Initiative: Optimization of Therapeutic Medical Devices through Team Science Mechanistic Research (RM1)
Can you apply?
This grant is for research teams investigating how therapeutic medical devices produce therapeutic effects. Eligible applicants include research institutions, universities, and organizations with capacity to lead interdisciplinary team science projects. Teams should include expertise in engineering, biology, pathophysiology, clinical care, biostatistics, computational modeling, or related fields. The program accepts mechanistic clinical trials, animal studies, and computational modeling projects on investigational and FDA-approved devices.
Geographic scope is national. Applications are not currently being solicited; this is advance notice for grant planning.
Key dates
- Mar 16, 2026 Applications open
- Oct 30, 2026 Application deadline in 151 days
- Jul 1, 2027 Award announced
- Jul 1, 2027 Project start
This grant is for research teams investigating how therapeutic medical devices produce therapeutic effects. Eligible applicants include research institutions, universities, and organizations with capacity to lead interdisciplinary team science projects. Teams should include expertise in engineering, biology, pathophysiology, clinical care, biostatistics, computational modeling, or related fields. The program accepts mechanistic clinical trials, animal studies, and computational modeling projects on investigational and FDA-approved devices.
Geographic scope is national. Applications are not currently being solicited; this is advance notice for grant planning.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research teams investigating how therapeutic medical devices produce therapeutic effects. Eligible applicants include research institutions, universities, and organizations with capacity to lead interdisciplinary team science projects. Teams should include expertise in engineering, biology, pathophysiology, clinical care, biostatistics, computational modeling, or related fields. The program accepts mechanistic clinical trials, animal studies, and computational modeling projects on investigational and FDA-approved devices.
Geographic scope is national. Applications are not currently being solicited; this is advance notice for grant planning.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form
- Project Narrative (Research Strategy)
- Budget and Budget Justification
- Biosketch (for all key personnel)
- Letters of support from team members
Program contact
- 👤 NINDS Translational Devices Team
- 📧 NINDS-Devices@nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this grant?
Research teams from academic institutions, medical centers, and research organizations with capacity for interdisciplinary collaboration. Applications must demonstrate team expertise across multiple relevant disciplines.
What types of projects are funded?
Mechanistic clinical trials, animal studies, computational modeling, and simulation of therapeutic medical devices. Projects may investigate investigational devices or FDA-approved devices in clinical use.
Are there deadlines mentioned?
The deadline is October 30, 2026. Applications are not currently being solicited; this is advance notice only.
What expertise should the team have?
Teams should include expertise in engineering, biology, pathophysiology, surgery, clinical care, biostatistics, software development, computational modeling, AI, regulatory science, or clinical trials. Interdisciplinary collaboration is essential.
Can I apply as an individual researcher?
No. This program requires interdisciplinary team science. Single-investigator applications are not appropriate for this mechanism.
💡 Tips for applicants
- Assemble your interdisciplinary team early. This program requires genuine collaboration across multiple disciplines, not just co-authors.
- Focus on mechanism of action. Clearly explain how the device produces its therapeutic effect, not just that it works.
- Plan your research design carefully. Specify whether you'll use clinical trials, animal models, computational approaches, or a combination.
- Include a regulatory science perspective. Consider how mechanistic insights advance device development or optimization.
- Demonstrate clinical relevance. Show how understanding device mechanisms will improve patient outcomes and inform clinical practice.
⚠️ Common mistakes
Submitting single-investigator applications or weak team composition lacking true interdisciplinary expertise. Focusing on device efficacy rather than explaining the underlying mechanisms of action. Failing to articulate how mechanistic findings will translate to improved clinical outcomes or device optimization.
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