USER TESTED


UTILIZING THE USER Army Maj. Sarah Sanjakdar, product manager in USAMMDA’s Warfighter Brain Health Project Management Office, understands the value and necessity of including users in product development. In 2019, Sanjakdar completed a month- long special mission in support of the U.S. Central Command Surgeon Staff Assistance Visit to conduct a comprehen- sive assessment of two FDA-cleared TBI diagnostic devices, used to detect mild to moderate TBI, that were being tested in theater.


Sanjakdar said that although both prod- ucts were commercially available off the shelf, the majority of clinical research had been conducted at trauma centers rather than in the field. Terefore, the user assess- ment was necessary to help determine if the devices would be useful for military medical personnel in combat.


“Questions that still needed answers focused primarily on the functionality and utility of these devices in an operational environment,” she explained. “Specific questions pertained to the devices’ ability to advance the current standard of care for triage, the devices’ diagnostic accuracy in triage, and the environmental appropriate- ness of the devices, such as in wind, rain, dust, different light conditions, etc.— which are crucial factors that may affect sensitive diagnostic tools where triaging and clinical decisions are made.”


Unlike typical controlled environments, where the majority of medical products are developed and tested, this U.S. Central Command user assessment provided criti- cal feedback captured from the utilization of both devices in their intended environ- ments, by medical personnel in theater.


“The mission lasted for 27 days, and we traveled around the U.S. Central


128 Army AL&T Magazine Fall 2020 MANUAL INSTRUCTION


Maj. Sarah Sanjakdar, center, learned the value of seeking feedback on the function and usefulness of two FDA-approved TBI screening devices at medical facilities across the U.S. Central Command area of responsibility, including Kuwait, Iraq and Afghanistan. (Photos courtesy of Maj. Sarah Sanjakdar)


Command area of responsibility, includ- ing Kuwait, Iraq and Afghanistan,” said Sanjakdar. “We visited several roles of [medical] care, ranging from Role 1 [at or near point-of-injury] to Role 3 [at the medical treatment facility], and we reached out to a total of 158 medical personnel, from medics at lower echelons of care to medical providers at the combat support hospitals.”


Sanjakdar’s user assessment was scheduled on very short notice, and she explained this was made possible by an effective collab- oration between U.S. Central Command and U.S. Army Medical Research and Development Command leadership.


“We looked to determine the operational suitability of both devices, to learn how well they work in the field, and if they provide a practical solution to enhance our deployed medical personnel’s current abil- ity to assess TBI in theater,” she said. “In other words, does either device give medi- cal personnel more capability than they already have when it comes to assessing TBI in our wounded warfighters?”


Sanjakdar said she was assigned to run the initial equipping actions in the U.S. Central Command area of responsibility, and worked with the U.S. Army Rapid Equipping Force to move these TBI-detec- tion devices into the hands of field medical


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