A local hospital called a Seattle makerspace to ask if anyone could help out to provide them with masks and visors. A bit of a scramble ensued to figure out who could do what.  Rory Larson, a maker with a mechanical engineering background, jumped in and spent the night iterating on a design. “So I kind of took the football and ran with it,” Rory told me. “In a night I produced my first (3D printed) maker mask.”

After working until 5 or 6am into Friday morning, Rory called his Dad to say: “Hey, look what I made.”  His father, Garr Larson, a tech entrepreneur, thought it was interesting enough to reach out to his network, including a family friend, Jonathan Roberts, another entrepreneur. “Rory was insistent that the design is open source and free to everybody,” said Garr Larson. Together, they set to work and all three of them saw the need to get it tested by health care professionals.

Rory Larson and his father, Garr.

The design was for a respirator mask.  “I wanted to address a more complex version of the standard masks that I was seeing,” he said. Rory explained that with a standard respirator mask, an exhaled breath exits the front of the mask and an inhaled breath comes in from the sides, which doesn’t dirty the filters as fast. While Rory had worked in labs and had a technical background, he felt he could understand how his mask needed to fit and what it needed to do.  The most technical challenge, he said, was making his design easy to print on a wide range of printers.

The mask is designed to use HEPA filters. “They can quickly remove the filters, put new cup filters in there, sterilize and clean and reuse the thing versus throwing them away,” said Garr.

3D model of Maker Mask

Exploded view of Maker Mask

Through a prior relationship with the Seattle Children’s Hospital, they reached out to Dr. Xuan Qin in the Microbiology Lab.  She told them that the hospital was low on masks and in a later call, she said they were out of masks. Jonathan and Garr arranged to have a mask delivered on Saturday morning.  Dr. Xuan Qin in the Microbiology Lab tested the mask, showed it to her staff and gave them a thumbs-up.

“They honestly just loved it,” said Garr. “This is fantastic. It’s reusable and takes much less filter material, which is really the hard thing to find.”  Dr. Qin said in her lab alone they would go five N95 masks a day. “That’s five times a day through two months,” said Jonathan “Over 300 masks were going to be needed.”

They created a small batch production facility in Epiphany Episcopal parish in the Madrona neighborhood of east central Seattle. A bunch of college students, having returned home, are working as interns and sleeping in the lab, which is in the upstairs of the Episcopal church. “We hope to be producing at scale,” said Jonathan, who said they are debating the actual number. “We could have a thousand a week run rate of masks coming out of that facility,” he said adding, but they may say 800.” Depending on the printer being used, the print time is somewhere between 3 and 5 hours.

I asked where the printers came from. Rory said that they came from the makerspaces in local schools. While the makeshift lab mix of printers, Ultimaker is the printer performing the best for them and old Makerbots not so well.  Garr said that Rory is also working on speeding up the print process. They’re quickly making files for the different levels of printers and carefully adjusting the printer specifications.

In my interview with the team, Garr and Jonathan clarified that the mask wasn’t intended for doctors working directly with patients.  “Because it is all plastic, it is thicker and it muffles sound,” said Garr. “It is for non-patient facing jobs, for clinicians, not for ER doctors, and beyond that also policemen and firemen, grocery workers, Amazon delivery workers.”

The Maker Mask team reached out to the Seattle Veterans Medical Center, and through the VA, they learned that a group of 3D printing experts in government had formed a new inter-agency group consisting of the FDA, NIH and the VA.

In showing the mask design to members of the group, they had a positive reaction but no official approval. The Maker Mask sent out an overeager press release that stated that the Maker Mask was the “first medically approved” mask but dialed it back by saying it was “medically reviewed.” When questioned about it, they said that they meant that Maker Mask had Dr. Qin’s approval, not the NIH, and in her lab, not the entire hospital.

Nonetheless, they did all the legwork to try and get some kind approval. Garr and Jonathan had access to people within government who would talk to them and who listened, understanding the urgency of the situation.  They aggressively sought some kind of approval. Maker Mask is now listed on the new NIH 3D Print Exchange as “under review.” It is not approved for use in healthcare.

This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment. …This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects.(NIH site)

The problem is with the PLA material used in 3D printing, not necessarily a fault of the design.  Garr Larson confirmed that the review points out that using PLA is an issue. It is not clear if the official position of NIH is that PLA has not been tested and is an unknown risk or whether it will approve any 3D printer mask projects that typically use an FDM process. (It is inevitable that government agencies will be more cautious with approvals, lagging behind the reality and urgency of the pandemic.)  Garr is continuing to work with people in various agencies, including a call until 2am this week. Meanwhile, the team believes that Maker Mask remains valuable for workers in essential services.  Inevitably, by sharing it openly, the Maker Mask will find its way into medical situations once the supplies of approved masks are no longer available. They see amazing community support with over 40,000 downloads of the design over the past weekend.

I asked them what’s next.  Jonathan said that they are thinking of a “franchise model of this small batch production.” They are thinking through all the elements to efficiently and cleanly operate the facility, that is, how to build teams, turn it into an operation and schedule the teams to do the work and operate in multiple distributed locations. “Can we operate 24 hours a day,” he asked “but have the long print jobs run at night so kids can go home and go to sleep?”  Rory described “creating a system that also optimizes the workflow of the cadence of each printer, so that way there’s no downtime.”

Rory has already done a number of training videos. “We’ll continue to do training videos,” said Jonathan “so that if you’re launching your own facility, you can come watch that stuff and learn from us.”

Rory gave a walking tour with his laptop of the makeshift lab facility in an Episcopal church, filled with 3D printers sourced from local schools and some mattresses for college students to sleep while the masks take shape.  “It’s the wild spirit of hobbyists,” said Garr.

 

Facility images and 3D renderings provided by Maker Mask.  Visit makermask.com to learn more.