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#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)
Episode 33614th September 2023 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
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In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.

Some of the highlights of this episode include:

  1. Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.
  2. Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.
  3. Building a quality-centric culture from day one to set the tone for long-term success in the MedTech space.
  4. How building a startup is akin to fixing a plane mid-flight – it's challenging but passion and clarity make it feasible.
  5. Tailoring communication, and how suiting it to the listener's background can be the game-changer in understanding and collaboration.

Quote:

"Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-Bensinger

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Transcripts

Christy Sheehy-Bensinger: They might spin a widget left and I would turn it right. You just want to see how it plays out in the real world. So I think for us, making sure that we have the right amount of revenue but still being able to maintain the rollout and keep track of how it's being used in the field is important.

Etienne Nichols: Welcome to the Global Medical Device Podcast.

Etienne Nichols: Where today's brightest minds in the medical device industry go to get their most useful actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Are you tired of having to look in so many places to find the information you need as a medical device professional? Are you looking to level up your career, your device, or just your day to day performance on the job? Greenlight Guru Academy was started with you in mind. Our goal is to bring you online learning on all the topics that are impactful for medical device companies. The Academy represents years of experience helping companies get their devices on the market and keep them there.

Etienne Nichols: I can't tell you how many times we've heard people say, I wish I'd.

zation to date. And as of May:

Etienne Nichols: We still have two stops on our.

Etienne Nichols: Roadshow this year, and I'm sure we'll be doing it again next year because it's been wildly successful. It's been super fun. The next one is in Orange County, California, on October 17, and then the one after that will be in Amsterdam, November eigth. So if you're in either of those areas, definitely check us out. We'll put a link in the show notes. You can check it out. We hope you enjoy today's episode in the Founder's Journey and overcoming challenges of startup life.

Etienne Nichols: Welcome back to the Global Medical Device podcast. With me today is Christy Sheehai Bensinger. I hope I'm saying that name correctly.

Christy Sheehy-Bensinger: Sheehe Bensinger.

Etienne Nichols: Shehe Bensinger. Thank you. So good to have you on the podcast today. For those of you listening, we are doing this in front of a live audience in Boston, Massachusetts, at the KPMG. We're really excited to be able to have this conversation, but why don't we start with a little bit of an origin story? Tell us about how you've come a long ways. And actually, I'm going to tell a little bit how I know Christy. I don't know her as well as I would like, but she and I met sort of two years ago at the Medtech Innovator when I heard her pitch to the investors there, and I was really impressed with the technology and her pitch. And two years later, I am so excited that I get to talk to her on stage. So what's your origin story, and tell us a little bit about where you came from.

Christy Sheehy-Bensinger: Yeah, so my background is actually engineering, so I'm a trained optical engineer. I worked at Corning for a little bit, which is a glass company in upstate New York. A lot of you know that here, and they paid for me to get my Master's, which is always awesome, but I decided I wanted more of a biomedical spin to what I was doing, and so I ended up applying to go back to school, and I ended up doing my PhD at Berkeley. So moved to California and did a PhD in vision science. So being able to apply my optics, lasers, all that cool stuff to the vision field. And so the core technology that we have here at SeaLight actually came out of my PhD work from Cal. And so it's been really awesome to see kind of what you've been working on to get your PhD become something that you can then bring to the world. And so for me, that's been the most rewarding because I think a lot of students think that their thesis will be on a library shelf, never read Collecting Dust.

Etienne Nichols: You're absolutely right. I talked to a lot of students, and I'm sure a lot of them think these different things. So tell me though, what about the transitions in your career? Because working in academia and then going on to medtech, innovator or raising money, that had to be a shift in mindset. And now even where you are today, how do you handle those transitions? What did it look like?

Christy Sheehy-Bensinger: Yeah, I think there are ways that it prepares you and ways that you're like, holy ****, I just jumped at the deep end. So being trained in academia, you're trained to think. You're going to assume that your first solution probably won't work. You're taught how to iterate and just think through problems. And so I think in general, startup life is a series of things that you haven't solved yet, and you have to go through them methodically and kind of make your way through to get to the finish line. On the flip side, though, in academia, there's very clear goals. Like, I publish a paper, I get my thesis written, I get a PhD, I get a grant. Startup life, you start off kind of begging for money. Let me show you that I can do this. I promise. My science is awesome. I have 20 papers. I didn't really have 20. I have a bunch of papers here that shown the science works, but everyone's looking for a reason. I felt like in the beginning to say no. And so you go from this environment where everyone's excited about science and wanting to learn. But on the flip side, in the investor world, they want the risks mitigated. So the most novel and exciting science, if there's risks with it, you have to prove why that risk is bigger or why that risk is worth the reward. And so for me, early on, you hear a lot of no's. You do your first pitches, you see investors say, no, you're too early, or that's not quite the route that we're looking to do. And you have to pivot and iterate and constantly keep pushing forward. And so that was hard at first to hear a lot of no's and then take those no's and turn them in your mind to like, not now.

Etienne Nichols: So one of the things that I hear investors complain about is you fall in love with your technology and not necessarily the problem. Was that something you experienced? And if so, how did you handle that?

Christy Sheehy-Bensinger: So with my technology in grad school, I had presented it at conferences, and I had professors asking me to build devices for them at their universities. I got to be a visiting scholar in Germany and build for them. And so eventually I was like, I don't want to keep building for fun. I want to make sure that we can transition this to something that could become a business. And so the big part of doing that transition is making sure that your unmet need is one that's worth it. So for me, I had family members with eye motion issues or issues where the eyebring connection might be impacted. And so coming from personal experience and kind of observing that, it helped motivate me to think that that would be a really great space to try to work in. And the best thing you can do is just ask potential customers, is this something you would pay for? So it was really just like talking to I think the NSF has like an ICORP program. Talk to a hundred potential customers, see what they have to say, see if your unmet need is worth being paid for. And if it is, then you've got something. So I think doing those initial interviews, making sure that people were interested in what we were doing, wanted to put money down for what we were doing and not just saying, oh, what a great science project.

Etienne Nichols: Yeah, that makes sense. So when you went through that process and now you have a company, what were some of the biggest challenges that you faced? Moving from academia, like you said, into business, maybe now you've got some funding, but now you're building a company. What were the things you really focused.

Etienne Nichols: On when it came to building that company?

Christy Sheehy-Bensinger: To start, it was hard because you have a device, you have your idea, you know, the unmet need. But a lot of the time with medical device, they want validation, they want proof that what you're going to do works. And so it's always chicken and egg of, well, I need the money to run the study to show you what you want. And so we ended up getting two NIH grants that allowed us to do our proof of concept validation work. And without those, we wouldn't have gotten anywhere because we had to show what our Imotion can do and that there's actual validity to what our machine could output. And so for us, those grants, which is totally nondilutive funding, were the best way to really kick it off to show that we were worth it. And then after that, you can go on and do accelerator programs and start to get that angel and venture capital money.

Etienne Nichols: Okay, so that's interesting to think about from the nondilutive funding. I know that's one of the focuses. Obviously you want to keep your company. How do you make the decision to let go part of it or do the equity game?

Christy Sheehy-Bensinger: Yeah, it's really about what you envision for your company. If you think that you'll stay a small company and not have as big of a reach, being self funded and using non dilutive funds is an easy yes, we're not going to hit that much in revenue. We're going to keep it small. But if you have a vision to help millions of people, if you want to scale so that you can put it in clinics across the whole country, you usually can't do that with just a nondilutive grant. Usually you need a lot more funding and honestly, expertise from venture capital or from angel investors who have done it before and can show you the way in which to scale properly. And so for us, our vision was we want to help the world. And so taking the venture capital money with an idea that we would have everyone wants to build that unicorn, but have an idea that could help so many people that a small percentage of something huge could end up being more than a big percentage of something small.

Etienne Nichols: Yeah, that's a hard principle probably to put in place. Mathematically, it makes total sense. I want to ask you a little bit about good money, neutral money, bad money, if we could in just a minute, if that's something that you're interested in. But before we get to that, maybe I'm getting ahead of myself. We have kind of an audience right here today of a lot of quality and regulatory. Did you use equity? And maybe I'm asking selfishly like, okay, so maybe I'm a regulatory professional. I'm listening to this. As CEO of a medical device company, what am I worth potentially to a startup like that? I'm curious, did you use equity to get talent or how did that look? If not, we're going to have to edit it out and you guys, sorry. We'll see.

Christy Sheehy-Bensinger: So we didn't end up using equity early on. We were able to fund consultants. And so we had regulatory consultants, we had reimbursement consultants for CMS. We learned very early on as a small team that we needed people that were experts in the field. And so we sought them out with the funding that we had to make sure that we were doing things. Dotting all the I's crossing the T's again.

Etienne Nichols: We'll edit it. Very cool. Okay, that makes sense. Okay, back to my question about good money, neutral money and bad money. You're probably familiar with it. What are your thoughts on that? And how did you go about approaching money, whether it's good or bad?

Christy Sheehy-Bensinger: Yeah, and I think honestly, that's evolved over the course of the company. I think early on you're so excited about any money that would come in that you're just like, oh God, we did it, we're funded. And then in the future when you're doing bigger rounds, these investors have a lot of interaction with you. They're on your board, they meet with you maybe weekly, monthly, depending on the type of investor you have. And so you want to have an investor that supports your mission but also supports you as a founder. And I find that there's not always that alignment. And so the best money comes in the form of someone who wants to make you as a person, the best leader you can be, but also scale and grow the company to help others. And so I think the good money, bad money is a real thing. And I've been lucky in my seed funding round that my two lead investors are phenomenal. I can say them. We have Yamaha Motor Ventures, which who know they did healthcare, but they do. I thought they were just boats and pianos or motorcycles. And then we have creative ventures as well. And so having groups that are supportive of first time founders, of female founders, of people that are doing medical device, everyone always says hardware is hard. Add regulatory onto that, it's even harder. So the idea of good money, bad money is a real thing.

Etienne Nichols: If you heard any of the last panel, I love failure stories. So if you have a failure story or a bad money story, I'd love to hear it. I'll give the example just so the audience is kind of aware of what I'm even thinking. So a bad money example that I'm thinking, and correct me if I'm wrong, would be something like, maybe I'm a software as a medical device, and I go to a SaaS investor who typically invests in technology, and he thinks, okay, I'll get a return quickly. But you have to educate him about the regulatory environment and the slowness through the process and things like that. So that might be a bad money situation, whereas maybe you're better off going to a medical device investor who recognizes the length of time. Do you have any examples kind of like that from your own experience?

Christy Sheehy-Bensinger: Yeah. So with our company, we are an eye movement monitor. We are basically just FDA cleared ten days ago, I think, not even two weeks. So it's a really exciting congratulations. And what we do is we look at the back of the eye, the retina, and we see how that moves. So if you've ever been to the doctor and they said to you, follow my finger, look at my finger, look at my nose, they're doing an eye tracking exam on you. Not in the most objective way. And so we can then provide a machine that can give you really objective ocular motor function outputs that medical professionals can then interpret and use for clinical care. So for us, we have a hardware component and a software component. And Digital Health has been a type of startup that's been really hot in the last couple of years. A lot of wearables people that use AI for healthcare. And so we have software, and we have an idea that in the future, potentially, we could use AI. And so I thought, well, maybe we could be Digital Health. And so I would go to pitch to investors in the digital health space and say, hey, we have a future AI play it's not right now, but see the big vision with me, and then they'd come back and say, well, you're a piece of hardware. And so for me, I wanted to share this vision of where data could go, but I was limited by the fact that we had a machine that had to go through regulatory clearance, and a lot of the digital health companies might not have that regulatory hurdle or that hardware hurdle. And so it was a big lesson learned for me. When I had done a bunch of prepping for fundraising, I had a huge digital health tab on my outreach page, and almost all of them had said no, and I thought I could spin it in a digital way, but we weren't ready yet. A lot of them said, we'll come back once you're cleared. Then we can really focus on your data and AI because your risk won't be there. So that was a lesson learned for me of just being able to accept where you're at right now and use that to keep moving forward.

Etienne Nichols: And so this is a really interesting conversation in my mind, even from a regulatory quality perspective, because knowing what a CEO is looking for or their goals or where they've been is probably helpful in knowing why you need to get through when you need to get through. So another question I might ask is I know a lot of companies, they may want to be acquired. And so they're probably thinking, okay, well, maybe I'm not going to think about manufacturing because we're going to be acquired. Before we get to manufacturing. Or maybe something along those lines. When if you look at the data. Typically, acquisitions happen post market, it seems. And so I'm curious what your goals are and how your different goals may have altered your approach. Do you have any thoughts?

Christy Sheehy-Bensinger: Yeah. And I think for us, our goal is how can we get the solution out to as many people as possible? And we're always open to what that could look like. So if that looks like a future, phillips comes over and says, we want to acquire you. We're going to help you scale big time. We're going to go from your 40 clinics to 400 in the next two years. That's huge. That's our goal is to be able to get as many devices out there to help as many people as possible. If that's something that we can end up doing on our own, we're open to it, too. So I think it's really creating that goal internally for your company, what you want to go for. And if acquisition is a way to achieve that goal, great. But if it's just acquisition for the sake of acquisition, maybe don't do it.

Etienne Nichols: Okay, that makes sense. All right, so we also talked a little bit about quality and the culture of quality. So you talk about building this company. So I'll put you on the spot here. How have you instituted or have you instituted a culture of quality within your organization. Any thoughts or tips?

Christy Sheehy-Bensinger: So we have a total unplanned plug, but we use Greenlight Guru. We talked a little bit about this before we hopped on, so we use Greenlight Guru, and that is because we aren't experts in quality ourselves. And so one of the perks for us of having Greenlight is that it comes with humans. So the idea that you're not just taking a QMS software and then someone says, good luck, have fun, you're going to be great, you have someone that actually takes you through each step of the process. I mean, we had someone literally email us last week, how's it going? I was like, oh my God, they care how we're doing? So I think that for us, has been huge. And we are a small team. So I will say, to start, we used a contract manufacturer to build the device where they have their own QMS, but we needed to integrate that QMS in house so that we would have a QMS simultaneously. And so that's where Greenlight Groover has come in over the past few months as we integrate our own quality in and start to build that culture in house as we gear up for a future distribution.

Etienne Nichols: Okay, just side note, who emailed you? If I might ask? Do you remember the name? It's okay.

Christy Sheehy-Bensinger: I can't remember the it was it was really nice to see someone cared how we were.

Etienne Nichols: There are certain ones. If it was Madison, she would probably hug you in person. So anyway, yes, they love you. Okay, so we'll move on from that. What about the CMO? How was your criteria? Maybe any vendor? I'm curious how you because you talk a lot about the consultants. You probably had to have a lot of criteria in place, even with the big vision. What was some of your criteria as you went through and chose these different vendors, consultants, the things you came up against?

Christy Sheehy-Bensinger: For us, one of the big things was transparency. So for us, being able to work with a CMO, that really allowed us to come along for the process and not just, here, give us your specs, we're going to build it. We wanted a really iterative back and forth because when you're building something new for the very first time, there's going to be a lot of hurdles you'll overcome. And so if you're open about them along the whole way, you won't reach a hiccup where you're like, oh, shoot, we should have redone those specs. Something didn't work. So transparency for us was huge and also just experience in the Ophthalmic space. So people who have done something in the eye, who understand some of the subtleties of using a system that you have to look at an eyeball. So what is the difference, the spacing between two eyes from chin to eye, all of those, ergonomic type things that you have to think about for Usability, if you've worked with a company who has worked through that with other firms, you're going to get through things quicker.

Etienne Nichols: So the theme that I feel like I hear you talking about is people. So you really want to work with human beings, whether it's transparent with CMOS and so forth. What are some I don't know, maybe I shouldn't ask this curious, if you had any non human interactions with people, how do you filter that out to determine whether or not this is really a transparent company?

Christy Sheehy-Bensinger: I think when we first started talking with different CMOS, the willingness to give more than just one reference. So here's like one person that we know is going to say something really nice. The firm that we worked with gave us like three here's three people we've worked with. So I'm like, okay, that's a breadth of opportunity. Not everyone's going to have a perfect experience. So having kind of that ability to be open to someone saying not something perfect, I think is important. Again, that transparency, again, when working with humans is, are they going to give you enough information to make a decision?

Etienne Nichols: Yeah, that makes sense. Okay, so now just ten days ago, you said FDA clearance. That's fantastic. What does it look like now for the future? And how is your relationship with your regulatory person right now? And I'm just kind of thinking a little bit more along the interaction and the relationship, a CEO to regulatory and how we could scale that thought out. What are your thoughts?

Christy Sheehy-Bensinger: Yeah, so for us, there are regulatory strategists. I mean, I'm like super cheerleader right now. I'm like, yeah, you got us clearance for the stage we're at right now. A lot of it is registration. So, like, have you done your Udi? Are you going to register online? It's a lot of semantics now that we're cleared to do the official things. So we're still very active. It's like you have this illusion that once clearance hits, everybody pops a bottle of champagne and suddenly your devices are falling off the shelf, money's being thrown at you. But there's a lot of just things that you have to go through, checkboxes to even distribute. So we're still actively, of course, working with our regulatory strategists to make sure that we're doing all the proper things before distribution.

Etienne Nichols: That makes sense.

Etienne Nichols: Sometimes when I think of quality versus regulatory, and I shouldn't use the word versus, we had a little bit of discussion in the panel earlier today about quality and regulatory and the interaction between the two. I like to think of as quality, as like a defensive line for the internal organization. And your regulatory is the one who runs the ball and to the different agencies potentially, and they have to work together. It doesn't really work, but when it comes to the leadership and really driving that culture of importance across the organization, is that something you focused on or thought about impressing on the rest of the organization, the quality is everywhere concept. Is that something you've thought about?

Christy Sheehy-Bensinger: It is something I've thought about. And honestly, when you first start a company, I would say for a lot of founders that are engineers or academics, it's not the first thing you think about. You think, oh, I have a cool thing sell thing, but I think having a supportive team. So my co founder, he's doing a lot of our AI. He does a lot of the engineering as well. He came from a field in his own previous startup where he knew quality. And so for me, joining Powers with him and understanding, oh, wow, okay, he can explain to me why that's important, what we need to do internally to kind of gear that up and how to translate that. That was huge for me because I hadn't had a previous experience with a startup and he had and he could share those insights. And so I think for first time founders, if you don't have an experienced co founder, the type of people that were on the panel earlier today, just checking in with those types of experts is huge early on because if you wait, you're going to miss that ability to become a quality first organization.

Etienne Nichols: Yeah, that's a really good point. So I got to speak at wraps last year with a guy in Minneapolis and we spoke on the quality Love languages. And I like to talk to people about the different languages across the organization because I learned early in my career, finance doesn't speak the language of product development. They just didn't like it when I came up with these ideas that I thought I had and everybody kind of speaks a little bit different language. You got to learn some of the jargon. What advice would you have for a quality or regulatory professional when it comes to CEO? Have you experienced that? I know you probably have to speak every different language. What are your thoughts and advice you might give to a medtech professional? When it comes to speaking with upper.

Christy Sheehy-Bensinger: Management, speaking their language is super important. So for a CEO whose background is engineering, if you can kind of tailor it to a little bit of an engineering spin, or if a CEO's background is science or medical giving, it kind of that background. So for me, if I was previous engineer, you're building all these really cool things. You're creating new CAD models, you have SolidWorks. We need to keep track of that. We want to know where you got from step A to step Z and everything in between. And then I could have directly link, oh, as I'm building this new thing, I need to just keep track of what I'm doing. I mean, it's layman's terms in that respect, but if you say it in a way that they're going to follow along with their own expertise. It's much easier to absorb. Otherwise. You might think about quality as this scary thing of like, oh my God, we have to implement it. I don't know how, but if I can compare it to what I already know, then that's easier.

Etienne Nichols: I love that, the idea of knowing the background of a CEO, because it's hard to imagine. I can remember one CEO I worked for. He did, he had a programming background and he asked to see some code. We're like what? No. Well, you're a little embarrassed of what we've got there, but that's a really good point, knowing the background of the people you're talking to. That's a good point. Another thought I might or another question I might have is you are where you are. And I'm sure a few years ago it's probably hard to imagine where you are. What advice would you have for yourself a little bit early on, maybe particularly around building your team or in the early days, if you look back at yourself a few years ago, do you have advice you would give yourself if.

Christy Sheehy-Bensinger: You go back there so much? I think one of the things I think is most important is getting people passionate about the journey. So I think for anyone that would join your team just to potentially think about the benefits of making money or just have a nine to five if they don't care about your end goal, if they're not really excited about how you could help millions of people in the medical field, they're probably not going to be a good team member. Because startups are hard. We describe it a lot internally that we are fixing a plane that's flying, and so some days you have a lot of air and you have some room to move a few screws, but some days you're really close to the ground and you sure as heck better screw those in fast. So I think if you're passionate about what you're doing, those days are going to be easier.

Etienne Nichols: What about any advice you would have for a medtech professional that you interviewed or spoke with early on? Any advice you would have for that.

Christy Sheehy-Bensinger: Person, the way in which the panel up here relayed how important quality is early on, it was very relatable and understandable. I feel like a lot of the consultants I spoke with, they didn't necessarily have this idea of, like, you should get quality early on. Here's how it can help your organization. It was, here's what I do, here's my expertise, here's my resume, here's all the groups I've worked with, and the idea of why they're important is usually left out. It's almost like it could be assumed. And I think for larger organizations, you can totally assume that everyone's going to know exactly why you're needed, what boxes you can help check, what things you can move along a startup might not know. And so if you can give them here's all the reasons why I'm awesome, which is what they all did. But also say, and here's why you need me, or someone like me. That would have been the missing piece. I think that would have helped.

Etienne Nichols: I love that because kind of evolving my thinking a little bit. It's almost as if you have to recognize your own value in order to portray that value. I want to ask the audience what questions they might have because I don't always know what the audience is thinking. I usually do, but I don't always just kidding. Any questions from the audience? Do you have any questions for So?

Etienne Nichols: Just a question. When you are getting started and building it. One of the challenges that I've seen, for example, in the past is when I was managing teams of people somewhere with coming from medtech background, some not from medtech background, so engineers from other fields. It was kind of first attracting but also retaining that talent once they get in and they understand like, oh my God, this is the medical device world. I have to document all this stuff. I have to work on all this paperwork. So how did you attract that talent? But also, how do you keep that talent once they were in house?

Christy Sheehy-Bensinger: I think going back to the company mission again is crucial. So if you have people passionate about the mission, if you have someone who said, my family member suffered from this problem and your machine could have directly helped, that a bunch of our people on the team that's happened to So, they're very personally motivated to go along for the ride. And that's always so rewarding to see. When you don't have that personal motivation, how can you bring that excitement to someone new? And I think that's really by again the company culture. So, is your culture welcoming? Is your culture open to a mistake? I think when startups are moving so quickly, people worry about perfection. If you're open to the idea that while moving fast something could happen, you have to change lanes and keep going, and that's okay. I think it opens people to the idea that it's not so regimented and structured and scary when people think about documentation, sometimes it can be scary, but I think if you give them the ability to see themselves in the position and not have to be perfect, that can help with some of the more stringencies of medical device world in general.

Etienne Nichols: I've worked for a lot of companies that maybe do different things. I remember one company working with where they had multiple quality management systems crammed into one. So you think about like FDA, of course, FAA. What if you have a defibrillator working on an airplane, but what if you have multiple product lines? One is not ever going to be on an airplane, but we still subject it to that quality management system, those parts. Well, now you have a Bloated quality management system and the frustration. It's amazing how people just don't want to do work for work sake. It's just kind of interesting how that works. People want to do meaningful work. So I think that's a good point. Recognizing that you can move fast but also examining your own processes is really a good idea, always. Any other questions from the audience?

Speaker E: So I had a question on the regulatory pathway itself. So you just mentioned that if you want to move fast then there might be some not mistakes but some loopholes which is never perfect. Right. So do you plan to use to follow everything? When do you say that, yes, we are in a place where we can now follow everything by the team. And when do you understand that you're at that mature level as a company?

Christy Sheehy-Bensinger: I think the important thing to understand is that you can document a mistake or document a spec that you prove to be wrong. So for example, if I have a spec for, I don't even know, tolerance in a screw and I realize that that screw actually isn't going to withstand shipping, I can go back and change that and all of that can be documented and there's totally nothing wrong with that. So I think a lot of us think that perfection has to be had in order to allow someone to keep track of it. And that's just not the way a startup can live because we're constantly iterating. We're on the edge of creating something entirely new for the world. And so if we waited till everything was perfect to start documenting it, I don't know if a startup would ever be able to because there's things every day that I think we can do better.

Etienne Nichols: Great point. Oh yes.

Christy Sheehy-Bensinger: Just a quick question. First of all, congratulations on your clearance. I guess my question is now that you have clearance and you already said it's not easy street necessarily, right? So what comes next? Where do you focus most of your efforts and how do you prioritize? Yeah, so I think for us there's a couple of areas that we want to focus on. One, the main one is quality. So ensuring that we can migrate all of the quality documentation over in house, make sure all of that is appropriate, kept track of, maintained. We are looking for a quality consultant to help us because we want to be able to grow into this and have this be something that we manage in house. So I'm sure I'm in the best environment for that. That's a big one. So quality is a big one. Investors always want money in sales. So thinking about how to scale the business, how to do a rollout of a first device, when you have something that's entirely new to the world, you might not want to sell 100, you might want to sell more of a limited amount to see how the clinics and how medical professionals use it? Is there something that they might spin a widget left and I would turn it right? You just want to see how it plays out in the real world. So I think for us, making sure that we have the right amount of revenue, but still being able to maintain the rollout and keep track of how it's being used in the field is important. So quality, revenue, and then really just a regulated way to monitor new change, I think everyone can always be better in every aspects of life, and so I'm sure our machine is no different for how we could improve. So having an R and D team, having an engineering team that is always thinking about that next step is important for us because we want to offer the most cutting edge solutions for healthcare. So those would be my kind of three main areas that we're focusing on now. And quality, of course, is a huge one. Now that we're cleared, this is the top priority for us internally.

Etienne Nichols: I think that's a really critical thing for regulatory, especially maybe a young regulatory person who maybe has a work in a startup to think about. Obviously, clearance isn't the end of regulatory. Now you said sales, which means marketing, which may mean determining your labeling, and that's a big subject. You don't want to market necessarily off label, and that's a whole nother subject, but all those different things, that's a whole strategy that has to be pursued and looked at. Whereas in a big company, maybe you've already established all of your intended uses, your indications are set in stone. We're not expanding until we go some completely different. And I don't know if that's something you've thought about, future indications for use, slowing down your language and thinking about those things, that's probably another topic. But those are all really interesting things to think about, startup versus a large enterprise that has been in the market for 50 years, perhaps. So I don't know if you have any comment on that, but thank you for my Ted talk.

Christy Sheehy-Bensinger: But yeah, I mean, thinking about future use and future indications is always important. And from a regulatory standpoint, you don't want to market those until you're there. So you have to work with FDA or your regulatory body to ensure that you're doing all the appropriate steps to get to that point. And if someone had asked me five years ago what would have been success for me at that point, being a first time founder, I would have said FDA clearance, because that meant we could sell to the world. And now that we have FDA clearance, I feel like I'm totally at a new starting line. I'm like, okay, let's go again. So I think thinking about the fact that we hit this huge goal, there's so many more goals we can hit now.

Etienne Nichols: I have one more question, then I'll see if the audience has another question. You're at the new starting line. How do you see yourself transitioning? Because you've already been through several transitions as a CEO, from academia to all these different things, how are you approaching this new transition?

Christy Sheehy-Bensinger: With a lot more of an open mind, knowing that I can surround myself with expertise that I don't have, knowing when to ask for help and to ask early, as opposed to know too long. For me, the new starting line isn't just me, which is really cool because when we got our first funding, it was investors funding Christy and her idea for this startup. And now I have a team of six amazing individuals. And so the starting line is a little more crowded, and I like it, and I'm not a runner, but I feel like I've trained now. I've run, like, a few marathons. And so now that I'm at the line again, it's not as scary. And so I'm ready to tackle the future, but with a team.

Etienne Nichols: Yeah. Any other questions from the audience?

Etienne Nichols: Thanks. You just mentioned your 510K clearance.

Etienne Nichols: How did you go about selecting your reference device and what thing you referenced and how did that iterate over time.

Christy Sheehy-Bensinger: Yeah. So selecting a Predicate is the big part of a 510K, figuring out what device you're most similar to, and if that can be done, if it can't be, then you're probably a Genovo pathway where you're going to be something a little bit newer. So for us, it was really digging into the Ophthalmic space. We had ideas of two devices that we thought we were most like. We thought, okay, we're definitely like this one, or actually maybe this one. So then we went through intended use, we went through summary statements. We kind of understood more of the nitty gritty tests that each device provided and then an eye movement monitor. At the end of the day, we had to look at our indication. That's what it came down to. What do we want to indicate to the world? And so for us, being able to track, fixation, and cicads, which are the look at my finger, look at my nose eye movements on a temporal scale, that's what we were doing, we thought perfect. And that's actually one of our first conversations we had with the FDA. So FDA offers what's called pre submission meetings, where you can meet with them before you do your submissions. We had two of them, and the first meeting was we've chosen our predicate and kind of, do you agree or not? And so many questions. And by bringing that to the FDA, here's our indication. They reiterated with us, indication is the most important. You choose your predicate based on indication. Even though you're using the Retina, the indication is what you want to focus on. Because we weren't sure if we needed to have a Retinal imaging device, and they said, no, your indication is for eye movement. Choose a device for a predicate that does eye movement, and luckily there was an eye movement monitor in the world and so it was a perfect fit.

Etienne Nichols: All right, thank you so much, Christy. I really appreciate you coming on the podcast and look forward to following your journey in the next two years. Maybe we can do this again when you have. All right, thank you, everybody.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, reach out and let us know either on LinkedIn or I'd personally love to hear from you via email. Check us out if you're interested in learning about our software built for Medtech. Whether it's our document management system, our Kappa management system, the design controls risk management system, or our electronic data capture for clinical investigations, this is software built by medtech professionals for medtech professionals. You can check it out at WW greenlight guru or check the show notes for a link. Thanks so much for stopping in. Lastly, please consider leaving us a review on itunes. It helps others find us. It lets us know how we're doing. We appreciate any comments that you may have. Thank you so much.

Etienne Nichols: Take care.

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