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.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) the degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.