Medical Technology Development

Abstract

Guidance for Development of the Force - Medical Technology Development provides funds 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 Program Element (PE) is designed to address the following: Secretary of Defense areas of interest regarding Wounded Warriors, capabilities identified through the Joint Capabilities Integration and Development System, and the strategy and initiatives described in the Quadrennial Defense Review. Program development and execution is peer-reviewed and fully 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. This coordination occurs through the planning and execution activities of the Joint Program Committees (JPCs), established for the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) funding. Research supported by this PE includes polytrauma (multiple traumatic injuries) and blast injury, diagnosis and treatment of brain injury, environmental health and performance, physiological (human mechanical, physical and biochemical functions) and psychological health, injury prevention and reduction, medical simulation and training, health informatics, pain management, regenerative medicine, and rehabilitation of neuro-musculoskeletal injuries and sensory systems. As research efforts mature, the most promising will transition to advanced concept development funding, Program Element 0604110. For knowledge products, successful findings will transition into clinical practice guidelines. For the Army Medical Command, the Hard Body Armor project focuses on scientific study and evaluation of injuries related to blunt trauma events on cadavers. Preventing blunt trauma injury is one of the critical components of body armor design. For the Army Medical Command and the Army Research, Development, and Engineering 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. For the Army Medical Command, beginning in FY14, Military Human Immunodeficiency Virus (HIV) Research Program funding is transferred from the Army to the Defense Health Program. This project funds research 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. For the Army Medical Command, the Armed Forces Pest Management Board (AFPMB) Deployed Warfighter Protection project provides for the development of new or improved protection of ground forces from disease-carrying insects. For the Army Medical Command, four Centers of Excellence (CoE) receive medical technology development funds. The Breast Cancer Center of Excellence (Army) provides a multidisciplinary approach as the standard of care for treating breast diseases and breast cancer. The Gynecologic Center of Excellence (Army) focuses on characterizing the molecular alterations associated with benign and malignant gynecologic disease and facilitates the development of novel early detection, prevention and biologic therapeutics (a medicinal preparation created by a biological process used to treat diseases) for the management of gynecologic disease. The Cardiac Health Center of Excellence (Army) provides evidence-based personalized patient engagement approaches for comprehensive cardiac (pertaining to the heart) event prevention through education, outcomes research and technology tools, as well as molecular research to detect cardiovascular (CV) (pertaining to the heart and blood vessels) disease at an early stage to ultimately discover a signature for CV 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. The Pain Center of Excellence (Army) examines the relationship between acute (rapid onset and/or short course) and chronic (persistent or long-lasting, usually longer than 3 months) pain and focuses on finding, implementing, and evaluating the most effective methods of relieving the acute pain caused by combat trauma and the effect this has throughout the continuum to rehabilitation and reintegration. In FY15, the Pain CoE funding line is transferred from Army to USUHS. In FY13, DHP funded the following Congressional Special Interest (CSI) peer-reviewed directed research: Amyotrophic Lateral Sclerosis (ALS) (degenerative neuronal disorder that causes muscle weakness and atrophy throughout the body), Autism, Bone Marrow Failure Disease, Ovarian Cancer, Multiple Sclerosis (MS) (disease that affects the brain and the spinal cord and causes severe physical and mental complications), Cancer, Lung Cancer, Orthopedic Research, Spinal Cord Research, Vision, Traumatic Brain Injury and Psychological Health (TBI/PH), Breast Cancer, Prostate Cancer, Gulf War Illness, Alcohol and Substance Use Disorders, Medical Research, Alzheimer Research, Joint Warfighter Medical Research, Global HIV/AIDS Prevention, Tuberous Sclerosis Complex (rare multi-system genetic disease that causes growth of non-malignant tumors in the brain and other vital organs), Duchenne Muscular Dystrophy (gene mutation affecting approximately 1 in 3600 boys that causes muscle degeneration and eventual death), and the Walter Reed National Military Medical Comprehensive Cancer Center. 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), funding in this program element supports the Air Force Surgeon General’s vision for “Trusted Care Anywhere” through a robust research and development program. Medical development programs are divided into five primary thrust areas: Enroute 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 from theater to Landstuhl and from Landstuhl to CONUS. Therefore, the Enroute Care thrust area studies include patient timing to transport, cabin altitude, noise, vibration, and environmental issues affecting patient physiology on the aircraft, and the Human Performance thrust area compliments Enroute Care through its studies on medic and aircrew performance on long missions, as well as special operations forces performance. Medical development and biomedical technology investments in FHP seek to deliver an improved force health protection capability across the full spectrum of operations with research that prevents injury/illness through improved identification and control of health risks. Under Force Health Protection, sub-project areas include: Directed Energy, Occupational and Environmental Health, and Advanced Diagnostics/Therapeutics. 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 Neuroscience CoE, the Prostate Cancer CoE, and the Center for Neuroscience and Regenerative Medicine. The Neuroscience Center of Excellence (CoE), formerly a Congressional Special Interest program, was chartered in 2002 to conduct basic, clinical and translational research studies of militarily relevant neurological disorders affecting US service members and military medical beneficiaries. The Center’s mission is to improve prevention, diagnosis and treatment of neurological disorders that directly affect warfighters through a multi-site research program that collaborates broadly with military, civilian and federal medical institutions. The Prostate CoE, formerly a Congressional Special Interest program, was chartered in 1992 to conduct basic, clinical and translational research programs to combat diseases of the prostate. The program’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 and participate in clinical trials. The Center for Neuroscience and Regenerative Medicine (CNRM) brings together the expertise of clinicians and scientists across disciplines to catalyze innovative approaches to traumatic brain injury (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.

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Document Type: R2 Budgetary Justification
Publication Date: Oct 01, 2015
Source ID: 0603115HP_2_0130_PB_2015
Change Summary Explanation: FY 2013: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), PE 0603115-Medical Technology Development (-$8.356 million) to DHP RDT&E, PE 0605502-Small Business Innovation Research (SBIR) Program (+$8.356 million). FY 2013: Congressional Special Interest (CSI) additions to DHP RDT&E, PE 0603115-Medical Technology Development (+$567.355 million). FY 2013: General Congressional Reductions to DHP RDT&E, PE 0603115-Medical Technology Development (-$1.057 million). FY 2013: Congressional Directed Reductions (Sequestration) to DHP RDT&E, PE 0603115-Medical Technology Development (-$132.475 million). FY 2013: Below Threshold Reprogramming (BTR) from DHP RDT&E PE, 0603115-Medical Technology Development (-$8.136 million) to DHP RDT&E PE, 0606105-Medical Program-Wide Activities (+$8.136 million). FY 2014: Congressional Special Interest (CSI) additions to DHP RDT&E, PE 0603115-Medical Technology Development (+$802.400 million). FY2014: Realignment from Defense Health Program, Research, Development, Test and Evaluation (DHP RDT&E), PE 0603115-Medical Technology Development (-$8.144 million) to DHP RDT&E, PE 0605502-Small Business Innovation Research (SBIR) Program (+$8.144 million). FY 2015: Reduces non-combat injury research funding in order to focus and continue the pace of progress in critical and high priority research areas for DHP RDT&E, PE 0603115-Medical Technology Development (-$77.072 million). FY2015: Transfer of Pain Center of Excellence (CoE) from Army DHP RDT&E, PE 0603115-Medical Development Technology Development (-$2.722 million) to USUHS DHP RDT&E, PE 0603115-Medical Development Technology Development (+$2.722 million). FY 2015: Change Proposal to merge USUHS DHP RDT&E, PE 0603115-Medical Development Technology Development (+$1.533 million) Center of Excellence for Neuroscience with Regenerative Medicine.
Service Agency Name: Defense Health Program

Medical Technology Development

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