Sample NIH Summary Statement: Impact Score 45 - When Reviewers See Potential But Major Gaps

SBIR Grant Writers · February 20, 2026

An impact score of 45 is below the payline at virtually every NIH Institute. This application will not be funded, and the applicant faces a choice: resubmit with major revisions, or substantially restructure and submit as a new application. The summary statement provides clear guidance on which path makes sense.

Note: This summary statement is entirely fictional. All company names, investigator names, and project details are fabricated for educational purposes.

The Application at a Glance

This fictional Phase I SBIR application proposed an AI-guided robotic microsurgical system capable of autonomous suturing during minimally invasive cardiac procedures. The system integrates computer vision, force-sensing feedback, and deep learning algorithms to execute suturing without direct surgeon manipulation.

The Resume Sets the Tone

Unlike the "split" language in mid-range scores, this Resume uses phrases like "substantial concerns," "very early stage," and "unclear." The committee acknowledged the potential significance of the concept but expressed consistent doubt about readiness. When the Resume lists more concerns than positives, the application has significant problems.

The Reviewer Scores

Reviewer 1

Reviewer 2

Reviewer 3

The Core Problems

Reading across all three critiques, four systemic issues emerge:

Insufficient preliminary data. The preliminary data showed 0.8mm accuracy on synthetic phantoms with a 72% completion rate - which does not even meet the proposed 0.5mm success criterion. Reviewers flagged that biological tissue presents substantially greater challenges than phantoms, making the gap between current performance and proposed targets very large.

Missing clinical expertise. No cardiac surgeon with robotic surgery experience was on the team. For a project proposing to automate a surgical procedure, this is a critical gap that every reviewer identified. One reviewer noted: "This is a drug discovery proposal led by someone who has never discovered a drug" - that same logic applies here to surgery.

No regulatory strategy. Autonomous surgical decision-making has no predicate device at FDA. Multiple reviewers noted this challenge was not addressed, which for a medical device application is a significant oversight.

Safety analysis absent. For a system that would autonomously place sutures in cardiac tissue, failure mode analysis and safety mechanisms are essential. Their absence suggests the team has not yet grappled with the real-world requirements of autonomous surgery.

Resubmit or Restart?

This is a case where resubmission could work, but only with major changes. The concept has genuine merit - Reviewer 3 explicitly said "a substantially strengthened resubmission could be competitive." The critical additions needed are: a clinical co-PI with robotic cardiac surgery experience, biological tissue preliminary data (even small-scale), a detailed regulatory strategy addressing the autonomous decision-making challenge, and a safety analysis framework.

If the team cannot recruit a clinical surgical collaborator, this application should be substantially restructured - perhaps focusing on surgeon-assisted rather than autonomous suturing - before resubmitting.

See Other Score Examples