MTEC-26-01-BloodBag Request for Project Proposals Pre-Announcement

The Medical Technology Enterprise Consortium (MTEC) is seeking proposals for the manufacture of single blood donor collection and storage bags in the Continental United States (CONUS). The goal of this project is to establish a domestic supply chain for blood bags to support the Armed Services Blood Program and far-forward medical services. The proposed solution should meet existing specifications, including compliance with FDA, ISO, and USP standards. The project will be divided into three phases, with the first phase focusing on technical planning, the second phase on standing up CONUS manufacturing, and the third phase on executing manufacturing to ensure rapid scalable production capacity. • The proposed solution should include detailed documentation and manufacture of blood bags that meet existing specifications. • The solution should support whole blood donor phlebotomy of 500 mL (+/-10%, 450-550 mL) or 450 mL (+/-10%, 405-495 mL). • The solution should contain a solution of anticoagulant and preservatives meeting USP standards that allows for storage of blood for a minimum of 21 days up to 35 days. • The manufactured bags should have a shelf life of 18 - 24 months at room temperature (15 – 30 °C). • The proposal should include a plan for surge production to increase manufacture to 240,000 bags every 60 days during times of increased demand.