Single Blood Donor Collection and Storage Bags Manufactured in Continental United States (CONUS)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) in support of the DHA in alignment with the DoD 2022 National Defense Strategy. This effort aims to invest in manufacturing capabilities within the continental United States (CONUS) is part of a greater effort to bolster the Defense Industrial Base and secure domestic supply chains. In recent years, there has been a shortage of much needed blood storage bags, which is acute within the DoD system where there is a requirement for individually wrapped blood bags for use in far forward situations. The Government is looking for solutions to stand up CONUS manufacturing capabilities to ensure rapid scalable blood bag production in the event of need.

Funding Availability: The Government currently has up to $4 million (M) for the initial Period of Performance of this effort. MTEC expects to make one or more awards for approximately $1-3 M to a qualified Offeror(s).

Number of anticipated awards: MTEC expects to make one or more awards to a qualified Offeror(s) to accomplish the scope of work.

Period of performance: The Government anticipates potential performance periods for an initial base period of performance (PoP1) not to exceed 12 months, but preferably 6 months. After PoP1 for subsequent stages of development (see Section 2.3 for more details) not to exceed 48 months, including all proposed phases of work (Phases I, II, and III) (see Section 3.4 for more details) based upon performance, military relevancy and funds availability.

Note: White papers are NOT required for this RPP. The Government will evaluate proposals submitted and will select the proposal(s) that best meets their current priorities using criteria in Section 5 of this RPP.

To view the full-length version of this RPP, please download using the link on this page.

Background:

DoD’s diverse capabilities involve Warfighters operating in a vast array of challenging, remote, and austere environments. In forward positions, there is a high probability of traumatic injury and wounds leading to blood loss. Hemorrhage is the leading cause of death in combat zone trauma. The gold standard for immediate treatment of hemorrhage is transfusion of whole blood. Delays in transfusion result in increased deaths. However, the availability of whole blood and conventional blood products on forward missions is very limited owing to challenging logistical requirements for transport and storage of blood components. Often, the best approach is to collect blood locally, as opposed to transporting over long distances.

In recent years, there have been supply chain disruptions across the continuum of military and civilian products, including components used in the manufacture of blood bags, from the polymers to the anticoagulant/preservative solutions within the bag. This has resulted in shortages of single blood storage kits most often used in austere environments especially for collections from on-site donors in “walking blood bank” scenarios. According to the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research product shortages website, the shortage of blood collection bag kits and products is ongoing. Shortages of ingredients, components, and manufacturing supplies, as well as delays in manufacturing and transport, are intermittent and unpredictable. A request for surge production may be required dependent on DoD needs. This vital product is required in steady supply to meet the needs of wounded warfighters to enable timely transfusion near the point of injury with donated blood.

Scope of Work

TECHNICAL OBJECTIVE:

This RPP focuses on the CONUS manufacture of single blood bags for use by the Armed Services Blood Program and far forward medical services as well as commercial/civilian blood services. The technical objectives of this program are to:

• Blood Bag Specifications: Produce detailed documentation and manufacture blood bags within the CONUS that meet the following existing specifications:

• Individually wrapped single aseptic collection kit inclusive of 16-gauge donor phlebotomy needle with protection needle guard, tubing, labels, and a sample diversion pouch
• Compliant with FDA (21 CFR 864.9100), ISO 10993 and 3826, USP and MIL 810H standards and guidance,
• Supports whole blood donor phlebotomy of 500 mL (+/-10%, 450-550 mL) or 450 mL (+/-10%, 405-495 mL)
• Contains a solution of anticoagulant and preservatives meeting the USP standards that allows for storage of blood for a minimum of 21 days up to 35 days. Novel formulation will be considered based on budgetary and regulatory provisions
• Foil wrapping that is easy to open requiring no tools and if practical, textured for better grip with brightly marked notches not only at the corners but also in the center of the packaging
• The manufactured bags should have a shelf life of 18 - 24 months at room temperature (15 – 30 ºC)
• Appropriate fatigue and distortion testing
• Achieve FDA clearance or exemption for the kit

• Manufacturing Expected Deliverables:
  • Capability to manufacture no less than 10,000 standard blood donor/storage bags per year
  • Have a validated surge capability plan to increase manufacture to 240,000 bags every 60 days during times of increased demand (i.e., near peer conflict or domestic disaster) for full single blood bag kits with compliant materials and processes
  • Demonstrate redundancy in sourcing of raw materials (e.g., anticoagulant solution, tubing, PVC, seals) from multiple vendors.
  • Develop contingency plans for raw material disruptions.

• Experience: Leverage the experience of a team that has relevant expertise:
  • Designing medical devices, specifically blood products, and adhering to verification and validation guidance.
  • Established current Good Manufacturing Practice (cGMP) ready methods with fully designed hardware and functional disposables

Additional points of consideration:

• Proposals are encouraged to include relevant industry partners, especially considering that the eventual goal is to transition products to industry for FDA approval and/or commercialization.
• Manufacturers implementing cGMP that require financial assistance to meet all requirements of the FDA with clear standard operating procedures and compliance documentation (21 CFR 864.9100) shall provide appropriate substantiating information.

To view the full-length version of this RPP, please download using the link on this page.

Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via webinar on January 8th, 2026 at 1pm EST. The intent of the Proposers Conference is to provide an administrative overview of this RPP and to present further insight into the technical requirements outlined in Section 3 of this RPP. Registration information will be posted to the MTEC website and forthcoming via email.

Points of Contact

For inquiries, please direct your correspondence to the following contacts:

• Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Team, contracts@mtec-sc.org.
• Technical and membership questions should be directed to the MTEC Biomedical Technology Liaison, Dr. Chuck Hutti, Ph.D., Chuck.Hutti@mtec-sc.org.
• All other questions should be directed to the MTEC Programs Team, suppport@mtec-sc.org.