It is difficult to remember a time when “coronavirus” was not a part of our day-to-day vocabulary. The COVID-19 pandemic emerged from the shadows and threw the world into a tailspin, demanding ingenuity and resourcefulness as it pushed worldwide healthcare systems to their limits.
As nations quickly scrambled to adapt and respond to the global pandemic, the world’s supply of sampling kits, diagnostics systems, and ventilators quickly diminished. The U.S. Department of Defense, along with the rest of the world, acted immediately to try and obtain the supplies necessary to protect the two million U.S. warfighters dependent on their care, an unprecedented demand that also pushed an otherwise stable supply chain to its limits like never before.
By April, the widespread usage of sample collection kits to diagnose and treat individuals suspected of COVID-19 infection had all but exhausted inventory sources of test kit equipment. Help was needed, and on April 10, 2020, the U.S. Army Training and Doctrine Command (TRADOC) turned to the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM CBRN Medical) for assistance.
The JPM CBRN Medical’s Deputy Joint Project Manager, Ms. Nicole Kilgore, quickly responded to the TRADOC’s demand signal by assembling a multi-organizational “tiger team” comprised of JPEO-CBRND JPM CBRN Medical team members, as well as personnel from both the U.S. Army Combat Capabilities Development Command Chemical Biological Center and the U.S. Army Medical Research and Development Command (USAMRDC).
Tasked with the arduous mission of delivering more than 5,000 U.S. Food and Drug Administration (FDA)-compliant sampling kits to six DOD locations in only 10 days, the race to deliver was on. It was up to the JPM CBRN Medical to determine how to best meet mission requirements, and the team’s resourcefulness in designing and developing new test kits did not go unnoticed.
As these multi-disciplined experts banded together to find a solution, it was clear that the current paradigm of what comprised a sampling kit must be discarded. Instead, the team opted to re-define the typical “swab and tube” standard, determined to design and assemble non-traditional kit components to achieve the mission. The new sampling kit would have to meet several non-negotiable FDA requirements, to include being safe to use on the individual and sterile, to ensure the accuracy of the diagnostic tests that would be using the samples. The sampling kit would also have to consist of a suitable sterile swab replacement, capped vial, and tube with transfer media; and the products from the sampling kit would have to be easily assembled on site by healthcare providers.
With all kit source components identified, it was just a matter of where to begin.
Inspiration sprang from the most unlikely of places as JPM CBRN Medical Chief Technical Officer, Dr. Kevin Wingerd, sat in his local dentist’s chair awaiting a root canal. During the procedure, Dr. Wingerd noticed that his dental surgeon was using a dental Microbrush®, a common dental tool supplied in sterile packaging. Aside from a few minor dimensional differences, the dental Microbrushes® were almost identical to that of the now hard-to-find nasopharyngeal swabs being sought after worldwide for COVID-19 sampling kits.
“Aha!” Dr. Wingerd thought, “Why not repurpose this existing tool?”
Reaching out to the dental Microbrush® supplier, the team was met with the unfortunate realization that the company would not have sufficient product ready in time to meet this initial 10-day delivery requirement. The team had stumbled across a component solution that would not be forgotten in later months, but for now, they needed an immediate solution in order to deliver and meet the TRADOC mission; the hunt continued.
Dr. Wingerd and Assistant Product Manager, Mr. Camilo Morales, continued to search for a suitable replacement swab, and eventually decided to look “outside of the box” at EnvisionTEC, Inc., a leading global manufacturer of desktop and full-production 3D printers and materials. EnvisionTEC’s Envision One 3D printer was capable of providing an alternative 3D printed swab solution, and more importantly, could produce up to 2,400 swabs in only 24 hours. These 3D printed swabs could be paired with 3mL sterile saline and 15mL Falcon® tubes (another ‘repurposed’ product) and turned out to be just the solution the team was looking for.
However, even with all test kit components identified, the tiger team’s mission was still far from over.
Now that the right products were identified, it was time to engage the FDA to request permission to distribute these kits. The FDA has an important consumer protection role to ensure that the public receives safe and effective products. As there were critical supply shortages across the United States, the JPM CBRN Medical team was able to leverage assistance from the USAMRDC FDA sponsor’s representative and Office of the Principal Assistant for Acquisition’s Senior Clinical Advisor to request permission from the Army Office of the Surgeon General and the FDA to implement their proposed approach to this critical supply shortage. Within days, the FDA agreed that the kits could be distributed and used within the Department of Defense during the Public Health Emergency.
For this kit to be accepted and integrated into practice, it was also the team’s responsibility to translate sample collection steps into an easily-understood, user-friendly manual, guaranteeing, as best possible, correct usage to deliver sterile and accurate sample results. The tiger team accepted the additional challenge. The team developed the instructional steps, worked out the “bugs,” and ultimately provided a brand new user manual to accompany their redesigned COVID-19 nasopharyngeal test kit. JPM CBRN Medical Assistant Product Manager, Mr. Charles Paschal, led this effort, not only translating all instruction material for the manual itself, but also coordinating with an artist to draw the images that would accompany the written instructions in the finished product.
Finally, with all test kit components identified and with the newly-completed user manual in tow, the remaining effort came down to logistics, and JPM CBRN Medical Director, Operations, Ms. Teresa Baal, led the effort, mastering the art of ordering and setting an urgency tone which moved orders forward through already-swamped businesses at an incredible speed. At the end of the day, the JPM CBRN Medical tiger team met the challenge, diligently identifying and gathering all test components, ensuring regulatory compliance, shipping to a contracted “kitting” company for assemblage, and delivering a solution to TRADOC training sites in only 10 days. This delivery supported screening in order to resume accession training for new Soldiers, ultimately supporting Army Readiness Priorities.
However, as much as we all wish that were the end of the story, the COVID-19 pandemic fight is far from over.
Scientific and medical experts continue to fight valiantly to find a treatment, a prophylactic, a vaccine, a solution to the COVID-19 pandemic. Sampling kits continue to be used up at an unrelenting pace, and it is clear that the demand for these kits will not be going away anytime soon. The JPM CBRN Medical team did win this battle back in April, but the war against COVID-19 goes on.
The JPM CBRN Medical has continued to support national pandemic response efforts, and team collaboration with Young Innovations, USA – the original dental Microbrush® supplier that the team looked to back in April – resulted in conversion of Young Innovations’ previously-established Microbrush® production line into that of swab production. Current test kit shipments have evolved to include these adapted Microbrush® nasopharyngeal swabs, which are recurrently provided to DOD military treatment facilities by the thousands as part of JPM CBRN Medical COVID-19 sample test kits.
Thanks to the audacious efforts of the tiger team, the DOD has been allotted more time; more time to continue to build their own sampling kits and, most importantly, more time to become more self-reliant than ever before. The team’s efforts in April set the stage, and today the DOD continues to expand upon those capabilities so they might never again have to depend on overseas or outside sources to provide critical materials.
“Our people drive the success of this organization,” said Col. Ryan Eckmeier, JPM CBRN Medical. “The tiger team’s unparalleled expertise, ingenuity, and passion to support our service members combined to address a serious gap. The unconventional approach used to rapidly deliver a critical element in direct support of the DOD’s fight against the COVID-19 threat clearly demonstrates that solid teamwork is essential to face this pandemic, and that no one in this space can do it alone.”
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