For the second consecutive year, the U.S. Army Medical Materiel Development Activity received a coveted recognition with the Defense Health Agency Outstanding Program Management Team Award on the first day of the Military Health Systems Research Symposium, Aug. 26, 2024, in Kissimmee, Florida.
Advanced developers from USAMMDA's Warfighter Readiness, Performance, and Brain Health team were recognized for their work on the Analytical Traumatic Brain Injury (ATBI) device program, which received U.S. Food and Drug Administration clearance earlier this year for whole blood assessment of possible TBI using a portable, handheld device.
“Receiving this award is a direct reflection of what a group of leading experts in a challenging field of medicine has truly accomplished,” said Damien Hoffman, product manager for the ATBI program. “The contributions of my teammates at USAMMDA, as well as our partners in the Department of Defense, academia and industry, have helped drive significant progress in traumatic brain injury.”
Closing the capability gap
The science on military-related TBI has evolved significantly since 2001. During combat operations in Iraq and Afghanistan, IEDs were a near-constant threat to U.S. and partner troops traveling in mechanized convoys. The U.S. quickly deployed mine-resistant vehicles, saving countless lives, but IEDs caused unseen brain injuries to hundreds of thousands of people with few diagnostic tools to inform medical and evacuation decisions near the front lines. According to Hoffman, the ATBI program is a response to a broader capability gap that can be applied to both the U.S. military and civilian health care systems.
This program management award recognizes the importance of research and development in the Department of Defense's efforts to bring life-saving and life-extending treatment capabilities closer to the frontline than ever before.
“We started with an urgently identified capability gap – the lack of an affordable, rugged, deployable and portable device to provide objective assessment of TBI during all operations in Iraq and Afghanistan – and built the program around the needs of the warfighter,” said Hoffman. “Not only is this system a user-friendly, forward-deployable medical device, it will have broad impacts on medical facilities and healthcare systems beyond the Department of Defense. It has been an honor to be part of the team that played a leading role in developing such a far-reaching capability and demonstrates the importance of USAMMDA in developing and delivering what is needed for military healthcare.”
'Game changer' for military and civilian healthcare
The ATBI program, developed in collaboration with industry partner Abbott, is designed to provide U.S. Joint Forces medical personnel with a portable assessment tool to test patients with suspected TBI on and near the front lines. The device, which can test plasma or whole blood, detects chemical markers in the sample that may be indicative of TBI. According to Bobby Mortimer, deputy project manager at WRPBH, the whole blood test is “game-changing” for U.S. military medical personnel because it helps reduce logistical challenges in remote, austere areas of the forward line during military training and operations.
“TBI is a major concern in combat medicine and a key area of focus for Army medical development,” Mortimer said. “In future combat operations, exposure to enemy ordnance and in-operation blasts and concussions will pose challenges for frontline medical personnel. The ATBI program is part of our efforts to research, develop and field modern solutions to future combat medicine challenges.”
The ATBI Device test is the first FDA-cleared blood test commercially available for clinical military and non-military use in the U.S. healthcare system to provide objective data on the presence of TBI. The whole blood cartridge is FDA-cleared for use in clinical settings, such as those found in military Role 1 field hospitals, shortening the time between the occurrence of a concussion and being able to test for a possible TBI.
Before ATBI was FDA-approved, most TBI diagnoses required medical evacuation from the injury site to a more advanced medical facility equipped with a CT scanner. In the near future, if all goes according to plan, trained medics at a battalion aid station will only have to wait a few minutes for test results, which will help determine treatment options for medics and evacuation priorities for front-line commanders, Mortimer said.
“ATBI is a rapid, FDA-cleared, and effective assessment device that can provide near real-time test results to medical professionals in the operating room to inform treatment decisions,” she said. “Our team anticipates this technology being deployed and integrated in 2025.”
“While the test alone cannot diagnose TBI or quantify the severity of TBI, it does provide valuable information about the presence or absence of markers in the blood that may indicate brain injury,” she added. “The results of the TBI test, along with other clinical data, will improve triage and evacuation priorities during dispersal operations and inform treatment at higher levels of care once injured individuals have been removed.”
“ATBI is portable, easy to use, reliable and accurate – giving frontline medical personnel the edge they need to deliver care in challenging environments where every second counts to save lives and maintain the fighting force.”
USAMMDA develops, delivers and deploys critical medicines, vaccines, biologicals, devices and medical support equipment to protect and sustain the lives of warfighters around the world. USAMMDA project managers guide the development of medical products for the U.S. Army Medical Department, other U.S. Armed Forces, the Joint Chiefs of Staff, the Defense Health Agency and the U.S. Special Operations community.
This process provides promising technologies from DoD, industry and academia to the U.S. military, from the testing required for U.S. Food and Drug Administration approval or licensure through fielding and sustaining the finished product. The USAMMDA Project Management Office will transition to a Program Implementation Office under the jurisdiction of the Deputy Assistant Secretary for Acquisition and Sustainment for the Defense Health Agency.
To learn more about USAMMDA and how to partner with the U.S. Army Medical Development Enterprise, visit https://usammda.health.mil/
Date taken: August 26, 2024 Date posted: August 26, 2024 15:31 Story ID: 479436 Location: Kissimmee, Florida, USA Web views: 4 Downloads: 0 Public domain
This work is by TT Parish and Cameron Parks, identified by DVIDS as a Program Management Award recipient for the USAMMDA Brain Health team during MHSRS, and is subject to the restrictions outlined at https://www.dvidshub.net/about/copyright.