A Valuable Supply Chain Lesson, Courtesy of Coronavirus

Mike Bowen is not in a great mood these days.

Ostensibly, there is no good reason for the discontent: His company’s sales are surging, product pricing is off the charts—up 20-fold in some instances—and demand is growing by leaps and bounds (as reflected by the constant cell phone pinging of new order requests).

So why the melancholy?

In a nutshell: Coronavirus.

More specifically: Supply chain vulnerabilities stemming from coronavirus.

The deadly respiratory disease spreading like wildfire around the world is exposing major weaknesses in the global medtech supply chain, especially among entities that rely heavily on Chinese manufacturing for certain products. With the Middle Kingdom’s production capacity currently at a standstill, these entities are now scrambling to find alternative manufacturing sources to avoid product shortages.

Bowen’s firm, Prestige Ameritech, is one of those sources. Based in North Richland Hills, Texas, the company bills itself as the largest domestic (U.S.) manufacturer of surgical masks. For weeks now, Prestige Ameritech has been inundated with orders for its signature product as China consumes more of the protective gear it normally produces and exports. Prestige’s orders have risen proportionally with the virus’ rapid spread, and while the company adjusted its production yield accordingly— churning out 600,000 surgical masks per day—it has hardly been enough to meet worldwide demand.

“This is 100 percent a vulnerability,” Saskia Popescu, a biosecurity expert and senior infection-prevention epidemiologist in an Arizona hospital system, told Wired in early February. “Personal protective equipment is always going to be a problem when there is an outbreak of something novel, because public health guidance will be unclear at first and there will be a run on supplies. Masks being made offshore is one more stress on the system.”

Bowen, Prestige’s executive vice president, has been warning about that stress for years. He’s pleaded with federal agencies and lawmakers to boost U.S. production of surgical masks (to no avail), and he’s cautioned two presidents about the nation’s inadequate surgical mask supply, predicting provisions most likely would be “disrupted, confiscated, or diverted” during a pandemic.

“What I’ve been saying since 2007 is, ‘guys, I’m warning you, here’s what is going to happen, let’s prepare,’” Bowen told Stephen K. Bannon on the Feb. 12 podcast “War Room: Pandemic,” according to The Washington Post. “Because if you call me after it starts, I can’t help everybody.”

And sure enough, Bowen can hardly help anybody. His company makes the N95 filtering respirator (mask) for frontline coronavirus soldiers (as recommended by the Centers for Disease Control and Prevention), but Prestige couldn’t possibly produce the billions of masks needed to protect American healthcare workers and first responders from the virus (even if it ramped up production to 1 million respirators/day). Most of that yield would have to come from China, which makes most of the world’s surgical masks, and is now hoarding supply to protect its own coronavirus warriors.

The Post reports that America has enough N95 respirators on hand to last another month or so. But the coronavirus is showing no signs of slowing down (43 countries, 81,279 cases and counting), prompting CDC officials to prepare for a potential pandemic.

Such a development would further kink the already knotty supply chain for surgical masks. The U.S. Food and Drug Administration (FDA) has already warned about product shortages in the event of a prolonged coronavirus outbreak, and currently is working with drug and device manufacturers to identify potential deficits.

Without ample domestic production, however, those shortages may be unavoidable, as the FDA has pulled its inspectors from China and suspended roughly 100 drug and device factory reconnaissance scheduled for February and March.

“The fact that the FDA has suspended inspections is worrisome,” Michael Carome, director of Public Citizen’s health research group, and an expert on drug safety and FDA oversight, told USA Today. “We start from a baseline position of they are not doing enough inspections in China… Any further delay or suspension in their inspections makes the problem worse.”

A delay also could push the U.S. surgical mask supply to the brink of depletion.

“We’re trying to do some projections,” an anonymous industry expert disclosed to The Post. “How do we get to the next three weeks, and how do we get to the three weeks after that?”

Good question.