Preparing A Winning NSF SBIR Phase I Proposal

Purpose

Provide information on how to prepare a National Science Foundation (NSF) Small Business Innovation Research (SBIR) 15- Page Phase I Proposal. The successful proposal enables U.S.-based first time entrepreneurs, startups, and small emerging firm to obtain a $305K seed grant and demonstrate the concept feasibility of a proposed novel health technology or MedTech concept.

Function

The Phase I proposal describes how a small company plans use NSF SBIR seed funding to (1) conduct research & development proving concept feasibility, (2) highlight the market opportunity, the market size, the competition, and the potential buyers, and (3) profile the experienced, qualified research team.

NOTE: This presentation is the second of three articles on preparing successful National Science Foundation (NSF) Small Business Innovation Research (SBIR) funding proposal documents: Project Pitch, 15-Page Phase I Proposal, and 15-Phase Phase II Proposal. You can read the first article, on preparing an effective Project Pitch, here.

NSF SBIR 15-Page Phase I Proposal Development Process

There are six significant sections comprising the NSF SBIR 15-Page Phase I Proposal. Project Summary, Intellectual Merit (Research & Development Plan), Company/Team, Broader Impacts, Commercialization Potential, References Cited, and Budget are the sections that encompass the 15-Page Phase I Proposal.

With defined page limits, small business applicants must provide specific, detailed, descriptive information in each section. Below is a discussion, with brief examples included, how each section should be prepared.

Project Summary

Consisting of one page, this section should be completed last because it summarizes the other proposal sections. In general, the section requires applicants to (1) describe the potential outcome(s) of the proposed project in terms of a product, process, or service, (2) describe the technical hurdle(s) that will be addressed by the proposed research & development (R&D) plan, and (3) indicate the potential commercial impact.

Project Summary Brief Example

The proposed Queen Bee Self-Care mHealth System is designed to help Hispanic women type 2 diabetics (T2DM) better monitor and management their chronic condition. After completing a fully functioning prototype during the first year of Phase II, the Queen Bee Self-Care mHealth System will be refined into a customer-ready minimum viable product (MVP) for early adopters. An aggressive pre-sales program will be conducted during the second year of Phase II. Before leaving the NSF SBIR program, the company plans to implement its cost-effective go-to-market (GTM) strategy resulting in generating significant paid orders and earning revenues. The initial promotional and outreach effort will focus on partnering with various medical groups and patient advocacy groups. These groups will help increase product awareness and spread the word among primary care physicians (PCP) and Hispanic women T2DM diabetics.

Intellectual Merit (Research & Development Plan)

This section is the heart of the Phase I proposal. First, the section includes a specific description about the company's proposed technology solution. Next, a detailed research and development (R&D) plan states specific objectives and steps, i.e., experiments, the will be implemented to demonstrate concept feasibility. The steps, in particular, describe what will be done, how it will be done, why the work (steps) are unique as well as challenging in achieving the outcome. Moreover, this section must indicate technical risks that must be overcome in performing the work. The section, finally, must emphasis how the research and development activities will lead to overcoming technical risk(s) and proving the concept is workable.

Intellectual Merit Brief Example

Objective #2: Upward Tension on Incision Testing?

Force testing will confirm whether the prototype can withstand upward lifting force while not exceeding the wound burst force. An anatomical model consisting of an artificial pannus torso model covered with artificial skin containing a sutured incision, and force gauges attached to the straps at a fixed point will be used to evaluate the effect of increasing tension on the incision. It is important the straps have enough tension to support the pannus away from the incision, but not enough tension to pull apart the incision. Straps will be continuously tightened until a suture has ripped or the incision opens up. Testing, repeated for different distance intervals between the prototype and the incision, will demonstrate if the device will be able to support the pannus while avoiding too much upward tension on the incision. Test results will be evaluated for optimal distance for lowering force on the incision while supporting the pannus at optimal height. ?

Company/Team

Using two pages, this section introduces the company and its research team. The section discusses how the company and the research team have the necessary expertise, resources/support to carry out the project and committed to building a viable business around the product/service being developed.

Company/Team Brief Example

Acme, a Boulder CO-based small emerging medical technology firm, was founded in 2019 to develop and commercialize a novel home urine analysis device to help monitor and prevent serious chronic conditions such as heart disease, kidney disease and diabetes. Acme prepared a written sustainable business model, established a foundation and built the internal capacity to conceive and produce innovative health technology devices. The company’s proposed urine analysis device will help Acme establish a foothold in the medical technology industry while generating consistent sales and revenue over the next five years. Acme intends to produce additional innovative technologies to help patients better monitor and manage their chronic conditions.

Bernie Holiday is Acme Solutions' Chief Technology Officer. Mr. Holiday earned a masters degree in Engineering Technology from the University of Washington. He earned a bachelor in technology, computer systems engineering from the University of Miami. He has more than 20 years of experience in sensor development. His professional experience also includes working in the electrical and electronic manufacturing industry. With more than 10 years of experience in sensor development, Mr. Holiday's professional experience includes working in the electrical and electronic manufacturing industry. He is proficient in 3D Design, prototyping, and software development. Mr. Holiday will be the project’s principal investigator. He is expected to work 174 hours per month.? His successful background in leading new technology development projects and in sensor development will enhance the project.?

Broader Impacts

Applicants use two pages to indicate (1) what is the motivation for the company to take on this project, (2) how and why the proposed technology will result in a societal benefit and (3) which communities, i.e., patient populations battling diabetes, will directly benefit from the proposed solution.

Broader Impacts Brief Example

Acme Solution specialize in producing health technologies for patients battling chronic conditions. The proposed system is designed to help Hispanic women, 55 years old and older, who suffer from Type 2 diabetes (T2DM). The system empowers Hispanic women T2DM diabetics to sustain physical activities, eat healthier, and adhere to their medication regiment while reducing glycated haemoglobin (HbA1c) below the 6.5% recommended level. Many of these women possess a low-rate of practicing self-care management. The low-rate practice is called nonadherence, which results in diabetes related complications such as strokes and amputations. The nonadherence leads to medication avoidance, unhealthy eating habits, lack of physical activities, and poor glycemic control (HbA1c). Non-adherence is among the largest factors associated with poor outcomes in T2DM patients.?Existing mHealth self-care solutions include insulin management applications, continuous glucose monitoring, and smartphone applications. Studies indicate patients are interested in using mHealth for self-care management. The studies also recognize no real consensus regarding which self-care management mHealth approach is predominant. The company's proposed mHealth solution, unlike competing approaches, slows the progression of diabetes, elevates patient outcomes, and diminishes healthcare costs.

Commercialization Potential

Applicants use three pages to explain the market opportunity associated with the proposed solution. In particular, this section needs to include the initial target market (potential buyers) and its size, value proposition, regulatory issue, intellectual property strategy, competitive landscape and sustainable competitive advantage. The discussion should center on how the company will succeed in the marketplace with its proposed solution.

Commercialization Potential Brief Example

The primary buyers are hospitals. In particular, community hospitals, which offer obstetrics and gynecology services, are the initial targeted buyers. Hospitals offering abdominal hysterectomies and laparotomies surgical services are the secondary targeted buyers.?ACE technology’s primary competitors are Laborie, Medline, Applied Medical Resources, CooperSurgical, and Medfix?. These companies produce products used for panniculus retraction. Although these competing companies offer similar products, ACE’s proposed Pannus Adapter has key competitive advantages which include providing pannus uplift & support during and after the operation, ?enabling unobstructed access to the surgical site, and enhancing operation room workflow. Thus, ACE’s Adapter helps hospitals with improving patient outcomes, postoperatively, by preventing or significantly reducing surgical site infection (SSI) and reducing readmission rates.?ACE’s proposed Pannus Adapter competes in the surgical retractor market.? According to Novaone Advisor, a market research firm, the global surgical retractors market size was estimated at $1.9 billion in 2022 and is expected to surpass around $6.8 billion by 2030.

References Cited

The company must provide a comprehensive listing of relevant references, including websites or relevant URLs, patent numbers, and other relevant intellectual property citations.

Reference Cited Brief Example

Lucija Gosak, MSc, Majda Pajnkihar, PhD, and Gregor Stiglic, PhD, The Impact of Mobile Health Use on the Self-care of Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Trial, JMIR Res Protoc. 2022 Jun; 11(6): e31652.?

Budget

Once the research and development (R&D) section is completed, the budget is prepared. The budget is dependent on information/data from the R&D section. In other words, the budget indicates how much money the project will spend on the research team and other key items needed to execute the R&D plan.

Budget Brief Example

Charlie Nix, Principal Investigator, will work the entire 6 months and lead the project.? She/He will work 174 hours a month at $100 an hour.? The total compensation is 6 months @ 174? hours a month $100 per hour = $104,400

Fringe benefits are requested to cover employer paid taxes and benefits such as medical, dental and coverage for employees. The fringe benefits rate, based on company policy, is 20% of direct labor costs.? Therefore, requested fringe benefits are 20% * $135,720 = $27,144 total direct labor costs.?

Summary

Preparing a NSF SBIR 15-Phase I proposal involves applying pertinent, illuminating information/data describing how your startup or small emerging firm will produce a marketable, problem-solving health technology or MedTech solution.

It is worth noting that the require information/data needed to prepare all NSF SBIR proposal documents, i.e., Project Pitch, 15-Page Phase I Proposal, and 15-Phase Phase II Proposal, is found in a company's startup business model. In fact, the NSF SBIR program expect applicants to use a business model as the primary strategy helping the company to produce its proposed original concept, successfully launch & market the solution and grow the business.

Learn more about preparing an effective, comprehensive NSF SBIR 3-Page Project Pitch, by contacting Mr. Darrell Williams at [email protected] today.

Mr. Darrell Williams is the founder, president and CEO of Eighteen Ventures. He possess extensive experience in preparing startup business models and National Science Foundation (NSF) Small Business Innovation Research (SBIR) seed funding proposals.

Eighteen Ventures is a Portland, ME independent, private small business development consulting firm serving U.S.-based first-time entrepreneurs, startups, and small emerging firms seeking to produce a novel health technology or MedTech solution.

Our services include preparing sustainable startup business models and NSF SBIR proposal seed funding proposals. We do not provide direct investment in startups or small firms.

Eighteen Ventures helped Sterile Geeks VR, a startup MedTech firm based in Jacksonville, FL, prepare a sustainable business model and produce a winning NSF SBIR Phase I proposal resulting in a $255K new technology development seed grant.

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