Educational Program on Translating Neural Medical Devices

现有的神经技术继续产生重大的临床影响，但科学家和工程师在将新设备从实验室转移到床边方面仍然面临挑战。在过去的两年里（通过R25赠款），我们开发了一个全面的，免费提供的在线短期课程神经技术翻译和商业化称为神经技术课程，具有20个自定进度的视频讲座，来自一个多样化和经验丰富的项目教师，专题问题，以及越来越多的在线资源目录，用于更先进的学习。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，良好实验室规范，器械测试，质量体系流程，监管机构互动，开发试验用器械豁免（IDE）申请的步骤，报销机构互动，临床试验设计，重点是目标参与的定量结果测量，特定于神经医疗器械的生物伦理考虑，确保强有力的知识产权声明的技术，为技术开发和临床试验提供资金的机会，以及将神经技术转移到成功的商业企业的建议。有了这笔赠款，我们建议通过（1）创建虚拟的“冲刺”，其中程序教师通过在线讲座引导参与者队列（以最大限度地坚持课程，并使参与者能够问后续问题沿着）来显着扩大这门课程。这些在线“冲刺”将与为期3天的实践研讨会（亲自和虚拟选项）相结合，参与者将与项目教师一起审查案例研究;通过一系列强化练习讨论最佳实践，通过创新过程满足临床需求;并通过制定自己的计划进行指导。该课程将针对高级博士后学者;学术和临床教师;和初创公司的科学家，工程师和企业家谁正在准备开发具有临床组成部分的研究补助金提案。本课程将作为早期创业者成功转向后期计划的重要桥梁，包括NIH C3 i，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.