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

The Defense Health Agency (DHA) is seeking a single prime contractor to develop a “Barrier Combination” prototype for battlefield wound infection prevention and treatment. The product must integrate a physical wound‑cover barrier with an embedded antibacterial/antifungal agent, achieve FDA approval or clearance, and reach Technology Readiness Level (TRL) 7 by the end of development, moving to TRL 8 after FDA clearance. The effort is funded under a prototype Other Transaction Authority (pOTA) and will span roughly 54 months, with overlapping objectives for barrier proof‑of‑concept, clinical development, and regulatory submission. Deliverables include a detailed technical approach, project management plan with integrated master schedule, regulatory strategy, 50 finalized prototypes, and final FDA approval documentation. The contractor must handle FDA sponsorship, comply with GLP/GCP, manage human and animal research approvals, and provide quarterly progress reports. • Develop and demonstrate the combined physical‑barrier and antimicrobial functionality. • Conduct pre‑clinical and clinical studies, secure FDA IND/IDE, and obtain final FDA approval/clearance. • Deliver 50 production‑ready prototypes and comprehensive technical, regulatory, and commercialization documentation.