Sitting in his Newnan home watching TV news early in the pandemic, Ken Milam got frustrated. And excited.
For days he had watched accounts of health care workers facing shortages of N95 masks, the gold standard in protection against the coronavirus. Could he help? Quite possibly.
Only three Georgia-based applicants have received required certification from the National Institute for Occupational Safety and Health (NIOSH) for masks to be marketed as N95. Two are units of multibillion-dollar global businesses, Kimberly-Clark and Owens & Minor.
The third is Milam’s little plastics manufacturing company, Newnan-based ThermoPore Materials Corporation, with just 12 workers including him.
Milam is setting up his first mask production line in an adjacent space that was until recently the home of a CrossFit gym. By January, he said, it will be churning out five N95 masks every 15 seconds.
There’s one glaring problem: He doesn’t have any customers lined up yet, even as COVID-19 cases and deaths are surging and most Americans still can’t get N95s.
Thermopore uses a raw material that isn’t what most, if any, other N95s are made from, Milam said. That could help avoid potential international supply bottlenecks but also may make hospitals wary of trying something new — especially from a tiny manufacturer they’re not familiar with.
Credit: HYOSUB SHIN / AJC
Credit: HYOSUB SHIN / AJC
Milam said he’s still trying to get backing from major corporations he’s approached about partnering to supply masks to health care providers, company workforces or store shelves. (Retailers such as Atlanta-based Home Depot stopped stocking N95s earlier in the year to keep more masks available for health care workers and first responders.)
And, of course, there’s uncertainty about whether demand for masks will tumble after vaccines are made widely available.
Milam said he doesn’t know how many production lines he should set up or how many masks the market needs. That’s convinced him to start with just one line, making up to 200,000 masks a week, which he doesn’t plan to sell directly to the general public.
“All this has been a little bit scary,” said the 51-year-old, who has a mechanical engineering degree from Georgia Tech, but spends his company time doing everything from HR to marketing, accounts receivable/payable and cleaning the bathrooms.
Breaking into the market for N95s — certified to filter out 95% of some of the smallest and most worrisome particles and designed to allow a tight fit — isn’t easy. Breaking in with a product that is different adds to the challenge, said Michael Fisher, director of product development at the Global Center for Medical Innovation.
“Medicine is very conservative about product adoption,” Fisher said.
GCMI, a nonprofit affiliated with Georgia Tech that seeks to accelerate commercialization of medical products, is working to try to help Milam connect with distributors. The Georgia Department of Economic Development has also helped.
One of the crucial differences of Milam’s product is that it relies on a different kind of filtering plastic than typical N95 masks, said John Morehouse, who directs the state’s Center of Innovation for Manufacturing.
Most rely on nonwoven material, much of which is often sourced out of Asia, that creates a spiderweb-like filter and has an electrostatic charge to catch more particles. Milam’s masks instead rely on a different kind of plastic that he turns into a film, less than one-sixteenth of an inch thick. Its structure is formed by tiny spheres partially melted together in a way that creates different levels of porosity, allowing it to block many particles and still let air through.
Credit: HYOSUB SHIN / AJC
Credit: HYOSUB SHIN / AJC
“ThermoPore’s solution really adds resiliency to the way that the United States can respond to a critical supply shortage,” Morehouse said. “It is a blueprint to one path forward for the U.S. to respond to emergencies like that.”
The Centers for Disease Control recently called for “universal use of face masks.” It recommends non-valved, multilayer cloth masks or nonmedical disposable masks for the general public, with hopes of preserving more protective N95 versions for health care workers and other medical first responders.
Health officials say N95 mask supplies are still thin. A spokesperson for the American Hospital Association told The Atlanta Journal-Constitution that hospitals and health systems’ inventories have improved but “serious concerns continue” and demand is outpacing production.
With supplies limited early on, many medical workers tried to sanitize and reuse N95s that had been intended as single-use products. Others relied on masks made under China’s KN95 standard, which is very similar to that for the N95, though it often wasn’t treated with the same esteem, the U.S. government couldn’t assess manufacturing quality controls and consumers have less certainty about what they are buying from less-familiar international suppliers. Some stumbled upon masks, including supposed N95s and KN95s, that turned out to be fakes or otherwise fall short of standards.
With demand booming, N95 manufacturing in the U.S. soared, makers say. In Georgia, Kimberly-Clark launched production at a LaGrange plant to supply its own manufacturing employees and, later, cleanroom and scientific sector customers.
Owens & Minor, with an office in Alpharetta that received N95 approvals, is making masks in other states, having boosted its production tenfold since February.
In Augusta, United Medical Enterprise, which makes other kinds of masks, hopes to win approval to start pumping out 30 million N95s a year there.
Credit: HYOSUB SHIN / AJC
Credit: HYOSUB SHIN / AJC
In the earliest weeks of the pandemic, many U.S. companies and entrepreneurs quickly pivoted to make safety items such as cloth masks and hand sanitizer.
Developing coveted N95 masks turned out to be a far more complex and costly undertaking.
Machines to make the masks were hard to get. Supplies of fibrous nonwoven materials typically used in N95s seemed shaky. There were struggles determining how many masks would be needed and how long demand would last. Getting NIOSH approval posed another hurdle.
Early on, the Food and Drug Administration and NIOSH, an arm of the CDC, coordinated to allow emergency authorizations of N95 masks, sharply speeding up the certification process with temporary approvals meant to last as long as the pandemic did, plus a grace period.
Overall, NIOSH has issued 85 new N95 approvals this year, 20 of them under the sped-up public health emergency authorizations.
Milam’s masks were approved under the emergency authorization. He praised the speed of NIOSH’s process and the support of its staff.
He had an outside lab conduct tests on his masks to ensure they would meet the N95 standard. Then NIOSH ran its own tests. Now, he’s hoping to sell them to other companies for about $1.50 a pop, which is more than many non-N95 masks go for.
Credit: HYOSUB SHIN / AJC
Credit: HYOSUB SHIN / AJC
Usually ThermoPore, founded by Milam 12 years ago, makes odd little porous items embedded in other companies’ products: filters used on pipettes in labs and on syringes used in surgeries or pharmaceutical facilities. Clear boxes of them are stacked at the company’s space near downtown Newnan.
When he learned about the pandemic’s mask shortages early on, Milam figured the microporous materials he specializes in — particularly a version he makes into long rolled-up sheets — could help medical workers.
He said he spent at least $250,000 on the project, including dropping $50,000 on Thermopore’s single-most expensive equipment purchase ever: a machine to test filtration efficiency.
But the biggest investment was assigning two engineers to work on the project for months rather than on other ones that weren’t such long shots — such as a pilot project to make the tips of coloring markers.
The engineers worked with virtual headforms supplied by NIOSH to try to devise carefully contoured masks that would fit on a wearer’s face more comfortably. Milam bought parts off of eBay in early tests of how to fashion masks.
“I kept waiting for us to fail — we always felt like it was a long shot — but we haven’t,” Milam said.
Credit: HYOSUB SHIN / AJC
Credit: HYOSUB SHIN / AJC
They made a few hundred masks. Some went to metro Atlanta hospital nurses, so they could get feedback to tweak the design. Others went for testing or to friends and family members.
Whit Costley, one of ThermoPore’s engineers, has been wearing the masks a lot. He’s got a three-year-old son with a medical condition. “I feel like it’s working on a special project. It’s for the greater good,” he said.
But it remains unclear even among ThermoPore’s boosters how many of the masks will end up in hospitals or stores.
“I’m not going to sugarcoat it: They’ve got their work cut out for them,” said Morehouse, at Georgia’s Center of Innovation for Manufacturing. “Are they going to cross the Valley of Death or not?”
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