Medsider: Learn from Medtech and Healthtech Founders and CEOs - Building Relationships, Raising Capital, and Establishing Reimbursement Codes: Interview with Oculogica CEO Rosina Samadani

Episode Date: April 25, 2022

In this episode of Medsider Radio, we sat down with Rosina Samadani, CEO of Oculogica.Rosina Samadani initially joined Oculogica in an advisory role, supporting her neurosurgeon sister’s plan to develop EyeBOX, a diagnostic medtech device for concussions. In 2015, Rosina transitioned into her current role as President and CEO of the company. With a doctorate in biomedical engineering from MIT, Rosina has been involved with multiple startups. She also serves as a judge for Stanford’s StartX Accelerator, and MIT’s $100K Entrepreneurship Competition. In this discussion,  Rosina shares the importance of relationships in the regulatory and reimbursement processes, why first-time entrepreneurs shouldn’t be intimidated by complex procedures, and lessons learned from her experiences raising capital.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech 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 healthcare 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 sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Rosina if you'd rather read it instead.

And the beautiful thing about being a startup is that if we're wrong, we can literally change it in about two hours. Right. So, and we, you know, we've done that with other things. Like so when COVID hit, we did five pivots in one week, right? On different aspects of our business. That's the beauty of being a startup is that we can say, okay, this is not working. And we're getting a lot of feedback that it's not working. Should we pivot to this?

Let's go try it. Let's go try it tomorrow. Welcome to MedSy. Sider Radio, where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of MedSider, I sat down with Rosina Samadani, the CEO of Oculogica.

Rosina initially joined the company in an advisory role, supporting her neurosurgeon's sister's plan to develop iBox, a diagnostic med tech device for concussions. Back in 2015, Rosina transitioned into her current role as president, and CEO of Oculogica. With a doctorate in biomedical engineering from MIT, Rosina has been involved with multiple startups throughout her career. She also serves as a judge for Stanford's StartX accelerator

and MIT's 100K entrepreneurship competition. Here are a few of the key learnings from Rosina's experiences. Put people first. It can be easy to lose sight of the fact that there's a human on the other side of every interaction. Forming authentic and meaningful relationships with your various partners, from investors to regulators,

goes a really long way. Second, prioritize function over flashy design, especially in the alpha and beta stages of your company. Prototypes should be easy to use and free of glitches if you want to move quickly through clinical trials. Third, don't be intimidated by complex initiatives. Breaking large objectives down into digestible action steps demystifies the process and makes challenges and tasks manageable to achieve. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of Medsider mentors. A print-based book that summarizes the key learnings from my favorite medsider interviews over the past six months. Look, I fully realize 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 a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Garh Hong Kong, founder of HealthQuest Capital, teaches you how to successfully pitch your startup. Patricia Ziliak, CEO of Ivinsons, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your

startup journey. That only scratches the surface, so if you're interested in learning more, head over to Medsider Radio.com forward slash mentors. If you're a premium Medsider member, you'll get free digital access and a print version sent straight to your door. 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 Erica Rogers, CEO of Silk Road Medical, Dr. David Albert,

founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. Hey, Rosina, welcome to Medsider Radio. Appreciate you coming on. Yeah, thank you for having me. Yeah, looking forward to the conversation. Let's go and dive in. I provided a very high level overview of your background at the kind of the outset of this particular episode. But I always like to start here, right? Can you give us, you know, kind of an elevator pitch for your professional background leading up to joining Ocalaetchka?

Sure. So I have a PhD in biomedical engineering and I started out my career at McKinsey. This is now my fourth startup and I'm not so much a serial entrepreneur but a parallel entrepreneur. I have a tendency to start something and then start something else in addition that augments the first thing and it ends up being a separate company, which can be a lot of fun. Everything is in healthcare and technology. The way that I ended up here is that my sister, is a neurosurgeon, and she was looking at cranial nerves and their dysfunction and how that affects eye movements, made a discovery that basically related cranial nerve palsies in concussion to eye movements, developed an algorithm, published it, patented it,

and licensed in the patent, started this company. I was watching from the sidelines, but also giving a little bit of advice and basically got caught up in it. and ended up being the CEO two years after she founded it. And that's how I ended up here. Cool. That's great. And we'll have the chance to kind of dig into that story in a little bit more detail. But I love the fact that you mentioned parallel kind of entrepreneur.

And I remember reading this piece. And we'll try to link to it in the show notes for this interview. But it was written by James Besheera, who hosts the below the line podcast. He also runs a few other companies. But he wrote the piece was basically like, this is the new framework for employment, right? where you have kind of like one main thing, but there's maybe a couple side projects that are at various stages and are moving,

moving along. And it sounds like that's kind of a path that you followed for. That's what happened until now. This has been all consuming, I will admit, and this is the only thing that I can do. But until now, that's what I was doing.

And we, so I had a management consulting firm. We needed, you know, very good physician market research. We couldn't find it. We built it. And then our clients started asking us if they could use that.

And so spun it out as a separate company. You know, it just happened very organically. And so, you know, you can do that at some stages in your career. In some stages, you absolutely cannot. And right now I can't. But in, you know, between my, you know, sort of McKinsey and then now, I definitely was a parallel entrepreneur. And it's interesting because they help you with, they each help you with, understanding where you could go in this other business because you get a very different

perspective. Right, right. And I completely agree. I think actually there's tends to be more upside, right? You know, not at the expense of, you know, you always have to be careful about losing focus, of course, but generally speaking, I'm in the camp that there's more upside and there's, there's more things that you can draw from other, other projects that you're working on, etc., that you can pull into kind of your main, your main thing. Absolutely. It's so helpful to be curious. Yeah, right? And to be doing lots of different things. It always helps. Yeah, that's good.

So tell us a little bit more about Ocologya. The main product is iBox, but more specifically, and we're going to, you know, we're going to go through a series of questions kind of learning about some of your experiences, you know, leading the company since you first joined. But tell us kind of how this, tell us a little bit more about, like how the idea came about. Yeah. So my sister, Dr. Usma Samadani, is a neurosurgeon. She works with a huge range of patients, some of them, you know, quite ill.

and she was looking for an outcome measure in patients that frankly couldn't do too much. And they, but they, you know, they were lying in a bed. They were able to watch TV. And she was looking for an outcome measure to assess their cranial nerves. And she had the idea of assessing how well they could watch TV. And that is the genesis for this idea. So she saw a correlation with, you know, people who had cranial nerve palsies. eye movements via extremely detailed eye tracking. And by detailed, I mean high fidelity, high

frequency. You know, you're using infrared to capture their pupils. And, you know, was looking at that information, thinking about it, and made the, a little bit of a leap to, in concussion, there are often cranial nerve palsies. And I wonder if we can also now assess concussion, eye tracking and looked at normals, looked at a concussed, saw a difference, developed an algorithm based on that eye tracking data. And I'm kind of simplifying things. You know, you'd use that eye tracking to develop metrics and, you know, you go through a number of steps, but basically come out with an algorithm that predicts whether or not you actually have a concussion. Got it. And so that's the invention.

Got it. And so what percentage of people that do you have a concussion have? cranial nerve palsy, is it pretty high? Yeah, so it's, it's pretty high. And those cranial nerve palsies, it's really not so much about that, but ocular motor deficits. So depending on who you talk to, there are either three, five, or seven subtypes of concussion. And one of those subtypes is an ocular motor subtype of concussion. So I was just actually talking with a doctor two days ago. And he said, saying that you're going to diagnose concussion is almost like saying you're going to diagnose cancer. There are many different types of the way that concussion presents itself. And you may have an ocular motor deficit, a vestibular deficit, you might have headache, you might have neck pain.

All of those things can contribute to a different cocktail of concussion for you versus for me. depends on how you got hit, how strong your neck is, where you got hit, your prior history, you know, not just for concussion, but for other things. And so it's just generally not a straightforward disease state. To answer your question, ocular motor, it's often there. And so, you know, we can capture a lot of them. Okay. And so, and give us an idea of the time frame when your sister's making this, these kind of, these, that leap, so to speak. So she started looking at this in 2011, and that's when she did some of the foundational work. She licensed in the original patents into the company in 2013 and founded the company May of 2013. I became CEO August 1st of 2015.

I think it was August 11th that I actually got a concussion. And that is not a prerequisite for joining our company. You don't have to go out and get a concussion. But ironically, I got a concussion within two weeks of becoming CEO of a concussion diagnostic company. So that's not really on the company timeline, but it's on my personal timeline. And then we did the FDA pivotal study. We submitted to the FDA in 2017. We got the clearance, our first clearance in December 2018. and that was the first clearance for any aid and concussion diagnostic that doesn't require a baseline test. Okay. And then since then, we've got three more clearances and a CPT code and a bunch of things.

Got it, got it. Okay, cool. And we're recording this early 2022. So hopefully, you know, everyone listening can kind of get a sense for sort of the general arc here that we're following. One other follow-up question before we kind of dive into some of these questions and try to gauge kind of your key learnings over the years. But specific to iBox, give us an idea of like how this is used. I mean, the Super Bowl is going to be, is coming up here? So I know.

Is this something that that's on the sidelines? Like how do, how are physicians using this to diagnose? Yeah. So there could eventually be a test on the sidelines. And it's so interesting because everybody says, oh, my gosh, the NFL and the sidelines. And this is where, you know, you guys are just going to kill it. And the NFL is probably not going to have this on the sidelines next year. In fact, they're definitely not going to have it on the sidelines next year.

They've got their concussion protocol and, you know, the way that they do things. They generally don't look at technologies, which are brand new or that. Rather, they look at them, but they don't incorporate them immediately. So they're not going to be the first folks to use this. We are a medical device. We're built to be used in a clinic under the supervision of a physician or another qualified health care professional. So we will be used in clinics and hospitals first. Eventually, we'll get to a sideline. But if you think about, you know, a sideline need at the very young age, basically, if in doubt,

sit them out. That's the mantra. You don't need a concussion assessment if you've got any concern whatsoever. And then at the very high end, they've got a whole bunch of other concerns that they have. And those side lines are very noisy and really not the best place to be doing a concussion assessment. And so there's a slightly different need there. It's in the middle where we're really going to play. All right. Okay. Cool. And we'll link to the website for those listening that want to learn a little bit more about this technology. Because it is kind of one of those interesting, interesting devices, right, in MedTech where it has a lot of kind of universal appeal. Because almost everyone knows someone that has had a concussion. Maybe they've been concussed themselves. It's remarkable. We are all.

always amazed. Whenever I give a talk, I ask people, raise your hand if you've had a concussion or if you know somebody personally that's had one. And so many, the majority of people in the room, race, now you know somebody, you know me. I think I've had a couple different concussions in the past for sure. But yeah, oculogica.com is the website, and we'll link to it in the show notes for anyone that wants to learn a little bit more about the iBox. And we'll get to it here as kind of this discussion unfolds. But let's start out with kind of with the early stages, right? You joined, you know, back in 2015, and I'm not sure exactly how far, you know, the prototypes were, how far the device was, was, had come along at that point in time. But you already mentioned,

you've got, you know, a bachelor's, master's and PhD in biomedical engineering, I think from some pretty well-known schools, right, MIT. I think people probably heard of MIT in Northwestern. So you know a thing or two about like how to how to build stuff. And so based on kind of your, you know, and your, your startup, your startup person, right? You've tons of experience here. So thinking about kind of the early stages of a of a med tech company, really speaking to founders, where do you see, where do you see people make the most mistakes kind of in these early kind of alpha and beta builds? So I've been honestly, the biggest mistake people make is not understanding product market fit. that is the thing that you really want to make sure that you are going to have for your product.

If I were to start a company now, the first thing that I would do is assess product market fit before I build anything before I do anything. When you're building something, our first prototype, we call it the duct tape prototype because it was literally held together with duct tape and secured to the table. And it was really difficult to put together and go set up at a clinical trial site. But it worked. And it was not expensive, you know, relative to, you know, some of the things out there. So it got us the original data that we needed.

When you go to do an FDA pivotal study, you need to have things under a little bit more control. So, you know, you definitely need to up your game on the quality front. But that early prototype was extremely, extremely basic, unbelievably basic. And so do you see a lot of founders kind of getting too lost in how this thing looks and not paying enough attention to, one, we've got to make sure it works. But two, you know, is this something that is even applicable? Is it needed? Does it have, you know, true product market fit?

Yeah. So I think there are two things. They're on the, like the product itself and getting a prototype out there. It has to be really stable and robust because your clinical trial sites, you've built it for you to use under sort of ideal circumstances and you know all of the nuances and quirks of this device. People on the clinical trial site, they're not going to have that knowledge and they're not going to have that instinct that you do. So you need the software to be stable and you need the thing

to be able to basically almost fall on the floor and still be okay. Because most likely that is going to happen. So that's like a, that's a major thing that you need to think about when you, you know, when you have your prototype out there. And then in general, from a business sense, yeah, product market fit. Cannot say it enough. Got it. Got it. It reminds me of I was reading a newsletter a few weeks ago and they were comments, you know, someone was commenting on a, on a lot of product launch that they recently had done in the landing page that they had set up to drive, you know, web traffic tool. Yeah. And he mentioned, you know, something they always do is like ask, you know, before they're launching this, this landing page, like they're having a, like two

into the spectrum. They're asking like a 12, 13 year old to look at it as well as like a, you know, 60, 70 year old to look at it. Just because to make sure it's like, it's, it's, Super straightforward. So simple. Yeah, so simple. It reminds me of your comment around clinical trial sites, ensuring that your device is, I'm not necessarily dummy proof. That's a bad way to describe it.

But it's like, it's so straightforward and so simple that it can't, it's hard to break, you know? Yeah. Yeah. And it has to be stable. Like if it keeps glitching, turning off doesn't work. It's so annoying for people.

You're not going to get people to enroll patients. Right. Right. Yeah. And, you know, that clinical trial timeline that you maybe had said at whatever, six or nine months is now going to be 12 or 15 months and you're meanwhile you're burning a bunch of cash so um no it's it's really it's a really good it happens all the time it happens all the time

you think you're ready and you get out there and you're not yeah it reminds um i had dr scott wolf on um the podcast last year he's the founder of um cool school to now uh founded uh Aaron medical as well and uh and yeah he mentioned kind of a similar point around around like he was referencing like what their what their generator box looked like for their clinical trial he's like you should see you're lugging this big hunky thing like all over the country and he was like the point was that it worked it was easy to use and it worked it didn't look great but it worked and it was like you know pretty pretty foolproof so um seems like uh seems like you've got similar similar feedback so on that note kind of talking about

burning cash you've also got a lot of experience raising funds from a wide variety of different different sources. And I think if I remember right, on your LinkedIn profile, you list your judge, right, for Star-X. Yeah, I judged for Star-X. And I've done the MIT, I think it's called the 100K entrepreneurship competition as well. Okay. Okay. So wide experiences here from like early kind of like very seed stage type of investment to, you know, raising, raising follow up rounds. You know, and I think you guys raised some financing from from Title Town, right? So- Yeah, from Title Town tech. which is a joint fund between the Green Bay Packers and Microsoft, which is kind of perfect for us. Oh, yeah, yeah, no doubt, no doubt. So thinking about like all of those experiences,

what do you think are some of the key points that, you know, any health tech or net tech entrepreneur needs to keep in mind when they're thinking about, you know, raising capital? Yeah. So definitely put yourself in the seat of the person you're talking with. So angel investors versus VCs, they think differently. about the return on investment that they need to get from their capital that they put in. And it really does make a lot of sense to understand when you're going to VCs in particular, what is their portfolio and what is their investment thesis? Because you're going to be wasting your time and their time if it's not a fit.

And I really try to, I learned that. I did not do that always early on. And you really learn that it's pointless, right? It's like banging your head against a wall and you're wondering, okay, now why am I not able to raise the funds? Well, you're not what these people are looking for. And there are people out there that are looking for you. You need to find them.

And you will, narrowing that down will really help you a lot. And then the sort of like the earlier investors, the angel, they're really looking for something exciting, but they're also looking for a return on investment. They're taking a chance on you. And they are willing to take that risk, but you have to lay out, you know, where could you go? From, you know, as you move through the kind of like raising funds process

and you get to more sophisticated investors, and it's not even really sophisticated, but like people that are putting in more and more money, they're really looking at how much have you derrisked what you've done. And in MedTech, there are a number of derisking stages. So there's the actual product and does it work? And then there's the clinical, the FDA pivotal study. And did you complete that?

Did you submit? Did you get clearance? That's a stage, right? And then reimbursement. You want to think through all of those even before you get there. Because I've talked with VCs very early on. We weren't even through FDA. and they were asking me, well, what about the reimbursement pathway for this?

There has to be a way for you to make money once you get through FDA. Getting through FDA is not enough. Right. So the two things that I'm kind of hearing from you, I want to ask you a couple follow-up questions, especially about your partnership with or the round of financing from Tidal Town because that's kind of an interesting story. But what I'm hearing from you is like definitely you got to know who you're talking to. You know, if you're talking to a VC that doesn't invest at either the stage you're at or is not

aligned with kind of your, your, your, kind of what you're focused on, probably not a good fit, highly likely that you're going to get a know. And then two, absolutely, absolutely. And they'll talk with you because they're curious, smart people, but it's not a good use of your time. Right. You know, and who wants to spend, unless, their wheels unnecessarily, right? When you're going to run a company and raise, race financing at the same time, it's a lot of work. But the other thing I thought was great, too, that you, that you mentioned. was thinking about like those stages, right? Like, you know, how, not only how much, like, how much am I raising and how far is this going to get me, but like, what's the next sort of

inflection point to de-risk the company, de-risk the project as a whole? So I like, I like that trade of thought. But tell us a little bit more about like the Title Town partnership and maybe frame that with, do you, like, what's your take on kind of more strategic money like that, right? Because it does seem like a really good fit at first blush. So, yeah, a little bit more about that. So, and they're really interesting because they're kind of a strategic and a VC at the same time because they've got this flavor of professional sports in there. And they can kind of semi get us access. You know, obviously not, you know, a free card there, but a little bit of access and insight. And that access and insight goes both ways. So the way that we

found that my sister and I actually grew up in Wisconsin and we happened to be Packers fans. That is not the way. We didn't just go like, you know, knock on Lambo. But we were funded, the round before that, we were funded by Golden Seeds. And they're an enormous large angel group. They fund women led and women founded companies. And they network like crazy. And they told us somebody there got in touch with me and said, did you know that the Green Bay Packers have a venture capital fund? And I said, no. And as soon as I researched them, I realized they knew somebody that, you know, that I knew from in Green Bay and that also knew the managing director over at Tideltown. And so I got an introduction that way. I also did a cold reach out. And I think the introduction way,

I know it did was better. Like, you know, they actually responded. They get a lot of incoming, right? And give them credit, they kind of picked it up and ran with it almost immediately. And I do think that a fund run by almost any NFL team would have, would really struggle with a concussion diagnostic. But the Green Bay Packers, I'm not, I'm not just a fan and saying this, but they really are a different team. I don't know if you know anything about them, but they're a community owned team. And so they're not run and owned by.

basically a billionaire. They're run and owned by a community. They have, I think, a slightly different perspective on a concussion diagnostic company. Got it. And you kind of hear that in the way that Mark Murphy, CEO of the Packers, talks about us. Got it. That's interesting. And so understanding, like you're understanding that historical background, right, how the organization is run side donor. Are you a shareholder of the Packers? Yes, I am. Yes, I am. I guess I should acknowledge my conflict of interest. I'm a shareholder in the pack. That's right. That's great.

And I presume you could probably be into a game or two. Oh, yeah, absolutely. Yeah, that's great. Best place to watch football. The one and only game that I've been to at Lambo, which is like a bucket kind of a bucket list. Everyone needs to go. Yeah, I was expecting it was in late November and you expect like,

you know, super, super cold weather. But like we were tossing the football around like earlier in the day. You know what I mean? So we kind of what would let out? Yeah, don't be scared. Don't be scared to go. Yeah, but unfortunately, that was that, that was at a time when, when Rogers was out, I think. Oh, because he had broken.

Yeah, I think it broke his collarbone. Yeah, it was that season. I can't remember it was like four or five years ago or something like that. But yeah, anyway, but no, that's great. I guess what I, the part about that is like just knowing that, again, knowing who you're talking to, knowing kind of the background. And it sounds like it didn't. It wasn't like, yes, you had an intro, but like you sent a cold email.

I mean, you kind of, you know, hit. them with some surround sound, but knowing who you're talking to and knowing who you're pitching, like, really helped. Yeah, you definitely want to know who you're pitching. And it's not that we didn't try and pitch other NFL teams venture funds or related venture funds, but we knew what we were getting into. I'll try. But I know what, you know, that it's going to be a most likely a no, right? So I'll very quickly move on. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only a via our private podcast for MedSider Premium Members.

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