Rapid detection devices for pathogen vectors are case study in leveraging small business innovation funding
By Maj. Vanessa R. Melanson
When military forces arrive in a new operational area, military preventive medicine personnel—preventive medicine specialists, entomologists and environmental science engineers—assess the environment, identify health threats and propose mitigations. Vector-borne diseases are one of the primary readiness threats, and the arthropods (insects and arachnids) that transmit pathogens to people account for about 60 percent of the military’s priority pathogens list.
Vector pathogen detection (VPD) provides military preventive medicine personnel the information necessary to implement specific vector-control measures and disease prevention countermeasures. VPD can minimize disease by sampling arthropods for pathogens before human transmission occurs, thereby decreasing the health impacts on military operations.
The Small Business Innovation Research (SBIR) program has been integral to the success of the VPD mission and the Arthropod Vector Rapid Detection Device (AV-RDD) program by providing research and development resources to the Military Entomology Research Program (MERP) at a time when appropriated funding for research, development, test and evaluation (RDT&E) is limited.
The SBIR program, coordinated by the U.S. Small Business Administration, centers on a competitive three-phase process designed to provide U.S. small businesses the opportunity to propose innovative research and development (R&D) solutions in response to government needs. SBIR proposals are useful in evaluating current states of technology. As Col. Russell Coleman, an entomologist with the U.S. Army Medical Research and Materiel Command (USAMRMC) and past head of the MERP, said, “the SBIR program is a powerful tool to help us better understand what is possible and what is not at that point in time.” The MERP has leveraged tens of millions of dollars through the SBIR program over the past decade, and other programs stand to benefit in the same way.
Federal agencies with extramural R&D budgets that exceed $100 million must reserve a percentage of that spending for small business projects. USAMRMC, through its Army and Defense Health Program SBIR initiatives, selects companies to provide R&D solutions that meet military medical needs.
The first step in an SBIR contract is a Phase I feasibility study, funded at up to $150,000 for six months. The objective is not only to establish the feasibility of the proposed effort, but also to establish the quality of performance of the small business. After proving the proposed concept, a small business may receive a two-year Phase II contract of up to $1 million based on the scientific, technical and commercial potential of the Phase I results. The company may pursue Phase III of the effort, which is essentially commercialization of the effort based on the first two phases. Phase III is not funded by the SBIR program.
An interim step between the second and third phases is a Phase II enhancement. This can be funded by SBIR, but the company must find matching funds from DOD acquisition programs or the private sector. The enhancement will extend the contract for up to one year and match up to $500,000 of non-SBIR funds. (See Figure 1.)
In the past decade, the SBIR program awarded funding for 22 Phase I topics, resulting in 37 Phase I projects that have supported MERP’s VPD mission. Usually multiple companies get the go-ahead to address a specific topic—the exact number of companies depending on available SBIR funding—followed by a down-select as the SBIR phase process ensues. Nineteen of these projects received Phase II contracts.
Along with Phase II enhancement and Phase III investment programs, the $450,000 leveraged through the SBIR program represents a 90 percent increase in the R&D budget dedicated to VPD. This increase in research capacity for a relatively small program comes as no surprise to J.R. Myers, USAMRMC’s SBIR project manager. “Motivated research groups such as the MERP are committed to partnering with small business innovators who are highly skilled and driven for success. This focus and dedication yields cutting-edge results for this program,” Myers said.
FROM CONCEPT TO CONTRACT
Coleman, past head of the MERP, initially leveraged the SBIR program to develop AV-RDDs in 2003, when he was serving as a major at a USAMRMC laboratory. As an entomologist deployed in Operation Desert Storm, Coleman was familiar with the limited scope of warfighter threat assessments in theater: collecting arthropods, shipping them stateside for pathogen detection and waiting in theater for the results. As he focused on developing a test or device for detecting arthropod-borne pathogens in the field, the AV-RDD effort materialized.
Coleman drafted an SBIR topic that focused on AV-RDDs for the plasmodium (malaria) parasite and arboviruses, or arthropod-borne viruses. After the topic received approval, he served as the contracting officer’s representative (COR) and awarded Phase I funding to three companies. After a down-select, followed by completion of a Phase II award, one company fielded the first AV-RDD for malaria with USAMRMC’s help.
This original SBIR topic allowed for further development of more AV-RDDs for arboviruses. The same company developed three more AV-RDDs (for the West Nile and the Eastern and Western equine encephalitis viruses) by 2007, which USAMRMC then fielded.
When Coleman deployed to Iraq in 2008 with the 520th Theater Area Medical Laboratory, he discovered the need for a Leishmania AV-RDD to support recommendations to leaders and medical planners on theater vector control measures and disease prevention countermeasures. Leishmania became an SBIR topic. Coleman and others established more SBIR AV-RDD topics to detect additional arboviruses such as the Rift Valley fever and dengue viruses. Coleman served as the COR on these Phase I SBIRs and directed their development.
The result is a much-improved detection process. AV-RDDs come in kits with the necessary materials to perform the test, such as sample holding tubes, grinding buffer and equipment for preparing the insects. Preventive medicine and entomologist personnel trap insects in the field, then sort and pool them by species. The kit has a mortar and pestle that the researchers use for grinding up the bugs in a buffer solution. AV-RDDs can detect pathogens collected from arthropods in about 15 minutes.
DEVELOPMENT AND FIELDING
Without leveraging the SBIR program, the MERP could not have developed any AV-RDDs. The MERP budget is a modest $3.5 million, relying mainly on allocations from 6.2 (applied research) and 6.3 (advanced technology development) RDT&E dollars from the assistant secretary of the Army for acquisition, logistics and technology, which must support seven different research programs on four continents. The VPD program, which encompasses the AV-RDD program, represents approximately 25 percent of the MERP budget. Using the SBIR program and establishing contacts with companies that have expertise the government may lack have benefited the AV-RDD and the larger VPD programs, as well as the MERP overall.
Users of the SBIR program within USAMRMC often find that proposals may address an unforeseen solution. As Coleman explained it, he often finds himself thinking, “I never would have dreamt of addressing this problem in this way. This is really cool.” By realizing the utility of currently marketed technologies, even if they don’t fully address a capability gap, a program can shape future efforts.
The SBIR program has also succeeded in bridging the gap between technical and research-based (tech-base) development and advanced development programs, and has been critical to fielding products. For example, a USAMRMC laboratory may work on tech-base research, only to find that there is no plan or budget for the product, nor perhaps an operational need by the end user. When that proves to be the case, the lab halts product development and terminates the effort. One way to mitigate this type of risk to USAMRMC laboratories is through the SBIR program, the beauty of which is that a small business may already have a potential solution to a real, operational need, or a great idea for one; all it needs is funding to do the research that could prove the solution. By initiating a topic, as with the AV-RDD program, the SBIR opens the door to potential solutions by telling small businesses of the need and asking them to fill it.
The SBIR program aims to preserve prospective products as projects move from tech-base to advanced development, using a series of well-defined checks and balances. As the example of the AV-RDD topics illustrates, SBIR program topics are specific and address well-articulated user requirements. By the time a project begins in Phase I, much of the critical thinking on operational need has been done. As the project matures and successfully completes milestones, it moves into the Phase II process with the potential for follow-on Phase II enhancement or Phase III funding.
As MERP officials have learned, an SBIR Phase I contract doesn’t necessarily guarantee accomplishment of the desired program without guidance and support from the program managers. When Coleman was head of the MERP, he established an understanding between the government scientists and the SBIR companies to ensure that for every SBIR contract awarded, core RDT&E dollars went to government scientists. This type of partnership facilitated the development of prototypes for military-specification testing by government scientists. It also allowed for feedback to the company and refinement of the prototype, if necessary, thus harnessing the strengths of industry and the expertise of government laboratories and program managers to deliver materiel solutions to the warfighter.
Many small businesses need assistance and incorporation into the strategic vision of an RDT&E program, such as the MERP, to ensure the proper oversight. “Unless you add SBIRs into the overall program, you can’t get that hand-holding to the small companies that may need it,” said Coleman. “But by thinking strategically and making it part of your core program, you can do this. It used to frustrate the heck out of me, when I’d hear briefings by various program managers and there would be no discussion about SBIR efforts. They should be considered part of our core program and briefed as part of our core program, but they were outliers.”
The AV-RDD program faced this issue of supporting small business during the development of the malaria AV-RDD. The company developed the product in 2003, but found there was little profit in production and closed operations in 2005. For nearly two years, the malaria AV-RDD was unavailable to warfighters until another company picked up the development and fielding of the product—through the SBIR program.
With the successful development and fielding of AV-RDDs through the SBIR program, personnel in all the services can perform the VPD mission. AV-RDDs make it possible to determine if, say, 90 percent of an area of operation poses no vector-borne disease threat, thereby allowing preventive medicine personnel to focus on the 10 percent of the area that does, which is a big win for warfighter health and operational stability.
For more information on the DOD SBIR Program, go to http://www.acq.osd.mil/osbp/sbir. For more information on the AV-RDD, go to http://www.usammda.army.mil/documents/Fact%20Sheets/AVRDD.pdf.
This material has been reviewed by the Walter Reed Army Institute of Research (WRAIR), which has no objection to its presentation and/or publication. The opinions or assertions in this article are the private views of the author; they are not to be construed as official, or as reflecting true views of DA or DOD.
Maj. VANESSA R. MELANSON is chief of the Diagnostics and Laboratory Services Department in the Entomology Branch at WRAIR, a subordinate command of USAMRMC. She leads the VPD Program, supervising research grants and work on vector surveillance platforms and assays, and human diagnostics. She also chairs the Vector Pathogen Detection Integrated Product Team for USAMRMC and the Vector and Pathogen Detection Committee of the Armed Forces Pest Management Board, a directorate in the Office of the Deputy Under Secretary of Defense for Installations and Environment. She has a Ph.D. in molecular genetics and microbiology from the University of Massachusetts Graduate School of Biomedical Sciences and a B.S. in biotechnology from Worcester Polytechnic Institute. She also holds an American Society of Clinical Pathologists microbiology certification. She is Level III certified in science and technology management and Level I certified in program management, and is a member of the U.S. Army Acquisition Corps.
This article was originally published in the April – June 2014 issue of Army AL&T magazine.
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