CREATING SUCCESS OUT OF NECESSITY

 

 

NEW NAVY SWABS: USAMRDC’s Additive Manufacturing Working Group was stood up to streamline the process assisting all DOD additive manufacturers interested in organically producing personal protective equipment and other FDA-regulated devices. Here, at Portsmouth Navy Shipyard, a staff member checks on the production of nasopharyngeal swabs. (U.S. Navy photo by Jim Cleveland)

 

 

USAMRDC’s Additive Manufacturing Working Group streamlines the process for additive manufacturers interested in producing PPE and other devices

 

by Leigh Anne Alexander and Ken Wood

All across our nation, most would agree that March 2020 was an odd time, full of unknowns and uncertainty. As we awaited the start of springtime, Americans were beginning to learn of coronavirus disease 2019, better known as COVID-19, which would soon redefine our “normal” lives. Citizens were asked to shelter in place, don masks and pause their lives for an undetermined amount of time. It was hard to imagine then that COVID-19 would still be affecting the entire world as we moved into the fall of 2020.

For the men and women of the U.S. Army Medical Materiel Development Activity (USAMMDA), our mission to develop and deliver quality medical capabilities in support of our service members simply could not stop. As a subordinate command of the U.S. Army Medical Research and Development Command (USAMRDC), USAMMDA continued forward in its efforts to develop drugs, vaccines, devices, blood products and medical equipment for our nation’s warfighters. However, COVID-19 posed a threat not only to our military forces, but to the world’s population.

In an instant, personal protective equipment (PPE) became a household phrase, describing the items not only required for health care workers’ safety, but now for the average person to keep themselves and their communities healthy. Supplies of masks, respirators, gloves, face shields, goggles and hand sanitizer could not keep up with the demand. In addition, sample collection kits for COVID-19 testing were in very short supply—namely, the nasopharyngeal swabs and viral transport media that comprise the kit. Fortunately, our team’s expertise in Army acquisition and product management could help with this problem—in the form of the USAMRDC’s Additive Manufacturing Working Group—but we didn’t realize then that we were going to turn our medical acquisition paradigm on its head.

NO SUPPLY, GREAT DEMAND

DOD medical acquisition traditionally relies on private industry for full-scale production of medical products because of the complexity of maintaining the necessary U.S. Food and Drug Administration (FDA)-compliant manufacturing processes. However, the suddenness and the scale of the pandemic—combined with the offshoring of medical supply chains—left DOD and the nation grappling with shortages in PPE and other critical medical supplies as COVID-19 spread across the United States. The U.S. Department of Health and Human Services and the Federal Emergency Management Agency took the lead to address these shortages, with DOD providing support. The government turned to the DOD organic industrial base, which has resource, acquisition, sustainment, manufacturing and maintenance professionals throughout depots, arsenals and ammunition plants to sustain life cycle readiness of military systems. The organic industrial base enterprise and its suppliers were used to leverage their unique capabilities to make PPE and other supplies in an effort to increase manufacturing and to alleviate these critical shortages. Managed by U.S. Army Materiel Command, the organic industrial base consists of 26 depots, arsenals and ammunition plants that manufacture and reset Army equipment.

Many government organizations have 3D printers used in the additive manufacturing of parts or tool applications throughout DOD. The DOD organic industrial base also uses additive manufacturing to support prototyping and the sustainment of military components for aviation and other vital military systems. There has been a recent emphasis within the government to use additive manufacturing to maintain the readiness of our military systems, but never before had full-scale production of medical products been part of that equation.

The public health emergency suddenly placed the ability to secure medical supplies at the fore of a different type of battle and prompted an entirely new way of thinking. There were skilled and dedicated workers across DOD at government facilities, but none had experience manufacturing a medical device. Nevertheless, they were eager to help. Organizations like the U.S. Army Tank-automotive and Armaments Command’s (TACOM) Rock Island Arsenal started asking how they could use their extensive manufacturing capabilities to produce medical devices and who could point them in the right direction. Ultimately, they were pointed in the direction of Fort Detrick, Maryland, and USAMMDA.

ANSWERING THE CALL

One Tuesday evening last April, during a phone call with Dr. Ana-Claire Meyer, the senior clinical adviser in USAMRDC’s Office of the Principal Assistant for Acquisition, Meyer mentioned fielding calls from teams across DOD requesting advice as they worked to respond to urgent supply shortages in hand sanitizer, PPE and sample collection kits for COVID-19 testing. She recognized that the DOD organic industrial base needed guidance on how to navigate the regulatory hurdles and meet the rapidly changing FDA guidance to mitigate critical shortages during the public health emergency.

In a single weekend, she had worked closely with the Naval Air (NAVAIR) Systems Command and TACOM to provide face coverings urgently needed across the fleet to enable full compliance with FDA regulations, which are not service- or military-specific. To implement these processes across DOD, she knew she needed assistance.

She thought our team at the Warfighter Expeditionary Medicine and Treatment Project Management Office may be able to help organize the effort across the enterprise.

“We have teams across the DOD with all of these great manufacturing capabilities that want to help in the COVID effort, but none of them have experience with medical,” she said. “We really need a team at USAMRDC that can help guide them through the regulatory and medical product development process, and make sure that their items are safe, effective and compliant.”

Our team fully understands what it takes to develop and produce an FDA-approved medical item. Not only is the process long, it is also quite complicated. As its name might suggest, the Food and Drug Administration regulates not only food, but also drugs, biologics, vaccines and medical devices to protect public health. The agency ensures the safety, efficacy and quality of these products. Our team at Fort Detrick was ready and eager to help, and it took just one phone call to pull the right players together.

Within a few days, the Additive Manufacturing Working Group was born. The primary intent of the working group is to expedite the delivery of medical products in short supply during the pandemic through two approaches:

• Using the DOD organic industrial base to manufacture medical materiel.
• Ensuring the quality and compliance of medical materiel procurements from alternative suppliers in the face of critical supply shortages.

Led by USAMMDA’s Warfighter Expeditionary Medicine and Treatment Project Management Office, the working group sought to help produce not only face masks, but also 3D-printed nasal swabs, face shields, protective barrier enclosures and N95 respirator masks.

Comprised of 24 professionals across the USAMRDC enterprise with programmatic, regulatory, agreements, clinical, legal and intellectual property expertise, the working group has been a force multiplier for DOD. To date, it has streamlined the acquisition, testing and regulatory processes to adjudicate 88 requests from DOD partners, including the Army, Navy, Air Force, Marines, Coast Guard, Defense Logistics Agency and the Defense Health Agency. Effectively, these efforts have mobilized DOD assets that are not typically employed in the medical space to manufacture safe, effective and compliant products for the prevention and detection of COVID-19.

Our approach to medical product development was to maximize the use of existing government resources. The USAMRDC Additive Manufacturing Working Group has all of the acquisition and regulatory expertise to manage a program, but it still requires partners to develop, test and manufacture the critical supplies needed. In some instances, we leveraged the intellectual property or clinical data from industry and academia to support production and distribution of the DOD-manufactured items. Any DOD partner seeking to produce a nasopharyngeal swab or N95 respirator could consult with our team, and our processes could quickly take them from prototype to production—all while properly engaging the FDA through our existing relationship with the agency.

BECOMING THE SUPPLY CHAIN

Working with a budget of roughly $2 million from the Defense Health Agency, in a very short amount of time we have been able to conserve critical resources and do a great deal of work with our partner organizations. We have been accomplishing things in weeks that usually take years by thinking creatively on how to do a lot with a little, such as building new pathways within the existing system to secure more partners within DOD, where before we would have focused primarily on leveraging our commercial resources. The strain on the entire nation has pushed us to look inward.

Because of the knowledge and expertise within USAMRDC, we have been able to close a huge gap between the organic industrial base and the medical community. The organic industrial base typically does not produce FDA-regulated medical products. Its focus has been on the sustainment or replacement of parts no longer procurable, rather than the development of a new item to supplement non-procurable items or to alleviate a constrained supply chain. No other team or organization in DOD had the mission experience to marry this all together.

There are currently two sites up and running that are producing the 3D-printed swabs: the Air Force’s 59th Medical Wing at Joint Base San Antonio-Lackland, Texas, and Portsmouth Navy Shipyard in Virginia. The Army’s Rock Island Arsenal in Illinois is leading the charge from the organic industrial base, receiving enforcement discretion to distribute nonsterilized swabs to military treatment facilities that can sterilize the swabs onsite. There are five more sites working to get online in the very near future, with the ultimate goal of centralizing sterilization and distribution through the DOD supply chain.

The capacity to produce these items directly supports the readiness of warfighters. Novel N95 respirator prototypes from four different DOD agencies and one industry partner are currently being evaluated through an agreement at the U.S. Army Combat Capabilities Development Command Chemical Biological Center at Aberdeen Proving Ground, Maryland. These particular N95 respirators have an innovative design and are produced via a unique manufacturing process. If any of these prototypes prove successful, DOD could have its own source of respirators, alleviating shortages in our national response efforts.

THE ROAD AHEAD

The military is called upon to solve problems every day, but this problem set, in particular, required a different type of team that had never worked together before. Meyer effectively threaded the needle, weaving together key stakeholders from the services’ additive manufacturing, medical, testing, logistics and regulatory communities. The “silver lining” of this pandemic has been the opportunity to work with a large group of dedicated, passionate and creative individuals in government, industry and academia to put together all of the puzzle pieces in helping to combat COVID-19—from the ground up.

Manufacturers in the DOD organic industrial base have been able to use their existing equipment and turn over their machines to make these critical items. They had the equipment, and our team had the medical product development and regulatory expertise. By combining our forces, DOD was able to organically manufacture and supply a medical product—for the first time ever.

In the course of only a few months, the working group has learned much about what can be accomplished by working together in the face of adversity. Our unique team of military, civilian and contract support personnel is living proof that anything is possible with the right plan in place. We continue to work around the clock to ensure medical products are moving toward distribution, when and where they are needed, to battle this worldwide pandemic.

THE FUTURE FIGHT

The lessons we are learning in responding to COVID-19 directly translate to the Army’s multidomain operations concept, where logistical supply chains will be degraded during large-scale combat operations. The success of the working group thus far has provided an opportunity to assess which equipment and capabilities can be force multipliers in our future operating environment. In our response to this crisis, we have been able to break down boundaries, bring together diverse resources and competencies from different organizations, and apply them in a manner to drive innovation and collaborative teaming for a DOD enterprise solution. We have come to learn that to control the supply chain, you must become the supply chain.

Ultimately, the COVID pandemic has highlighted the vulnerability of DOD’s operational readiness because of the globalization of the medical supply chain. Future conflicts with near-peer adversaries will present even greater challenges to continuity of global supply chains. As we manage supply chains for our critical weapon systems, the Army must control the supply chain that ensures the health and readiness of our operational forces. Building an enduring and sustainable capability for production of critical medical supplies within the Army and with its domestic suppliers, is key to the DOD organic industrial base readiness mission.

 

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For more information on the Warfighter Expeditionary Medicine and Treatment Project Management Office and other projects being developed by the U.S. Army Medical Materiel Development Activity, go to https://www.usammda.army.mil/.

LEIGH ANNE ALEXANDER is deputy project manager for the Warfighter Expeditionary Medicine and Treatment Project Management Office at the U.S. Army Medical Materiel Development Activity, responsible for nine U.S. Army and Defense Health Agency medical acquisition programs that aim to develop safe, effective and suitable medical solutions aligned to the national defense strategy and multidomain operation tenets. In July 2016, she became an Army civilian with the U.S. Army Medical Materiel Agency as a product manager, and joined USAMMDA in October 2018. She holds a B.A. in both chemistry and American studies from Lafayette College in Easton, Pennsylvania, and an M.B.A. and an M.S. in biotechnology from University of Maryland, University College. She is a certified Project Management Professional, Defense Acquisition Level III-certified in program management, and is a member of the Army Acquisition Corps.

KENNETH L. WOOD is the acquisition and industrial base director for the Materiel Systems Organization at TACOM at Detroit Arsenal, Michigan. He is responsible for oversight of the TACOM industrial base supply chain health and served as the Additive Manufacturing COVID-Response program manager for TACOM. He holds an aerospace engineering B.S.E. from the University of Michigan, and an electronic mechanical computer controls M.S.E. from Wayne State University. He is Level III certified in program management and systems engineering, and a member of the Army Acquisition Corps. He has received commercial certifications in Program Management, Design for Six Sigma, and Shainin Quality methodology.