Educational Program on Translating Neural Medical Devices

现有的神经技术继续对临床产生重大影响，但科学家和工程师在将新设备从工作台转移到床边的过程中仍然面临挑战。在过去的两年里(通过25卢比的拨款)，我们开发了一个关于神经技术翻译和商业化的全面、免费的在线短期课程，名为Neurotech Course，其中包括来自不同且经验丰富的项目教职员工的20个自定进度的视频讲座、主题问题，以及越来越多的更高级学习的在线资源目录。这些短期课程视频讲座涵盖临床前模型系统、安全性和有效性研究、良好实验室实践、设备测试、质量体系流程、监管机构互动、开发研究设备豁免(IDE)应用程序的步骤、报销机构互动、临床试验设计(重点是目标参与度的量化结果衡量)、特定于神经医疗设备的生物伦理考虑因素、确保强有力的知识产权主张的技术、可用于技术开发和临床试验的资金机会，以及关于将神经技术转化为成功商业企业的建议。有了这笔赠款，我们建议通过(1)创建虚拟的“短跑”来显著扩大这门课程的规模，在这一过程中，项目教员通过在线讲座指导参与者队列(以最大限度地遵守课程并使参与者能够在学习过程中提出后续问题)。然后，这些在线“冲刺”将与为期(2)天的实践研讨会(面对面和虚拟选项)相结合，参与者将与项目教员一起审查案例研究；通过一系列强化练习讨论最佳实践，在创新过程中满足临床需求；并通过制定自己的计划进行指导。该课程将面向资深博士后学者、学术和临床教师，以及准备开发具有临床成分的研究资助提案的初创公司科学家、工程师和企业家。本课程将作为早期创业者成功过渡到后期项目的重要桥梁，这些项目包括NIH C3i、NSF I-Corps、孵化器和加速器。

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.