Moving Quickly and Safely in Pharma and BioTech
This week I am talking to Robert Fenton (@robpfenton), the CEO and founder of Qualio (@Qualiohq). Robert is a pharmacist by training. He was born and raised in Ireland and worked with a range of pharmaceutical companies working in quality and drug development roles. It was this early work focused on delivering safe products and as he described it the “false binary choice between product quality and business philosophy”.
What emerged from the early ideas and concepts was Qualio – a worldwide company that provides quality management solutions and software to meet complex regulatory compliance requirements without sacrificing speed to market. Along the way, he was an early adopter of remote working, something that came about with distributed workforces that had small offices in different cities and the realization that the same work and team could be formed without physical office space.
Their solutions offer a simplified approach to FDA and ISO regulatory compliance speeding up the development process and ensuring the early inclusion of quality into developments in Life sciences, something that no longer takes place in the rarefied air of big corporations but is now importantly taking place in large, small and medium-size organizations who are speeding up the innovation process without compromising safety or trust in our healthcare treatments.
Listen in to hear how they were able to integrate product best in class solutions and built an ecosystem to support all the participants from devices companies, pharmaceutical, and biotech all the way through the regulated network they depend on from design development, laboratories, testing, manufacturing, distribution, packaging makes it easier for everyone to collaborate
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Raw Transcript
Nick van Terheyden
And today I’m delighted to be joined by Robert Fenton. He is the CEO and founder of qualia. Robert, thanks for joining me today.
Robert Fenton
Thanks for having me, Nick.
Nick van Terheyden
So as I do with all my guests, tell us a little bit about your background and how you arrived here, you’ve got some international components that I think are interesting. And obviously a journey that has led you to this specific point in time, share a little bit of that, if you would, please,
Robert Fenton
of course. So the short version of my story so far is that I’m from Ireland. Growing up, I was fascinated by science and technology chemistry, followed that into studying Pharmacy in University, where I was fortunate enough, while studying and shortly thereafter to work in some of the world’s largest pharmaceutical companies, and quality roles and drug development roles, and also make friends with several people across the broader life sciences like medical devices and other support services. And that’s where I realized basically 12 months after graduating, that there was this very interesting problem set that we felt nobody else is really solving for, and started working on what eventually kind of became the idea for for quality, oh, and graduating in 2008 gives you a different perspective, right from other times of the world. So you tend to be a bit more creative with relief, where you spend your time and your focus. So started, started working on the problem, which came from that observation, which was essentially that companies in healthcare, I think we all understand this, right. So companies in healthcare make this clinical promise that Hippocratic Oath the doctor takes. So we take the Hippocratic Oath, a part of that is our first do no harm. In order, in order for you, as a doctor, as a medical professional to make good on that promise, you might use a stethoscope or you might give somebody a drug, or you might do one of a million different therapeutic diagnostic devices to support you. They need to be safe, to be effective, and to work consistently. That is essentially this promise of quality. And what I noticed was that these was archaic how these companies were able to deliver on that. And the way I viewed the problem was that it’s incredible that as far as I’m concerned, the greatest challenge facing teams trying to get life saving products out into the world is this false binary choice between product quality and business philosophy. And that was like the the Insight back a decade ago now that we started pulling on that kind of lead to quality. Oh, and, of course, after launching and bootstrapping, for a couple of years, realized most of our customers were here in the United States. So decided to take the leap from from Ireland to California and living here now in the Bay Area since and have built a company up from there. So that’s a short version of the background.
Nick van Terheyden
So I’m, I’m, I was going to say a big change from Ireland to the Bay Area, but actually I’m not so sure. I think, you know, there. It’s quite an international area, I’m sure. You know, and you found customers there. So not so much. And obviously that was part of the reason for the move, for the benefit of people listening. Tell them what qualia is and what it does.
Yeah. The easiest way to describe quality Oh, is that we are a modern quality platform for companies across medical devices pharma and biotech. What we do is we help you bring safe products to market quickly and then scale successfully. We do that by simplifying FDA and ISO regulatory compliance. And we also give you for the first time a single source of truth that connects all teams and processes in data that impact ultimate product quality, be it product issues, customer issues, suppliers, and connecting all your product development together. So you can prove that or know yourself that this device has been tested to meet that really important requirement. It’s incredibly complicated. And, you know, complexity does not equal success. And we found a way to build it in a way that’s simple, accessible, and, again, solves for that problem that we see in the world, which is, you know, quality and philosophy are being seen as opposing forces and in this new world we’re in that’s just not okay. We’re in a world right now. We’re in you know, before we started the recording, we were just talking that we have customers who were one person in their garage all the ways to public companies to a household name in the vaccine r&d business. And what’s amazing is is that the, the new companies being born into space are faster moving, they’re smaller, they’re nimbler, and for them, velocity is like oxygen So for this revolution that’s happening in healthcare to be successful, we need to be able to help them move, you know, at a very high speed, to build, iterate and launch new products, while still giving them the ability to meet quality standards that exist for really good reasons.
Nick van Terheyden
So I think for most people listening, and you know, this is even true for myself, as I sort of look at the environment for development of medical devices, pharma, and so forth. A lot of that’s a mystery. I think there’s been an awful lot of people suddenly become more aware as a result of the pandemic, and, you know, more focus on trials. And, you know, I’ve certainly got an awareness, but when it comes to the regulatory piece, you’ve really got to be deeply invested in it before you came along. And not you individually, but you qualify to and you know, a different way of looking at it. How did this happen? What What was the process? And why was it so difficult?
Hmm. Well, the why was it so difficult, I think can be answered with when it comes to the products we put in and on our bodies, you know, we want to trust they’re safe to work effectively, we’re consistently right, this idea of quality, without technology to support that. Doing that is an incredibly time consuming process. We’re trying to connect every every single activity in the company, such that if something happens down the line, you can trace it back and find out who to decide on what date to what version of your software, or what batch of your product. And it was an incredible paperwork mountain, I will tell you that some of our first customers one of them was and the ROI for qualia was to be purchased a building next door for paperwork, or do we purchase quality, just to put that in some perspective. And even in university studying Pharmacy, we were studying some of the the drug development pathways, right, which is one of the core segments that we support. And it’s like 10 years and $10 billion insanity. And I think the things that have driven that all of our new world are a the type of companies being born it’s not only Johnson and Johnson and Pfizer and Merck and Gilead and Boston Scientific now building products, there are people being funded and startup accelerators for $100,000. People bootstrapping their way. So that is a major change in in like, what’s changing how it all works. But on the on the regulatory side. I mean, before these regulatory agencies will allow you to sell your product, you have to prove to them not only that it works in a safe, and it’s effective, but you have all the data that supported that. So how did you design a product or molecule? How did you prove with an audience that it was safe? Did you randomize those? Are they all the same demographic? Are they all in the same country did they have? Did some of them have comorbidities or conditions. And that’s that’s like, I don’t think people understand how complicated that really is. So it made sense that it took that time. Now what we’re seeing though, is technology is being applied. So for example, in the clinical trial space, several of our customers are revolutionising that where you can very quickly get this one up really great data in ways that are way quicker at the quality of side give you just one example of one of our one of our customers are called Pat Acad. They build Harold hardware and algorithms to basically build the future of decentralized clinical trials. And they use AI to kind of analyze data to do that, with quality, they were able to use a product development system that they love this case of like Atlassian, JIRA, and some other product development tools. And using that quality of automatically pulled all that data together, stitched it, so that they were able to just build a great product and quality output all the voluminous documentation needed for the FDA. So they could confirm that, yes, it was safe. And yes, it was effective. So that they’re just a couple of couple of examples that are kind of worth sharing.
Nick van Terheyden
So, you know, historical process, threading back, I think you highlight one of the key areas in you know, the innovation and development that’s taken place over the course of history. And, you know, over the last couple of years, certainly, I’ve always been an avid reader, but you know, reading a lot of the history of the development of our treatments, you look back and go wow, it’s shocking. We’ve come as far as we have with some of the the the mistakes, but we’ve benefited we’ve learned from that and that contributes obviously that’s part of the process that you’ve included. But one of the things that strikes me as I’m talking to you and you know specifically with your move, is this just a US solution or a you encompassing a broader set because I imagine there are differences and I’m not as familiar as you know, in EU regulatory or other countries? What’s your sort of approach to that international aspect? I mean, at some point, we ought to be able to do it all in one place. But we’re not there. Yeah,
you know, it’s the same. And it’s different our customers, like, just like we’ve teammates in over 150 cities, globally, our customers are the same. And our first customers were in Ireland and Europe, right. So we do have a lot of customers in the United States, because the healthcare market is so vibrant here, in terms of company company development. But I know our customers span everywhere. And I think the way I look at it is, is that you know, aspirin was first synthesized at scale in 1897, I believe, you might want to double check the date of sometime around then. And how that process evolved was there were mistakes that cause harm to the world, and trust went down, therefore, bureaucracy went up. So in a way, going from then to just recently, it was the c sub trust versus bureaucracy. And if you look at trust at a systems level, that’s how it works. When trust goes down, paperwork goes up. It’s like, it’s like two opposing sides of a balancing act. What we’re seeing now is are ways to both automate the bureaucracy. And also ways to build better systems of trust, better data reporting, and better ways to automate information flow, better ways to spot problems earlier. And that’s kind of like that’s what’s really happening now to accelerate everything I know, that’s a very kind of 50,000 foot view on it, but that’s kind of how we look at it. And the different look, the different global agencies be at you know, the FDA here in the US, or the HPRA, in Ireland, or MHRA, and you know, the UK or all those different areas, there is an awful lot of consolidation over time, because you know, there is only one best way to a degree, and we’re seeing them get closer and closer. And but every company we serve wants to be a global company. And what matters is what market you want to sell into. And from the very beginning, it was incredibly important for us to be our job is to be the quality platform that powers your success to market and scale. Our job isn’t to pass an audit. That’s like not interesting our job that we celebrate, you celebrate. And to do that we need to be able to support you to scale globally.
Nick van Terheyden
So for those of you just joining, I’m Dr. Nick the incrementalist today. I’m talking to Robert Fenton. He is the CEO and founder of qualia, we were just talking about the global nature of development, the differences but you know, as you describe it, a consolidation. I mean, I think in hopefully, you know, there is only one way to do the right thing, or not, maybe not hopefully, I think, you know, we we focus in on that single right way. There may be multiple ways. But you know, hopefully, as we learn over time, you’re obviously supporting that provided a distributed system. Again, as I listened to you, I’m thinking, I go back to the electronic medical record. And, you know, what do we do for that? We said, Oh, well, this is how we collect paper records. Let’s automate that. And you know, that really wasn’t the smartest move, we didn’t sort of rethink it. Have you managed to bring new thought processes, new ways of sort of approaching that gathering of information and that quality flow process?
Yes, there are a couple of ways to to look at that I think are useful. One is, and I think there’s a fundamental re re imagining of what the core problem is, right? I think at the beginning of our conversation we spoke about I spoke about this idea that we believe the greatest problems industry faces is this false choice between moving quickly or moving safely. You know, there’s the old adage of it can be fast, it can be high quality, or it can be cheap, well, healthcare isn’t cheap. So it should be fast and high quality. It’s not it’s typically just slow and expensive. And I think that the industry is operated with that as accepted that. And we’ve said, No, our job if we’re providing value as as a product that’s helping this industry is to help you move at higher and higher velocities, and deliver on, you know, of highly effective products. And we do that in a variety of ways. There’s an impure product level. And we understand that the job isn’t to help you translate literally what you do with paper directly into software, because that’s not adding value. And you explain that very eloquently yourself. Our job is to understand what is the job to be done. For example, let’s take a medical devices company. One of the core pains they have particularly in earlier stages is the idea of creating traceability from patient needs to product requirements to specifications to testing to prove that works. Connecting all those dots could be 1000s and 1000s, and 1000s of different like linkages and a spreadsheet. B could just pull software like some people have done that just kind of builds that view and you’re just working in a software version of like an Access database. Instead we said okay, wait a second. What are public companies doing? Old outside of the industry, and how do the customers we speak to want to build, okay? These products like Jira, Azure DevOps, and they use GitHub to use these . Why don’t we integrate with all of those in an automated real time fashion, pull all the data together. And instead of you building a traceability matrix, we would say, Nick, before you push this product for release, yet, you forgot to test that this thing won’t break if you drop it. And it’s been used by people who have some grip issues should probably check that are. And it’s all automated, so that the quality team for the first time can be partners, with the organization and the product teams and building great products quickly, as opposed to being the checkbox at the last step who said no, gotcha. And you’re smiling, people can’t see that. But like, that is that is the lived experience for people. And it doesn’t need to be that way. So that’s just an A pure product level. Then there’s this idea of the ecosystem. And I talk about this to everybody all day long every day, which is in the modern world, we are no longer. We no longer live in an age where you know, Pfizer does everything a tizzy. We see that with the vaccine, Pfizer biotech vaccine, I mean, bio entik did the hard work. The entire world today is tightly connected ecosystem. And when you speak to some of the leaders at these large multinational companies, and founders of early stage three to five person startups, they will tell you that so much of what to do depends on their critical supplier partners, so much of the data flows from them. And that’s why we built our product to serve the entire supply chain. So we work with devices, companies, and we work with pharmaceutical biotech companies, we also support the regulated network they depend on from design development, laboratories, testing, manufacturing, distribution, packaging, and that allows us to be like a part of the the ether are part of the scaffolding for this ecosystem, which makes it easier to collaborate across companies. So that’s, that’s another thing that again, helps move this industry forward. The last thing I’ll share is that, you know, we deliberately decided to focus, when we first started building the company, on, we felt were the most innovative companies in the world in this space, because they would push us to think differently. Around the product offerings, we looked at the ad companies that were not the top 20 pharmaceutical medical device companies, we looked for the companies that people didn’t know about yet, but who were doing incredible things and they push us really hard. And now, we’ve had several of them IPO over the last year. You know, and it’s amazing now to growing with those companies and having them educate us around what really matters for like the best and breed of the New World has helped us kind of build a viewpoint, most of what I’ve said cheerleading in this in this conversation so far, is from working with these new companies. Right. And I think that’s given us that that edge, and also has given us this ability to hopefully, you know, really see where the puck is going, so to speak and go that with the market.
Nick van Terheyden
So AI brings up an interesting point. And it’s it to me, this is one of those incremental insights, as you look back, it sounds like identifying not the leaders in the space, who are maybe sitting on their laurels and saying, life’s good work, we’re okay. But finding those that are sitting under the radar, hungry for business who are truly making a difference and changing the way that was what allowed you to really sort of innovate, is that a fair assessment?
Oh, it is it is the key. And I think so many it’s it’s the innovators dilemma, you know, the Crossing the Chasm, if read that book by Geoffrey Moore, and that you’ll learn about that, that it’s, you want to make sure that you’re anchoring yourself to the right patient population, like the right product, customer segment population.
Nick van Terheyden
So, you talked a little bit about you know, this quality as an afterthought reminds me a lot of security, that’s always an afterthought builds on similarities. Yeah. And, you know, this is sort of building it in it sounds like the on ramp for this is exactly the same as you know, literally people in their Garriage I’ve seen this at DEF CON at the you know, hacking health section where people are building their own bio reactors creating concepts, this is something that anybody can jump into at any point in time and included as part of their process.
And 100% So we we work with companies from the from the first steps or product development through like I said to IPL, right and beyond. And because that’s really important. We are a core piece of infrastructure, who’s there to help you win. And if you’re going to outgrow us or need to move off that’s we’re not really adding any value for Are you and it’s also for me personally, is valuable to be able to watch companies go on that journey. I think your examples are fascinating, right? Maybe not a friend or a hackathon weekend, go crazy. But the moment you start trying to think, well, there’s something here, we got to make sure this works. And we have to figure out how to build it such that it can be accepted by the world, and will be safe. That isn’t quality. Oh comes in. Intro like, I think quality becomes important. I, you know, the the area rather than what we do, I think that’s in quality becomes important and starting to think about that. Yeah.
Nick van Terheyden
So, um, you know, go back far enough, you’ve sort of been on this journey for a long time. Some things that you’ve learned along the way, one of the things that you identified, and you know, this has been a foundational piece is that this distributed company? Why was that? Was that part of your international heritage? I mean, I think you’ve been proven right? I’m just gonna say pandemic said, Yay, that’s the right thing. But you saw it before. What was it that gave you the the insight that said, We should do that? Well,
at the time, we’ve always had that part of our DNA from the beginning. And always felt, I always felt right to me, in some ways, just as that working that way, then it was in early 2019, we had a few of us going into a small, a small, tiny office in San Francisco, a tiny office in Dublin, a tiny office and Ross off in Poland. And we thought to ourselves, hey, like, why are we getting the worst of both worlds? What if we just known went into these tiny offices? For a month? How would it be, we ran it for a month, and everybody was like, never, it was no one would have gone back if I wanted them to. So we just leaned right in. And part of that comes from this, I have this core belief that as somebody who didn’t grow up grew up in a large urban, urban Metro, I grew up in a small town. And so many people feel they have to leave their communities leave their families to have a career that’s challenging and interesting. And I feel that’s like, again, a false choice, right? The world doesn’t need to be that way we can do something else. And there’s a better way to lock people and unleash people. And now I get to work with people. Over 150 cities around the world, powering qualia. And that’s exciting for me to know what’s going on and be part of that and help encourage it, right. So there’s something deeply meaningful, and it also gives us an edge purely because we get to be local everywhere to our customers. Easily.
Nick van Terheyden
Right. So, um, as you think about the future, you know, what are you excited about? And as you look back, what would you say, maybe you would have done differently or you think was really helpful in that sort of journey.
Looking forward, the thing that stands up most is that we are very clearly at the very beginning of something that’s like a runaway train like a reimagining of what of the healthcare this decade. And it’s exciting for me as a participant. And as a you know, a person at the consumer end of this ended as an observer to watch this. It’s incredible that it’s finally happening here again, since over 100 years ago, this kind of kicked off, and only now they’re really taking off. So it’s a great time to be to be in this industry to watch this. Looking backwards. I got asked this from time to time, my answer is like, I think we would have taken some bigger bets sooner. Because we had taken a very contrarian view on the world when we started this. And there wasn’t a lot of independent data to support this. And we had to prove it step by step. You know, we did a prudently we did it step by step. But I think knowing that the benefit of hindsight, of course, you can go all in right away. So, you know, I don’t think I would do differently if I was back, because I probably still owed the same way. But if I could send a letter back to myself, I say go for it faster.
Nick van Terheyden
Interesting. So I think, you know, potentially, as we sort of move to this end of one that sort of customized precision medicine, we’re going to see more of this earlier, you know, applied in sort of more generic terms, exciting times for that innovation. You know, and I, your comment about bigger, better reminds me a lot of a phrase that I heard repeatedly in sales, you know, go big or go home. Sometimes that’s not always the way but it’s clearly a learning opportunity. As you look back, unfortunately, as usual, we’ve run out of time, so it just remains for me to thank you for joining me on the show. It’s been a great pleasure, brother. Thanks for joining me. Thank you.
