NIH Highlighted Topic: Digital Twins for Biomedical, Biological and Behavioral Research
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is encouraging innovative research and prototype development of digital twin technologies for biomedical, biological, and behavioral research and human health. NIH uses the 2023 National Academies definition: a digital twin is a virtual model that mimics a real system, is dynamically updated with data from its physical counterpart, has predictive capability, and informs decisions. The two-way link between the virtual and the physical is central.
NIH wants fit-for-purpose digital twins that accelerate discovery, support intelligent medical technologies, and enable decision support across clinical, laboratory, and healthcare settings. Priority areas include verification, validation, and uncertainty quantification (VVUQ), real-time assimilation of multimodal and longitudinal data, interoperable and scalable computational architectures, and responsible governance of digital twin technologies.
Institute interests are broad. NCI wants cancer digital twins that predict treatment response and inform clinical trial design. NHLBI highlights patient-specific modeling and medical device design. NEI is interested in twins for glaucoma, macular degeneration, and diabetic retinopathy. NIBIB supports sensor-linked physical assets and readiness evaluation tools, while NIDDK, NIMH, NIDA, and NIGMS each outline uses ranging from clinical decision support to virtual clinical trials and drug-response prediction.
How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. The Office of Data Science Strategy does not award grants itself, so applications must also fit the mission of at least one participating Institute or Center. We recommend contacting the relevant ICO scientific contact to confirm fit before writing.
This highlighted topic is led by the NIH Office of Data Science Strategy (ODSS) with participation from NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIBIB, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NLM, and ORWH. NCCIH, NIDA, NIDCR, NIDDK, and NIMHD note they may give special consideration to meritorious applications in this area. The topic is active from September 10, 2026 through September 10, 2028.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of digital twin platforms, software, and enabling tools for biomedical research and healthcare.
Eligible activities may include:
Fit-for-purpose, bidirectional digital twin prototypes for a defined disease, organ system, or care setting
Verification, validation, and uncertainty quantification (VVUQ) tools and benchmarking frameworks
Real-time data assimilation pipelines linking sensors, wearables, imaging, and EHR data to virtual models
Interoperable, modular digital twin architectures and reusable software platforms
Virtual clinical trial and in silico testing tools for drugs, devices, and interventions
Clinical decision support prototypes and usability testing with clinicians and research end users
Commercialization planning, regulatory strategy, and market validation
Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable digital twin product aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have 500 or fewer employees including affiliates.
Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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