Startup aims for FDA clearance on medical device to improve communication in surgery

A Baltimore startup is working toward gaining clearance from the U.S. Food and Drug Administration for its device that could improve in-surgery communication.

Surgical situations can be stressful, and clear communication between and among medical staff and patients is important. An inability to effectively communicate could lead to misunderstandings or even errors, a situation which Allysa Dittmar, co-founder of Baltimore's ClearMask LLC, has personally experienced.

Dittmar is deaf. She underwent a surgery a few years ago and had requested a sign language interpreter who never showed up. Dittmar managed to get through the pre-operation stage by reading lips and other visual cues, but when she got into surgery and half of everyone's face was covered by a surgical mask, she felt lost.

"She felt dehumanized. Eventually everyone stopped trying to communicate with her, and she couldn't even answer any confirmation questions like her name or blood type," said ClearMask CEO Aaron Hsu, recounting Dittmar's story. "It became obvious to her that there was a gap in surgical care."

ClearMask was founded with the goal of filling that gap. The company has developed an entirely clear surgical mask that is intended to allow for fuller communication and comfort in medical scenarios. The company is currently working with Harbor Designs firm to finalize the design of the mask, before production moves forward.

The state-backed Maryland Technology Development Corp. recently accepted ClearMask into its mdPACE program. The TEDCO initiative, which is also funded by a U.S. Department of Commerce grant, is aimed at helping companies get their medical devices FDA cleared. MdPACE will help ClearMask gain clearance in 12-18 months, less than the 36-42 months typically needed by an inexperienced, unguided team. 

The startup has gained funding and business support from several other programs, including the National Science Foundation's Innovation Corps program and Johns Hopkins' Social Innovation Lab. ClearMask is also a cohort member of Accelerate Baltimore, an accelerator program by Emerging Technology Centers that provides mentorship, training and $25,000 in seed funding.

ClearMask has yet to raise any private funding, but Hsu said it may be seeking a round next year to help with the patent process.

Hsu said the company's goal for the year is to finalize its initial product and work toward FDA clearance in the U.S., as well as equivalent clearances in some international markets. ClearMask has worked closely with the deaf community — two of its five team members are also deaf — and consulted with physicians to develop the most effective and comfortable mask possible.

"It can help anyone who relies on visual cues to communicate...deaf people, children, people who speak another language," Hsu said. "It’s basically the equivalent of inflection and tone for auditory communication."

ClearMask also hopes to produce its first round of products in 2018, and host some official pilots of the technology with local partners.