NIH SBIR/STTR Grant Writing - Ventura Solutions

If you are looking for a way to fund your existing small company or startup, NIH SBIR/STTR funding can be a great non-dilutive option for you!

Ventura Solutions has helped clients raise millions of dollars in NIH SBIR/STTR funding. We assist clients in developing high quality NIH SBIR and STTR grant proposals in the medical device, pharmaceutical, and combination products industries. Clients work directly with our Grant Writing Specialists, who provide expertise in obtaining grant funding in the client’s technical field. Our services include writing and submitting full proposals as well as critical scientific review and editing to increase the competitiveness of the grant applications.

Writing effective NIH SBIR grants: Know your Review Categories

The NIH SBIR/STTR program is highly competitive. Each year thousands of qualified applicants are denied funding. Learn what it takes to write a winning SBIR/STTR grant and improve your chances by partnering with the seasoned experts at Ventura Solutions. We have helped dozens of small med-tech companies raise millions of dollars in non-dilutive funding. We are former SBIR recipients, and reviewers. We can help prepare your company to be extremely competitive. Are you ready to compete? Consider the 5 major NIH SBIR/STTR review topics below:

Investigators

Principal Investigator

The P.I. is the party responsible for overseeing all aspects of the project. The PI should have a background carefully matched to the scientific/clinical goals of the proposed work and hopefully significant experience.

Internal Team

The applicant needs to demonstrate the availability of strong in-house expertise to support each Specific Aim. Describe how your team is prepared to meet the proposed technical or commercialization challenges.

Environment

Lab/Office Space

Ideally, physical products are developed and/or tested on-site with project-appropriate equipment and staff. An actual lab/office improves reviewer confidence that the company can meet tangible outcomes. An all-virtual approach should be confined to software-only projects.

External Team

The review panel understands that project success is multi-factorial and expects applicants to collect additional necessary expertise in the form of high-quality external partnerships / collaborators / consultants.

Significance

Health Economics

It is critical that applicants clearly outline the financial/societal benefits that come from the clinical benefits associated with the proposed technology. A reimbursement strategy is essential

Preliminary Data/Prototype

While SBIR review criteria specify that no preliminary data is necessary (for Phase I), most funded proposal include some level of technical feasibility. This establishes confidence in the project and the team. Phase II projects must have extensive, high-quality, supporting feasibility data.

Innovation

Intellectual Property

Serious applicants will already have made some efforts at protecting the intellectual property associated with the proposed technology. A national and international plan is reasonable.

Product Novelty

The goal of the SBIR program is to support innovative ideas with commercial potential. Applicants must work hard to differentiate their product/approach from competitors and clearly outline what is new and different.

Approach

Scientific Rigor

Great ideas can’t get through the review process unless applicants propose a scientifically sound research plan including strong metrics of success and the statistical analysis that will be used.

Risk Mitigation

It’s commonly accepted that things may not go as planned during a research project. Reviewers appreciate when applicants understand potential risks of proposed experiments and suggest alternative approaches that will be employed if needed.

We’ll help craft your winning story!

Reviewers will score your application in the 5 categories shown above and then provide a single overall project score to your submitted grant. The proposal must stand on its own, applicants are not allowed to be present or give additional information later. The idea, its commercialization potential, and your path to market must synergistically lay out an exciting path that captivates reviewers. Your final score can be impacted by a large number of additional features. Are you ready to compete? Consider some other important issues below:

Eligibility

NIH SBIR/STTR funding is restricted to US-based, for-profit, majority American-owned companies with < 500 employees. The PI must be employed at the company at least 51% time for SBIR and at least 10% time for STTR.

Commercialization Plan

Similar to a Business Plan, the SBIR/STTR Commercialization Plan is a 12-page document that outlines your company’s proposed pathway to market. It should include succinct overviews on proposed yearly revenue, sales, reimbursement, regulatory, marketing etc.

Regulatory Strategy

As part of the Commercialization Plan, it is critical to highlight a strong regulatory strategy. If the company has not yet formally established one, there should still be language discussing probable approaches and a budget request for a regulatory consultant.

Letters of Reference

Reviewers need confirmation that your idea and/or research plan has buy-in from other stakeholders. Work aggressively to get supporting letters from external partners, potential investors, clinicians etc.

Available resources specializing in SBIR/STTR NIH Grant Writing:

Grant Writing Specialists
Medical Device Engineers
Combination Products Engineers
Quality Engineers

Ready to get Started?

We provide our clients with NIH Grant Writing resources though our Consulting, Staffing & Recruitment, and Outsourced Partner Solutions.

Consulting Services

Staffing & Recruitment

Outsourced Partner

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“Ventura Solutions has been our strategic R&D consulting vendor since July 2017 and has been instrumental in the updating of our risk management quality system as well as authoring risk deliverables for our top projects. His consultants truly became an extended part of our organization as they quickly embraced our company culture, people, and processes to seamlessly integrate onto project teams. They share the same sense of passion to improve physician efficiency and patient satisfaction worldwide. and deliver on commitments with a high level of professionalism and quality. Ventura Solutions is an outstanding resource extension vendor that truly partners with you to exceed your business objectives.”

- Patrick Lee VP R&D Laborie Medical Technologies Corp.

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