HEAL Initiative: Optimization of Therapeutic Medical Devices through Team Science Mechanistic Research (RM1)

The National Institute of Neurological Disorders and Stroke (NINDS), with other NIH Institutes and Centers (ICs), intends to publish a Notice of Funding Opportunity (NOFO) to investigate the mechanisms of action of therapeutic medical devices with the overall goal of improving clinical outcomes with device-based approaches. Medical devices are essential in managing health conditions, complementing drugs and behavioral interventions, and often offer unique benefits. Despite the commercial availability of numerous medical devices and ongoing development of new technologies, many have shown inconsistent results in preclinical studies, failed translation to humans, and exhibit varied patient outcomes. To overcome these challenges, it is crucial to understand the mechanisms by which medical devices produce a therapeutic effect, to identify physiological markers of neurological conditions, and to assess how device-based therapies influence these markers. Advancing this knowledge will improve device-based interventions, inspire new device designs, and optimize current clinical approaches.

Applications will be invited from interdisciplinary teams pursuing innovative research on how medical devices produce a therapeutic effect. Applicant teams will likely exhibit expertise in areas such as engineering, biology, pathophysiology, surgery, clinical care, healthcare delivery, biostatistics, software development, computational modeling, artificial intelligence, regulatory science, and clinical trials. This program will accept projects on investigational devices and those already FDA-approved and in clinical use. Applications are expected to include strategies for developing or optimizing therapies that could significantly improve patient care. Supported research may include mechanistic clinical trials, animal studies, and computational modeling or simulation. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.