Medical Systems - Adv Dev

Mission — Medical Systems - Adv Dev source

This Program Element (PE) funds development of medical materiel within the early system integration portion of the System Development and Demonstration phase of the acquisition life cycle using 6.4 (Advanced Component Development and Prototype) funding. Program efforts support transition of promising Science and Technology candidate medical technologies (drugs, vaccines, medical devices, diagnostics, and mechanisms for detection and control of disease carrying insects) to larger scale testing in humans for safety and effectiveness. Programs are aligned to meet future force requirements identified within concept documents and organizational structures. This PE also provides funding for Food and Drug Administration (FDA) regulated human clinical trials to gain additional information about safety and effectiveness on the path to licensure for use in humans. These efforts are managed by U.S. Army Medical Materiel Development Activity (USAMMDA) of the U.S. Army Medical Research and Development Command. The FY 2026 request was reduced by $0.003 million for civilian personnel to optimize the workforce in compliance with Executive Order 14210, "Implementing the President's Department of Government Efficiency Workforce Optimization Initiative."

Mission — Counterdrug, DDR, Sys Development & Demonstration source

Supports the Secretary of Defense approved counterdrug advanced development efforts used in a major re-design of the Forensic Toxicology Drug Testing Laboratory (FTDTL) information management system used to test urine samples for the presence of illegal drugs. The Drug Testing Program - Client Collection System (DTP-CSS) is comprised of several variations of a desktop application used to select service members for random drug testing, prepare labels for urine specimen bottles, and print corresponding chain-of-custody documents. This Project will standardize DTP-CSS across all services and migrate it to a Web-based system.

Mission — Field Medical Systems Advanced Development source

This Project funds the demonstration and validation of medical products for enhanced combat casualty care and follow-on care. This Project funds human clinical trials to test the safety and effectiveness of biologics (products derived from living organisms) and devices necessary to meet medical requirements. The Project Manager (PM) also considers factors to reduce the medical logistics footprint through smaller weight, volume, and equipment independence from supporting materials. All clinical trials are conducted in accordance with U.S. FDA regulations. Products from this project will transition to PE 0604807A (Medical Materiel/Medical Biological Defense Equipment - Eng Dev) /Project 832 (Field Medical Systems Engineering Development).

Mission — DoD Drug & Vacc Ad source

This Project funds development of candidate medical countermeasures for endemic infectious diseases of military relevance. These efforts are in: vaccines, drugs, diagnostic kits/devices. These funds support human clinical effectiveness (capacity to produce a desired size of an effect under ideal or optimal conditions) trials of the drug/vaccine in larger groups that are designed to assess how well the drug/vaccine works and continue safety assessments in a larger group of volunteers. Funding supports both technical evaluations and human clinical testing to assure the safety and effectiveness of medical diagnostic kits and devices. This work, which is performed in military laboratories or civilian pharmaceutical firms, is directed toward the prevention of disease, early diagnosis, and accelerated recovery time once diagnosed to enhance battlefield readiness. All clinical trials are conducted in accordance with United States (U.S.) Food and Drug Administration (FDA) regulations, a mandatory obligation for all military products placed into the hands of medical providers or service members. Product development priorities are determined based upon four major factors: (1) the extent and threat of the disease within the Combatant Commands theater of operations, (2) the clinical severity of the disease, (3) the technical maturity of the proposed solution, and (4) the affordability of the solution (development and production).

Accomplishments & Planned Programs (2)