Small Business Translator: MedTech and Digital Health Technologies

The Small Business Translator: MedTech and Digital Health Technologies is a forecasted funding opportunity released by the National Institutes of Health (NIH), under the U.S. Department of Health and Human Services. This grant initiative is designed to support small business concerns in advancing technologies aimed at preventing, diagnosing, monitoring, and treating health conditions aligned with the missions of various participating NIH Institutes, Centers, and Offices. The announcement highlights collaboration with prominent trans-NIH initiatives such as the Blueprint for Neuroscience Research, the BRAIN Initiative under the 21st Century Cures Act, and the HEAL Initiative, which addresses the opioid crisis. The goal of this funding opportunity is to facilitate translational research and clinical studies to develop MedTech and digital health technologies. These technologies may include wearable devices, digital tools, imaging-based biomarkers, in vitro diagnostics, implantable systems, and medical-device-development tools (MDDT). The funding supports a range of activities from clinical prototype development and non-clinical safety testing to IDE submissions for significant risk studies or IRB approval for non-significant risk studies. Clinical studies addressing the safety, usability, feasibility, and efficacy of these devices are within the scope of funding. This program operates through a cooperative agreement mechanism, making it milestone-driven and involving NIH program staff in both the finalization of the project plan and ongoing progress monitoring. Award recipients are expected to conduct the majority of their research activities within their own facilities. Additional resources may be requested to support collaborations with consultants in areas such as regulatory affairs, reimbursement strategies, intellectual property, commercialization planning, and strategic partnerships. Applicants are also allowed to request access to NIH contract services for specialized needs including animal testing, sterilization, biocompatibility assessments, manufacturing, and clinical or medical monitoring services. Small business concerns with established collaborations with device manufacturers, or those developing their own devices, are particularly encouraged to apply. This inclusive support model aims to enhance the transition of promising biomedical technologies from concept to clinical utility. The opportunity is open to a wide range of applicants including small businesses, for-profit and nonprofit organizations, higher education institutions, public housing authorities, and various governmental bodies including state, county, and tribal governments. No cost-sharing or matching funds are required for this grant. Key dates for this grant opportunity include an estimated post date of July 21, 2025, a submission deadline of October 20, 2025, and an estimated award date of July 1, 2026. The project start date is also expected to be July 1, 2026. The primary contact for inquiries is Dr. Nicholas Langhals at the National Institute of Neurological Disorders and Stroke, and he can be reached at 301-435-0090 or via email at Blueprint-MedTech@nih.gov.