Small Business Innovative Research Project Research Articles

Bringing technology to market: National Heart, Lung, and Blood Institute SBIR Phase IIB projects

Abstract The National Heart, Lung, and Blood Institute (NHLBI) is the fourth largest institute in the US National Institutes of Health (NIH). Surprisingly, there is a conspicuous void of policy studies related to the research activities of NHLBI in comparison to NIH or the National Cancer Institute. This paper investigates the likelihood that a business funded through NHLBI’s Small Business Innovation Research (SBIR) program will commercialize from its Phase IIB translational support. Commercialization is one performance metric that quantifies a policy dimension of the success of the funded SBIR project. Based on an empirical analysis of sixty-one Phase IIB projects, we find that the most significant covariate with the likelihood of commercialization is the growth in human capital within the business since the Phase IIB award.

Innovation Transition Success: Practice Doesn’t Make Perfect

The authors of this research examine and evaluate organizational factors associated with commercialization under the Air Force Small Business Innovation Research (SBIR) program. Their objective is to improve return on investment. The data set used was the SBIR Phase II program data set, which contains information on 433 SBIR topics with closed contracts reported during Department of Defense (DoD) fiscal years (FYs) 2015 to 2018. Each data point contained characteristics of the topic, including commercialization. Military capability or topic areas were hypothesized to have varying commercialization rates. Incumbency was theorized to be a characteristic of successful programs, while increased company size was theorized as a characteristic of unsuccessful programs. Variables were analyzed through graphs and logistic regression. Small businesses (1 to 31 employees) have a 2.6% increased commercialization rate compared to large businesses (32 to 499 employees); this increase is significant when compared to the 8.8% global success rate of SBIR projects. No learning effect or improved performance was observed between companies new to the SBIR program (fewer than 14 contracts) and incumbents (15–419 contracts). The opposite—learning—was observed with new entrants outperforming incumbents. A bump in the data appears for newer entrants with some experience. In FY 2019, DoD obligated $1.8 billion in SBIR funding, and previous research indicated the commercialization rate of SBIR Phase II contracts is approximately 8.8%. This exploratory research looks at factors and trends seen in successful programs. Findings indicate factors that may guide investment choices to improve commercialization rates.

Knowledge begets knowledge: university knowledge spillovers and the output of scientific papers from U.S. Small Business Innovation Research (SBIR) projects

Scientific papers submitted for publication from U.S. Small Business Innovation Research (SBIR)-funded research projects are an innovative output that has yet to be studied systematically. Using a knowledge production framework, we identify empirically covariates with the number of scientific papers resulting from SBIR projects over the period 1992 through 2001. We find empirically that when the firm involves a university in its funded project, more scientific papers result. When the form of university involvement is taken into account, we find the greatest impact on the output of scientific papers comes from the inclusion of an individual from the university who originally developed the technology being pursued by the firm in its SBIR project. In other words, the project-specific technical human capital knowledge from the university that spills over to the firm’s project begets (i.e., brings about) additional knowledge in the form of scientific papers submitted for publication.

Decreasing the Toxicity of Radiation Therapy: Radioprotectors and Radiomitigators Being Developed by the National Cancer Institute Through Small Business Innovation Research Contracts

The use of radioprotectors and radiomitigators could improve the therapeutic index of radiation therapy. With the intention of accelerating translation of radiation-effect modulators (radioprotectors and mitigators), the Radiation Research Program and SBIR (Small Business Innovation Research) Development Center within the National Cancer Institute issued 4 Requests for Proposals (RFPs) from 2010 to 2013. Twelve SBIR contract awards in total were made in response to the 4 RFPs from September 2011 through September 2014. Here, we provide an update on the status of SBIR contract projects for the development of radiation-effect modulators. To assess the status of research and development efforts under the 4 RFPs on radiation-effect modulators, we searched PubMed for research articles, google.com for published abstracts, clinicaltrials.gov for ongoing or completed clinical trials, and company websites for press releases and other news. All information obtained and reported here is publicly available and thus protects the intellectual property of the investigators and companies. Of the 12 SBIR projects funded, 5 (42%) transitioned successfully from phase 1 to phase 2 SBIR funding, and among the Fast-Track contracts, this rate was 100% (3 of 3). The Internet search identified 3 abstracts and 6 publications related to the aims of the SBIR contracts. One-third of the companies (4 of 12) have successfully launched a total of 8 clinical trials to demonstrate the safety and efficacy of their investigational agents. Two drugs are in clinical trials for their indication as a radioprotector, and 2 drugs are under evaluation for their anticancer properties (an immunomodulator and a small molecule inhibitor). The National Cancer Institute's SBIR has provided pivotal funding to small businesses for the development of radioprotectors and radiomitigators, which resulted in multiple early-phase clinical trials. Longer follow-up is needed to determine the full impact of these novel therapeutics that enter clinical practice.

On the failure of scientific research: an analysis of SBIR projects funded by the U.S. National Institutes of Health

The Small Business Innovation Research (SBIR) program is the primary source of public funding in the United States for research by small firms on new technologies, and the National Institutes of Health (NIH) is a major contributor to that funding agenda. Although previous research has explored the determinants of research success for NIH SBIR projects, little is known about the determinants of project failure. This paper provides important, new evidence on the characteristics of NIH SBIR projects that fail. Specifically, we find that firms that have a founder with a business background are less likely to have their funded projects fail. We also find, after controlling for the endogenous nature of woman-owned firms, that such firms are also less likely to fail.

On the Failure of R&D Projects

There is an extensive literature on the success/failure of firm-funded R&D projects, but growing policy interest focuses on publicly funded R&D projects. We discuss this literature, which builds on a long stream of research of which Albert Rubenstein was a prime investigator, and use the literature to motivate the theoretical and empirical parts of the paper. Using data from 1878 Phase II R&D projects funded through the U.S. Small Business Innovation Research (SBIR) program, of which 624 had been discontinued prior to technical completion, we provide for the first time quantitative findings on the success/failure of publicly funded firm-performed R&D projects. Using a single-equation qualitative choice model, we find that prior R&D experience with the technology funded by SBIR projects, the amount of the SBIR award, and having a female as a principle investigator, other factors held constant, are all negatively related to the probability of project failure. In contrast, firm size is positively associated with project failure. We did not find evidence that human capital, experiential knowledge embodied in the firm conducting the R&D, or university involvement in the R&D project affected the probability of project failure. We discuss the implications of these findings for practice, policy, and further research.

Application of Systems Engineering to USAF Small Business Innovative Research (SBIR)

The US Air Force Small Business Innovation Research (SBIR) program is a vital element of the Air Force Research Laboratory (AFRL) portfolio. The SBIR program funds early-stage R&D projects at small technology companies that support a US Department of Defense (DoD) need and have the potential for commercialization in private sector and/or military markets. We report on research measuring the application of Systems Engineering (SE) and the degree of Systems Engineering applied in SBIR projects through analysis of subject-matter expert (SME) interviews. SMEs were sampled from AFRL as well as other USAF organizations. The research methodology assessed the current application of SE in SBIR as well the SE expectations government offices have for SBIR projects. The research specifically examined current US DoD and US Air Force Systems Engineering Policy and found that it does not adequately address SBIR projects. SE processes are not well documented within the community. We then identified applicable SE tasks found in Air Force SE policy and suggest a tailored Systems Engineering approach for SBIR projects. We present a SBIR SE checklist recommended for use by SBIR program managers tailored according to the phase and scope of any SBIR project.

Employment growth from the Small Business Innovation Research program

This paper investigates employment growth in small firms funded by the U.S. Small Business Innovation Research (SBIR) program. Using data collected by the National Research Council for each of five federal agencies, our analysis shows that on average over two-fifths of all projects retained zero employees after completion and over one-third retained only one or two employees. Thus, on average, the direct impact of SBIR funded projects on employment is small, especially when compared to the mean number of employees in the firms. However, there are substantial cross-project differences in the number of retained employees that are explained by differences in the firms and their SBIR projects. We find across funding agencies that projects with intellectual property—patents, copyrights, trademarks, or publications—retained more employees after completion of the project. Also, we find that the public funding of research by the SBIR program is more likely to stimulate employment when the government created a market for the products, processes, or services developed by the research projects.

Condition-based Maintenance and the product improvement process

The evolution of enterprise services is changing the approach for enabling Product Lifecycle Management (PLM) and Supply Chain Management (SCM) business processes. Enabling systems are migrating to process- and service-oriented solutions. In particular, the paper demonstrates how the new technologies can be used to enable a critical process that links vehicle health maintenance to PLM. Our hypothesis is that Condition-based Maintenance (CBM) and PLM integration is achievable through composite application design. The key process for linking CBM to PLM must convert prognostic and diagnostic information into actionable information that can be directed into a project-level PLM environment that supports the end-to-end product improvement process. To test this hypothesis, we designed a composite application within the context of a Small Business Innovative Research project that is sponsored by the US government. This paper motivates the problem from the strategic level to the implementation level and describes the successful test of the hypothesis.

Creative Partnerships for Funding Nursing Research

The Small Business Innovation Research (SBIR) program and the Small Business Technology Transfer Research (STTR) program are two federal funding mechanisms that some nurses in academic positions have used to support research and development of innovative nursing products or services. Both the SBIR and STTR mechanisms are excellent sources of funding for nurse researchers who want to capitalize on relationships with small businesses or obtain seed money to fund high-risk projects with potential to attract new venture capital. This article provides an overview of National Institutes of Health (NIH)-funded SBIR and STTR programs and summarizes similarities and differences between the programs. The article also describes unique features of NIH SBIR and STTR funding mechanisms that differentiate them from other R-series funding mechanisms, reviews evaluation criteria for SBIR and STTR projects, and discusses critical partners and resources for proposal development. Finally, the article describes characteristics of successful partnerships and provides examples of SBIR/STTR-funded projects.

Government as entrepreneur: Evaluating the commercialization success of SBIR projects

Thinking of government as entrepreneur is a unique lens through which to view a subset of government actions. The lens is not a template for an evaluation of government policy; rather, it is a characterization that underscores the government's purposeful intent, ability to act in new and innovative ways, and willingness to undertake policy actions that have uncertain outcomes. Our focus is on the U.S. Small Business Innovation Research (SBIR) program. We argue that the innovative action of government – the innovative use of public resources through the SBIR program to target and support research in small firms – does lessen innovation barriers that cause small firms to underinvest in R&D. However, this government action is subject to entrepreneurial risk, namely the a priori uncertainty that the funded research will result in a commercialized product, process, or service. We quantify the uncertainty that the government accepts in the context of innovation supported by the SBIR program; or stated alternatively, we quantify the probability that a project funded by the SBIR program will fail to commercialize its results. Our empirical results show that the entrepreneurial risk that characterizes the SBIR program is, on average, somewhat more than the probability of failing to get heads on the toss of a fair coin. Importantly, however, our evidence shows that there is a large range in the entrepreneurial risk that the government accepts—across the projects, the predicted probability of failure covers essentially the entire range from 0 to 1.0.

Private Investor Participation and Commercialization Rates for Government‐sponsored Research and Development: Would a Prediction Market Improve the Performance of the SBIR Programme?

An objective of the US Small Business Innovation Research (SBIR) programme is the private sector commercialization of funded R&D projects. However, our estimate of the actual or expected probability of commercialization of such R&D is fairly low; our analysis of Department of Defense (DoD) Phase II awards suggests that the estimated probability of commercialization is only 0.47. We investigate econometrically whether outside private investors have useful information about proposed SBIR projects' prospects for commercialization. Our findings suggest that they do, thereby providing support for the possibility that a prediction market could improve the performance of the SBIR programme.

Practical issues in adopting a traveling wave thermoacoustic cooler for use in a food storage refrigerator

CFIC/QDrive has developed a food storage refrigerator for the Army based on thermoacoustic technology. This ‘‘Phase II’’ SBIR project is a continuation of a ‘‘Phase I’’ effort that explored using a standing-wave thermoacoustic cooler for the refrigerator. The standing-wave cooler was found to be too inefficient with too low a power density to be practical, so it was switched to an acoustic Stirling, or traveling-wave thermoacoustic (regenerator based) cooler for Phase II. The major challenges of this project were adapting the Stirling-style cooler to a food storage application, and not the fundamentals of the cooler itself (the one exception being the issue of acoustic streaming). The challenges include: Running at 60 Hz (without frequency-shifting electronics), heat exchange without circulating fluids, dynamic balance, guarantee of long life, efficiency, and compactness (power density). How these challenges were met and how they drove the design, in most cases away from what would be ideal for the cycle itself, will be discussed. Time permitting, how the additional pressure of low unit cost would affect this type of product development will also be discussed. [Research supported by the U. S. Army through a Small Business Innovation Research (SBIR) grant.]

Model-based specification and testing applied to the Ground-Based Midcourse Defense (GMD) system

Cognitive Concepts LLC (CC) is a small business that specializes in software reliability engineering. In the past several years CC has become convinced that the best available practice for software reliability on complex systems is model-based specification and testing (MST). CC completed a small business innovative research project with the Missile Defense Agency in 2004 in which the goal was to demonstrate the feasibility and value of applying MST on some aspect of the National Missile Defense (NMD). This paper describes the results of that research effort.

Evaluating Thermal Protective Performance Testing

Abstract Even as better materials are developed for protective clothing, NFPA data indicate the number of burn related fire fighter deaths and severe injuries is increasing. These injuries are unexpected for the most part. As a result, questions arise about Thermal Protective Performance (TPP) ratings and whether performance changes are due to use or the effects of aging. As part of a NIST-sponsored Small Business Innovative Research project, current TPP test techniques were evaluated. Some changes and extensions are suggested. In TPP tests, dry fabric samples or ensembles are exposed to heat flux of 83 kW/m2 with nominally 50% radiative and 50% convective heat transfer. Heat transmission through the test sample is measured with a copper calorimeter. The TPP Rating is the time in seconds required for a 2nd degree burn. Current problems include: 1) Current test methods overestimate time to 2nd degree burn. 2) No information is provided on maximum potential burn damage. 3) No information is provided on heat transfer or fabric properties. 4) No information is provided on how performance changes with use. Suggested changes and extensions include: 1) Change the heat source — use a modified radiant protective performance technique. 2) Replace the copper calorimeter with a thermal skin simulant sensor. 3) Estimate burn damage using a two step analysis method. 4) Obtain both dry and damp thermal properties for modeling clothing performance.

Applied Perception awarded $1 million Phase II Plus Small Business Innovation Research Project to expand the development of agile robotic vehicles for wounded soldier extraction and sentry/reconnaissance tasks

Applied Perception awarded $1 million Phase II Plus Small Business Innovation Research Project to expand the development of agile robotic vehicles for wounded soldier extraction and sentry/reconnaissance tasks

Implementation of magnetohydrodynamic energy bypass process for hypersonic vehicles

The global political structure has changed dramatically since the breakup of the former Soviet Union, and world changes have caused the United States to reprioritize its national hypersonic needs. The US Government has looked at the needs of the future, and the hypersonic aerospace plane is one of the systems included in alternative force structures. One hypersonic aerospace plane concept would involve magnetohydrodynamic (MHD) technology (i.e., the AJAX hypersonic flight vehicle concept) originally proposed by Russian scientist Vladimir Fraishtadt. This paper reports on the current progress and findings of an air-breathing horizontal takeoff and landing design concept using an MHD energy bypass injector ramjet engine being studied at MSE Technology Applications, Inc., HyperTech Concepts, and several universities for the National Aeronautics and Space Administration Langley Research Center under a Phase II Small Business Innovation Research project. The areas that are addressed in this paper include: (1) ionization required to achieve the required energy bypass, (2) utilization of a nonequilibrium model to calculate nonequilibrium engine ionization conditions, (3) hydrocarbon fuel reforming, and (4) vehicle performance and sizing. A quasi-onedimensional electromagnetic code combined with a new scramjet model, as well as other tools, were used to examine total system performance.

Enabling Interoperability Between US Shipyards

In recent decades there have been numerous computer advances put to use in US shipyards in areas ranging from design through manufacture. These tools have generally worked well and improved productivity in their specific areas. However, these tools were largely installed as isolated "islands of automation" and did not necessarily function smoothly together, even though each tool performed its own function successfully. At the same time, the market situation in the shipbuilding industry required shipyards to team together and work jointly on most new design and construction contracts. The problem of needing enhanced interoperability among the many new computer tools and systems has been addressed by several projects funded under the National Shipbuilding Research Program (NSRP). In particular, the Integrated Shipbuilding Environment (ISE) Project, the HARVEST Project, and the Integrated Steel Processing Environment (ISPE) Project have all focused on resolving these problems. There are also several Small Business Innovation Research projects that have addressed these issues. They have employed the use of Standard for the Exchange of Product Model Data (STEP), eXtensible Mark-up Language (XML), and various Web technologies to achieve these lofty goals. This paper summarizes the many accomplishments of these tasks in helping US shipyards develop integrated systems and become more productive. The theme is enabling interoperability between US shipyards, and it discusses data exchange needs from various business viewpoints. The presentation will start with a review of the paper and then show highlights of the ISE Year3 Demo presented in April 2003.

SBIR first decade-results, benefits, problems from a Michigan perspective

This paper reports on the economic contributions and impact of the Small Business Innovation Research (SBIR) Program in Michigan during the first decade. The Michigan SBIR experience is examined to learn how researchers and small businesses use the SBIR Program, whether to start or strengthen businesses, how they view SBIR after a decade, and how the program has served Michigan businesses that have successfully carried out Phase I, Phase II, and Phase III SBIR projects. From the beginning of the SBIR Program, MERRA has coordinated annual SBIR conferences for Michigan companies. The MERRA staff has helped small businesses prepare suitable R&D projects and write effective SBIR proposals. Numerous SBIR awards have resulted from MERRA supportive efforts, and the MERRA small business outreach activity has kept MERRA in touch with successful firms to assist them in getting the best results from their SBIR projects and to assess progress. For this study, in-depth evaluations were made of various Michigan firms that won SBIR awards, including both mature small businesses and start-up companies to learn in what ways their SBIR experiences are parallel and in what ways they diverge. The study covers those that have used SBIR funds to diversify and add new areas of business to existing core areas. Other companies examined were created by researchers associated with universities, industry, or research organizations who utilized SBIR awards to assist in starting new businesses. Also considered were Michigan companies at different levels of development that have employed SBIR awards as seed money to perfect innovative new products for marketing.

Commercialization activities in the SBIR program: Changes over time (part 2)

In order to explore how the extent of commercialization changes over time, longitudinal surveys were conducted by telephoning several sets of awardees in the Small Business Innovation Research (SBIR) program. A model was formulated that predicts how the distribution of SBIR projects among five commercialisation levels changes from one year to the next. It was found that the distribution in any given year is dependent on the distribution in the previous year only. Projections show that as many as 30% of SBIR projects may eventually achieve commercialization.