In response to the COVID-19 pandemic, the U.S. Army Medical Materiel Development Activity’s Warfighter Expeditionary Medicine and Treatment Project Management Office, as part of the U.S. Army Medical Research and Development Command’s Additive Manufacturing Working Group, has played an integral role in the ramped-up effort to produce N95 respirators for health care and frontline workers across the nation.
As stated on the Food and Drug Administration’s website, an N95 respirator is “a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.” Compared to a surgical mask, which is loose-fitting, the edges of the N95 mask are designed to form a very tight seal around the individual’s nose and mouth, providing the highest levels of protection against infection from COVID-19.
Air Force Maj. Daniel Williams serves as product manager of the WEMT PMO’s N95 respirator efforts at USAMMDA. These include coordinating programmatic and regulatory support, leveraging existing government resources and developing synergies within the Defense Department’s organic industrial base to successfully generate N95 respirator products. He explained that his primary task is to ensure the medical device meets military needs and regulatory requirements, and that development of the product remains on schedule and within budget.
In a recent interview, Williams offered a great deal of insight with regard to USAMMDA’s N95 respirator efforts, and the work to produce and distribute these products as quickly as possible in the battle against the spread of COVID-19 throughout our nation and the world.
As product manager within the WEMT PMO, please describe your responsibilities in regard to the N95 respirator effort.
The N95 effort is a slightly atypical experience, in that we are primarily working with DOD partners who have never manufactured medical devices. However, they have extensive experience in various methods of manufacturing, including additive manufacturing, also known as three-dimensional, or 3D printing. So, our primary responsibility is assisting these DOD manufacturers in navigating the medical device world, including compliance with U.S. Food and Drug Administration and National Institute for Occupational Safety and Health regulations. Further, we facilitate test and evaluation of their products, by leveraging DOD laboratories and government partners to obtain performance feedback on respirator prototypes.
Please describe the features of the N95 respirator, and why this device is superior to others currently on the market. What is its significance, especially with regard to COVID-19?
It’s not so much superiority as it is availability. One of the highest levels of respiratory protection for medical purposes, to include viral infection, is a NIOSH-certified N95 respirator. These come in multiple forms, but all are held to the same standard of filtering at least 95% of relevant particles, such as the Sudden Acute Respiratory Syndrome Coronavirus-2 virus. Most people are familiar with what is called an FFR, or a filtering facepiece respirator. These are the standard disposable, one-time-use products typically worn by our health care workers. However, at this time, these types of masks are nearly impossible to 3D-print. Our group has been working on what is called an elastomeric half-mask respirator, which is a reusable frame produced by a 3D printer, with a disposable media or cartridge that filters at the 95% level.
When the pandemic hit, the on-hand supply of N95 respirators, specifically FFRs, was quickly exhausted and traditional N95 manufacturers were not prepared to meet this new demand. Therefore, the primary purpose of the N95 working group is to develop N95 respirators to supplement existing supplies of respirators, as well as to develop new manufacturing capabilities within the DOD’s organic industrial base, which consists of military arsenals, maintenance depots and ammunition factories. Ensuring the DOD has the capability to independently manufacture protective respiratory devices will help to protect frontline workers during the COVID-19 pandemic, and it will also help to maintain our military readiness in the face of future pandemics or biothreats.
Please detail the current status of the N95 program, and explain what lies ahead.
Currently, we’ve partnered with multiple organizations across the DOD including the Army, Navy, Coast Guard, and the Defense Logistics Agency to support N95 respirator design, manufacturing and distribution through existing logistics. To date, we’ve facilitated testing of 18 iterations of respirator design, and two have successfully passed preliminary evaluation at the Army’s Combat Capabilities Development Command’s Chemical Biological Center. Our next steps will be to assist these manufacturers with the NIOSH application and process, to obtain an N95 certification for these respirators. Further, we are continuously seeking new partners within the DOD who have N95-related efforts, so that we may be able to assist.
The COVID-19 pandemic has clearly illustrated that civilian medical supply chains were unprepared to rapidly scale-up production of critical medical supplies such as medical personal protective equipment, including N95 respirators. Although this crisis will end, the next one could come along at any time. Additionally, the impact of critical medical supply shortages on military readiness could occur again in future battlefields from natural pandemics or biothreat agents. By continuing to focus on producing medical devices within the DOD organic industrial base, we can translate the lessons we’ve learned with medical personal protective equipment shortages into better preparedness for the next medical crisis, as well as for future conflicts in a multi-domain operational environment.
Why was the WEMT PMO tasked with the N95 respirator effort?
The WEMT PMO’s everyday mission is to develop and deliver medical devices to our service partners in the Army, Navy, Air Force and Marines. In response to the COVID-19 pandemic, our program office was able to naturally pivot and leverage our staff’s medical product development expertise and apply it to the crisis at hand. This is truly what project managers do — we find creative ways to deliver effective, suitable and timely medical solutions when and where they are needed most.
Please list the other members of the N95 respirator program team and detail their responsibilities in the overall effort.
The team has been phenomenal and is comprised of many professionals. However, the N95 program is actually a subgroup of the USAMRDC’s Additive Manufacturing Working Group, and nothing could have been accomplished without its assistance and guidance. The AMWG oversees three specific product lines: diagnostic swabs, ventilator parts and accessories, and the N95 respirator. As the lead for the N95 line of effort, I was tasked with outlining FDA and NIOSH requirements, initiating agreements between organizations and leading an N95 working group to facilitate collaboration amongst all of our partners.
The N95 team specifically, can really be split into three different components, and we’d be nowhere without the ongoing collaborative effort from each component. First are our manufacturing partners, the U.S. Navy Underwater Warfare Center-Keyport, U.S. Forces Korea, Defense Logistics Agency and the U.S. Coast Guard Academy. These organizations have the technical and subject matter expertise to not only design an N95 respirator, but actually to produce it through additive manufacturing methods.
Second is our AMWG team members at USAMRDC, comprised of the Office of Regulated Activities, Office of the Principal Assistant for Acquisition, Legal office, and USAMMDA’s Office of Research and Technology Applications and the WEMT PMO. The USAMRDC ensures all regulatory requirements for the respirator have been met, appropriate agreements are in place between organizations, and that any concerns with patents or intellectual property on the respirator designs have been addressed. It also provides clinical expertise on potential products, and facilitates test and evaluation of N95 respirator prototypes.
Last, but certainly not least, is the Army’s Combat Capabilities Development Command Chemical Biological Center. The CCDC CBC has been evaluating all forms of respirators for decades, and has an unparalleled knowledge of respirator design and evaluation. Once our manufacturing partners have produced a prototype, it is sent to CCDC CBC for evaluation to determine whether it will meet the NIOSH standards for an N95 respirator. The CCDC CBC has been critical in providing performance feedback and offering design suggestions for our manufacturers, allowing iterative prototyping to expedite development of respirators.
Other than for the current pandemic, what are some other uses of the N95 mask?
The N95 was thrust into the spotlight due to COVID-19 being an airborne respiratory illness. However, the N95 respirator has long been used as medical PPE to prevent against other airborne illnesses, as well as in industrial settings to protect workers against airborne environmental toxins. Therefore, even when the COVID-19 pandemic ends, the N95 respirator will still be a much-needed product in these types of situations.
Is there anything else you would like to say regarding the N95 working group?
Tireless effort is put in on a daily basis, from N95 working group members, internal and external to USAMMDA and USAMRDC, to USAMMDA’s higher headquarters. It has been such an honor to work with such an amazing group of professionals, spanning the medical and non-medical communities, and a truly unique experience to see so many different specialties come together for a common goal. I am extremely grateful to have been a part of it, and I would like to say a sincere “thank you” to everyone involved!
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. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.