UC San Francisco Pediatric Device Consortium

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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.