Medical Systems - Adv Dev

The Medical Systems - Advanced Development program is a U.S. Army Research, Development, Test & Evaluation (RDT&E) initiative focused on advancing medical materiel from promising science and technology concepts to larger-scale human testing and eventual fielding. Managed by the U.S. Army Medical Materiel Development Activity (USAMMDA) under the U.S. Army Medical Research and Development Command, the program aims to address future force requirements by developing drugs, vaccines, medical devices, diagnostics, and disease vector control mechanisms. A significant objective is to support Food and Drug Administration (FDA)-regulated human clinical trials to ensure the safety and effectiveness of these products, ultimately leading to licensure for use in military and potentially civilian populations.

DoD Drug & Vaccine Advanced Development specifically targets the development of medical countermeasures for infectious diseases of military relevance. The project funds technical evaluations and human clinical trials for candidate vaccines, drugs, and diagnostic devices. The primary goals are to prevent disease, enable early diagnosis, and accelerate recovery, thereby enhancing battlefield readiness. All clinical trials are conducted in accordance with FDA regulations, and priorities are set based on disease threat, clinical severity, technical maturity, and affordability. The project also provides ongoing civilian manpower support for the Project Manager Soldier Medical Devices, ensuring continuity in medical product development and management.

Field Medical Systems Advanced Development is focused on the demonstration and validation of medical products to improve combat casualty care and follow-on care in operational environments. This includes funding for human clinical trials of biologics and devices, with an emphasis on reducing the medical logistics footprint through lighter, more compact, and equipment-independent solutions. The project supports the development and prototyping of lifesaving field medical systems, such as mobile medical platforms and shelters, and the integration of medical devices into these platforms. A key objective is to enhance interoperability and situational awareness for deployed forces, supporting both Army and joint medical requirements for prolonged and effective casualty care.

Within this effort, two major congressional adds in FY 2024 were the Arctic Medical Evacuation and Treatment System and the Wearable Medical Device for TBI Prevention. The Arctic Medical Evacuation and Treatment System is being developed in coordination with the Office of Naval Research to enable medical transport on tracked vehicles in extreme cold environments, addressing unique operational challenges in arctic conditions. The Wearable Medical Device for TBI Prevention, directed by the Defense Health Agency, focuses on evaluating the effectiveness of the Q-Collar device in preventing traumatic brain injury through animal studies, fit assessments, and durability testing. These efforts are intended to improve Soldier survivability and long-term health outcomes.

The Counterdrug, DDR, System Development & Demonstration line item supports advanced development efforts for the Forensic Toxicology Drug Testing Laboratory Information Management System. This project is critical for maintaining the integrity of the Department of Defense drug testing program, which selects service members for random drug testing, manages specimen labeling, and ensures proper chain-of-custody documentation. The current objective is to standardize the Drug Testing Program - Client Collection System across all military services and migrate it to a web-based platform, thereby improving efficiency, data management, and compliance with regulatory standards.

Across all projects, the Medical Systems - Advanced Development program employs a strategy of leveraging both in-house and commercial partnerships to conduct extensive clinical trials and prototype development. The acquisition approach is designed to ensure that military-specific requirements are met while making judicious investments to achieve FDA licensure and fielding of new medical solutions. The program also aligns with broader Department of Defense initiatives for workforce optimization and efficiency, as reflected in minor adjustments to civilian personnel funding.