For the second consecutive year, the U.S. Army Medical Materiel Development Activity is walking away from the Military Health System Research Symposium with a coveted recognition, receiving the Defense Health Agency award for Outstanding Program Management Team today during the symposium’s first day in Kissimmee, Florida, Aug. 26, 2024.
Advanced developers from USAMMDA’s Warfighter Readiness, Performance, and Brain Health team were recognized for their work with the Analyzer-Traumatic Brain Injury (ATBI) device program, which received U.S. Food and Drug Administration clearance earlier this year for whole blood assessment of possible TBIs using a portable, handheld device.
"Recognition for this award is a direct reflection of what a group of leading professionals can truly accomplish in a challenging area of medicine," said Damien Hoffman, product manager of the ATBI program. "The contributions made by my teammates here at USAMMDA, and our partners across the Department of Defense, academia, and industry, were the driving force behind major accomplishments in traumatic brain injury."
Bridging a capability gap
The science behind military related TBIs has evolved greatly since 2001. During combat operations in Iraq and Afghanistan, Improvised Explosive Devices were a near-constant threat for U.S. and partner nations forces during mechanized convoys. And though the U.S. quickly adopted mine-resistant vehicles that saved countless lives, IEDs caused hundreds of thousands of unseen brain injuries with few diagnostic tools available to inform medical and evacuation decisions at and near the front lines. The ATBI program is an answer to a wide capability gap with applicability both in the U.S. military and across civilian health care systems, according to Hoffman.
This Program Management Award is a recognition of the importance of research and development to the DoD’s efforts, which are aimed at moving lifesaving and life prolonging care capabilities nearer to the front lines than ever before.
“We started with an urgent identified capability gap – there were no affordable, rugged, and deployable handheld capabilities to provide objective assessment of TBIs during all our operations in Iraq and Afghanistan – and built the program around the needs of the Warfighter,” said Hoffman. “Not only is the system a user-friendly, forward-deployable medical device, it has wide implications across the Medical Treatment Facilities and non-DoD health care systems. It is an honor to be part of a team that held a leading role in development of such far-reaching capability, and it exemplifies the criticality of USAMMDA in the development and delivery necessitated by military medicine.”
A ”game changer” for military, civilian medicine
The ATBI program, developed alongside industry partner Abbott, is designed to give medical providers in the U.S. Joint Forces a portable assessment tool for patients with possible TBIs at and near the front lines. The device, which can test either blood plasma or whole blood, detects chemical markers in samples that could indicate TBI. The whole blood assessment is a “game changer” for U.S. military medical providers because it helps mitigate the logistical challenges during military training and operations in far-forward, austere regions, according to Bobbie Mortimer, deputy project manager with WRPBH.
"TBIs are a major area of concern for combat medical care and are a focus area for Army medical development," said Mortimer. "During future combat operations, enemy weapons and exposure to blasts or concussive events during operations will present challenges to frontline medical providers. The ATBI program is part of our effort to research, develop and field modern solutions for future combat medical care challenges."
The ATBI device test is the first FDA-cleared blood test that is commercially available for health care systems in the United States for clinical military and non-military uses to provide objective data regarding the presence of TBI. Because the whole blood cartridge is cleared by the FDA for use in a clinical environment, like those found in a military Role 1 field hospital, the time between concussive events and the ability to test for possible TBI will be shortened.
Before the ATBI’s FDA approval, most diagnoses of TBI required medical evacuation from the point of injury to a higher echelon of care with CT scanners. In the near future, if all goes as planned, trained medics at a battalion aid station will only need to wait minutes for test results, which will help inform medical provider treatment options and evacuation priorities for frontline commanders, according to Mortimer.
"The ATBI is a fast and effective FDA-cleared assessment device that can give theater-based medical providers near real-time test results to make treatment decisions,” she said. “Our team forecasts fielding and integration of the technology in 2025.
While the test alone does not diagnose TBI nor quantify TBI severity, it does provide valuable information regarding the presence or absence of markers in the blood that may indicate brain injury," she added. "The results of the ATBI test, along with other clinical data, will improve triage and evacuation priorities during dispersed operations and inform treatment at higher echelons of care once a casualty is moved.
The ATBI is portable, user-friendly, reliable, and accurate, and it gives frontline medical providers a needed edge in providing medical care in austere locations, where every minute counts to save lives and preserve combat strength."
USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA Project Managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Operations community.
The process takes promising technology from the Department of Defense, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product. USAMMDA Project Management Offices will transition to a Program Executive Office under the Defense Health Agency, Deputy Assistant Director for Acquisition and Sustainment.
For more information about USAMMDA and how to partner with the U.S. Army medical development enterprise, visit https://usammda.health.mil/.
Date Taken: | 08.26.2024 |
Date Posted: | 08.26.2024 15:31 |
Story ID: | 479436 |
Location: | KISSIMMEE, FLORIDA, US |
Web Views: | 170 |
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