SBIR: Smart Whole Blood Field Transfusion system (SWiFT)

OUSD (R&E) critical technology area(s): Biotechnology, Biomanufacturing

Objective: Develop and demonstrate a self-contained, autonomous device capable of blood collection, temporary storage (<4hr), diagnostic testing, and transfusion, with continuous donor/recipient monitoring and alerts to issues, revolutionize safe, efficient and effective blood collection and transfusion in both military and civilian settings.

Description: The current processes for blood collection and transfusion are complex and labor-intensive with real-time decision-making presently executed by numerous skilled medical professionals and varied systems and technologies, and prone to human error. Data from Combat Training Centers (CTC) demonstrate that less than a 60% success rate at WB transfusion and that the average time from initiating a walking blood bank to completing the transfusion of one unit of blood is over 40 minutes. This data is also obtained without significant duress for the trainees – no patient is dying and there is not actual risk to the medical providers (i.e., no actual indirect or direct fire). Multiple factors contribute to this including the identification of suitable veins for venipuncture, to ensuring accurate typing and crossmatching of blood, to the physical requirements of priming IV tubing, agitating the blood collection bag, maintaining gravity for drainage… each step presents opportunities for mistakes that at best risk lost units of blood (and lost donors) and at worst have life-threatening consequences. These outcomes and considerations highlight the intrinsically complex difficulties of the process and greater impact to expected outcomes in Department of War (DoW) workflows with and for its warfighters.

This SBIR topic seeks innovative proposals for a single, integrated device that addresses these challenges through complete automation and continuous monitoring of both the donor and recipient. The device should be easily applicable to a wide range of patient sizes and ages and must autonomously collect blood (assess adequacy of vascular access and provide pump action, real-time mixing of citrate anticoagulant to ensure each drop of blood is usable in the event of a “short” donation, continuous unit agitation), type and screen the donated blood, type and crossmatch the recipient to ensure viability for donation, and transfuse blood with heated circuit. Additional options include: pressure transfusion to rapidly transfuse blood, direct donor-to-recipient transfusion, up-to-double unit collection from a single donor, autonomous venipuncture for other procedures requiring vascular access, blood unit extraction for other uses. All equipment to perform all functions are housed within the device and there is absolutely no need to access or manipulate anything. In configuration one, attach the device IV tubing to the donor’s IV (and/or the recipients IV) and push “go.” In configuration 2, place the device on the respective donors or recipients for venous access and push “go.”

The device should also incorporate cost permissive non-invasive sensors to continuously monitor donor and recipient vital signs (e.g., HR, SpO2, respirations, blood pressure, temperature). The device must be programmed to recognize abnormal vital sign patterns or other concerning indications of a blood transfusion reaction and automatically alert medical personnel.

The goal is to create a self-contained unit that can be applied to a blood donor or recipient and, with minimal human intervention, perform all necessary steps for safe and effective blood collection and transfusion. The continuous monitoring and alert system will further enhance safety by providing an early warning of potential adverse events. This will reduce variability and errors, increase precision and reproducibility, enhance efficiency and efficacy, eliminate the need to manage individual equipment elements, and free up medical personnel for other critical activities.

The proposed device should integrate and miniaturize existing technologies, incorporating robust sensors, AI-driven decision logic, and secure data connectivity. The device must meet stringent safety and reliability standards, with built-in fail-safes and comprehensive monitoring capabilities. The device should also be ruggedized for use in austere environments.

Successful proposals will demonstrate a clear path toward a deployable prototype that can significantly improve blood transfusion services in both military and civilian settings. Target cost for such a device should be less than $300 at market price, weigh less than 5 lbs when empty, be rugged enough to drop from a standing height, and be designed to fit in a “golden hour cooler” if the blood will not be used immediately and to be discarded after transfusion is complete.

The devices must include end-to-end automation of the process and anticipate a single product submission for FDA approval. The essential steps to automate (and integrate) include:

1. Vascular access (placement of IV catheter in patient).
2. Miniaturization of automated vascular access.
3. Human hooks donor/recipient up IV tubing to IV/IO.
4. Assessment of the suitability for drainage of a placed vascular access (IV or IO).
5. Assessment of donor blood type.
6. Infectious disease screen.
7. Infusion of appropriate amount of anticoagulant (citrate) in real-time (avoids problem of underfilling).
8. Agitation.
9. Stoppage when bag is “full” (avoids problem of overfilling and over collecting in the event that donation and transfusion are synchronous).
10. *Individual must remove and reset/connect the device to recipient
11. Assessment of recipient blood type (by finger/skin prick, no IV/IO required) - synchronous or asynchronous execution.
12. Assessment of recipient vascular access - synchronous or asynchronous execution.
13. Determine Whether to Initiate Transfusion ALLOWS TRANFUSION ONLY AFTER CONDITIONS MET (matching blood type, access sufficient) – avoids anaphylaxis, lost time, lost blood.
14. Transfuses blood on pump (faster than by gravity).
15. Transfuses calcium after blood transfusion complete to reverse anticoagulant effect of citrate (optional).
16. Report successful completion of procedure.
17. Secure or Discontinue IV catheter.

Phase I: Feasibility and Conceptual Design

Objective: To establish the technical and practical feasibility of the SWiFT system by conducting a comprehensive systems integration study, developing a detailed conceptual design, and creating a risk-mitigated roadmap for Phase II prototype development.

Key Activities

Technology & Component Down-Selection:

• Conduct a trade study of existing COTS (Commercial Off-The-Shelf) and emerging technologies for each critical subsystem: robotic venipuncture, microfluidic blood typing/crossmatching, compact refrigeration, automated fluid handling, and non-invasive vital sign monitoring.
• Evaluate and select candidate components based on performance, size, weight, power (SWaP) constraints, ruggedness, and biocompatibility.
• Perform a systems integration analysis to identify primary interface challenges, data communication protocols, and power management strategies for a unified device.

Conceptual Design & System Architecture:

• Develop a detailed 3D CAD model and conceptual design of the integrated SWiFT system, outlining the placement of all major subsystems.
• Define the end-to-end autonomous workflow, from donor vein acquisition to recipient transfusion, including all safety interlocks and error-handling procedures.
• Architect the intelligent alert system, defining specific physiological thresholds (e.g., for hypotension, tachycardia, signs of transfusion reaction) and the logic for escalating alerts to medical personnel.

Risk Reduction & Phase II Planning:

• Identify the highest-risk technical challenges (e.g., miniaturizing the refrigeration unit, ensuring reliable venipuncture across diverse patient populations) and propose specific risk-mitigation strategies.
• Develop a detailed project plan for Phase II, including a work breakdown structure, schedule, and resource allocation for prototype fabrication and testing.
• Outline the preliminary regulatory strategy, identifying the likely FDA classification and key requirements for future clinical validation.

Phase I Milestones:

• Month 2: Technology Assessment Report: A comprehensive report detailing the results of the trade study, the down-selected components for each subsystem, and the systems integration assessment.
• Month 4: Conceptual Design Review (CDR): Presentation of the complete conceptual design package, including CAD models, system architecture diagrams, and the defined autonomous workflow and alert logic.
• Month 6: Final Feasibility & Phase II Plan: Delivery of the final report summarizing the overall feasibility, risk-mitigation strategies, preliminary regulatory pathway, and the detailed, actionable plan for Phase II development.

PHASE II: Prototype Development and Validation

Objective: To develop, integrate, and validate a fully functional, ruggedized alpha prototype (TRL 6) of the SWiFT system, demonstrating its capability to perform the end-to-end transfusion process autonomously and safely in a laboratory setting.

Key Activities:

Alpha Prototype Fabrication & Integration:

• Procure all selected components and fabricate custom parts required for the SWiFT prototype chassis and internal structure.
• Integrate the mechanical, electrical, and fluidic subsystems into a single, cohesive benchtop unit.
• Develop the core control software for process automation, data logging, and system diagnostics.
• Integrate the non-invasive vital sign sensors and develop the intelligent alert system software, testing its ability to trigger alerts based on simulated physiological data.

System Refinement & Ruggedization:

• Conduct iterative testing of the integrated benchtop prototype to identify and resolve software bugs, hardware conflicts, and workflow inefficiencies.
• Based on benchtop testing, design and fabricate a second-generation "alpha-ruggedized" prototype, focusing on miniaturization, durability, and a user-friendly interface for field operation.
• Perform environmental testing on the ruggedized prototype to assess its resilience to shock, vibration, and temperature extremes relevant to military operational environments.

Verification & Validation (V&V) Testing:

• Develop a comprehensive V&V test plan with clear pass/fail criteria for every system function.
• Conduct extensive laboratory testing using blood analogues and whole blood samples (per appropriate protocols) to validate the system's performance in blood collection, typing, crossmatching, and transfusion accuracy.
• Validate the vital sign monitoring and alert system against calibrated medical simulators to confirm its accuracy and reliability in detecting adverse events.

Phase II Milestones:

• Month 9: Benchtop Prototype Integration Complete: A functional, integrated benchtop prototype capable of executing all core software commands and mechanical actions is complete.
• Month 18: Alpha-Ruggedized Prototype & CDR: Completion of the second-generation ruggedized prototype. A Critical Design Review (CDR) is held to approve the design for final validation testing.

Phase II Milestones (Option):

• Month 21: Full System V&V Report: Submission of a comprehensive report detailing the results of all laboratory and environmental testing, with performance data validating the entire end-to-end system and the intelligent alert functionality.
• Month 24: Final Demonstration & Transition Plan: A live, end-to-end demonstration of the final ruggedized prototype for project stakeholders. Delivery of a detailed plan for Phase III, outlining the path to FDA clearance, manufacturing scale-up, and commercial transition.

Phase III dual use applications

Commercial: Emergency Medical Services (EMS), remote clinics, hospitals, blood banks. Improved efficiency and safety in blood transfusions, reduced labor costs, expanded access to blood products in underserved areas, and enhanced patient safety through continuous monitoring and alerts. Disasters and Mass Casualty Incidents.

DoW/Military: Tactical combat casualty care, forward operating bases, mass casualty events. Rapid and reliable blood transfusions in austere environments, reduced reliance on external blood supplies, improved survival rates for wounded warfighters, and enhanced real-time patient monitoring capabilities.

References

1. Autonomous robotic device designed to perform automated blood draws
   Vitestro. (2025, March 6). Vitestro Unveils Aletta®: The World’s First Autonomous Robotic Phlebotomy Device™ (ARPD™). Vitestro. Retrieved from https://www.prnewswire.com/news-releases/vitestro-unveils-aletta-the-worlds-first-autonomous-robotic-phlebotomy-device-arpd-302394488.html.
2. Electronic crossmatch system
   Zaavia. (n.d.). Understanding Electronic Crossmatch: The Future of Blood Transfusion. Retrieved from https://zaavia.net/blogs/what-is-an-electronic-crossmatch.
3. Autotransfusion technology
   Medtronic. (n.d.). autoLog IQ Autotransfusion System. Retrieved from https://www.medtronic.com/me-en/healthcare-professionals/products/cardiovascular/blood-management-diagnostics/autolog-iq.html.
4. Cardiac Monitoring
   VitalConnect, Inc. (2023, June). QuickStart Guide for Cardiac Monitoring. (MKT-198 Rev.C). Retrieved from https://vitalconnect.com/docs/mkt198/MKT-198_RevC_Cardiac_Compact_QuickStart.pdf .
5. Advance BP sensing
   McMurray, J. P., DeVries, A., Frazee, K., Sizemore, B., Branan, K. L., Jennings, R., & Coté, G. L. (2025). A Novel Wearable Device for Continuous Blood Pressure Monitoring Utilizing Strain Gauge Technology. Biosensors, 15(7), 413. https://doi.org/10.3390/bios15070413.
6. Bijender, B., Kumar, S., Soni, A., Yadav, R., Singh, S. P., & Kumar, A. (2024). Noninvasive Blood Pressure Monitoring via a Flexible and Wearable Piezoresistive Sensor. ACS Omega, 9(6), 6355–6365. https://doi.org/10.1021/acsomega.3c04786.
7. Alarms/alerts
   Stryker. (2026, February). Vocera Engage. Retrieved from https://www.stryker.com/us/en/acute-care/products/vocera-engage.html.

Keywords

Automation, Blood Transfusion, Medical Device, Robotics, Sensors, Diagnostics, Autotransfusion, Blood banking, Vital Sign Monitoring, Patient Safety, Wireless Alerts

TPOC-1-PoC

DARPA BAA Help Desk

Email

SBIR_BAA@darpa.mil