United States Army Medical Materiel Development Activity

The United States Army Medical Materiel Development Activity (USAMMDA), a subordinate unit of the U.S. Army Medical Research and Materiel Command at Fort Detrick, Maryland, serves as the U.S. Army’s executive agent for the development of new drugs, vaccines, and medical devices for service members.

USAMMDA product managers take promising new concepts and technologies developed in U.S. Army laboratories, guide them through the regulatory bureaucracy to obtain U.S. Food and Drug Administration certification, and develop plans for fielding products in conjunction with a sister agency, the U.S. Army Medical Materiel Agency (USAMMA).

Overview
USAMMDA is the Department of Defense’s (DoD) advanced development activity for products designed to protect and preserve the lives of service members. USAMMDA develops new drugs, vaccines, and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DoD, and maximizes survival of medical casualties on the battlefield.

USAMMDA project managers guide the advanced development of medical products for the U.S. Army Medical Department, other U.S. Services, the Joint Staff, the Office of the Secretary of Defense and U.S. Special Forces community. The process takes promising technology from DoD and academia to U.S. Forces, from the testing required for FDA approval or licensing to fielding of the finished product.

Mission & Vision
Mission: Develop and deliver quality medical solutions to protect, treat, and sustain the health of Our service members.

Vision: USAMMDA is the premier developer of world class military medical solutions.

Project Management Offices
USAMMDA project managers address critical readiness issues identified in user requirement documents to meet cost, schedule and performance objectives. Tailored procurement, rapid prototyping and a variety of cooperative and contractual arrangements with academia and industry are among the most current acquisition procedures used. Project Management Offices (PMO) include:


 * Medical Support Systems (MSS) PMO advances development of medical products used to sustain and support the Warfighter. Product managers analyze functional requirements, conduct market investigations, and plan for all acquisition program phases. MSSPMO designs, develops, and tests field medical equipment and specializes in developing innovative technology as well as adapting commercial off-the-shelf (COTS) systems. The Medical Prototype Development Laboratory is a small team of engineering technicians who rapidly design and build prototype medical devices, and harden COTS products for use in a field environment.


 * Pharmaceutical Systems PMO centrally manages the development and acquisition of pharmaceutical and biological products (drugs, vaccines, diagnostics, protective and therapeutic modalities for use against infectious diseases and similar products for combat casualty care). Product Managers work with USAMRMC laboratories, academia, and industry partners (both domestic and foreign) to identify, develop, license, and field products to remedy deficiencies identified by the Army Medical Department Combat Developer.


 * Armed Forces Institute of Regenerative Medicine (AFIRM) PMO is a multi-Institutional, interdisciplinary network working to develop advanced treatment options for our severely wounded service members. AFIRM is managed and funded through the USAMRMC; with additional funding from the U.S. Navy, Office of Naval Research; the U.S. Air Force, OTSG; the National Institutes of Health; the Veterans Administration; and local public and private matching funding.


 * Hyperbaric Oxygen (HBO2) Treatment For Mild Traumatic Brain Injury (mTBI) is the administration of oxygen in a chamber at greater than sea-level atmospheric pressure in which oxygen becomes increasingly dissolved in the blood, resulting in greater than normal every day oxygen tension in cells and tissues in the body. There is some compelling anecdotal evidence to suggest this may be beneficial in the treatment of acute and chronic symptoms linked to traumatic brain injury. Stronger evidence must be obtained prior to determine if HBO2 should be used as a treatment for TBI.


 * Neurotrauma and Psychological Health (NPH) PMO was formed in May 2011 to support advanced development of materiel and select nonmateriel (Medical Knowledge) products to protect, sustain and care for Warriors with TBI and psychological health issues including Posttraumatic Stress Disorder. Additionally NPH provides advanced development assistance to USAMRMC Military Operational Medicine and Combat Casualty Care Research Programs and associated Joint Program Committees.

Regulatory Divisions
Division of Regulated Activities and Compliance (DRAC) is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to support the USAMMDA mission. DRAC provides full service regulatory support for products through the DoD acquisition spectrum, from individual investigator-initiated clinical studies to products in the advanced development pipeline. DRAC carries out its delegated responsibilities as the Office of The Surgeon General Sponsor’s (OTSG) representative for the Army regarding medical materiel development, and its operations are mandated in FDA, DoD, and Army regulatory requirements. DRAC supports investigators at medical centers and laboratories, institutional review boards, and product development teams in laboratories and advanced development organizations throughout the Army and the DoD.

Clinical Service Support Division (CSSD) supports the development of medical products by providing expert assistance in the areas of IND product manufacturing, testing and accountability; clinical study monitoring; clinical data management; biostatistics, including study design and data analysis; and adverse event monitoring and reporting.

Executive Agency
Force Health Protection-Investigational New Drugs (FHP-IND) is an Executive Agency under the Army OTSG. FHP-IND provides services to all DoD Components as the lead organization for using medical products under Emergency Use Authorizations (EUA) or IND applications in response to chemical, biological, radiological, or nuclear warfare or terrorism and other health threats. FHP-IND provides an urgent treatment capability using novel investigational countermeasures to protect U.S. Forces against man-made or natural threats in accordance with federal regulations and DoD instructions.

Critical Tasks:
 * Provide a safe and compliant program to protect the force using IND countermeasures.
 * Provide logistical support for the unique requirements for acquisition, storage, shipping, and testing of investigational countermeasures.
 * Deploy personnel and investigational countermeasures in support of civilian authorities or military commanders.