NIH SBIR Proposal Guide: Mission & Review Fit

Show NIH You’re Mission-Aligned

The NIH isn’t just looking to fund innovative science — it’s looking to fund science that serves its mission to improve health and reduce illness. That means your SBIR proposal has to do more than demonstrate technical merit. It needs to make a clear, credible case that your project supports a specific health outcome or addresses an unmet need within the public health system. And that alignment needs to be obvious to reviewers.

NIH is made up of dozens of Institutes and Centers (ICs), each with its own area of focus — from mental health to cancer to rare diseases. Your proposal must map directly to one of these ICs to be eligible. But matching your topic isn’t enough. You also need to mirror the IC’s priorities in your Specific Aims, significance narrative, and commercial impact statements. This means using relevant keywords from the IC’s mission statement, citing aligned program goals, and describing how your innovation supports that IC’s strategy.

NIH awards are mission-driven
NIH does not fund proposals based solely on scientific novelty. Each project must align with the public health focus of a specific Institute or Center.

One of the best ways to ensure fit is to explore NIH RePORTER — a database of funded research. Search for projects similar to yours and note which ICs funded them. If your technology aligns with projects under NIAID or NIDDK, for instance, that’s a strong clue about where your proposal should go. Each IC also publishes a strategic plan or list of funding priorities. Quoting or referencing these documents shows reviewers you’ve done your homework.

Before you submit, connect with a Program Officer in the target IC. These officials can tell you whether your project fits their mission and may even suggest framing tweaks to improve alignment. Send a 1-page executive summary or your draft Specific Aims — just enough to get preliminary feedback.

Finally, don’t treat mission alignment as a check-the-box requirement. Reviewers (and the second-tier Advisory Councils) consider it a deciding factor. Your proposal should read as a purposeful contribution to NIH’s overarching goal: better health, longer lives, and reduced disease burden.

Nail the Review Criteria (Phase I vs. Phase II)

Understanding how NIH reviewers evaluate SBIR proposals is critical — and often overlooked by first-time applicants. NIH uses five standardized review criteria across both Phase I (R43) and Phase II (R44): Significance, Innovation, Investigator(s), Approach, and Environment. These criteria are familiar across NIH grants, but for SBIRs, they’re viewed through both a scientific and a commercial lens.

Here’s what each criterion really means — and how it shifts between phases:

Reviewers don’t assign scores for each criterion — they weigh them collectively to produce an overall impact score. However, “Approach” often dominates the discussion. Weak or unclear experimental plans are a common reason for lower scores.

Also, remember that the Commercialization Plan is officially scored only in Phase II. But even in Phase I, reviewers are trained to assess commercial potential through your Significance and Innovation sections. Don’t ignore market context just because it’s not in a separate document.

By tailoring your proposal to address each of these five review areas, and understanding how their importance shifts between phases, you give reviewers a roadmap to score you well — and a reason to champion your application in review meetings.

Write for Reviewers: Practical Tips

Writing an NIH SBIR proposal is not about sounding impressive — it’s about being clear. Your readers are expert reviewers, and their job is to find flaws. That means your job is to make the proposal easy to follow, logically sound, and complete. Every section should answer the question: “Why this? Why now? Why this team?”

Start with the Significance section. Use it to define the specific problem or gap in the field your innovation addresses. Include data where possible — prevalence rates, cost estimates, failure rates — to quantify the need. Then make the case for why solving this problem matters to public health and why your solution is a good candidate.

In the Innovation section, don’t just say your idea is novel. Say why. Use phrases like “This approach is distinct from existing solutions because…” or “To our knowledge, no other technology provides X under Y conditions.” This flags innovation clearly for reviewers and makes it easier for them to justify a strong score.

In the Approach, reviewers are looking for structure, not just ambition. Lay out your technical plan in steps: what you’ll do, how you’ll measure success, and what potential risks exist. Address limitations directly and propose contingency strategies. It’s not a weakness to admit what might go wrong — it’s a strength to show you’ve thought it through.

When discussing market potential, especially in Phase I, be honest but strategic. You’re not expected to provide a full business case, but reviewers want evidence that your innovation could matter in the real world. Mention customer discovery, unmet needs, competitive landscape, and why your approach may gain traction.

Make it reviewer-friendly
Use bolded subheadings, clear language, and declarative statements. Reviewers may skim — your key points should still land.

Ultimately, a winning proposal is not just well-reasoned — it’s reviewer-ready. Write with empathy for the reader: anticipate their questions, give them answers, and make your proposal easy to champion.

Get the Team Right

NIH reviewers want to fund people as much as projects. A strong team section demonstrates that you have the expertise, experience, and structure needed to execute the proposed work. This applies not only to scientific credibility but also to your ability to commercialize the outcome — especially in Phase II.

The Principal Investigator (PI) should have clear qualifications related to the technical work. Prior publications, patents, prototypes, or relevant product experience all help make the case. It’s also important to state that the PI will be primarily employed by the small business during the project, as NIH requires. Reviewers will check that the PI and team members have sufficient time committed to the project, so be precise in describing effort levels.

You don’t need a full team in-house to cover every domain — but you do need to explain how gaps are addressed. Consultants, subcontractors, or academic collaborators can fill technical, regulatory, or market-facing roles. Make sure their roles are well defined and their qualifications are included in biosketches or support letters.

Beyond qualifications, reviewers look at team cohesion. Do the key personnel cover all critical skill sets? Is there a commercialization lead or advisor? Have you previously worked together? These factors contribute to confidence that the project will be executed as planned.

In summary, a compelling team section connects the dots: who’s doing the work, why they’re qualified, and how their effort aligns with the project scope and stage. Don’t just describe your team — prove they’re the right team for this specific award.

Beyond the Science: Public Health Impact & Commercialization

Your NIH SBIR proposal must do more than showcase technical promise — it must convince reviewers that your innovation can improve public health and succeed in the real world. Even in Phase I, where feasibility is the focus, reviewers are asked to consider how the project, if successful, could affect healthcare outcomes and market adoption.

NIH isn’t looking for a polished business plan at this stage. But it does want evidence that you understand the landscape — both the health problem and the market environment your innovation will enter. Below are three essential components to include:

In Phase II, expectations rise. Reviewers will expect detailed plans for go-to-market strategy, scalability, and sustainability. But even now, in Phase I, showing that you’re thinking ahead can elevate your proposal from a promising experiment to a promising business.