Small Business Translator: MedTech and Digital Health Technologies
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for small business concerns developing medical devices and digital health technologies. Eligible applicants must be SBCs pursuing translational activities and clinical studies. Activities include device prototyping, safety testing, clinical trials, IDE/IRB approvals, and regulatory support. SBCs developing their own devices or collaborating with manufacturers may apply.
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Key dates
- May 28, 2025 Applications open
- Oct 20, 2025 Application deadline
- Jul 1, 2026 Award announced
- Jul 1, 2026 Project start
Program description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage eligible small business concerns (SBCs) to pursue translational activities and clinical studies to advance the development of technologies to prevent, monitor, diagnose, and treat disorders within the missions of participating Institutes, Centers, and Offices. The NOFO will include participation from trans-NIH initiatives including the Blueprint for Neuroscience Research, the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and The Helping to End Addiction Long-term (HEAL) Initiative. Technologies responsive to the program may include diagnostic, therapeutic, rehabilitative, and/or monitoring devices including wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, medical-device-development-tools (MDDT), implantable or non-invasive systems, clinical tools, and other device-related technologies. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. Clinical studies and trials addressing safety, usability, feasibility, and/or efficacy of these technologies would also be included. This is a milestone-driven cooperative agreement program and will therefore involve participation of NIH program staff in negotiating the final project plan before award and monitoring research progress. Participants in the program will receive funding for all activities to be conducted in their own laboratories. In addition, applicants may request support to collaborate with consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also request access to contract services that specialize in animal testing, sterilization, biocompatibility, manufacturing, and clinical support/medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project narrative/proposal
- Budget and budget justification
- Small business certification documentation
- Regulatory strategy and timeline
- Device specifications and prototype status documentation
Program contact
- 👤 Nicholas Langhals, PhD National Institute of Neurological Disorders and Stroke (NINDS)
- 📧 Blueprint-MedTech@nih.gov
- 📞 301-435-0090
Funding track record
Recent awards under CFDA 93.865 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$1,073,967,938
-
$719,372,575
-
$276,059,721
-
$155,556,396
-
$155,482,198
-
$103,665,364
-
$74,151,078
-
$72,701,366
-
$52,238,426
-
$47,450,377
Top States by Funding
- WA 1 awards $1,074.0M
- NC 7 awards $925.9M
- MD 4 awards $501.6M
- MA 3 awards $190.0M
- PA 3 awards $145.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.865). How funding has trended year over year.
| 2024 | $1,282,226,682 | |
| 2025 | $1,333,391,690 | |
| 2026 est. | $184,920,723 |
FAQ
Who can apply?
Small business concerns (SBCs) developing medtech and digital health devices. Applicants must plan translational activities and clinical studies.
What types of devices are eligible?
Diagnostic, therapeutic, monitoring devices including wearables, digital health tools, imaging biomarkers, in vitro diagnostics, implantable systems, and clinical tools.
What activities are supported?
Clinical prototype testing, safety and efficacy testing, design validation, IDE/IRB approvals, and clinical trials. Consultation support for regulatory, IP, and commercialization is also available.
Can I collaborate with manufacturers?
Yes. SBCs with established collaborations or developing their own devices are both eligible to apply.
When is the deadline?
The deadline is fixed at October 20, 2025. This is a milestone-driven cooperative agreement with NIH staff involvement in planning.
💡 Tips for applicants
- Clearly demonstrate your small business status and device development stage before applying.
- Emphasize translational activities and clinical pathway from prototype to market.
- Include detailed milestone plans since this is a milestone-driven cooperative agreement.
- Budget for consultants in regulatory affairs, reimbursement, IP, and commercialization as allowed.
- Align your technology with NIH priority areas: neuroscience, BRAIN Initiative, HEAL Initiative, or other participating institute missions.
⚠️ Common mistakes
Applying with non-device technologies or purely research-focused projects without translational pathway. Failing to identify clear milestones and clinical development endpoints. Underestimating regulatory requirements or timeline to clinical approval.
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