Advanced Development
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:
- PM Pharmaceutical Systems (USAMMDA)
- PM Medical Support Systems (USAMMDA)
- PM Integrated Clinical Systems (USAMMA)
- PM Medical Devices (USAMMA)
- PM Enterprise Information Technology Project Management Office (eIT PMO) (PA(ACQ))
- PM Theater Enterprise-Wide Logistics System (TEWLS) (PA(ACQ))
USAMMDA Advanced Development Programs:
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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.
PM Pharmaceutical Systems
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.
PM Medical Support Systems
The Medical Support Systems Project Management Office (MSSPMD) manages medical equipment (non FDA regulated items) products supporting the medical mission. MSSPMD supports the Warfighter's medical materiel needs by analyzing functional requirements, evaluating products, developing technical and program strategies for product acquisition, and sustaining those products throughout the products' lifecycles. When applicable, MSSPMD engages non-AMEDD Program Executive Offices (PEO) to ensure military medical requirements are addressed.
USAMMA Advanced Development Programs:
PM Integrated Clinical Systems
PM ICS centrally manages all imaging, image management, and major clinical systems which integrate with the DoD Electronic Medical Record.
Specific responsibilities include managing PACS, imaging, and teleradiology program initiatives, execution of the Technology Assessment and Requirements Analysis (TARA) program, and management of the Information Assurance requirements for all medical devices.
Three ICS subordinate product managers execute a patient-centric system of systems approach to ensure timely delivery of affordable, sustainable, interoperable, and information assurance compliant capabilities in support of clinical requirements for fixed and deployed medical treatment facilities
- The Product Manager for Imaging Systems (PM IS) executes the teleradiology portion of the TARA Program and provides lifecycle management of diagnostic imaging technologies.
- The Product Manager for Image Management Systems (PM IMS) assists in the TARA Program and provides lifecycle management of PACS, teleradiology, and other image management capabilities.
- The Product Manager for Clinical Systems (PM CS) executes the expanded TARA Program and provides lifecycle management of non-imaging clinical systems.
http://www.usamma.army.mil/PM_ICS.cfm
PM Medical Devices
The PM for Medical Devices (PM MD) manages all TOE medical (FDA-regulated) devices supporting patient and animal care. It is comprised of three Product Managers:
- Acute Care
- Ancillary Care
- Medical Scientist
The PM MD manages all major end items and associated unit assemblages in trauma and emergency medical treatment, medical transport, general surgery including surgical subspecialties, recovery, central materiel service, ophthalmology and optometry services, laboratory, dentistry, veterinary services and general medical care.
PA(ACQ) Advanced Development Programs:
PM Enterprise Information Technology Project Management Office (eIT PMO)
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 two FDA compliant capabilities; an Electronic Document Management System (EDMS) and a Serious Adverse Event (SAE) reporting system. EDMS is a document management system used to track and store documents and scanned images of paper copies, and provides version control and audit trails. SAE is used to capture and report serious adverse events that occur during clinical trials and provides an audit trail. EDMS and SAE are both commercial-off-the-shelf (COTS) products configured to satisfy USAMRMC functional requirements. The third capability, an Electronic Data Capture - Clinical Research Data Management System (EDC-CRDMS) is currently in development with a target production date 4th quarter FY12.
PM Theater Enterprise-Wide Logistics System (TEWLS)
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.