November 30, 2023

One year after the start of the pandemic, the disposable, virus-filtering N95 mask remains a sought-after protective device. The ongoing shortage has forced doctors and nurses to reuse their N95s, and common Americans have scoured the internet – mostly in vain – to get them.

But Luis Arguello Jr. has plenty of N95s for sale – 30 million of them made by his family-run company DemeTech in its factories in Miami. He just doesn’t seem to find buyers.

After the pandemic uncovered a huge need for protective equipment and China closed its inventory to the world, DemeTech, a medical suturing manufacturer, stepped into the mask business. The company invested tens of millions of dollars in new machines and then went through a nine-month approval process to make the masks marketable.

However, demand is so low that Mr Arguello is preparing to lay off some of the 1,300 workers he had hired to ramp up production.

“It’s crazy that we can’t get these masks to the people who need them badly,” he said.

In one of the more confusing divisions between supply and demand, many of the nearly two dozen small American companies that recently jumped into N95 manufacturing are facing the brink – they cannot crack the market despite the vows of both former presidents Donald Trump and President Biden is expected to “buy Americans” and boost domestic production of essential medical equipment.

These companies need to break through the ingrained buying habits of hospital systems, medical care distributors, and state governments. Many buyers are reluctant to try the new crop of American-made masks, which are often slightly more expensive than those made in China. Another obstacle is companies like Facebook and Google, which have banned the sale and promotion of N95 masks to prevent profiteers from diverting critical medical devices needed by frontline medical professionals.

According to public health experts and industry executives, an ambitious strategy that includes federal loans, subsidies and government purchasing guidelines is needed to ensure the long-term viability of a domestic industry that is vital to the national interest.

“The government needs to call outsourcing American mask supplies for what it is: a national safety issue,” said Mike Bowen, owner of Prestige Ameritech, a Texas mask maker who testified before Congress that domestic manufacturers need support .

Based on his experience during the 2009 swine flu pandemic, he said that many of the startups would likely not survive without systemic changes. “We’ve seen this movie before,” said Bowen, a 35-year industry veteran. “If and when the pandemic is over, it will be a bloody bloodbath.”

Domestic heavyweights like 3M and Honeywell ramped up N95 mask production last year, in part spurred on by the War Production Act during the war. However, the 120 million masks they produce in the US each month cannot meet the annual health sector needs of N95 3.5 billion. Most of the major players’ masks are forwarded to medical distributors who supply the major hospital systems in the country.

Smaller companies could help fill the gap. Together, 19 companies that recently received federal certification produce tens of millions of masks a month. Northwell Health, a large hospital chain, has used a total of 300,000 masks a month in its 23 hospitals.


Apr. 10, 2021 at 3:39 am ET

Companies include Protective Health Gear, a New Jersey start-up founded by a chiropractor and store manager who was struggling to find permanent customers, and ALG Health, a lighting company that manufactures 1.5 million masks a month in Bryan, Ohio. but cannot get the final investment required to meet the target of 30 million per month production.

Unlike his predecessor, Mr Biden has made face covering an important part of his plan to contain the pandemic. In one of his first acts as President, Mr. Biden directed federal agencies to aggressively use the Data Protection Agency to encourage domestic personal protective equipment manufacturing, and a subsequent executive order is designed to encourage government purchases of state goods. Still, none of the half-dozen startups interviewed for this article said they had been contacted by federal officials.

“I am encouraged by the first steps in the Biden administration,” said Scott Paul, president of the Alliance for American Manufacturing, an industry group. “But the federal government really needs to step up its game and reassure American companies that have responded to the national call to action, not just for this crisis but also for those of the future.”

Tim Manning, the White House’s Covid-19 supply coordinator, said the administration would announce a number of new DPA contracts for personal protective equipment in the coming weeks, but the bigger problems in the supply chain would take longer.

“One of our priorities in our pandemic response is to do this in such a way that we can make sure the industrial base expansion can be sustained so that we don’t end up in the same situation next time,” Manning said in an interview .

Companies like United States Mask, a Fort Worth, Texas start-up that began manufacturing N95 in November, may not hold out much longer. John Bielamowicz, a commercial real estate agent who started the company with a friend in the first few weeks of the pandemic, said he was frustrated with the lack of interest from hospital chains, long-term care facilities and local governments who buy in bulk.

Although the company’s masks have been certified by the National Institute for Safety and Health at Work, a division of the Centers for Disease Control and Prevention, many buyers are reluctant to try unfamiliar products, according to Bielamowicz. Large hospitals prefer to stick to masks they already use as it is time consuming to test new models on staff. However, many cost-conscious bulk buyers prefer to buy cheaper Chinese ones.

One of the more painful rejections came from Tarrant County, where Mr. Bielamowicz’s factory is located. Last month, the county disqualified its company’s offer because officials wanted to buy certain Chinese-made models. District officials did not respond to requests for comment.

“We got into this business because we were concerned about America’s reliance on foreign manufacturing and wanted to do something about it,” said Bielamowicz, whose masks sell for $ 2.25 apiece – pennies more than China’s manufactured. “Are we going to die on the vine if we make N95 at a competitive price?”

While hoping for Washington intervention, United States Mask and other N95 manufacturers said the ability to sell to the public through online retailers like Amazon would help them stay afloat.

Dr. Monica Gandhi, an infectious disease specialist at the University of California at San Francisco, said the vast majority of Americans who have embraced wearing masks and are concerned about new variations would eagerly upgrade to N95 or other types of virus filter masks when you were available.

“Right now, high filtration masks are more important than ever,” she said.

The problem is getting consumers to their retail websites. Right now, anyone trying to buy N95 masks on Google Shopping or Facebook Marketplace will be greeted with a blank page. On Amazon, a search for N95 leads to a multitude of vendors selling KN95 masks, a Chinese-made equivalent that researchers say is less effective. As of Wednesday, the website appeared to allow a handful of masks to be labeled the N95, but not all are listed on the NIOSH website. Another included a disclaimer that the masks are not recommended for use against Covid-19.

Google and Facebook said they have no immediate plans to change their policies, which are based on guidelines from the CDC and the World Health Organization, to ensure that healthcare workers have adequate protective equipment. Amazon did not respond to requests for comments.

Lance Brown, the managing director of Rhino Medical Supply, a South Carolina distributor, has been solely focused on selling N95s, which are made by the new generation of American entrepreneurs. Their masks, he said, are superior to most made in China, but his appeals to national pride often don’t push institutional buyers who are focused on the bottom line.

Mr Brown has also urged online retailers to reconsider their sweeping bans on N95 masks. The problem could easily be fixed by creating exemptions for government-certified masks.

“How come you can spread conspiracy theories on Facebook, but we can’t sell N95 masks to the millions of Americans who need them right now?” Asked Mr. Brown. “I can understand that Facebook doesn’t want to sell masks made by a man in their garage, but these masks meet strict NIOSH guidelines.”

On the one hand, Mr. Bielamowicz discovered the advantages of a small public exhibition. Last month, when he and his partner were debating whether to throw in the towel, a local newspaper columnist wrote about their troubles. The company was instantly overwhelmed by orders from school nurses, cancer patients, and key staff, many of whom said they had given up looking for N95 masks.

Within three days, the company had sold out its entire inventory of 250,000 masks.