Y. Kostov, N. Langhals, L. Angelone, S. Gutowski, J. Tilghman, M. Wolfson
National Institute on Drug Abuse,
Keywords: medical devices, neurotechnology, translation
Summary:All novel medical innovations begin with an idea carried forward through research, translation, and eventual implementation in the clinical arena. However, in medical device development, there is a well-known “valley of death” between basic research and clinical implementation, wherein many devices cannot surpass the extensive financial hurdles that hinder continued development through the translation phase. An analysis done by several NIH Blueprint Institutes and Centers that support translational studies of medical technologies highlights the underlying issue: most applicants are unprepared to take the leap from discovery-based research to translation. Thus, there is a clear need to fill the gap in translational research support between discovery and development of novel medical devices. The NIH established the Blueprint MedTech program to address this gap and support projects proposing research and development for devices intended to diagnose and treat diseases and disorders of the nervous system. The program catalyzes innovation by providing investigators access to resources, including non-dilutive funding and additional support from NIH-funded contract research organizations and consultants with relevant expertise. These extensive resources will assist device developers in overcoming the chasm of translation and bringing new medical devices to patients. By building upon validated biological targets, Blueprint MedTech will support projects after the concept and discovery phases with the previously demonstrated rigorous mechanistic basis for the indication and propose a Target Product Profile before pursuing larger-scale R&D efforts. The goal is to sufficiently de-risk technologies to enable industry partners and additional investments to bring these new diagnostic and therapeutic products to market.