Medsider: Learn from Medtech and Healthtech Founders and CEOs - Build Evidence in Layers, Not Leaps: Interview with May Health CEO Colby Holtshouse

Episode Date: December 3, 2025

In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon’s acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.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 Colby Holtshouse.

I've just not been in a single launch where you don't find out something in the first few months. We're like, oh, well, that is certainly interesting and something we now need to account for. Not necessarily bad, maybe it's good, you know, maybe it's just different, and you can solve it potentially with training, you can solve it with messaging and expectation setting, or maybe you do need a product fix or a packaging fix. There can be all sorts of things that are adjustable. So listening really, really carefully in that early launch for what's the feedback you're hearing, but leaving your customers when they tell you something.

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 sat down with Colby Holtes, a president and CEO of May Health, a clinical stage company, developing a minimally invasive therapy to restore ovulation in women with PCOS and PCOS related in fertility. Previously, she served as global Mentech commercial lead at Organon, overseeing the worldwide launch of the Jada system following Organ's acquisition of Alidia Health, where she held roles, including COO, interim CEO, and VP of Marketing. Colby has also held leadership positions at Pelvalon, Access, Medtronic, and Guidant. Here are a few of the key things. that we discussed in this conversation. The first data set sets the tone, so make it airtight. Early studies don't need to answer every question. They need to answer the right ones.

Kobe uses a phased approach, small bulletproof trials with credible investigators first, then broader data sets later. In an era where proof thresholds keep rising, sequencing your evidence strategically is what earns belief from regulators, clinicians, payers, and even your own team. Second, a small controlled launch prevents uncontrolled surprises. The first wave of real-world use will service things no clinical protocol ever could. Workflow nuances, expectation gaps, and subtle friction points that only show up outside a study. That's why Colby prioritizes depth over speed, a tight group of trained early adopters, close observation, and rapid feedback loops. When companies learn slowly and deliberately at the start, they build the

conviction, messaging, and refinements needed to scale with confidence later. Third, your raise should drive the pitch, not the other way around. Founders often reshape their pitch to match each investor, but Colby takes a more disciplined approach. Define the race first, how much you need, what milestones it funds, and what type of partner fits the plan. That clarity accelerates conversations and saves months of misaligned meetings. All right, before we dive into this episode, I'm pumped to share that volume 7 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 MedTech 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 in in the interview.

All right, Colby, welcome to Medsider Radio. Appreciate you coming on. Thanks, Scott. It's great to be here. I am very much looking forward to this conversation. I know we probably know a lot of the same folks and share a lot of the same network, but glad to finally connect and definitely looking forward to learning a little bit more about your journey and what you're building at May.

So with that said, let's start at the top. I recorded a very, very short bio that doesn't do your background justice. So maybe give us a two-minute overview. elevator style kind of overview pitch of what you're doing before taking on the CEO role at May. Sure. Thanks. Well, I've spent most of my career in medical device. I was originally attracted to the space after working in technology investment banking because I loved science and technology, but I wanted something with a little more soul and a place where I could, you know, really lean into meaningful work. And I first found that at Guidant, the first med device company ever

worked with, learned a lot from that company about how to keep the patient first, how to help people build, you know, well-rounded careers. And I think I've tried to live some of those values forward ever since. I had the chance to work at Medtronic, then moved into startups still in cardiovascular with access closure, great first place to go as a startup with so many talented people to learn from. And then pretty much ever since then I've been in women's health, I worked at a company called Pelvon and the Eurogine Incontinent Space, then went to Alidia with a postpartum hemorrhage device, which we sold to Organon. Spent about three and a half years there working on trying to build out a bigger women's health platform, which was really exciting. But recently

had this opportunity to come back to startups, get back to May Health. It's right in the stage that I love to be at where both Pelvon and Alidia were when I started, which is, you know, we've got the feasibility work done, the devices constructed, those brilliant founders have done their work and I can come in and say, okay, now we're going to tell the story of this great technology, find the, you know, physicians who are going to be passionate to take it forward, build out the clinical evidence. I love doing clinical research at the stage. And yeah, get ready for commercialization. Awesome. That's a great, great snapshot of kind of where you've been and then where you're at currently and anxious to kind of dig into a little

bit more as the kind of the conversation unfolds. So Mayhelf, for those that are kind of hearing about the company for the first time. I'm looking at the website now, Mayhealth.com, just as it sounds, like the month of May and then health. That's it. Give us this idea of ovarian rebalancing. For those that haven't spent as much time as you have in women's health, what is it? What are like, what's the main problem you're trying to solve? And, you know, maybe because you've spent like, like have such kind of deep experience in this space, like what drew you to this in the first place? Well, what's exciting about May to me is is kind of at the intersection of two huge problems.

So one is PCOS, which is polycystic ovary syndrome. So that's an endocrine disorder, really a hormonal imbalance, which leads to this wide variety of symptoms for patients. So there's the ovulation, you know, the direct ovarian function that's impaired, so you're not ovulating, making it difficult to conceive women typically don't have periods or have very irregular periods. But then there's also visible symptoms like hercitism, which is facial hair. acne, weight gain, male pattern baldness. And these all come from that hormonal imbalance of having

too much of the androgen hormone, you know, basically testosterone and male sex hormone, more than women should have, which keeps other hormones from being produced at the level that you need, the level that helps, you know, with ovulation or helps with the regular hormonal function and balance. So that's PCOS. And it impacts 10 to 12 percent of women, which is really remarkable. And the symptoms you're living with from puberty to menopause, like the entire time that you want to have good hormonal balance for healthy living, you know, you've got this thing going wrong in your system. That's really devastating and many women are living without a diagnosis for a long time and everyone's living without a cure. There's really no cure. There's a few band-aid solutions,

but there's not an overall way to address the syndrome. So there's one huge problem. And then, you know, right in the middle of that is the fertility problem. And if you, look across the world today, you know, many governments are grappling with the crisis of fertility. Many families are grappling with fertility crisis. So we have both, you know, very personal, deeply held challenge of being unable to build your family to have the baby that you're longing for, as well as a population crisis of not replacing our population fast enough. The governments are starting to say, hey, we need to lean into this with funding and with support. So that's a global issue. And so,

I looked across this scope of problems all coming together, and we have the opportunity with our device to provide a one-time procedure that's ovarian ablation, so delivering radiofrequency ablation directly to the ovary, to try to reduce the amount of tissue that's overproducing androgens, that male sex hormone, that can enable patients to then regain hormonal balance, regain the ability to ovulate, and then hopefully, you know, conceive a baby. That's the purpose, the mission of the technology. We're investigational. We're still working on our pivotal trial and you know, working on developing proof for those goals. But that's what we're looking at. And I couldn't think of a more, you know, exciting and important place to be working right now. So if I understand

right, I'm not over, I'm not obviously as familiar with kind of women's health as you are. But you have this, this significant underlying driver of PCOS then kind of overlay the infrastructure, the massive infertility issue, which maybe we can dive into that in a little bit more detail later on. because I do think, just to touch on that real quick, I remember a podcast I was listening to with, I think Justin Mayors, I'm not sure if you know Justin, but he's like mostly well known for like his thoughts

and like more consumer wellness, but I think I remember him touching on like what he thinks is like one of the biggest opportunities to tackle in healthcare, which is this infertility issue. And I'm sure those listening have seen like the graphs that are like down into the right across the world in terms of like, you know, fertility, which is a which is pretty, pretty shocking. So you've got anyway, these two kind of like,

if you looked at a Venn diagram, right, like they're very much overlapping. And then your device, tell us a little bit more about your device. It sounds like it ablates the ovaries, which does solve for this kind of this hormonal issue. Let's fast forward to maybe when it's commercially available. Is this something that, you know, someone would be treated in a clinic and like an office? Can I clinic say that again? Yeah, exactly.

So it's interestingly built on a technique that's been used for a long time. So, you know, physicians a long time ago looked at the polycystic ovary and said, wow, it's really big, right? So maybe if we just remove some of that tissue, it'll produce less. So the first attempt was just a resection of the ovary, just cutting out a slice, which is pretty crazy. And then they said, okay, that, you know, that actually has benefit, but it's quite invasive. So what else can we do? And started to approach with ablation, but laparoscopically. So thinking about going through the abdomen, making an incision,

and then sort of using unipolar energy to burn both the outside of the tissue straight into the inner core. And so what we're trying to do is take that to the next level of minimally invasiveness. So instead of going laparoscopically, adomily, we'll go transvaginally with just a tiny needle. So the needle goes through the vaginal wall into the ovary. And then we have a bipolar system. So all the RF energy is staying within these two electrodes that are inside the ovary. So just targeting the tissue on the inside of the ovary,

not burning or churning the outside of the ovary at all, which removes some of that risk of adhesion that can happen when you're ablating the outside of an organ. So the idea there is actually that transvaginal procedure targeting the ovary is just like what reproductive endocrinologists do when they're retrieving eggs for IVF. So if you're doing an egg retrieval procedure, you're also using an ultrasound probe to visualize the ovary, deliver a thin needle out to the ovary and then pull back eggs. What we're doing instead of pulling out eggs is just delivering energy.

So same sort of setup where we're seeing most of our centers are, you know, doing the in the office, conscious sedation, and patients are observed for a couple hours before they go home. Okay, got it. So your early days, maybe in cardiovascular, you saw this trend, right, of like many more devices being delivered, you know, through a capital-based approach. It sounds like that's sort of similar to kind of to an extent with what you're doing at May. So that's cool. And I mean, just to like build on that, one thing that is really classic in women's health is we're doing all the same sort of things that happened in other spaces,

10 years later. Like, hey, you know what? This is actually a huge problem and deserves us trying to make this a more minimally invasive approach. These are really well-worn pathways that are sort of just finally getting to these target areas that have been underserved for so long. So just building on your great observations. I don't know if it's a great observation. It's probably maybe one of the more obvious ones or for kind of more of a women's health dummy like me. Although I will say this. We have six kids, fortunately, right? So we haven't struggled too in that area per se but but my wife is yeah she's she's she's in her early 40s now and you know starting to deal with the normal kind of women's health things and like this idea of of you know pelvic

you know pelvic you know pelvic floor kind of you know dropping and like all of those all of those issues like all it's drawn my attention to know I'm like I've kind of walked away with the same conclusion it's like I'm you know more I've been involved in the in the you know pure play cardiovascular and it's like all of these like kind of methodologies and tools are readily available in other arenas like why haven't they been applied to write to this, yeah, just the space. So it's interesting that you kind of kind of bring that up, especially considering your, your background and kind of growing up in that arena. So that's helpful. You mentioned that you started at May in earlier this year, right? So we're recording this in Q3 of 25. You started in, I think, Q2. So what's like

four or five months into it? Five months. Five months into it. And you came in, you came in and you said the feasibility work is done. So give us a sense for kind of, you know, where the company is at, like currently as of, you know, Q3, 25. So the company had done, um, usability studies in Europe and the U.S., 32 patients and saw, you know, really healthy rates of ovulation and 12 pregnancies out of the 32 patients that we had studied. And as of our 12-month outcomes, we had eight live births, which is really exciting. It's still a couple of pregnancies underway. So we'll see as the study is complete. And today we are doing our pivotal study here in the U.S. So IDE study, FDA review protocol in preparation for a PMA. And we need to treat

150 patients in a randomized controlled study. So we are almost to 40 patients treated, which is really exciting. Really great progress. Still some work to do to get that fully enrolled. And then at the same time, we are working on a C.E. Mark that's underway, you know, getting ready and looking forward towards commercialization, both in Europe and in the U.S. Okay, got it. So very much in the throads of some pretty significant clinical work. And then if you had to take a guess, and I won't hold you to it, but commercialization, is this like, you know, maybe sometime in 2006, potentially, or, you know, are you looking

a little bit further out? Yeah, I think, you know, we're hoping to finish the pivotal study, finish enrollment next year, three-month endpoint, and then we'll probably spend 2027 on the PMA process. And so U.S. commercialization probably would be end of 27, early as 28. But we do have this opportunity in Europe where we have our CE mark underway. We have gotten really good progress. Our system is broken up into three different sections, but one of them is already approved. One is very close to the final signature.

And then the other one has a little more time to go. And that gives us the opportunity to do some early work in Europe. We would like to get our next-gen product approved in Europe to, you know, do that pilot. But that would be a great opportunity to start collecting postmarket research, better understanding, you know, how the device is used, you know, in real world use, which I think is always so important to watch carefully, spend quality time with a small group of clinicians. You know, we can talk more about commercialization. But that's kind of what we're thinking is we look forward towards commercialization. That could be as soon as 26.

Got it, got it. So maybe an opportunity to commercialize in advance of the U.S. PMA in in Europe, it sounds like. So, okay, cool. That's at least helpful. It gives people listening a sense kind of for generally speaking, kind of where you're at and where you're, where you're headed over the next couple years anyway. So again, for everyone listening, if you don't get to the full summary write up on MedSider, mayhealth.com is the website, just as it sounds, mayhealth.com. Very cool site. I highly encourage everyone to check out this technology in a little bit more, a little bit more detail. So with that said, Kobe, let's spend the next maybe 20, 30 minutes kind of going through what I typically consider like some key cross-functional kind of

areas, right, that every startup is going to have to navigate at some point in their journey if they're going to make it, right, if they're going to make it to the finish line, whether that's in the form of commercialization, an exit, an IPO, et cetera. So with that said, let's talk about clinical work. You mentioned that's one of the things that kind of excites you, right, at this stage of your career. You've been around a lot of it previously. When you think about whether it's certain learnings that you picked up previous to May or maybe how you're approaching, you know, the current kind of clinical roadmap at May specifically, are there like one to two things that really stand out that other med tech founders or CEOs really need to give it to mind as they

think about, you know, doing some of this either early feasibility work or even even IDE type of type of sophisticated clinical studies. I mean, first of all, say clinical research, I think is a fun process and excites me. Clinical evidence is just, it's everything to your med device startup, right? You are nothing without that. that peer-reviewed, the last article that sort of declares that your technology really works and that can be deeply reviewed by FDA and, you know, ensure your regulatory pathway. I think about every stakeholder, right? Every customer from patients to physicians to the nurses, you know, everyone in that category,

regulators, you know, your investors, even your own team and employees, they really need to see that evidence to continue to believe. just feel like the threshold for belief is only raising, right? As we have more and more devices, there seem to be fewer and fewer dollars, right? The threshold for evidence is really high. So you have to think really carefully about your strategy to build evidence and don't underinvest in it. So, you know, how to go about that. I think staging it out is wise. You don't need to do everything in the first pass, right? So when I look back at Alidia, you know, we had a really robust, small first women's study. Then we did 100 patients in a very carefully controlled

study. And then we studied 800 patients post-market in a much lower rigor manner. And that cadence of evidence really helped us grow the story, expand the story, also keep coming at our customers with new information. And, you know, 100 patients doesn't seem like a lot when you're first coming to market. But if you have really deep evidence on those 100 and you've done that work with really credible thought leaders, you can get a long way and then build on it with sort of a less rigorous data set in a much bigger group. And so that was really helpful for us, especially thinking about, you know, how much you're able to raise when you're still pre-commercial, when you're still, you know, building conviction. You don't want to do a giant study if you

don't have to, but just making sure that it's really, really well done, well thought out, bulletproof so that you can't publish it and build from there. And, you know, if you have that sort of end goal in mind, with this study, we just need to get KOL belief, regulatory belief, you know, early customer belief. And then with the next set, we can get X, Y, Z, right? That helps you stage out your clinical program. That's a really healthy kind of framework to kind of think about that. And maybe a little bit makes it less daunting, right? Because it sometimes can be, can be overwhelming, especially if you're doing something pretty novel, right? Like this therapy is not. It's not like this has been around for 20 or 30 years and you're just doing it a little bit

better. It's like it's pretty new. And so, you mentioned Europe, right? And I'm not sure if that was, you know, it sounds like, you know, when you came into May, like there had already been, like the wheels had already been turning, right, in Europe. But if you had to kind of start from scratch, maybe take your May half, your May hat off for now, right? If you had to kind of start from scratch, would you pursue just a U.S. only strategy or what are your thoughts on how to balance, right, U.S. versus Europe, because historically, right, 10, 15 years ago, everyone went to Europe, get your C.E mark, then maybe come to that, come to the U.S. That pendulum has swung quite dramatically, I would say probably over the past, you know, four to five years, especially

post-MBR. So what are you generally, I mean, you got all, this is, you know, this is your wheelhouse, you know, and so like, what are you, you know, what are your general thoughts on that? My general thoughts are that at an early stage, when your company is less than, you know, 20 people, less than 10 people, it's hard to do more than one thing really, really well. And you still have to do multiple things, right? You've got to produce your product. You've got to run the study. You've got to keep your quality system going.

You know, you've got to prepare for commercial and raise money. So there's always going to be multiple things. But keeping the whole organization sort of really focused on one key milestone at a time, I think is very helpful. So, you know, at Alidia, where, you know, we didn't raise as much there as we have already at May, we only were focused on one market. We did have a sub-program looking at low-middle-income countries because we originally founded on the concept of trying to reach women in low-resource settings

with our device as well. And our investors came on board because they were supportive of that and wanted us to carve out some time and energy for that. So I guess that brings me to the second point, which is you have to be really closely aligned with your investors on where your goals are. So for our investors at May Health,

you know, we were incubated at MD-Star, which is the Sofanova incubator in Paris. And so that is how we got our start in Europe, did all our feasibility work in Europe, and that has become a really important part of our strategy because now we have KOLs on board there. The fertility market is so robust in that country. So we really want to keep that as part of our key focus.

But then we know the FDA pathway is long and challenging in the U.S. market is important. So we did make that decision to go after both at once. But now we try to sort of stage it out. So right now it's the big enrollment phase. We have the CEM market application process running on the side. And then we probably won't aggressively go after commercialization until we're done enrolling so we can kind of shift our focus over.

Got it. That makes sense. And it may be the takeaway here is not that you can't pursue multiple geographies at once, but like thinking about the focus that's required at the time, right, through these various stages, I think is really crucial. And to your point, especially considering, you know, startups don't have endless resources, right? And investors are going to want to see, you know, their portfolio companies hitting certain milestones and not being being spread too thin.

So on that note, it looks like May raise. Let's talk a little bit about capital raising because May raised, I believe, are closed on a series B. 20, what am I know, say? 24 million, I think, is what maybe what was reported. 25, 25 million. And about a few years ago. All credit to the prior team. That was here when I got here. Yeah. So you came in with money in the bank. But you've been around, you've been around a lot of startups, right? I mean, dating back to your access closure days. And so you kind of know how that the sausage is made. So when you think about whether it's engaging with startups to run a, you know, basically run a financing campaign, if you will, or just ongoing engagement with investors in general. What are the most crucial

kind of pieces of advice that other CEOs need to consider there? Well, I think maybe a desire, you know, as you're getting started in fundraising to sort of say, let me find out what this investor needs and then see if I can meet their needs, right? I will adjust my story or, you know, my capital strategy to the funder that I'm talking to. And I've come to think that that is really doesn't serve you well in terms of your time spent, likelihood of success, et cetera. I think it's really important to start up front to say what exactly are the goals of this raise. How much money do we need? And then what does that mean? We need one lead with this much and then maybe a bunch that are smaller, you know, can we just have a bunch of smaller investors?

Do we want one person who's taking the whole thing? And then you can approach investors with exactly what you're looking for and they can tell you if that's something they would ever do because there's really nothing more frustrating than going through a whole pitch and then waiting and then falling up and having you know someone come back and say you know it's just it's too early for us or it's you know we'd rather write a bigger check or whatever then you've spent a lot of time trying to get that introduction get prepared just to find out that it probably was never really going to be a fit um so i think doing that homework of who you know which funds are first what you need, and then which funds align to what you need, and then trying to stay true to that

so that you don't, you know, spread yourself too thin. That's probably my first piece of advice. And of course, we have to be flexible. It's a difficult fundraising environment. It feels like it's always a difficult fundraising environment. But, you know, we always say that. And so you have to be flexible. And you do have to try to kind of work with what the market is going to offer you. But I think that's, you know, that's probably the most important piece. And really knowing the audience that you're talking to so that you're not asking them for something that they're not likely to want to do. Yeah, no, it makes a lot of sense. And I'm, yeah, to your point, we're kind of joking or laughing about it. It's like, it's always hard raising money in early stage met tech. And then there's

like, then there's really, really hard times, right? So I don't think there's ever like a, oh, the timing is great. Couldn't have asked for easier money, you know? So, you know, maybe if everyone slapped an AI, you know, descriptor on their, on their company name or their product name, maybe that would help a little bit. But, but joking aside, I think, I think, I think, kind of how you lay that out is really helpful. And, you know, I think most people listening would probably, you know, understand this idea of getting to a quick no, right? Get to a quick no or get to a quick yes, so you can kind of move on. And it's not necessarily even a no. It's more like a quick answer, you know, because oftentimes, right, as you know, like no, it doesn't

necessarily mean no. It may mean no now, but it could be, you know, more of like a really true kind of a maybe, but let's circle back around in a year or maybe when the companies, you know, hit another milestone. And so, but yeah. Such a good point. That everyone you talk to could be your investor later, you know, maybe in this company, maybe in a different company. It's a pretty small world of folks who are willing to invest in med tech. And so, you know, treating every opportunity to get to know the folks that you're pitching to. Yeah, no doubt. But you bring up a really good, like, you're, I guess the first point you really hone in on is like, do you need to sort of like be a chameleon to a certain extent, right? And kind of change kind

of your positioning or maybe raising a little bit more money because you know who you're talking to, you know, typically it's not going to write a, you know, a $10 million check. They're going to always, you know, their mandate is to write, you know, is to deploy 20 million on a minimum. But the reality is like to stick, oftentimes it's best to be very transparent and very kind of like upfront about what your ask is. And, hey, if it's not a good fit, better to kind of have that answer now versus kind of wasting two or three months and follow up and, you know, ongoing, you know,

questions and calls, right, only to only to get to an answer that you could have had, you know, relatively quickly. So anything else you'd add kind of on the fundraising topic before we get to hiring? Because I'm curious to get your thoughts on this too. I mean, I will just say from, I had this great experience over the past three years to work at Organon and be on the other side. So I listen to a ton of pitches. And it really humbled me about pitching, first of all. It just is hard. And the people listening are obnoxious. They can get distracted. They can ask totally off-topic questions. If I have a thing I really want to find out about, I'm going to ask you right in the middle, and you probably have this plan of where you're going to go. So I think just being

prepared during the pitch that the amount of time you need to spend talking is two-thirds or less of the time that you have in the meeting so that you are not flustered or thrown off or, you know, distracted by questions because it's just human nature. With people listening want to follow up and throw out their ideas and ask questions. And If they don't have a chance to do that, then they are probably getting bored at some point in the pitch. And then you don't have their full attention, which is never great. Yeah. So just making sure you balance the talking and the listening.

Hey, everyone. Let's take a quick break to talk about Fastwave 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 an oversubscribed $19 million round in just a few weeks, bringing the total investment into Fast Wave 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 wait list at fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. I'm glad you brought that up because that's such a good point. If you're able to get through your entire pitch flawlessly without any interruptions, that's probably not a good sign. That means the audience is probably sleeping. But yeah, that's probably one of the like even my, you know, one of the key learnings probably I would I would probably point to over the past even two, three years is going in, especially if it's, if you're maybe in the second or third meeting and you're, and, you know,

that investor is starting to bring in, you know, other partners, et cetera. That means, you know, they're getting more and more serious. You need to think about, like, what are the main points that you absolutely need to get across in this? Knowing for well, you're probably not going to get to everything. But like, if you, if you get through half your pitch and you've only covered maybe one of the three most important points, like, that's not great. I mean, because that's your shot at really kind of really emphasizing, you know, some key, key things that stand out about your company. And if you don't get to those, don't sort of pace the presentation well enough, then you know, you're not giving your, you're not putting yourself in the best position, right?

So I think it kind of reminds me of just this idea that if you're new to pitching and new to these like investor, you know, investor, you know, meetings starting out with like a kind of more low risk audience, right? Where you can struggle and kind of, you know, make a lot of mistakes. That's oftentimes the best place to start. And so, yeah, good stuff. Let's get to hiring though, because this is a question that I've started to kind of insert a little bit more in these interviews because it's, it's so key, right, to any startup. I want to say make or breaks a startup, but it can really, it can really hurt if you make a bad hire. And there's so many people, I think, that have this appetite to want to join a startup.

It's fun. It's fast pace. Yeah, it's a lot of work, et cetera. But maybe it's not a good fit for them, right? They've spent their entire career in large strategics. And that's not to say that you can't make the move plenty of people have. But when you think about all the hiring you've done, right, across your, basically your startup journey, then in the, you know, Oregon on and spent a little bit of time inside a, again, kind of a bigger, bigger company, larger strategic. and then back at a startup again,

what are some of the things that you think are absolutely critical to nail, like, you know, when you look to make, you know, certain hires? There's a lot of pieces. I do think that when you come to a startup, and people told me this early in my career, you know, you got to bring something to the table, right? You can't just be brand new to everything because there's not enough time for people to teach you.

So coming with a really strong skill set and whatever, you know, domain you're moving into is very helpful. certainly at a leadership team level obviously I'm looking for people who've kind of done it but at the same time I think it's really helpful if there's a piece of every role that's new and I want that for myself too right? Because if you're

just doing the same thing you did before you don't necessarily have the same sort of hunger, curiosity, drive to learn. So I'm looking for people who want to continue stretching themselves into a new area and that they have something that they're kind of working on right

and I've always in every role that I've had there's been some dementia more like, oh, I've never done it before. Like, I'm really excited about this piece and I'm going to go learn it and get some mentors and et cetera. I think when you look around your leadership team, it's ideal. If not everybody has the same gap. Right. So if, you know, you're building a startup, you want some people who have been at a bigger company and know what the destination looks like, right? And then you want, you need at least some people who've really been in a startup before and know what it means to have to pick up every single ball and, you know, take ownership all the way down to the detail level.

So, you know, I think a mix is good. And, you know, we could talk about different functions and sort of key criteria. But then the last piece is trying to build a team that can work really well together. And, you know, I tend to think no one person can get everything done. And so I strive to have a leadership team where the groups can give each other feedback on their domains and how their domains fit together so that, you know, I'm not sitting a strategy and telling everybody what to do, but we're all working together on how each piece can contribute and fit so that it is most efficient, logical. And I want to work with people who have that sort of big enterprise mindset, right? They can see the full company strategy and how their part

fits in so that it's not about, oh, I want to optimize my department or my division and our contribution, but I want to optimize the whole company. And here's how we can contribute. And here's how I think you can contribute and we can work together. That's good. That's good point. And you touched out kind of like the, um, how someone's going to fit into, right, the current group or the, you know, whether you call that culture or like the team, etc. But the reality is like it's like, it's like, like, how are they going to work and collaborate together with these, you know, the existing people on the team? And that's so, I'm, again, I'm kind of really glad you brought that up because there's,

I'm sure you've, you've seen this scenario before too where you've maybe had a couple like really good candidates, maybe one in particular that's really strong, but just, yeah, you question whether or not it's going to, it's going to be a fit, right? And sometimes it's, you know, your intuition may tell you like, it's not going to be a good fit. at their, the resume or what they've done prior, like, really stands out. And that's, that can be really, really challenging. But I, you know, if you're listening to this and you're maybe going through that, I would highly encourage you to really, really think about that fit, right?

Because it could, it could really derail a lot of, a lot of progress, right? Even if they're exceptional, right? If they're not going to, it's not going to gel. It's oftentimes not going to work out, not going to work out too well. Yeah. So, yeah. Figuring out the core of, like, the hard skills that you absolutely must have and can't compromise on.

And then how much additional sort of skill or, experience do you need in that category versus just great attitude, you know, has demonstrated their ability to come into new situations and figure it out quickly. There's multiple ways to get there and you can evaluate, you know, every rule may be different, right? You may need very technical skill set for something and then you have a little less will have a room on other things. Yeah, yeah, no doubt. And this, this idea of like curiosity, right? And I think that applies to kind of, you know, the interviewee side as well as the interview you side. So like if you're interviewing for a startup, if you're, like, if you're not, if the idea of kind of learning new

things and, like, being stretched too thin, having to, like, literally pick up a lot of different functions because there's no resources around to do it for you, that scares you, you know, maybe it's time to kind of take a step back and rethink whether or not to, it is, it is, like, the best move at that point in your career. And vice versa, right, if you're interviewing and you don't, you don't get a sense for, like, the person's kind of that natural curiosity or that, that, that willingness to be like, I don't know much about that. Like, tell me more. like that's super interesting and is like that that's maybe something to look out for as well. Like if you can't sense that, that also may be a, you know, a signal of, you know,

whether or not that person is going to, is going to fit in as well. Absolutely. Yeah. So a couple, couple good points to consider kind of when we all think about hiring. So let's talk a little about about commercialization too, because like this kind of this, the stage of running more, I would say, you know, sophisticated, you know, clinical work and then getting into like early commercialization, you've done that quite a bit, right, throughout your career, both at startups and then, you know, even most recently at

at Organon. So when you think about your approach to commercialization, you kind of touched on it earlier, right? Like kind of going deep with a small group of, a small group of, you know, customers. When it comes to like novel technology or things that are new and different, you know, what are some of the key things that you think, you know, you absolutely need to get right, you know, at Bay or maybe, you know, frame that up for other, other CEOs that are kind of in this similar stage on the precipice of commercialization or kind of staring it down over the next maybe year or so. What are the, you know, top one or two things that, Either they, mistakes to avoid or things they really need to get right.

I think that we talked about this earlier, that the threshold for evidence is like higher than ever, right? So for physicians, for practices, for hospitals to bring a new technology on, they're asking for more and more to get through the process. So first of all, just having that clinical evidence fully baked, ready to go, will serve you really well. but then also taking your time to work with your expert group, your KOL group, maybe they're academic KOLs, maybe they're just really high-volume practitioners who are credible and have done a ton of procedures, but making sure you understand the experience that your customers are going to have with their product and then having those customers be willing to speak on your behalf to, you know, say, yep, it is as easy as they say or

as effective as they say, or, you know, whatever the key things are that you're trying to pitch. I think that early launch phase where you're keeping your expansion limited and you're going deep to build that credibility is really key. And then you're also using that time to learn because you do not know everything about your product. Just because you got through a clinical trial and regulatory, there are always surprises. I've just not been in a single launch where you don't find out something in the first few months. So you're like, oh, well, that is. certainly interesting and something we now need to account for not necessarily bad maybe it's good you know maybe it's just different and you can solve it potentially with training you can solve

it with messaging and expectation setting or maybe you do need a product fix or a packaging fix you know there can be all sorts of things that are adjustable so listening really really carefully in that early launch for what's the feedback you're hearing believing your customers when they tell you something if they tell you something crazy you know they're right They're the customer. You've got to go, like, really dig in and find out what that's about. And then, you know, try to have a mitigation in place when you go for your broader launch. Yeah.

Because this concept of knowing that you're going to start out with a tip, and ideally start out with this small, kind of this smaller, I would say, this more narrow kind of customer base and go deep, learn a lot, hopefully use that as leverage, right, to expand. How much of that is baked into your clinical approach, right? Or how much do you start thinking about that, even in an IDE trial, right, that you're in the throws of right? know. Yeah, I mean, definitely we want to flesh out as much as we can in the clinical stage. I think

what's different is that you're telling your doctors exactly where they're allowed to use your product in the clinical stage and they really can't break the rules or you go have a serious conversation with them. But then they start to push the envelope and, you know, they start to deal with more real world patients or real world scenarios where they don't, you know, maybe there's a new staff member that's coming in as opposed to your same research staff who really knows everything about screening your patients. You know, maybe you get a patient who's not necessarily off-label, but just outside of that type population that you were studying. Maybe it's just a new type of patient who just didn't happen to show up in your first 150 cases. There's a lot of new that starts to happen

outside of that controlled clinical launch. So yes, we, you know, one of the things that we're really diving in right now is how are we training physicians and setting expectations because we're hearing their feedback that it feels different than they expected it to, not better or worse, just not what we were prepping them for. So we're like, okay, we've got to reset the way we're telling people what it's going to feel like so that when they get into the procedure, it's in line with their expectations. That's a great thing to discover early in a clinical study, right? I'm really glad you touched on that earlier too, is like even though you maybe run a full-scale IDE, right? And in your case, a full-on PMA, you get to this point of commercialization.

It's so easy to think about or have great sort of grandiose ambitions on how quickly you're going to scale, right, at that point. But the reality is that not only can that get you in trouble, right, because there's a lot of things, as you pointed out, that you simply don't know about your device. But secondarily, you sort of want to protect, right, to a certain extent, right, that early launch, not only on the guise of learning a lot about your device, but like where does it really shine, you know, in a real world setting where maybe doesn't it work out, right? knowing full well that once it starts to live and breathe on its own in the wild, it's going to be used and, you know, off label maybe in some cases as well. You know, and so, yeah, so I think that's, that's, you know, going into a commercial launch after, you know, getting, getting through a pretty, pretty onerous or rigorous, you know, clinical, clinical pathway, still, still being mindful of methodically approaching that

commercial stage really, really important. I'm looking at the clock and I want to get to a few other, a few other questions before the rapid fire portion in the interview. So one of them is which this, you know, kind of going back to spending time kind of on both sides of the table, right, as, you know, spending 10, 15 years and startups. And then, you know, I can't remember how long I don't have your exact resume in front of me on an organon, but at least a, you know, enough years to be dangerous inside the inside of a strategic again. Give us a sense for how you, like how you approach strategics now, I'm back on this side of the table, right? Whether it's in the form of investment, whether it's in the form of, you know, potentially, you know, some sort of partnership, whether it's a structured acquisition or licensing, et cetera. What do you think are some words of wisdom for other CEOs that are maybe, you know, thinking about or currently engaging strategic right now? First of all, just to absolutely be a student of their business, I mean, these are all public companies. You can learn a ton just from reading

and following. Don't assume because you read about them last year, it's the same, you know, follow the earnings reports, listen to the CEO talk with analysts. There's just so much there that helps you understand their priorities, what they're grappling with, you know, what they're looking for. And many of these strategics are sending, you know, their business development teams to conferences to speak on panels. And they talk very openly about, you know, what they're looking for, what their pediatric areas, they're interested in, you know, what stage they're willing to acquire or invest in. So a lot of that is discoverable, which is great. And then, you know, you spend enough time in a space and there's kind of a limited number of people you get to know

them. Don't on that note underestimate the value of a long-term relationship. Right. So you may think I'm very early and I am nowhere close to selling my company. It will still help to start to set up meanings, go to those pitch events, you know, get in front of the strategics to explore, you know, how do they react to your technology and also just to get on their radar yourself and your idea so that when the time comes that you are ready, you have a better indication of who's going to be a better fit, their level of interest, you know, how they work, et cetera. And just know, they take good notes, right? So you have a meeting one year and you say, oh, yeah, a year from now, we're going to, you know, be done with our 510K. You're going to sit down

and they're going to say, so did you finish your 510K? 10? You know, and you just say, oh, well, actually, you're submitting to get, you know, so just be thoughtful about how you're sort of laying out your future. And of course, everybody's used to milestones changing. That's just the nature of startups. But, you know, as you have those conversations, be aware that you're having a long-term conversation with people who have institutional memory, you know, and are interested in your trajectory. Yeah, such a good point. And kind of circling back around to, like, I have lessons learned even for me personally over the past couple years. It's being very mindful of like, of that type of communication and demonstrating actually that, yes, you may have slipped, you know,

timelines may have slipped a little bit, but showing thoughtical, consistent progress is probably one of the bigger things that stands out right with these these strategics but kind of going back to your first point about kind of being a student of their business that's a good a really good way to frame it up and you're listening to this and thinking i don't have time right i've got to do x y and z and there's too many balls being in the air that sounds overwhelming it's like well like look you could literally i mean especially if they're publicly traded like take the earnings transcript pop it into gpt and ask for a uh a line full point summary of like key lessons or i mean it literally takes like less than probably five or 10 minutes at most to have a pretty good understanding kind of where that, where that company's

at. And so definitely, definitely leverage tools like that. It's a lot more easier with LLMs today than it ever has been. But I really like that idea. Being, you know, being a student of their business is going to really help you stand out in some of those conversations. Last topic before the rapid fire portion of the interview is on, is on boards, right? Because you've got a really impressive board at May Health. Currently, you've been at some other exciting startups that have, you know, really, really strong boards as well. What are your, you know, what have you learned over the years about how to how to best sort of manage and instill kind of a healthy, healthy board structure, especially when you're dealing with, you know, some cases, some big personalities, right?

And rightfully so, maybe, you know, maybe they've seen a lot, right, in their career. So what do you think? What's your, what's your advice for how to, how to win friends and influence people at the board level, I guess? Number one rule is no surprises, right? I think people talk about this all the time, no surprises in the boardroom when you get to the meeting, people should know what you're there to talk about and, you know, have a pre-read and a pre-discussion. But I think it kind of goes even deeper than that in terms of, first of all, I'm just a super transparent person. That's how I work. So of course, I think that's a value and maybe, you know, others will disagree. But I like to

be really transparent with board members about what they can expect for me, you know, how I think I'm going to approach something. And then I like to keep them posted. So when, you know, when we get news, I'm going to forward it along. You know, if something difficult happens, I want them to know. If I have a win, I would also like them to know. Right. So that we're sort of in communication and they're kind of keeping a pulse on the company. I think that's really key.

Like there's sometimes I see a tendency to want to hold the board more a little bit at arm's length and say, well, they only need this. They only need that. These are investors. You know, I don't think that, you know, leads to success. I think they've seen a lot. they know where the pitfalls are. So if they're asking questions,

it's because they've seen this inflection point for a different company turn into a disaster, right? So I don't want the disaster either. So I'd rather know, you know, what do you think is the sort of critical success factor for us at this point? And that comes to the other half of managing boards, which is they're on your board for a reason. They bring something to the table.

Often it's obviously that they've invested in the company and hopefully they will again. But there's more to it than that, right? they picked you because they are a believer in this technology, they've got some kind of, you know, view on this space, leverage that, right? They're going to help you tell that story to other investors. They're going to help you, you know, sharpen your stories. You bring it forward to strategics.

They, you know, and as I said, they've seen this before. Sort of like you go to the doctor, you're a little embarrassed about some issue. Yeah, they've seen it before. They're not going to be surprised by the thing that's happening. Yeah. So better to just own it and collaborate. on solving it. And knowing that every individual in your board has different perspectives and strengths.

So knowing who you can call for specific issues and help, I think is. Yeah. And to your point, leaning into transparency, even though it may sometimes feel uncomfortable, right, especially if it's like something that's not gone well, it's never probably going to feel really comfortable being like, hey, I've got some not so great news to share. But that's oftentimes, I mean, lean into it, right? I guess that's the only way to maybe just, you don't describe it,

because to your point, most of the, most of the people on the board have seen that before, right? And probably not once, probably multiple times. But even certainly back around to like no surprises. I remember seeing this post on this X, on X. I think it was like either this week or last week, it was like the meeting should be quite simple, right? It's like, what information do we need to have to make this decision? Do we have that information? And then what's the decision, right?

And so thinking about those first two points, right? What information you need do we have it? Like, those should be covered, right? Leading into a board meeting, not, it shouldn't be like, shouldn't be having a lot of, a lot of discussion around those first two points at the board meeting. I thought that's probably going to lead to some frustrations, you know. So, yeah, it's really good stuff. I know we only have a few minutes, a few minutes left.

So I wanted to leave a little bit of time here for the rapid fire portion of the interview. So before we get there, again, mayhealth.com is the website. We'll link to it the full write-up on MedSider. If you're new to these MedSider interviews, these write-ups are meant to summarize and really highlight a lot of the key learnings that are guests like Kobe shared throughout throughout the course of the discussions. I really encourage you to check that out. If you don't get there, again, mayhealth.com.

M-A-Y-Health.com is the website. I definitely encourage everyone to check that out in more detail and learn a little bit more about this technology around ovarian rebalancing, which I really like the way that's described. That's kind of cool. Makes you, your ears kind of perk up, you know, when you first hear that, at least it did mine. So, all right, first question on the rapid fire list is, let's fast forward to two a year from

now. Take us out to kind of mid-2, 26. What are you most looking forward to? What gets you really excited about that, that time frame? Well, that is the time that we should be finishing. of our pivotal study, which would be a major milestone for the company. Of course, we'll have to wait three months for the primary endpoint, but it will be before the end of 26. But seeing the impact of the technology, you know, sort of like, you know, finding out the gender of your baby, there's

there's only a few times in life where you get to like really see something come together like that. And so this pivotal study will be a big deal for us. And we're really excited about that. Yeah, it's like the, it's the data reveal party, right? Is it going to be like, you know, fancy fancy wines are going to be like bud light. That's the review. That's the reveal. Something you have to plan. All right. Since joining May, you know, we call it five, six months ago now, is there anything that's been surprising or unexpected that you've learned? I have not, you know, I've worked in women's health for a long time. And I guess I didn't really realize how different fertility would feel. So I had the chance to go out to Esre, which is the European REI conference. And the technologies,

just amazing, right? So we're in there with IVF and it's really been fascinating to learn about the fertility journey. How amazing the technology is and what we can do for families, but also how much pain families have to go through. You know, it's not just a women's health problem. Obviously, it's a family building problem, which applies to to everybody, all types of couples, individuals, people who want babies. It's a very difficult, sort of humbling process. And the, you know, there's never been a better time to try to build a family. If you struggle with that, the options that are out there to support you are amazing, but they're not enough. So I'm really happy to be joining the party. That's cool. You're in the Bay Area. So this question,

you know, probably probably, probably been to a number of these types of dinners, right? Let's say, let's say you've got a small group of, you know, I don't know, 15, 20 med tech entrepreneurs and, you know, you're, you know, drinking that maybe that glass of wine after the solid data reveal. What's the one lesson that you really want them to understand or take home coming away from that dinner that they hopefully will get right if they're going to experience any sort of success at their startup? I think it's just staying absolutely true to the patient you're serving and the mission that you're on for that patient. There is always a temptation to try to make the story bigger than it is, to drift away, you know, looking for sort of shiny objects. The path

way to success in the space is absolutely in understanding that major problem and just doggedly going after solving it. All right. Last question. Maybe take us back to your your guidance days or maybe your metronic days, right? So kind of careers beginning to take off in the device space, anything you'd whisper in the ears of the young Cope at that point in time. Yeah, just keep stretching. I took some big stretch roles, but I also would oftentimes get advice from people to, you know, build sequentially. You get this, then that, then that. And I don't regret any stuff that I've taken. And I'm glad for all of my experiences. But I sometimes have met, you know, younger folks today who are taking leaps and bounds in their careers and really pushing the envelope of,

you know, what you can do when you have that high energy of a young person. Just go for it. If you see the thing you want to do, just get out there and do it. Don't let somebody tell you you're not ready. That's a good way to wrap it up. But I couldn't agree more. Like that's probably, you know people that are younger in the career that's oftentimes like and they kind of are maybe leaning towards like the world of startups it's like that's what I often say it's like there's never going to there's never going to be like a perfect time right and it's sometimes not going to feel like it makes all the sense in the world but you know in retrospect kind of stealing the line from Steve Jobs you know that the dot you can begin to connect the dots a little bit you know so

so yeah it's a good good way to wrap it up again mayhealth.com is the website definitely check that out we'll link to it in the full write-up on medsider and we'll also link to Kobe's LinkedIn profile as well. So you can check out her background and with kind of a greater degree as well. So Kobe, I can't thank you enough for coming on the program. Now, this is fun. Yeah, thank you, Scott. This has been a really great conversation. I appreciate it. Yeah, I'll have you all online. But for everyone listening, thanks as always for your attention until the next episode of Bed Sider 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 even more ambitious doers who share our passion. So if you found value in this podcast, if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with Medsider, please take a moment to leave us a review. It's super easy. Just open your Apple podcast app or the podcast app of your choice, search for our show and scroll down to the ratings and review section. Leave your honest thoughts and hit that five-star rating if you think we're worthy. Your feedback is incredibly important and so the best way to ensure we keep bringing you awesome discussions with leading founders and CEOs. So take a moment to be a good friend and leave that review today.

As always, thanks for being a part of our journey and for helping Medsider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews. Stay tuned for another informative episode coming at you soon.