Medsider: Learn from Medtech and Healthtech Founders and CEOs - Embracing Ambition Without Arrogance: Interview with Luminelle CEO Allison London Brown

Episode Date: August 23, 2023

In this episode of Medsider Radio, we sat down with Allison London Brown, CEO of Luminelle, who has over 25 years of experience in the healthcare space and has been involved in nearly every aspect of product development for women's health.From Fortune 50 companies like Johnson & Johnson and GE Healthcare to founding startups, Allison has seen it all. Now, as the CEO and co-founder of Luminelle, she's channeling her decades of knowledge into a revolutionary new device aiming to transform gynecological procedures.In this interview, Allison shares insights on how to best understand your strengths and weaknesses, the potential pitfalls of 'one size fits all' regulatory strategies, and innovative methods to secure capital in a risk-averse economy. Before we dive into the discussion, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's a link to the full interview with Allison if you prefer reading.

And you don't have to know everything. That's arrogance. That's pride. You don't have to know everything. I'm okay with saying, I don't know something. Let me go find that out for you. I think that's a really critical thing. This is not, you don't have to be American psycho. 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. In this episode of Medsider, I sat down with Allison London Brown. With over 25 years of experience in the healthcare space, she has been involved in nearly every aspect of product development for women's health.

From Fortune 50 companies like J&J and GE to founding startups, Allison has seen it all. Now as the CEO and co-founder of Luminell, she's channeling her decades of knowledge into a revolutionary new device aiming to transform gyneological procedures. Here are a few of the key things that we discuss. in this interview. First, lean into your strengths and weaknesses as a med tech entrepreneur. It's not about being an expert in all areas, but about recognizing your own gaps in knowledge

and looking for partners or team members to fill them. Second, there's no one-size-fits-all strategy for gaining regulatory clearances or approvals. Look for consultants that are experienced and accomplished in your domain, but don't expect them to be superheroes either. Third, raising capital for medical devices or any other technological breakthrough is challenging, especially considering the current economic climate. To be successful with your fundraising efforts, you need to get creative about getting attention from prospective investors. Before we jump into this episode,

I wanted to let you know that we just released the latest edition of MedSider Mentors Volume 3, which summarizes the key learnings from the most popular Medsider interviews over the last several months with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajent Vascular, and other leaders of some of the hottest startups of the space.

look, it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes.

If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Nadine Yared, CEO of CVRX, Renee Ryan, CEO of CalaHealth, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. All right, Allison, welcome to Medsider Radio. Looking forward to this conversation. Oh, great. I'm looking forward to speaking with you today as well. Yeah, well, let's start out with, um,

At the outset of this episode, I provided a very high level kind of overview of your background. But let's start there. If you can kind of, you know, without going too far into the weeds, give us a sense for kind of your professional career leading up to Luminell. Yeah. So I've been in the healthcare space for, I'm going to say it, a little over 25 years. I hope that doesn't tell you how old I am. But I've been doing this for a while. And I feel like I've been involved in probably almost every single women's health.

product that there is out there it feels like, but just have been really enjoying the new world of entrepreneurship over the last few years. It's certainly different than being in corporate America. But I was able to start at J&J, great training ground and then GE and then, you know, several startups here and there. So I kind of run the gamut. That's great. And if I think you founded Luminell, gosh, in it. We're going on what, close to seven, eight years now? Seven years. Okay, seven years. Yeah, seven years this year.

Seven years in the making. So give us a sense for kind of what, we'll definitely link to it in the full write-up for this interview. But give us a sense for kind of the product, what it does, and maybe a little bit of the origin story for the technology as well. So like every great startup, I think you learn things, you have a great idea, you go out and then you figure out, well, maybe there's a better idea or there's a different idea. idea or you pivot, you know, as we talk about. Pivoting is a strong thing that entrepreneurs need to learn. I would say we started Luminell with the idea of providing a low-cost, easy-to-use endoscopy system for specifically for uterine and neurological health. So we're looking at the uterus, the cervix, the vagina, the bladder. And the goal was just to have something that's really designed

for the office. So it enables physicians to be able to do simplified, you know, those 70 to 80% of what they want to do right in the office and don't have to go to the hospital. Then as we really have spent so much time and, you know, I sold an endoscopy system when I was at J&J. So I knew quite a bit about uterine health. But over the last few years, we became very aware of a challenge in diagnosing. uterine disorders very simply. And right now, people are doing this in a blind fashion. They're not even using a scope. They're using a very small suction device, suction curate. And so we have started delving into oncology and really understanding how we can make a difference in early and accurate diagnosis for women. Got it. Got it. So is the core, the core system is still sort of an

an endoscopy, endoscopic sort of approach, right? Absolutely. Theological health, got it. Yeah, I would say, you know, our goal is to provide clinical support or true clinical solutions to problems that need visualization. Got it, got it. And I'm looking at your site, Luminell 360 for those listening. It's L-U-M-I-N-E-L-E-R-S-E-S-D-C-T-E-S-D-C-T-E-L-E-SY.com.

We'll link to it in the full summary of this interview on MedSiter.com. But Lumil-3-60 is the site. And so you mentioned kind of providing an easy-to-use solution for the office. Historically, are most of these procedures done in more of a hospital-based setting, then? Yeah, I think over time we saw kind of a 70-30 split is what most data. sets would tell you, I would say during COVID, we saw that migration or even, I would call it almost a flight from the OR because these procedures were being considered electives. They were being pushed out of the OR, which was great for us, certainly and great for patients, because it's a lot cheaper and a lot

easier to do some of these things in the office than it is in the OR. Got it, got it. Okay. So it seems like that sort of that procedure shift may have accelerated a little bit over the past several years. Yeah, we're seeing more of a 60-40 split now, 60% of them in the office because there are so many groups that have said, you know, in hospital systems that have said, we really want these things out of our ORs. Yep. I mean, let's be just face it, a 15-minute procedure shouldn't be done in an OR, right? Yeah, yeah, no doubt, no doubt. My hunch is that you're sitting in a decent spot because probably once physicians started getting accustomed to doing these procedures outside of the OR in an office space setting, they're like, why didn't we do this sort of? Right? Exactly. Well, you know, I think there's always a learning curve. There's a learning curve on how to use a scope. There's a learning curve on what's going to matter for your practice. So we're we try to really partner with our positions and not just, you know, dump a piece of capital on them and then run away. So there is, you know, that handholding and support that they need. Got it. Got it. And then you mentioned earlier that that you've had it yet you've had a, you've had a, you've had a, you've had a, you've had a, you've had a, you've had a, you've had a,

you know, pivot quite a bit, right, since since the early inception. But to help set the stage, I guess, for the rest of the conversation, give us a sense for like where the company's at now in terms of, you know, development, reg, and, you know, and commercialization as well. Yeah. So our product portfolio is highly developed. We have 510Ks on four devices. We have four patents that we own. I would say where we've had to pivot has been more in the commercial side. And I do think that the industry has changed so much in last even five years in terms of commercialization. There used to be such a way of going to distributors or these small little regional groups. And now there's pilot ways to commercialize.

There's digital ways to commercialize. And so we've tried to look at all of those. And we are still pivoting, I would say. Right now we are figuring out our final plans for low. larger scale commercialization. Got it, got it. Okay, cool. So still sounds like there's some ongoing work with respect to commercialization.

Absolutely. But this product is, you know, it's in market. I can, if I'm a, okay, yeah, if I wanted to call up, call up the company and order a system for myself, I could, I could do that, you know, presuming I'm a physician. Well, if you're a physician, yes. Right, right. Okay. If you were a gynecologist, you can't just play one on TV.

You actually not beat one. Yeah, yeah, exactly, exactly. Okay, cool. So let's spend the next maybe 20-ish, 25 minutes or so, kind of walking through some of the functions, right, that you need to execute on as a startup company. And maybe let's start first with development. You've been, you know, we talked about this earlier. You co-founded the company about seven years ago. I'm sure the systems that are in market right now probably look a fair amount different than maybe those early earliest versions. But what's your, you know,

if you can provide some high-level advice for other entrepreneurs that are in the early phases, right, of their company. And they're trying to be as capital efficient as possible working through various iterations. What do you think it's most important, you know, during those early days when you're kind of moving from, you know, alpha to beta and trying to get the early development off the blocks? Yeah, I think there's a few key things that we were fortunate or, you know, successful at being able to do. But I would say first and foremost is you have to have a good team. And I know people say that all the time, but it really is true. I myself, do have a scientific background, but I am not an engineer.

I am not a mechanical engineer. I am not electrical engineer. I know enough to be dangerous about how my computer works, much less designing a scope, right? So I was fortunate to find a partner who came on later to really help design something that is elegant and simple. I think the other thing for entrepreneurs is you've got to really know, your end customer. Again, it sounds cliche, but I think it's not just the top dogs. It's not just

the top KOLs. You've really got to know who are the high volume users spend the time on whether it's your GUI, like if it's a software system, make sure your GUI really works for nurses, what really works for patients or whatever it is. In our case, it's making sure like our scope handle. We spent, I think, like three months designing a handle to fit a woman's hand. And I happen to have a very small hand. So we spent a lot of time in ergonomics. Don't overlook those things. And then I think the last piece of this is, you know, in medical device land, it's how are you going to manufacture cost effectively? And again, my partner, Eric Dreyer, who's our COO, he is kind of an expert in design for manufacturing ability, again, not anything I know how to do, but make sure when you're designing,

even if it's CAD designing in that alpha stage, that whatever you're creating, you can actually make. I've seen so many, I sit on pitch fest and I judge other pitches and I help other medical device companies and I see these things that come out and they're gorgeous and they're beautiful, but it's going to cost you a gazillion dollars to manufacture it. So it's not practical. So you always have to think about, you know, cost. You've got to think about manufacturing. You've got to think about that end game and work somewhat backwards from there.

Got it. Kind of as a follow-up since you mentioned it, you're looking at your background, your wheelhouse is definitely, it seems to be more on the commercial side, right? You're not an engineer by background. There's a fair amount of, you know, And I would say it seems like most early stage device companies, they're either physician-led or engineer. Physician or an engineer, exactly. Exactly.

But for those that are listening to this conversation, and like you, like me, have a little bit more of a commercial background and are not as experienced maybe on the early stage development, what have been maybe some keys that have helped you kind of overcome maybe some gaps there, you know, as you're working on early stage projects. Yeah, I mean, I think what I brought to the table is I know the market. really well. I know the physicians. I've, you know, I've got lots of connections in the, in that world. So I could tap into that to help my, you know, R&D team connect the dots. So again, I think, you know, as I said, it's a team. You need to have that those two heads, uh, or brains, however you want to say it at the very beginning. You need to have a commercial market intelligence, pricing, all those things. Market and, you know, the commercial side. and the R&D design, maybe even clinical side,

have to be married at the very beginning. If you don't have that, I think you're going to really miss. And that doesn't mean that we were 100% perfect. We were not. But you're going to miss. So that would be something to really think about. Yeah, hearing your thoughts kind of reminds me of a recent conversation I had with Carol Byrne.

She's the CEO of a Cajent vascular. And she mentioned something very similar because I think for most of her career, even though she spent, you know, the past, I don't know, probably decade or so in early stage companies, the first part of her career was mostly in customer facing roles, right? Whether it was marketing or position training or sales, et cetera. But that's something that she mentioned as well. It's like if you're running a MedTech startup and don't have maybe an engineering background or vice versa, maybe you don't have the commercial chops. You need to recognize that and don't pretend that you're some expert in that arena. Fill the gap with, you know, be cognizant of that gap

and fill it, you know, with a, you know, a strong group of people. Well, I mean, you look at all the functions in a big company, right? So when I think about I was a general manager at GE, and I can look and say, you know, you have all these boxes on an organizational chart, right? And then as a startup, you've got to figure out how am I going to fill all those boxes? And it's not people necessarily. It can be consultants. It can be other things.

But how am I going to fill all those boxes in order to reach the goal? And I think the ability to quickly tap into resources, to find consultants, to find kind of bootstrap ways. to get at the end result is it's really critical for entrepreneurs. But again, I think you're right. I can't tell you how many pitches I've been to from physicians or from engineers that just forget that you got to make money at the end of this. So when you ask them like, well, how much is that going to cost or what's the price point? And you know, you get kind of the deer in the headlights.

It's like, well, you might want to kind of think about that. Yeah. Yeah. Yeah. Yeah. No doubt. And yeah, and the same thing applies, right? If you're listening to this and have a strong engineering background, if you're not thinking about the commercial implications early on, it's probably, probably a mistake.

Probably need to definitely bring in. If you don't have that already, bring in some of that expertise. Yeah. Yeah, it can't be, I always say, you know, you can't have that technology looking for a home. And I mean, I've been guilty of it in my past. I get really enamored with some, you know, new molecule or some new widget. And then you become technology looking for home. And that rarely works out well.

Right, right, no doubt, no doubt. And one of the things also that has always stuck with me is a conversation I had with Duke Roline. This is years ago. But he said one of the things that he recognized earlier in his kind of startup career is, or one of the things he did actually was look at strategic portfolios, right, in the domain that you're kind of operating in, whether it's cardiovascular or urology or gyne or gynecology or whatever, look at their portfolios and recognize, you know, where the gaps are. Where the gaps are, absolutely. And as you begin to like develop your device, if you're building something that in a competitive space and is, you know, is already sort of in the portfolio of your natural acquirers, well, that might be a bit of a difficult road ahead, right? Well, you know, conversely, if it's a gap in a lot of strategic portfolios, that might be, you know, something worth working on. So, so yeah, definitely need to be thinking about the commercial implications early on.

With that said, let's transition if you're cool with it, Alison, to talk about reg and clinical. And you mentioned, I know you're involved and you sit on a lot of, you know, involved in a lot of startups, advise a lot of startups, et cetera. So you've seen a lot. And this topic, I think, can be daunting, right, for any, any startup, you know, how do we, I mean, even if the reg pathway is relatively straightforward, you know, how do we design a clinical trial, you know, that, you know, serves a lot of different, you know, stakeholders and meets, you know, meets our key needs, but also, you know, potentially moves the needle, you know, when it comes to commercialization as well. So when you think about, you know, this function in general, Reagan, clinical,

have there been a couple, couple key things that that you've learned along the way or that you typically see other entrepreneurs do wrong or you need to kind of help them, you know, coach them up kind of across this topic? Yeah, I would say do not underestimate the impact of the FDA. I mean, I mean, that's probably what most people understand. But I've spent time with people who just actually did not even think they had to submit to the FDA. Maybe they had a wearable or they had, you know, something that was software related. And if it's in contact with patients or if it's patient decision making or any of that kind of stuff,

do not underestimate the fact that the FDA is going to want to be involved. So that's, you know, first and foremost is make sure you know what your regulatory is and get your regulatory people as early as possible. We went through four different regulatory groups trying to land on somebody. and it could take some time. And the bad regulatory person, they always say the bad hire, it can be devastating and very costly. And then from a clinical perspective, I think medical device world, we're in an in-between time where 510Ks used to be the norm and everything was great.

I see more and more de novos. And honestly, I, you know, I think there's a real need to make sure that your device really does work in a human being before you just launch it out to the world. world. And that's what we do. We always have a very limited or a beta launch. And our beta is post-510K in a human being, do it with three patients, one physician, let's control it really well, even with something as simple as an endoscope. You know, you think, oh, it's just a camera. But you want to confirm that the thing works the way you intended, right? And I think that a lot of times we just we miss that piece. And we just think, oh, we're just going to launch the product and off we

go. And then in terms of that clinical design, you know, don't miss the opportunity to gather data. I mean, you get one physician in 30 patients. We've got enough to publish. And you can ask all kinds of questions about the patient's impact or what the patient thought or maybe it's the nurses or it's the staff or it's the anesthesiologist or it's the whoever or the, you know, the hospital purchasing group. Think about all of the stakeholders. even in a clinical design because you can get those secondary endpoints that could be very impactful for you. That's good stuff. I want to circle back around to your comments around evaluating a reg partner, right? You said you, I think most recently or one of the previous companies, or even

at Luminell, you evaluate four different groups. Four different partners. When it comes to this function, how important do you think it is for your reg, you know, partner, whether it's a consultant, whether it's someone internally, to have domain expertise in the, in the therapeutic arena that you working in. Is it crucial? Like, you absolutely should find someone that's kind of been there, done that, or as long as they are an experienced regulatory professional, it's not as important. Well, that's kind of a catch-22 question, isn't it?

Because if you get somebody who's already knowledgeable, yeah, they may know the people at the FDA, they may have seen there, been there, done that. But then they may apply the same rule to you that they apply to somebody else and maybe that's not the right way to go. At the same time, if you've got somebody with no domain expertise, are they going to charge you to learn that? So, you know, we, we chose to work with somebody at the end. So my first person was great. I knew her for a long time. And unfortunately, she ended up not being able to work with us for various reasons. But she had significant domain

expertise and I thought, you know, that was the right way to go. Then we tried a couple other people that didn't work at all. So we finally worked with a group Method Sense who's here in Raleigh, and they have a broad base of understanding in MedTech. And they have, I think, a great way of strategically looking at a problem versus cut and dry way of, you know, it's not just plug and play for them. They are, you know, kind of thinking through the challenge at hand. And do think of it from business perspective versus just, you know, here's QA and RA and I'm over here. They're thinking of it from how that impacts the greater, greater company structure or company strategy. So I think that's important. I will say if you are not in a, if you're more in a life science, if you're in a biologics

or, you know, in those kinds of things, that is when I think you really need somebody who is domain expertise. Yeah. Hey there. It's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of CalaHealth, Nadine Miarid CEO of CVRX, and so many others.

As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition, you'll get a copy of every volume of MedSider mentors at no additional cost. To learn more, head over to medsiderradio.com forward slash premium. Again, that's medsiderradio.com forward slash premium.