Pivoting Operations to Meet PPE Demand during Pandemic

April 14, 2021


Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.



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Some highlights of this episode include:

  • Breathe99’s mask filters 97-99% of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.
  • The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.
  • The kickstarter for the B1 mask didn’t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.
  • Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.
  • The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.
  • Alison discusses how Greenlight Guru has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.
  • The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval. 
  • Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, user needs, and why it’s important to design appropriate, safe, and effective products.




Breathe99 on Twitter

Breathe99 on Instagram

Breathe99 Email

Alison Lee’s Email

Alison Lee on LinkedIn

FDA - N95 Respirators, Surgical Masks, and Face Masks

FDA - Emergency Use Authorization (EUA)

CDC - National Institute for Occupational Safety and Health (NIOSH)

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru


Memorable Quotes from Alison Lee:

“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”

“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” 

“That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” 

“Be aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.”


Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: There are times at Greenlight Guru where I feel like I have the best job in the world, and today's one of those moments on the Global Medical Device Podcast. I get to talk to Alison Lee. Alison is the Director of Operations for a startup called Breathe99. Now Breathe99 is an interesting story, they've developed a mask to help in the current pandemic needs. And it's a great story, and it didn't start as a need for a goal of pandemic, it actually started out of a necessity for somebody who was a runner and wanted a mask to help him limit any sort of pollution as he's running in an urban environment. And so it's just interesting to see the origin story of this company and how they've pivoted and now at a point where they're making really cool product to meet a really important needs. So enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast, this is your host and founder at Greenlight Guru, Jon Speer. Pretty cool episode today we're going to dive into, we've got a lot of customers at Greenlight Guru that are, frankly, on the front lines of developing products and technologies to help during the COVID pandemic. And today I've got a great pleasure to talk with Alison Lee. Alison is the Director of Operations for Breathe99. Alison, welcome to the Global Medical Device Podcast.

Alison Lee: Thanks Jon, great to be here.

Jon Speer: All right, so for the folks that maybe don't know that much about Breathe99, I guess that might be a good place to start. What is Breathe99?

Alison Lee: Sure, in short we're a startup company based in Minneapolis that makes high-quality face mask that filters 97 to 99% of airborne particles. Can't say we're N95 certified yet, but those are the requirements that we've designed our mask around and something Greenlight's helping us to get there. So that's in short what we're doing crosstalk.

Jon Speer: All right so I guess let's talk a little bit about the journey of Breathe99. I mean, I don't know how long you've been with the company. I mean, you said it's a startup. I think it's probably been around for... I guess how long has Breathe99 been around?

Alison Lee: Well, the idea and the, I guess the prototypes, the early parts of the company, have been around for several years now. Our CEO, Max, first got the idea to make this high quality respirator-style mask when he lived in Singapore. And he's a runner, so he wanted to run, but there was often days where there was a lot of urban pollution and it wasn't really... He wasn't sure if it was healthy to go outside, but also couldn't find any kind of protection that he felt was adequate for someone in a smoggy city. So he was thinking about that in the back of his head as he finished his degree in mechanical design, started working at a design firm, and been working on the prototype of this mask that seals completely around the mouth and the nose and features high quality, breathable filters. So back before the pandemic, about two years ago now, he and a couple friends... That's really when Breathe99 was founded, I suppose. And so we launched the Kickstarter for the B1 mask, which was targeted at people who are concerned about urban pollution and wanted to be outside or needed to be, for example, commuting or cycling, running outside. And that Kickstarter didn't quite reach it's goal and so then it remained in the back of his head. But then the pandemic started pretty soon thereafter and all of a sudden there was this really obvious, really urgent, and really serious need for high quality respiratory protection. And they had already done a lot of the work in the prototyping and user testing. And so that's when we launched the Kickstarter for the B2 mask back, I guess, in April of 2020. And that's also when I joined the company to help out on the filter design side. And yeah, throughout the summer we had two successful Kickstarter campaigns, raised over$ 750,000, which really allowed us to launch the company in full. And it's more of the company that we are today.

Jon Speer: Wow. I mean, 750, 000 on Kickstarter, that's impressive. I mean, obviously, the circumstances in the world were right, too, but my goodness that's amazing. So from April until today, I mean, you've had the Kickstarter. I'm guessing you've been in production, I'm guessing your masks are available to folks, the B2 mask. Talk a little bit about what you've heard or seen or some of, I guess stories, from folks that have been using your products, if you have any.

Alison Lee: Yeah, honestly, that's what keeps us going. We love hearing about how people feel safer wearing our mask. It's allowed them to continue doing their job. And we hear from a lot of teachers, a lot of people who volunteer, who have underlying health conditions, who otherwise wouldn't feel safe interacting with the public. And they're surprisingly, to us, since we're not officially certified, but we do have quite a lot of doctors who use our mask at work. And they say that it's very comfortable compared to your typical, the N95 respirator, which are not available to them. And it just allows them to continue their job and feel a lot safer than maybe the other alternatives that were available to them, like just a surgical mask that doesn't have the proper seal.

Jon Speer: I've worked, I guess sort of tangentially, with a couple of initiatives. Slightly different products, but that also... Those that are pursuing the EUA with FDA and then also explore N95 with... Hang on, I forgot the organization.

Alison Lee: NIOSH?

Jon Speer: NIOSH, yeah, it was on the tip of my tongue.

Alison Lee: There's a lot of acronyms in the industry.

Jon Speer: totally is. But the whole NIOSH thing is, it's a completely different path and process from dealing with the FDA. I guess I'm curious, is that something that's still on the horizon or something that you're still pursuing at Breathe99?

Alison Lee: Yeah, it's definitely something we're planning for. And I'd say NIOSH is probably even the more relevant one for us to be able to call ourselves a respirator, an N95 respirator. We're a team of six people, two of us have engineering backgrounds and medical adjacent experience, but none of us have gone through a regulatory approval of a product before. So I'd say in the beginning, we were maybe a bit optimistic about how straightforward the process might be, but definitely as we've been documenting our user needs more and exploring what all of the detailed testing and requirements would be, we've realized it is quite a longer term path that now we've been able to plan properly for and realistically for. So it's definitely on the horizon, that that stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product, to enter certain medical networks. So definitely, but at the same time we know that right now, even without it, there's a lot of people who can really, greatly benefit from our mask. And actually what we've done in lieu of knowing that we're not going to get the NIOSH certification, that we weren't going to get it back in 2020, in the summer, we have done independent testing with the University of Minnesota. And we've published those results in a white paper so that, at the very least, if someone is more scientifically minded and familiar with regulations, they can go look up that white paper and make a call for themselves if they feel comfortable using our product.

Jon Speer: Sure, yeah, that makes a lot of sense. Folks, I want to remind you, I'm talking with Alison Lee. Alison is the Director of Operations for Breathe99 and you can learn a ton more about their product by going to Breath99, and the 99 is 9- 9, the number, dot com. So B- R- E- A- T- H- E99. com. And, man, the website is super informative, there's some blog posts, there's ways to learn more about the product and fit, and all that sort of things. So really, I encourage you all to check that out. Also wanted to start talking a little bit, Alison, about your Greenlight experience. And I guess before we do so, I want to remind folks that Greenlight Guru, we're here to help. Whether you're developing a product to help with the pandemic or another medical device for other purposes, we're here. And I would encourage you to go to www.greenlight.guru to learn more about the medical device quality management system software platform, the only one in the market today, designed specifically and only for the medical device industry by actual medical device professionals. So if you're interested in learning more about how our workflows and our team and our products and services can help you streamline your practices and ensure compliance along the way. Then again, I would encourage you to go to www.greenlight.guru to learn more. All right, so Alison you talked a little bit about being a small team, a couple with some engineering backgrounds or adjacent types of disciplines. How many of you have been through the medical device process before?

Alison Lee: So none of us have worked directly on a product that's gone through medical device certification, but Max, our CEO, worked at a mechanical design firm for many years that worked on some medical products. So he's been around that process. And myself, the other engineer... In a previous life, I worked at a startup that was part of the electronic signature process for manufacturing regulated devices and pharmaceuticals. So I became pretty familiar with the electronic signature regulation and the fact that the regulatory environment. But none of us have gone through it directly with a product that we've created. So it's been a learning process.

Jon Speer: Well for sure and I'm glad that you're going through this. I guess what I'm curious a little bit about is, if you can share some of your experiences on how Greenlight has been a resource for you and the team during your journey to bring the B2 masks to market.

Alison Lee: Sure, yeah. We really appreciate all of the resources that Greenlight has available online, especially breaking down all the contents of the design history file. We're still defining our user needs and all the design inputs and just seeing the full picture of how that's going to come together. And being able to plan for what needs to link to what, and it's just helped us lay things out, because it's so complicated. And there's many ways that one might go about documenting all these things, but the fact that, just being able to link things and not getting lost in folders upon folders upon folders. That peace of mind has been really great for us and it's allowed us to go step-by-step at the pace we need.

Jon Speer: Good. What have you found to be, I guess, most challenging in navigating the overall design and development process?

Alison Lee: I think that the fact that most of our teammates have not worked on a regulatory product. There's a lot of checks and balances that, if you're not a medical device, that you don't have to take into account. Like the change order process, for example, just there's... You have to train people on the change order process, but you also have to first teach them why it needs to exist. It seems very bureaucratic and it takes a lot of time, so that's been... You have to learn why you're learning it, almost. So it's another layer to introduce our team, to change their frame of mind.

Jon Speer: Yeah. I mean, I hear this often from startups is, when you're new to med device, I mean, it feels like... And I know you didn't exactly say this, but sometimes a little more burdensome than it needs to be. But at the same time, I mean, I have to imagine that the team very much understands the mission of Breathe99 and the purpose of your products. And so I would imagine that understanding the importance of a product being designed appropriately and safe and effective that that helps connect the dots, so to speak. I guess, what do you think is, if you were giving advice to another startup who is thinking about pursuing their medical device journey, do you have any tips or pointers for them?

Alison Lee: I guess just find out as early as you can everything it's going to take, start plotting out your user needs, and if you don't already know your users and their environment intimately, as soon as you can, go and talk to real people and find out just the entire scope of how your product is going to be used. Because for us, we're up for masks, so it's obvious to think about the person wearing the mask. But when that person is a doctor or a nurse at a hospital, and they're wearing that mask that has been given to them by their employer, there's all of these other factors to consider. Who makes these purchasing decisions in the hospital? Who distributes and trains their employees? There is a reusable portion of a product, of our mask, there's a fabric part and then a flexible plastic part, how might that get cleaned? What are laundering processes in the hospital environment? So there's a lot of, just be aware of your scope. And you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought that the regulatory process would be a lot faster. Maybe six months or something, we'll complete the paperwork. Not having done it before. And I think, the more we peeled the layers of the onion, so to speak, we realized there was a lot more to discover before we could go ahead and even apply.

Jon Speer: Yeah. There's a couple of things I want to, I guess, dive a little deeper in on that last little bit that you shared. Let's first talk about the user needs side of things. I think that's really important and I think it's a great tip for those listening. I think a lot of times we maybe don't give the user needs the time, effort, and energy that they deserve. But I have to imagine with your product, I mean, you said the founder, his first inspiration was to have a mask in an urban, polluted environment, so he could go running. But then you had to pivot with COVID to build a different kind of mask. Were the user needs the same? Were they different? How did that all go?

Alison Lee: Yeah, so I mean, and this is where you really have to talk to your users, because I mean, the functional needs are basically the same. The seal and the filters have to perform, to a certain size particle, to a certain percentage. But the way people are thinking about this product and the degree to which they need it to be, they need to feel the seal is a 100% and they need to understand, and emotionally feel, like it's protecting them. Even though not all of our users are science or engineer type people. And there's just, in the context of the pandemic, the context in which they're using our product, it's just mask overload in the media. And it's really hard for someone who's never thought about masks or respiratory protection to figure out what they need. And there's a lot of misinformation as well and conflicting advice, so we have to take that into account as well when thinking about our users in the context of a pandemic. Is that there's all these heightened emotions and that's all part of their experience. And that could affect, for example, the degree to which they read our instructions. How frustrated or not they may become if they don't understand how to assemble a certain part of our mask. And even in the customer support process, just feeling confident in our company makes someone feel confident when they're wearing our masks. And so there's this whole other layer during the pandemic that's very, very different than just selling something that'll protect you while you cycle to work.

Jon Speer: The other thing I want to explore a little bit is your discovery about the regulatory process maybe being a little longer and more tortuous and challenging than maybe you first thought. And I think that's a common thing. I mean, over my career, I've worked with inventors and entrepreneurs, and a lot of times at the beginning of that journey with them, they already have a prototype that's pretty far along. And, granted, they may not always have design controls documented or the risk and that sort of thing, but the product essentially works. Or it's pretty close to being a production version, if you will. And then I have been the bearer of bad news from time to time as like," Oh, well, this is a class two device, this is going to require this submission and that sort of thing, and it's going to take another six, nine, 12 months before we get there." And that could be a little frustrating. So I guess talk a little bit about that, once the team discovered that," Oh, wow, this regulatory side of thing is a little bit more complicated and lengthy than we thought." I imagine that that could have been a little discouraging, so talk a little bit about that roller coaster.

Alison Lee: Yeah, it is, I guess, a little bit discouraging at first. And most of all, it hard to message to our followers, our customers, especially our crowdfunding backers, who also don't come from a med device background. You might think it's as straightforward as, well how much does it cost and how long does it take them to process your application? And to explain why we actually need to do more work in the design stage and possibly do some redesigns before submitting our product, a medical version of our product. Without getting into too much detail, it's hard to justify why we seem to be taking so long. But on the flip side, we have, because of the pandemic and talking to our users, there are a lot of really great use cases for our masks that don't require the NIOSH approval. So we've been able to find plenty of good uses for our mask in the meantime. And, yeah, while we do the proper diligence and reset our expectations beyond that yeah.

Jon Speer: Breathe99, did you go the EUA route?

Alison Lee: No, so in the end-

Jon Speer: And I guess, let me clarify for folks, EUA stands for Emergency Use Authorization. It's a provision that is part of FDA for times of need, like we're in right now, from a pandemic perspective. And it's a different path to get some level of regulatory approval for products that meet the global need. So anyway, I interrupted you, but why was EUA not necessarily a path that made sense?

Alison Lee: Yeah. So this is, again, from other feedback we got from our crowdfunding backers who are the first users to get our mask. There's a few foundational things that we want to change about our mask before we put it forward as the med version. The big thing is sizing. we noted that our mask is designed as a one size fits most mask. And we've found that it fits typically people whose faces are on the smaller side or who are tolerant of... It's quite a compact mask, which is part of the design, that it's not this huge thing on your face. But some people do have a preference for a mask that feels very roomy and large. So we would like to do a bit more work and research on the sizing before submitting for any kind of regulatory approval, even in EUA, just so that it can fit a wide enough portion of the population. And in doing that, we're also realizing just how difficult a challenge it is to fit around the nose and mouth area of the human face, and just how varied the geometries are between people. So we're working with this lab at the University of Minnesota, called the Human Dimensioning Lab. And that's pretty much what they said is, of all of the human dimension problems to solve for things that are worn by humans, wearing something on your face that needs to seal around the nose area is the number one challenge. So that's why we want to take our time and do it properly and offer something that'll fit a wide range of people.

Jon Speer: Yeah, so you're just being very deliberate about the entire process, it makes a lot of sense.

Alison Lee: Yeah.

Jon Speer: All right. Well, Alison, as we wrap up our conversation today, any other tips, pointers, message that you want the listeners to hear before we call today's episode a wrap?

Alison Lee: Yeah, I guess we're optimistic now that... We've noticed lately, last couple of weeks, there's been a renewed media attention on the need to wear a mask. And I guess the current advice seems to be double masking, but I think that's going to... We're trying to push the conversation further in that, just wearing two masks is not necessarily better, or it's not better by a lot. And there's been a huge call for a mask that actually is better. And we think we're working towards that and we understand what those requirements are. So we're looking forward to talking to policy makers, we're looking for investment in our company to help us go forward with design changes and regulatory approvals. So, yeah, we're optimistic about how this year is going to go and develop, because we feel like we're reaching a turning point in the public understanding and awareness of masks and regulatory protections. So we look forward to being leaders in that space and to being part of the solution and to hopefully end this pandemic sooner rather than later.

Jon Speer: Okay. And Alison, if folks want to help Breathe99, or learn more about your venture and your products and your path, how do you suggest they get a hold of you? Do they just go to the Breathe99 website and fill out a contact form? Or is there some other way that makes more sense?

Alison Lee: Yeah, you can always email us hello @ breathe99. And actually, if you're listening to this podcast you can just email me, Alison, A- L- I- S- O- N @ breathe99. com. Or we're on social media too, you can tweet at us, follow us on Instagram. Yeah, it's not too hard to get in touch with us.

Jon Speer: All right folks, exciting company and a really cool product. I mean, this is a compliment, it's a very simple design. And I think that's what's important about a lot of products these days is, simple oftentimes does mean better, because... Some of the things that Alison shared with us a little bit earlier, sometimes you get into certain product spaces or certain environments or circumstances and situations, and maybe stress levels are high or people are frustrated about other things. So if they can instantly see your product and understand how it works, and it's just intuitive, it's just going to be a better design. So take that to heart. I want to thank Allison Lee-

Alison Lee: Definitely.

Jon Speer: Yeah, absolutely. I want to thank Alison Lee. Alison is the Director of Operations for Breathe99. Again, check it out, breathe99. com to learn a whole bunch more about their products, it's really cool. And again, thank you all so much for being loyal listeners of the Global Medical Device Podcast, the number one podcast in the medical device industry today. Continue to share this with your friends and colleagues, and of course, if you're so compelled, I would also encourage you to go to www. greenlight.guru to learn, again, about the medical device quality management systems software platform that we have had in the market for... Man, it's been, I think, six years now. So, crazy times, but we're working with companies like Breathe99 and others all over the world who are making a difference and improving the quality of life. So again, go check that out. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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