Attendees of the U.S. Army Medical Materiel Agency Noninvasive Neurological Assessment Devices industry day were able to meet with vendors showcasing their assessment devices for detecting mild to moderate traumatic brain injuries in Baltimore, Maryland, Dec. 6-7.PHOTO BY: Brian Dacanay, USAMMA
The USAMMA, which is a subordinate command of the U.S. Army Medical Research and Materiel Command, invited 35 vendors to an industry day with subject matter experts from the Department of Defense.
“The objective of the day was to capture information from the latest medical products developers and bring mild TBI device manufacturers and DOD subject matter experts together for open forum discussions,” said USAMMA Advanced Developer and Product Manager Brian Dacanay.
TBI is a significant issue that affects not only individual Service Members, but subsequently the level of unit readiness and troop retention. The impacts of TBI are felt within each branch of the military.
Since 2000, more than 350,000 U.S. Service Members have been diagnosed with a traumatic brain injury. A TBI can be classified as mild, moderate, severe and penetrating, and sustaining one can lead to changes in cognitive abilities and control of emotions, mobility, speech and senses. Left undiagnosed and untreated, a TBI can have a huge impact on how a person thinks and acts, and on his or her mental health. The severity is determined at the time of injury. Nationally, TBI is responsible for more than 52,000 deaths per year in the U.S., making it the fourth leading cause of death in the country.
The USAMMA’s mission is to develop, acquire, provide and sustain world class solutions and capabilities to enable Army medical readiness globally, and the command strives to advance the development of noninvasive neuro-trauma associated assessment devices to help ensure their mission’s success. The USAMMA is currently seeking information on technologies that have shown, through clinical studies, will provide improved assessment of patients with mild to moderate traumatic brain injury and other forms of neurological trauma, which is currently lacking in some roles of military care.
Increasing triage effectiveness, through early detection and patient evaluation of mild to moderate TBI or associated head injuries, is critical for the care of patients as this will lower the incidences of secondary neuro-traumatic injuries. Proper diagnosis will also reduce fatalities.
“The NINAD Industry Day provided the most efficient means of meeting with industry face-to-face, discussing the specifics of their company's technology, gleaning applicability to the Warfighter's health and medical care, and fostering collaboration among industry and government representatives,” said Col. Sidney R. Hinds II, Department of Defense Brain Health Research Program coordinator. “This event allowed discussions to occur which would otherwise have taken several months to accomplish via telephone or email."
Devices will be prioritized, and the USAMMA may provide regulatory expertise (programmatic expertise that includes regulatory advise, funding, etc.) to assist with obtaining Food and Drug Administration clearance for the designated indication to aid in the diagnosis of patients over the age of 18 presenting with suspected mild to moderate TBI (Glasgow Coma Scale 9-15) or associated head injury. Such a device will assist clinicians and medics to further define medical intervention requirements.
“The goal was to identify portable medical device technologies that are capable of diagnosing mild to moderate TBI with the intent to field them as far forward in the field as possible, and I believe that the day was successful,” said Dacanay.