Federal · SAM.gov · Frederick, MD

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

Federal AgencyIssuing agency·Frederick, MD·via the SAM.gov Get Opportunities API

29days left

Due Oct 23, 2026·Posted Sep 24, 2026

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AI takeaways

The Defense Health Agency (DHA) is soliciting a prototype Other Transaction Agreement (pOTA) for the development of a Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination (BC) product, a combination wound treatment with a physical barrier infused or impregnated with antimicrobial/antifungal properties requiring FDA approval or clearance.
The place of performance is Frederick, MD, and work will also be performed at the Performer's facilities and various clinical trial sites within the United States.
Proposals are due by 12:00 PM Eastern on Friday, 23 Oct 2026, and questions are due by 12:00 PM Eastern on Friday, 02 Oct 2026.
The estimated period of performance is 54 months, with Objectives 1 and 2 each estimated at 24 months and Objective 3 at 6 months.
The procurement method is a Request for Project Proposal (RPP) under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022.
The solicitation is issued by the Defense Health Agency Contracting Activity (DHACA) in support of the Defense Health Agency’s Warfighter Protection and Acute Care Project Management Office (WPAC PMO).
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 will be a Firm Fixed Price (FFP) or cost-plus fixed fee (CPFF) type pOTA, and the Government prefers a FFP type.
The Offeror must serve as the FDA Sponsor for this development effort and submit a Sponsor Indication Form FDA 1571.
The Offeror must submit a written technical approach, a Statement of Work with milestones, a Project Management Plan with an Integrated Master Schedule, a Commercialization Plan, and a Regulatory Strategy.
Requirement: The Offeror must submit written confirmation that the Offeror will serve as the FDA Sponsor for this development effort per 21 C.F.R. 312 Subpart D, and other applicable FDA regulations, guidance, and International Conference on Harmonization (ICH) guidance, including the Sponsor Indication Form FDA 1571.
Requirement: The Offeror must fill in and submit Attachment F - Warranties and Representations, specifying the critical technologies being offered and/or the significant extent of participation of the Nontraditional Defense Contractor (NDC) or nonprofit research institution or cost share.
Requirement: To be eligible for award, a proposal must demonstrate that at least one of the following conditions are met: (A) at least one nontraditional defense contractor or non-profit research institute participating to a significant extent; (B) all significant participants are small businesses or nontraditional defense contractors; or (C) at least one third of the total cost is paid by non-Federal parties.
Requirement: The Offeror shall indemnify the government through the purchase of liability Insurance, including bodily injury/death, no-fault medical expenses, legal defense costs, settlements, product and professional liability, and protocol-driven medical expenses.

Term: 54 months
Method: Request for Project…
Documents: 14 files

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Contact the buyer

Bryan Heickman

bryan.g.heickman.civ@health.milEmail

Location:

Frederick, MD

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Notice

8c30e6dea71f45a58c3ad8ad9942652c

HT9427-26-R-E020

Method

Solicitation

Duration

54 months

What this bid is asking for

AI-generated

Develop a Barrier Combination prototype product composed of a physical wound barrier with antibacterial and/or antifungal activity.
Obtain U.S. Food and Drug Administration (FDA) approval or clearance for the final product.
Conduct preclinical testing and clinical studies/trials to demonstrate safety and efficacy in humans for an adult indication.
Deliver up to fifty (50) final design prototypes for operational test and evaluation, including instructions for use.
Submit all required deliverables including a Regulatory Strategy, Project Management Plan, Commercialization Plan, and monthly reports.

Posted Scope of Work

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.

Scope, read from the documentsAI-generated

The scope of work includes all activities required to develop the BWI P&T BC prototype product and achieve FDA approval or clearance. This includes Objective 1: demonstrating the prototype's ability to provide a physical barrier and establish antimicrobial activity, completing preclinical testing to support an IND or IDE application, and delivering a working prototype ready for clinical study evaluations. Objective 2: executing clinical studies/trials to demonstrate safety and efficacy in humans for an adult indication, including preparing human use protocols, managing regulatory submissions to the FDA, establishing Chemistry, Manufacturing, and Controls (CMC), and delivering up to fifty (50) final design prototypes for operational test and evaluation. Objective 3: delivering notice of FDA clearance or approval. The final product must meet required attributes including submission of documents for FDA approval/clearance, TRL 7, a minimum shelf-life of 12 months, antimicrobial efficacy to prevent bacterial infection, and barrier integrity for a minimum of 24 hours.

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Documents

Download zip

HT9427-26-R-E020-RPP for BWI-PT-Barrier (pOTA).pdfPDF

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

What this bid is asking for

Posted Scope of Work

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

What this bid is asking for

Posted Scope of Work

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Documents

Questions & answers

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Not the right RFP for you?