Necessity breeds innovation: East coast family comes together to redesign the N95

November 18, 2020 Joule staff

A pile of different types of masks and N95 respirators

“During this pandemic, health care professionals are making many daily sacrifices to care for patients and the communities in which they live. We’re hoping to give them a product that provides superior protection, so they can focus on caring for patients with confidence.” – Dr. Susan Ripley, CMO, Takaya Technology Inc.

Dr. Susan Ripley, an acute medicine hospitalist, was eight months pregnant when the reality of living and working during the COVID-19 pandemic set in.

Right after completing her morning rounds at the QEII Health Sciences Centre in Halifax, the unit manager handed her a mask and told her that everyone working in the hospital needed to wear it at work from now on.

“I’ll never forget that feeling,” said Dr. Ripley. “I felt vulnerable. For someone to be able to do their best work, concerns about personal safety must be addressed.”

Current evidence now shows masks are pivotal safety equipment for all front-line workers.

 

Fit for change

With the demand for personal protection equipment (PPE) soaring in February, entrepreneur Andrew MacKean was leveraging his international connections to procure respirators for the province of Nova Scotia.

“We focused on the N95 respirator because we were advised it was the most difficult piece of essential equipment to procure,” he said.

Despite being able to acquire a number of N95 respirators, from a multitude of manufacturers, what he learned in the process was that many failed fit-testing, despite holding all the proper internationally recognized certifications and regulatory clearances.  

According to the Centre for Disease Control, an effective N95 mask filters out at least 95% of particles —  from small particle aerosols to large droplets. Proper fit is essential to reduce the wearer’s exposure to COVID-19.

“We were really disappointed and concerned,” he explained. That’s when he turned to his sister, Dr. Susan Ripley, for help.

“It became clear to us that there was an opportunity for us to work on a project that’s really near and dear to our hearts, both professionally and personally,” said Dr. Ripley.

“The pandemic presented a unique opportunity for us to come together and work towards a common cause: redesigning a critical piece of personal protective equipment.” – Dr. Susan Ripley

In the right place at the right time with the right expertise

With their combined experience in medical device development and entrepreneurship, the siblings felt they had a good base to start. Pooling their own funds, they created Takaya Technology Inc.

Andrew MacKean took on the role of CEO and another sister, Erin MacKean, who has more than a decade of experience in biotech, joined as their chief operating officer.

“Building a business can be stressful,” she said, “and in these challenging times, ever more so. To have that solid trust of working with family has made it easier.”

They immediately got to work, building a team around Dr. Ripley’s first-hand experience as a practising clinician and biomechanical engineer, and sourcing experts in Canada, the United Kingdom and the United States with  backgrounds in engineering, material science, and regulatory and market access. They also leveraged relationships with overseas manufacturers to secure needed materials.

“The typical process for commercializing a medical device can be long and arduous. We sought out some of the world’s best help to shorten that timeframe and expand our reach,” Andrew MacKean explained.

Dr. Susan Ripley received a COVID-19 Innovation grant from Joule for her work with Takaya Technology Inc. on the re-engineered N95 mask. Learn more about the program and grant recipients.

Members of the Tayaka team: Dr. Susan Ripley, Erin MacKean, Andrew MacKean and Lee Babin

Key members of the Takaya Technology team, from left to right: Dr. Susan Ripley, Erin MacKean, Andrew MacKean and Lee Babin, Takaya’s Lead Engineer

User-centric design

From the very beginning, the team focused on getting users’ needs to inform and direct the design.

“We had the challenge of having little time to get a product to people, who needed it yesterday,” said Andrew MacKean.

Once they began prototyping, it was an iterative process to get the right fit with potential users, so they fostered a constant negative feedback loop to reach inter-user reproducibility: a mask that works for everyone, every time they put it on.

“There wasn’t a simple, one-size-fits-all solution,” said Andrew MacKean. “We had to consider facial variables and how the innovation would stand up to the demands of clinical use.”

With a design in hand that both meets the regulatory requirements and feels comfortable, the Takaya Technology Inc. team are now just a few weeks away from getting their prototype into the hands of medical professionals to collect their feedback and make adaptations.

Their next steps include obtaining regulatory body clearances and putting the masks into production.

“To be able to provide a product with a superior performance is one of the most valuable things we can do to really make a difference in this pandemic.” – Dr. Susan Ripley

This material is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. The opinions stated by the authors are made in a personal capacity and do not necessarily reflect those of the Canadian Medical Association and its subsidiaries including Joule.

About the author(s)

Joule staff

Joule is a Canadian Medical Association (CMA) subsidiary designed to assist physicians in the pursuit of clinical excellence. Joule does this explicitly through the support of physician-led innovation, and by inspiring physician-adoption of knowledge products and innovative technologies and services.

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