Let’s look at a standard N95 mask to understand why the U.S. is so dependent on overseas suppliers for personal protective equipment (PPE).
It has several individual components: filter, shell, coverweb, nose clip, nose foam, and straps.
Each of those requires raw materials, chiefly polyester, polypropylene, and aluminum.
So while the N95 is made by one company, even one based in the U.S., those components and materials can and mostly do come from many places around the world.
And N95s are just one part of the PPE equation for frontline healthcare workers during a pandemic. Also needed are surgical masks, bonnets, gowns, goggles, gloves, faceshields, powered air purifying respirators (PAPRs), and more.
Despite calls from politicians to bring PPE manufacturing back to U.S. shores, the global and secretive nature of the supply chain has made it difficult to reverse decades of offshore sourcing and production. As well, offshoring has always been driven by cost, and that advantage for overseas suppliers isn’t going away. Manufacturers and buyers of finished products will always be looking for the best deal — which in recent decades has come from low-wage foreign countries.
Some companies have indeed boosted domestic PPE production capacity, but to make the U.S. self-sufficient in meeting its PPE needs for the next pandemic — or even to continue to meet the needs of the current one — it would take a sea change, industry representatives and analysts told MedPage Today.
Made in the USA
The two largest producers of PPE in the U.S. are 3M and Honeywell. Both companies told MedPage Today that they’ve boosted domestic production of various PPE items since the pandemic began.
By October, 3M plans to produce 95 million N95 respirators each month on U.S. soil, amounting to more than 1 billion respirators produced here annually — about half of its total N95 production, according to company spokesperson Tim Post. That’s up from 50 million per month made in the U.S. in July.
That increase was made possible by two contracts with the U.S. Department of Defense, along with additional investments made by 3M, Post said.
But further details about U.S.-based production of other types of PPE, such as PAPs and elastomeric respirators, were a black box: “Generally we don’t publish production numbers for proprietary reasons,” Post said.
Honeywell was similarly reluctant to offer up specifics on overall domestic PPE production. Spokesperson Jennifer Gammage said Honeywell launched production of N95 masks in existing facilities in Smithfield, Rhode Island, and Phoenix, Arizona, during the pandemic. Each site was up and running in just five weeks — “a process that could typically take up to 9 months,” Gammage said.
Both sites combined have thus far shipped “more than 5 million masks” to healthcare workers and government organizations, she said.
Yet it’s not clear how long current levels of domestic production will last at either company. As 3M’s domestic production rose, for instance, so too did its global production, as demand in other countries grew apace.
Nor would Post or Gammage say whether they had domestic suppliers of raw materials or components.
Transparency and Uncertainty
This lack of transparency makes it difficult to determine just how much of companies’ PPE production occurs on U.S. shores, and by how much that domestic production has increased, said Tinglong Dai, PhD, an expert in operations management from Johns Hopkins Carey School of Business who has been studying “reshoring” of PPE production.
“If we do not have basic information about the supply chain, there’s no way for us to assess its vulnerability,” Dai told MedPage Today.
Dai noted that current regulations only require PPE makers to report the locations of their facilities, not their domestic and overseas production capacity. At the very least, publicly traded PPE manufacturers operating in the U.S. should be required to disclose what proportion of their products are made in the U.S. versus overseas, he said.
At the same time, he understands why companies may be hesitant to return large swaths of their manufacturing capabilities to the U.S., especially given the unknowns about future demand. With the 2009 H1N1 pandemic, for instance, companies built up capacity only to be stuck with inventory that hospitals didn’t want after the pandemic subsided.
“If the pandemic recedes and demand shrinks, we would have unused machines, and engineers and workers who don’t have jobs,” Dai said. “We would have to deal with that consequence.”
Chaun Powell, group vice president of supplier engagement and disaster preparedness at Premier, the country’s largest hospital group purchasing organization, echoed that uncertainties about future demand pose a challenge to reshoring PPE production.
After the surge of 300 million in the first half of 2020, “will we trail back off to 25 million masks [annually] in February?” Powell questioned. “Manufacturers are hoping that demand doesn’t dry up, but they have to prepare for the worst.”
The Next Pandemic
One path forward could be developing an “industrial commons” of manufacturers that could shift from their individual industries to meet demand. Taiwan provided a key example of this early in the pandemic, Dai said. Their electronics manufacturing workforce pivoted to PPE production and was able to meet the country’s needs.
They had the manufacturing technology and the personnel to make it work, but that wouldn’t necessarily be the case with the U.S.’s current “hollowed out manufacturing sector,” Dai said.
Dai’s dream scenario? Having a network of facilities, similar to national laboratories, that regularly fund engineers and scientists to refine manufacturing technologies, which could then be deployed during a pandemic. He likened it to national defense, where the U.S. has significant weapons production capability even though it’s not at war on a regular basis. “The idea is to prepare, to support an ecosystem of production facilities and human resources and expertise,” he said.
Powell said his company favors a “balanced” approach to global production, where capabilities exist onshore and near-shore (like North and South America) as well as offshore.
“If we took everything from China and put it in Iowa and Nebraska, for instance, we’d still have the same issues,” Powell said, noting that geographic concentrations make companies vulnerable. “If we have a large percentage of our raw material, subassembly or product coming from a single geography, things can impact that, like a tornado ripping through one state and putting production at risk.”
“It’s not just about bringing manufacturing back to the U.S.,” he said. “It’s about understanding where the gaps in the supply chain are and finding solutions whether domestic or near-shore.”
Both President Donald Trump and Democratic presidential nominee Joe Biden have championed producing medical supplies and PPE in the U.S., diminishing the nation’s reliance on China.
Aside from his March 18 executive order invoking the Defense Production Act, Trump hasn’t issued any specific directives on reshoring PPE production. On his campaign website, Biden outlines a plan for investing in workforce skills to bring back manufacturing so in future crises the country will be able to quickly ramp up production.
Congress similarly has taken little action on reshoring PPE. Sen. Gary Peters (D-Mich.) introduced two bills regarding the U.S. medical supply. The Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act would require manufacturers to disclose foreign and domestic manufacturing data to the FDA on a quarterly basis. The Help Onshore Manufacturing Efficiencies for Drugs and Devices (HOME) Act would assess supply chain weaknesses.
In the House, Rep. Elissa Slotkin (D-Mich.) introduced the Buy American Medical Supply Chain Act, which would require items in the National Strategic Stockpile to be made in the U.S.
“The government needs to provide a stronger commitment to ensure long-term capabilities,” Dai said. “We need good public-private partnership solutions.”
“We have a lot of resources. It may take billions, but that’s manageable,” he added. “We just need a national plan to make it happen.”