SAM #HT9427-26-R-E020

Prototype Development for Battlefield Wound Infection Prevention and Treatment Barrier Combination

This opportunity is for the development of a prototype Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination product for the Defense Health Agency and U.S. Army Medical Research & Development Command. - Government Buyer: - Defense Health Agency (DHA), Medical Products Warfighter Protection and Acute Care Program Management Office (WPAC PMO) - U.S. Army Medical Research & Development Command (USAMRDC) - OEMs and Vendors: - No specific OEMs or vendors are named; open to qualified manufacturers with relevant expertise - Products Requested: - Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination prototype - 50 final design prototypes required - Product must combine a physical wound barrier with antimicrobial and/or antifungal properties - Must achieve Technology Readiness Level (TRL) 7 by FDA submission - Minimum 12-month shelf life - Must include instructions for use - FDA approval or clearance required - Services Requested: - Regulatory and clinical trial services - FDA regulatory communications - Chemistry, Manufacturing, and Controls (CMC) development - Clinical studies/trials to demonstrate safety and efficacy - Preparation and submission of FDA packages - Quality management and project reporting - Unique/Notable Requirements: - Product must be suitable for battlefield use, preventing and treating wound infections - Must meet specific efficacy, shelf-life, and usability criteria - FDA approval or clearance is mandatory - Contract includes prototype development, clinical trials, and regulatory submissions - Delivery of 50 prototypes for operational test and evaluation - Period of performance is approximately 48 months, with overlapping objectives for development and clinical studies, followed by FDA review - No specific part numbers or brands are listed; opportunity is open to innovative solutions from qualified manufacturers.

Description

This RPP is being issued by the Defense Health Agency Contracting Activity (DHACA), in support of the Defense Health Agency’s Portfolio Acquisition Executive (PAE) Medical Products (MP) Warfighter Protection (WPAC) & Acute Care Program Management Office (PMO) Care located in Frederick, Maryland at Fort Detrick. The Warfighter Protection and Acute Care Project Management Office (WPAC PMO) has a requirement for the development of a Barrier Combination product. The Barrier Combination product is defined as being composed of both a physical barrier to protect a wound and an antibacterial and/or antifungal activity released from the barrier to prevent the spread of organisms and avoid systemic infections.

This RPP will result in one award to develop the Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination (BC) prototype product.

The final product MUST be a combination wound treatment that includes a barrier component that is either infused or impregnated with antimicrobial and/or antifungal properties and have U.S. Food Drug Administration (FDA) approval (or clearance).

The award, as a result of this RPP, will be awarded under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022.

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