SEPTEMBER 18, 2020 – The U.S. Army Medical Research and Development Command assembled a team of experts to help Department of Defense additive manufacturers produce and procure medical materiel in response to equipment shortages in the wake of the COVID-19 health crisis.
Led by the U.S. Army Medical Materiel Development Activity’s Warfighter Expeditionary Medicine and Treatment Project Management Office, the team of experts, self-named the “USAMRDC Additive Manufacturing Working Group,” works to ensure the rapid delivery of medical device development guidance to USAMRDC’s partners. The group supports DOD stakeholders who, although unfamiliar with medical product development and U.S. Food and Drug Administration regulations, sought to respond quickly to the medical supply shortages within the DOD. The team determined that a whole-of-government approach was needed to identify critical partners for the production, testing and regulatory submission required for medical devices.
Among its many efforts, the group is managing 3D-printed nasopharyngeal swabs. A standard nasopharyngeal swab, similar in size to a coffee stirrer, is integral for providing diagnostic testing. Due to FDA’s designation of it as a medical device, the 3D-printed swab must pass all of the necessary testing and quality assurance standards in design and manufacturing prior to use. The swab must be able to collect a mucus sample safely from the patient, prior to delivery to a testing laboratory for analysis.
With national supply shortages of commercially available swabs, the USAMRDC Additive Manufacturing Working Group partnered with the DOD Organic Industrial Base to determine if there were existing capabilities within the government to produce an alternative. Fortunately, several organizations across the services were willing to utilize their 3D printers, along with designs from academic and industry partners, to respond to the swab shortages.
Since the group’s establishment in early April, the USAMRDC has collaborated with offices of the Army, Navy, Marine Corps and Air Force to assist in developing a strategy to produce 3D-printed swabs across multiple sites. Currently, agreements with the Dental College of Georgia at Augusta University, and the University of South Florida provide updated swab designs and clinical data that have been instrumental in driving forward the DOD’s mission to up-scale efforts against COVID.
“Our partners at Portsmouth Naval Shipyard, U.S. Army Rock Island Arsenal, Marine Corps Systems Command and Navy’s Fleet Readiness Center–South East are working with the USAMRDC to request FDA Enforcement Discretion for 3D-printed test swabs that can be distributed throughout the DOD in order to detect Service Members with COVID-19,” said Edward Brown, product manager for USAMMDA’s WEMT PMO and member of the USAMRDC Additive Manufacturing Working Group. “This is helping to ensure the DOD can continue to accomplish its mission in a safe and secure environment during the ongoing public health emergency.”
“This Defense Health Agency, multi-service ‘proof-of-concept’ project builds upon the successful work of the Air Force’s 59th Medical Wing, who through a collaboration with the USAMRDC Additive Manufacturing Working Group earlier this year, received Enforcement Discretion to produce and distribute 3D-printed swabs,” he added.
The USAMRDC leverages internal expertise within its Office of Regulated Activities and Office of the Principal Assistant for Acquisition, as well as USAMMDA’s Office of Research and Technology Applications and the Office of the Staff Judge Advocate to guide the DOD’s Additive Manufacturing Community through the FDA process in order to ensure compliance with all FDA requirements prior to distribution and use of any medical equipment.
“Regulatory affairs is a gray zone that requires a lot of attention to detail, with the potential to change the entire course of a project,” said Air Force Maj. Scott Baker, USAMRDC Regulatory Fellow. “The true collaboration across so many groups of people with varied expertise is the foundation of these successes, ensuring all the parts move together.”
After production, it is necessary to test the swabs to ensure they meet performance standards. Again, partners within the DOD answered the call. Through an agreement with the Joint Program Executive Office for Chemical, Biological, Nuclear and Radiological Defense–Medical, the 3D-printed swabs will be analyzed for their compatibility with viral transport media and testing kits used to detect COVID-19.
To understand the mechanical properties, the U.S. Army Combat Capabilities Development Command–Solider Center was able to develop testing procedures to simulate swabbing a person’s nasopharynx to ensure the swab would not break when being used. Having these capabilities readily available, with DOD experts in these analytical and testing areas, is the key to delivering a safe and effective product to the Service Member.
In the face of the pandemic, the team at Fort Detrick, Maryland, has responded quickly to deliver needed medical products. Using mechanisms such as Emergency Use Authorization, Public Law 115-92, and enforcement discretion requests, the USAMRDC is able to leverage its relationship with the FDA to expedite the approval process for swabs that are ready for submission. The Additive Manufacturing Working Group is working around the clock with the FDA to monitor, mitigate and combat COVID-19 through collaborative efforts with other federal partners, international regulators, medical product developers and manufacturers.
The FDA Sponsor’s Representative from USAMRDC, Mark Paxton, commented on the professionalism of the working group and its members. “The team is made up of a varied group of persons with highly diversified expertise, which allows them to perform with unprecedented collaboration across USAMRDC command elements. It has been an absolute pleasure to work with such an awesome team.”
Outside of USAMRDC, the working group remains in constant communication with its partners to ensure success for the DOD.
“We should continue to solve problems the way the USAMRDC team has done for the COVID-19-related additive manufacturing efforts,” said Joe Murphy, Portsmouth’s Innovation Project superintendent. “They continue to be our guide through the uncharted territory of 3D-printed medical devices, and without their help, there is no way we would be able to contribute 12,000 useable swabs per day to the DOD.”
Robert Hunt, liaison for the Fleet Readiness Center Southeast, praised the group’s medical guidance in working with partners. “This collaboration has made me hopeful for future endeavors in working with any or all of the parties involved, because of how attentive and engaged the stakeholders have been,” he said. “[Navy] Lt. Cmdr. Schonberg and Ed Brown have been amazing assets to lean on with whatever questions we have, providing a bit of paternal guidance in our medical equipment infancy.”
The USAMRDC Additive Manufacturing Working Group’s whole–of-government approach to coordinate across the Army, Navy, Marine Corps and Air Force has been an unprecedented force multiplier to harness the unique capabilities of the organic industrial base with the medical acquisition community.
Going forward, the lessons learned and the relationships codified will inform and enable the internal capabilities of the DOD to work – together – in response to future medical crises.
About USAMMDA
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. USAMRDC is leading research to prevent, detect and treat COVID-19. USAMMDA is applying existing field-leading research capabilities, a global research network and established partnerships to support the Whole-of-Government response to COVID-19.
By Daniel Patterson, Warfighter Expeditionary Medicine and Treatment Project Management Office, USAMMDA