Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Navigate Clinical Trials and Fundraising Challenges: Interview with Eyevensys CEO Patricia Zilliox

Episode Date: January 19, 2022

In this episode of Medsider Radio, we’re sitting down with Patricia Zilliox, who has spent her entire career working in ophthalmology, including 30 years at American-Swiss medical company Alcon. In 2017, Patricia became CEO of Eyevensys, a biotech company in the clinical stage of making a drug delivery system to fight various eye diseases. In this interview, Patricia gives advice for navigating the complicated world of regulatory affairs, the dos and don’ts of planning clinical trials, and why raising capital is the most frustrating part of her job.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 exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Patricia if you'd rather read it instead.

But really struck me was that it was fascinating that these companies make a promise that is a co-ecoacal promise that hypocritical oath the doctor takes, right? So where a doctor says at first you know harm, if you're working on a medical device right now that's going to diagnose or treat or something really important, it must be safe, it must work effectively and it must work consistently, which is essentially the promise of quality. Yet watching how these companies made good on their promise was interesting. They tried really hard, but the big problem was that it seems that there was this impossible binary choice to have to make, which is velocity as a company or quality in the product. Choose one or the other. You can't really have both. Welcome to MedSider Radio, where you can learn from proven med tech 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 Robert Fenton, who's the founder and CEO of Qualio, a cloud-based all-in-one quality management system for life science companies. Prior to founding quality in 2012, Robert studied pharmacy for five years at the University College Cork, practiced as a community pharmacist and spent time in quality and R&D roles at global pharmaceutical companies, including Pfizer and Leo Pharma.

Robert made the move to San Francisco back in 2016 after, bootstrapping Qualio in his home country of Ireland. Here are few of the key learnings based on the conversation with Robert. First, funneling all involved parties through a single quality management system increases efficiency and allows med tech and health tech companies to move with speed without sacrificing quality. Second, sharing data with integrated APIs will unlock quality and create a flow of information. While quality control has historically been viewed as a bottleneck, new technologies allow the

quality function to become valuable partners, contributing to important. improve therapies without slowing down the process. Third, the medtech industry is on the precipice of a new era. People want to pursue meaningful work. And as a result, there's never been a better time for med tech companies to scout out new talent. Okay, so before we jump into the discussion, I want to mention a few things. First, this episode is brought to you by Qualio, one of the most trusted providers of quality management software for life science companies. That's Qualio with a Q, Q-U-A-L-L-O.

Over 300 leading worldwide therapeutics, medical device, and clinical research organizations leverage Qualio's cloud-based quality management system software to unite their team's processes and data. With Qualio, life science companies can safely scale and swiftly bridge product development and quality management while also seamlessly addressing complex compliance and regulatory approvals. To see Qualio in action, visit MedsiderRadio.com forward slash qualio. Again, that's MedsiderRadio.com forward slash qualio.

For Medsider listeners, Qualio put together a free guide on how to transition your company to a paperless eQMS. It's available at no cost by visiting Medsiderradio.com forward slash paperless. Again, that's Medsider Radio.com forward slash paperless. So there's two links for you to remember. See Qualio in action by visiting Medsiderradio.com forward slash Qualio and get Qualio's free guide on how to transition to a paperless eQMS by visiting Medsiderradio.com forward slash paperless. Okay, second, if you're into learning from proven MedTech leaders and want to know when the 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.

If you want even more inside info from MedTech 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 exclusive Ask Me Anything interviews and masterclasses

with some of the world's most successful MedTech founders and executives. Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to medsider.com to learn more. All right, without further ado, let's get to the interview. Robert, welcome to Medsider. Appreciate you coming on. Thanks for having me, Scott. Looking forward to the conversation,

learning a bit more about Qualio and really kind of these, some of the broader trends that you guys are seeing in participating in because there's a lot changing, kind of in the broader life science community. So we'll get into the substance, I think, of this discussion which centers around a lot of these trends and changes. But let's start out first learning a little bit about you. At the outset of this interview,

I recorded a short, a short bio to give folks a better idea of kind of who you are. But I always like to start out with having you add a little bit of color. So kind of leading up to the formation of Qualio, tell us just a little bit of more about your professional background. Yeah, I appreciate that. And I think that I can weave my background and the idea for Qualio probably together. So the short story is that I'm from Ireland, live here in the Bay Area in San Francisco Bay Area

right now. the first time I started to experience this problem set was really the beginning of my professional career. So I studied pharmacy and was fascinated about the drug development and how all that worked. And while at university and shortly after graduating, I got to both work in some of the world's largest pharmaceutical companies in quality roles in drug development with a bunch of PhDs. So that was incredibly fascinating seeing how companies go from idea to the spank. science to the proof of concept and then bring that to trials and beyond. And I also had the opportunity to make friends, close friends with a number of people working

in med tech and medical devices. And what I thought was, you know, that was just after graduating, right? After graduating in 2008, when it was an interesting time to enter the working world. So after a small bit of that professional experience, what really struck me was that it was fascinating that these companies make a promise that is... a co-economic promise that hypocratical growth the doctor takes, right? So where a doctor says at first you know harm, if you're working on a medical device right now

that's going to diagnose or treat or something really important, it must be safe, it must work effectively, and it must work consistently, which is essentially the promise of quality. Yet watching how these companies made good on their promise was interesting. They tried really hard, but the big problem was that it's, seems that there was this impossible binary choice to have to make, which is velocity as a company

or quality in the product. Choose one or the other. You can't really have both. And I always thought from first principles that was that didn't make a lot of sense. Does that really make any sense? I don't think so. It's already expensive. So the old phrase is you can have it fast, you can have it high quality, or you can have it cheap? Well, they're not cheap. So why can't you have speed and quality? And I'm kidding a small bit with that. But I always felt that was a strange, lens the world used. And everybody spoke about quality and regulatory with that language as well. It was accepted top to bottom. And that was really the idea for Qualio and how that's really how my professional experience led as well. So I worked after university for less than a couple of years

before realizing there's something here and that this was what I felt I wanted to solve for. Of course, at the time, yeah, it was seen as an interesting concept that first of all, The most interesting thing to do is to look at the non-top-20 farm and medical device biotech companies, but to look at the earlier stage activity as the place to solve for it, because people generally believe the smartest venture capital is, you'll speak to. Look, there isn't a market there. These companies don't really exist. If they do exist, they're not going to buy a cloud native product.

And if they do, you're not going to be able to effectively acquire those companies. So that was really at the beginning, had this idea. And we had those headwinds, but just started pulling on that problem, like that thread of, well, from first principles, there's something really important here. We're not sure exactly what this is. How do we uncover that and how do we start working on that? So that was the kind of beginning of quality back when I lived in Ireland. And it's still the guiding principle today around that, like, hey, we think, you know, that the highest purpose we can have is to help teams launch and scale lifesaving products. That's great.

I love the framework around like the choice when delivering on that promise, on a quality promise, as you mentioned, the choice shouldn't be binary, right? You should be able to move fast. You shouldn't have to, you know, you shouldn't be so expensive, right, to build out like that quality system. So that's a great way to frame it. And it lines with your, it sounds like you're a big, you're a big believer in using first principles and kind of like using that as a foundation to build upon. Possibly frustratingly so at time. It's a bit like the smartest people I've ever met and the people you read about. One of the things that you learn is that they're incredible at reducing things down to the least complicated truth, right? From that you can build up, but it's very hard to go the other direction. And I'm curious, I mean, like with Big Sky Biomedical, with a fast wave, I mean, is this still lived experience as you're seeing it right now? Yeah, no, and I, 100%. And I try as much as possible. I'm not an engineer by training. I've worked with, I guess, enough brilliant engineers to pick up

a few things, you know, right over the past 10 to 15 years. But I totally agree with you. It seems like the best thinkers that can actually execute against their sort of their thesis, are those that follow kind of first principles thinking, you know, and trying to get sort of this root cause, this root base case scenario. And as you said, build up from there versus kind of going to the opposite direction. I think the hard part, though, is trying to like get to the real, the real kind of true, true problem, right? That's hard. It's not, it's easier, much easier said than done from my perspective.

Yeah, it's much easier just do a lot of activities. Yeah. When you're at early stage company, as you know as well, you also have to do a lot of work. You can't be precious about the idea. And it's like this idea is to search for, it's to search for truth. It's what really matters. And at the early days, that was what it was. It was, this seems like there's something here.

But consensus is against the consensus. except, well, what can I do in the next week, month, quarter to go, is this worth further investment or not? And we just kept getting positive signs. We like launched in 2014. We bootstrapped for over five years, getting, you know, to, you know, seven figures in revenue and all these items. And from there, then we felt we had proven product market fit. We'd proven those initial hypothesis right on those three core things. And from there, like it's been, you know, the, what's been an incredible growth story and an incredible journey. any since then.

I mean, and to almost 250 people, you know, from, you know, zero in raised capital to over $63 million and raised capital, you know, 400 plus customers, just like it's been a really interesting. Wow. Interesting kind of journey just in like two and a half years. But that came from a whole lot of deep work and thought around what is, what is the, what is the smallest unit of value from which we can build an

incredible company, which sounds really, you know, easy to say. But like you said, there's so much work in that. Yeah, yeah, no doubt. I had no idea that sort of the breadth and scale that, you know, Qualio is kind of working, working on now. That's great to hear. Before we go too far, though, let's take a step back and say, and I want to hear kind of your, the very short elevator pitch on Qualityo. And maybe frame that around. And you already mentioned some of like the root kind of challenges that you're trying to solve for. But maybe let's tease that out and like help us better understand kind of what you're, what you're some of those problems that you're trying to solve. So I might reiterate some of the initial concept,

and then I'll talk a bit more plainly about Qualio as a product and what it does. I think going back to the beginning, look, our mission at Qualio is to help teams, you know, launch and scale life-saving products. And a lot of that is based on the premise that the biggest challenge facing teams building lifesaving products, particularly only in like the MedTech area, is this false binary choice between product quality and business velocity. Like that is the angle of attack we have just from every conversation we have. So it's like how we build our products.

The quality as a product, the simplest way to describe this is like it's a modern quality management platform that helps you bring safe products to market quickly and then scale successfully. And we do that by simplifying the complex FDA ISO regulatory compliance. And we give you a single source of truth for everything to do with all the processes and all the data that impact product quality, be it your content, be it like capturing training, be it your suppliers and internal issues, external issues, your product development traceability and design controls,

creating a unified experience around that that helps you move at velocity. You know, we don't celebrate you passing an audit. We celebrate you getting to market. We don't celebrate you having a 5% improvement in some upics. We celebrate you feeling like you can move at a velocity that's getting your business. business where it needs to get. And that's why the reason that people choose quality all the time is that it's this customer success focus on business goals. Got it. Got it. And would you say, I guess that was going to be my next follow-up question when company, like, because, you know,

as we talked about earlier before I hit the record button for this conversation, I'm involved in a number of projects, fast wave, crossfire, various kind of other stealth projects as part of the big, sky incubator. But if I'm like for anyone, whether they're at working on a startup, like, like, you know, some of these that I mentioned, or maybe they're a little bit further along and they've raised some capital, or maybe they're at a big, you know, a small cap or a midcap, you know, a company that's, you know, already commercial and, you know, they're delivering on this, on this quality promise that you mentioned. And they're considering a change in a quality management system, like, what's your pitch to them, right? They're, there may be considered,

maybe they're using paper-based format, right, still. Yeah. And they're, and they're considering, like, this new, this new cloud-based, you know, kind of play or opportunity. Like, what's your, what are the top two or three things why they should consider a system like qualio? Yeah, in simple terms, it's a choice between quality as an adversary or quality as a partnership. And I think that is still embedded in the industry. And it's unfortunate because of the important work. You know, again, the fundamental promise companies make us this promise of quality. And that's a mindset shift you get to when you use a product like Qualio.

You see that in everything from product development or quality to bottleneck to the engineering product development team or quality to partner or quality department or something to make sure that the product is really great. I give a ton of examples around what that looks like. The second thing is that every company wants to scale. And every company is worried about as the growing pains that every company goes through. And we're the only product I think out there in any category tangently in life sciences, which is used and loved by companies from three to four people on their own to literally household names in the vaccine business.

So we're the only company out there right now that's demonstrable scale the whole way through the IPO and beyond. And we had, I don't know how many of our customers IPO last year. It's incredible being part of that journey with them. And the last part is, is that we did some research and surveys of our customers recently. And we were surprised, happily surprised to learn that we asked customers for really makes quality of stand out and it was just customer success across the board. because there's a fear, right?

When you think about quality, you want the people in quality and companies want to win. But there's a huge fear of getting it wrong, right? And it does this tie off of, well, yeah, we'd like to gain an advantage to make this better. But if it fails, it will really, really hurt us. And it was really incredible to see that feedback from hundreds of our customers that, hey, look, qualios are part of us. They're there for us. And they know our business.

Yeah. So it sounds like the fact. that you're incredibly customer focused, right? Yeah. It sounds kind of cliche, but it seems like your whole it is driven around that, right? Which is why I was very careful to say, we don't say this, our customers told us this,

and we thought it might be true, but it really came back that that's the case. Right. And that was really, really nice to see that as well. Right. Something else stood out and kind of hearing you kind of answer that question is the fact that you're working with such a wide variety of customers, right?

the three to four, you know, person startup and, you know, the thousand employee plus sort of enterprise. Yeah. And they all universally sort of love the software. It reminds me of like when I first went in house at Cavidian. And I'm trying to remember the name of the quality system that we used. But it was the most, I mean, people hated it across the board. Everyone. Like no one, I can't think of one person that actually enjoyed using it. And it was the most painful thing. And I thought, surely, you know, the size of the company, like, there has to be. alternatives here. And like it was just kind of the probably weren't none. Yeah, there weren't. Yeah. I mean, this was kind of back in like whatever 2012, 2013 time frame. So maybe maybe at the early

stages of quality. So you guys weren't around yet. But man, it could be painful. I mean, for those listening that aren't experienced with this, I mean, it can be. It is painful. Yeah. I've been part of like the three year review and update of standard operating procedures and it's global multinational. And yeah, that's just that's just like a lot of unproductive, doing important work, but what ends up being unproductive time. Yeah. and being an anchor to velocity. I will share that one of the interesting things about that scale is that I think sometimes people think,

what do you mean, quality of that you serve the entire supply chain? Does that mean you don't know our business? Well, actually that's the single most important thing we could do because we look at, well, I want to look at, we know now that the life sciences industry across devices, therapeutics, and support chain, support network around them is this,

it's like a close. loop economic ecosystem that is interdependent and interconnected. So we have, it gives us an expertise and a first principle is level understanding of what's happening in the world that no one else can have. So I think that's something that again, we believed we could do this and now seeing it in practice. It's incredible. Yeah. Yeah. Well, you're on to, you're on to something right. If you can get sort of like, you know, feedback across the board like that, you know, that's pretty impressive. It also means that, you know, now we're starting to see where one of our customers might have a vendor of theirs who's already running on Qualio. Oh, interesting.

This will be a medical devices company that might have some, I don't know, clinical trial stuff to do. Ah, yeah. So like we're not going rabbit holding too much in that, but I think we're probably going to talk a bit about connectedness in a while. But we have this thesis that connecting the ecosystem is a way to generate value across the entire network in a way that's something only we can do. So I'm very excited about that. watching that be successful, again, ignoring the quality lens, just broadly watching that model work. Yeah, yeah, no doubt. Well, let's actually serves as a good transition. Let's talk about some of these, kind of these key sort of overarching trends that you're not only seeing kind of in the market,

but you're trying to like, whether you're, you're trying to participate in or trying to capture or trying to deliver on, I think this is going to just make for, you know, an interesting kind of conversation. So let's start out, you know, and you guys, I think, authored a piece recently. And I'll link to it in this show notes for anyone listening that wants to kind of read the full, kind of the full sort of white paper for lack of a better description. But you talk about four kind of key, key areas. One was, you know, connecting this, which you just mentioned, data sharing and IPIs, which is kind of, you know, pretty intertwined with that.

And then quality as an enabler and then mission-driven work. Those are kind of four key kind of areas that I believe you guys, if memory serves me right, kind of kind of tackle that piece. But let's, I'd love to hear kind of like you add some color commentary. around these and maybe start out with connectedness and interdependence. I think I might have jumped ahead a small bit, but I think that like the last part of our conversation we spoke about that, I think we can't look at the network in isolation.

We have to look at it as like this economic hole that's interdependent. And we're seeing this become, you know, so much more important. Maybe step out of med tech. I think an example we will always know. It was a Pfizer or Pfizer and Bioentech that created that. back seat really. 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 Cala Health, Nadine Mared, 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.