From concept to design: How a team of innovators found a solution to the N 95 mask shortage in record time

For human centered designers, there’s always a story behind the innovation.  That’s because Human Centered Design begins with the people you are designing for and finding a solution that fits their needs. The human-centered design methodology uses empathy as a core value and creates an innovative solution.

“Once you empathize with your user group, you start defining the problem, narrowing it down from something really big to something smaller and more measurable,” explained Joshua Kim, MS, Senior Designer in the Department of Surgery.  

The next step is the ideation process where the designers create new ideas. “One of the favorite brainstorming exercises some designers use is what we call a ‘magic wand idea,’” said Kim. “Where we basically say if we have a magic wand and finances weren't an obstacle and technology was limitless what kind of solution could we create.”

According to Kim, this ideation process really opens up the possibilities for your future design and can help generate new ideas that are a better fit for the end user. Moving into the next phase of design – prototyping and testing – it’s critical to design without the fear of failure in order to discover the best possible prototype for the end user.

Using this design process, Kim and a team of innovators at MUSC were able to find a solution to the N95 mask shortage in less than a week.

 “When the shortage of N95 masks became a major concern in the United States, Dr. Baliga, chair of the Department of Surgery, asked if there was anything I could think of that would be a possible solution,” explains Kim. “What we knew was they were in short supply and there were ineffective masks that were being used or N95 masks were being overused due to shortages that basically rendered them ineffective, putting healthcare workers at risk.” 

Kim reviewed the design problem by breaking down the biggest question of “what’s special about these N95 masks that makes them in such short supply?” and realized the problem wasn’t with the masks but with the filter.

So the design plan for this project then became to understand what the N95 filter does, set the bar to replicate a filter that is equal to or better than the 95% filtration rate and fit it to an easy-to-produce, comfortable 3D mask with a proper seal and airflow.

Although the cartridge system can be retrofitted onto an aerosol mask, they were in short supply.

As with any good design process, Kim set his sights on prototyping the filtration system from his home while a collaboration was occurring concurrently in the lab where dentists Walter Rene, DMD, Christian Brenes Vega, DDS and John Yost, a student and independent contractor, were developing the 3D mask prototype to resolve the shortage of aerosol masks.  

As a result of the iteration process, Kim and his team broke down the global N95 mask shortage into a simplified concept that focuses on creating major design requirements for a project to be considered a success: Create a filtration system that can not only be retrofitted to an aerosol mask but also fitted to a 3D printed mask.

 “This was an incredibly accelerated process,” Kim said, “in large part due to collaboration, where a lot of credit goes towards our interdisciplinary team that was able to tackle this project from multiple angles simultaneously.” Within four days and with the guidance and support from Michael Yost, Ph.D., vice chairman of Research in the Department of Surgery and David Mahvi, M.D., chief of Surgical Oncology, the team was able to go from concept design to completion.

Here’s how it rolled out:

Day 1: First filtration prototype was developed; cartridge prototypes were printed. An aerosol mask was used for basic user testing. First failure during testing led to the first prototype discovery: the filter was so strong it created pressure within the mask, lifting the mask off the face. The prototype needed a simple one-way valve to release the pressure.

Day 2: First test with the one-way valve. While the cartridge provided adequate filtration, the seal did not conform to the face so the team added a neoprene foam gasket around the mask to provide a comfortable seal between the mask and face. Simultaneously, the team was printing the 3D mask prototypes and testing printing materials that would be readily available to the community. 

Day 3: The team was able to put all of these ideas together and came up with a disposable cartridge system and a 3D printed mask, all using materials that can be found in a local hardware store. The MUSC emergency department staff tested the masks and the masks passed with flying colors.  

Day 4: The documentation phase, critical to medical device design, was started. This included the project plan, cleaning instructions, and legal documentation. Further testing was done at the request of the FDA. All tests were passed and they submitted for FDA emergency use authorization. The team also created a humanitarian use license that allowed them to get the product out to the community while also protecting the design.

Once the plans were completed, MUSC created a press release on the masks, a website was built where the design plans were hosted, and the information was also disseminated through social media.

The impact was great. Within a week, the article posted to the website received 45 percent of all web traffic in the MUSC news center, with over 92,000 visits coming to the website specifically for the information. The article was shared over 2,000 times in social media platforms, and the team has been contacted by the U.S. Air Force and Navy, as well as requests for the design from a hospital in Turkey and groups in the U.K., Canada, Ireland, and across the U.S.

Locally, groups all across the Lowcountry responded to the call to action to create 3D masks. Local high schools and colleges printed the masks. Most recently, MUSC received 500 3D printed masks produced by the Citadel Baker Business School headed by Dr. James Bezjian, Director of the Business Innovation Lab, using the MUSC 3D-printed design. The masks were assembled by the Charleston Historic Rotary Club, Citadel alumni, and students, and delivered with notes of gratitude written on them.

“Although we don’t know exactly how the designs are being used, it’s clear our S.A.F.E. Cartridge system and 3D mask design has had a global impact,” said Kim. “This accelerated innovative design shows the medical community how human-centered design can create a new future in medical device innovation.”