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.

PROJECT NARRATIVE For pediatric medical device innovators unaccustomed or under-resourced for navigating the challenging waters of design iteration and prototyping, patenting, conducting preclinical and clinical trials, gaining regulatory approval and reimbursement, commercializing a device, and finally entering the hospital supply chain, the UCSF-Stanford Pediatric Device Consortium offers a wealth of expertise that is easily accessed through our weekly `open innovation' meetings, our interactive web portal, our comprehensive advising services, and our semiannual Pediatric Device Accelerator pitch competition, which provides expert consulting, commercialization mentorship, and direct funding to advance pediatric device projects with strong market potential towards market availability and the pediatric population.