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Speaker 1: From the campus of Harvard Medical School, this is Think Research, a podcast devoted to the stories behind clinical research. I'm [? abi. ?]

Brendan: And I'm Brendan. And we are your hosts. Think Research is brought to you by Harvard Catalyst, Harvard University's Clinical and Translational Science Center.

Speaker 1: And by NCATS, the National Center for Advancing Translational Sciences.

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Brendan: At the start of the COVID-19 pandemic, ventilators were a critical tool that suddenly became scarce. Engineer Jim Richards saw a need and got to work. He and his colleague Tyler Dailey set out to build a low-cost ventilator that could fill the need of hospitals overwhelmed by patients who were dying because of a lack of oxygen.

Together with pulmonologist Keith Romano of Brigham and Women's Hospital, they created the AeroBreath, a ventilator that can operate electronically or manually and costs less than $100. The AeroBreath has the potential to dramatically improve oxygen delivery in hospitals and clinics.

Thank you all for joining us, Dr. Romano. And I'm here with Jim Richards and Tyler Dailey, who were also collaborators on the AeroBreath. Before we get into what the AeroBreath is, could each of you just give us a short intro to yourselves?

Keith Romano: Sure. So I'm Keith Romano. I am a pulmonologist and critical care intensivist in the Division of Pulmonary Medicine at the Brigham and Women's Hospital in Boston, and also a research fellow, and have a PhD background in biochemistry and molecular genetics and chemical biology lab at Mass General within the Mass General Brigham system.

Jim Richards: I'm Jim Richards. I'm an engineer and partner at Aerodyme Corporation. Have an MIT '77 EE, and a couple of careers. One in consumer electronics, but then the last 20 years in aerospace.

Tyler Dailey: I'm Tyler Dailey. I'm a mechanical engineer at Aerodyme, and on the AeroBreath Project I did a lot of the design work testing.

Brendan: So the AeroBreath is a low-cost ventilator that the three of you developed. Tell us about the problem that you saw during the pandemic. There was a lot of stories about how ventilators were in short supply, and people were trying to build ventilators. What was the problem that you saw and how did you try to solve it?

Keith Romano: I can comment a little bit on what we saw. I think we all saw it. I don't think you have to have a degree in medicine to-- we all kind of had witnessed what was going on, which was we were facing this global pandemic. It was certainly coming our way. We had limited information about what was going on overseas in China.

And at the time, around March of 2020, there was quite a crunch in Italy as well. So developed countries with good health care infrastructure were having basically waves of patients come in and overwhelming their hospital systems. And so immediately I think a lot of people, both engineers and physicians, public health experts, were all concerned about the number of ventilators that we had to support patients as we were facing this crunch.

And so I think there was an initiative worldwide to check our stockpiles. Hospital systems were bracing for impact basically. And there was a very real possibility even in our own system within Mass General Brigham that the number of patients who were soon to be coming to the hospital would soon outstrip our capacity to care for them.

And I'll let Jim talk from his perspective, because Jim was the one who with this information really had the motivation to do something about it, with his background in aeroscience and in engineering. So this laid the groundwork for what would soon be a serendipitous collaboration that lasted for, I would say, over a year.

Jim Richards: One of my first reactions on behalf of my family was to check as to whether there were any ventilators actually still available. And I did find a ventilator, a Philips Respironics 102b, that was available on eBay, as I recall. It was a used unit. No guarantees made. It was about 20 years old. It was dated from about the year 2000. And I decided to buy it.

So shelled out cash, got that unit in here. I called up the local medical center, the UVM health center, and said, hey, I've got this unit over here. And if you need it, you can have it. But I said, we've brought it in to help us understand what this challenge might be like.

Brendan: Tell us a little bit more about how your meeting happened. Jim, did you start working with Tyler, and then you got connected with Keith? Is how that happened?

Jim Richards: Well, Tyler and I were both here at Aerodyme time at the time, engaged in our ordinary aerospace business day-to-day. And then as the restrictions began to go into place, it got down to just the two of us and one other individual here. And we were able to continue a certain amount of our aerospace activity during that very tight time.

But it gave us the space and the time, the tools and so forth, which were all around us, to create mechanical devices and test them and engineer them and so forth. And so we began to spend a fair amount of time on this prototype.

And we really hadn't talked about it much out of the family, really, when the connection occurred with Keith. And that was through one of my daughters. Also an MIT grad, it turned out. And she through the MIT forum connected with Keith. You take it from here. Do you remember the--

Keith Romano: Yeah. So this is actually a pretty funny story because Jim, I don't think you're pretty active on social media. And I'm certainly not active on social media.

Jim Richards: No. [laughs]

Keith Romano: But I think during the pandemic, especially in the early days, there was a lot of nervous energy on my part when not working COVID- related shifts. There wasn't the normal jobs that we would typically work during the day. It was largely lockdown, down trying to protect your families.

And it was really, really kind of funny, actually, because I was not spending any time on social media. Jim was not spending time on social media. But it was Jim's daughter and my wife who both are connected on social media through an MIT connection, both being alumni of MIT.

The first call between Jim and I that I got set up, my wife came running in, being like, they're looking for a pulmonologist. Someone's looking for a pulmonologist to talk to. And I'm like, I'll do it. I'll do it. So I get Jim's number and we call. And we have this back-and-forth conversation, which Jim is actually good at recounting.

Jim Richards: I think Keith and I were 45 minutes of a 50-minute conversation, working the problem up until the patient was in the ICU, trying to understand, could simple technology help? Could a relatively inexpensive and highly producible unit help in that on-ramp that ultimately might end up in the ICU for some patients? And we were having some difficulty finding an affirmation there in our discussion.

But then somehow there was that moment where Keith or I, somebody just tipped it in such a way to begin in the conversation, talking about what happens from then on out. And Keith then began to talk about the loading, the fact that you had to deal with the patients all the way through to their ultimate recovery. And even when they might be able to be discharged from the ICU, they might still need ventilation, and had to go with them, in effect.

And one of his biggest problems at the time-- or worries-- was that any patient exiting the ICU was going to take one of Keith's sophisticated ventilators with he or she into the recovery area. And you might not get it back for three or four weeks. And so then we began to see that part of the problem. And I think rapidly concluded within another five minutes of conversation that, yes, much lower-cost-- drastically lower-cost, drastically simpler technology very likely could help with that part of the overall situation.

Keith Romano: I think a real important concept to get out up front is at the time, there were people who were making very basic-- what we call bag-squeezers. You might want to call it a respirator. And these were not very sophisticated devices. Just think of a person squeezing a bag, and getting a machine to do it, getting some sort of a motor to do it for you, but not very sophisticated.

So you can't breathe comfortably as an awake patient with a bag-squeezer-type device because you can't control when you get a breath and when you don't get a breath. It's just going to give it to you when it's programmed to give it to you. A lot of people were shifting towards that kind of a solution. So that if there wasn't a ventilator available, people could be sedated, sometimes even paralyzed, and put on bag-squeezers just as a temporizing measure.

What Jim and I were struggling with is I was watching hospital systems that didn't necessarily just need that. You could imagine a situation where, if you have too many patients coming in, they can't all go on bag-squeezers. You're going to be getting a line of people on bag-squeezers going out the door.

So the eureka moment we had is to try to add functionality at a low cost so that you liberate the hospital system using this type of a ventilator to now also use it in an awake and breathing patient. So it could be a weaning ventilator. So when patients are getting better, and they don't need the state of the art ventilator anymore that we typically have on the floors and in the ICUs, you could transition to this affordable alternative that could also be used to help patients wean. They're not quite ready to come off the ventilator, but we can put them on it as they're getting better, and we're not expecting them to get worse.

Brendan: So Tyler, tell us-- why don't we pick back up with you and what your experience was in the development process.

Tyler Dailey: As Jim said, we looked at it over an afternoon just to get an idea as to what it actually does and what sort of features it had. And we started to come up with our own ideas as to how that could be done more inexpensively. Ventilators are sophisticated air pumps, basically. So we came up with our own air pump, in effect. And once we tested that out, we started to add some of the features that the Respironics had.

Jim Richards: As we first shared with Keith, we probably had-- what, Tyler-- basically just the volume delivery. So we were reciprocating, we were delivering the breath, but it really wasn't much else, much other sophistication. And the electronics weren't present. We initially were thinking just in terms of a mechanical device to keep it absolutely simple. As simple as possible. So you could construct these in Africa, probably from relatively available materials.

Later on, with Keith's guidance, it came to have simple electronic control, and began to have, as Tyler mentioned, pressure modes, ability to sense pressure. There were safety aspects that Keith helped us engineer in. And there were also functionality aspects that meant that a patient in more trouble with breathing would be able to use it. So you're able to catch it.

And I think, Keith, at the end of it, I think we were very close to where you concluded that even emergency room use itself was not out of the question. The sophistication had come up over the development months of the AeroBreath, that we were very close to having sufficient functionality for use in an ICU, maybe in a pinch in a smaller hospital environment where they just didn't have the big gun machines available.

Keith Romano: Yeah. I think that's right. I think the trifecta of things we were looking to achieve was low-cost, full functionality, and an ease of use-- intuitive. Something just very intuitive that could be easily trained, factoring in the human resource component, that the humans need to interface with it. Not just the patient, but the providers, the respiratory therapists, the physicians, the nurses.

So that was built into the design. And I think within that idea of functionality, inherent to that was the flexibility that you could use this particular ventilator throughout the spectrum of illness. So in patients who are sick and sedated, not breathing on their own, who are effectively sleeping. And then to those who are awake and breathing, and breathing at the rate that they desire, which required a little bit more of the electronics and the controls and pressure-sensing.

Jim Richards: As these features were discussed, as Keith would inform us-- he would help us understand what we might be missing in terms of safety and in terms of functionality. And then good interplay, a good, rich interplay, between his knowledge and our knowledge as to not only what we could do, but what we could do and remain low-cost. Because certain things would seem to tip you into a lot more sophistication.

For instance, we got all the way through this right to the very end, with that high level of functionality on board, with no software involved in the product. It was still just very simple electronic control using operational amplifiers. One of my senior electives at MIT in 1977, op amps. So here we were, however many years later it was, using two or three op amps to completely implement the electronics of this thing. No microprocessor, no code, no software, none of that complexity to worry about. You might have left a few things behind because you didn't have it on board. But the simplicity you gained and the low-cost point you could hit was very important to us.

Keith Romano: Yeah. Two things worth mentioning. One, when Tyler says they looked at it, what he means is they took it apart all the way to its core components. And what I've learned over my time knowing these two is that if Jim asked me for my iPhone to look at it, I would say no, you may not have my iPhone, because you're going to take it apart and you're going to tell me how it works.

So they stripped this poor little PLV 102b down to its skivvies, and they looked at it and figured it out. But to piggyback on that, in layman's terms, the brilliance of what Jim and Tyler were able to do is a lot of people were looking forward to technology, being like, we're going to put state of the art engineering and technology into this unit. And we're going to get a new ventilator together. And a lot of that was going on simultaneously.

I think the genius of what Jim and Tyler did is they went back in time. They said, hey, we're going to take this PLV 102b Philips Respironics ventilator. Presumably, a dozen engineers worked on this for the better part of three or four years and got FDA approval and put this technology into a unit that was a standard operating ventilator in ICUs for over a decade.

So they went back to that past art, that past design, and then they said, now let's use modern technology to make it cheaper. And then layered on a few engineering bits on top that was just a beautiful design, all towards the aim of containing cost. And so that, I think, in layman's terms was the part that I appreciated about their approach, which is it's just so simple. It's just beautiful, when you think about it.

Brendan: Just for a little context. So it's December 2021. We're recording this now. What time frame did this all take place in?

Jim Richards: Does anybody have track of time? My goodness. It's scrubbed all our time machines out. We applied to the FDA for EUA, emergency use approval in March or April of 2020.

Brendan: Wow. So this happened really quickly.

Jim Richards: Yeah. Yeah. We were through the elementary formation of the design in a couple of months' time, and then continued on to look at the more subtle-- Keith spread the audience looking at it at Partners and at Brigham's. And as more people looked at it, they had more questions. And so we took up those questions. And Tyler and I would go off and brainstorm and try and understand how we could, again, stay low-cost, stay easy-to-produce, and yet maybe add an indicator or a mode or another safety provision.

But we did have papers into the FDA quite early. One of the great disappointments in the project is that the FAA-- the FDA, sorry-- aerospace-- the FDA didn't respond for nine months. And we DUNed many times, we pinged, we tried to work it through some political channels. And admittedly, they were clearly flooded. There were many other teams around the country looking at other designs and so forth.

And anyway, we didn't get our response until really outside the window. Probably the window of criticality during the initial wave of the COVID pandemic had really begun to close by the time the FAA finally-- FDA-- finally responded to us.

Brendan: Yeah. Tell us about what the status of this project is now.

Keith Romano: In this time, a lot of people were-- there was a mad dash to create ventilators to help. And some of it was goodwill, I think. Some of it was a bit self-serving. People who are adept at making ventilators could pop them together pretty quickly.

And a lot of those flooded to the FDA by means of an emergency use authorization. So with the anticipated shortage, the FDA was authorizing. And often those in the best position suited financially and otherwise to put together a ventilator that's cheaper, they're the ones who are most successful.

So I think from the beginning, Jim, Tyler, and I, we had a mantra of, we're not going to join the rat race. We can't compete with that, nor do we want to. And so I think we always had an understanding. And I certainly had an understanding of this, and I conveyed this to Jim and Tyler, that we're addressing a problem that always existed.

There might be a ventilator shortage in the United States. There certainly was one in Italy, in places in Africa, in places in the Caribbean, places in Latin America and Central America. There's no guarantee that your oxygen supply chain is going to be intact. One day it might be there, and then a mudslide might cover the road, and then you have no more oxygen to that area.

So we were very, I think, confident that we had a needs base that we were addressing, regardless of whether the pandemic fizzled out or persisted. So I think in that sense, we did collaborate and we did talk. We had early talks with a lot of the global health organizations, particularly the academic ones, like Partners in Health, to talk about what we were doing and how it might fit in a way to suit their needs. And those conversations are still ongoing.

So while we ended up not going through the EUA pathway, I think that as we speak today, the AeroBreath ventilator I think is in excellent shape from a design standpoint. I think what it's in need of is funding to propel it into a space where it can actually make an impact. I think that Jim, myself, Tyler, we all agree that it could be incredibly impactful in some of these places, both to conserve oxygen.

We did some early testing on the ventilator, pairing it with oxygen delivery devices. And we think that something like the AeroBreath could make one oxygen tank last twice as long. So that's how much oxygen we think we could save with it. So there are certainly applications that we're developing. I think at this point, we're just looking for partners.

Brendan: What has this experience taught you about collaboration or just how you think about your own work?

Jim Richards: In aerospace, and really at large, no question is a dumb question. The approaches to collaboration are very important. And I think Keith was willing to let his guard entirely down. And the same for Tyler and I. It's the way we operate in the aerospace industry. It's all open book. It has to be tremendous transparency, where we are enabling people to be thousands of feet in the air in metal boxes. And so you can't have communication blockages amongst your team members and your key contributing engineering groups and so forth.

And so that's what we brought to this from Aerodyme and from this side. That's what we brought to Keith, was a willingness. If we didn't understand something, we asked him to explain it again. We weren't embarrassed to say, Keith, we're really not getting that. What did you mean? Can you give us a different explanation of that so that we could grasp it from our experience base?

And Keith was the very same way in working with us the other way around. So that he would, again, guard down, and just tell us he didn't get something or know, whatever. So it was a willingness. I think that's very crucial to really get to the heart of collaboration, is that openness and that transparency and that understanding that no question is too dumb or anything like that.

Keith Romano: I think to put it in a slightly different way is that this was a very good collaboration. We liked each other. We could talk effectively with each other. There was no judgment, or there was no perceived animosity ever. Ever. So from the minute we spoke, I feel like the minute I met Jim and Tyler, I was like, this is going to work.

And we spent-- I don't know if this is coming across, but I mean, we spent hours and hours and hours together. Always remotely, but man, we spent a lot of time together, day and night. Jim would call me any time, and I'd pick up, and we would talk, and vice versa.

And I hope that's not just unique to us because-- but then again, it might be. I don't know. But a lot of what came out of this project is certainly a product of how the personalities meshed in a way that was very productive, in a way that was really neat and fun. And I look back very fondly on the entire time, perfectly honest.

The other thing I'll mention, what I learned is it really shows what a multidisciplinary collaborative effort can achieve. What I always say is that engineers fix problems. But in the medical space anyway, it's the clinician, the provider, the person with the clinical knowledge, whether it's doctor, nurse, respiratory therapist, somebody with hands-on experience at the patient side, that shines a light on the problem. And there are plenty of examples of technologies that were siloed from their application, or things that were made that were inherently flawed.

Somebody was just doing a bronchoscopy-- we drive cameras down people's lungs-- the other day. Just case in point. A small example, but it's an example. Driving new bronchoscopy disposables. Great. Infections control-- you just basically drive the camera once, and you can dispose of a disposable part and reuse the handle. Beautiful technology. I'm sure a company is making good money on it.

Except the cord's way too short. So we were trying to do a bronchoscopy on a patient, and we're twisting and turning, and we're like, nice screen, beautiful screen, great view. But man, the cord is too short. Did anyone try this? Did anyone test this out? That would've been a very simple thing. That had they just talked to a provider sooner, it would have worked.

But I'll tell you, it's not like there's just like a pipeline of providers and engineers to do a matchmaking. It's not like we do speed dating rounds and be like, all right, I like your idea. I like who you are. Let's get together and make this technology work. The world we live in is so IP-protected, that the doctor input is very limited on a contractual basis.

Whereas what Jim and I did, we were like, we're going to put our guard down. We're in a global pandemic for goodness' sake. Let's just do this. And we just had this very unique collaborative interaction. And look what happened. So that was, I think, the coolest part.

Jim Richards: Yeah. It was great. And I remember calling Keith one night after I'd first ventilated myself using the AeroBreath and asking Keith things about what should I be feeling. I'm not ill, I'm healthy. But what should I be feeling? What should this feel like to me? And then we'd talk about various ways that I by breathing in a certain way could simulate to some extent an illness and so forth. It was great. And we were trying to-- how do you describe what breathing should feel like?

But we'd go at it, and we'd get it figured out so that we could actually be sure early on that what we were delivering was actually effective ventilation. That we weren't fooling ourselves. We were in fact ventilating in a way. And I'd have the gauges on my fingers and so forth. So all guard down, just back-and-forth. What should it be doing? How do we know it's working? What should we try next? [laughs] It was a lot of fun.

Brendan: Wow. It sounds like a really fun collaboration and productive, too. So it was great to have this conversation with you, Jim Richards, Tyler Dailey from Aerodyme, and Keith Romano, Dr. Keith Romano from Mass General Brigham. Thank you all for joining us, and it was a pleasure to have this conversation with you.

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