- Allysa Dittmar was about to undergo surgery in 2015 when a nightmare scenario occurred: Her interpreter was late.
- Dittmar was born deaf, and not having her interpreter meant she couldn't understand what her doctors were saying about her operation.
- The terrifying experience led her and three fellow students to create the ClearMask, an FDA-approved transparent face mask.
- ClearMask went from $0 in revenue in 2019 to more than 12 million masks sold worldwide since April, Dittmar told Business Insider via email.
- As the company tries to meet surging demand, due to the pandemic, it is now running into familiar challenges of scale.
- However, the cofounders believe the increased pressure to perform will set them up for future success, after the crisis is over.
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Imagine lying on the operating table under bright lights, about to undergo surgery. You can tell that your doctors are speaking to you, but you can't hear a word they're saying; and you can't lip-read because they're all wearing surgical masks.
Allysa Dittmar, who was born deaf, had this experience in 2015 when her sign-language interpreter didn't show up in time for her surgery.
"It was a very dehumanizing experience" and caused "a lot of anxiety, confusion and fear," Dittmar told the Wall Street Journal.
It was a nightmare she never wanted anyone to experience, so two years later she and her three cofounders invented a solution: ClearMask, a transparent face mask that is now FDA-approved.
ClearMask is experiencing a surge in demand this year as individuals don face masks for protection during the pandemic, effectively closing off communication for those who rely on lip-reading and facial expressions. The company went from $0 in revenue in 2019 to more than 12 million masks sold worldwide since April, Dittmar told Business Insider via email.
(Dittmar declined to share exact revenue figures for the Baltimore-based business, but a box of 24 medical masks typically costs $108.)
"It's not just traditional deaf people," who could benefit from clear face masks, said Gerry Buckley, the president of the National Technical Institute for the Deaf, through a sign-language interpreter. "You have military vets who are experiencing hearing loss and grandparents who are having communication problems. When they go into their doctor's or financial advisor's office, communication becomes a barrier."
Now, as ClearMask looks to scale the business and meet the increased demands of the pandemic, its cofounders say the challenges they face today could provide solutions for millions, even after masks are no longer a daily necessity.
'We couldn't fix the problem because no one had invented the solution yet'
Dittmar is one of the 48 million people in the US who are deaf or hard of hearing, according to the National Association of the Deaf. While transparent masks can help someone lip-read, they're also helpful for understanding sign language and interpreting facial expressions, said Howard A. Rosenblum, CEO of the National Association of the Deaf.
For instance, a facial expression can help modify the signs someone makes with her hands.
After Dittmar's own scare in the hospital, she relayed her experience to fellow students at Johns Hopkins University, including Aaron Hsu, who would become CEO and one of ClearMask's four cofounders. Hsu was planning on attending medical school after Johns Hopkins but withdrew his application to create the company.
"We couldn't fix the problem because no one had invented [the solution] yet," said Hsu, noting that his parents, who emigrated from Taiwan to the US and are not fluent English speakers, also rely on facial expressions for communication. "That was what really drove me, the fact that it was so obvious."
Dittmar and Hsu recruited classmates Elyse Heob and Inez Lam, who now serve as COOand CTO respectively, to form the founding team.
120 interviews in 6 weeks
The cofounders recognized they had three stakeholders who'd be interested in transparent face masks: the medical staff who'd need to wear them, the patients who'd benefit from doctors wearing them, and the administrators who'd buy them.
The cofounders then worked with the National Science Foundation's Innovation Corps — a program that teaches researchers about entrepreneurship — and interviewed more than 120 people in six weeks to gain insight into what those specific groups needed and wanted.
They learned the masks needed to be mass-produced, comfortable to wear, provide enough value to patients that administrators would buy them, and designed in a way that shows as much of the wearer's face as possible, Hsu said.
One of their most surprising insights was that masks with ear loops can cause feedback for people who wear hearing aids. So the cofounders designed ClearMask with an adjustable strap behind the head.
They also added foam to the part of the mask that rests on a person's face, to avoid discomfort, and built the clear shield with a proprietary plastic that won't fog up and prevent lip-reading. Hsu declined to share more details about the type of plastic used in ClearMask, as to avoid tipping off competitors.
FDA emergency authorization arrives right on time
Since ClearMask's inception, the cofounders wanted the masks to be FDA-approved for use in medical applications.
"I don't know if we necessarily needed it, but we wanted to do this the right way," Hsu said. "We wanted to show that the masks are safe and effective because there are masks out there that aren't."
The team submitted its application to the FDA in late 2019. By early April, as coronovirus cases began to surge, the mask was approved under the FDA's emergency use authorization.
ClearMask's cofounders built the majority of the business with $150,000 in grant funding before receiving a $300,000 investment in March from the Maryland Technology Development Corporation.
The team scaled operations rapidly as demand increased, going from making one million masks a month to four million. Existing relationships with suppliers and using a form of plastic that wasn't in high demand for personal protection equipment helped the company avoid supply chain issues, Hsu said.
Then came issues of scale.
For starters, the team hadn't yet opened a bank account beyond the "bare bones" one they initially set up, Hsu said. So they opened a proper business account.
They also turned to their manufacturing and logistic partners for help, finding that many were eager to provide advice or services to help propel the cause forward.
"When we were starting to burn out, it really boosted our morale to get random emails or messages saying, 'let me help you,'' Hsu said. "To this day, some people still haven't asked for compensation."
The team worked until the early morning hours every day, racing against the clock and surging demand. "Every single day mattered," Hsu said. "We were in an all-out sprint."
Looking toward a mask-free future
Today, the company sees a future in expanding production outside of the US and getting ClearMasks into schools.
While the pandemic emphasizes the need for transparent face masks today, Hsu said ClearMask will continue educating individuals on the importance of its device after the crisis is over. For instance, ClearMasks are especially helpful for younger children who may be hard of hearing.
"A lot of people don't understand how much children rely on visual communication," Hsu said. "When you take away that innate part of an interaction, they don't understand as much."
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