Contributor: Made in NC—Reimagining the PPE Supply Chain and Saving Each Other Just in Time

In 2020, there is no item more precious than the N95 respirator mask—a symbol of scarcity due to the systematic failures of coordination, preparation, and policy solutions to respond to the coronavirus disease 2019 (COVID-19) pandemic. The N95 is the one you see cupped to the faces of health workers and one of the more challenging pieces of personal protective equipment (PPE) to procure. I have spent the last 140-plus days doing what it takes to make these masks from scratch here in North Carolina.

I admit that I am guilty of not showing enough appreciation for N95s. As a doctor, I would sometimes find one scrunched up deep in the pockets of my white coat on laundry day. On the eve of the start of my third-year medical school rotations, I remember the mild humiliation associated with N95 mask fit tests. As instructed, my classmates and I donned masks under marshmallow shaped hoods designed to trap a bitter tasting aerosolized spray. We would breathe heavily while jogging in place as those in line behind us giggled at the absurd scene. Singularly focused on finishing the test, I hardly noticed that the mask had lived up to its name, filtering out 95% of airborne particles and leaving no bitter taste.

We did not think twice as we threw those masks into the trash at the end of the spectacle.

Nor did we know that those masks traveled to us from China, an epicenter of N95 production. From fabric to fabrication via specialized mask molding machines, production of N95s had moved overseas where they are cheaper to produce. These masks rely on a supply chain and distribution system designed to feed just the right number of masks to meet the typical demand of the health care market in the United States.

We’ve now witnessed this “just in time” supply chain for N95s buckle against the tsunami of demand due to COVID-19, exacerbated by the lack of coordinated networks in place to match rapid fluctuations in demand with the world’s existing supply of masks. This past spring, social media and news articles were filled with pleas from frontline health care workers begging for PPE, specifically N95s. There were streams of photos of tired faces of health care workers around the world with the skin beneath their eyes raw and worn down by the suctioned rims of these masks. These masks were now being worn all day and re-sanitized in an effort to extend the life of the mask.

We all wished we could go back in time to empty those trash bins of barely used masks.

N95s are superior to surgical masks in protecting health care workers against COVID-19. While many health care facilities have moved toward “universal masking” for health workers, this universality usually refers to the easier to procure and less protective surgical masks. In an ideal world where supply was plentiful, would we have seen a move to “universal N95” masking for health workers?

We’ll never know. N95s have remained scarce and coveted, on lockdown and rationed out on hospital floors across the country. In the outcry for more testing, we often forget that exponential growth in testing usually necessitates more PPE, including N95s. There may never be enough supply to truly cover our demand. At the peak mismatch of supply and demand this past spring, profiteers and counterfeiters appeared from the shadows—months later, those counterfeits persist. Stories abounded of fake N95 masks or N95 masks that previously sold for around $0.60 each now selling at extortionary rates of $7 or higher per mask. Enterprising scientists and businesses had begun to develop and sell machinery to re-sanitize and reuse these masks that we had once labeled as disposable after one use. Clinics and hospitals filled with newly labeled N95 mask recycling bins.

It was around this time that I was introduced to Behnam Pourdeyhimi, PhD, of North Carolina State University’s Nonwovens Institute. In my capacity at Blue Cross and Blue Shield of North Carolina (Blue Cross NC), I followed up on a lead about this professor in Raleigh creating N95s “from scratch” in the lab. Early on into our first conversation I learned that Pourdeyhimi and I are bound by the same, self-interested compulsion to get N95 masks onto the faces of our family members and friends on the front lines. Selfishly, I wished I could have one on hand in my primary care clinic and glue one onto the face of my husband on his way into work at the hospital each day. I would also learn that Pourdeyhimi is also a master and teacher of nonwovens, which are fabrics comprised of fibers of polypropylene bonded together—requiring mechanical, thermal, or chemical energy to make them into bonded webbed structures.

Pourdeyhimi knew that all the money in the world could not make an assembly line of N95s magically appear overnight. First, they require multiple layers of carefully constructed nonwoven materials. The literal secret (and proprietary) sauce is the middle layer comprised of “melt blown” ultra-fine fibers that most commonly require (by happenstance appropriately named) electrostatic “corona charge.” The secret is in how the machine configures the fibers to effectively filter 95% of particles. This special web of fibers has ultra-high porosity to allow air in and out to breathe but creates a tortuous pathway so that particles “touch” fibers and find themselves stuck in the web. The most penetrating particles are drawn toward the web due to the electrostatic charge of the fibers. This magical, middle layer is incredibly delicate and fragile, requiring immediate placement between 2 or more layers of polypropylene spunbound nonwoven fabric that give the mask structure. As COVID-19 cases began to escalate in February, Pourdeyhimi began pulling odd hours in his office and laboratory to concoct and perfect a special recipe that would enable the mass production of completely novel nonwoven fabrics needed to make N95 masks here in North Carolina.

Second, to make a N95 mask you need specialized machines to convert and mold these fabrics into cup shaped masks that will successfully seal onto a wearer’s face. If Pourdeyhimi wanted to make these fabrics into masks, he would need machines that are not readily available in the United States.

And so, while we have never met in person, in these past 5 months Pourdeyhimi and I have forged an unlikely companionship focused on the improbable and covert task of establishing a re-imagined, North Carolina–based supply chain for N95 respirator masks. In early April, we secured a charitable donation from Blue Cross NC (my employer) so that Pourdeyhimi and his team could purchase 2 mask molding machines from China and install them here in North Carolina, converting his special fabric into N95 masks, specifically small-sized masks that are particularly scarce.

In the 140-plus days since our plan was set into motion, I have been consumed by 3 sentiments. The first is of relentless worry. The questions I ask daily: Will these machines escape detection and safely make their journey to North Carolina? Can N95s be made completely and successfully in North Carolina?

To survive this worry, you have to willfully drown out the stories of heartache by hospitals and health care providers across the state as hard sought after supplies of N95s evaporated overnight, reportedly outbid or confiscated by federal officials or found to be fakes that failed testing after making the long journey to the United States. You also celebrate, albeit quietly and privately, the signals of progress. In July, Pourdeyhimi sent rolls of his precious fabric to the factory in Tianjin, China, to test the machines. A week later, he texted me a video. Set to a pulsing techno music beat, it featured the first machine pumping out, on beat with the music, 20 N95s per minute. In the background you could hear and see the sustained purr of Pourdeyhimi’s fabric unrolling to feed it. The machines had passed the test and could begin their journey to the United States, which would be chronicled through cryptic text messages from Pourdeyhimi over the next few weeks. Last week, he texted, "The machines are in the US and have cleared customs." What a relief to exhale, after holding one's breath for more than 140 days.

The second sentiment is trust. We trust that no one person or organization alone can save us. In North Carolina in 2020, dire necessity has proven to be the mother of innovation and trust among strangers the best hope we have for our survival. The roster of individuals and organizations who have joined the effort grows longer each week. Together they will make Pourdeyhimi’s fabric into N95s that meet the highest quality, safety, and regulatory standards, ensure that these standards are retained as production is ramped up to scale, match supply and demand for this new supply of N95s among the state’s health care organizations, and deliver these products just in time and at cost, where they are needed most. In doing so, we all can reclaim some sliver of control over our shared destiny in this era of chaos and uncertainty.

The third sentiment is exasperation. While we may find comfort in newfound friendships among a motley crew of collaborators, we also know that this elaborate production should never have been necessary. We sought to fill the absence of a coordinated national response to contain the pandemic and to heal a diseased PPE supply chain. On the day the idea was hatched, we prayed for it to become obsolete. Now, more than 140 days later, circumstances are largely unchanged, with the specter of the pandemic worsening on the horizon. Those who came together to stitch together this supply chain have shared the grief of loved ones lost to COVID-19, motivating us to move faster.

We can pause to celebrate a feat of human ingenuity and cooperation, while also bearing witness to the potential destruction of the most vital and precious part of the American health care system: its people, especially frontline workers. As they approach this season of exhaustion ahead, we must reinvigorate strides to protect them against the continued spread of COVID-19. This should include investment in local manufacturing and innovation to rapidly and sustainably expand the supply of necessary personal protective equipment. We can save ourselves by saving each other and reimagining new ways to do just that.

Azalea Kim MD, MBA, MPA, is chief of staff to the chief medical officer of Blue Cross and Blue Shield of North Carolina. She is also a primary care physician and faculty in the Department of Internal Medicine at Duke University School of Medicine, and adjunct faculty at Duke Forge, Duke University's center for applied health data science.