗器械来解决紧急儿科临床问题的创新者提供器械开发的基础设施、专业知识和资源。 该小组由Michael Harrison博士领导。（小儿外科）和Shuvo Roy博士（生物工程）。 位于旧金山弗朗西斯科的加州大学儿科器械联盟汇集了临床医生、科学家、工程师和器械行业代表，以帮助促进儿科器械开发的挑战性过程，包括设计和开发、专利申请、获得监管批准、进行临床试验和销售器械。 可以在每两周一次的会议上和通过交互式门户网站访问儿科器械联盟的专家。 为了最大限度地提高生产力和覆盖范围，儿科器械联盟以核心人员和资源基础设施（原型设计能力、测试设施和顾问网络）为中心，这些都可用于所有单个项目。 有了这个支助系统，这些个别项目就有了一个基础，可以吸引自己的资金来支付更昂贵的开发费用，自联合体成立以来，已经吸引了200多万美元的新的外部资金。 位于旧金山弗朗西斯科的加州大学儿科设备联盟目前正在促进十几种儿科设备的开发。 以下五个项目是拟议的组合项目： 1. Roboimplant治疗早发性脊柱侧凸 2. 小儿脑积水无线压力传感器 3. 磁压缩吻合器 4. Magnap：磁性呼吸暂停预防装置 5. 用于临床试验的远程机载传感、数据记录和安全下载设备。 除了维持每两周一次的会议、门户网站和使用测试设施外， 儿科设备联盟每年将提供启动资金（10，000至15，000美元），以启动单个项目，并帮助它们吸引更多的资金。 该联盟还开发了一个顾问网络，可以提供产品开发，制造，生物力学测试，监管批准，风险投资和临床试验方面的专业知识。 在接下来的两年内，儿科器械联盟将专注于获得 电气工程师，改善成员沟通，通过为其成员提供培训机会加强教育部分，加强为器械所有者提供的援助，以引导监管和商业化途径，为单个项目吸引更多外部资金，并继续与MISTRAL器械联盟合作。

DESCRIPTION (provided by applicant): The mission of the University of California at San Francisco Pediatric Device Consortium is to provide the infrastructure, expertise, and resources for device development to innovators seeking to solve urgent pediatric clinical problems by designing and developing novel medical devices. The group is led by Michael Harrison, M.D. (pediatric surgery) and Shuvo Roy, Ph.D. (bioengineering). The University of California at San Francisco Pediatric Device Consortium brings together a diverse group of clinicians, scientists, engineers, and device industry representatives to help facilitate the challenging process of pediatric device development, which includes design and development, patenting, gaining regulatory approval, conducting clinical trials, and marketing the device. The Pediatric Device Consortium experts can be accessed at biweekly meetings and through an interactive web portal. In order to maximize productivity and reach, the Pediatric Device Consortium is centered on core personnel and resource infrastructure (prototyping capabilities, testing facilities, and a consultant network) which are made available to all of the individual projects. With this support system, these individual projects have a basis from which to attract their own funding for more expensive development costs, which has resulted in over $2 million in new outside funding since the consortium began. The University of California at San Francisco Pediatric Device Consortium currently is facilitating the development of over a dozen pediatric devices. The following five projects are the proposed portfolio projects: 1. Roboimplant for early onset scoliosis 2. Wireless pressure sensor for pediatric hydrocephalus 3. Magnamosis: Magnetic compression anastomosis device 4. Magnap: Magnetic apnea prevention device 5. Remote on-board sensing, data-logging, and secure downloading device for clinical trials. In addition to sustaining the bi-weekly meetings, web portal, and access to testing facilities, the Pediatric Device Consortium will provide start-up funding ($10,000 to $15,000) per year to initiate individual projects and help position them to attract more substantial funding. The consortium also has developed a network of consultants who can provide expertise in product development, manufacturing, biomechanical testing, regulatory approvals, venture funding, and clinical trials. In the next two years the Pediatric Device Consortium will focus on obtaining an electrical engineer, improving member communications, strengthening the education component through training opportunities for its members, strengthening assistance provided device owners to navigate the regulatory and commercialization pathways, attracting more outside funding for individual projects, and continued collaboration with the MISTRAL Device Consortium.