Medical Products Support and Advanced Concept Development
Abstract
Guidance for Development of the Force - Medical Products Support and Advanced Concept Development: This program element (PE) provides funding to support: 1-advanced concept development of medical products that are regulated by the US Food and Drug Administration (FDA), 2-clinical and field validation studies supporting the transition of FDA-licensed and unregulated products and medical practice guidelines to the military operational user, 3-prototyping, 4-risk reduction and product transition efforts for medical information technology applications such as coordination with the Program Execution Office for possible integration into the Military Health System (MHS), and 5-medical simulation and training system technologies. Research in this PE is designed to address areas of interest to the Secretary of Defense regarding Wounded Warriors, capabilities identified through the Joint Capabilities Integration and Development System, and sustainment of Department of Defense and multiagency priority investments in science, technology, research, and development. Medical research, development, test, and evaluation priorities for the Defense Health Program (DHP) are guided by, and will support, the Quadrennial Defense Review, the National Research Action Plan for Improving Access to Mental Health Services for Veterans, Service Members, and Military Families, the National Strategy for Combating Antibiotic Resistance, and the National Strategy for Biosurveillance. Research will support efforts such as the Precision Medicine Initiative, translational research focused on protection against emerging infectious disease threats, the advancement of state of the art regenerative medicine manufacturing technologies consistent with the National Strategic Plan for Advanced Manufacturing, the advancement of global health engagement and capitalization of complementary research and technology capabilities, improving deployment military occupational and environmental exposure monitoring, and the strengthening of the scientific basis for decision-making in patient safety and quality performance in the MHS. The program also supports the Interagency Strategic Plan for Research and Development of Blood Products and Related Technologies for Trauma Care and Emergency Preparedness. Program development and execution is peer-reviewed and coordinated with all of the Military Services, appropriate Defense agencies or activities and other federal agencies, to include the Department of Veterans Affairs, the Department of Health and Human Services, and the Department of Homeland Security. Coordination occurs through the planning and execution activities of the Joint Program Committees (JPCs), established to manage research, development, test and evaluation for DHP-sponsored research. The JPCs supported by this PE include medical simulation and information sciences, military infectious diseases, military operational medicine, combat casualty care, and clinical and rehabilitative medicine. As the research efforts mature, the most promising will transition to medical products and support systems development funding, PE 0605145. The Army Medical Command received FY 2016 DHP Congressional Special Interest (CSI) research funding focused on Peer-Reviewed Traumatic Brain Injury/Psychological Health, Joint Warfighter Medical Research, and Core Research funding. Because of the CSI annual structure, out-year funding is not programmed. For the Air Force Medical Service, funding in this program element supports technology development for the rapid transition of medical products and capabilities from Air Force laboratories, and the ability to perform modifications/enhancements required to integrate commercial off-the-shelf (COTS) and near-COTS products into the military operating environment. Ability to enhance or modify existing COTS is a cost effective technique we should maximize where possible, ensuring warfighters have appropriate technology at hand to care for wounded at the point of injury through definitive care and on to rehabilitation and reintegration at the most efficient cost and schedule possible. Significant benefits can be obtained from rapid insertion of high value/impact technologies into healthcare operations to address capabilities that enter the acquisition life-cycle at high TRL levels that can readily be implemented with significant upside potential. The viability of S&T and translational research with a materiel component cannot be ensured without correctly programmed funding for logical progression and transition of those activities in the product development lifecycle. This PE ensures viability of S&T and translational research efforts with a materiel component by providing programmed funding for logical progression and transition of those activities in the product development lifecycle.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2019
- Source ID
- 0604110DHA_2_0130_PB_2019
- Change Summary Explanation
- FY 2017: Realignment from DHP RDTE PE 0604110-Medical Products Support and Advanced Concept Development (-$13.403 million) to DHP RDTE PE 0603115-Medical Technology Development for the rebalancing of the Joint Program Committees (+$13.403 million). FY 2017: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), Program Element (PE) 0604110-Medical Products Support and Advanced Concept Development (-$9.738 million) to DHP O&M Account, Budget Activity Group (BAG) 3 - Private Sector Care (+$9.738 million). FY 2017: Realignment from DHP RDTE PE 0604110-Medical Products Support and Advanced Concept Development (-$7.000 million) as a result of DoD CIO Health Information Technology Optimization review. FY 2017: Realignment from DHP RDTE PE 0604110-Medical Products Support and Advanced Concept Development (-$2.394 million) to DHP RDTE PE 0603115-Medical Technology Development for Breast, Gynecological and Prostate Cancer Centers of Excellence (+2.394 million). FY 2018: Realignment from GDF DHP RDTE PE 0604110-Medical Products Support and Advanced Concept Development (-$8.343 million) to DHP RDTE PE 0603115-Medical Technology Development, Uniformed Services University, Applied Proteogenomics Organization Learning and Outcomes (APOLLO) Consortium (+$8.343 million) so support the White House-directed Cancer Moonshot initiative.
- Service Agency Name
- Defense Health Agency
Entities
Organizations
- Defense Health Agency
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