In one sentence: A needle shaped like a hockey puck is a ‘revolutionary’ medical device that can deliver epinephrine during a severe allergic reaction on Earth or in space.
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Overview
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EpiPens and other emergency auto-injectors have changed little for decades, though there are known limitations in their accidental (mis)use. Conor Cullinane, co-founder of Pirouette Medical, shows us his team’s surprisingly non-needlelike auto-injector that is shaped smooth, flat, and round, and easily totable so those at risk can have, in the company’s words, “freedom without fear”.
Following a patient-centered design process supported by the founders’ expertise in human factors engineering for bioastronautics applications, the team is shepherding their medical device through the US Food & Drug Administration review process. We have a front row seat in how they are managing the translational process of medical device design and development.
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Show Notes
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In one sentence: A needle shaped like a hockey puck is a ‘revolutionary’ medical device that can deliver epinephrine during a severe allergic reaction on Earth or in space.
—————
Overview
—————
EpiPens and other emergency auto-injectors have changed little for decades, though there are known limitations in their accidental (mis)use. Conor Cullinane, co-founder of Pirouette Medical, shows us his team’s surprisingly non-needlelike auto-injector that is shaped smooth, flat, and round, and easily totable so those at risk can have, in the company’s words, “freedom without fear”.
Following a patient-centered design process supported by the founders’ expertise in human factors engineering for bioastronautics applications, the team is shepherding their medical device through the US Food & Drug Administration review process. We have a front row seat in how they are managing the translational process of medical device design and development.
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Show Notes
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It's very intimidating, very anxiety-driving, very fear-driving, and all of these things add up to where when we were looking at our study of patients that were just using trainer devices in a calm, clinical setting 15% of these individuals refused to actually try and perform an injection.
Announcer:Welcome to Tough Tech Today with Meyen and Miller. This is the premiere show featuring trailblazers who are building technologies today to solve tomorrow's toughest challenges.
Forrest Meyen:Welcome to Tough Tech Today! We have a special guest, Conor Cullinane. Conor is the CEO of Pirouette Medical, a company that is making a revolutionary new auto injector device. Hi, Conor, welcome to the show.
Conor Cullinane:Hey, Forrest, thank you for having me. Thank you, Jonathan. It's great to see both of you and get to share a little bit about my journey.
Forrest Meyen:So Pirouette Medical, what kind of company is that? Do you make some sort of medical ballet slippers? Or what is what is your company about? Why did you pick that name?
Conor Cullinane:Yeah, so that's a great question. One we we often get, I think a lot of people are always intrigued by the name, we found it to be very helpful. As far as its origins and what the company does, we are a medical device manufacturer and design company. So we found a need in in the medical space, we developed a device to meet that need. We're currently taking that that design, to practice manufacturing, and then through FDA approval, and onto the market. That's the overall process of what we've set out to do as a company. Why Pirouette Medical? It is based on the actual dance move a little bit. So what you know, and you do a pure wet, it's a it's a revolution, it's a spin. We like to play on that a little bit because of the the design of our device, as well as, because of the connotation that it has with that revolution. We saw what we were doing as very different than what had been done before. Rather than saying we're revolutionising that space, we like to say that we're making a pirouette in that space. I really liked the name and, and we've, we've, we've definitely had a great time, sort of leading with that and continuing to keep that thought process. As we look at different technologies, or different applications of our technology, and really focus on continuing to make that revolution or that pure wet in, in the medical technology space.
Jonathan:Thank you for explaining that. That's a nice tie-in in terms of the way that the device works and the philosophy that you have for the company, for our listeners and our viewers. Could you elaborate on the problem area that you had identified, you mentioned that you found this opportunity in the medical space? Could you elaborate on what that is, why it's important? Why we should care?
Conor Cullinane:Yeah, you bet. It was at a period of time when I was completing my PhD, and essentially, came across a couple of news articles over a very short period of time. So you know, one day I basically read an article about a child who was exposed to a light, a life threatening allergen, I think the the first article I had read was a exposure to a peanut at a school cafeteria, the child unfortunately, didn't receive a life saving dose of epinephrine in time, and, and unfortunately, passed away. And so it's a very sad story and, you know, something that popped up and, and, you know, be my so my PhD focus was medical engineering and medical physics. And so, you know, sort of a space I was already really interested in, and, you know, it definitely struck a chord. And, you know, a couple of days go by, and I, all of a sudden see an order another article. And it's another child who was exposed to an allergen, in this case of the sting out playing in a field at a park and didn't receive their life saving dose of epinephrine in time and unfortunately passed away. And, you know, one of those articles, you see that and it's, you know, whoa, you know, something, something is is wrong here. And then you see two of those in a matter of of days, you know, this was all within a week. And it's like, okay, let's, let's take a look here and see what's actually going on. You know, it's, it's tough to hear it, that, that that's actually still happening. And so we started to dive into that that aspect of a medical device that really didn't seem to be solving the problem that it was really there to solve. And, you know, our thought process was, well, well, why why didn't these children receive their life saving dose in time, you know, it's, it's very evident, you know, how they became exposed to an allergen, you know, you're never going to be able to escape those 100%, you know, you and your family and your parents or whoever can do everything they can to protect you from exposure. But oftentimes, those exposures happen at a time when, you know, you have you have no idea and no expectation. And so our initial thought process was, Well, hey, this is a, this is a portability issue. And so we looked at existing injection devices, and we said, they're too big, they're too bulky, they're too hard for, you know, a 12 year old kid to carry around and try and remember it, when they go anywhere. And that's, that's sort of where we started
Jonathan:Is injection, the only way to mitigate these effects, once the allergies are occurs, the reaction?
Conor Cullinane:Once the allergy occurs, the the current emergency treatment is an intramuscular injection of epinephrine. There are other treatments on the horizon. There are other companies looking at ways in which we can have other emergency treatments that could potentially mitigate these these issues. But currently, that's the, that's the only way, we have to save a life in this in this scenario. And, you know, you you hope that when you're exposed, you're you don't have a severe enough allergic reaction, that there's going to be a life threatening issue. But unfortunately, that's not always the case for everybody. And oftentimes, the individuals who have these These reactions that are life threatening, those situations are extremely rapid, as well. After exposure, some of these individuals can actually pass away within five minutes, if they don't receive that aboard of the life saving dose in time. So it's, it's extremely scary, and you and you can start to think about, well what needs to happen during that period. You know, if let's say you've got your device in a backpack, or it's in the glove box, or your car, or wherever it is, right, you first have to find the device, then you have to get it to the individual that needs it. So if it's yourself, you know, you've got to find it and, and then be able to use it on yourself, if it's a parent with a child, they need to be able to dig through that backpack and grab it or, you know, run back to the car and grab it, bring it back to that child and then use it and five minutes is not a long time. Right and, and, you know, it's it's a very scary scenario. And, and one of the big things that we really started to figure out, as we went out and talk to patients and potential, you know, users who rely on these devices to save their life is, you know, a huge part of their life is just filled with constant fear. Because if you're allergic to a bee sting, or if you're allergic to a peanut, you don't know when you're going to come into contact with one of these things. And so, you know, you could be out mowing the lawn, you know, I have a really good friend who, who is severely allergic to bee stings life, they're in one of these life threatening manners, just like we were talking about. And he has been out mowing the lawn before, was stung by a bee and, and barely survived. And, you know, this is an individual who actually did perform an injection on himself, actually carries currently carries an epi pen and carries that epi pen on a holster on his on his belt. And so, you know, if, if you're thinking about, you know, this is an adult, right, and they're, they're constantly in fear of a situation where they might need a life saving dose so much to the, you know, to the extent that they need this on their belt, you know, no matter what they're doing wherever they go outside, right, because a beak, you know, could get them at any point. And then you think Alright, well, you know, as a child going to have that same discipline to make sure they have that and that's where it starts to get really scary and sort of dangerous as you you look across not everybody has that discipline. And he he if he didn't have it with him that close it would have been fatal. So it's it's extremely scary for these individuals. This problem has been around and since since since humans have had severe allergies and so what then gap Did you see to be able to make a A one and novel medical device for this patent of patents were granted and pending, and then began wrapping a company around it, because that's a whole different thing of here's a problem, but then coming down the path of finding a way to be reimbursed for this kind of medical engineering that you're doing. Exactly, yeah. So when we started to, to initially Look at this, this landscape, and the current devices that were there, you know, you can kind of trace it back all the way to, you know, when injection started, and, you know, the first types of devices, which were really syringe like, and then you kind of have the full blown syringe safety syringes, those sorts of things. And they developed, you know, over time to the point where, you know, providing an intramuscular injection is something routine can easily be done, but this is really healthcare provider dependent, right, you're, you're, you're receiving an injection by somebody who has the training to provide that injection, right, you're dealing with a needle, you're dealing with a syringe, you're dealing with the drug, you have to get all three of those components together, you have to get it, you have to get the drug at the correct volume, the correct dose, right. And then all of that has to happen in one of these, you know, high stress, blood pumping environments where, you know, you use somebody's life is on the line. And so you come from that, that sort of preliminary world where it really works great for, you know, a lot of the early injections, but in an emergency use scenario, it really wasn't cutting it. And so then, in the 70s, there, there was the development of the auto injector. And so, you know, this essentially was the automation of the use of a syringe. So that's sort of kind of how this technology came to be. Right? You know, you, you have all this fear. And this anxiety associated with overcoming the use of existing technology that was such a barrier, that at home delivery of these injections was was, especially on a mass scale, you know, we're talking about today, 10 million devices a year or more, you know, is was prohibitive, right. And so then, you know, the auto injector came around, and it was essentially, like I said, that automation of that injection. And, you know, you really can think of those technologies as just that you basically have inside of those technologies, the needle, the glass vial or syringe that's actually holding the drug, you know, a plunger, the stem. And when I say that's automated, it's basically got has a big spring that sits on top. And when you try to perform, when you go to perform the injection, you're basically releasing that spring, the spring pushes that needle down, it pushes the plunger down, forces the drug out of the needle, and you're basically, you know, automating a syringe, right? So it's a, it's that sort of how that technology kind of in a in a, in a very iterative way came to be right, it was trying to try to take that injection out of the healthcare providers hands and place it into the, into the patient's hands. That way at a time when you know, you're, you're, you're in that life threatening scenario, you try and remove as much guessing as possible. Well, what we found out was, you know, even though these technologies are somewhat solving that problem, they're not completely solving that problem. So, as you mentioned, it's difficult for, for kids to use the current system. Yep. Yeah. So that's what that is that the big pain point that you've been addressing is making this so like 10 year olds can do a self administered auto injection. Yeah, so our thought process is sort of a, you know, basically three pillars. So we think about affordability, portability, and usability. So if I take you through all three of those, it really describes sort of what the current issues are, and, and why we saw a space in that market for what we developed. So on the affordability side, you know, there has been a lot of talk especially in this epinephrine space about the increase in price, especially over time in the United States, where you know, the the epi pen got to a$610 price tag for a two pack, right. So you you Yeah, exactly. So you have these devices, which are essentially springs plastic, and what is a, you know, a 15 cent syringe? Like, it's like the cost of the drug in there. Yeah, exactly. And, you know,
Forrest Meyen:In your pocket!
Conor Cullinane:Exactly, and, and, I mean, so this is a, it's still a price that most people aren't paying with insurance and things like that, but, you know, your out of pocket prices are still just extraordinarily high. One of the things that's interesting there from the affordability side is, even if your insurance does cover One of these epinephrine auto injectors, oftentimes families want more than what they're capable of purchasing on on their health plan. And so, you know, you have individuals that, you know, want to have one at their neighbor's house want to have one at school want to have one in their car, right. And so you're left with buying them on your own at a at a cash price. And, you know, there are ways to get coupons and discounts and things like that. But, you know, it's, it's, it's very difficult for these families to have to focus on that, and, and then it becomes a yearly purchase, right? It's, you know, my kids going back to school, I need to buy another one of these, you know, I throw out all of the ones that we didn't use last year. So I why why do you have to throw them out? Yeah, so that that's something that is sort of another wrinkle to sort of big issues that that current patients have with with devices, and that's on the, the actual shelf life of the device. So epinephrine is a pretty finicky drug, it's susceptible to degradation in a number of ways. One of those is temperature excursion. So if it's not at room temperature, if it gets too hot, or it gets too cold, the efficacy of the drug can actually go down. If it's exposed to oxygen over time, you know, you've got that plunger and the glass and the needle. And if any of those seal off points around the drug during your, you know, year of storage, have leakage of oxygen, then then the efficacy of the drug will will degrade over time. And so, you know, if you look at an epi pen today, there's actually a window on there, where you can look in and you're, you're you're actually supposed to inspect the drug or be able to inspect the drug prior to performing an injection, and what you're looking for while you're like, suffocated, and stuff you're supposed to like, exactly, exactly. I mean, what you know, though, the hope is that you have patients who will routinely look at their device, you know, take it out and say, okay, you know, it's still good. Let me look at the expiration date, let me look at the drug. But we all know that's, that's by and large, probably not happening. And so, you know, and then do you expect a patient to be looking at the the drug for clarity and color, right before they're performing injection to save their own life or somebody else's life in a five minute, you know, maybe five minute window? Probably not, right? And so. So what happens is, it just becomes a cycle and you say, you know, it's gonna last me let's say, this year, I'll throw them out, I'll get a new one, right. And then you start facing that affordability piece as well. And so, you know, I broke it up into those three pillars, because we tried to think about the patient experience. That's really what purohit is all about, you know, what, what issues does the patient have? And how can we resolve those? And so, you know, it goes all the way from procurement on this, on this affordability side to the portability piece, you know, how can they bring it? How can we make it so that it's easy for them to bring it wherever they go to the usability side, when it when it comes right down to the final? You know, okay, this is it, I need to perform an injection, how do we make that easier as well. So we've talked about the affordability side, a little bit about the, the the shelf life and, you know, the actual stability of the drug and, and how that that actually plays into more of the affordability piece as well. And you know, if that can be extended, and that's helpful. When we go to the portability piece, that's actually where we've we first focused, it was, you know, kind of why we started pure wet, it was a, it was a thought process on. All right, the existing devices today are fairly bulky. Most individuals that are prescribed these devices are told Hey, carry too, especially for reliability purposes, when you're when you're talking about a device that may malfunction. Or if the efficacy of that drug has reduced, it may not actually save your life. So carry too. So if you inject that first one, and it doesn't work, go ahead and inject a second, right? And so you think about one of these devices, which is about six inches tall, it's a long, you know, one inch wide, pen shaped device. And then there's kind of this s clip that will pair two of those devices together. And then you're supposed to stick that somewhere, right and be able to take that with you wherever you go. And I told you I gave you the anecdote of my friend who
Jonathan:One thing is that, as you describe this, you make it sound like it's obvious that this is something that could be changed, but I'm sure that when you when we backtrace to the past 'you', you mentioned that there's a patient-centered design process, like human factors engineering, and that's something I think, would be really interesting to understand is the process of how did you start you and your colleagues figure out that this is a problem that needs solved? One thing is seeing the problem, and one is the discovery of that. Then how to figure out a decent solution or in this case, a really clever way of addressing those human centered challenges.
Conor Cullinane:Oh, you bet. Yeah. So we we did it in two ways. So essentially, we started with what do we think the problem is based on our understanding of the, of the current landscape, the current devices just sort of looking there? And like I said, we started with portability. We're like, these things are huge and bulky, you know, how could anyone carry them around? And so we're, we basically thought, alright, how can we make an injector smaller? But, you know, your question is a little bit bigger than that. And it's, it's very interesting as well, because you start to think about well, you know, I was, I was telling you guys how these were around in the 70s. Right, so now it's, you know, 2017. Back, which is sort of the time I'm referencing, we started to talk about this portability issue. And it's like, Alright, well, you know, obviously, there's an issue with, you know, making these devices smaller, how come nobody's done it. And there, there's quite a, quite a bit that goes into that. Some of it is really this whole sort of iteration type design, where you've got something that's working, and it's like, how do we make it a little bit better, you know, these guys have an auto injector, let's make an auto injector. And then if you start to compare all these auto injectors to each other, right there, they look the same, they feel the same, they sort of work the same, they have the same general shape. And, and a lot of that came from Well, it's working, you know, to some extent, we with the epi pen, for example, by 2016, they had captured over 97% of the market was something that was, you know, essentially not the perfect solution, but a solution. Right. And so why change that. And so, so there's, there's a little bit of that, and then there's a little bit of iteration,
Jonathan:Iteration wouldn't be a way to get to get on the path toward having like a really innovative solution, or do you think that iteration is absolutely sort of a prerequisite activity? that could lead to a really kind of game changing medical device translational engineering?
Conor Cullinane:No, I think it was really an economical decision of how much how much R&D do we want to put into this when we're already capturing huge percentage of the markets, and it's already shown to work. And I think you're right, you know, iterations are great. But at the end of the day, if you want to have a giant leap in this sort of change in technology, or, you know, as we describe it, this pure wet and technology, you kind of have to start with a blank slate, which is what we did, and we and to go back to sort of that human centric design that you were referring to, we love that that's what we focused on from the very, very beginning. And I mentioned earlier, we sort of did that in two ways. So the two ways we did that were the first was by performing patient surveys. So we literally tried to contact as many patients as possible, who rely on these devices have who have used all the various types of existing epinephrine auto injectors. And we basically performed 1000 of these where we, we, we developed a survey, we went out, we tried to get them completed, and we said, you know, what device do you use? What do you like about it? What don't you like about it? You know, obviously, it was a lot more questions than that. But that was essentially the the basis of what we were looking for, right? You know, what are your issues with existing devices? And then can we take that information and build that into our design requirements? And then start with a clean slate and say, how do we solve this problem? Not how do we make a little bit better device than this one that exists already so so we did that. And then we also performed we we brought a advisor on board who's a Board Certified allergist, who you know, prescribes these epinephrine auto injectors on a on a daily basis. And he often spends a lot of time training patients on how to use the device. He works with children, trains them on how to use it trains their parents on how to use it. And so he sees a lot of the pitfalls with existing devices, what do they do wrong with it? And so we worked with him to conduct sort of a small study where he was basically handing a trainer device of the existing technology to these patients saying, Okay, go ahead and perform the injection. And then monitoring, you know, okay, if they if this was a real device, they would have done it right. Or they would have done it wrong, or they would have done it, you know, if they did it wrong, here's what would have went wrong. And so, two of the things that we've so I guess we found a lot of information that we really hadn't thought about I mentioned we were sort of really focused on this portability piece making the device smaller, but we built out so much more than that. When we really talked to these patients and found out, you know, everything that they were, they were really thinking about. And I kind of alluded it alluded to this earlier. But really what we discovered was along that entire pipeline from procurement, to maintenance and bad maintenance, I mean, bringing the device where you maintaining it wherever you go, and then actual administration of that of that election. Along that entire process, there was essentially this overarching, what we describe as fear and anxiety. So patients were worried about how they're going to pay for it, how they're going to procure it, they were worried about how do I bring this with me wherever I go, what happens if I, if I come in contact with it with an allergen like a bee sting, and I don't have it, you know, what it what it? What are the options for me there, and then I'm super scared to use this device. And that was where we really, it really started to dawn on us that like, okay, you may have removed the health care provider. But you really haven't made this mainstream, so easy to use, that you've removed that anxiety and fear. And there still is quite a hurdle that these patients have to overcome, to go through the process of performing an injection. And even if they overcome that hurdle, we see problems that arise even at that stage. And so from that usability piece, we really focused on two injury mechanisms that can occur during that process. So one of them is an accidental injection, where the device is used upside down. And they can actually get a needle into their thumb, for example, we also call that the last dose hazard, because you know, you're not necessarily going to be causing much health risks, you you do have a lot of vasoconstriction, because of the epinephrine drug that will happen in that location. And you do have to oftentimes treat that thumb or other finger or other digit that gets that injection. But at the end of the day, what the what the scary pieces there is if you're, let's say a dad, and you're injecting your child, you know, who just got stung by a bee. You swing this thing, and you've got your injection into your thumb. And we call that the last dose hazard, because now that child doesn't receive a dose, and they still are in a life threatening scenario, right. So that's very scary. And now you basically have two patients instead of one. And the other mechanism we looked at the injury mechanism we looked at was lacerations, which is where you basically have these tall skinny injection devices, and you try and perform an injection, it's very hard to control the position of that injection. So if I, if I show you, you know, my pencil here, right, this is typically how you're holding a pen injector, right? And so you're basically making this motion, it's contacting the injection surface, and the needle is then then going down into the tissue. But you can see where my hand is several inches away from the injection site. And it's, you have very poor control over the actual needle. And what happens is, oftentimes, that injection system can slide and you're dragging a needle through tissue causing a laceration. And what we often see is a V shaped laceration, where the first cut happens, and you try and correct for it, and you actually cut in the other direction. And so it's it's, you know, very intimidating, very anxiety driving, very fear driving. And all of these things add up to where when we were looking at our study of patients that were just using trainer devices, in a calm, you know, clinical setting 15% of these individuals refused to actually try and perform an injection out of fear and anxiety alone. And this is something we never thought trainer device with a trainer device. So there's no needle, no drug. And 15% of people said, heck, no, I'm not doing it. It's too scary. We actually had reports from that study where there were children running out of the room, because they didn't want to receive an injection. And, you know, if you're, if you're performing an injection on yourself, it's often a little bit easier to maintain control over the injection device, because you kind of know where your leg is going and what it's doing. But if you're trying to perform an injection on a child who's so scared that they're ready to run out of the room, imagine trying to swing this thing onto their leg and hold it steady with your hand several inches away from that injection site while the child is pulling their leg away, right? Yes, it's almost impossible. And so you see research articles now that actually talk about, you know, hey, if you're going to perform an injection on a child, you know, with one of these devices, you're basically putting them into a you know, WWE wrestling move in order to lock all motion, and then try and perform that injection. It's just, you know, as we sort of see it, not an ideal solution. And so that's really...
Jonathan:This is a great characterization of the problem and what I think a lot of people even today experience. Do you have a show and tell, of what you have, because it is fascinating and it does not look like a needle or anything like that it's completely different. It's like a hockey puck.
Conor Cullinane:Exactly. So I have one here. And as I show it...
Forrest Meyen:Can you demonstrate on yourself?
Conor Cullinane:I can't demonstrate it today. The version I have is a is basically a show device for for giving pitches and talks and things like that. And unfortunately, right now, with us working remote, the devices that we have that are currently functioning are actually at my CTOs office, and I wasn't able to get one in time for this for this demonstration, but he so we have reduced these to practice. We have the devices, you know, delivering the drug with the needle extending and but unfortunately, those those fully functioning versions of the device are currently at at his office. So but I do have the device that will show you that process. And I'll walk you through, you know how that how that would work. And so to give you sort of that high level view again, you know, we thought about affordability, portability, usability. And as we talk to the patients and perform these studies, the things that we thought about were the patient anxiety and what drives that anxiety, all of those pain points that built up towards that overall patient anxiety, and how can we change that total patient experience? So you know, you're exactly right, our device doesn't look anything like the existing technologies, it's, as we describe it, sort of a low profile disc, you mentioned a hockey puck, we used to call it a hockey puck all the time. But what happens is, people think of, you know, the size of a hockey puck, and they're, you know, it starts to grow in their mind about how big it is. And you know, if you see it in my hand, it's it's not as big as a hockey puck, it's a little bit smaller. But we tried to find a happy medium as well, because you're gonna have people who, you know, need to manipulate this device, at the end of the day, you obviously want it to be as portable as possible, throw it in your pocket, take it wherever you go. But at the end of the day, you know, somebody needs to operate the device, use it to administer an injection, and to do that, you know, it has to be at least, you know, a certain size to to manipulate the surfaces. So the way it works, right, it's like a Canada tobacco, you know, just put it in your back pocket. Yeah, exactly. We got a way to sell it to the kids. Yeah, in terms of size and shape, it's very similar. But yeah, you know, it's in that regard, I think, talks, you know, to the points of portability. In terms of usability, we tried to reduce the process to, you know, what we saw as low barrier steps, as well as highly controllable steps so that at no point were we driving anxiety for the patient. And our whole thought process is if if somebody walks by who's never seen our device before, they can pick it up, read the visual instructions on the top, so we have the graphics that represent those three steps, and say, Oh, that's easy, I can I can do that. And I can save this person's life, you know, with with their device in their pocket, right. So that was the that was really the push on the usability side. So what you actually do is, and, and the Compare and contrast piece, we basically took those tall, skinny devices and went to a short, flatter device, right. So it kind of will remind you more of a of a patch pump type injection system, but the big difference is, rather than like a subcutaneous injection, we're still fully intramuscular. So even though our devices low profile and much closer to the injection site, we're still hitting that intramuscular injection depth. And which, you know, brings us back to that direct comparison with the, with the auto injectors of today, right so So essentially, the three easy steps that we go through are twist and remove this safety plate, so there's a red safety plate on the bottom. After you twist and remove the red safety plate, you place the injector down on your injection site. In the case of epinephrine, we're talking about the vastus lateralis. So you're sort of top outer thigh, just so you guys can see it. I'll sort of demonstrate it on the deltoid intramuscular location, but essentially you would remove that safety plate, and then you're going to place the injector on to wherever your injection site is for you guys. I'll use my deltoid to demonstrate the injection. So basically you twist or remove the safety plate on the bottom. It's a very easy twist motion. there's a there's a lot of narrowing and ridges on the device and places for your fingers to hold. Once you once you do that and open the device, it's already correctly oriented in your hand for placement on the injection site. So you would just place it and we actually could say use the term apply it, apply it to the injection site. And one of the unique characteristics of our device in comparison to the other injection systems is we have this large, flat surface area that comes into contact with that injection site. And so what we did there is we actually covered that injection site with a with an adhesive. So we're helping hold that device on location in a number of ways. One is that form factor being low profile and close to the injection site. You know, we talked about having your hands several inches off the injection site before now you can sort of see, you barely can even see the device, right? If I move my fingers, you know, there it is. But if I place my hand on the device to perform an injection, you barely see it, you know, and now my hand is basically flat and pushing up against the injection site, I can actually grab on to my arm and pin that device in between. and at this stage, you simply push down. So it's easy steps, remove the safety cover, apply that device onto your injection location, and push down. And one of the really unique things. Yeah, so we kind of, you know, we don't want to get in any copyright trouble. But it's basically like pushing a big easy button, right. So, you know, we really describe it as trying to reduce the administration of performing an injection, the administration of injection to as easy as pushing a button. And really, that's what you know, the whole process was driving towards by reducing that anxiety, making it so simple. And one of the unique things is when I when I push down to perform an injection, that force that I'm pushing down with is not actually pushing the needle into the tissue, it's not forcing the drug out of the device, it's simply activating the device. So no matter how fast you push down, how slow you push down how hard you push, all you have to do is bottom out that device, then when you when you push that button down, the device is going to perform the injection for you with a tuned amount of force every time the needle is going to extend to the same length to get to that at that same intramuscular depth, the same amount of drug is going to be delivered, right, so all the guesswork is gone, all you've got to do is push down and it does everything else. After a year you let go of that device, it actually pops back up to its height before you push the big button. And it locks out completely. And three flags appear circumferentially around the device, with a big red flag with white letters saying used, one of the things we wanted to avoid is the issue that we learned about when talking to patients were devices that they have previously used and then put on the ground, someone will come by and have no idea that that device has already been used and try and use it again. Mm hmm. So this device locks out, you can never push it down again, you never see the needle before you never see the needle after which also removes anxiety, it's a much less assuming shape. So you know, one of the things we heard from patients as well was, you know, the whole thing looks like a needle to me, it's super scary. So we tried to remove that as well. And it all kind of you know, was able to build together into you know, the device was smaller to begin with, it was lower profile that had benefits for portability that had benefits for usability. And then at the end of the day, we call it an elegant design, because it uses as many standard off the shelves, technologies in the pharma industry that are already used today, we tried to streamline that entire process, we tried to streamline the manufacturing. So you know, you have this improved functionality. But you don't have big cost drivers behind that. So you're in terms of your cost of goods, you're basically the same as other injection technologies, but you have this leap in functionality. So that's why we call it sort of an elegant design as well.
Jonathan:This is really clever engineering, though, as we've got engineers in the room here. We know that to build something cool in an elegant design, there's, there's a satisfaction in that. But that's also not the only battle that you would have to be able to translate this to be able to work in the market to get it like if I were a loved one could benefit from this kind of device. Can I get it now? And if not, what's the what's the pathway that you're pursuing to be able to get it to people who need this?
Conor Cullinane:And that's always something that, you know, is is always tough for us to hear, because we'll talk to people who, you know, rely on these devices. And they you know, the question is, you know, when can I get it and, you know, at the end of the day, it's a it's a long road for medical devices. And what we have here is a combination product. So it's a, you know, injection technology that we've paired with a specific drug and that has to go through regulatory approval, and when we're talking about here in the United States, that's FDA approval. For our specific device to dive a little deeper there, we're talking about a sort of streamlined pathway, but it's still, you know, a very rigorous pathway. And well, it should be, you know, it. And so there is a lot of time and a lot of money that goes into taking a device from reduced to practice to a point where, you know, it's safe and effective for consumption by by the the patient, right. So, you know, we we were not, you know, I, I would say we're not against going through these steps, it's just that it is a process that takes a lot of time. And that's the hard part, when we're talking to patients, we tell them, you know, is a great device, it's on the way, but, you know, there's a lot we have to do between now and FDA approval and going to market and bringing you this device. And so, to give you a little bit of perspective on what has to happen is so, you know, we we talked to the patients, we performed our studies, we, we took all that information, we put it together, and we set that into our we were able to convert that into design requirements. And then we go through our preliminary design, our detailed design, we go through a lot of iteration in that design based on putting some of those early concepts, early prototypes in the hands of the patient. So these are all things pieces of the this pipeline that we've done. And then based on that information, we went back, change the design to make it even easier. And that's how we got to these, you know, three super streamlined, easy to overcome steps. And the form factor that we have today, not making it too small, but making it something that people can actually, you know, work with and handle, especially if it's a patient that, you know, may have limited dexterity or whatever. So you know, all these things that continue to come up. And then we look and we took every single component. And we went to potential manufacturers and we said, Hey, you know, what would it cost to manufacture one of these? And how would you do it? What would it cost a manufacturer 1000 1,000,010 million, right? And you go through that process of what are the cost drivers? And, you know, can we change or remove those major cost drivers while still maintaining the reliability and functionality of our device. And so we did that on a component by component level. And then we went and now we're going through that process on a larger scale, which is a sort of manufacturing and assembly scale, where we're actually going through these process developments to understand, you know, okay, we can do this with one device. But can we do it with millions and millions of these as we would continue to scale this out for epinephrine or a future application. And so, by doing that, you know, we continue to increase the elegancy of the device, you know, the reducing the cost on a per component basis, but also on an assembly basis. But from here where we have to go after this, the stage that we're in right now, which is going through that process development for that large scale, manufacturability The next step is to go through basically a full litany of testing that is required by these regulatory agencies in our case, you know, we're talking about the FDA, for example. So, you know, there's certain tests that we have to perform, which are, you know, as we describe them, kind of into in different buckets. But some of that is what we would describe as human factors, which you which you sort of alluded to Jonathan earlier, which is, you know, okay, you know, you went and asked the patient, what they wanted, or what they didn't want, and then you set that into your design requirements, and you built something, but how do we know it's really addressing what they what they were targeting. And so that piece of testing is literally putting it in the hands of a user and saying, I'm not gonna tell you how to use it, you go and use it, and we're gonna watch you. And basically, it's the, you know, the classic one way mirror, right? And you're, you're in a scenario, whether it's a school cafeteria, or whatever, and that users basically left to their own devices to you know, either have the device sink or float, you know, did it work the way we work?
Forrest Meyen:They're left to your devices.
Conor Cullinane:Yeah, they're left to our devices yeah, exactly. So that'll be a big and exciting step. And one of the reasons why we did a lot of sort of some of that iterative testing early on, because we wanted to know going into that, you know, hey, you know, we want to be pretty confident that this is going to be successful when we get far along in this in this adventure. So, so that's a big chunk of the testing that has to be performed and all that data has to be collected. Then, and presented to the regulatory agency for approval for approval. And so and that's one piece of it. Then another another piece is actual device performance testing, you know, does the device perform exactly the way you said it's going to perform? And does it perform that way over and over and over again, when we're talking about a, a emergency device that's going to be used to save a life in those five minutes. There's a very high bar for reliability. And, you know, you heard me mentioned before that a lot of these devices, they say, hey, carry two of them. If it doesn't work, the first time or the efficacy has dropped, you know, inject a second, we're talking about trying to have such high reliability that, you know, you could potentially just carry one number would that be like, one in 100,000 failure rate, or what? Yeah. So it would be a lot better than that. So we're talking about what we describe as five nines of reliability. So that 190 9.999%, so to actually hit that, you know, you're talking about, you know, specific statistical methods in order to look at that sampling for your testing. And you're talking about very extreme reliability. So, you know, one of the things that you can already, if you start to think about that process of developing and manufacturing these devices, you could really already basically just remove humans from that process. Because if you put somebody in there who's assembling one of these by hand, you're, you're gonna have a hard time hitting high reliability levels. And so, you know, this is this is a computer automated process that's putting devices together. So a robot has to assemble the entire device. Yeah, not only that, but you're going to be checking subsystems throughout that entire assembly process. So, you know, your, your devices put together, you know, via complete automation. And at the same time, each of those steps are verified, you know, whatever that that method is, you have to make sure that, Okay, this one that we just put together was put together correctly, right. And so you, you basically have those in process checks throughout that piece, as well, which is, you know, it's a, it kind of gets back to something that's on the top of, of all of this, which is as a funding piece, right. So, you know, it takes a lot of time to perform this testing, it takes a lot of time to, you know, go through putting that data, you know, into a format that needs to that's easy to be reviewed, easy to be understood, easy to be seen, you know, you take a lot of time in the manufacturing process, you take a lot of time in the design process, all of it's a lot of time, but you know, it's also a lot of money. And a lot of upfront capital, the, you know, fully automated assembly lines aren't cheap, you know, in general, when you're talking about a combination product, the ballpark I like to throw around is, you know, $70 million in 10 years, right to develop one of these types of devices. So, it's very, it's a very uphill battle. Where us being a smaller, you know, more nimble company, we try to undershoot both of those, so, you know, do it faster and do it cheaper. And, you know, a lot of that relies on us as founders, you know, and, and employees to, you know, figure out ways in which we can do things ourselves rather than outsource. And one of the reasons why I love having a founding team that's made up of engineers, you know, with with great engineering backgrounds, as you know, we didn't have to outsource that early design process, we knew and understood human centric design, we knew and understood that combination of humans and system. And you know, where does our device lie in that process? And how do we actually design each of these parts? How do we design the total system? How does it get put together? And, you know, if you outsource that you're talking about a lot of time and a lot of capital that's required, in addition, and if you can do it on your own, you save a lot of that you can stay much smaller earlier on, which we which we tried to do and remain capital efficient through that process.
Jonathan:The relationship with Covestro, is that to help on a sort of manufacturing, and some of the say the tactical aspects of the design life to the point of like figuring out which kind of plastic is useful that maybe you that your founding team of engineers may not have had known that certain types of polymer chemistry that would work for this middle grade medical grade kind of application. Why a partner with a large company like this, was that the only pathway available?
Conor Cullinane:That's a great question. One of the sets of testing that we didn't talk about beyond sort of that device performance testing is looking at the materials that are actually in your device and making sure that those aren't going to irritate somebody's skin or affect, you know, effectively cause a reaction where we're trying to save a reaction, right. And so one of the things that we can do by working with one of these resin suppliers is basically say, okay, we need it to be medical grade from the beginning. And already that D risks a huge portion of that downstream testing, because that plastic material has already been shown, has already been shown to effectively pass that testing. And then by combining multiple types of that plastic material, we know that we're not introducing any materials into the device that are going to harm a potential patient. So we start there, but then you're the exactly what you mentioned, which was, you know, can we also rely on their expertise to say, okay, hey, we need a part that looks like this, here's how we designed it. And here's the forces it needs to stand up to needs to be medical grade, what do you got, right, and so they can come back and say, hey, we've got these two resins, that can withstand the huge forces that you're talking about, you know, and then fit all the rest of your requirements. And that's, you know, I, I love the video you're alluding to, because I'm not sure where I came up with that on the fly. But I said, you know, essentially, what we're trying to do is pack a little punch into a big punch into a little package, right. And that kind of goes back to what I had mentioned before, with the existing devices being these big, tall, skinny devices that have these huge springs, and they're basically pushing a ton of force through to get to the intramuscular space, it's not easy to have to have an automated system to deliver a needle that deep into the tissue, and then get your drug to bolus through. We cut off this device an inch above the surface, and we still need to get down to that depth. And so, you know, some of our our parts that are smaller, because we're in a little package, need to withstand fairly large forces in order to do what we're asking them to do, and reliability and reliably and not fail. Right. And so that was sort of that relationship there. It's like, you know, we need some really good resins, what do you have, and that was that,
Jonathan:I think that's something really important and for fans of the podcast, the YouTube channel, it's that if you're looking at medical device design, and you mentioned earlier that, you know, we, we pretty much had to start with a blank clean sheet designed for this kind of problem.
Conor Cullinane:Yeah.
Jonathan:But the the asterisk on that, I'd say is that it's a clean sheet with both some very specific sort of design criteria that you're thinking of designing for manufacturability. And so that we do have a down selection, it reduces your sort of search space, which is really helpful to to be able to come up with a new type of medical device. And so I'm curious then, given that you're hitting targets on like, reliability, durability, shelf life, and affordability, how have you considered not just, you know, working with the FDA, of course, for, say, the United States market, but also in some of the perhaps lesser developed or less mature medical ecosystems around the world are there because I know I've talked with medical device companies that are like, oh, we're gonna test it in somewhere else, and get a lot more sort of clinical numbers earlier there, and then come back to the FDA.
Conor Cullinane:In terms of our strategic vision there, it's a little bit different from, I'd say, a more typical med device space where, you know, that is sort of an option. And and the reason I say that is the first place we looked at, for a number of reasons, you know, not only because it was the first introduction into auto injectors, but the first place we looked is epinephrine, right? And there are, so there are a number of reasons why we're talking about the United States first. So one of them is the actual regulatory process to get an approval for an epinephrine combination product is a little bit more streamlined than just a typical combination product. And that's because the FDA sort of understands and knows about some of these existing issues, and wants to see more competition, it helps with innovation around the device, the functionality around the device, it also helps with affordability, you know, with with additional players in the space. So I think there is some pressure to see, especially based on sort of the you know, media coverage and political pressure, there's there's definitely pressure to see new devices in this space. And I think that's why we have started to see new devices in this space as well as you know, potential new incumbents like us are coming you're coming into the space. And then the other the other piece of that is the market. So you know, the United States today is In the vast majority, the you know, epinephrine auto injector market. And so we're pairing, you know, our pathway to approve, we're the pathway to approval with post approval, revenue generation capability and making our decision for FDA US market first.
Forrest Meyen:Is that because people in the United States have more allergies, or is it these products sell for more? Why is the US the biggest market?
Conor Cullinane:There are definitely different factors. Some of it is awareness, the actual prescriptions, the prescriptions are growing at about 8% annually. And that that really is based on sort of an A, A awareness of these of these allergies. And, you know, even if you're not an individual who's that five minute, a fatal individual, and you still have some allergic reaction to it, oftentimes, you'll still be prescribed and injector. And so, you know, because at the end of the day, we don't know how these allergies are gonna be progressed. If you're stung by a bee one day, and you're fine. Or you're having an allergy, but you're, you're okay, and you can work through it with some Benadryl, for example, that doesn't mean that, you know, a month later, it's going to be that same process. And so, you know, there, there's that thought process there. And then, you know, one of the other big allergens that we talked about is allergens to medication. And we we have an elderly population as well, that takes a lot of new medication and a lot of medication in general. And those individuals are also often susceptible to severe allergic reactions with their, with their medication.
Jonathan:As we come to the to the top of our time together, Conor, you've been through a lot in this process. Is there some advice that you'd have for the past you, the up and coming engineer who's just hot, like, I think I might try to build a magnet medical device and save lives? What advice would you have to that person?
Conor Cullinane:Yeah, that's a really good question. So I think in general, some of the things that I did that were, I think, most helpful for me that, you know, it, which is advice that I would give is, you know, first of all, be patient, you know, these things take a lot of time and, you know, just getting the design done and getting, you know, reduced to practice, that's only the beginning. And we've talked a lot about that. So I think, you know, be patient is one another is surround yourself with people that can help make the barriers to, to the finish line. Lower, right? So if you can pair yourself up with somebody who's gone through this process before or, you know, you know, has been through the FDA process before, whether it's with a combination product or not, or, you know, has experience working with a lot of these larger pharmaceuticals, right, you know, all of that type of, of experience is really useful. And I think one of the things that we struggled with early on was, you know, hey, we've got a great new device, but we're going up against, you know, what is a thriving industry where there are a lot of large players who are trying to, you know, hold on to or grow market share, and we need to be able to play in that space. And, you know, it's going to be it, we need a lot of power in our corner to do that. So I think, I think that was, you know, something that I would, I would always say to somebody who's getting into this space is, you know, do your best to, you know, reach out to people who you think, you know, will will be really interested in what you're doing want to help you and can be effective in sort of reducing the bar that it takes to get to to the finish line.
Jonathan:One question or comment is that I understand this is a topic shift. Conor, I understand that you have a publication coming out the Encyclopedia of Bioastronautics, is that right?
Conor Cullinane:Yeah, it is.
Forrest Meyen:What is that?
Jonathan:What is that?
Conor Cullinane:I'll go back a little bit more and kind of just give you guys a little bit of a sort of more of a story of my background. I think that'll address what that is and why it's important to me. So I grew up in Southern New Hampshire, right next to a grass strip airfield. My window was looking at the airplanes go by all day. So I really was into into aviation. I wanted to be a pilot. I started by flying you know, a little RC planes and eventually went on to get my pilot's license and my undergrad degree was in aeronautical engineering. So you know, basically the basis of mechanical engineering, but you're really applying that to, you know, the development of flight hardware and, and, and planes in general. Right. So that was a lot of fun. And interestingly enough, when I was in undergrad, this was at Clarkson University in upstate New York. I, I also added a minor in biomedical engineering, I was really interested in the medicine side as well, I worked on a vibrotactile feedback system for lower limb prosthetics, you know, I was always really interested in that combination of taking the human body and medicine and combining that with engineering and and during that period, I started to think, Hey, you know, maybe I want to go to medical school and become a physician. But after getting involved in a lot of these projects, in undergrad, these engineering projects, I was like, you know, these, this engineering is way too fun, I want to stick with this. So I ended up going after a PhD. And I basically settled on what I found to be the perfect Ph. D. Program, which was it's called the Health Sciences and Technology program. It's a joint MIT and Harvard Medical School program, where, essentially, you're doing just that you're combining engineering with medicine, it actually came out of a conversation with MIT boosters who wanted MIT to start a medical school and MIT basically went through some analysis and said, Hey, you know, we've got Harvard Medical School right down the street, rather than starting our own, let's just collaborate. And the thought process behind HST was, rather than taking physicians, and trying to teach them to think like an engineer, so that they can solve problems in the clinical setting, they took engineers, and showed them the clinical setting and brought them into that world and, and allowed them to, you know, continue to think like an engineer and solve problems, but understand that clinical settings so that you know, what they're developing, didn't go to the clinical setting, and then just become obsolete because they didn't really understand that process. So it was really the marriage of the two which really fell into what I was doing. But as part of that program, you you're able to choose a concentration. My concentration was, of course, aeronautics and astronautics. So I was I was in the AeroAstro program at MIT. And then within the HST program, Health Science and Technology, there are two specialized training programs. One is in bio imaging, the other was what they call this bio astronautics training program, which is going sort of deeper from Aero Astro, it's the it's basically the human body in space. So my expertise after my PhD, and the work that I had done, there was really on anything that can happen and does happen to the human body in space. So I really was able to pull all that like love for aviation, aerospace, as well as medicine together at the right time. And actually, you know, one of my clinical rotations was with the flight surgeons at NASA. And I was able to do sort of a lot of really fun things during that period that, you know, it was just a blast got to work with the spacesuits, that was what my thesis was on, sort of developing a spacesuit, which was really that close marriage of the human body medicine and, and technology and engineering side. So it's been a lot of fun. But yeah, one of the things that I worked on while I was as part of while I was part of that program was the Encyclopedia of bio astronautics, which was basically an opportunity for me to work with one of the professors at MIT, Larry young, as well as with the National Space Biomedical Research Institute to and Springer who is publishing this, this, this work, as well as all the SMEs, right, the subject matter experts in these space spaces and, you know, talk to them on a daily weekly basis, take their knowledge integrated into this into this work, you know, and and that was probably one of the best experiences I had, you know, having the ability to interface with all of these amazing people who were the experts at the top of their field in bio astronautics, which I had, you know, just got my degree and, and, and help put this work together. So, yeah, it's very exciting.
Jonathan:That's so cool. Let's hope that maybe eventually close the loop and be able to send some of pure wet medicals, you know, medical devices up into space, because even though there might not be as many bumblebees up there, there may be, I mean, it's
Forrest Meyen:So it'll work in space, right?
Conor Cullinane:It will. And, you know, we're talking about epinephrine first, but there are there are obviously other applications that would be very well suited to an easy to use and portable injection system and I think mentioning, for example, space, there is a great way to just sort of wrap that all up into one and say there's plenty of other places that a technology like this can go as we think about, you know, how do we expand beyond epinephrine? How do we expand beyond the United States? And maybe how do we expand beyond the world? Well, that wraps it up for episode. Thank you very much for joining us today, Conor.
Jonathan:Thank you, Conor.
Conor Cullinane:I'm Conor Cullinane, and I'm one of the cofounders and CEO of Pirouette Medical. Stay tough!