SBIR: Broadening Availability of Regimens for K-9s (BARK) - Open Topic

OUSD (R&E) critical technology area(s): Biomanufacturing, Contested Logistics Technologies

Objective: Develop medical products that are interoperable and compatible across humans and dogs to meet the health needs of both human warfighters and military working dogs.

Description: Military working dogs (MWDs) are critical to national security, serving as force multipliers by enhancing the lethality and survivability of their teams through their unique senses, agility, and autonomy. Providing effective medical care for MWDs is critical but imposes significant challenges. Not all human medical products work for canines (K-9s), who sometimes require separate, specialized veterinary products. MWD handlers must therefore carry extra medical equipment to provide emergency care for their K-9 partner, exacerbating equipment loads and impeding operational capacity. Specialized equipment also expands medical materiel requirements and dependence on the less-resourced veterinary market, encumbering acquisition and sustainment activities.

Medical technologies that are interoperable and compatible across humans and dogs can address unmet needs of valuable MWDs while lessening the burden on medics, logisticians, and other contributors to force health protection. Species-interoperable medical technologies, particularly those supporting acute and tactical care, will improve lifesaving medical care for these MWDs while mitigating logistical and operational burdens of treating both human and K-9 warfighters.

The Defense Advanced Research Projects Agency (DARPA) is soliciting medical technologies that are interoperable and compatible across humans and dogs. Technologies of greatest interest allow for the replacement of existing products in medical sets with interoperable products, reducing the total amount of medical supplies—expanding capability without expanding the kits. Examples of specific technologies of interest include, but are not limited to:

• Filters for donor plasma capable of removing cross-reactive antigens that impede compatibility across species;
• Universal synthetic plasma designed with all necessary functional components for transfusion;
• Sensors and form-factors that enable physiological monitoring (e.g., core body temperature and blood pressure) or triage in both humans and dogs;
• Medical devices (e.g., splints, backboards, tourniquets, mechanical ventilators) designed to be rapidly adjustable at point of care for flexible use across anatomies;
• Interoperable medical countermeasures (MCMs) and form-agnostic personal protective equipment to mitigate or protect against chemical, biological, radiological, and nuclear threats; and
• Delivery mechanisms that can modulate dosing, including through excipients or combination devices (e.g., autoinjectors), to enable universal use of pharmaceuticals and MCMs.

The aim of the solicitation is to create a demonstrative prototype that can quickly progress to pre-clinical or clinical testing during a contracted SBIR Phase II period of performance (PoP). Research that merely tests existing products, including collection of data to titrate dosages or support label expansion of a marketed product to an additional species, is unlikely to achieve the degree of technical innovation a successful proposal should demonstrate. New drug discovery is discouraged but may be considered in particularly compelling cases. Products enabled by proposed research should feasibly be safe and effective in both humans and canines—to be verified in future trials—for use cases where no single existing product serves both patient sets. Technologies of interest should be capable of achieving substantially equivalent or superior performance in humans compared to currently approved options.

An initial white paper describing the technical approach is required and will be evaluated. If DARPA selects a white paper for further evaluation, the Government will issue an invitation to submit a full proposal. The technical white paper should include an overview of the proposed concept with details to support feasibility. The overview should address the bullets below, which are listed in order of importance:

• Proposed concept: Describe the proposed research and medical product. Outline the design and operation of the main components that are being proposed for development and mode(s) of action. Use clear calculations, preliminary data, or mechanistic justifications to support feasibility of the proposed concept.
• Concept of employment: Identify how the proposed product could be employed. Provide details on the intended use, indication, and effect, and the prevalence and impact of the addressed medical condition. What benefits, including new capabilities or improved metrics, does the proposed solution provide compared to current commercial off-the-shelf (COTS) options (e.g., commercially available human- or canine-specific products)?
• Path to market: Identify relevant predicate or otherwise established products that have been approved, licensed, authorized, or cleared by the U.S. Food and Drug Administration (FDA) or other relevant regulatory authority. Provide a general plan or strategy for securing market access and ensuring regulatory compliance for both humans and canines if the proposed technology is successful and shown to be safe and effective. For any special FDA programs noted (e.g., Breakthrough Device designation, 513(g)), ensure that the white paper describes how the medical product meets the program requirements.
• Scalability: Provide a brief analysis of the feasibility of scaling the technology across both the DoD and industry. Are the achievable production costs low enough to merit widespread adoption, especially if alternative human- or canine-specific products are available? Is the system sufficiently familiar or intuitive to medics, handlers, and clinicians that large-scale deployment and administration wouldn’t require significant training or modification of protocols? What are the projected maintenance and storage requirements, operational availabilities, and service lifetimes, and, if applicable, how do they compare with COTS alternatives?

Phase I

During Phase I, the company should research and develop innovative technologies to make medical products that are interoperable and compatible to meet the health needs of both humans and canines. The company should develop, or apply in a novel way, technology that directly enables one or more medical products that address use cases where no single existing product serves both human and canine patient sets. The company should determine technical feasibility of the conceptualized medical product and design a preliminary prototype. Feasibility demonstration may comprise modeling and simulation, where appropriate. All foundational scientific testing necessary to proceed to future animal testing should be performed during Phase I, and success criteria (e.g., biomarkers, clinical or surrogate endpoints, etc.) for such future testing should be established. The company should also perform an analysis of predicted performance achievable through the technical approach and identify whether this performance could be substantially equivalent or superior to currently approved options for human use, if any exist.

Testing during Phase I should be conducted in vitro or in silico, and proposals should justify the approach and applicability to humans and canines. Human subject research (HSR) and use of animal subjects in the proposed research is not allowed in Phase I. The DoD defines an animal subject as a living or dead vertebrate, a larval fish or amphibian, or an egg-laying vertebrate after hatching. For details, refer to DoD Instruction 3216.01: Use of Animals in DoD Conducted and Supported Research and Training at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321601p.pdf.

Proposers should recommend technical milestones that will be used to demonstrate their progress to DARPA throughout Phase I. Phase I fixed payable milestones for this program should include, in the final month of effort, a Final Phase I Report. This written report should, at a minimum, detail the approach, provide a comprehensive summary of all key testing and analysis of results conducted during the effort, compare the approach with alternative COTS and state-of-the-art technologies, and include a feasibility analysis addressing the technical, financial/commercial, clinical, and regulatory considerations impacting potential implementation at scale. The report should also set the stage for Phase II by substantiating, if justified, that continued design and development could feasibly result in a prototype demonstration and feasible work plan to achieve a fieldable prototype during Phase II. Monthly financial and technical summary reports will also be required throughout the PoP.

Phase II

Building upon results from Phase I, the company should further develop, fabricate, demonstrate, test, and validate a prototype. The company should experimentally establish the prototype’s performance parameters in pre-clinical settings, in accordance with the success criteria developed in Phase I. User testing should be conducted to establish, or inform future work towards, operational viability in fieldable environments and use cases. Prototype(s) may be provided to appropriate DoD entities for further testing and evaluation by personnel. In addition, companies should provide a detailed regulatory and commercialization strategy for DoD and non-DoD applications, which will likely require engagement with the FDA during (or prior to) the Phase II PoP.

Proposed topics may be identified by the program manager as research involving Human and/or Animal Use. In accordance with DoD policy, human and/or animal subjects in research conducted or supported by DARPA shall be protected. Although these protocols should not be needed to carry out Phase I, significant lead time is required to prepare the documentation and obtain approval to avoid delay of a Phase II award. Please visit https://www.darpa.mil/work-with-us/communities/small-business/sbir-sttr-overview/ and click on the Human Research Guidelines link or the Animal Research Guidelines link to understand what is required to comply with human protocols and animal protocols. Proposers are encouraged to separate research tasks from tasks involving human and/or animal use in the technical proposal and cost proposal to avoid potential delay of contract award.

Proposers should recommend technical milestones that will be used to demonstrate their progress to DARPA throughout Phase II. Phase II fixed milestones for this program should include, in the final month of effort, a Final Phase II Report. This written report should, at a minimum, document all final prototype designs and production methods/protocols, methods and results of all testing—including those related to or indicative of tolerability, safety, and efficacy—and any scientific advances that have been achieved under the program. The Report should include quantitative metrics on decision-making benefits, costs, risks, and schedule for implementation of a full prototype capability based on the experimental demonstration, as well as a go-to-market strategy informed by these parameters. A quantitative comparison to alternative COTS and state-of-the-art technologies should be included in the decision-making metrics. Monthly financial and technical summary reports will also be required throughout the PoP.

Phase III dual use applications

Potential dual-use applications encompass those of corresponding medical products currently used to treat human and canine military and civilian patients. Technologies should expand the current applications of established medical products. Medical technologies, particularly those supporting acute and tactical care, may be used in emergency medicine spanning hospital, ambulatory, and first-aid settings. In DoD/military contexts, such equipment could replace current products found in the medical sets and kits of medics and dog handlers, as well as products used globally in Military Medical Treatment Facilities. Applications are also abundant in veterinary medicine, providing medical care for companion animals, service animals, and civilian working dogs (including operational canines, like those serving in civilian law enforcement, search and rescue, and emergency response) in addition to MWDs.

References

1. Joint Trauma System, “Military Working Dog CPGs (Canine),” Clinical Practice Guidelines (CPGs), Sept 2025. J. Spencer, “The Dogs of (Urban) War: Lessons from Oketz, the Israel Defense Forces’ Specialized Canine Unit,” Modern War Institute, Jan 2025. https://jts.health.mil/index.cfm/CPGs/cpgs
2. M. Lagutchik et al. “Trauma Management of Military Working Dogs,” Military Medicine, Sept 2018. https://doi.org/10.1093/milmed/usy119
3. J. Giles, “Role of Human Health Care Providers and Medical Treatment Facilities in Military Working Dog Care and Accessibility Difficulties with Military Working Dog Blood Products,” The United States Army Medical Department Journal, Apr-Sept 2016. https://medcoeckapwstorprd01.blob.core.usgovcloudapi.net/pfw-images/dbimages/Apr-Sept2016.pdf
4. L. Miller et al. “Causes of Death in Military Working Dogs During Operation Iraqi Freedom and Operation Enduring Freedom, 2001–2013,” Military Medicine, Mar 2018. https://doi.org/10.1093/milmed/usx235
5. K.E. Hall et al. “Breaking barriers in trauma research: A narrative review of opportunities to leverage veterinary trauma for accelerated translation to clinical solutions for pets and people,” Journal of Clinical and Translational Science, Apr 2024. https://doi.org/10.1017/cts.2024.513
6. United States Government Accountability Office, “Working Dogs: Federal Agencies Need to Better Address Health and Welfare,” GAO-23-104489, Oct 2022. https://www.gao.gov/products/gao-23-104489
7. U.S. Army, “Army Futures Command Concept for Medical 2028,” AFC Pamphlet 71-20-12, Mar 2022. https://api.army.mil/e2/c/downloads/2022/04/25/ac4ef855/medical-concept-2028-final-unclas.pdf
8. U.S. Department of Defense, “Four-Legged Fighters.” https://www.defense.gov/Multimedia/Experience/Four-Legged-Fighters/
9. A. Spook & J. Campbell, “Employing Military Working Dogs in Large-Scale Combat Operations,” Center for Army Lessons Learned NO. 24-910, Aug 2024. https://api.army.mil/e2/c/downloads/2024/08/30/5d7487d1/24-910-employing-mwds-in-lsco-aug-24.pdf
10. J. Spencer, “The Dogs of (Urban) War: Lessons from Oketz, the Israel Defense Forces’ Specialized Canine Unit,” Modern War Institute, Jan 2025. https://mwi.westpoint.edu/the-dogs-of-urban-war-lessons-from-oketz-the-israel-defense-forces-specialized-canine-unit/

Keywords

Medical Equipment and Supplies; Medicine and Health Sciences; Military Dogs; Combat Casualty Care; Military Medicine; Battlefield Medicine; Veterinary Medicine; Biomedical Technology

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