Educational Program on Translating Neural Medical Devices

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. Over the past two years (through an R25 grant), we developed a comprehensive, freely-available online short course on neurotechnology translation and commercialization called the NeuroTech Course featuring 20 self-paced video lectures from a diverse and experienced group of program faculty, topical questions, and a growing catalog of online resources for more advanced learning. These short-course video lectures cover 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. With this grant, we propose to significantly amplify this course by (1) creating virtual “sprints” in which program faculty guide participant cohorts through the online lectures (to maximize adherence to the curriculum and enable participants to ask follow-up questions along the way). These online “sprints” will then be coupled with a (2) 3-day hands-on workshop (in person and virtual options) in which participants will work with program faculty to review case studies; discuss best practices through a series of intensive exercises taking a clinical need through the innovation process; and be mentored through the development of their own plans. The course will target senior postdoc scholars; academic and clinical faculty; and start-up company scientists, engineers, and entrepreneurs who are preparing to develop research grant proposals with a clinical component. This course will serve as an important bridge for early-stage entrepreneurs to be successful in moving to later-stage programs, including NIH C3i, NSF I-Corps, incubators, and accelerators.