July 12, 2022 – Sitting at his desk in Sea Girt, NJ, John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.
The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.
This fall, Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.
After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services.
Like the rest of us, Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic, but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.
The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).
While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
Preview of Masks to Come
“We’ve seen some really amazing things,” Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”
One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
And the Finalists Are …
ReadiMask 365: “I can wear this all day long,” Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”
He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”
ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Hsu says.
“Being able to work with BARDA and getting their wisdom is invaluable,” he says.
Hsu thinks masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless.” He predicts health care settings will become stricter about wearing masks.
“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.
4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.
Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she say s. It went on the market in November, 2020.
Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Ngo said.
Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.
Levi Strauss & Co.: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.
Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.
SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.
StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
Bye-Bye N95?
“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.
“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.
Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
Getting from 1,500 to 10
In the first phase of the challenge, Lippold says, “The goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.
Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Lippold says.
The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.
