Allysa Dittmar had no idea a pandemic was only a few years away when, in 2017, she founded ClearMask LLC with a team of other Johns Hopkins University graduate students. The new company’s focus was to offer fully transparent medical-grade face masks so deaf and hard of hearing individuals could better communicate through visual cues.
ClearMask spent years researching, designing and developing its masks. “So much of communication is in the face; in fact, over 55% of communication is visual,” says Dittmar, the company’s president. “We all rely on critical visual cues to fully communicate—including facial expressions and lip-reading.”
In April 2020, ClearMask achieved clearance from the Food and Drug Administration—making its masks the only one of its type that is FDA-cleared. Since then, it has sold more than 12.5 million masks—entirely through the ClearMask ecommerce site, Dittmar says.
Birth of innovation
Dittmar, who is legally deaf, came up with the idea for ClearMask in 2015 after she had an adverse experience during surgery. “Traditional surgical masks blocked my providers’ faces, impeding effective communication and safety,” she says. “As someone who depends on facial expressions, visual cues and lipreading daily, it was quite a dehumanizing experience and one that I never want anyone else to go through.”
After connecting with her fellow graduate students who embraced the business idea, her team set out to develop the transparent medical face mask. “We did years of prototyping and market research to actually see if our idea of a fully transparent mask could actually work in terms of comfort, fit, anti-fogging, ergonomics, and whether it could be cleared by the FDA and mass-produced,” Dittmar says. “We built hundreds of different product iterations, changing and testing different designs, materials and ideas to get to a minimum viable product.”
By 2017, they had developed the mask and ultimately submitted it for FDA clearance. “It took approximately a year to prepare for FDA submission,” Dittmar says. “It’s a lengthy and rigorous application requiring independent, third-party lab testing.”
Pandemic challenges and opportunities
Only after it achieved FDA clearance in April did ClearMask started selling its products. But its website had been up and running since 2017. Prior to COVID-19, ClearMask saw an average of 6,000 unique visitors to its site each year, with approximately 15,000 annual page views.
Then the pandemic struck.
“Back in 2017, we thought our masks would mostly serve specialized populations in healthcare, including deaf and hard of hearing children and older patients,” Dittmar says. However, with the pandemic, ClearMask’s product would help fill in the personal protective equipment (PPE) shortage. But the company recognized it could become an essential general usage tool that enabled full and visual communication for many different people.
ClearMask quickly decided to expand its product line—making a consumer version immediately available for sale at a lower cost than the medical mask. “The consumer version follows a strict quality management system with regular inspections and testing to follow standards for good manufacturing practices (GMP),” Dittmar says, adding, “While the quality standards and regulations for both versions share many similarities, the FDA has their own set of documentation requirements that must be followed for the medical version. The added requirements create additional overhead, leading to the higher cost of the FDA mask.”
The company then had to quickly set up ecommerce for individual consumer ordering while maintaining its B2B bulk sales, which amounted to hundreds of thousands, sometimes millions of masks. To do this, they had to hire billing and accounting staff to process orders and establish order processes to accommodate individuals as well as large organizations. And they had to choose, set up, and customize the ecommerce platform.
“We initially didn’t plan to roll out our product so quickly in such large volumes,” Dittmar says. “But because of the pandemic, we found ourselves in a critical position to help fill in the PPE shortage.”
From April until mid-September 2020, ClearMask’s site traffic spiked to 2 million unique visitors with an average of 2.5 million page views. In those five months, the company experienced nearly a 34,000% increase in site traffic compared to 2019. And it sold nearly 13 million masks.
Ecommerce at work
ClearMask relies 100% on ecommerce for sales. “Without ecommerce, we would not be where we are today,” Dittmar says. “Ecommerce allows us to quickly reach customers and organizations around the world, particularly in this unforeseen pandemic environment.”
In addition to hospitals and healthcare organizations—which make up ClearMask’s largest customer base—the company’s other top customers include state, national and international governments; all types of schools; and private companies in retail and customer service.
All of ClearMask’s orders are placed and processed through the company’s online Shopify platform, including the B2B bulk orders. Depending on the product, orders are shipped to the customer by the manufacturer or from strategically located warehouses closest to the customer. In most cases, shipping is expedited and free.
Customers can also order the ClearMask through various distributors, such as Cardinal Health, Oaktree, McKesson and Henry Schein.
As part of its growth plan now and beyond COVID-19, ClearMask is expanding internationally. “While our platform has the capability to serve any customer of any order size, our specialty is bulk orders serving large organizations and customers, which aligns with our goal to reach as many people as possible during this pandemic and beyond,” Dittmar says.
Cate Flahardy is a Chicago-based freelance journalist covering business and technology.
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