The advanced development process takes promising technology from USAMRMC laboratories, the industrial base, academia and other Government Agencies to US Forces. It encompasses the testing required for US FDA approval or licensing to fielding of the finished product.
Project and Product Managers (PMs) from the US Army Medical Materiel Development Activity (USAMMDA), the US Army Medical Materiel Agency (USAMMA), and the Office of the Principal Assistant for Acquisition (PA(ACQ)), guide the advanced development of medical products for the US Army Medical Department (AMEDD), other US Services, the Joint Staff, the Office of the Secretary of Defense, and the US Special Forces community. PMs 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.
The advanced development of promising concepts and technologies fall under six project managers:
USAMMDA's Quality Office and Division of Regulated Affairs and Compliance (DRAC) guide advanced development products through the regulatory process to obtain US FDA certification. DRAC's oversight of USAMRMC product development activities ensures compliance with Army, DoD, and FDA regulations and policy.
The Pharmaceutical Systems Project Management Division (PSPMD) centrally manages the development and acquisition of drugs, vaccines, diagnostics, repellents, blood products, and resuscitative fluids. It fields products for prevention, diagnosis, and treatment of infectious diseases and injuries contracted during military operations.
PSPMD monitors military, industrial, and university research projects for potential solutions to identified problems. It also leverages and partners USAMRMC laboratories with domestic and foreign pharmaceutical companies to remedy deficiencies identified by the combat developer.
Project Manager Medical Support Systems (PM MSS) manages the development and acquisition of products supporting field medical treatment facility infrastructure, preventive medicine, pest management, combat casualty care support systems, military operational medicine, and ground and aeromedical casualty evacuation vehicles. PM MSS collaborates with the Armed Forces Pest Management Board and non-Medical Program Executive Offices (PEOs) to ensure military medical requirements are addressed in development programs such as medical treatment vehicles/ambulances.
PM MSS manages the Medical Prototype Development Laboratory that designs, develops drawings and technical data packages, and rapidly prototypes far-forward medical equipment in support of the USAMRMC.
The PM MSS also manages all major end items and associated unit assemblages in preventive medicine, chemical and biological protection, treatment and decontamination, field medical care support systems, medical evacuation/transport and enroute care.
Read more: http://www.usammda.army.mil/MedSupport.html
Primarily responsible for product management of advanced development efforts and new product ideas in support of both Army and Defense Health Program. Manages development of medical device solutions for combat casualty care, military operational medicine and rehabilitative and restorative care. Also houses the Office of Research and Technology Applications (ORTA) for the Agency in support of Cooperative Research and Development Agreements (CRADA's).
The APM-MMS is responsible for devices in trauma and emergency medical care, medical transport, general surgery, recovery, and general medical care.
The APM-MMS provides oversight and management for technology, engineering, and manufacturing development efforts utilizing Army and Defense Health Program (DHP) Research, Development, Test & Evaluation (RDTE) funds utilizing 6.3, 6.4, and 6.5 program execution dollars. Facilitates and leads Integrated Product Teams (IPT's), represents the PjM on Joint Program Committees (JPC's), reviews and responds to submissions through the USAMRMC New Product Ideas program, negotiates and manages.
Technology Transfer Agreements (TTA's), and manages pivotal/clinical trials with MEDCOM Medical Treatment Facilities (MTF), USAMRMC research laboratories, and partnering Academic Institutions.
The APM-MMS operates under the guidance and constraints prescribed by DoDI 5000 series, DoDI 5000 series; AR 40-60 Policies and Procedures for the Acquisition of Medical Materiel, AR 40-61 Medical Logistics Policies, AR 70-1 Army Acquisition Policy, AR 700-127 Integrated Logistics Support (*RAR 002, 03/26/2012), AR 70-57, Military - Civilian Technology Transfer. The following are functions of the APM-MMS:
The Enterprise Information Technology Project Management Office (eIT PMO) provides and sustains a suite of USAMRMC Medical Research Enterprise IM/IT solutions that meet the needs of the Command and its collaborators. We are customer-focused, flexible, and responsive. Our workforce is professional, highly trained in IM/IT systems, and knowledgeable of FDA regulations.
Currently, the eIT PMO portfolio includes a suite of FDA compliant capabilities including the Electronic Document Management System (EDMS), the Serious Adverse Event reporting system (SAE), the Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS), the Clinical Trial Management System (CTMS), and the electronic Common Technical Document (eCTD) system.
EDMS is a document management system used to track and store documents, scanned images of paper copies, optical character recognization (OCR) capable, and provides version control, audit trails, and tools to streamline business processes.
SAE is used to capture and report serious adverse events that occur during clinical trials and also provides an audit trail.
EDC-CRDMS supports the life cycle of clinical trial studies from study inception through data field definition/specification, data entry, data query, data transfer/output into stand-alone statistical tools, and study close-out.
CTMS is an end-to end clinical trial management solution with tools to plan, start, conduct, and manage clinical trial studies and supports the monitoring and regulatory activities associated with those trials.
eCTD enables the Command to publish electronic regulatory submissions and transfer the information to the FDA in the required electronic submission format.
EDMS, SAE, EDC-CRDMS, CTMS and eCTD are commercial-off-the-shelf (COTS) products configured to satisfy USAMRMC functional requirements.
Theater Enterprise-Wide Logistics System (TEWLS) is an Army managed project planned for transition to the Defense Medical Logistics Standard Support (DMLSS) system following deployment.
The system supports the intermediate medical logistics functions for distribution and materiel management and ties together the national, regional, and deployed units into a single business environment. It creates the necessary links for planners, commercial partners, and DoD medical logisticians to accomplish essential care in the theater through a single "customer facing" portal.
By transitioning from a server system at each site to an enterprise system with a single instance of actionable data for all sites within the enterprise, TEWLS removes the many islands of data that today are inefficient and ineffective silos of activities.
Finally, TEWLS supports today's modern, non-contiguous battlefield at the regional, Combatant Commanders, and Service levels.