Educational Program on Translating Neural Medical Devices

神经医疗设备翻译教育计划

• 批准号: 10672811
• 负责人: Jennifer French
• 金额: $ 26.66万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10672811
• 关键词: Acceleration; Adherence; Adoption; Applications Grants; Awareness; Biological Models; Businesses; Cancer Education Grant Program; Case Study; Catalogs; Clinical; Clinical Trials; Clinical Trials Design; Communities; Coupled; Dedications; Development; Devices; Education; Educational Curriculum; Educational workshop; Engineering; Exercise; Faculty; Failure; Feedback; Foundations; Funding; Funding Opportunities; Future Generations; Grant; Healthcare Systems; Hour; Hybrids; Incubators; Innovation Corps; Intellectual Property; Knowledge; Lead; Learning; Link; Marketing; Medical Device; Mentors; Mentorship; Modeling; Neural Pathways; Nursing Faculty; Outcome; Outcome Measure; Participant; Persons; Postdoctoral Fellow; Pre-Clinical Model; Process; Regulatory Affairs; Research Project Grants; Resources; Scientist; Secure; Series; Solid; System; Techniques; Technology; Testing; Thinking; Training; Training Programs; Training and Education; Translating; Translations; United States National Institutes of Health; Update; Work; bench to bedside; cohort; commercialization; design; efficacy study; experience; first-in-human; follow-up; good laboratory practice; human study; ideation; innovation; interest; lectures; meetings; neural; neurotechnology; online course; online resource; pre-clinical; programs; safety study; success; technology development; virtual

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.

现有的神经技术继续产生重大的临床影响，但是在将新设备从板凳上移到床边的科学家和工程师仍然存在挑战。在过去的两年中（通过R25赠款），我们开发了一门全面的，免费的在线在线简短课程，涉及神经技术翻译和商业化，称为Neurotech课程，其中包含来自潜水员和经验丰富的课程教师的20个自定为视频讲座，以及越来越多的在线资源的目录，以提供更多的高级学习。这些短道视频的讲座涵盖临床前模型系统，安全性和效率研究，良好的实验室实践，设备测试，质量系统过程，监管机构互动，开发研究设备豁免（IDE）应用（IDE）的应用，报销机构相互作用，临床试验，临床试验设计，强调针对性的智能范围，这些特定的智能范围，是针对性的，是针对性的，生物ETH的定量范围，是针对性的，生物ETH的范围，是针对性的，生物ETH的定量范围，索赔，用于技术开发和临床试验的资金机会以及将神经技术转移到成功的商业企业中的建议。有了这笔赠款，我们建议通过（1）创建虚拟的“冲刺”来大大扩大本课程，在该课程中，课程教师指南通过在线讲座参与同伙（以最大程度地遵守课程，并使参与者能够沿途提出后续问题）。然后，这些在线“冲刺”将与（2）3天的动手研讨会（亲自和虚拟选择）结合在一起，参与者将与计划教师合作审查案例研究；通过一系列强化练习来讨论最佳实践，通过创新过程来临床需要；并通过制定自己的计划来召唤。该课程将针对高级博士后学者；学术和临床教师；以及准备使用临床组成部分开发研究赠款建议的初创公司科学家，工程师和企业家。本课程将成为早期企业家成功转向后期计划的重要桥梁，包括NIH C3I，NSF I-Corps，孵化器和加速器。