DON26BZ06-DV088 TITLE: DIRECT TO PHASE II: Minimally Invasive Remote Blood Collection Device for Free-Ranging Cetaceans
OUSW (R&E) CRITICAL TECHNOLOGY AREA(S): Biomanufacturing (BIO)
COMPONENT TECHNOLOGY PRIORITY AREA(S): Biotechnology
PROJECTED CMMC LEVEL REQUIREMENT: Level 2 (Self)
OBJECTIVE: Adapt an existing capillary blood collection device initially designed for humans and develop prototype hardware for use on Fleet dolphins and free-ranging cetaceans of varying epidermal thickness to improve proactive marine mammal monitoring, health measurements, and insight into behavioral responses to ensure ongoing mission reliability of Navy operations.
DESCRIPTION: Navy bottlenose dolphins are valuable Fleet assets whose health and well-being are essential to sustaining mine countermeasures, port security, and object recovery missions. Medical issues compromise performance and have direct implications for Navy mission readiness, longevity, and reliability. Additionally, for the U.S. Navy to meet environmental compliance requirements under the Marine Mammal Protection Act and Endangered Species Act, it is essential to understand the effects of sound and military activity on marine mammals, including physiological, behavioral, ecological, and population-level effects. While technologies and techniques for assessing marine mammal health are growing rapidly, many barriers remain for these Fleet assets as well as other free-swimming large cetacean species that can be used as biological sensors of the undersea environment. A transformative diagnostic tool will provide unparalleled access to physiological data and biomarkers of health, stress, and disease from free-swimming cetaceans with applications in clinical care, operational biosurveillance, and conservation.
Blood sampling of captive trained dolphins and/or stranded marine mammals enables researchers to evaluate individual and population health, age, genetics, exposure to pathogens and toxicants, and physiological responses to anthropogenic and natural stressors. By enabling minimally invasive blood sampling in free-ranging cetaceans, these animals can be used as biological sensors for persistent surveillance of the undersea environment, providing early warning of pathogens and other ecosystem stressors in operational waters. However, current blood collection methods in marine mammals are designed for use on stranded or captured individuals and are therefore limited in their capability of rapidly assessing health for larger free-swimming species. The lack of such a tool for health assessments is particularly urgent for Fleet animals and free-ranging animals in the region of deployment, where timely and accurate health assessments are essential for informing recovery efforts and mitigating population decline. As such, there is a critical need for a minimally invasive blood collection tool for remote application to the skin of free-ranging cetaceans to address significant gaps and improve our understanding of marine mammal health across spatiotemporal scales, providing unprecedented data on physiological responses, health metrics, and population dynamics.
This SBIR Direct to Phase II topic seeks to develop a prototype minimally invasive blood collection device for remote application on free-ranging cetaceans by further developing an existing capillary blood collection device initially designed for humans. This prototype device should be able to be remotely deployed using current techniques used for the deployment of suction-cup electronic tags on free-ranging marine mammals (i.e., pole-based or drone dropped) under diverse environmental conditions. This prototype will include a blood collection device, waterproof housing, delivery device using suction cup tag carrier, and suction cup-based tag attachment. This prototype waterproof device should be capable of remotely deployable blood collection across cetacean species of varying epidermal thickness. The target size and weight of the blood collection device (not including the suction cup housing) should be approximately 3.40x2.25x1.30 in in size and weigh between 0.85 and 0.95 oz. This prototype device should sit flush and seal against the skin and use suction to draw 200-800 uL of capillary blood with minimal clotting into an internal reservoir (independent of orientation) and mix the sample with anticoagulants or other stabilization chemicals. At minimum the Phase II prototype should be able to collect blood samples from species with epidermis of < 2.5 mm thickness with a plan to successfully collect blood samples from species with epidermal thickness of > 10 mm. During this collection period, the device needs to make a narrow incision (< / = 0.15 mm in width, < 5 mm in length) such that rapid wound healing is possible. Further, the device needs to account for pressure variations underwater such that it detaches from the animal after a set time (< 3 minute duration) or when it reaches a critical depth or, at a minimum, be able to identify samples that may have ex vivo red cell hemolysis. In addition, the device will need to protect the blood sample from seawater intrusion. Blood samples collected via this prototype device need to have comparable blood test values to those collected via standard venipuncture methods through the Peri-Arterial Venous Rete (PAVR). As such, to optimize reliable blood collection from the prototype device, development must address challenges including clotting, lancing depth, and anticoagulant use.
This minimally invasive blood collection prototype device will result in reliable remote deployment on free swimming cetaceans and significantly improve the capability to assess physiological responses and health measures in cetacean populations across spatial and temporal ranges. For the Navy Fleet bottlenose dolphins in particular, this prototype device will enhance the ability to detect health changes, reduce unplanned medical stand-downs, and provide more continuous health oversight by providing a minimally invasive diagnostic tool to detect infection and inflammatory markers, as well as subclinical infections. It will offer a novel tool to enhance systemic and organ-specific health monitoring, providing individualized biomarker data that can be applied to preventive medicine, geriatric care, and environmental health. Consistent with the Navy’s Clinical Research Pipeline, if this diagnostic tool proves successful, it will be integrated into the Navy’s Marine Mammal Program health program to directly improve the health and readiness of Navy dolphins, with potential translational benefits to conservation and human health.
Overall, this device and its resulting data will directly support the warfighter, improve the reliability of Navy biological assets, support environmental compliance needs, and contribute to broader undersea warfare biosurveillence objectives.
PHASE I: Develop concepts and determine feasibility of existing blood collection device adapted to be suitable for marine species- in a compact, waterproof, remotely deployable, and cost-effective design, capable of collecting capillary blood samples from species with at minimum < 2.5 mm epidermal thickness. Develop key component technology milestones and conceptual designs for hardware. Develop plan for validation study comparing blood collected from this prototype device again collected from standard methods.
FEASIBILITY DOCUMENTATION: Offerors interested in participating in Direct to Phase II must include in their response to this topic Phase I feasibility documentation that substantiates the scientific and technical merit and Phase I feasibility described in Phase I above has been met (i.e., the small business must have performed Phase I-type research and development related to the topic NOT solely based on work performed under prior or ongoing federally funded SBIR/STTR work) and describe the potential commercialization applications. The documentation provided must validate that the proposer has completed development of technology as stated in Phase I above.
DoW Animal Use Requirements [Ref 4] should be taken into consideration when submitting proposals. The DoW Vet review process can take 2-3 months. Proposals can NOT be funded until all animal use documentation, permits and protocols are received by the SBIR Program Office and approved by the DoW veterinarian. Some of this documentation can take months to acquire, so investigators need to plan to submit paperwork to the SBIR program office once the proposal has been selected for funding.
DoW Animal Use approval is not required at the time of proposal submission to this SBIR topic. However, the proposer must be prepared to provide all required animal use documentation at the time of proposal selection to ensure that this approval is received before the contract is awarded.
PHASE II: Develop prototype payloads and technology hardware based on adapting an existing capillary blood collection device (initially designed for humans) for use in a waterproof, remotely deployable device capable of collecting capillary blood samples from species with at minimum < 2.5 mm epidermal thickness in a compact, efficient, cost-effective design. Refine the prototype or plan to re-engineer the prototype device to iteratively test and successfully collect blood samples from across a diversity of species with epidermal thickness >10 mm. Deliver a prototype device for species with epidermal thickness < 2.5 mm and at minimum a plan for species with epidermal thickness of > 10mm at the end of Phase II, ready for integration and testing by the Government. Prepare and submit a Phase III commercialization/transition plan.
PHASE III DUAL USE APPLICATIONS: Support transition of the device to the Government and into the wider scientific community.
Businesses that provide marine mammal monitoring capabilities to a wide range of government agencies having equities in marine life issues could leverage the devise. NOAA National Marine Fisheries, National Ocean Service, Office of National Marine Sanctuaries, Bureau of Ocean Energy Management, U.S. Geological Survey, and the U.S. Fish and Wildlife Service, among others would benefit from this capability. A key goal of this phase will be making the technology available to the broader research and Navy communities.
REFERENCES:
KEYWORDS: blood sampling; blood collection; minimally invasive; health assessments; marine species health; rapid health assessment
TPOC 1 : Michael Weise
michael.j.weise.civ@us.navy.milTPOC 2 : Anurag Kumar
anurag.kumar.civ@us.navy.mil
** TOPIC NOTICE ** |
The Navy Topic above is an "unofficial" copy from the Navy Topics in the DoW FY-26 Release 6 SBIR BAA. Please see the official DoW Topic website at www.dodsbirsttr.mil/submissions/solicitation-documents/active-solicitations for any updates. The DoW issued its Navy FY-26 Release 6 SBIR Topics pre-release on September 2, 2026 which opens to receive proposals on September 23, 2026, and closes October 21, 2026 (12:00pm ET). Direct Contact with Topic Authors: During the pre-release period (September 2, through September 22, 2026) proposing firms have an opportunity to directly contact the Technical Point of Contact (TPOC) to ask technical questions about the specific BAA topic. The TPOC contact information is listed in each topic description. Once DoW begins accepting proposals on September 23, 2026 no further direct contact between proposers and topic authors is allowed unless the Topic Author is responding to a question submitted during the Pre-release period. DoD On-line Q&A System: After the pre-release period, until October 7, 2026, at 12:00 PM ET, proposers may submit written questions through the DoW On-line Topic Q&A at https://www.dodsbirsttr.mil/submissions/login/ by logging in and following instructions. In the Topic Q&A system, the questioner and respondent remain anonymous but all questions and answers are posted for general viewing.
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