Office of Translational Initiatives and Program Innovations, National Institute on Drug Abuse, Bethesda, MD 20894.
Subst Use Misuse. 2023;58(5):735-738. doi: 10.1080/10826084.2023.2184209. Epub 2023 Mar 3.
: Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. : National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD. NIDA aims to support research and development of medical devices intended to monitor, diagnose, or treat substance use disorders. : NIDA participates in Blueprint MedTech program is part of the large NIH Blueprint for Neurological Research Initiative. It supports the research and development of new medical devices through product optimization, pre-clinical testing, and human subject studies, including clinical trials. The program is structured in two main components - Blueprint MedTech Incubator and Blueprint MedTech Translator. It offers free to the researcher services that are typically unavailable in academic environment - business expertise facilities and staffing to successfully develop minimum viable devices, pre-clinical bench testing, clinical studies, planning and executing in manufacturing, as well as regulatory expertise. : Through Blueprint MedTech, NIDA provides innovators with expanded resources to ensure the success of the research.
: 药物过量导致的死亡已达到危机水平,据 2020 年 4 月至 2021 年 4 月的报告,超过 10 万人因此死亡。急需采取新方法来解决这个问题。: 国家药物滥用研究所(NIDA)正在领导开创性的综合努力,开发安全有效的产品,以满足受药物使用障碍影响的公民的需求。NIDA 旨在支持旨在监测、诊断或治疗药物使用障碍的医疗器械的研究和开发。: NIDA 参与 Blueprint MedTech 计划是大型 NIH 神经科学研究蓝图倡议的一部分。它通过产品优化、临床前测试和人体研究(包括临床试验)来支持新医疗器械的研究和开发。该计划由两个主要部分组成——Blueprint MedTech 孵化器和 Blueprint MedTech 翻译器。它为研究人员提供了通常在学术环境中无法获得的免费服务——商业专业知识设施和人员配备,以成功开发最小可行设备、临床前台式测试、临床研究、规划和执行制造以及监管专业知识。: 通过 Blueprint MedTech,NIDA 为创新者提供了扩展的资源,以确保研究的成功。