Attachment 3, titled “MINIMUM ESSENTIAL CHARACTERISTICS (MEC),” outlines the essential and desired characteristics for a device to be considered acceptable by the government. The document, likely part of an RFP or grant application, requires vendors to indicate whether their device meets minimum and desired criteria for several key characteristics. These include providing a safe and efficacious physical barrier with antimicrobial properties, maintaining efficacy and stability during storage at ambient temperatures for at least 12 months, and achieving a minimum Technology Readiness Level (TRL) of 4. Desired characteristics include versatility against both bacterial and fungal infections, stability at extreme temperatures, and efficacy for over 12 months. The document also provides space for additional comments, ensuring a comprehensive evaluation of proposed devices.
This Request for Information (RFI), HT9427-26-RFI-BWI-PT, issued by the Defense Health Agency (DHA), seeks market knowledge for a battlefield wound infection prevention and treatment barrier combination product. This is not a request for proposals or quotations, and no contract will be awarded based on responses. The DHA's Operational Medical Systems (OPMED) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO) aims to develop medical products for battlefield wounds and subsequent infections, specifically focusing on a barrier combination product as part of a Family of Systems (FoS) approach. Responses, including company and product information and adherence to minimum essential characteristics, are due by January 20, 2026, 2:00 PM Eastern, via email. This RFI is for planning purposes only, and the government will not pay for information submitted.
The document outlines Technology Readiness Levels (TRLs) for pharmaceuticals and medical devices, detailing the developmental stages from initial scientific awareness (TRL 1) to post-marketing surveillance (TRL 9). For pharmaceuticals, the TRLs progress from hypothesis generation and basic research to preclinical and clinical trials (Phases 1-3), culminating in New Drug Application (NDA) submission and approval. Medical device TRLs follow a similar path, including design concept evaluation, laboratory and animal model testing, clinical investigations, and ultimately Premarket Approval (PMA) or 510(k) submission and approval. Each TRL specifies decision criteria, research activities, and regulatory milestones, such as IND/IDE applications and FDA meetings. This structured framework ensures systematic development, rigorous testing, and regulatory compliance for both drug and device development, crucial for federal grants, RFPs, and regulatory submissions.