Innovating for Health: Conor Cullinane's Vision at Pirouette Medical

Jake Aaron Villarreal: Welcome to our podcast, From the Ground Up, where we interview startup founders exploring their journeys, their success, challenges, and lessons learned. We hope you'd be inspired in discovering what it takes to build a thriving startup. I'm your host, Jake Aaron Villarreal, and here with us today we have Dr. Conor Cullinane, co-founder and CEO of Pirouette Medical. Conor, welcome to the show.

Conor Cullinane: Thanks for having me, happy to be here.

Jake Aaron Villarreal: Great. Well, Pirouette is a medical device company launched by rocket scientists. If that sounds exciting, make sure to listen to the whole episode because it is a fascinating story. A little bit more about Dr. Cullinane: he obtained a BS in Aeronautical Engineering from Clarkson University with minors in Biomedical Engineering and Mathematics. He obtained a PhD in Medical Engineering and Medical Physics at MIT and Harvard Medical School in the Health Sciences and Technology Program. While there, he also received a concentration in Aeronautics and Astronautics and was part of the specialized training program in Bioastronautics. His work, whether it's on lower limb prosthetics, spacesuits, or auto injectors, bridges a gap between the human body and tightly coupled medical systems. It's an incredible background of experience, and we're going to dive into it. Before we do that, um Conor, share with us where you're calling in from today.

Conor Cullinane: Today I am uh currently in Green Bay, Wisconsin. Uh I kind of travel back, back and forth between our facility headquartered in uh Portsmouth, New Hampshire and then Green Bay, Wisconsin, where my wife is actually currently going to medical school.

Jake Aaron Villarreal: Oh wow, great. All in the family. All medical or all high-level educated individuals. Are you uh originally from one of those cities?

Conor Cullinane: Yeah, so I was born in Boston at uh Brigham and Women's, and then grew up in Southern New Hampshire, about 20 minutes away from where uh our facility is currently located. Um, and then Clarkson University is in Upstate New York. Uh, so [I] spent time in, in Upstate New York, and then uh returned obviously to the Boston area for grad school, uh, which is actually where I met my, my wife, uh, while we were both in the Boston area, both in grad school.

Jake Aaron Villarreal: That's great. Um, can you share a little bit about your upbringing and what shaped you to eventually at some point become an entrepreneur?

Conor Cullinane: Yeah, absolutely. Um, I have, you know, [a] fairly unique upbringing in that uh, uh, I'm one of six kids, um, and it was five boys and then one girl. Uh, and we sort of had the reverse um in terms of uh our, our parents, where my mom worked and my dad was a stay-at-home dad. Uh he, he was called "Mr. Mom" and uh even had the license plate, uh the vanity plate "Mr. Mom." Uh we, [he] drove us around in a big 15-passenger van, so we were known all around town. Uh, and he was our coach for everything.

And um what was really funny is you know, our mom working, she, she was a mechanical engineer. Uh they, they met at Northeastern University. Uh and uh you know she continued uh to push forward in, in her career, continuing to rise through the ranks into management, into the executive level. Um, and we, we really followed in her footsteps: myself and a lot of my uh siblings ended up uh following the engineering path. I think one thing that in particular shaped my path forward was uh my window in, in Southern New Hampshire, in, in my uh in the house that I grew up in, looked right at the pattern of a small grass strip airfield that basically, the planes would just fly over my house all summer long. Um and so I really grew a passion for aviation, for aerospace.

Um and so as I thought about kind of my engineering journey, I really kind of dove first into aviation. Um and I started at a really young age kind of flying uh model aircraft, and then went, went on to you know, start flying real aircraft. And went to Clarkson to, to receive my degree in aeronautical engineering. Um and then you know somewhere along the way I kind of continued to follow a, a different passion for uh medicine as well, which you know you heard in, in the intro, kind of the, the minor in biomedical engineering. Um and so kind of things continued from there. But I would say really what shaped my kind of future path was really kind of that, that very interesting, unique, uh very competitive environment that I grew up in. Uh and then you know just seeing those planes fly over every day.

Jake Aaron Villarreal: Yeah, that's fascinating. You know, I grew up looking out a window in uh Silicon Valley that looked out the, the Los Gatos, Santa Cruz Mountains. And I always believed that if I could get to the top of that mountain and see what's on the other side, maybe I could discover something incredible. Which I did, which was the Pacific Ocean. [I] ended up becoming a big surfer, and Silicon Valley tied to technology was a combination of my destination as well. Um but it's really cool to hear that sometimes proximity ends up being what you end up doing in life. And it sounds like going from you know, a pilot to, as you know, aeronautical, and educating yourself in that space, that eventually getting into what we're going to talk about you're doing now, uh makes a perfect path for a great journey.

Conor Cullinane: Um yeah, certainly. The Atlantic Ocean isn't as conducive to, to surfing, so [I] had to find something else to do. Right?

Jake Aaron Villarreal: That's awesome. Uh you know, we had a call before this and you mentioned a little bit before we dive into your call, or your um your company that you're building, that you had an opportunity to work for NASA. And at NASA, what were they recruiting you to do and what would you have been working on if you joined, and, and what made you decide not to take that route?

Conor Cullinane: Yeah, absolutely. So you know, kind of taking the uh sort of formation journey into aviation that we talked about, sort of the, the next iteration of that was, was a transition into aerospace. So kind of think about aviation first and then aerospace uh thereafter. And really one of the things that I continued to do throughout my entire journey to where I am today is uh I would ask myself you know, "is, is this going to be awesome?" And if it was I would, I would do it. And, and that's what brought me from aviation to uh to aerospace. And so uh when I was at Clarkson, [I] worked with a couple of colleagues, Matt and Eli, who you'll hear more about later. Uh and, and we actually developed what was called a Rocket Division there. We worked on uh the development of a 7.5 foot tall uh rocket test bed for large-scale model rocket enthusiasts. Uh we were designing a new attitude control system for that uh for that rocket. And that was kind of my first foray into it.

And then as I finished out my uh undergrad degree and was looking at uh graduate programs, I initially was actually thinking about medical school. Uh ultimately decided that the PhD route fit my sort of interest much better. I got to stick a little bit closer to the engineering side. But ultimately settled on a program that was a perfect hybrid. Um so the, the PhD program that I was in, as, as you mentioned, the Health Science and Technology program, was 50% of the time at MIT, hardcore engineering, uh medical engineering, medical physics, but also aeronautics and astronautics. And then 50% of the time at Harvard Medical School taking all the medic- the medical courses with the true HMS students that were going to go on and get their MD degrees. Um and that was really based on sort of healthcare innovation and turning that, that on its head. But while I was there, I had the opportunity to um to work at NASA as a NASA Space Technology Research Fellow. Um and, and what I was doing was I was actually working on the new suits for lunar and Martian exploration.

Um and the way that I was contributing to that program was really in line with the overall PhD program that I was in. And so in terms of healthcare innovation, we really think a lot about you know, the ability for clinicians to identify issues, um but then they don't necessarily have an engineering background to adequately solve that issue. And then you have engineers who don't really understand the clinical setting but have that sort of engineering thought process to solve a problem. But they may not necessarily be coming up with a great solution. And so that program was really thinking through that entire process and you know, I kind of boil it down to human-centered design. And so I was taking that mentality to do spacesuits, where instead of building a $15 million suit and then putting an astronaut inside and saying "hey can you tell me where it hurts?" um I was thinking about it more on a uh human-centered design perspective, really on a healthcare innovation uh mindset. Where we take the human first and then we build the suit around what we want the human to be able to do.

So thinking about things like uh a standard range of motion when you'd want an astronaut on the moon to be able to bend over and pick up a rock... something very simple, um but if you don't build the suit to have the same range of motion as the human from the start, then you're already putting that astronaut at a disadvantage. And so my work was really on modeling the suit, modeling the human, and thinking about those two systems as a very tightly coupled um system that had to work seamlessly together from the very start. And you could do that design process and iterate the design in a way where you could try and predict what injuries were going to occur and design those out of the system before you spend $15 million on a, on a prototype and uh and then just ask the individual inside how it hurts. So, so that's kind of where I got started with NASA. I got to do all sorts of fun stuff, I got to fly on four parabolic flight missions, uh which was a ton of fun. That's kind of the, the "Vomit Comet" if you've heard of that, where you're flying 30 minutes, 30 seconds of weightlessness at a time. Um that was a, that was a fantastic experience.

And um anyway, as I got towards the end of the PhD, um sort of had the opportunity to go and, and continue working at NASA. And that was really kind of where the critical transition point started to happen for me where I started thinking about entrepreneurship. And really it was because you know, you can kind of see your entire career laid out in front of you at that point, as, as you look at what you'd be doing, when, what you'd be making even you know 50 years from now. Um and it seemed a little bit too stable for me. Uh not that it wouldn't have been uh really exciting work, and obviously I am a huge supporter of uh what NASA is doing, what commercial space is doing, and I continue to follow that industry. Um but it was... it, like I said, it was a little too stable for me and um yeah, that's, that's kind of when I started to get the bug of entrepreneurship.

Jake Aaron Villarreal: Yeah, that's great. Yeah, you know life and careers are made up of left and right decisions and you have to decide you know what path is right for you. Entrepreneur, startup, one way, maybe more stable uh bigger corporate company or industry uh the other path. Um we're focused on the, the, the journey of the, the entrepreneur on this podcast. And so I want to dive into that uh here. You know, you've built um Pirouette Medical. Um was this your first startup?

Conor Cullinane: It was, yes. Um sort of the, the Rocket Division that I had alluded to at Clarkson was kind of a mini startup experience. We got to manage that project everything from you know the, the timeline to fundraising to the design, to build, manufacture, all that. Uh but it wasn't a true you know, isolated on its own startup. Uh P- Pirouette Medical was definitely uh the, the first there.

Jake Aaron Villarreal: That's great. So you, you, you come up with the idea and then you had to convince people to join the company and, and, and, and build a product that maybe has an opportunity to, to scale. Tell us about what inspired you to create the product or the company that you're building today. And then more importantly, what was the pitch that got others to join you in the journey?

Conor Cullinane: Absolutely. Um so kind of being neck-deep in the medical engineering and medical physics space, um I just happened to come across, really towards the end of the PhD program... I just happened to come across an article about a child that was exposed to an allergen, didn't receive a life-saving dose of epinephrine in time, and unfortunately passed away. Um and that kind of, right away uh had me recall back to my childhood where uh one of my uh many brothers, uh he carried an EpiPen. Um and you know, so I got to see what that looked like up close and personal, what it was like for you know him to have to try and take that device with him wherever he went, and even got to feel some of that fear and anxiety associated with potentially having to uh administer a dose to, to save his life. And so that started kind of getting the wheels turning.

And then literally about four days later, without looking for it, another article popped up on uh my newsfeed or whatever it was. I, I read that article, it was a separate incident. Another child exposed to an allergen, I think the first one was a bee sting, the second one was a peanut allergy. This child also didn't receive a life-saving dose of epinephrine in time, unfortunately passed away. And you know, right, at that point it kind of clicked for me where you know, I, I realized, you know, I started thinking about "this, this technology has been around since the, the late '60s and se- '70s and you know, we still have issues where I'm just seeing uh articles pop up where children are, are still passing away." And you know right, right there, really started thinking about a new technology that would be much more portable. Um eventually added on a, a number of additional f- functions that uh really would end up addressing uh much more than just portability for patients. But um, kind of had the idea for a new way to uh, to control the internal mechanisms inside of a device like that to make it much smaller, more compact, and then also much more user-friendly.

And so started kind of working on that on the side. And I, I mentioned uh uh Matt, my colleagues Matt and Eli earlier, and I said you know that, that I would definitely talk about them again. And that's because [I] loved working with them at Clarkson University on uh building that seven and a half foot tall rocket. Uh I think what really tied the, the three of us together even though we're very different personalities is a, is a common love for difficult engineering problems. And also working really, really, really hard. I always tell people you might find three individuals that uh are smarter than us, but you'll really never find three individuals that work harder than us. Um and I think that's crucial in a startup. And so when I was thinking about this technology and the criticality of the team and those that I wanted to build around this technology, I immediately thought of, of Matt and Eli. And you know, you can imagine, we worked together at Clarkson. At this point I was getting my PhD. It had been a number of years, we stayed in touch. But uh you know they, they went on and did, did great and amazing things as well. Matt was uh, had received his Master's at the University of Notre Dame and was... and had then continued working there uh uh developing turbomachinery for jet engines. Eli was building up a greenfield oil refinery down in Texas. Uh and so you know, when, when I made the call and said you know, "Hey, I've got this great idea, uh you know would, would you guys consider uh leaving your jobs and, and coming and working on this with me?"

You know, at first we kind of worked on it on the side and tried to look at the feasibility. And you know, once we got it to a certain stage, it sort of clicked again in my mind, "I think this is really something. Uh I think it can be something and I think it can be really beneficial for patients." And so I, I really wanted to push it forward into a company. And you know I think there were a couple other things that were happening in my life where I got to see a startup grow and succeed uh in, in kind of my network. And so that was pushing me towards entrepreneurship as well because I saw how exciting that was. And so I, I was really gung-ho about it, and uh uh we, we sat and we talked about it, myself, Matt, and Eli. And I remember Matt said, "You know, I'll quit my job if, you know, we can raise uh $50,000." And he's like, "At that point, I'll quit my job, I'll come out, we'll, we'll do it." And uh so I'm like "Oh my gosh, that's more money than I've ever seen in my life at that point." Right? Um and so I put my, you know, first pitch deck together, which you know, looking back on it now, it's, you know, a terrible pitch deck. Uh but put that first pitch deck together, and then uh was lucky enough to have friends and family in my network who were in the pharmaceutical space and sort of knew the industry. And my thought process was "I'm going to go and pitch them and learn from their comments and make my pitch better, and then go out and try and pitch you know, an angel investor or whatever." But at that point, you know, [I was] pretty naive in terms of the, the fundraising process and, and kind of all that was involved there.

And um so yeah, so I put my uh first ever pitch deck together, got the uh, the, the two potential investors uh at that time, really just thinking about them as advisors in a room. Uh and the, the, the funny part of this is uh, these, these two uh uh advisors were uh at the time my wife's mom, so my mother-in-law, and then another individual who was her acquaintance, who subsequently they've actually uh gotten married, my uh, my mother-in-law's a, a widow, but um yeah. So, so you know, continuing to, to grow the Pirouette family as we call it. But anyway, I went and pitched them. Uh it was you know, I wasn't sure what to expect, but uh uh it was probably a 25, 30-minute pitch. Uh really talking about, about uh the, the technology and what, what I think it could do. Because at that point it's really just uh you know, some ideas on paper, some drawings, a few feasibility studies, but really it's, it's very, very rudimentary at that stage. And you know they said, "Oh, this is really cool," and uh you know, and then that was it.

And then the next day I got a call from uh uh my mother-in-law and she said "Oh, you know, I... it was a really cool idea you know, I'd love to put $50,000 into it." And uh at that, at that point I was like "Oh my gosh, this is crazy." And uh and then I got a call later in the day uh and uh from, from the other individual that I pitched, and uh he said uh, "Oh, I hear you know she's putting in 50k. I'm going to put in 50k as well." So all of a sudden, my first pitch, we were at 100k. And like I said, you know, the, the threshold I was given was 50. And so you can imagine after getting those phone calls, I was on the phone pretty quick uh you know, "Hey, all right, time to quit your job, get out to uh uh Boston, and uh we're doing this."

And you know, I think kind of the funny thing that I always think back to in those early days is uh, as I mentioned, I grew up 20 minutes from where we're actually physically located now, and uh so my parents are empty nesters. And when uh Matt and Eli moved from Texas and from uh uh from South Bend, uh they actually spent the first summer living in the, in my parents' house. And so I always joke you know, "I'm so unsuccessful that I had to move back in with the folks, but not only did I, my friends did too." So... but it was a fantastic you know first summer. And you know, those early days we don't have a lot of money um and we're not really paying ourselves, and uh you know I look back very fondly on those days because you know they're the true startup days where um you know, you're, there's really no distinction between life, life and the startup. Your, your life is the startup and every waking hour is pushing that startup forward. And um it was so much fun and uh yeah it was, it was a really cool start to the company.

Jake Aaron Villarreal: Yeah, no, well said. I like that, essentially yeah, your life is the startup and it goes as you go. What, um, talk about the product you've created. So for the listeners that don't know, you've got the two, you got the partners, you went through Y Combinator, you've got funding, um and now you're building a product, you're bringing it to market. What, what is the product and what, who is it helping?

Conor Cullinane: Yeah, absolutely. So the product in general is an auto injector. So it's a type of drug delivery device. I, I think the most famous uh device, you know obviously we've been talking about anaphylactic reac- reactions, severe allergic reactions, so the most famous device is, is an EpiPen. That's the one, that's the auto injector that most folks are familiar with. So at its core what we're developing is an auto injector. It's an automated system to deliver an injectable drug product. But what we tried to do is really again take that same um healthcare innovation mindset that I had cultivated over a number of years and really think about a human-centered approach. And so rather than taking a syringe and wrapping plastic around that to try and automate the process of a syringe, we started with a completely blank slate, and as we describe it, a blank whiteboard as we use whiteboards for everything.

Um and then in the early days of the company, the first thing we did was we just went out and we talked to as many patients or potential users as possible. So at that time we really focused on uh anaphylaxis sufferers uh and family members. So it was a lot of you know um parents of children who are susceptible to allergic reactions like bee stings or, or peanut allergies, um and, and just tried to find out everything that they liked about existing technologies that they relied on to save their child's lives. And also everything that they didn't like, or, and all of the things that they thought were missing. And through those interactions, we really narrowed down on three things. And one of them was portability, which is you know, kind of the thing that jumped out to me at the beginning. You know, if they don't have their device with them, uh then they're going, then they're not going to be able to, to administer a dose of, of a life-saving drug. Um so portability was huge. But ultimately we saw that there were two other really important factors. Affordability, some of these devices are very, very expensive, multi- multiple thousands of dollars. Um and then the other was usability. So even if individuals had the devices with them, many patients literally will not even attempt an injection because the devices are so scary to use.

And so as we thought about those, those functions, um we built that all into our design requirements um based on those user needs. And what we developed, and what we came up with, was a totally different looking auto injector. And that has a number of benefits that I can kind of talk to. But the way most injectors look, and you can imagine based on a syringe, is they look like a, a, a pen or a tall uh syringe shaped injection system. And ours is a low-profile disc shape injector. Um and I think the, when you see our device next to existing devices, you can, you get that stark sort of just form factor difference. And it may not jump out to you right away what the you know major functionality differences are. But one of the kind of things that we'll hear from potential users is "oh, it's much less unassuming." And I think when we talked to patients, um especially in those early days of the company and even now, they would, the, the, the words we would hear are "fear and anxiety" all the time, fear and anxiety. And so we wanted to remove as much of that fear and anxiety as possible. So that unassuming form factor is really useful. Um you can imagine a low-profile disc is also really easy and portable to carry around. In terms of the affordability piece, we really thought about low cost of goods from the very beginning. We always wanted to be able to offer our device at a final price, a list price, that was reasonable for patients such that they're not having to decide between food on the table and a life-saving injection.

Um and then ultimately the usability piece was what really opened the door uh I think to, as, as your question uh uh was asking, you know, "who does this benefit?" Our first indication, the first thought that we had was really epinephrine, life-saving drug for uh emergency reactions, uh um uh. But beyond that, there are many other emergency drugs, as well as sort of routine injections, that can be delivered with our technology. And so you can imagine you know, the, the injectable market today is close to $600 billion. Uh with our...

Jake Aaron Villarreal: Yeah, it's huge.

Conor Cullinane: Uh and with our device, um where we were originally developing it for epinephrine, we ultimately realized it was actually a platform technology that was great for epinephrine, but it's not just a better epinephrine delivery device, it was actually very useful for a multitude of drugs. Um and so with our existing as we call it "platform auto injector," it's applicable to close to half of that $600 billion dollar market. So you know, 250 to $300 billion. And today the auto injector market is a mere fraction of that. It's about a $6 billion industry. And you ask yourself "Well why is that?" And it really comes, comes down to those three factors that we heard from all of these patients that we talked to, again in the early days, close to a thousand patients we talked to: the overall portability, the affordability, and the usability. And so by addressing those, all of a sudden we're opening the door to many additional markets. But those first two uh or the first one uh, we're still really focused on, on epinephrine. It's a very um uh uh visible market. It's also a great proving ground where we can show our technology and, and how much patients will uh will like that technology. And then the other emergency drug that we're working on right now is naloxone for opioid overdose. And, and we actually just recently received an award from the NIH and the National Institute on Drug Abuse to pair naloxone with our device. Um and so yeah, we really boil it down to uh a platform that can be paired with multiple drugs and at its core it's inexpensive, it's intuitively uh usable, and um yeah, just widely applicable.

Jake Aaron Villarreal: So for the listeners out there that can't see, maybe they're driving down the road and listening to this, they can't see your device, but you held it up. To me it looks like uh maybe a little bit bigger than the size of a silver dollar in terms of the diameter of it, but in terms of the, the physical grip of your hand, it almost looks like a small hockey puck. Um it's much smaller than that even, but yeah. And it's a color red with the top color looks like there's a plastic and maybe some, some, some blue in there. Um walk us through uh the actual size of it and how it works.

Conor Cullinane: Yeah, absolutely. So just as you indicated, um it's, it's quite small. I think you know we often hear "hockey puck" because it is very similar to the puck shape. Um but it is quite smaller than the hockey puck. We really, we struck a balance between making it small enough that it's portable, but large enough that when you go to use it, even the individuals with limited dexterity or if you're wearing gloves, you can still interact with it uh uh adequately. So it's about a 2 inch diameter um and it's about an inch tall. And um in, in order to perform an injection, you basically grip that red safety cover that you described on the bottom of the device. And by doing that, we're actually forcing all users of the device to orient the, the auto injector properly. That's one fear that many patients have when using existing technologies, where it might be upside down and they actually get a needle into their thumb, we call it an accidental injection. So you grip the top of the device, you rotate the device to remove it from the safety cover. At that point you expose the base of the device, which has that nice wide 2 inch diameter disc. Again, it's still very low profile, it's, it's already properly oriented in your hand to perform an injection. But there are also a number of additional uh features that continue to tell you what the orientation of the device should be. There's a ridge on the top, uh there are um labels along the sides of the device that point to the down direction, there's labels that tell you the needle side. And then one thing that's also really unique about our device is because we have a nice wide stable base in comparison to pen injectors, uh we also have a medical grade adhesive on the base of that device. So if you were to touch that, it also gives you that same sensation of uh using a Band-Aid: sticky side goes towards the skin.

Um and at this point, literally all you do is you place that injector on the injection site. Um this uh first application is really geared towards an intramuscular delivery. So I'm going to show you the uh delivery on my shoulder. But you could, you would be able to do this on uh your thigh, uh on the shoulder really, as long as you're getting the, to the uh uh musculature. Um but at this point literally after placing the device on the injection site, all you do is push down. And so you see, it's hard to see the device when I do that, because you're basically uh pancaking that device between your hand and the injection site. But as I collapse the device, there's an audible click, you feel a vibration, and at that point the injection is actually complete within less than a second. Um the instructions tell you to hold it for 2 seconds. And after you hold it for 2 seconds, all you do is let go. The device actually pops up to a, about 2 inches tall, so it's taller than it was before. It has "used" labels that appear all around, circumferentially around the device, and it's fully locked out. It basically becomes its own little sharps container. So it's extremely usable. Obviously I went very slow, um but we've seen great results with our usability studies. And um we really tried to slow down the process of an injection and make every step very controlled, very simple, very easy to overcome, and, and eliminate as much of the fear and anxiety as we can. Um and you know there, there are all sorts of visual and tactile clues and sensations and indicators that really help you along that way. Um and, and it, and it just intuitively works the way you would expect it to. And, and that we see as being a primary benefit. Where a naive individual, naive passer-by who may be called to save your life at the park you know, by pulling this device out of your pocket and administering it, even though they've never seen it before, should be able to look at the instructions on the top of the device and go ahead and perform an injection correctly the first time, every time.

Jake Aaron Villarreal: Yeah, that's great. So as you were applying it, you were applying it to the right or maybe your left arm on the shoulder area where you would normally get a shot if you went to the doctor. But what you weren't able to see is there was no visible needle, or there was nothing that would psychologically connect you with your getting a dose or a shot. Now maybe if you're a patient you know, in some you know severe condition it wouldn't matter either way. But if you're going to give a shot, you might not necessarily know how to give a shot. So it really makes it easy to look at as just applying a device to a part of your body and pushing down, and you're executing the shot basically, the injection.

Conor Cullinane: Absolutely. Yeah, we, we typically will say uh "injection's as easy as pushing a button." And uh you know, it truly is. And when I was pushing down on the device as well, one thing that uh you know is always useful to clarify is I wasn't pushing a needle into the tissue, I wasn't forcing a drug out of the device, I wasn't mechanically contributing at all to the injection itself. I was simply activating the device. So it doesn't matter how hard you push or how fast you push it down. As long, long as you bottom out that stroke, the device takes over and performs the injection with a tuned amount of force every time. Um and so it is a very... we very much try to remove any possibility of user error or any, any needing to think about "well what should I be doing here or is, is this a potential for uh an accident or doing something wrong." We try to remove all of that. And like you said, it's just, you push down and that's it.

Jake Aaron Villarreal: Yeah, that's a great user experience and the application of doing that product or applying that product to a patient looks really streamlined. Talk to me about the, the, the, the market you addressed. But manufacturing auto injectors now, and, and, and how, how will you scale the business for commercial production?

Conor Cullinane: Yeah, absolutely. So that's something we spent a lot of time on. You can imagine, just like any startup, there are many phases to that startup at first. Right? It's a napkin with a, with an idea on it and you're trying to turn that into a feasible prototype. After prototyping, you're trying to scale that up into preliminary manufacturing so that you have a certain level of devices that you can continue to test through. And you know, for us, that, that came to a decision point where we had to decide between outsourcing manufacturing or doing that in-house. And really what we found was that doing that in-house ourselves was really important because we were able to short cycle the time that it takes to uh iterate on a process for manufacturing and even iterate on a component design. Um and so we can build devices very rapidly and in that same day be testing those same devices. And we'll be able to look at that data, review that data, and make design decisions that very next day. Um where we really wouldn't have that opportunity if we were outsourcing that capability.

So we've really built up our overall technological uh capability from a manufacturing uh standpoint, from a testing standpoint, and from an iteration standpoint in-house so that we can continue to short cycle that. And then where we've gone is kind of one-up manual assembly to semi-automated fixtures. And the next phase will be more semi-automated to automated, such that we can support not just initial production but really support the ramp of production through the first few years. Um and then the idea is within those first few years we would be building up an entire fully automated manufacturing line that, that removed the human as much as possible. Um and so it's very much a, a crawl, walk, run process for us. But at every step of that manufacturing process and scale-up, we're learning, we're not leaving the learning to somebody else. Um we're learning internally, not just on the design, but on the manufacturing process for each of the steps, and how all of those interplay together. And all of that learning feeds into the next phase so that we can make that leap as efficient as possible. So it's really important for us. You know, we recently expanded, we're in 10,000 square feet now. We have two 30-foot ceiling high bay manufacturing spaces, one of those we've built an entire thousand-foot uh Class 8 uh clean room. And, and um, and, and then you know, we've invested a significant amount of capital into that facility as well as all the testing equipment that I alluded to uh that really helps us to continue to short cycle the development process and get uh to new product introduction so that we can really start helping patients.

Jake Aaron Villarreal: That's great, got it. Almost sounds like the Tesla you know manufacturing plant where robotic arms are building the cars and supply chain is optimized and cars are you know moving through the, the process faster than they ever did. And you know, applying AI sounds like it's somewhere in the future if not already for what you guys are doing, I'm assuming, but um yeah, it's really great to hear that. Um I think more than anything about the story I love the mission, you're actually saving lives at the end of the day in volume, uh in ways that isn't you know, being done at the level it could be. Is the product that you're creating approved by insurance carriers or is this... what's the cost of something like this if you just want to buy one for your child that might get a bee sting someday, or might you know, be allergic to peanuts and is at school and you want to make sure that you know, the yard duty that's nearest to them can apply your product. What's, what's, what's, what's that look like?

Conor Cullinane: Yeah, so once we obtain uh regulatory approval for any one of our uh drug-device combinations, so talking about for example, epinephrine or... paired with the device, um thinking about kind of that entire process, basically we would sell to wholesale distributors, wholesale distributors would sell then into retail pharmacy. And so for a prescription controlled version like epinephrine, um a patient would receive a prescription, they'd go into the, the pharmacy. And, and if they had coverage, our goal is to try and make those devices, those Pirouette Medical auto injectors uh uh, a zero out-of-pocket cost for that patient. So if they have coverage, it would be covered. If they don't have coverage, we still... as, as we discussed before, we want to make that purchase a, an easy decision. Life-saving device, affordable price, let's buy it. I don't have to decide between that and groceries on the table. And so what we're trying to, to get our retail price at is under $100 uh for a two-pack. So that's two devices, a trainer, and all of the uh carton and instructions and everything that comes in, in there. So um you know it's, it's a very affordable price for patients. And in the epinephrine market, that kind of brings it back to uh a price point where the, the market used to be and I think patients were okay with. Um today the, the prices are much higher, it's you know on average over 3, $350 uh for a two-pack. And some of them are over $600 for a two-pack. So uh it's very expensive. And at one point there was you know devices that were multi-thousands. Um and, and we saw something similar in, in the uh uh naloxone space.

And I think one thing that's critical for us in terms of pricing is, you know we're, as I mentioned from a platform perspective, we're not just trying to disrupt epinephrine, we don't want to just make a better epinephrine auto injector. And that means that we're going to have devices across multiple markets that don't bear the same price, uh the same high prices that you'd see in an epinephrine market. And so it's really critical that we set a price that's just reasonable. You know, obviously we're not going to try to price gouge. We need to be able to make a profit. But other than that, our mission as a company is to help patients, and that's it. And so you know, our true goal is to get the devices out there and, and increase access, really. Um, and so you know, a, a reasonable AC price across all markets. And the nice thing about that too is you, you think about costs which really drive our ability to have that low price. The more markets we go into, the more devices we're building. And because it's a platform, most of the device is exactly the same across these different drug products. So the more we're building, the more the economies of scale feed back into all those different markets, and the, the costs come down, and the prices that we can offer those devices uh continue to come down as well.

Jake Aaron Villarreal: Yeah, that's great. Well, anything that's helping someone save a life uh I could absolutely get behind. You went through Y Combinator, you got seed funding. You went, I believe you raised your A round and are looking to do more funding to really scale the company. Where, where are you today in terms of your, your focus on funding?

Conor Cullinane: Yeah, absolutely. So uh just prior to Y Combinator, we raised our final uh uh seed round. It was led by uh Safar Par- Partners, who's been our fantastic lead investor. Uh they're a venture um, a venture group in Cambridge, Mass. Um they, so they led the seed round prior to Y, YC. At the end of YC, we raised our Series A, Safar also led that round, um and, and they've contributed half of those rounds each time. We're currently uh raising a subsequent round, I'm calling it kind of our A+ round. And it's really geared towards accelerating everything we're doing with epinephrine and naloxone and really driving us forward to regulatory approval. And uh one thing that we're doing that's really unique with this round is... again, Safar Partners is leading the round, contributing half of that round. Uh we're trying to raise 10 million. And uh we've, we've got additional VCs as part of that round as well. Uh notable investors like um uh Gaingels um and, and again Safar Partners.

But one of the things that we're trying to do that's really unique with this round is we're bolting on a community round. And so what we're trying to do is be able to go out and get investors from these two communities that we're really trying to help, as well as the communities of individuals that rely on uh injection systems you know for any injectable drug product. Uh because they see our device coming down the line towards you know approval and could one day be a technology that would make their, as you, as you said as well, their patient or user experience that much better. And you know, you mentioned saving lives, 300 uh Americans are still dying every day of opioid overdoses. And so if we can continue to increase access to life-saving naloxone in a very effective and affordable way with the auto injector, you know that's one market that we're, we really think that tapping into at this stage in the fundraising process can be really useful. Um and so we're really excited about that. That's going to be launching shortly, and probably by the time this comes out that'll actually be live. Uh we're raising with through Wefunder, which is another Y Combinator uh and helps to facilitate these types of uh community rounds where you get to tap into those communities that your technology is really helping. Um so we're, we're, we're very excited about uh that round. And the fact that those investors get to come into uh and participate in a round that is led by a big VC. Uh it's not something that you know is, is typically uh typically done. But because of the very intuitive nature of our device, and because of the fact that uh it's so easy to understand the benefits of what we're bringing uh or what we'd like to bring, it's, we see it as a perfect opportunity to engage those communities.

Jake Aaron Villarreal: Yeah, that's great. I love it. As you look at a 2024, what, what are you excited about? What's on the roadmap as you, as you look to uh turn the page here?

Conor Cullinane: Yeah, so uh I would say continued development of sort of these first two life-saving products, continuing to scale our manufacturing, um and, and really getting us uh another step closer to regulatory approval ultimately. Uh that's kind of the next major milestone that we really think a lot about. Because you know, we talked about it before, at a startup there's many phases from the design on the napkin to where we are today. And there's still a lot of ground to cover between where we are and actually getting approval, and then being able to offer this device to those communities that really need it. And um so for, for 2024, we think about that as being a very pivot, pivotal year in tackling uh some of those major sort of interim milestones on the way to regulatory approval.

Jake Aaron Villarreal: That's great. We'll talk a little bit about how people can find you if they want to maybe invest or maybe find your product, but before we do that, we're going to wrap up here with three questions. I just call them Three Questions with three simple answers, more personal to you. What, what, where do you go to brainstorm or to think big?

Conor Cullinane: Yeah, that's a great question. Uh I typically uh do most of my brainstorming uh out on a run or out on the bike. Uh I, I'm a big fan of uh triathlons and uh uh running marathons and things like that. So usually out uh when I have a time to think uh, just out on the road.

Jake Aaron Villarreal: Yeah. And are you an Ironman triathlete or what you...

Conor Cullinane: I am. Ju-, just uh a little over a year ago had completed Ironman Lake Placid, which was a uh a huge endeavor. And uh I always, I always uh like to have something like that physical going on in my life, and an accompaniment to kind of the entrepreneurship and the family life and all these other things that are going on. Because you know, if you can tackle that, it sort of makes everything else seem a little bit easier.

Jake Aaron Villarreal: That's incredible. Wow, lots of energy. What advice have you gotten from another founder that you felt was priceless that you can share with the listeners?

Conor Cullinane: Yeah. So with uh you know, part of why being part of YC was fantastic... one other experience that we had as a company is we uh participated in a course called Field X at Harvard Business School, which is really designed to help budding uh uh entrepreneurs uh learn how to launch and run companies. And, and actually uh continue to mentor for that, that course uh even today. But while we were uh taking that course, myself, Matt and Eli, we heard a fantastic talk. And you know the, the one thing I remember hearing that, that has really stuck with me is "Successful entrepreneurs are those that are just willing to walk through walls." And what that really means to me is, it doesn't matter what is put in front of you on any given day. And, and that's part of the fun of entrepreneurship: every day you wake up, you, you really don't know what's in store for that day. Um but you, you just can never say that you're giving up. And, and that's really just a death wish for, for a startup. So anything that comes in your way you just need to be willing to walk through walls. And, and I, I always kind of attach that back to the reason why I reached out to Matt and to Eli when we uh when we launched the company. Uh the three of us are willing to walk through any wall that anyone will put in front of us.

Jake Aaron Villarreal: Yeah, I love that. Um what do you do mentally to stay positive on the roller coaster of the startup journey?

Conor Cullinane: Yeah, that's a, that's a great question as well. Uh so I think you know, having a balance um, a little bit of a balance between you know what you're doing and how you're being stressed. I think I, I tend to like stress, but if all of your stress is coming just from your startup, you know, then, then you haven't really balanced out that stress. So you know, I've got family life as well and that's a different type of stress. And so when you move from one to the other, you, you kind of get a nice change of gears. And then like I said, working out and exercising and doing triathlons or running a marathon, that's a totally different type of stress. And having you know that physical component. The other thing I like to do is sort of just u-, odd jobs around the house, uh you know doing different types of renovations and things like that. And you know working with your hands and kind of getting a totally different type of experience. So changing things up and you know, following your passions, doing different things. Um I, I'm a pilot as well, as I mentioned, so going for a flight, you know watching the sunset from the air, things like that, really tend to just shake it up. And you know, before you know it the, the stress doesn't seem so stressful and you can go back to it with a uh with a clean slate and with a different perspective and, and, and walk through that wall.

Jake Aaron Villarreal: Yeah, amazing. Well, what a fascinating story. Pirouette is a medical device company launched by rocket scientists. And you've heard it here, um God, an amazing story Dr. Conor Cullinane has shared with us today. If anybody wanted to get a hold of you or find your company, where should they go?

Conor Cullinane: Yeah, check out our website pirouettemedical.com. Pirouette is just like the uh the dance move, pirouettemedical.com. And uh there's a "contact us" page, and uh we would, we would definitely be happy to uh continue a conversation.

Jake Aaron Villarreal: That's great. Well Conor, thanks so much for joining. Appreciate you taking the time and having the courage to tell your story. And we'll share your story. And to all the listeners for listening today, means the world to me that you spent your time with us. My name is Jake Aaron Villarreal, I'm the host of the show, and look forward to catching up with everyone on the next episode. Until then, take care.

Before we wrap up, I want to give a big shout out to all the entrepreneurs that have joined to make this podcast possible. And for all the listeners for listening, it means the world to me that you chose to spend your time with us today. I'm your host Jake Aaron Villarreal signing off for now, but can't wait to connect with you all soon on the next episode. Take care.

This show is sponsored by Match Relevant, a company that helps venture-backed startups find the best people in the market. And they do it in three simple steps. First, they sit down with founders to understand their story. Second, they tell their story into multiple candidate channels. And third, they schedule interviews within 48 hours. Find us at matchrelevant.com to learn more about how we do it.

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