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

非技术性：由于缺乏当前的良好制造规范(CGMP)认证，研究人员无法获得FDA在临床环境中测试设备的许可。大学实验室未经认证的性质阻碍了创新，并减少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开发，并使美国处于创新医学研究的前沿。这次虚拟会议将汇聚研究工程界的领袖，讨论并概述基础设施的需求，以加快美国大学和初创公司开发的生物电子设备的临床转化。这次会议讨论了社区研究的优先事项、国家经济竞争力和总体健康。这次会议将是建立学术CGMP设施的第一步。这将反过来加速全国范围内的创新神经技术研究工作，并使美国处于医学研究的前沿。技术：这次虚拟会议将把人类神经调节设备的领导者聚集在一起，讨论并概述对基础设施的需求，以加快美国大学和初创公司开发的生物电子调制设备的临床翻译。目前，FDA批准的大多数设备只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正在开发植入式设备的有效性，但由于大学实验室的未经认证的性质，本可以允许更安全和更有效的审讯和调制模式的技术进步无法获得FDA的批准，从而阻止了法官的创新，并减少了研究对患者和纳税人的好处。大多数被认证为符合FDA当前良好制造规范(CGMP)规定的实验室，这些规定对制造过程中使用的方法、设施和控制提出了最低要求，这些实验室几乎完全是行业资源，这为学术开发的生物医学技术的台式到床边翻译制造了成本和便利障碍。在大学校园内创建CGMP设施可能有助于加快全国范围内的创新神经技术努力，并将美国置于植入式医疗设备的前沿。拟议的研讨会将专门关注大学和初创企业开发的神经调节设备临床翻译方面的当前进展和差距，并概述填补这一差距的基础设施的需求。该研讨会将是在大学校园内建立CGMP设施的第一步，该设施将有助于加快全国范围内的创新神经技术努力，并使美国处于植入式医疗设备的前沿。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.