The U.S. Army Medical Materiel Development Activity’s (USAMMDA) project management offices have seen success recently with medical products and devices, ranging from tafenoquine—the first U.S. Food and Drug Administration (FDA)-approved prophylactic drug for malaria in nearly two decades—to the Laboratory Assay for Traumatic Brain Injury (TBI), which is the first-ever blood-based assay to detect instances of mild TBI. In current conflicts overseas, loud blasts are common because of the ease of creating improvised explosive devices, which are used by militants as roadside bombs to attack allied forces. The Defense and Veterans Brain Injury Center reports that since 2000, more than 417,000 service members worldwide have been diagnosed as having TBI, with an average of more than 24,000 cases occurring annually over the past decade.
In light of this, USAMMDA’s Warfighter Brain Health Project Management Office (WBH PMO) is charged with the development of diagnostic and treatment capabilities to aid military TBI patients throughout all roles of care in the operational environment. Building on the success of the Laboratory Assay for Traumatic Brain Injury effort, the WBH PMO is pursuing development of a far-forward diagnostic for TBI that may be used by military medical personnel closer to point of injury on the battlefield, as part of the Non-Invasive Neuro Assessment Device (NINAD) program. Moreover, USAMMDA is continually searching for medical products and devices that may offer additional value in the detection of TBI.
In creating a device suitable for field use, however, the USAMMDA team understands the importance of iterative testing and evaluation to achieve a final product that will be accepted by the end users. A critical component of the standard testing process involves gaining feedback from frontline users who will be the recipients of these essential items. This task is overseen by USAMMDA’s product managers, who help to guide and expedite the process to ensure the welfare of our service members throughout the world.
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 monthlong special mission in support of the U.S. Central Command Surgeon Staff Assistance Visit to conduct a comprehensive 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 products were commercially available off the shelf, the majority of clinical research had been conducted at trauma centers rather than in the field. Therefore, the user assessment 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 appropriateness 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 critical feedback captured from the utilization of both devices in their intended environment, by medical personnel in theater.
“The mission lasted for 27 days, and we traveled around the U.S. Central Command area of responsibility, including 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 collaboration 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 ability to assess TBI in theater,” she said. “In other words, does either device give medical 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-detection devices into the hands of field medical personnel. The Warfighter Brain Health Project Management Office was charged with determining the operational feasibility and suitability of two medical devices designed to identify those at risk for a brain bleed after head trauma. Sanjakdar was selected for the mission because of her medical, acquisition and operational background.
Taking charge of the program shortly after initiation, Sanjakdar quickly developed the plan for equipping and training the units, determined the necessary points of contact at the U.S. Central Command operations center, and designed the manner and approach for obtaining user feedback to inform the future acquisition strategy. She successfully equipped 17 units with 55 devices, and she conducted monthly progress reviews to receive feedback from the field.
Although Sanjakdar held teleconferences to provide the initial training and to answer preliminary questions from the user group, she said the only true way to perform a field evaluation is for a member of the project management office to meet face-to-face with those who will be using the devices.
“Seeing the product in use firsthand, you may notice something that the user may not necessarily think to convey,” she explained. “As a product manager, your perspective will differ from the user, so seeing the device in action will guide your understanding of how it fits into the operational setting. Being in the deployed environment will also inspire your work towards future products that may be a better fit for the end user.”
Sanjakdar truly believes in the benefits of incorporating this critical component into product development across the board, and she feels it is very helpful to build strong relationships with users at all levels of product development.
“While there, we wanted to conduct various interviews and surveys, so we brought in a fellow research psychologist from the Walter Reed Army Institute of Research,” she said. “He assisted with the gathering of data and is now leading the final analysis and report being generated on the outcomes of this data collection.”
Sanjakdar praises the ability of the Rapid Equipping Force to make possible these focused “small-equipping actions,” pushing critical medical products and devices to users for testing, which can help to ensure the health and readiness of our nation’s military personnel at home and abroad. Through this type of initial user assessment, these items are vetted in their intended environment, which can help illuminate both the benefits and the limitations of each.
THE NECESSITY OF FEEDBACK
“User feedback was very important, because we received some very interesting responses from medics that differed from providers, who have more training and experience, and may be much more critical of these devices,” said Sanjakdar. “The providers can compare their own abilities to what each device offers, and it will be a more stringent comparison than that from the medic, who may not have the same medical background to assess TBI as thoroughly as a trained neurosurgeon or neurologist.”
During her assignment, Sanjakdar met with nearly 160 medical personnel, which included nurses, physician assistants and medics. She explained that her team specifically reached out to the entire spectrum of medical care as, inherently, there will be different perspectives at the different roles of care, and from the different types of caregivers as well.
In her role as a product manager at USAMMDA, under the umbrella of the USAMRDC and its higher headquarters, the U.S. Army Futures Command, Sanjakdar clearly understands the importance of being both “effective” and “innovative” in her team’s approach to product development. However, she also realizes the value of “agility” in this process, and recognizes the significance of failing early and responsibly, in order to learn from an unfavorable situation and parlay this knowledge into future success.
“From this single mission, our users have communicated to us what they would like to see, and it has helped to better define the requirements and path forward in the Warfighter Brain Health PMO,” she said.
Sanjakdar explained that the respective programs for both devices are now backtracking a bit, because the detailed feedback helped to identify previously unrealized user requirements. The information collected from the users in theater indicated a lack of operational effectiveness and suitability for both devices, although one of the devices may be accepted if it is improved based upon the findings.
“The WBH PMO has considered all of these key recommendations to help refine requirements for products to best meet user needs,” said Sanjakdar. “Our group is now conducting a more thorough market analysis to see what other products may be available to better meet the needs of the end users. Also, from the feedback we received, we are currently developing electronic tablet apps that could aid in the return-to-duty decision in the deployed environment.”
“We’re trying to open up our aperture to see what else may be out there,” she added. “I think it’s necessary to ensure end-user input is a constant factor in product development, especially when we’re talking about military medical products. When you are out there in a deployed setting—on the battlefield—everything is dynamic, it’s always changing. In light of this, we must ensure that we, as DOD product managers, anticipate and adapt to changes in user needs, to develop and deliver the best possible products.
“Although we have general requirements, and gaps identified by our capability developers, it’s really those deployed medics, nurses, physicians’ assistants and doctors that will help guide and define exactly what it is we need to work towards delivering out there in the field—that’s why the end user should always be involved in the process.”
Traveling between 10 stops in less than four weeks to meet with product users, Sanjakdar admits the assignment was intense, but she says it was well worth the effort involved—particularly in support of our warfighters. In fact, she feels USAMMDA’s other PMO teams may now follow suit, finding opportunities to connect with their respective users as well.
“Involving the operational end user is a key piece of medical product development that was previously under-represented, but it has recently become more vital as the Army moves into its new multidomain battlefield operations concept,” said Sanjakdar.
“I believe this assignment has helped our PMOs restructure their programs around better defined user requirements,” she continued. “This experience has allowed us to incorporate user input to inform fielding decisions—to make sure that we develop products that meet the warfighters’ needs. You are less likely to develop something they need, and want, without their direct involvement and input.”
When it comes to trauma sustained in combat, Sanjakdar understands the importance of having the right product or device “in your bag” in order to save lives. However, she also realizes the “right” product or device can only be developed through the collaborative effort of key partners, both at home and abroad. While USAMMDA’s PMO teams work on their end to find effective solutions to satisfy the needs of our warfighters throughout the world, the involvement of product users remains paramount for success.
“This is something that I now do regularly, to build, maintain and grow those vital connections with our end users,” she said. “We have to bridge those gaps within and between medical and operational communities, to really just work as one team, together. That’s what this valuable assignment has provided for our WBH PMO, and hopefully all of our PMOs—and for me as a product manager.”
For more information on the work and mission of USAMMDA, please visit its website at http://www.usammda.army.mil/..
JEFFREY M. SOARES is a senior technical writer and communications specialist with General Dynamics Information Technology, providing contract support as chief writer for the Public Affairs Office and Office of the Commander at USAMMDA. For the past 13 years he has served the U.S. Army Medical Research and Development Command at Fort Detrick, Maryland. He holds an M.A. in English language and literature from the University of Maryland and a B.S. in education/English from the University of Scranton.
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