Battlefield Wound Infection Barrier Combination Prototype Development
United States of America > DEPT OF DEFENSE > DEFENSE HEALTH AGENCY (DHA) > DEFENSE HEALTH AGENCY
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Description
The Defense Health Agency seeks one performer to develop a Battlefield Wound Infection Prevention and Treatment Barrier Combination prototype under prototype Other Transaction Authority. The product must combine a physical wound barrier with antimicrobial and/or antifungal activity released from or incorporated into the barrier, and must progress to FDA approval or clearance. Technologies at Technology Readiness Level 5 or higher are preferred; the product must reach at least TRL 7 at FDA submission. Required attributes include at least 12 months of shelf life, prevention of bacterial infection, and barrier integrity on the wound for at least 24 hours. The government also recommends capabilities addressing fungal infections, portability, ease of application, wound coverage, packaging, safety, and compatibility with standard wound-care products. The scope includes prototype development, preclinical and clinical studies for an adult indication, FDA regulatory strategy and submissions, chemistry, manufacturing, and controls development, quality management, manufacturing validation and stability testing, commercialization planning, and delivery of up to 50 final-design prototypes with instructions for use. Proposals must include technical, management, administrative, and cost/price volumes, with either a firm-fixed-price or cost-plus-fixed-fee approach. The estimated period of performance is 54 months, consisting of 24 months for Objective 1, 24 months for Objective 2, and 6 months for Objective 3; Objectives 1 and 2 may overlap but may not exceed 48 months combined before the FDA review period.
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Requirements
- Bodily injury/death
- No-fault medical expenses
- Legal defense costs
- Settlements
- Product liability
- Professional liability
- Protocol-driven medical expenses
Documents
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