Educational Program on Translating Neural Medical Devices

PROJECT SUMMARY AND ABSTRACT Existing neurotechnologies continue to make significant clinical impact, but challenges remain for scientists and engineers in moving new devices from the bench to the bedside. This grant will support the development of a comprehensive educational training program on the best practices for successfully navigating the translational and commercialization pathway for neural medical devices. The educational program will include (1) a series of publicly available video lectures that will be assembled and curated into a certificate program by a diverse group of program faculty with significant experience in moving neurotechnologies from the bench to the bedside. These short-course video lectures will cover the following topics: preclinical model systems, safety and efficacy studies, good laboratory practices, device testing, quality system processes, regulatory agency interactions, steps in developing an investigational device exemption (IDE) application, reimbursement agency interactions, clinical trial design with an emphasis on quantitative outcome measures of target engagement, bioethical considerations that are specific to neural medical devices, techniques for securing strong intellectual property claims, funding opportunities available for technology development and clinical trials, and advice on moving neurotechnology into successful commercial ventures. In addition, the educational program will provide (2) an annual three-day workshop in which participants will work with program faculty to think through and develop submissions to an institutional review board (IRB), the FDA, and/or funding groups for their own devices or devices inspired by relevant case studies. The workshop will be open to academic researchers, clinician scientists, and small-business entrepreneurs who are interested in gaining expertise that will help them translate their own neural medical devices. Participants of the workshop will be encouraged to continue interacting with program faculty through regular online follow-ups. The hands-on workshop will be offered for two years during the grant funding period with the goal of extending the workshop in future years through collaborations with our ongoing relationships with neural interfaces conferences.