Airway Management is Epic

Steve Melito: Hey everybody, welcome to New York State Manufacturing Now, the podcast that’s powered by FuzeHub. I’m your host, Steve Melito. Today we’re talking to Dr Eric Moses, the co-founder and CEO and CMO of Epic Airway Systems, a Schenectady-based company that’s developed an easy-to-use airway device for patient care. We’ll also be talking to Keith McKenna, the company’s COO. In 2023, Epic Airway Systems was awarded a $50,000 commercialization competition award at the New York State Innovation Summit, and that’s just some of what we’ll be talking about today. Eric and Keith, welcome to New York State Manufacturing Now. Thank you, Steve. Thanks Steve, Great to be here. Excellent. So, Eric, let’s start with you. Tell us about yourself. You’re a medical doctor with an MBA who co-founded a company. To me, that sounds like a pretty interesting story.

Eric Moses: Yeah, it has been interesting, and thanks, Steve. Thanks for the question and thanks for welcoming us on this show. I’m a local boy, so I’m in upstate New York. I was born and raised in the Niskayuna area. I went to SUNY Buffalo for undergrad, got my EMT and started working in the airway world in about 1991 as an EMT. After graduating college I had several jobs in EMS. I was a flight medic, I was an educator, a Yellowstone Park paramedic, and then eventually found myself in medical school in 1999. After medical school I did my residency in anesthesiology at Albany Med and started a real estate business with my new wife at the time. She and I built an apartment business in Albany, New York, while I was training for anesthesia practice, thinking being a landlord was a great way to have a family business. I worked in cardiac anesthesia after residency at Schenectady for about eight years, came back to Albany Med, ran a surgery center for them, got my MBA and realized that I am more of a business of healthcare than a hospital leader. So that’s when I, through the incubator at Albany Med, I was able to find a startup company in my space, in the airway space, that I could wrap my arms around as a new med tech leader and got going on. Really, the first thing was to just build a team and find out who I could work with. That could fill in the gaps, because I’m only a doctor and a landlord. But I don’t know the med tech space. But I’ve learned it over the last three, four years.

Steve Melito: Only doctor and only a landlord. That’s a pretty interesting story, just like I thought, so thank you for that. Now you’ve got a website, of course, EpicAirwaySystems.com, and when I went there to prepare for today’s podcast, I read that quote pre-hospital tracheal intubation skill sets are deteriorating and process success rates are failing. I’m not a doctor. That surprised me, however, because I know medical professionals are well-trained. So what’s going on here?

Eric Moses: Medical professionals are well-trained, but things have changed in the training. You know, I spent the whole 90s in EMS and I worked in urban, rural, I worked in wilderness in Yellowstone, I worked as a flight paramedic. So I saw all the different scenarios and if there was one skill that a paramedic had that had to be flawless, it was tracheal intubation. So when you put a breathing tube into a patient, there’s really through the mouth there’s two holes that can go down and one of them hopefully will save your life and one of them definitely won’t, and there’s no way around that and that it is a difficult procedure. Oral tracheal intubation the standard way of putting in a breathing tube. It requires a lot of practice and a lot of oversight and unfortunately over the years I would say the last 20, 30 years the amount of opportunity for that oversight and practice has diminished. There’s an EMS crisis of providers. It’s just not as an attractive position to be in. It’s a very hard and stressful job. Ptsd is not uncommon, to have people take this type of trauma home with them. So, as in a lot of industries, skill sets have deteriorated and unfortunately in pre-hospital care and we’re talking about pre-hospital with the skill set degradation, we’re not talking about the perioperative and we can discuss the two different venues, but this is the emergency setting, where skill sets if they’re not flawless, then people die and that’s unfortunate, but it’s just the truth, and the military is dealing with the same challenge right now as the cities are, and the country settings the pre-hospital care. If you can’t intubate the patient, the patient dies.

Steve Melito: That’s simple and that’s stark. It really is a matter of life and death, then it is. So let’s talk about your product in some more detail, and I know some folks are going to be just listening to the audio only version of this podcast, but we do like to feature some video content where we can. Can you show us the product and talk through it for those that can’t see it?

Eric Moses: Sure. So this will take us back to also when I was first introduced to the product in three, four years ago, when it was that aha moment where I thought why didn’t I think of that Right? What we’ve done is we’ve combined the two most commonly used medical devices airway devices in the OR and in the pre-hospital setting the two that we go to one or the other often have to switch between the two for various reasons, often start with one, end with the other for various reasons. So what we’ve done is we’ve combined the endotracheal tube, which is a simple breathing tube.

Steve Melito: Sort of U-shaped.

Eric Moses: Yeah, it’s flexible, but it ultimately starts at the ventilator and ends in the patient’s trachea right, so it’s like an elongation of the trachea right. So it’s the most definitive type of airway when in place. What I mean by that is the one you can leave in the longest and it’s the most reliable with the least amount of problems once it’s in place. The problem is when you get into that skill set degradation. It’s in place. The problem is when you get into that skill set degradation. This is very difficult to put in, there’s a lot of complications with putting it in, there’s a high failure rate and it’s expensive. This tube is not expensive, but the scope you need to put it in and the medications that are required to insert this in a perioperative setting add up to quite a bit of dollars. The other device is what we call a supraglottic airway, and there’s many, many. This is just one version of this. This fits in the back of the throat but not down into the trachea, and this is used for many different reasons in the operating room and in the pre-hospital setting, and often we have to switch from this device to this device, and in the operating room we often switch from this device back to this device. So what we’ve done at Epic Airway is we’ve invented, we’ve patented and we’ve developed the future of airway devices, and that’s Epic Airway, which is a supraglottic airway with a deployable and retractable endotracheal tube built right inside. The big feature of this, Steve, is that when you switch between devices in the current method the patient has to be taken off the ventilator. Right, you’re pulling out one airway device and you’re putting in another. In that period of time you’re not ventilating the patient, they’re not getting any oxygen, not removing any carbon dioxide. Hemodynamics change meaning blood pressure, heart rate all react to that. There’s time delay, pressure, heart rate all react to that. There’s time delay, there’s anxiety amongst the staff, it’s a lot of pressure, and then you know things tend to get worse before they get better. And then we’re very good at what we do and usually everything works out fine. But what we’ve done is made this solution where, when the patient is hooked to the ventilator in the typical way, right same type of way, we can switch between these devices without unhooking the patient’s ventilator. Got it, got it. And that’s where you know we’ve been called a game changer, paradigm shift in airway management and one more thing I want to throw in is that this is a low tech device. All the solutions that have come out in the last 20 years to help address intubation and extubation of the patient are high tech. They use video or they use fiber optics. They cost a lot of money, they’re fragile and they may be applicable in, you know, a tertiary hospital where they have the finances and the carefulness and the security to make sure they don’t disappear. But in the rest of the world, this will be a life-saving device and in the operating room, where our market entry is, this will save time and money. And saving time and money and improving safety is what we should all be concerned with in the operating room.

Steve Melito: Absolutely, and you’ve done a fantastic job explaining that in a way that a non-medical person like myself can understand, and you’ve also brought in the business aspect of it, how it saves time and money. So let me ask you part of becoming a successful company is doing the work of customer discovery, and Epic Airway Systems did that through the National Science Foundation’s Innovation Corps or I-Corps program. Can you tell us about your experience with NSF I-Corps? And part of the reason I ask is I’d like to see more companies that we talked to at FuzeHub did what you did, yeah.

Eric Moses: Yeah, Steve, I had to be encouraged to join the I-Corps training program. It’s a big lift and actually I can thank Kelly Reardon from University of Albany. She was at RPI at the time and lucky enough to get on a call from a good mentor and someone who said I know it’s a big lift. It won’t be a financial lift. They’ll help you financially with the expenses. The government will be a financial lift. They’ll help you financially with the expenses, the government will. But it’s a seven to 10 week program, 15 to 25 hours a week for two people. So it’s a big lift. We did ours through Cooney down in New York City and it was an invaluable experience. It just an invaluable experience. It just we thought we had one or two value propositions and after interviewing 25, 35 different not all practitioners, not all anesthesiologists or paramedics, but surgeons and buyers and other manufacturers other barriers you could say to entry, to find out if the device could be manufactured for a reasonable amount of money, to find out if there’s really users at the end that would use this device instead of other devices. So what I found was I get that they want to train entrepreneurs to be entrepreneurs and translate technologies, help the economy. That’s their whole basis. But what they do is they make you turn stones over that you wouldn’t have turned over and I’ll give you a great example. They teach you what an influencer is, not just the buyer and the user of a device. So when you build a device or any business, you think you really only have to talk to those who will hopefully use your device and maybe those who make the buying decisions of the device. But what we found was the surgeons are very concerned about the way the airway is being managed in the operating room. Maybe they don’t always speak up I mean, they speak up a lot, but maybe they just figure it’s the standard of care. But there are some safety factors, time factors and cost factors that are noticeable in the operating room, especially by those who are not necessarily the ones who are using the airway device. And we’ve tapped into neurosurgeons and ophthalmology surgeons, some cosmetic surgeons that would really like to. Even if there’s a little bit of a price bump, it’s not going to affect the big bottom line of a big surgery, but they see that it could make things safer and faster and thus less expensive.

So through that program, through the I-Corps program, I learned the value of the influencer who, if they ask for Epic Airway by name, then the anesthesiologist and the buyer will be more likely to have access to it. So I strongly recommend to every startup, especially the ones that I think you know who’s going to actually need a certain type of raincoat hanger that only works for raincoats when most of us don’t wear raincoats anymore. So I strongly recommend, if you don’t want to end up with a garage full of something that was your dream and a lot of friends and family that are disappointed in how much money they spent, then make sure you ask the hard audience if they would use it, not the easy audience.

Steve Melito: Very good. That’s a great description. Thank you for that and, Keith McKenna, you’ve been sitting there very patiently. You’re the COO. I wanted to talk to you about prototyping because I read on your website that the company developed 15 prototypes before getting to a manufacturable and functional product at an acceptable price point. So you get an A-plus for persistence. What are some of the things that you learned during all of these iterations?

Keith McKenna: Thanks, Steve, and actually taking a quick note because we’re actually up to prototype 17. How time flies. How about that? But anyhow. So I’ll have to update that. Short answer is a lot. You know 17 prototypes. You’re learning a lot through all the entire process. But the long answer is there’s two buckets of learning. Some are product learning and some are the actual process learning. On the product side, as Eric was explaining earlier on, we’re trying to address multiple value propositions and one is tied to the ability for a lesser trained individual to intubate a patient. To successfully do that, placement of the endotracheal tube in the right position and at the right angle is critical. So a lot of the prototypes that we’ve done in the past six months have been optimizing that placement and that deployment so that it can go through the airway opening and through the vocal cords blindly. You know, this is where we think there is a great opportunity to help those that don’t have the skills, that used to have the skills. So that was a lot of the work that we did. The other thing we’ve worked on is a lot towards the optimization of the performance of the device sealing, improving the ability to meet the industry standards for leakage and for force and contact with the soft tissue of the body. So that’s been a lot of the work we’ve done with the product. We are actually the last one prototype is building out multiple sizes. So we now have been focused on up to now on one size, but we need to go to market with three sizes and so this last round is rolling out the two other sizes Very close to finishing up the prototyping activity. On the process side and especially in the med device space. You know we learned a lot about you, know how you go off and make your choices on your design. I think that we early on did a proof of concept that proved that the idea was feasible and, as Eric mentioned, going back to the I-Core, they had that available to show people and explain to people. At the time that was just taking existing product and modifying it to show that, hey, the concept works. We quickly pivoted and went to down the rabbit hole that engineers often do and throw complexity into the product, putting some bells and whistles in, and we regrouped about a year and a half ago and said we need to get to an MVP, so a minimally viable product, which drove us towards simplicity, and that’s where we are. We’ve spent the last few months also taking the complexity out, reducing the amount of failure modes and things like that in the product. So I think, if you were to pick on the product side, we did a lot of work to optimize the design and the process. We’ve learned along the way.

Steve Melito: Excellent and, as I had mentioned at the top of the podcast, epic Airways Systems won a $50,000 commercialization competition award last year. How did you spend that money?

Keith McKenna: So we’re still I mean we aren’t done. We have a small amount left that we’re working on, but the vast majority of it went to a few areas, as Eric mentioned early on with the I-Corps, a lot of that tied to customer discovery. You know, in the med device space we need to go through the FDA. The FDA is going to review our design files, our design history files, and that’s all compliant with ISO 1345 standards. The FDA frowns upon the idea of well, it’s right, because I’m a doctor, I’m the expert, I know it’s right. They look to you to have good customer investigation and good translation into specifications. So a lot of the money went to working with our engineering team that is in this space. We’re very lucky to have found an engineering team that works in the airway space and they’re helping us build a design history file out. A lot of it was developing the design input, so taking that market research that Eric had done and converting it to tangible things that we could design around. The other thing that the FDA really likes for us to focus on is risk management, and so whereas the first the design inputs is sort of reactive to the customer feedback, the risk management is sort of a proactive approach. So you start to strategize about how the device can fail, how the user can misuse it, and then you build those risks out of the device. And so that was a big chunk of it as well. And now the third one is really working with our current contract manufacturer through design for manufacturability. The initial product cost when we were pitching at the FuzeHub was roughly about $50 an item. We knew we had to get it down substantially. We had a design review last week and we’ve achieved a $33 cost of goods, which is a huge win. We knew we had to get down to around $35, so we beat that target, which is great.

Steve Melito: Sure, congratulations on getting those costs down. You know the money part is always important, so is time, and taking a medical device to market takes exactly that. What is the status of your product today? It sounds like you have a contract manufacturer but are still working through FDA approvals. Can you give us a sense of that? Absolutely.

Keith McKenna: So we are very fortunate to have partnered up with a group called Aptics, locally here in the upstate region. They have a facility in South Glens Falls. That’s who we started with. They have experience in the space. Eric mentioned earlier on about the two devices a supraglottic airway and a endotracheal tube. Aptics actively manufactures endotracheal tubes as a contract manufacturer and they have worked on supraglottic airways before, which is a great benefit for us in trying to optimize the design. So that’s where we are relative to manufacturing. Once we lock that we’ll be in good shape. We intend to do what’s called a design freeze In the FDA world. That’s when you stop iterating the design, you start to do all your testing and validation work. Our current target is for the fourth quarter. So somewhere between November and December we’re going to freeze the design and then start doing all the work necessary to satisfy an FDA 510K submission. Once we freeze the design, we’ll also go off and purchase tooling also go off and purchase tooling. So we have already started. Part of the design for manufacturability and cost out tied us to the design of the tools. So a lot of the tool design has been completed but we need to start purchasing the tools, which is a pretty big lift. Our current quotes are running about three quarters of a million dollars just in the tooling alone, which is a big hurdle that we need to come across very quickly. That should take about three months to get through, and then we’re into testing. So the FDA requires a lot of testing around the validation of the product’s ability to perform to the customer requirements, the ability to satisfy certain human factors, like can the instructions for use actually be performed. There’s a lot of things that we need to do, and that’s a long period of time. That’s roughly about a six-month period for the testing itself. The one good thing is that we are a class two device within the FDA that by nature, does not require clinical trials, and so we feel that our lab testing and our cadaver testing will satisfy the requirements without having to do clinical trials, the things that typically scare investors and others off because they take so long, and so that’s one of the benefits we have with the pathway we’re pursuing with our team right now, and ultimately, we’re looking at a 510k submission to the FDA somewhere in the second half of 2025.

Steve Melito: Okay, that’s great. That’s not that far away either, no. So, Eric, let’s give you the last question here. How does someone, such as an investor, contact you to learn more about Epic Airway Systems?

Eric Moses: We are in a pre-seed round right now to support all the expenses that we’ve been discussing here. Our valuation is quite low for a medtech startup company. We are looking for qualified investors. The easiest way to reach out is probably just to Google Epic Airway Systems. You’ll find our website and you can go to contact us or inquire. We’re always looking for friends of Epic, as we call them, even clinicians that don’t know about whether they want to invest. We have a mechanism to invest through a angel group, so we have a minimum investment to us, but there are mechanisms to invest less through another entity, so I could give all that information out. So please feel free to contact me I’m really Eric at EpicAirwySystems.com, or you can go through the website and it’ll bounce to me.

Steve Melito: All right, excellent. It sounds like my dog’s going to be recorded for posterity on this podcast. I guess he’s always wanted to participate. But, Eric and Keith, thank you for being a part of New York State Manufacturing Now.

Eric Moses: Our pleasure. Thank you very much, Steve.

Keith McKenna: Thanks, Steve, appreciate it.

Steve Melito: Wonderful. We’ve been talking to Eric Moses and Keith McKenna of Epic Airway Systems, a Schenectady-based company that was awarded a Commercialization Competition award at last year’s New York Innovation Summit. We’re going to see Keith out there in about a month or so as part of a panel discussion, and I’d sure as heck like to see everybody out there listening come to the Innovation Summit as well, and this year’s event is scheduled for October 28th and 29th in Syracuse, new York. You don’t want to miss it, whether you come as an exhibitor or an attendee, it’s the place to find out about innovative technologies that are really transforming the way things work in New York State and beyond. To learn more, go to NYSInnovationSummit.com and if you didn’t get that URL, just send us an email at info at FuzeHub.com. So, on behalf of FuzeHub and New York State Manufacturing Now, this is Steve Melito signing off.