MsRI-EW: Workshop for Clinical Translation of Implantable Devices. To be Held Virtually, August 10-12, 2020.

非技术：由于缺乏现行良好生产规范（CGMP）认证，研究人员无法获得FDA在临床环境中测试器械的许可。大学实验室未经认证的性质阻碍了创新，降低了研究对患者和纳税人的好处。在大学校园内建立CGMP设施将加速植入式设备的发展，并将美国置于创新医学研究的前沿。这次虚拟会议将汇集研究工程界的领导者，讨论并概述基础设施的需求，以加速美国大学和初创公司开发的生物电子设备的临床转化。本次会议将讨论社区研究重点、国家经济竞争力和一般卫生问题。这次会议将作为建立CGMP学术机构的第一步。这将反过来加速全国创新神经技术研究的努力，并将美国置于医学研究的前沿。技术：本次虚拟会议将汇集人类神经调节设备的领导者，讨论和概述基础设施的需求，以加速美国大学和初创公司开发的生物电子调节设备的临床转化。目前，大多数FDA批准的设备由少数几家公司控制，这对医疗保健成本产生了负面影响。尽管研究表明，全国各地的大学都在开发可植入设备的有效性，但由于大学实验室未经认证的性质，可以允许更安全、更有效的审讯和调制范式的技术进步无法获得FDA的许可，从而停止了实验台上的创新，减少了研究对患者和纳税人的好处。大多数通过FDA现行良好生产规范（CGMP）认证的实验室，包含了制造过程中使用的方法、设施和控制的最低要求，几乎完全是一种行业资源，为学术开发的生物医学技术从实验室到床边的转化创造了成本和便利障碍。在大学校园内建立CGMP设施可能是一种帮助加快全国神经技术创新努力的手段，并将美国置于植入式医疗设备的前沿。提议的研讨会将特别关注大学和初创公司开发的神经调节装置临床翻译的当前进展和差距，并概述对填补这一差距的基础设施的需求。该研讨会将作为在大学校园内建立CGMP设施的第一步，这将有助于加快全国创新神经技术的努力，并将美国置于植入式医疗设备的前沿。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

Nontechnical:Researchers cannot obtain FDA clearance to test devices in a clinical setting due to the lack of Current Good Manufacturing Practice (CGMP) certification. The uncertified nature of university laboratories blocks innovation and reduces the benefit of research to patients and taxpayers. The creation of CGMP facilities within a university campus will accelerate the development of implantable devices and place the U.S. at the forefront of innovative medical research. This virtual conference will bring together leaders in the research engineering community to discuss and outline the needs for infrastructure to accelerate the clinical translation of bioelectronics devices developed by U.S. universities and start-up companies. This conference addresses community research priorities, national economic competitiveness and general health. The conference will serve as the first step toward establishing an academic CGMP facility. That will in turn accelerate innovative neurotechnology research efforts across the country and place the U.S. at the forefront of medical research.Technical:This virtual conference will bring together the leaders in human neuromodulation devices to discuss and outline the needs for an infrastructure to accelerate the clinical translation of bioelectronics modulation devices developed by U.S. universities and startups. Currently, the majority of approved FDA devices are controlled by only a handful of companies, which negatively impacts the cost of healthcare. Despite research demonstrating the effectiveness of implantable devices being developed at universities across the nation, technological advances that could permit safer and more effective interrogation and modulation paradigms are unable to attain FDA clearance due to the uncertified nature of university labs, thus halting innovation at the bench and reducing the benefit of research to patients and taxpayers. The majority of laboratories that are certified to meet the FDA’s Current Good Manufacturing Practice (CGMP) regulations, which contain minimum requirements for the methods, facilities, and controls used in the manufacturing process, remain almost exclusively an industry resource, creating a cost and convenience barrier to the bench-to-bedside translation of academic-developed biomedical technologies. The creation of CGMP facilities within university campus settings could be a means to help accelerate innovative neurotechnology efforts across the country and place the U.S. at the forefront of implantable medical devices. The proposed workshop will specifically focus on the current progress and gaps in the clinical translation of neuromodulation devices developed in universities and startups, and outline the needs for an infrastructure to fill this gap. The workshop will serve as the first step toward establishing a CGMP facility within a university campus that will help accelerate innovative neurotechnology efforts across the country and place the U.S. at the forefront of implantable medical devices.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.