Medical Technology Development

Abstract

Guidance for Development of the Force - Medical Technology Development: This program element (PE) provides funding for promising candidate solutions that are selected for initial safety and effectiveness testing in animal studies and/or small scale human clinical trials regulated by the US Food and Drug Administration prior to licensing for human use. 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 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. The program also supports the Interagency Strategic Plan for Research & 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. As research efforts mature, the most promising will transition to advanced concept development funding, PE 0604110. For knowledge products, successful findings will transition into clinical practice guidelines. For the Army Medical Command - The Underbody Blast (UBB) Testing medical research project provides funds to establish a scientific and statistical basis for evaluating skeletal injuries to vehicle occupants during ground vehicle UBB events. Areas of interest to the Secretary of Defense are medical research that provides an understanding of the human response and tolerance limits and injury mechanisms needed to accurately predict skeletal injuries to ground combat vehicle occupants caused by UBB events. This enhanced understanding will support the establishment of an improved capability to conduct Title 10 Live Fire Test and Evaluation and to make acquisition decisions. The military human immunodeficiency virus (HIV) research project provides funds to develop candidate HIV vaccines, to assess their safety and effectiveness in human subjects, and to protect military personnel from risks associated with HIV infection. The Armed Forces Pest Management Board Deployed Warfighter Protection program provides for the development of new or improved protection of military personnel from insects and tick vectors of disease pathogens. Three Centers of Excellence (CoEs) receive medical technology development funds. Management of the Breast and Gynecological Cancer CoEs transfer from the Army to the Uniformed Services University beginning in FY 2017. The Cardiac Health CoE (Army) provides evidence-based personalized patient engagement approaches for comprehensive cardiac event prevention through education, outcomes research and technology tools, as well as molecular research to detect cardiovascular disease at an early stage to ultimately discover a signature for cardiovascular health, to find new genes that significantly increase risk for heart attack in Service members and other beneficiaries, and identify molecular markers of obesity and weight loss. In FY 2017, Congressional Special Interest (CSI) funds were added to support peer-reviewed research programs: Amyotrophic Lateral Sclerosis (ALS), Autism, Bone Marrow Failure Disease, Ovarian Cancer, Multiple Sclerosis, Cancer, Lung Cancer, Orthopedic, Spinal Cord, Vision, Traumatic Brain Injury and Psychological Health (TBI/PH), Breast Cancer, Prostate Cancer, Gulf War Illness, Alcohol and Substance Use Disorders, Medical Research, Alzheimer’s, Reconstructive Transplant, Tuberous Sclerosis Complex, Duchenne Muscular Dystrophy, Epilepsy, and Tick-borne diseases. CSI funds were also provided for Joint Warfighter Medical Research, Orthotics and Prosthetics Outcomes, Trauma Clinic Research, HIV/AIDS Program Increase, Global HIV/AIDS Prevention, and Core Research Funding. Because of the CSI annual structure, out-year funding is not programmed. For the Navy Bureau of Medicine and Surgery, this program element includes funds for research management support costs. The Outside Continental US (OCONUS) laboratories conduct focused medical research on vaccine development for Malaria, Diarrhea Diseases, and Dengue Fever. In addition to entomology, HIV studies, surveillance and outbreak response under the Global Emerging Infections Surveillance (GEIS) program and risk assessment studies on a number of other infectious diseases that are present in the geographical regions where the laboratories are located. The CONUS laboratories conduct research on Military Operational Medicine, Combat Casualty Care, Diving and Submarine Medicine, Infectious Diseases, Environmental and Occupational Health, Directed Energy, and Aviation Medicine and Human Performance. For the Air Force Medical Service (AFMS), medical research and development programs are divided into five primary thrust areas: En-Route care, Expeditionary Medicine, Operational Medicine (in-garrison care), Force Health Protection (FHP) (detect, prevent, threats), and Human Performance. Expeditionary Medicine is focused on care on the battlefield and in field hospitals prior to transporting patients out of theater to CONUS, and studies trauma resuscitation, hemorrhage control, and other life-saving interventions to keep critically wounded patients alive in the golden hour and to the next level of care. The AFMS is the only service transporting patients on long aeromedical evacuation missions. Therefore, the En-Route care thrust area studies include investigation on the impact of transport on patient and providers (including cabin altitude, noise, vibration, and environmental issues affecting physiology on the aircraft), patient safety factors during transport, medical technologies for use during transport, and research to support education and training with simulation for En-Route care providers. The Human Performance thrust area focuses on optimizing airmen physical and psychological performance, assessing the physical and cognitive demands on the operator (pilot/aircrew), facilitating a safe aviation environment through technology and equipment assessment, and improving/ sustaining airmen performance through training. Medical development and biomedical technology investments in FHP seek to deliver an improved FHP capability across the full spectrum of operations with research that prevents injury/illness through improved identification and control of health risks. Under FHP, sub-project areas include Occupational Hazard Exposure (Includes Flight Hazards and Integrated Risk), Targeted Risk Identification, Mitigation and Treatment (Formerly Pathogen ID and Novel Therapeutics and includes Big Data), FHP Technologies Development and Assessment (Assay and disease detection), and Health Surveillance, Infection, Injury & Immunity. FHP also includes Innovations and Personalized Medicine. Operational medicine is focused on in garrison care – our next most critical issue post OIF/OEF – and how to care for the whole patient and consideration of comorbidities in treatment of wounded warriors and dependents. For the Uniformed Services University of the Health Sciences (USUHS), medical development programs include the Prostate Cancer Center of Excellence (CoE), the Center for Neuroscience and Regenerative Medicine (CNRM), the Pain CoE, the Breast Cancer CoE, and the Gynecological Cancer CoE. The Prostate CoE, formerly a CSI, was chartered in 1992 to conduct basic, clinical, and translational research programs to combat diseases of the prostate. The Center's mission is fulfilled primarily through its three principal programs -- the Clinical Translational Research Center, the Basic Science Research Program, and the Tri-Service Multicenter Prostate Cancer Database, which encompasses its clinical research work with other participating military medical centers. These affiliated sites contribute data and biospecimens obtained from prostate cancer patients who participate in clinical trials. CNRM brings together the expertise of clinicians and scientists across disciplines to catalyze innovative approaches to TBI research. CNRM research programs emphasize aspects of high relevance to military populations, with a primary focus on patients at the Walter Reed National Military Medical Center. Beginning in FY17, the Breast Cancer CoE funding line and the Gynecological Cancer CoE funding line are transferred from the Army to USUHS.

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Document Type: R2 Budgetary Justification
Publication Date: Oct 01, 2022
Source ID: 0603115DHA_2_0130_PB_2022
Change Summary Explanation: Project 519 was created for CARES Act - H.R. 748, (P.L. 116-136) funding totaling $315M.
Service Agency Name: Defense Health Agency

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Medical Technology Development

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