MedTech Mindset Podcast: Saving Infants In Respiratory Distress

MedTech Mindset Podcast

December 04, 2018

MedTech Mindset Podcast: Saving Infants In Respiratory Distress

"Every year, over one million infants die of severe respiratory illnesses, making it one of the leading causes of under five mortality in the world.

99% of those are in low to middle income countries, which shows you that there are good treatments for these conditions, but they're not reaching most of the world."

NeoVent_Stephen_John_AIMTech

On this episode, we sit down with Stephen and Anna John, a brother-sister team of medical device developers, working to bring life-saving respiratory therapy to the developing world. Their device, NeoVent, is a low-cost, mechanical solution to deliver two levels of air pressure to infants in respiratory distress without the need for continuous electric power.

Stephen and Anna grew up in rural Nepal, where their family worked to meet the medical needs of an undeserved population. Their father, Sunil, is a pediatric cardiologist and continues to split his time between practicing in Kalamazoo, Michigan and Nepal. Sunil is serving as a clinical advisor in the development of NeoVent.

They're working to bring NeoVent to market through their company, AIM Tech. You can contact them through their website or by sending an email to stephen.john@aimtechhealth.com.

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Stephen and Anna demonstrate NeoVent during a visit to the hospital in Nepal in the town where they grew up.

 

NeoVent began as student project while Stephen and his friend Joseph Barnett were undergraduates at Western Michigan University. NeoVent was a winner of the 2015 Lemelson-MIT National Collegiate Student Prize Competition and has since won several other awards and taken significant steps towards commercialization. 

Episode Transcript

Dan Henrich: Welcome to another episode of Med Tech Mindset. I'm your host, Dan Henrich, and I'm director of marketing here at Smithwise. A few weeks ago, I had the opportunity to take this show on the road to Kalamazoo, Michigan. I met there with Stephen and Anna John. They're a brother and sister team developing a new medical device called NeoVent. NeoVent is intended to bring ventilator support to infants in respiratory distress in emerging markets.

Stephen is a mechanical engineer, and Anna is a biomedical engineer. Both are currently in medical school, Stephen at University of Michigan, and Anna at Western Michigan University. We're also joined by their dad, Sunil. Sunil is a pediatric cardiologist, and is serving as one of the clinical advisors on this project. The John family draws their inspiration for NeoVent from their experience living in Nepal, where Sunil worked and Stephen and Anna spent most of their childhoods. Sunil continues to split his time between caring for patients in Michigan and Nepal.

NeoVent is a simple mechanical device that's added to an existing bubble CPAP machine to deliver two levels of air pressure to the patient at a very low cost and without the need for electric power. You can see a video of NeoVent working if you go to our blog and find the post for this episode.

I sat down with Stephen, Anna, and Sunil at their home to talk about NeoVent and the experiences that led them to this project. So let's jump into my conversation with Stephen, Anna, and Sunil.

Sunil, I think it'll be really interesting for our listeners to hear, our families have known each other for a while, but you're new to all of them. Can you tell us a little bit about how you and your wife ended up in Nepal? You grew up, I think, in this area, but your parents came here from India. Most people who do that do that for the educational and economic opportunities it'll provide their kids, and yet you took that and went back to a developing world. Can you tell us about that journey?

Sunil John:     Sure. So yeah, my parents came to this country, and I was actually born in Detroit, Michigan. We had a chance to go to India fairly often, and when I was a teenager, actually in college, I was just gripped with the fact that there's such a disparity in terms of resources in the world. I went to a conference in a place called Urbana, Illinois, and decided at that point in time that I wanted to work in a place that had a much greater need.

When I first met Gina, I suggested this to her, and she said, "What exactly will that mean? Mud house, tin roof?" And I said, "Well, I don't know. We'll see." To make a long story short, one day I got a page at the office saying, "there's this opportunity for a pediatrician in Nepal. 135 bed hospital in the foothills of the Himalayas, and there's an e-mail address. What do you think?"

We sent an e-mail and went there for a look-see, and the next thing we knew, we had fallen in love with the place and the people. Where there were 35 pediatricians, two neonatal units and a pediatric intensive care unit in Kalamazoo, there were no pediatricians for a population of several million in the area that we were going to. So we were able to live there for a number of years, for 11 years, actually, from 2000 to 2011. Our youngest son was born there, and Stephen and Anna spent most of their childhood there.

Dan:    Tell me about kind of the typical patients that you see there, how far from there do they come to your place, and what are the closest medical facilities besides yours?

Sunil:  Well, now there are many more medical facilities than there were when we first went. When we first went, people were coming from as far as India, sometimes walking two and three days to get to the hospital. But now, there are many more hospitals, but it's still a fairly busy place. We see, the pediatric ward, for example, has about 50 beds. We see lots of babies, infants, children, as well as of course the adult portion of the hospital. So a busy place with lots of individuals who often have fairly severe illness that's finally prompted them to come visit a hospital.

Dan:    Mm-hmm (affirmative). Let's hear kind of about the problem that you are working to solve in terms of infant respiratory therapies and kind of the state for the device that you're working to bring to market.

Stephen John:            So, every year, there's over one million infants that die of severe respiratory illnesses, making it one of the leading causes of under five mortality in the world. And when you look at those deaths, the breakdown, so 99% of those are in low to middle income countries, and kind of shows you that there are good treatments for these conditions, but they're not reaching most of the world.

So that was really the problem. We sort of experienced it first hand in Nepal, but then we came to realize, "Hey, this isn't just happening in Nepal, it's happening all over the world."

Dan:    Gotcha. And so, when you and I spoke about your project ... Why don't you tell us about the name of your project, the name of your company that you've formed around it, and kind of the unique challenges that you have to solve. I think you mentioned three particular areas in our conversation before this.

Anna John:    Yeah, so the device is called the NeoVent, and the company is called Aim Tech, Advanced Innovative Medical Technologies. The three areas that we were targeting were cost, not dependent on continuous electricity, and simplicity of usage.

The first thing is, in many of these areas in these low to middle income countries, they can't afford the $30,000 to $40,000 ventilators. They just don't have access to that, that's just out of their budget and scope. Additionally, even if these ventilators are donated, which in some cases they are, oftentimes the people to manage them, take care of them, maintain them, run them, are not there. They're complicated, and here in the States, we'd have respiratory therapists who would run that, but in those settings, often, you're already limited on staff to begin with and you don't have someone who can necessarily devote the time to take care of those things, so complexity was a big issue.

And finally, electricity there is sporadic. In many areas, Nepal, and around the world, electricity will come and go and that could mean, if an infant is on a ventilator, they could suffocate and die just from electricity going. So those are kind of the three areas that we really wanted to target, to make it low cost, to make it really easy and intuitive to use, so a busy nurse could quickly put it up and set it up so that the child could get the care as soon as possible, and to have it not depend on electricity.

Dan:    When we post this on our blog, at least, we'll include some links to the videos of your device working, but can you describe it for the people who won't see it? How your device works and the basic engineering behind it.

Stephen:         Sure. So, we wanted to have a purely mechanical design. As Anna mentioned, it needs to be non-electric. So, we have this little inverted flow valve that basically collects bubbles that are coming from your expiratory tubing. You've got your inspiratory tubing, sends air to the patient, the expiratory tubing carries air away from the patient. That's lowered in a container of water, and so it's bubbling. So this little float valve collects those bubbles. Once it's collected enough of them, it becomes light and buoyant and rises. Once it rises, it vents, so it becomes heavy again and it sinks. So you're using the bubbles to basically have this little valve move up and down. We've designed the valve so that as it moves up and down, the pressure is also moving up and down. So the nurse could explain to the patient, "Hey, keep an eye on this little valve. If it stops moving up and down for some reason, call us, we need to check to see if there's a leak in the circuit or something has happened because it's not working."

Stephen:         So yeah, basically just a little mechanical valve that moves up and down.

Dan:    So is it powered, then, entirely by the patient breathing out?

Stephen:         It's powered off of compressed air. A lot of hospitals will have a big oxygen cylinder, and you can get these little [inaudible 00:09:22] devices that will entrain air, so that you're delivering air and oxygen. These places have power, and there are places that can compress the gases for these cylinders. The problem is that the power is sporadic, so once you have that oxygen cylinder at the bedside, you're guaranteed that for the whole duration of that cylinder, you've got continuous power. So it's almost like a battery of sorts.

Dan:    Yeah, yeah. So, your device then, does it rely just on that compressed air being-

Stephen:         That's it. Yeah, so the particular hospital where we lived actually has an oxygen compressing plant, where they can make their own. A lot of smaller hospitals will just have a Jeep that drives from a nearby city and will have a bunch of these oxygen tanks in the back, and every week they'll get more tanks. They'll get the full ones and then they'll send the empty ones. That's usually what hospitals will do.

Dan:    Okay. And I think I saw, and I remember a little bit from our conversations previously, there's sort of a continuous air CPAP technology that has existed for quite some time, but what is new about this is the two different levels of pressure. Is that correct? For breathing in and breathing out.

Stephen:         Exactly. So, bubble CPAP is an intervention that has been used extensively for the last 30, 40 years. It's kind of recently started to get even more popular, just because it's so simple, but still very effective. With bubble CPAP, you've got your compressed air that comes to the patient, and then again, that expiratory limb is lowered in a container and it bubbles. However deep that's submerged, so if it's submerged five centimeters, that's the pressure in the whole circuit that the kid is experiencing. So it's very intuitive. The doctor writes seven centimeters, and then somebody just makes sure, "Oh, it's seven centimeters deep." And if the kid is not doing well, you can maybe make it a little bit more deep. So that-

Dan:    Mm-hmm (affirmative). Just by adding water to the cylinder.

Stephen:         Exactly. So, that's used here in Michigan, that's used in Nepal. It's used in many places. Here in the States, though, if somebody was too sick and needed additional support, they would take you off of the bubble CPAP and put you on a ventilator in some sort of mode, right? But for most of the rest of the world, that's all that they have. So our goal was, can we design something to provide additional care, but to do it in the same way as bubble CPAP?

Stephen:         Bubble CPAP is low cost, it's non-electric, it's very intuitive. So we need to preserve those attributes if our technology is to actually reach those settings.

Dan:    Okay. Tell me about the cost of your device when you bring it to market versus other ventilators.

Stephen:         Sure. So, we're hoping to be able to bring it at a price point much less than existing ventilators. Presently, it costs us a couple hundred dollars, just because we are producing it in such small quantities, but we're hopeful that as we produce it at scale, we can drive that down significantly.

Stephen:         I think the challenge is making sure that where it's still using very robust materials, particularly given these environments and having a very solid product, while keeping it very affordable. So yeah, hopefully the cost will decrease even further from what it costs us now to make, just because of economies of scale. And molding instead of 3-D printing, for example.

Dan:    Hey listeners, just a quick break to remind you that Med Tech Mindset is a production of Smithwise, a medical device development firm with offices in Boston and Philadelphia. We help innovators accelerate new medical technologies along their path to market, from concept all the way to commercialization. Visit us at smithwise.com to learn more.

Stephen:         Yeah, so we've had extensive support from many people. We've got a team of engineers at Western who have been helping us develop and validate the product. We've got a team of clinicians at University of Michigan who have helped us as we've tried to validate the product at each of the different pre-clinical stages. Clinicians from Respiratory Therapists Without Borders, a non-profit that we work very closely with to try and figure out, "Hey, is this something that, what we designed, will it be applicable to other settings beyond the setting that we know?"

There's probably many more. Oh yeah, collaborating with a respiratory therapist school here in town to do some more advanced lung simulator testing.

Anna:  And we have, in this past year, we had some mentorship from a regulatory consultant as well as another individual who was also doing a medical device start-up. That was very, very helpful, they gave very practical help as we were getting to the specifics of design development.

Dan:    And this project is several years old, so tell me about where you are in terms of the different prototyping rounds you've been through. You know, how many iterations have you had, and sort of where do you consider it in the process?

Stephen:         Sure. So, if you count all of the early prototypes, we've had hundreds of prototypes. But I think yeah, over the last year or two we've definitely gotten much closer to ... I think over the last couple of years, we've had a design that worked and that we knew that the concept was good, but making a device that's easier for people to use. I'll give you an example. Two years ago, when we took devices to Nepal for nurses to use, it took them about two and a half minutes to set up, and we had a couple O rings and some small connectors that they weren't really big fans of. So over this last year, what we've been doing is to try and simplify the design as much as possible.

Stephen:         This last summer, when we took devices there for nurses to use, it was down to under 30 seconds, to go from nothing to whole thing set up, so they were much happier.

Dan:    Yeah.

Stephen:         So, yeah.

Anna:  And additionally with that, in the last year, we've been really working to make the device out of materials that can be cleaned and that are patient-safe and all that, so that's something we've particularly focused on this last year as well.

Dan:    I understand you've done some bench testing, you've done some animal testing. Tell us about that.

Stephen:         Sure. So, we sort of took it in different stages. The first question is, can we deliver the right level of low and high pressure over thousands of cycles? Because it's not enough to do it once or twice. So on infant mannequins, we set up our device and we had it run over several thousand cycles to see, how reliable is this. Then the second set of validation was to look in an infant lung simulator, where you can actually set the resistance and compliance to match an infant in respiratory distress. What we wanted to see there was, all right, your traditional ventilator in sort of a bi-level mode, and then NeoVent, are we able to deliver the same pressures and volumes. How close are these?

Stephen:         The third set of tests were actually in a living model. In a sedated rabbit model at the University of Michigan, we wanted to see, can we actually generate the same oxygen, carbon dioxide, and pH levels as your traditional ventilator? In a living system, there's the ventilation, but there's a whole bunch of other things, because it is a living system. So that was sort of the approach that we used to kind of convince ourselves and also be able to show others that, hey, we're able to deliver the right pressures each time on a simulated infant lung, and then in a living system. It appears that we're able to deliver the same ventilation. So I mean, all of that's really, hopefully building a case that, hey this is something that's safe to use in trials.

A lot of the work that we're doing now is to try and get those human studies started. It's been exciting to kind of go to clinicians, show them all the work that's happened to date, and sort of brainstorm with them some of the specific details of, "Okay, how do you structure this trial so that it can really show you, with the least amount of effort, but show you, hey, this is helping kids effectively." So yeah.

Dan:    There's several awards that your team has won. Can you tell me about those, and any funding that's come with them that's helped you in the development process?

Stephen:         Sure. So to date, actually, we've exclusively funded the project through those sorts of awards, so that has been a huge bonus. The awards, also in addition to the funding though, helped us ... I'll give you an example. One of the prizes, the Lemelson-MIT prize, having that award then, as we're going and demonstrating to clinicians in a lot of these settings sort of gives a bit of a stamp of approval that, "Oh, some very smart people have looked at this and they think it's a legit technology." They were also able to connect us with many other start-ups, like Anna alluded to, that were a bit farther ahead of us, but that were also developing health care products for emerging markets, but that had already started selling their products. Those connections and being able to talk and ask those people a lot of questions were immensely helpful. I think the competitions were helpful from many different fronts. The funding, the networks and mentorship, and also sort of the third-party validation. Yeah, we've been very blessed.

Dan:    Yeah, absolutely. And how about, Anna, I think you mentioned regulatory ... You've been working with a regulatory consultant, and that's sort of maybe taking up a lot of the time at this point in the development process. Can you tell me about, what are your regulatory goals? Obviously this is intended for emerging markets. Are you looking to clear it through FDA, through individual regulatory bodies in the countries where you're working? Tell me about that.

Anna:  Sure, yeah. So the past year, as we've been kind of working to get our design controls off the ground, the focus was really first and foremost to make sure we had it, tried to have a good quality system in place, and making sure that we're analyzing our risks, that we're understanding our specs, testing them, documenting that testing, and really doing that, so that getting feedback from the regulatory consultant and this other med device start-up was really helpful in the details on how to do that. As we've been doing that, the goal is to aim towards, we are looking at getting 510(k) clearance here in the States and additionally, we have to take into account the regulatory boards in the countries themselves, the ministries of health, their process. But I do think that having that 510(k) clearance is definitely a benefit. When they see that it is approved in the States, that that would definitely open doors. And not all countries would require that necessarily, but even if they didn't, we'd still want to make sure that our device is to a very high-quality standard and is meeting the requirements as much as we can.

Dan:    Yeah. So do you anticipate, then, that the testing you have done up to this point will be sufficient data for your 510(k) process to show safety and efficacy, or do you anticipate you'll need to do additional testing?

Anna:  I think we'll have to see. I mean, the data to date has been very good, but from talking to other companies, it seems that the FDA can ask for more, so we'll just have to be ready to provide more if need be. So it all depends on how they see it and how we can compare it to the predicates. But I think the data to date has been very good, and has clearly demonstrated very good results as well, so I think that we are off to a very good start with that.

Dan:    Have you had any direct interactions with FDA yet? Pre-submission [inaudible 00:20:40] or anything like that? Not yet.

Anna:  No, not yet.

Dan:    So that's kind of the next great hurdle that's coming. [crosstalk 00:20:45]. Great, okay. So, we've talked about, there's a bunch of different angles, I think, that our listeners are interested in. Working in the med tech space, there's of course the engineering angle, the clinical angle, the regulatory angle.

Let's talk a bit about the business angle. What's your model, sort of? Your target is to have a very low cost device that is accessible to patients and to health care providers that don't have a lot of money. What is the model for distributing this device, and who will ultimately pay for it?

Stephen:         Sure. So there's a couple different groups that will buy it. Ultimately, the baby in respiratory distress is the one benefiting from the treatment, but the question is how do we get it to each of those hospitals. In our markets, it looks like there's a couple different camps. So first, a lot of these places will have some sort of government health care system. We've had the chance to show the product to a couple of ministries of health and their staff to just sort of gauge whether this is something that they could see potentially rolling out in their government facilities. So that's one angle.

The second angle is sort of relief agencies, groups that support many hospitals, particularly from the equipment side, again, in emerging markets. So in a similar way, we've gone to the people heading up those organizations and shown them the product and tried to get a sense of, "All right, is this something that you like and would find helpful?" And as we've been discussing it, it's kind of seemed like it would make sense to basically implement in a couple hospitals, and then if it goes well, then that agency can then look at distributing it to all of their hospitals. So you sort of try it on a small scale, and then [inaudible 00:22:34] deployed everywhere.

The third group is just independent hospitals, so mission hospitals and the like, where they're not getting equipment from the government, they're sort of in charge of their own equipment. But they still have sort of their own networks that we can, again, show that the device works in a couple of those hospitals and then spread it to other areas.

It's been exciting, so we've started to meet with some distributors who take care of the in-country distribution, as well as some international med device distributors that will take it from your warehouse in the States or wherever to those local distributors. It seems like there are some players that are now setting that up pretty well, to really reduce costs through economies of scale. It seems like actually getting the device to the customers, whether it be a direct hospital, or whether it be some of these larger governments or organizations, might be less difficult than it would have been ten, 20 years ago.

Dan:    Mm-hmm. And how about funding hurdles? You mentioned that you basically funded this up to this point with prizes from competitions that you've entered, and there may be several more of those that you may consider entering. But do you have kind of a, are you in search of investors? Are you working on types of grant applications or anything like that? What's your plan for kind of the bigger hump that it will take to bring it to production?

Stephen:         Sure. So, we're always looking for funding from various sources, and you always have a couple of grants that you send out and you see what happens. But yeah, I think we've been fortunate, because our product is so simple and there's so few components, that's how we've been able to get this far just with the prize money sort of here and there. Yeah, it sort of remains to be seen whether we can continue with that route, to reach for sales, and then start to have income, and then sort of organically grow, versus whether it will need either a larger grant or investment or something like that.

Dan:    Sure. Sure. Yeah, I would imagine that in the near future, you'll get to the point where you need to move from 3-D printing to injection molding, I would imagine, right? And then [crosstalk 00:24:51] once you're tooling injection molds, then the cost per unit may go way down, but the overall cost may go way up.

Stephen:         It's difficult markets to reach, for many reasons. So it yet remains to be seen whether this product truly is affordable enough, simple enough, intuitive enough, for people to just pick up and use and be happy with the results that it's delivering. We definitely have much work yet to do, and there are many risks. I think it's been very exciting. So, this last summer, as we went throughout some countries in Africa and in southeast Asia, sort of explaining device concept, showing the device, and getting feedback from clinicians, it was very exciting for people to be like, "Okay, how much do they cost? Can I order them now?"

And we had to explain to them, "I'm sorry, we're not selling this now. We're trying to get your feedback and understand," but that was very reassuring. I think if we can get the regulatory clearance and start selling to these people who are interested, I'm hopeful that we'll be well on our way. So I think regulatory is one of the big pieces we're working on now.

Dan:    Yeah, great. So, I understand that you have been involved sort of in the clinical testing, or in some respects, in bringing the prototypes into your hospital. Can you tell us a little bit about that process?

Sunil:  So, you know, the reality is, I've spent many, many hours with a hand bag just giving manual ventilation because we didn't have other supportive equipment available. The first time we went back, we came back to the United States, the biggest things in our suitcase on the way back were two ventilators and all the supplies. And then those would run out of battery life, or you would have some part that was missing. Everybody was scared about all the knobs and the buttons and everything. So I spent a lot of time, actually, in the hospital training our nurses, training other staff in how to use these ventilators, only to find that when I was gone or when other people were there that were not comfortable with them, they would just sit in the cupboard. So that was really frustrating.

We had a gentleman visit from Respiratory Therapists Without Borders, and he brought this wonderful, high-tech nasal cannula system, but it required electricity, and the first time we had a power surge, a vital component in that also got fried. So the setting that we were in, if you came to our hospital and looked in the closet, you would find a bunch of used ventilators that really hadn't solved the problem other than for the isolated patient here or there. Well, this gentleman that came, after he saw that these solutions just weren't fitting well for our hospital said, "How about bubble CPAP?" And that got us started on this whole bubble CPAP idea. I have to tell you, that was a game changer for our hospital, because little babies who had been really very desperately ill, now with a little bit of support provided by just a tube submerged under some water, were able to get additional strength.

So the first step for any hospital to be able to use a device like what Stephen and Anna are talking about is for them to have really good bubble CPAP, and that's not as easy as you'd think. So for the past two or three years, we've actually been working to get a very good level of bubble CPAP and a good level of monitoring. For example, if there's not a good seal at the nose, if for whatever reason the bubbling stops, that means that the child is not receiving the ventilation that they should receive. So because the nurses and medical staff have become quite familiar with bubble CPAP, the powerful aspect of the NeoVent device is it's a single connection switch. So you have a baby who's on bubble CPAP, you can literally just take it off, put the child on the NeoVent. The whole process takes about five seconds, and now you have two levels of pressure.

So it's been exciting to work with the staff in the hospital, the nurses and the doctors, who are all very enthusiastic about starting to use this. We're a little disappointed that they couldn't just start using it right away, that we needed to go through all of this testing, et cetera, but they are very eager to start putting it into effect for those babies who are a little bit sicker than what bubble CPAP can provide support of.

Dan:    Well, I think we covered a lot of the talking points that we had discussed over e-mail, but anything else you want our listeners to know about the project?

Stephen:         No, always happy to talk about the project, and yeah, I mean, it's exciting for us as we get closer, hopefully, to bringing this to market, after these years of product development. We're always looking for additional folk to collaborate with us or for a fundraiser or for anything along those lines, yeah, to keep it going.

Dan:    Great. Great. Well, this is a really inspiring project. I want to thank you all for making the time to talk with me, I'm glad we could do it in person. I want to tell you, I think that I and our listeners and our team at Smithwise really admire the work that you folks are doing.

Sunil:  Thank you so much.

Dan:    Wanted to thank you all for joining me.

Anna:  Thank you.

Stephen: Thank you for having us.

Dan:    And that's our show for today. If you liked it, please subscribe and leave us a great review on your podcast platform of choice. Med Tech Mindset is produced by Smithwise, right here in our Philadelphia office. Our theme music is composed and personally curated by The Polish Ambassador. Thanks to our guests today, and thank you for listening. We'll catch you next time on Med Tech Mindset. 

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