Simpler Grants.gov #FOR-NS-25-017

NIH Funding Opportunity for Medical Technology Development by Small Businesses

This opportunity from the National Institutes of Health (NIH) seeks small businesses to accelerate the development of innovative medical technologies for a range of health applications. - Government Buyer: - National Institutes of Health (NIH), including participating Institutes, Centers, and Offices - Products/Services Requested: - Development and advancement of medical technologies, including: - Diagnostic, therapeutic, rehabilitative, and monitoring devices - Wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, medical-device-development-tools (MDDT), implantable and non-invasive systems, and clinical tools - Services supported include: - Clinical prototype implementation - Non-clinical safety and efficacy testing - Design verification and validation - Obtaining IDE or IRB approvals - Clinical studies for safety, usability, feasibility, and efficacy - Access to consultants for regulatory, reimbursement, IP, commercialization, and strategic partnerships - Access to contract services for animal testing, sterilization, biocompatibility, manufacturing, and clinical support - Unique/Notable Requirements: - Milestone-driven cooperative agreement structure with NIH staff participation - Open to small businesses, for-profit organizations, state/local governments, educational institutions, and nonprofits - Part of trans-NIH initiatives: Blueprint for Neuroscience Research, BRAIN Initiative, HEAL Initiative - No specific OEMs or vendors are named; applicants are expected to propose their own technologies and solutions.

Description

This Notice of Funding Opportunity (NOFO) encourages eligible small business concerns to pursue translational activities and clinical studies to advance the development of technologies for preventing, monitoring, diagnosing, and treating disorders within the missions of participating NIH Institutes, Centers, and Offices. Technologies may include diagnostic, therapeutic, rehabilitative, and monitoring devices such as wearables, digital health tools, imaging biomarkers, in vitro diagnostics, and implantable or non-invasive systems. Supported activities include clinical prototype implementation, safety and efficacy testing, design verification, obtaining IDE or IRB approvals, and clinical studies addressing safety, usability, feasibility, and efficacy. The program is milestone-driven and cooperative, involving NIH staff participation and funding for activities conducted in applicants' laboratories, with options for collaboration and contract services support.

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