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FastTraCS is a small group of biomedical engineers who support UNC Health physicians, nurses and staff by identifying problems in clinical settings and creating innovative, technological solutions.

Like millions of people across the country, Devin Hubbard is working from home. The new, makeshift office he has set up in his living room includes the usual items: a small desk, a Mac computer, and pages of notes. But he also has equipment and supplies more likely to be found in a research lab: pieces of medical grade materials, mask prototypes, and a certified, quantitative fit test machine for N95 masks.

As an engineer at the UNC/NC State Joint Department of Biomedical Engineering (BME), Hubbard is accustomed to dealing with unique challenges. But he never imagined he would face some of the biggest challenges of his career from his living room, in the midst of a pandemic.

While his 10-month-old daughter naps in the next room, Hubbard fires up the fit test machine. He straps a mask prototype onto his face while the machine instructs him to “breathe normally.” For the next 15 minutes, Hubbard will run through a series of exercises – bending over, turning his head side to side, and breathing deeply.

As the test finishes, Hubbard hears his daughter waking up from her nap. His wife, a physician at Duke, won’t be home for another eight hours. During that time, Hubbard will juggle responding to dozens of emails and phone calls, participating in Zoom meetings with colleagues, teaching a capstone medical device design course online, and making adjustments to mask prototypes.

And he has been doing this all day every day for over a month.

Coming Together

On the other side of Chapel Hill, Nicole Wiley signs into a Zoom meeting. Hubbard appears on the screen, and holds up his most recent mask design, fresh from one of the 3D printers in his garage.

Wiley and Hubbard work together at FastTraCS, a small team of biomedical professionals within the North Carolina Translational and Clinical Sciences (NC TraCS) Institute at the University of North Carolina at Chapel Hill. The mission of FastTraCS is to harness engineering expertise and resources to create medical devices and diagnostic tools for UNC Health.

As the first reports of COVID-19 in the U.S. started to trickle out in late February and early March, the FastTraCS team was busy working on prototype projects related to OBGYN, Otolaryngology (ENT), and Gastroenterology.

On March 12th, the team came together for their usual weekly meeting, but instead of discussing prototypes they had been working on, they started talking about an entirely new challenge.

“We were all thinking about this one big question,” says Andrew Kant, Assistant Director of FastTraCS. “Should we totally shift our efforts to COVID-19 response?”

Three days later, the decision was official. The team put a hold on all their current projects in order to turn their full attention to supporting UNC Medical Center during the pandemic.

Full Speed Ahead

On March 18th, Paul Dayton, chair of BME, sent an email to all of his faculty members. The subject line was “Masks”.

If any faculty have expertise in technology that could be used as masks – or can suggest people to talk to that might have technology ideas for alternative mask products, please contact me directly.

Hubbard responded immediately: Our team over at FastTraCS is presently looking into this, he wrote.

Less than a minute later, Dayton emailed him back: Excellent, thanks Devin. This is a real crisis situation, and the Hospital has reached out to BME to help solve this. Please go full speed ahead on coming up with engineering solutions quickly.

Working under clear directives from Carol Lewis, Vice President of the Center for Health Innovation, Dayton, Hubbard, and many others jumped into action.

“In the BME department, we live to apply engineering to solve problems in medicine – and here are some urgent problems that need to be solved,” Dayton says. “We got that call from Carol, I started coordinating with Devin and his team immediately, and we had prototypes of masks within a week.”

“The idea was to attack the Personal Protective Equipment (PPE) shortage from every possible angle and explore every nook and cranny,” Hubbard says.

Dayton helped spearhead an effort to round up spare PPE from shuttered research labs on campus. FastTraCS team members Nicole Wiley and Emiley Joyce started working on crafting masks for pediatric patients. Hubbard began looking at how to generate an alternative to an N95 mask.

A New N95

Amidst the hundreds of emails that flooded Hubbard’s inbox during the second week of March, he received one from Ethan Smith, an undergraduate BME student. He had a question for Hubbard about a potential glaucoma research project.

Though he is only a sophomore, Smith is highly proficiency in CAD (Computer-Aided Modeling), the standard professional software used by biomedical engineers for design and simulation of new medical devices — exactly the skillset Hubbard was looking for at that time.

“I have another problem that requires urgent attention,” he told Smith. “Would you be willing to work on a new design for an N95 mask?”

As PPE shortages have made headlines across the country, engineers like Hubbard have worked diligently to come up with alternatives. But the designs for these types of masks are generally not public information, and the materials are not widely available.

“We’re not trying to reinvent the N95 mask,” Hubbard says. “What we come up with is not meant to be a first-line replacement—but this could provide a decent backup plan if the hospital runs out of everything else.”

Just two days after Hubbard asked about his interest, Smith sent him a design. For the filter, Smith utilized non-woven material produced by Behnam Pourdeyhimi and his team at the Nonwovens Institute at North Carolina State University. To create the mask frame, Smith used CAD to generate a shape that can be properly fitted to different faces.

Dealing with variation in human faces turned out to be the most difficult part of the process, according to Smith.

“We’re making a product that goes on a face, yet everyone’s face is different,” he says. “We have to figure out where the greatest amounts of variation exist – around the nose, and cheeks – and make adjustments for that.”

Over dozens of Zoom meetings, Smith showed various iterations of the 3D printed mask to the FastTraCS team. Hubbard and Wiley provided feedback, posing questions about materials, mechanisms and logistics.

“We have to think about how will the clinician put this on his or her face? What is the quickest way?” Wiley says. “Do we want the mask to be single-use? How can they take it off without contaminating themselves? Will it be individually packaged? Will it come out of autoclave?”

It takes anywhere from one to five hours to print each prototype. After spending hundreds of hours making design adjustments and printing dozens of masks, Smith remained energetic and eager to help.

“This is why I came to Carolina,” he says. “But I never thought I’d have this type of opportunity as a sophomore in college. It really is incredible. The potential to help just one person – even just one medical professional – that’s why I want this to be my career.”

Good Teamwork

The row of 3D printers sitting in Hubbard’s garage symbolize the collaborative nature of this monumental effort: he borrowed one printer from his research lab, another one from the BME department, and a third from FastTraCS.

Likewise, the N95 fit test machine in Hubbard’s living room wouldn’t be there if it weren’t for the fast-acting leadership at UNC.

After a team of people at the NC governor’s office found a company that rents fit test machines, they reached out to Carol Lewis. She connected them with Hubbard, who was able to secure funding from FastTraCS. “It was on my doorstep within 24 hours,” Hubbard says.

Even with a house full of cutting-edge equipment, Hubbard knows he wouldn’t have made nearly as much progress over the past month without such a hard-working, committed team.

“We’re a small team of five, and we’ve only been together for about a year, but it feels like we’ve worked together for 20 years,” Wiley says. “Even though it’s hectic, it’s really seamless. The positivity is really high. It makes working in a crisis like this actually less stressful.”

Laser Focus

Late one night, after another long day, Hubbard is on the phone. Again. This time he is talking to an anesthesiologist at UNC who also happens to be a close friend.

“Anesthesiologists are one of the providers at highest risk because they’re putting people on ventilators and intubating them,” Hubbard explains. “Inserting an endotracheal tube through the mouth and down into the trachea puts them at a very high risk for being exposed to droplets.”

Despite his exhaustion, Hubbard listens attentively as his friend shares anxieties, as well as new ideas for fighting the virus.

“At one point he tells me about an idea he has for helping patients out,” Hubbard says. “Engineering something to make them more comfortable.”

With his plate already overflowing, Hubbard knows he and his team must stick to the task at hand: generating vital protective equipment for medical providers.

“It’s a good idea,” Hubbard tells his friend. “But I have to stay focused on saving you guys first.”

Check the NC TraCS website in the coming weeks to see the latest developments from FastTraCS in the fight against COVID-19.

Devin Hubbard, PhD; Andrew Kant, MS; and Nicole Wiley, MS are members of the FastTraCS team. Paul Dayton, PhD, FAIMBE is the interim chair of the UNC/NC State Joint Department of Biomedical Engineering. Emiley Joyce and Ethan Smith are both undergraduate students in the department. The FastTraCS team also publishes the GuideWire podcast, a behind-the-scenes peek into the world of medical device innovation and problem discovery.

NC TraCS is the integrated hub of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC that combines the research strengths, resources and opportunities of the UNC-Chapel Hill campus, partner institutions RTI International (RTI) in the Research Triangle Park, North Carolina Agricultural and Technical State University (N.C. A&T) in Greensboro, and North Carolina State University in Raleigh.