DEVELOPMENT OF A FORMULATION-AGNOSTIC AUTOINJECTOR PLATFORM

The Department of War (DoW) is seeking information, design concepts, and capabilities for a formulation-agnostic autoinjector platform. The goal is to identify or develop a modular, ruggedized, and highly reliable autoinjector device capable of delivering single-chamber liquid, dual-chamber liquid-liquid, or dual-chamber solid-liquid (reconstitution) formulations. The device should meet FDA reliability requirements of 99.999% and be capable of delivering volumes ranging from 0.4 mL to 2.0 mL (Threshold) up to 5.0 mL (Objective). Key technical parameters include reliability, flexibility, ruggedization, and target compounds such as Atropine, Pralidoxime Chloride (2-PAM), Midazolam, and Naloxone. • The autoinjector platform should be operationally suitable and commercially viable beyond military use. • The device should be capable of rapid incorporation of new medical countermeasures while minimizing changes to the autoinjector design and production line. • Respondents must include their most up-to-date research and designs, and provide a comprehensive product development plan with scheduled milestones. • The submission should include a company overview, technical solution, regulatory pathway, manufacturing strategy, and commercial business case strategy.