One of the positive developments to unfold during the COVID-19 pandemic has been the incredible work to meet urgent needs for medical supplies. The non-profit MasksOn.org is one such effort, and it has taken a creative approach to filling gaps in personal protective equipment (PPE) supplies, in both device design and business strategy. The project also serves as a blueprint for innovators and startups on how to innovate quickly while developing viable manufacturing and regulatory pathways to market.

“The early days of MasksOn.org were a little bit chaotic,” recounted Sanjay Vakil, executive director for MasksOn.org. Working in Boston as a senior product manager in software development at Google, he had heard about a pair of anesthesiologists working at Brigham and Women’s Hospital who were looking to adapt a snorkeling mask into a solution that could provide some sort of protection. Those doctors, Alex Stone, M.D. and Jacqueline Boehme, M.D., had emailed another Google product manager, Eugene Mann, who in turn reached out to the engineering community within Google, and that’s when Vakil decided to “jump in to figure out how to help." 

Vakil and Stone will join a few other members of the MasksOn.org team during the upcoming BIOMEDigital virtual event in the November 4 session, Heroes of Manufacturing - Boston Non-Profit Aids in Fight Against COVID-19 with Unique Reusable Face Shield. Also speaking are Devon Campbell  (Founder of Prodct as well as CPO, Head of R&D, MyBiometry) and Jon Speer  (Founder and Vice President of QA/RA, Greenlight Guru). MD+DI spoke with Vakil, Campbell, Speer, and another member of the team, Ken Block, president of Ken Block Consulting.

“One of the amazing things about this group is that it’s not a team flush with medical device engineers and experienced medical device executives,” Campbell told MD+DI. “It was an organization of people rising to the occasion, and they were from all sorts of different industries—from Google, from the CAD and drafting industry, from design teams, just all over the place. People were just helping and doing what they can during the front of the pandemic when a lot of people were in this fevered state to figure out what they can do to help and make a difference.” (To learn more about how the team members worked together, how they worked with clinicians to test their designs, how they raised donations, and what their potential plans are for the future, please check out our podcast below.)

Eventually Vakil and his initial team got to the point where they needed to bring in medical device expertise, Campbell said, particularly when it came to medical device development, regulations, and quality systems, and that’s when he got involved. Block then joined and helped the team understand FDA, CDC, and NIOSH definitions and expectations for face masks and shields and adapt its regulatory strategy to comply with an FDA EUA for face shields. “The product design didn’t change, but what changed is how we talked about it . . . and how we fit it into the regulatory environment,” Vakil told MD+DI.

Following Stone’s and Boehme's original vision, “the design is an extension of an existing full-face snorkel,” explained Vakil. “The full face snorkel . . . consists of a piece that covers you from the top of your forehead to underneath your chin, and that entire section is clear. To help you breathe, it has a snorkel that sticks out the back—you look like an giant underwater unicorn with your horn facing the wrong way.” Such snorkeling masks are designed to be air and watertight, with a removable snorkel sealed with a pressure-fit O-ring. “What we did is we removed the snorkel and made an adapter that fit onto the same port as the snorkel and took advantage of the same geometry, the same O-ring, and the same fitting capabilities, and narrowed the port down to fit an anesthesiology or circuit tube filter. . . So rather than breathing in and out of a snorkel, you are breathing through the filtered mechanism through these circuit filters.” They also blocked the mask’s original purge valve near the chin, “so the only way air gets in and out through the mask—in or out of the clinician—is through the filtered port.”

Clinicians tested out designs after working long shifts, and Vakil said some even wore them while working out. They provided feedback on designs via email and Slack. “It was a remarkably efficient iteration process, as we used 3D printed versions of the adapters to tweak the design to their satisfaction,” he said. (To hear more about how clinicians participated in the iteration process, listen to our podcast.)

Development unfolded at amazing speeds, which Campbell compared to doing “software sprints in a matter of hours rather than weeks.” Vakil agreed, also comparing development to the “rapid iteration” commonly seen in software.

Not knowing any of the obstacles and barriers a traditional medical device company might face was to the team’s benefit, Speer said, “because they didn’t let them get in their way and then they knew when to bring in people like Devon, Ken, and myself to help make sure everything was on the straight and narrow and on the right path. . . “

After settling on a design, the team turned assembly work over to Lightspeed Manufacturing, which specialized in rebuilding computers for the aviation industry. Interestingly, a member of Lightspeed’s team used to be the supply manager at Dartmouth Hitchcock Hospital and was familiar with hospital supply needs, so he “put himself right in the middle of the manufacturing line and ended up doing the quality check for every mask before it went out because it was important to him to get it right,” Vakil said.

Despite being a newcomer to medical device assembly, Lightspeed proved to be a valuable partner. “The most important decision an emerging company can make or break a company in the long run is picking a great manufacturing partner,” said Campbell.

Another amazing feat is that the MasksOn.org team funded their work entirely through donations and in turn has been donating face shields to clinicians who don’t have access to PPE. As of October 27, MasksOn.org has donated more than 33,000 face shields providing more than 2.3 million clinician-days of protection for those who don’t have access to PPE.

Donations to MasksOn.org have slowed, however, as PPE shortages haven’t been making headlines as much as they did earlier in the pandemic. “But the need is still there,” said Campbell. He says the team is now focused on answering this question: “How can we continue our mission of protecting clinicians even in an environment where we’re not necessarily getting the funding that we were getting toward the beginning of the pandemic to be able to keep meeting that need. One of the ideas we’ve been exploring is [whether] there a manufacturer out there that has the bandwidth, has the capacity, is already involved in this value chain somewhere that could take it over . . . and continue forward with an engaged partner.” (Listen to the podcast for insights on how the team has readied MasksOn.org for such a transition.)

For more insights from the MasksOn.org team and to hear Dr. Stone's perspective, please attend the November 4 BIOMEDigital session, Heroes of Manufacturing - Boston Non-Profit Aids in Fight Against COVID-19 with Unique Reusable Face Shield, and check out the MD+DI podcast for lessons learned from the team. Dr. Boehme also explains the orgin of the idea in this video https://youtu.be/h-YVNhV5NnY.