Prototype development for Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination

The Defense Health Agency Contracting Activity is seeking a single award to develop a Battlefield Wound Infection Prevention and Treatment Barrier Combination prototype. This medical product must integrate a physical wound barrier with antimicrobial and antifungal properties to prevent the spread of organisms and systemic infections in combat scenarios. The project aims to advance technologies starting at Technology Readiness Level 5 or higher, with the ultimate goal of achieving TRL 7 or 8. Key requirements include the execution of preclinical testing and human clinical trials, the development of Chemistry, Manufacturing, and Controls documentation, and the successful submission for FDA approval or clearance. The procurement is conducted under prototype Other Transaction Authority 10 U.S.C. 4022, meaning it utilizes a tailored agreement rather than standard FAR-based contract structures. The estimated period of performance is 48 months, divided into three primary objectives: prototype demonstration, clinical studies and regulatory submissions, and final FDA clearance. The final deliverable includes up to 50 final design prototypes for operational testing. Packaging must be individual, waterproof, and capable of being opened with gloved hands in low-light environments, while maintaining sterilization and resisting temperatures between 0 and 110 degrees Fahrenheit. Proposals are evaluated based on technical capability, management capability, and cost. Eligible participants are typically small businesses or nontraditional defense contractors; otherwise, a one-third non-federal cost share is required. Awardees must maintain active SAM registration and comply with CMMC cybersecurity frameworks and DoD instructions for Controlled Unclassified Information. Payments are processed electronically via Wide Area Workflow within 30 days of an acceptable invoice.