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.
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.
