Medsider: Learn from Medtech and Healthtech Founders and CEOs - From Nurse to Medical Device Entrepreneur: Interview with Swiftsure CEO Deanne McCarthy

Episode Date: December 1, 2023

In this episode of Medsider Radio, we sat down with Deanne McCarthy, founder and CEO of Swiftsure Innovations, a company developing a device capable of safely and effectively cleaning the oral cavity of patients on life support. Deanne was a critical care nurse before she decided to make the switch to medtech entrepreneur. With Deanne's commitment to empowering nurses and enhancing patient outcomes, Swiftsure has assembled an adept team and a robust group of advisors that has enabled the company to move incredibly quickly across key functions like product development, regulatory affairs, and commercialization. In this interview, we explore the invaluable role of mentors and connections in Deanne's journey, her insights on accelerator programs, and how her initial lack of startup experience gave her the tenacity to seek out and validate collaborative partners.  Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the recently launched Medsider Mentors Volume IV. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Deanne McCarthy.

Well, I think coming in, like, blind, like you say, makes you extremely curious. And also with like a healthy skepticism, like if someone tells you something, you're like, okay, I'm not sure. I have to go check with 10 other people before I know for sure that I can believe what you're saying. Right, right. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson.

Hey, everyone, it's Scott. This episode of MedSider, I sat down with Deanne McCarthy, founder and CEO of Swifshur innovations. Deanne was a critical care nurse before she decided to make the switch to MedTech entrepreneur. With Deanne's commitment to empowering nurses and enhancing patient outcomes, Swifshare has assembled a phenomenal team in a robust group of advisors that has enabled a company to move incredibly quickly across key functions like product development, regulatory fairs, and commercialization. Here are a few of the key things that we discussed in this conversation. First, good accelerator programs will allow you to tap into a wealth of expertise. Don't be shy about converting your

mentors into active players in your startup. Second, not knowing everything is perfectly okay. Harness your curiosity in every facet of your venture to ensure you find the right resources to reach your milestones. Third, don't be afraid to ask for favors. And to reciprocate, Approach your network with the spirit of generosity. Before we jump into this episode, I wanted to let you know that the latest edition of Medsider mentors is now live. Volume 4 summarizes the key learnings from the most popular Medsider interviews over the last several months with folks like Rob Ball, CEO of Shoulderner, Kate Rumroll, CEO of Abolative Solutions, Dr. Christian Ramdo, CEO of Tempe Health, and other leaders of some of the hottest startups in the space. Look, it's tough to listen or read every Medsider interview that comes out, even the best ones.

But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to Medsider Radio.com forward slash mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library. of interviews dating back to 2010.

You'll also be able to see all of our playbooks, which are handpicked collections of the most insightful interviews with the brightest founders and CEOs. Whether you're looking to master capital fundraising, navigate early stage development, tackle regulatory challenges, understand reimbursement, or position your venture for a meaningful exit, MedSider Playbooks have you covered.

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All right, without further ado, let's jump right into the interview. All right, Dan, welcome to Medsider Radio. I appreciate you coming on. Oh, thanks so much for having me here. I'm really excited. Yeah, yeah, likewise, especially considering kind of where you're out with the company. This should be a fun conversation. So with that said, I recorded a short bio. I'm at the outside of this interview. It was very short. So I always like to start here. If you can kind of give us an elevator pitch of your background, kind of leading up to co-founding the company, that'd be great. Yeah, after finishing high school, I did a bachelor, a business admin and had some great work

experiences with that. I was an executive assistant for a regional director for an international company that did contract management for public-private partnership possible developments in Victoria, BC. And I was a community liaison lead for that project. So, yeah, that work gave me a lot of understanding of contracts, relationship management, legal requirements, fiduciary responsibilities, corporate governance, communications. And my boss also taught me to play golf at this annual fundraiser that was really cool. I still play golf to this day. But after having my second child, I moved back to the east coast of Canada, where I'm from to be closer to family. And then at that time, I went back to do my bachelor nursing.

And I quickly found love with critical care and emergency care. And our organization did a really good job of providing excellent education for many nationally accredited programs, such as ACLS, PALS, PASS, EMPC, TNCC. So we were a regional center that cared for, like, a range of patients from pediatric, trauma, cardiac, post-op. And so I was really lucky in my career to have, like, strong. nursing mentors who were leaders in that environment. And I really modeled myself after other nurses that I deeply respected. And so I had obviously professional standards as a nurse, but my personal standards were guided by like if this was my critically ill loved one, would this be acceptable to me? So I kind of always did my best kind of regardless of what happened that day. And, you know,

I could kind of sleep at night kind of knowing that. And so, but like a few things obviously did keep me up at night. And I was always dissatisfied and really even frustrated. by providing oral care for patients on life support. And one patient in particular, you know, had a really good prognosis for recovery. He was a man in his late 50s. And he had really poor oral health that we couldn't correct, despite our best effort, the limitations of the supplies at our disposal. And he ended up developing ventilator-acred pneumonia,

became septic, went into multi-organ failure and died as a result. And it was really heartbreaking, you know, his kids were in high school. And so, yeah, so I really started obsessing over oral care after the situation. And I had another patient shortly after who had been a difficult intubation and ended up with a large amount of dry blood in their mouth. And, you know, I couldn't get the blood out by wiping and suctioning. And regardless of how much I wiped in suction, I wasn't able to do a good job. And it was kind of a stark visual indicator of the poor job I was doing. So that night, I literally lied awake thinking, you know, how am I going to clean this patient's mouth?

And I remember thinking, you know, if I could rinse it, I could really do a good job of cleaning it. And like, literally that's kind of when the concept came to me. And that's, um, kind of how that's where it all started. Kind of that's where my journey to entrepreneurship began. So you started the company. Um, looks like early 2020. Is that correct? Yeah. 2021 is when we incorporated and that was for, um, so we can assign IP to a company and 2020, September, 2021 was when. we closed our first random funding. Okay, okay, got it. And we're recording this and, you know, kind of back half of 2023 here. So about two years in or so, at least to the formally two years in. I'm sure the ideas and brainstorming kind of started before then. So that's super helpful.

So give us that origin story of Shwisket is super helpful. So maybe give us a little bit more detail on the product itself. And then give us a sense kind of for where you're at currently. You know, you mentioned you raised a round of financing. So I would love to learn a little bit more about what the company's out today. Yeah. Okay. So the issue with patients on life support,

so they've got that tube connecting the mechanical ventilator to the patient's lungs, obviously. And that's creating a direct route for bacteria in the mouth to enter the lungs. So oral care has been shown to decrease the incidence of ventilator-acquired pneumonia. So it makes sense. It reduced bacteria in the mouth, and you can reduce the amount that enters the lungs. It's just the problem that oral care in ICU is it's really terrible.

You know, us nurses can't visualize the oral cavity because these patients are unconscious and sedated. And, you know, the tube is crowding the oral cavity, making it impossible to clean above or behind it. And so these patients also are unable to eat or drink anything. And the average length of mechanical ventilation is five days. So, like, you know, we're not able to rinse their mouth because there's no way to make sure that fluid wouldn't travel down the respiratory tract and increased risk of aspiration. So just like for yourself, look, imagine how terrible you'd feel if you slept all night with your mouth open and then woke up in the morning with. that super dry mouth and like literally couldn't go rinse your mouth after. And so that's what these

patients on life support experience. And the average like the mechanical ventilation is five days. So I've seen literally a decline in oral health status for all of my mechanically ventilated patients beyond one day. So the switch gets really simple. It's a consumable single use mouthpiece that easily fits into the oral cavity and its elegant design makes it easy to rinse all areas of the oral cavity. So it uses gravity to suction fluid at the same time it's introduced. It's the first device of its kind. And nurses who use the device like it because it allows them to cleanse areas that they couldn't previously reach. And it's fast and easy to use and fits within the workflow of an ICU.

And we've even had nurses that we've engaged with want to put it in their own mouth and try it, needing to understand like how it works and how it will safely rinse the patient's mouths. And after using it, you know, they can't believe how well it works. and however refreshing it feels to have their mouths rinsed in this way. And we have some really great tailwinds too. So the VAP prevention guidelines were published in 2022 in May. And it urged for the de-adoption of chlorohexidine, which is an antimicrobial that was commonly used for years to limit bacteria in the oral cavity.

And so they're urging now for the de-adoption of chlorohexidine, making, you know, providers scrambling kind of to find a solution to use in its absence and also those standards for the first time deemed tooth brushing and essential practice, meaning that all acute inpatient hospitals need to adopt tooth brushing, which is really exciting for us since our product completes toothbrushing by rinsing away everything that's been mechanically dislodged throughout the toothbrushing process. So we've been working on a product development for almost a year before these guidelines were published, so the timing is incredible for us. That's great. That's great. I love hearing about some of those tailwinds. You need everything you can

get, right, trying to push the boulder up the hill. I say, absolutely, like, we didn't plan that. Yeah, yeah, definitely works into your favor. So where are you at now? I mean, like I said, we're reporting this in September of 23. You've been, you know, the company has been formally kind of incorporated for a couple years now. So where are you at in terms of, you know, development, Red Klan, commercialization, etc.

So, yeah, so we closed our pre-seater round in September 2021. we did multiple rounds of iterative prototyping with many end user groups and critical care nurses in the ICU. We reached design freeze in the summer of 2022, transferred to manufacturing, completed our clinical use validation study at the Cleveland Clinic in Ohio, which was very positive in Q1 of 2023, and also at the same time registered our device, which is class two, five, 10K exempt. So we were registered with the FDA. So we did all this work in less than 18 months with less than $1 million of funding. So our team's incredible. And I'll get into that later. But so currently we're now doing our limited commercial launch and we're targeting hospitals

that have really strong nursing leadership and are passionate about oral care and its ability to prevent pneumonia. And so, you know, our work with early adopters is going to help us validate our business model, our pricing assumptions, help us to optimize our training materials and help us really solidify relationships with our reference customers. And, you know, during our staff commercial launch, we really want to make sure that we've done everything to make implementation for new customers as seamless as possible during our full market launch in 2024. Got it. And we're also helping for our next study at the Cleveland Clinic right now. Okay. Okay, cool. That's super helpful overview. And I absolutely

love teams that move fast, right? And especially considering it's not like you had, you know, four or five swings under your belt, you know, and have been able to learn through, you know, various various ventures you sort of like when you know are tackling this almost from scratch probably from a with with a fresh out of eyes and saying well why can't we do that or why is it taking so long right like asking those obvious questions that some of us you know that have been sort of around the block aren't used to maybe asking you know so absolutely well it's i think coming in like blind like you say makes you extremely curious and also like with like a healthy skepticism like if someone tells you something. You're like, okay, I don't, I'm not sure. I have to go check like 10 other,

with 10 other people before I know for sure that I can believe what you're saying. Right, right. Yeah, you see the matrix of tests that need to be done. You're like, why do we have to do 100 million tests on this thing? You know what I mean? I'm kind of just joking. But yeah, no, I love the sense that I can probably imagine, right? You're, you're seem like a like naturally curious, right? And I'm sure that's been, you know, probably applicable and helpful, right? As you, as you, as your team is kind of moving, moving quickly. You know, hearing you describe, kind of the simplicity of the device, it feels very much like kind of one of those, and correct

me if I'm wrong, but I bet you get a lot of this reaction of like, oh, why haven't we had something like this before, right? Because it's a big problem. Sounds like the standard of care. I'm not overly familiar with like this, this sort of this environment within the healthcare setting, but it sounds like it's a big problem and the standard of care doesn't really work that well, especially if the guidelines are changing. We literally every single critical care nurse that we've interacted with acknowledged that this is a massive gap in oral care. That's, likely leading to poor patient outcomes 100%. Yeah, yeah, that's cool.

I think that's a good kind of transition point to kind of go back in time and learn a little bit about the journey, even though you're moving fast. You've been able to accomplish a lot in a short amount of time. I think there's going to be some helpful learnings for other founders, CEOs or kind of, you know, startup people that like startups to learn from your experiences. So let's use this as an opportunity to kind of go back in time. But for those that are listening and don't get to the full summary article on MedSider, website is swiftshure.com.

So Swift and then sure, just as it sounds, swifter.com. We'll link to it in the full summary on Medsider as well as Dian's LinkedIn profile. But again, feel free to check out the technology there if you don't get a chance to visit the full write-up. So with that said, I want to go back in time and first maybe cover kind of some of the early development, right? And you mentioned that you went through, I think roughly about 12 months of iteration on your product development.

And I can only imagine, right? Because there's a fair amount of people that are coming from kind of a provider environment, right? You're a nurse by background. There's other physicians that have ideas for devices and they're like, I don't even know how to get started. But you did. You got started and accelerate and move like, you know, extremely, extremely quickly. So give us a sense for kind of how you thought about tackling kind of this early stage development, especially knowing that you didn't have a lot of capital to work with. Right. So when we raised our first round of funding, we had a lot of really great advisors. We had been through this program called the Creative Destruction Lab, the health stream. So

it's kind of like a global business mentoring program that was super helpful. And we connected with some really experienced advisors and mentors that I had formed a relationship with. And so we already kind of had a tactical plan and our strategic imperatives were already in place kind of by the time that I'd raised the round of funding. But the first thing that we did was outsource product development to Ironstone product development. It's a full ISO 1345 certified medical device design company in the greater Toronto area. And so really that's how we were able to move quickly. It was like literally just outsource and then pressure test everything with external consultants, really. And the interesting thing is that those external consultants actually threw it to become

employees. But that's kind of how we set everything up super early. And, you know, it was peak COVID pretty much, right? So like we, what we did, we were able to do, get in basically and work with some really brilliant groups of ICU nurses. So we take in the device and I literally would act as the subject, the healthy volunteer. And so they would use the device basically on me. And we would videotape everything and then have like a systematic like interviews with each of the end users like to kind of unpack questions that the design team had. And this really like allowed us to observe the same feedback and and unpack it from different perspectives for quality and engineering, clinical manufacturing, marketing.

They all kind of like look at that feedback from a different perspective. So that was really cool. And so we bring back, incorporate basically the changes and then bring it back against. We did that five different times and having the insights from these like really experiences, smart nurses was really invaluable. And it's kind of how we were really quickly able to move and achieve design freeze with what we feel is the very best design in terms of, you know, material specifications. and user requirements, marketing requirements, that kind of stuff.

Got it. So a couple follow-up questions kind of hearing you riff a little bit on this topic. So one would be, I could see, I could see, you know, someone listening to this and being like, you know, D&U make it sound so easy, right? You just identified a great design partner, design a development partner and, you know, curated a team of experts and you're off to the races. But I think most of us have sort of been there in that early stage and maybe picked the wrong, the wrong partner right, out of the gates and, you know, kind of stumbled along a little bit.

So were there, did you go, really broad in terms of how you identified the right partner to work with? Or did you, were you kind of just fortunate to kind of, you know, find, we did a ton of research. So we did like interviews with like four or five different product development companies, chat to companies that they had worked with, found companies that they didn't give us as references, talk to them. Like it was like that, that piece that a lot of research went into finding like the right partners. And then also, you know, like I said, I'm not a quality expert.

I've definitely went out and learned as much as I can't could about all of those different work streams that are necessary, but I then had to go out and find a quality expert to attend those meetings and pressure test everything that we were being told by the larger design team. And it was just kind of a logical way to approach it. I didn't have enough time to learn everything about all those aspects of product development, but I found good people to work with, I think,

and make sure that we were de-risking the, company in that way. Yeah, yeah. I greatly appreciate the fact that like you didn't, again, you're kind of coming coming into this kind of the startup startup ecosystem. I mean, running a startup in another vertical is hard enough, but yet alone, it's all of the constraints inside of inside the kind of the med tech space. I always like to say it's like playing the, playing the startup game on hard mode. And so, you know, super impressive that you're able to like curate those experts. So even thinking, you know, kind of taking a step back and kind of you referenced the, I think, accelerator or the, what would you go, Destruction Lab, I think,

was some sort of like incubator. Creative Destruction Lab. Yeah. It was phenomenal. It was a great program. Yeah. I was going to say, did you kind of have a knack for, for like, how to put some of these pieces together, these functional work streams together or like coming out of that, like,

creative destruction lab or that, like, that kind of quasi incubator, were you, I mean, did you, did you learn enough there where you felt like, hey, I'm ready to kind of like really start going after, going at this? Yeah. And it gave me the best part about CDL is that it literally just gives you the network of people to tap to as well. So it's super interesting. So it starts in the fall, ends in the summer. And basically you go every eight weeks and say these are our strategic comparatives that we're working on.

This is what we think is most important. Because you know what it's like you start and you're like a chicken with your head cut off. And you need to really focus on like what things do you need one foot in front of the other kind of thing. Yeah. So you go pitch. First you have these five meetings with like. five, 20-minute meetings with four or five different people in each one. So you get to research them, figure out what questions you want to ask them. And then you present to like the larger room.

And then someone either can choose to mentor you or not. So we ended up having some really great mentors who kind of stayed with us throughout the program. And one of our mentors there ended up being the lead of our pre-seat round. Ray Mazuka from Threshold Impact. So, but also like it just gives you that like, you know, if they don't know how to answer the question, they know someone else in that network who can help you kind of thing. So it was the network is there, like helped us put together the pieces and being able to tap into people like with various backgrounds and specialties is really awesome. Like we definitely wouldn't have moved so quickly without that early experience. Yeah, yeah.

That network is can just accelerate, right, how quickly you can build on the network, you know, moving through a, moving through a kind of an accelerator or incubator program like that. So before we kind of jump to kind of Klin, right, because again, you've been able to accomplish. quite a bit in that sort of topic area in a short amount of time. But before we get there, anything else that you can think of with respect to kind of your early stage development that was either ended up being super helpful or, you know, something that maybe redo things again that you do differently. Hmm. I don't know. I feel like we were really lucky to be able to move forward so quickly, especially given that we were all working remotely as a virtual team. Like, I think the plan that we had put together really worked well. But I think to like, again,

pressure testing with other experienced well-recommended consultants in terms of regulatory, clinical and all that stuff. And you need to have a backup plan always because you never know if something's going to fall through. Like there's like you need to have kind of multiple irons in the fire all the time. If you want to move forward quickly and pursue like multiple parallel paths at the same time, you need to have like multiple options for each different thing in case something doesn't pan out. Yeah. Yeah. No doubt. I heard. Kate Rumroll, who's the CEO of a blade of solutions was recently on the program, and she's a good phrase, right? She's like, as a CEO, you, especially in kind of the life sciences,

you always need to be, you know, looking around the corner, or at least trying to, right? You know, maybe your plan B and plan C aren't going to end up working, but you need to at least have them, you know, and be thinking about kind of what's next, even if you can't see around the corners, which I thought was a very, very good. And it's interesting to you, like, not every other organization is able to move as quickly as you are as a startup.

And they're also maybe not motivated to move as quickly as you are. the startup too, I would say sometimes I joke and I'm like, I feel like my job is like, you know, walking the line between like, you know, pestering people and still being likable. That's interesting. I mean, there's a good, there's a really healthy balance to play there, right? Because if you're not sort of pestering, if you're not being that squeaky wheel, you're probably not pushing hard enough. But at the same time, you sort of need to be winsome too, right? Because if you're always being the, you know, that squeaky wheel or that annoying, you know, startup person, you know, you're not going to able to win over, right, a team, whether it's an

internal team or an external team, you know what I mean? So it's definitely a healthy balance. I think another thing, too, it's like, you know, one thing is people are so generous with their time. Like people that you meet in your network are like, hey, like willing to talk to you and introduce you to someone else. And like, you know, it's interesting too. Like you, you also can't be, you know, there's a balance there too. But I always joke that I'm constantly asking for favors. And I'm excited to one day be in a position to return favors or do favors for other people. because literally at this point, I'm always asking. Yeah, yeah, yeah.

I mean, it seems like a constant theme with some of the most, kind of the fastest moving, kind of the more ambitious founders and COs out on the program is like they're always kind of just sort of curious and they're not afraid to ask, right? They're not afraid to just ask the question and, hey, maybe it's a silly question to someone who's done quality for 20 years, but I don't know. I don't really care. I need to understand. Yeah, exactly.

Yeah, exactly. Yeah, exactly. Yeah, exactly. Sorry to interrupt, yeah. Yeah, exactly, exactly. Yeah, no, it's good. It seems like a very common characteristic of a lot of really, really solid founders and CEOs. Before we get to Ray Clinton, I do want to ask you, since we're on this topic,

this is one of the things I noticed when kind of looking at your background and the team that you have in place at Swiftshire is really the group of people that you've been able to curate alongside you, right? Which I think has obviously been instrumental, it sounds like, in being able to move as fast and kind of reach the number of milestones that you have in a short amount of time. but that's not easy either, right? Especially being someone new to kind of like building, you know, sort of building their first startup. And so when you think about like, you know, looking back, I guess, right,

over that journey of kind of curating the right group of people around you, you know, what has been maybe super helpful or like how you've been able to do that? Maybe is the best way to, the short way of asking that question. So I think. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for Medsider Premium Members.

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