Biodevice Innovation Training Program

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Project Summary The UC San Francisco Department of Surgery, in collaboration with the Department of Bioengineering and Therapeutic Sciences, proposes to establish an interdisciplinary R25 research education program in clinical and translational “Biodevice Innovation” for surgical residents. Surgeons possess extensive knowledge of anatomy, are intimately familiar with the needs of their patients and the limitations of current technology, and possess strong problem solving abilities developed out of the necessity to constantly improvise solutions in the operating room. However, the declining levels of NIH-funded surgeon-investigators necessitates structural changes in surgical training programs and the introduction of innovative approaches in order to engage more surgeons in research. Device innovation is becoming increasingly recognized as a research area in which surgeons can make significant creative contributions that profoundly impact patient care. Designed for surgical residents interested in careers as clinician-innovators, the proposed program would provide hands-on research experiences for residents during their two dedicated research years to work alongside prominent faculty innovators from Surgery, Bioengineering, Radiology, and other relevant clinical disciplines to develop and translate novel device-based solutions for unmet clinical needs. In the process, participants will develop the requisite bioengineering research skills, knowledge of the medical product development process, and mentor relationships to help launch their own research careers, successfully compete for grant funding, and successfully engage in device innovation as independent surgeon-scientists. The leadership team has a multi- year history of collaboration translating advances in bioengineering into innovative new treatment paradigms and breakthroughs in clinical care through successful programs such as the FDA-sponsored UCSF Pediatric Device Consortium and UCSF's Surgical Innovations Initiative. Many of the key elements of the program are already in place, including ties to the UCSF-UC Berkeley Joint Graduate Group in Bioengineering, the UCB- UCSF Master of Translational Medicine Program, the UCSF-Stanford Center of Excellence in Regulatory Science & Innovation (CERSI), and a robust infrastructure supporting device innovation at UCSF. The training program is supported by an outstanding mentorship team including faculty internationally renowned for their achievements in device innovation.