Medsider: Learn from Medtech and Healthtech Founders and CEOs - How Resource Constraints Can Enhance Your Development Process: Interview with Reia CEO Kaitlin Maier

Episode Date: November 18, 2025

In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.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 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and 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 latest Medsider Mentors Volume VII. 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 Kaitlin Maier.

We were pretty constrained with kind of like our first grant being 150,000, even once we did get a grant and then we did get more funding after that, but kind of still in that phase. We, you know, elected to build our own quality management system as well as run our own clinical trial instead of hiring a CRO just because it wasn't the best use of our funding. at the time. And I think that kind of has then set us up for success today where our team is still actually the four original co-founders. I mean, we have had a great group of consultants across all fields along the way and still working with us today.

But we're the ones who are now taking on, like learning how to do a marketing campaign. And I think kind of like that mindset of being as flexible and willing to take on every new town. task that you kind of need just from the onset. 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 Neseposite of MedSider. I sat down with Caitlin Mayer, co-founder and CEO of Ray. where she leads business strategy, IP development, and product design. Mechanical Engineering graduate of Dartmouth, Caitlin previously worked at Sherpa Technology Group developing patent strategies for leading life science and technology firms. She and her co-founders began Rhea as a senior thesis project,

ultimately creating the first self-managed pestry to bring long overdue innovation to women's pelvic health. Here, a few of the key things that we discussed in this conversation. First, use constraints to sharpen design and development discipline. When you're building with limited funding, every prototype and decision has to earn its keep. Raya's team couldn't afford to design in isolation. They involved clinicians and patients from day one, iterating more than 50 times on feedback alone. That discipline turned constraint into focus and ensured the final product solve real

usability problems before accelerating development. Second, turn regulatory feedback into your next milestone. When FDA required clinical data that Raya hadn't planned for, the team pivoted fast, designing a pragmatic trial that met agency expectations and deepened their understanding of the device. That experience shaped their next move, launching a larger, NIH-funded RCT to validate usability and outcomes beyond what was required. Ultimately, the feedback sharpened their evidence strategy and accelerated trust with physicians. Third, non-diluted

funding buys time, leverage, and control. Rather than rush into venture capital, Raya fueled its development entirely through NIH small business grants, securing over $5 million without giving up a single share. Those awards forced long-term planning, but allow the team to move deliberately, refine the technology, and approach equity investors from a position of strength. we dive into this episode, I'm pumped to share that volume seven of Medsider Mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health and other proven

med tech founders and CEOs. Look, we get it. Keeping up with every Medsider interview isn't easy. That's why we created Medsider mentors. These e-book volumes distill the best practices and Insider Secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to MedsiderRadio.com forward-slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources.

If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider Playbooks, curated guides packed with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more.

And if you're fundraising, don't miss our exclusive investor database featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive into the interview. Caitlin, welcome to Med Sider Radio. Appreciate you coming on. Thank you so much for having, Scott. Yeah, very much looking forward to this chat.

I know we've had several, I think, founders in the women's health space, right? It's definitely a growing sort of arena that probably, I think you would agree, that deserves more attention, generally speaking. So definitely looking forward to this chat and learning a little bit more about Raya. So with that said, I recorded a very short bio, right? That probably didn't do your background justice at the very outset of this episode. but let's start there. If you can give us kind of a two-minute elevator pitch on your professional journey leading up to co-founded the company. Yeah, absolutely. So I studied mechanical

engineering at Dartmouth and Raya actually started as a senior thesis project with two of my other co-founders. So with Ari Soper and Megan Daigler, the three of us were looking to redesign something in the women's health space because, as you mentioned, it was an area that we felt kind of lacked invasion and we went around and interviewed a number of doctors, midwives, nurses in the area and trying to kind of understand where the shortcomings were and what we could address in this sort of 10-week project. This is when we got connected with our fourth co-founder, Dr. Paul Hineskin, who is a urogynecologist at the Dartmouth Hospital. And this is the first time that we learned about pelvic organ prolapse and kind of the current solutions. So this is

where we all settled to work on with Dr. Hennessy and as our advisor at the time, kind of thinking that this would be, you know, a design project for the next couple of weeks. Then we go our separate ways, but we were so excited by kind of what we had come up with, and it was pretty sticky that we did have jobs lined up after graduation, but then we continued to work nights and weekends because we just couldn't let the idea go and the fact that it was, you know, something that we kind of had a shared passion on. So in that time period for three years, I took a job at an IP advisory and brokerage firm where I helped with valuations of technology and IP portfolios and kind of developing some

patent claim strategy. But, yeah, in the background, we actually were applying to NIH grants. And so when we got our first grant, kind of three years later, we were able to all leave our other jobs and go full time towards Raya. And so yeah, we've been there for the past, yeah, seven years now. Yeah, classic startup, startup journey. Yeah, I love it. I'm anxious to kind of get into some of the details, especially around IP, right? Because that's, I think that's a bit of a unique sort of background, I guess, is your experience kind of in that arena. So with that said, though, I'm on the website right now, which is Rayahealth.com, R-E-I-A health.com. So R-E-I-A-Halth.com. Give us a sense for kind of your, the device, you know, what it does and maybe frame it up as if like I'm completely unfamiliar with women's health and learning about this literally for the first time.

Yeah, absolutely. Because this was kind of our experience when we first came across the condition that we are looking to solve or help relieve some of the symptoms for, which is called pelvic organ prolapse. So it's when the pelvic floor can no longer support the uterus and other pelvic organs. and they begin to descend. So this condition actually affects 50% of women over the age of 50, a statistic that we were pretty floored by that it was so prevalent yet so little talked about. It also can be a big problem postpartum as well.

And so the kind of the options from there are surgery, which in kind of when we started doing this project in about a decade ago, is when there was a number of surgical solutions that involved a mesh repair, which ultimately would be recalled by the FDA a couple of years later. And even the ones that were successful, initially, they did have relapse rates of about 50%. That is kind of one route to go. The other route to go is a non-surgical solution.

This device is universally called a pestry. So the pestry is an object that is inserted into the vaginal canal to sort of replace the pelvic floor. it then acts as a shelf to hold up the descending organs. Sort of a fact that we like to kind of put this all in perspective is that the first known documentation of the pesteries from 400 BC with Hippocrates and it was a pomegranate that was used. Wow. And so we kind of like to say that there was little innovation since then.

So the kind of more modern version is a silicone disc, but they're very rigid and difficult to manipulate. So users often can't self-manage them. So while it's not surgically implanted, basically the shape of them requires a physician to place it and then remove it basically every three to four months to clean it and then put it back in. So due to this prolonged wear, users can develop like a lot of complications just from have an important body inside them. Also, it really limits at general independence in their health care, especially when we're developing this in New Hampshire, which has a big rural population. We heard of people traveling three hours or so to come to these sort of quarterly

maintenance visits. Wow. This is kind of the problem that we were looking to address where both practitioners and patients were pretty fed up with the available options. So we developed a new vaginal. Pessery with the goal of making self-management easy and comfortable for all users. So our device will collapse basically to kind of the shape of a tampon for the insertion and for the removal process.

And then once it is in situ, it will expand to that full shelf state. So that is how that was kind of like our design goal. And then also to make sure that the ergonomics worked for the demo. who typically uses it, which because it tends to affect an older population, having something that can be used with limited hand dexterity just as easily. So with that, we also kind of developed a companion applicator, which makes the insertion process even easier for everyone who would like to use it. Got it. Super helpful explanation. And again, on the website, reahealth.com, if you're listening to this, we'll link to it in the full write-up on Medsider. But if you don't get there, Rayahealth.com,

You can check out the device. It's a really cool website. Just about the full, you kind of get an idea of what it looks like. The device is kind of sitting ironically enough on a shelf, right? I'm not sure if that was intentional. I imagine it was. But, but yeah, so in essence, the pelvic organs begin to, with age and maybe there's some other sort of factors that go along with this.

The pelvic organs begin to kind of like, in essence, sink or collapse. And this device, as you just mentioned, and I think that shelf example is really good. It's inserted into the vaginal canal and it almost flowers out. and kind of expands to become that, that shelf to help hold up the pelvic organs. Is that kind of like a decent way of kind of explaining this? Yes, it's a great description. And yes, kind of childbirth and having children is the biggest indicator that you'll develop prolapse, which is the inspiration for their name, Rea, who is the goddess of fertility.

Ah, got it. Very good. And this is like a huge issue. And maybe it's maybe just, it resonates with me personally because we have six kids. And so, and my wife is, you know, getting a little bit older with. with each one. And so, so yeah, I mean, she started, you know, doing these pelvic floor exercises, and I was like, what is this for? Like, I don't really know anything about this arena at all and sort of started going down this rabbit hole. And I was amazed at, like, the lack of options

that you just mentioned, you know, because most, like she was talking about, like, one of her friends that I would say is relatively younger. I think maybe in her late 30s, early 40s, and she had, I think some pretty severe pelvic, like, prolapse issues. And, like, the physician that she went to was like, I think we're going to have to take out your uterus. And it was like, no, like, I kind of don't want that to happen. You know what I mean? Still, still reasonably, you know, reasonably young. And so, yeah, and there was just not a lot of great options, which is quite, quite astonishing,

considering it's 2025. And, you know, this is a pretty big issue. It seems like it affects a lot of women. Yes, absolutely. And, yeah, I think the, like, general awareness and to the patients as well of what their various options are is, like, it's pretty lacking. And so general education about, you know, a condition that many people don't even know exists and, like, can also see improvement. Yeah, yeah, no doubt, no doubt. Yeah. I think we'll get into that a little bit and how you're kind of thinking about

commercializing this device. Because it is, I mean, your website has a very, like, patient-centric feel to it, right? Unlike most kind of medical device companies, but this is, does this require a prescription then? Yes, it does. It does. Okay. Well, basically, from the very onset, both pest reuseers and practitioners were intimately incorporated into like the design and the feedback for how we got to the final device because we just continually found how resilient and resourceful the prolapse patient community is. They have a lot of online presence and a lot of advocacy for themselves. And so kind of making, we wanted to make something that also was easily accessible to that community, even though they do need to, you know, get a prescription

from their doctor. We've had a number of patients who have been able to, like, obtain our pest rate by introducing their own doctor to our device as an option. So we really try to also kind of reach out to them as well as going directly to the practitioners who would ultimately have to prescribe as well. Yeah, awesome. Very good. And then we're reporting this in, let's call it mid-2020-Q-3 to be specific. You've been at it, you know, I think you said, since really 2017 timeframe, right? So give us a sense for kind of where the company's at

in its life cycle. Yeah, so we just got our FDA clearance, the end of last May. So, and we started sales after a couple of months of production ramp up last October. So, yes, we're in the first year of sales, which has been really exciting to hit that milestone of finally moving from the development

in the testing phase to where we are now. Awesome. Yeah, exciting, exciting times to get to this point, right? Where we're actually seeing this being used, you know, in patients. So that's very cool. So with that said, again, rea health.com is the website, R-E-I-A-health.com. Highly encourage everyone to check out the device, the technology, as well as the, you know, the people behind it, right, in more detail. We'll, of course, link to Caitlin's LinkedIn profile as well on that full med-sider write-up,

as well as well as the company's website. So with that said, let's spend the next 20, 30 minutes kind of going through some of these key functional areas, right, that most startups have to navigate at some point in their trajectory. And the first one I want to talk about is product development, which I think is obviously right in your wheelhouse, right, as an engineer and then spent a little bit of time, right, kind of in the world of IP, right,

helping other founders, other entrepreneurs and companies protect their IP. Let's start with development. And you kind of mentioned the, I guess, the close collaboration early on, right, with both practitioners and patients leading up to the design, right, that you're that you're commercializing with. So take us back to kind of those early days, you know, I imagine iterate relatively quickly, right, but without a lot of resources, you know, it wasn't really until, you know, I think that first, that first significant grant that allowed you to kind of leave your other,

leave your other job and kind of go all in on, on Raya. So give us a sense for kind of what, what that was like and maybe, maybe frame it up, you know, for, you know, with other other maybe pieces of advice for, for other, you know, entrepreneurs that are taking the first swing at a startup. Yeah, absolutely. Yes. In the kind of the nights and weekend space, we basically were, all of our funding was coming from kind of like really small on the order of, you know, like a couple of hundred to a couple of thousand dollar, like pitch competitions that we would participate in. And all of that would go into kind of the initial prototyping. And yes, as mentioned, we really wanted to incorporate the practitioner and the user feedback from the very beginning.

And I think the fact that we were so resource constrained also kind of helped that process along as well because we couldn't spend too much effort going down any one path without it having some sort of validation. So this did really reinforce us constantly checking in with all of our key stakeholders. on a, yeah, so on a very regular basis to make sure that kind of the design decisions we were making would work both from a user standpoint as well as a practitioner standpoint. And I think that was kind of like we were able to kind of waste less time, I guess, that way where we kind of started off with five very distinct designs and quickly narrowed down from there onto like one general path and you know from there we had 50 iterations onwards from that but as we kind of progressed we were able to get a little bit more funding from our grants and

that would you know enable us to kind of then get into more of the specific testings of you know color like how physicians would ultimately store the device like various things that were got to like a more of the aesthetic element. But kind of starting with those like fundamental building blocks of like how the device functioned, we were able to work through pretty quickly just like kind of thanks to constant user feedback. Yeah, I want to circle back around to this concept of constraints, right, and how that maybe affected your early years at Rea. But talk to us, talk to me a little bit about the aesthetics of the device because that's, that's interesting. And it's probably something that maybe a lot of other founders, CEOs of early-stage companies maybe gloss over and don't

think it matters. So like what was the, there's a little bit more. It sounds like there's a little bit more, right? I mentioned this earlier, right? Your device has a lively feel to it, right? It's like, it's kind of compelling, you know, to sort of look at. And so, so yeah, give us a sense for kind of how that, how that played into the design of Raya. Yes, absolutely. So kind of the the standard pestries that we were looking to replace are kind of silicone sort of mushroom or cube shapes. There's actually like 10 different varieties, but kind of the most common ones look like a disc, a solid mushroom or a cube. And so people kind of had like pretty adverse reactions to kind of just these looking like large pieces of silicone that immediately

visually, they're like, this does not look that uncomfortable for someone to insert inside me. They are a pretty high derometer of silicone, so like they're much, they're pretty stiff. So these were kind of, and also most of them are a light pink to a white color. And so they would often see some discolour. with long-term use with, while not harmful to patients, is not necessarily something that, you know, users think was designed for them if this is an, so those are kind of like various elements that we heard along the way that we were looking to address. So we, first of all, like, chose the softest silicone derometer that we could go with that was still effective because we wanted something

that felt very comfortable in people's hands and very approachable. We also then we did like focus groups just around color to find something that. So ours is kind of a light blue, which ultimately people found as like something associated with a medical device, but is like a nice color that they like seeing on a regular basis and also doesn't have this discoloration issue. And then kind of in terms of the shape is that. sort of as we did user research with kind of our really, really rough early prototypes that sometimes, you know, we're built with cardboard and other things that were like strung together.

We started noticing where users started using like what we would associate as like more positive adjectives with certain decisions. So like when they would call them a flower or they call it like an umbrella as like something that seems like as a supportive state, we sort of, would then move towards those designs because of like the associations of both effectiveness as well as approachability. That's super, super interesting. And hearing you kind of describe kind of the feedback, right, it's sort of you can begin to, I mean, obviously I'm not as intimately, you know, familiar with this domain,

but you can kind of start to connect the dots of like how, why some of this would be like really, really important, you know, to the end user and inpatient. So yeah, super interesting. And it kind of just reminds me of like how how important it is, right, to be as close to, you know, in your case, both patients and and physicians, right? And if you're, you know, you find yourself sort of slowly moving away from, from kind of that intimate kind of, you know, relationship, it's never probably a good thing, right? It's just, it's so, so highly valuable to kind of be as close to the action as possible. But kind of circling background of the constraints, it kind of reminded me

of an interview I did with Dr. Stephen Michelson, who's an electrophysiologist, but He's largely kind of credited with ushering in the field of PFA, PFA, or Post Field Ablation, and Bossa Scientific, when they acquired his company, Farapulse, when they, their first year commercializing the device, they did almost, I think, a billion dollars, or maybe a little bit over a billion dollars in the first year, which is a completely wild number. And I remember him mentioning that in the early days of Ferrapulse, he had like 40 grand or something like that.

And he was sort of tasked with building the first generator, right? And so it's like he didn't, I mean, you can't take that to like some CDMO. and ask them to start helping them build a, build a generate. He had to literally like come do it himself. And so, and he brought this up within the context of sometimes it's actually beneficial to like, in those early days, to work, to have less money because it forces you to be more creative and more, I don't know, just force you to flex some muscles and maybe that you wouldn't otherwise use.

And so was that kind of the, I mean, did you feel like looking back that was kind of the case for you and your team? Oh, absolutely. And it 100% set us up, I think, for success today to continue doing that. I think kind of when we initially started this, we never imagined it would go beyond the design phase of it with, you know, resources from college. And then once we did continue that, but we were pretty constrained with kind of like our first grant being $150,000, even once we did get a grant. And then we did get more funding after that, but kind of still in that phase, we, you know, elected to build our own quality management. system as well as run our own clinical trial instead of hiring a CRO just because it wasn't the

best use of our funding at the time. And I think that kind of has then set us up for success today where our team is still actually the four original co-founders. I mean, we have had a great group of consultants across all fields along the way and still working with us today. But, you know, we're the ones who are now taking on, like, learning how to do a marketing campaign. And I think kind of like that mindset of being as flexible and willing to take on every new task that you kind of need just from the onset, like you said, given how restricted everything is just really can only help you later on. I mean, sometimes it's easy to look back on these experiences and see the value.

But when you're living them, it can be, it can be like really challenging, right? I mean, it can be stifling handcuffed, you know, sometimes you're being handcuffed because you just don't have a lot of resources. But, but I guess maybe the takeaway for, you know, if you're listening to this and kind of at that stage with your startup, this is very normal, right? Oftentimes, in almost every case, right, you don't, I mean, most of us don't have a lot of capital to work with in those early days. And so don't lead into that, right? I guess is what I'm, what I'm trying to say, right? It's usually, usually there'll be some things that you realize after the fact that are very beneficial, right?

things that kind of instill are sticky kind of within the company culture, you know, even later on. So with that said, let's move on to IP because I mentioned this, you know, a few minutes ago when we were talking about your background, a little bit unique, right? And the fact that you, you know, you spent, you know, a cup, it looks like two or three years based on your LinkedIn profile, kind of in the, in the weeds on IP. And I think this is an interesting topic as certain trends start to kind of take shape in the world of IP, right? You've got, you know, traditional med tech where IP has been, you know, and I think still today is like is valued, you know, to a really, really high degree. But then you've got very clear examples of the PTAB kind of

stepping in and, you know, considering, you know, patents and invalid. And then you've got, you know, on the exact opposite at end of the spectrum, you know, someone like Elon that's like IP, I think his quote was like IP is for the week or something like that. You know, and he's basically challenging anyone to come and copy his stuff. It's too complicated to copy, you know. And so. When you think about this, especially with your engineering experience and your backdrop kind of spending some time in the weeds, what do you think is, maybe you can answer this a couple different ways, but like what do you think either startup founders really need to get right when it comes to IP or maybe some mistakes that you've seen, right? Others kind of experience based on your world kind of living and breathing this for a few years. Yeah, absolutely. And yes, definitely where you said resonates. I think going in make with an understanding that the IP, landscape is ever evolving and the importance does fluctuate and also is different country to

country. So I think kind of with that understanding how important IP is in your specific product, which can differ pretty significantly from product to product and company to company. So I think, you know, kind of with I would say like engineers probably have this inclination to want patent everything. That's kind of like been the standard and engineering for a while, but that doesn't necessarily make the most sense, especially for a startup where IP is quite expensive. And so making sure that you prioritize both what you're filing for having, you know, pretty elegantly worded patents so that you don't need to file multiple necessarily, as well as being strategic about where you're filing if you are looking to go abroad because there are kind of different understanding

of the strength of IP in different locations. I think where it also helped us specifically is that because we did have some university ties, making sure that you understand your relationship with your tech transfer office. If you are a med tech company that is either somehow tied to a university or a hospital. So Raya has retained full rights of their IP. And I think kind of my background helped set us up for that because we were able to negotiate our kind of contract with filing IP so that we would ultimately be able to retain it when we bought it back. This is not the case that can exist for everyone depending on what their contract is. But I think kind of understanding that really early on with your specific tech transfer office, if it's applicable, is really

important because that can really affect kind of what happens with the company in terms of what rights you have versus what rights they have. And it's always, and if you are looking to kind of negotiate to retain full rights or, you know, even some deal in between, starting that as soon as possible before you get too far down the line is always easier. So I think that's definitely something I would keep in mind. Give us a sense for expected time frame, right? For other early stage founders, entrepreneurs that are maybe in the throes or like, you know, thinking maybe they're at an academic, you know, institution right now. I'm thinking about spinning off a, spend off an idea, what, what time frame should we kind of allocate

towards kind of working through that contracting process? Hey everyone, let's take a quick break to talk about Fast Wave Medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy systems, or IVL for short, to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player. In early 2023, we opened up an investment opportunity to our community, and within a month, we secured close to $10 million. Then in early 24, we closed and oversubscribed $19 million round in just a few weeks, bringing the total investment into FastWave to over $40 million.

Corporate interest in the IVL space is growing too, the $900 million acquisition of Bolt Medical by Boston Scientific, and then J&J's $13 billion acquisition of Shockwave Medical signals a lot of attention towards emerging IVL startups like FastWave, and we're making some serious progress. FastWave recently received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first inhuman study

of our advanced electric IVL system with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor waitlist at fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. Yeah, so that was probably about, a year, year of time of working through the contracting process. So I think kind of like starting

that as early as possible, or at least, at the very least, like understanding what your obligations are if you're like an employee or a grad student and going from there. Yeah, certainly there's obviously a lot of nuances here, right, based on kind of the specific office that you're trying to transfer the technology out of. I'm sure it varies kind of depending on, you know, or varies, you know, from academic, institution to another academic institution. But yeah, maybe that kind of the key takeaway is that started early, right? Because this is not something that you'll typically get through a month. And so the earlier conversations, the better. And then it sounds like don't necessarily gloss over the contract either, make sure that you spend a fair amount of time, probably in

most cases, working with experts in the field to make sure that you would do retain some optionality when it comes to IP. But yeah, Caitlin's circling back around to, to prioritization, right? Because I think you brought up something very interesting. And all of us, I think, whether or not you're an engineer or not, get excited about various ideas in the earliest stage of where you could go. But you mentioned really kind of honing in on, you know, on making the call on what truly do you want to try to patent here, right? What's novel? What's patentable, et cetera? And then also the kind of geography factors into that equation too. And so in most scenarios, how do you, I mean, any advice for kind of how to think about maybe

prioritizing some of that? Because I imagine you probably worked with a fair amount of, you know, founders or, uh, or entrepreneurs, right, that came with like some huge laundry list of things that they wanted to patent and you were like, whoa, slow, slow down a little bit. Like this is going to be, if we go down this path, it's going to be very, very expensive, right? And so, you know, help us understand kind of how to maybe best, best think about that. Yeah, absolutely. So I guess like kind of off the bat, I would recommend. taking advantage of the provisional patent, which is basically when you can kind of put as many ideas down as you want on a piece of paper and submit it. And it basically gives you a year

to then file from there. So if you're not quite sure about where anything is going, I would recommend starting with that. And it gives you some optionality to at least think about it for a little bit. And then I also would consider kind of like, like at least in the U.S. patent system, what the like the process is for keeping that like line of patents open. So you can file like continuations off of existing patents if you do within a certain period of time. So I definitely would recommend working with an IP lawyer 100 so they can help you kind of keep on top of that. But I think that also kind of takes a little bit of the pressure off to patent everything all at once at the beginning. If you kind of can start with the

fundamental design, this is kind of how our patent worked because we, we have filed five pittons. So our very first patent was the extreme bare bones of our design. Our second patent was then kind of the improvement on the overall structure from that bare bones design. Our third and our fourth patents were about specific design features that we had conversations with our IP attorney about patenting from there. And then our fifth one was on our applicator that is like a, you know, a companion device. So kind of starting if you're not, I guess, you know, if you haven't fully designed the entire device yet, kind of we started broad and then we're able to narrow down. But kind of in that process from our very first provisional patent that had probably like 10

designs on it that if you looked at it, you would think were very scary and something you would ever want to go through, like those all dropped off. And then it just kind of stayed with what is the evolution of our current design. Yeah. Your funnel of ideas is quite wide, right, in the earliest stages. And the only thing I guess I'd add to that, and this, you know, I want to be fully open with the fact that this conversation could be a full hour alone, right, talking about IP. and different kind of, I guess, approaches and tips and tricks, etc. But your comment about starting with a provisional, right? The only thing that I'd add to that is, like, you need to be far enough along with your project,

right, for that to make sense because, you know, you don't necessarily want to be disclosing a lot of the stuff in the public domain only for that year to expire, right? And I think I've seen some folks, I guess, in my network maybe start that process too early and they're not quite serious or they're not quite ready to even like go all in on a certain on a certain project. And so I'm not sure if you would agree with that, but you certainly need to be serious enough, right, to go to kind of start that one year clock. Oh, absolutely. That's great advice. And then I guess conversely, you don't want to be, you know, approaching big meetings where you're concerned about confidentiality. You haven't filed anything where you are intending to.

Yeah. Yeah, no doubt. Yeah, good stuff. All right, let's let's transition. to kind of Ray Klin. And you mentioned the 5-2K clearance that you received, I think last fall. Was it last October you mentioned? We applied and then we received it at the end of last May. Okay, last May. Okay, got it. Got it. Okay. So about a year post-clearance. And your device is it, it's a 5-10-K, but is it a non-clin-K, I'm assuming? Meaning clinical data was not required as part of this submission? It actually was required. Oh, it was required. Okay, got it. Okay, very good. Wow, that's interesting that you had to do actually, okay. Wow. Okay. I wouldn't have expected that for for this device so so yeah you've got you've had to do a fair amount of i mean you guys

have accomplished a lot with with uh even really really capital efficient you know getting a getting a five to a clinical 510K cleared device um so good good good good good work to you and your you and your team for sure but you know thinking about your your experience is kind of navigating this right especially as the first time as a first time founder sometimes this this area can be you know quite daunting and to figure out like what's the best predicate device to use you know should we go down this certain path that is, and maybe you're in your case going to require clinical data versus maybe, you know, a different path. So when you think about everything that you've learned over the past, you know, five, six years at Raya, any, any, any, any, any, any, any, any, any, any, any, any, any,

any, any, any, any, any, any, any, any, any, any, any, any, any, any, other founders or CEOs need to keep in mind when they think about building out their the Ray Clinton roadmaps. Yeah, absolutely. Um, so we, um, so we work very closely with a regulatory expert. I think like he's, yeah, just an absolutely vital member of our team. helping us navigate that. I do think that this is an area where I do encourage everyone to kind of like structure capabilities as much as possible in the startup. But I do think that this is definitely bringing in someone who's an expert can save you a lot of time and a lot, make a lot more efficient process. Because, yeah, kind of like you said, that we actually, we didn't think that we

would have to run a clinical trial either. This did come out in a pre-submission meeting that we had with the FDA. So I think my other piece of advice is to try to make an open line of communication with the FDA. There are these formal channels where you can have, you know, pre-submission meetings and discuss, you know, more specifics of your application. But having kind of a relationship where we were able to like have quick phone calls with various people on our review teams to kind of clear something up because we had that relationship where we basically had. had enough meetings with them that we were kind of able to skip some element of like the formal process to expedite something. So I would also recommend that to basically like be as open

and transparent in the process from the beginning because they ultimately will be reviewing your entire application. So if you can maybe touch on that a little bit more detail. So you mentioned that this surfaced right out of your first Q sub with FDA, this deed for clinical data. And I want to circle back around to the current trial that you're running to as well as kind of post-clearance. But did you try to sort of pitch the agency on, you know, your path, your expected path, I guess, without clinical data? Or was this more of a, you know, kind of an ongoing conversation? And they responded and said, no, no, you're going to need to run a clinical study as part of your 510 case submission. We did pitch our original path of not needing to provide clinical data,

given that, you know, material is 100% silicone and kind of the, like, nature of the safety and the fact that the predicate is so close to what we're providing. So I guess, yeah, another kind of like piece of advice I would pass on is to kind of like pick your battles. It seems, I think, both based off of like what is like time and energy efficient for you. but also I think you can kind of tell which ones you're going to win and which ones you're going to lose. And so we did, you know, had this Q-7 meeting where we did pitch this path board and they said, no, we want to see clinical data. And we can leave that saying that we disagree with them and this is why. But I think when it comes to something that is that substantial of a piece of a data set that they want to see, it is really hard to come up with the justice

that they will end up accepting. So we did then work with them to write clinical trial and tried to kind of like pick battles elsewhere. We were more certain that we would actually have like a justification. They would find acceptable. Yeah, such a good point. And I'm glad you brought that up because I think it's a very, very, it's not only very real, but it's also very practical, right?

Because if you notice early on right in your engagement with, with FDA that like they're really probably not going to let something go, right? Whether it's, in your case, maybe it was, you know, the need for the clinical data, or maybe it's something else. You could literally waste years and a lot of money trying to fight a battle that you're never going to win. And so I think that's a, that's a really, really good, really, really good point. Talk to us a little about this ongoing clinical trial that you're running too, because it sounds like that obviously isn't something that was needed, or this RCT wasn't needed for the purposes of your, of your clearance, but you decided to pull the trigger on it anyway. So give us a sense for kind of how you're thinking about that.

Absolutely. So the child that we had to perform for our clearance was based on safety and efficacy and comparing it to current pestries where current pestry users basically acted as their own control where they used their own pestry for one month. And then they used our pestery for three months after that. But those, yeah, design, we did get, because we were interested in certain kind of design elements of our pestries specifically, we did get data on, you know, usability, comfort, kind of those features. but those were secondary endpoints compared to the safety and efficacy that the FDA was looking at. So then we are currently running a randomized control trial where we are taking pestry naive subjects. So people who had never used a pestry before. And this one is focused really on studying our specific elements, design elements of our pestry compared to the current ones. So they either get assigned the existing pestry or our pestry and we're focused. more on like usability, self-management, comfort over the studying those as a comparison. While we are like kind of collecting some post-market data, I think that this is like a really

nice way to quickly get data about certain elements that we would like to know more information, more, you know, validate our design, especially a kind of school of thought that hasn't ever fully been tested that if you are able to remove your pest reignitly and kind of give you tissue break that you are able to kind of reduce these complications associated with long term. Like fewer like abrasions and bleeding and things like that. So that's kind of like, yeah, like practitioners generally like think that that's a reasonable assumption, but being able to kind of test that. So that's kind of our focus on our current trial.

So we're kind of doing that more for, you know, like further, like, research and marketing purposes while we're also collecting, like, other post-market events. Got it, got it. And you're running this trial sort of internally, right? Not sort of outsourcing everything to a CRO? We are a bit more hands-off in this one where we, our lead site is running it. So it's being built at nine hospitals around the U.S., but to kind of also create that like, separation between the industry and the research that ultimately we hope is published.

We are a little bit more hands off than the last trial that we ran. Okay, very good, very good. And so most companies, I think, would hesitate, right, to, like, run an RCT. Even if it's, like, maybe a lower cost RCT, it's still a big endeavor, right? So you obviously felt the need, you know, to sort of substantiate, right, some of the differences with your design versus others, yet that still seems like a monster lift. So, you know, was that just, was that largely rooted in feedback from, you know, from physicians that felt like they, they needed it? Or you feel like you kind of operate under the guys that

just more, more data is better. And it's worth, you know, it's worth allocating resources towards, towards this. Like, what was the thought process there? I think that's kind of like our general, like, company mindset is that, like, the more data for any new technology is better. And we've heard that from both, like, the practitioner side as well as pastry users and LOPP patients who, you know, will go on clinical trials.gov and look up their own research. So kind of being able to continue to contribute to the general education of the community, that's, you know, something that we're particularly interested in. We are getting, like, a lot of, you know, post-market feedback that of, like, how

intuitive our design seems and the switch, you know, makes sense. I think it's like always nice to validate that. It is also being run with an NIH grant. So that's kind of like where the focus of that grant for the, for that specific trial is as well. Got it. I want to get to that here in a second. I had knitting Sunluke on the show, Gus, it's just probably like, I don't know, four or five months ago. He's a CEO of a company called Sapira. And he, it's a phrase that he used that kind of stuck with me for a while now is like, you know, once you get to a clinical stage, right, clinical, it's best to view clinical data is currency, right? That is sort of the lifeblood of your startup. And the more, in essence, the more clinical data that you can continue to

collect, oftentimes is the better way to go, right? Even if it's more resource intensive, and don't get me wrong, it's not like you just want to run random studies. There should be some pretty thoughtful process around how you're going to do it, what it's going to ladder up to, etc. But in most cases, being biased towards running additional studies is going to be going to be more valuable, right, than not. So, so again, kudos to your team for getting this far along with not a lot of capital. Because I just want to continue to reinforce that. We'll get to this kind of how you've, how you've been able to do it, right, through largely NIH or largely non-dilutive grants thus far. But, you know, kind of zooming out, you've been at it, you know, since 2017.

Granted, it wasn't full time in those early years, but, you know, you kind of continue to make progress, now having a 510K cleared device, by the way, require clinical data. You're in the throws of an RCT. Most people would hear that and be like, oh, she must have raised, you know, $15 million, $20 million. And no, that's not the case. And it sounds like based on our research, you've been largely able to capitalize the company through this, through these non-dilutive grants. I think what? It's like $5 million, maybe total so far, roughly. Is that correct? Yes. Yeah, all $5 million through NIH grants. And yeah, I guess. you know, a smattering of low stakes pitch competitions on the side. So yes, pretty much all

NIH grant funded. Yeah. So, so I guess maybe we don't have a ton of time to get into this, but what, what, what, what, what, what, what's like the one or two things that you think other other entrepreneurs need to get right when they think about grants, maybe? Because you obviously have had a lot of success here. And then how are you, how are you kind of parlaying this into, I would imagine eventually you'll raise, you know, a dilutive, you know, equity-based financing. So how are you kind of using that to your advantage, you know, moving board? Yeah, absolutely. So I think everyone kind of needs to figure out, like, what the pros and cons of financing is for their specific company. We really found the benefits of NIH grants to be the kind of like the planning yet the, like, flexible nature of them.

So you basically write out your broad milestones for two or three years out, which does definitely provide. you know, a guiding light and some structure for a small team, but it also does provide the flexibility to kind of, you know, roll with the punches that inevitably occur when developing in MedTech. So we are able to kind of, you know, like pivot slightly within all of those, as long as we end up reaching kind of like our end milestone that the grant was. set out for. So I definitely think it's kind of like a real positive in that way, especially early on when, you know, maybe your design or even kind of your, the thesis of your idea is not fully tested out. So it kind of does give you that flexibility to pivot within that if needed. The

timeframe of grants, though, can be quite extended. So you can, you know, apply and not here for about a year later. So kind of making sure that you are able to withstand or put off any funding gaps and actually link those together, which in turn can then kind of also force you to make a like more thought out plan that helps you kind of like constrain yourselves to reach your end goal. Yeah, I think it's also, you know, going into conversations now with strategic partners and as we're thinking about kind of the next steps for fundraising, being fully grant funded is a big positive. People do see that as, you know, pretty impressive that we were able to, you know, submit

three successful grants given there's like, you know, the published rates of acceptance are pretty low. So it's kind of like a nice portion to your resume in addition to, you know, retaining full control of your company up until this point. that's super valuable feedback with respect to kind of how you approach non-dilutive funding. And I can only imagine, right, that's extremely, like, extremely positive signal, right, for other investors that are thinking about, you know, writing, you know, dilutive checks at this point, right, which is probably going to be the next phase in the,

in the company's journey. And I think you brought a good point before we get to kind of the rapid fire portion of this interview around some people can think about grants, right, and the time it takes to actually receive the funds, right? but it does, to your point, it does force you to kind of like really be mindful and thoughtful about the planning, you know, that surrounds kind of that timeline. So I think that's, it's this sort of a sword that cuts both ways, right, but it can be also, you know, very, very beneficial in some regards, right? And it does maybe, kind of similar to what we talked about

earlier, forces you to kind of maybe flex those muscles and work, work those muscles a little bit, a little bit harder, right, than you, you may have not otherwise done in earlier stages. So, so again, just huge congrats to, to you and your team, right? for getting this far, not just with the design of the device, but also running a, you know, a clinical study, submitting for 510K, getting a device cleared and out, you know, in the throes of a, throws of an RCT. So really, really good work. So with that said, reahealth.com is the website, R-E-I-A-Halth.com. I highly encourage you to check everyone to check this out. It's really cool device, really cool site too. We'll link to it in the full write-up on MedSider as well as

Caitlin's LinkedIn profiles. You can reach out to her if you want to connect. But Caitlin, last few questions here, a rapid fire nature, if you want to expand a little bit, certainly feel free to do that. What are you most excited about at Raya over the next 12 months? Take us out to kind of mid, mid-2026. Yeah, I think it's continuing to grow sales. I mean, so far we've seen month over month growth as we've just started in October and every month we're getting into new hospital. So kind of just excited to continue to see it out in the world. No doubt, no doubt. Since co-founding the company, take us back to those very, very early days and the arc of kind of the journey getting this far, anything surprising or unexpected that's come up. I'm sure there's a lot, but anything that kind of stands out to you. I think kind of when we touched on this before is just generally how adaptable our entire team can be to take on new tasks and, you know, going from submitting, learning about the regulatory,

system and submitting a 510K to, you know, being on the line, making production parts just kind of would never expect to be involved in all facets that closely. And so that's been very exciting. Oh, no doubt. No doubt. You've got definitely a savvy, savvy group of folks there at Rhea, right? So, all right, last question. Maybe we're in the Northeast and we're doing a small dinner in New Hampshire, you know, your stopping grounds, right, at Dartmouth. And you want to leave, maybe it's a group of other med tech entrepreneurs and you want to leave them with like one key thing, right, that they really need to get right or they really need to think about, you know, hard before, you know, if they're going to experience any sort of success in their,

in their startup. What would that be? Yeah. So I think I wouldn't underestimate how resilient, kind of the central passion can make you. So make sure that you are kind of going after something that you really care about. In med tech, you will inevitably counter tons of roadblocks. I mean, we encountered, you know, regulatory grant writing, COVID shut down our clinical trial, you know, one of our materials were discontinued at some point, kind of you will go through, you know, your equal set of challenges and being able to kind of push through them, I think really takes dedication to the cause and kind of inspiration from those people around you that you're working with and who you're helping. Awesome. Really good feedback. Great way to kind of wrap up the

conversation. Caitlin can't think you enough for for carving out some time, right? And thinking about these questions in advance. And oftentimes when I imagine we sit over the questions, you're like, there's a forced to kind of relives, you know, some of these, some of these things that you've, you've been through, you know, getting, getting ready to this, the stage. So a huge congrats to you and your team. And again, thanks, thanks for sharing a lot of your lessons learned over the past nearly decade now. Thank you so much. Really appreciate it. All right, I'll be hold on the line. But for everyone listening, thanks as always for your attention. Again, we'll link to Rea's website in the full write-up on Medsider.

But until the next episode of MedSider goes live, everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach

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