Medical Products and Support Systems Development
Abstract
Guidance for Development of the Force – Medical Products and Support Systems Development: This program element (PE) provides funding for system development and demonstration of medical commodities delivered from the various medical advanced development and prototyping Department of Defense (DoD) Components that are directed at meeting validated requirements prior to full-rate initial production and fielding, including initial operational test and evaluation and clinical trials. These clinical trials are conducted to obtain US Food and Drug Administration approval, a requirement for use of all medical products. 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 DoD and multi-agency 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 which seeks to increase the use of big data and interdisciplinary approaches to establish a fundamental understanding of military disease and injury to advance health status assessment, diagnosis, and treatment tailored to individual Service members and beneficiaries, 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 Military Health System. 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 (JPC-1), military operational medicine (JPC-5) combat casualty care (JPC-6), and clinical and rehabilitative medicine (JPC-8). The funding also supports the clinical evaluation of hyperbaric oxygenation for post-concussion syndrome (PCS). The effort encompasses development, initiation, operation, analysis, and subsequent publication of clinical trials to compare and assess the long-term benefit of hyperbaric oxygen (HBO2) therapy on Service members with PCS. As the research efforts mature, the most promising will transition to production and deployment or to industry. The Army Medical Command received DHP Congressional Special Interest (CSI) research funding to Core Research Funding. Because of the CSI annual structure, out-year funding is not programmed.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2020
- Source ID
- 0605145DHA_2_0130_PB_2020
- Change Summary Explanation
- FY 2018: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), PE 0605145-Medical Products and Support Systems Development (-$0.315 million) to DHP RDT&E PE 0605502-Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) Program (+$0.315 million). FY 2017: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), PE 0605145-Medical Products and Support Systems Development (-$0.376 million) to DHP RDT&E PE 0605502-Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) Program (+$0.376 million). FY 2017: Congressional Special Interest (CSI) Additions to DHP RDT&E, PE 0605145-Medical Products and Support Systems Development (+$0.145 million). FY 2017: Realignment from DHP RDTE PE 0605145 (-$0.913 million) to DHP RDTE PE 0603115 for rebalancing JPC portfolios (+$0.913 million). FY 2017: Realignment from DHP RDTE PE 0605145 (-$0.633 million) to DHP RDTE PE 0603115 for Breast, GYN and Prostate Cancer Centers of Excellence (+$0.633 million). FY 2017: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), Program Element (PE) 0605145-Medical Products and Support Systems Development (+$0.594 million) to DHP O&M Account, Budget Activity Group (BAG) 3 - Private Sector Care (+$0.594 million). FY 2018: No changes.
- Service Agency Name
- Defense Health Agency
Entities
Organizations
- Defense Health Agency
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