In the last several months, we have been living in a world that we may have once thought of as science fiction, because of the worldwide pandemic – COVID-19. We now live our lives six-feet apart, wearing masks and washing our hands far more than we ever imagined we could. There have been shortages at home, in the workplace and most importantly, in our medical fields with personal protective equipment and diagnostic testing.
The Department of Defense recognized the need to move quickly in addressing the critical need for medical supplies, such as PPE and sample collection kits for COVID-19 testing.
Leading research and development efforts to prevent, detect and treat COVID-19, the U.S. Army Medical Research and Development Command stood up a streamlined process to assist all DOD additive manufacturers interested in organically producing PPE and other U.S. Food and Drug Administration-regulated devices. This team — dubbed the “USAMRDC Additive Manufacturing Working Group” — is led by the U.S. Army Medical Materiel Development Activity, a subordinate command of USAMRDC. USAMMDA is the Army's medical materiel developer, responsible for developing, acquiring and fielding new medical capabilities.
“In order to alleviate pressure on the already strained commercial market, the mobilization of an organic DOD response seemed a win-win situation for both the government and industry,” said Leigh Anne Alexander, deputy project manager for USAMMDA’s Warfighter Expeditionary Medicine and Treatment Project Management Office. “Additive manufacturing, specifically three-dimensional printing, quickly became an attractive solution for meeting shortfalls in both PPE and test kit components, such as swabs, as a current capability existed within the DOD’s laboratories and manufacturing facilities.”
However, PPE and collection kits are medical devices that are regulated by the FDA. Devices, as with drugs, require FDA review prior to distribution to ensure they meet performance and quality standards.
“In addition, the DOD has its own policies in place to ensure all Service Members receive medical products that are both safe and effective,” said Ana-Claire Meyer, senior clinical advisor to the Office of the Principal Assistant for Acquisition, USAMRDC.
Combining USAMRDC’s in-house regulatory, legal, clinical and medical acquisition expertise and experience, the working group assists DOD organic manufacturing facilities and research laboratories to develop high-quality products and navigate complex FDA regulations. In addition, the working group can act as an interface with the FDA through coordination with the Sponsor’s Representative at the USAMRDC, who has the authority, delegated by the Surgeon General of the Army, to request review and approval of medical products from the FDA.
“The working group’s primary goal is to ensure that anything manufactured by the DOD has been appropriately authorized by the FDA for safe use,” said Alexander.
While coordination with the USAMRDC Sponsor’s Representative is mandated for Army organizations, this working group supports all Services and has interfaced with the Air Force, Navy, Marines and Coast Guard, who are manufacturing 3D-printed nasopharyngeal swabs and N95 respirators in response to the COVID-19 pandemic.
Recent successes include obtaining FDA enforcement discretion for the 59th Medical Wing and Portsmouth Navy Shipyard to additively manufacture and distribute nasopharyngeal swabs for DOD-wide use during the COVID-19 public health emergency. Portsmouth Navy Shipyard has the ability to produce approximately 280,000 swabs per month, and the 59th MDW can produce approximately 10,000 swabs per month. The swab design was from University of South Florida Health and Northwell Health.
Combining the manufacturing capabilities of the DOD organic industrial base with the USAMRDC’s medical acquisition, regulatory and legal expertise will enable the DOD to solve key COVID-19-related supply shortages. In addition, the DOD can apply these lessons learned from COVID-19 to ensure medical preparedness and response in future emergencies or conflicts in which global supply chains are disrupted.
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.