How to Maintain a Quality Culture during Explosive Growth

 


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Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in privacy. Lawyers are developing into tech-savvy individuals by need to help people improve quality of life.

Sidekick Health was founded by two doctors, who worked for years treating patients with lifestyle-related illnesses. They explored ways to prevent chronic illnesses, help patients manage them, and improve their quality of life. Sidekick Health combines strong clinical validation with gamification, behavioral economics, and artificial intelligence (AI) to deliver engaging and personalized patient experience.

Previously, Kristinn worked as a consultant focusing on General Data Protection Regulation (GDPR) before joining Sidekick Health in November 2019. Since then, he has focused on registering Sidekick Health as a manufacturer of medical devices. In doing so, Kristinn has gotten involved more with quality matters. 

Sidekick Health’s platform is rated in the top 0.1% in quality by ORCHA, which has more than 30,000 users and clinical validation and successful customer launches across multiple therapeutic areas – ranging from type 2 diabetes to ulcerative colitis.

Key Takeaways:

  • How to enter new markets
  • Why quality is important for Software as a Medical Device (SaMD) companies
  • How to scale your business while keeping culture top of mind 

Show Notes: 

Kristinn Gylfason on LinkedIn

Sidekick Health

General Data Protection Regulation (GDPR)

FDA - SaMD 

FDA - Classify Your Medical Device

Pfizer

ORCHA

eHealth Award 2020

No Rules Rules

Application to be on the show: From Lab to Launch

Music by keldez

 

Transcript

We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Robert: Thank you for trusting us and believing us to support you folks on your journey. I was taking a look the last couple of days before we had a chance to connect. Second of all, thank you for volunteering some of your time to share some of your story and journey here today. It means a lot you doing that.

Kristinn: Yeah, of course. Qualio and Sidekick are in a fairly, or at least in my mind, similar growth path. It’s interesting to basically support each other through this.

Robert: Most big movements start as communities as well. The second similarity is as the life sciences industry is going through this big transformation, I think there is a change in the type of company that’s starting up. Either to be an enabler in the industry or be in the industry. It’s different, but I could dig in there for a long time why I think it would be really useful for our listeners.

To kick-off, for those of us who don't know Sidekick Health, just give us just a small intro as to what you folks do at Sidekick Health and how you folks help improve lives.

Kristinn: Yeah, no worries. Basically, Sidekick believes there's a void in the treatment of chronic diseases. And soon, it will be unacceptable to leave the doctor's office without any digital care as a part of the treatment. That's sort of our mission statement. And then we also believe that in coming years, [...] will be launched on the market without a digital companion. Our vision and mission is basically to provide digital companionship or digital care that augments pharmacotherapy to boost outcomes.

Robert: Can you give a couple of examples of that? I think there are quite a few interesting ones.

Kristinn: Yeah. We're working with Pfizer, for example. And in Finland, you will find little Sidekicks on certain drug packaging which is followed with a QR code to download the application and get a program, which helps you change and modify your lifestyle to the condition you're dealing with.

Robert: That's fascinating. That's also a milestone for you folks. Maybe looking at the other milestone, which I’ve really wanted to ask you about, is a pretty big claim is you folks have been recognized in the top 0.1%. It’s almost the 1% of the 1% in terms of quality by Orcha I believe is how it's pronounced. Can you tell me a bit about that? That's a big statement. It's impressive.

Kristinn: Yeah. That's far from my task, actually. I’m really not capable of shedding any light on that. Sorry about that.

Robert: No problem. I think we'll add to our show notes a link with some information on that. It’s something that we noticed doing some research.

Let's go back to your story because I think we look at your background, so you're a lawyer originally and you specialize in privacy. You have done a lot of work in GDPR, and now you're working at Sidekick in this Compliance Officer role. I think a lot of the most interesting conversations we have here are really about how do people like you get into the roles that you're in? That narrative I think is always fascinating because people don't typically go to university—I want to study this course to get into this role, so I think it's fascinating.

What's your background? Can you maybe walk me through how you got here?

Kristinn: Yeah. As you said, I’m a lawyer by training. In my earlier professional life, I focused a lot on privacy. I still do. I am also focusing on privacy here at Sidekick. I actually worked as a consultant for Sidekick before I joined them. When I joined, it was always on the table that I would be the Data Protection Officer and Privacy Officer at Sidekick.

But one of my first missions here was to finish our first registration or register Sidekick as a manufacturer of a medical device. That was the big task that was on my desk basically from day one was to finish that registration. We did that in about three or four months. Obviously, our Class I under MD is not the heaviest process to go through. You asked about my path to this role, I’ve always been fairly tech-savvy for a lawyer.

Robert: A lot of lawyers these days are tech-savvy.

Kristinn: Yeah. The stereotypical image of a lawyer is someone who only prints and staples documents. That's as far as technology goes in the stereotype. But the lawyers are developing into tech-savvy individuals by need, basically. What fascinated me about Sidekick was the possibility to help people improve their quality of life and to generally help them live a better lifestyle through this application and through the portals we have.

What's obviously fascinating is the clinically validated programs. The general quality of the product is fascinating and the quality of the people here is just unbelievable.

Robert: Yeah. I’ve seen just looking at some of the therapeutic areas, with that registration, I believe probably unlocked [...] like type 2 diabetes, inflammatory bowel disease, and particularly ulcerative colitis. It’s great to see that.

You also won the eHealth Award last year as well. It’s impressive. You folks are just racking up a lot of these awards. I think it's a sign of what we see is [...] to what you're doing particularly in today's world where we see that yes, traditional device development is a valid pathway. Now we're seeing if the software has been [...] the world for the last couple of decades, we're now seeing how software and also biology are merging. I think there's a ton of applications that I’m sure you folks are working on and stuff that we're not even aware of yet.

I think you folks are just taking part at the Plug and Play health accelerator over here in Silicon Valley?

Kristinn: Yeah. We did that. As you said, obviously, the industry got sort of a kick in the butt or in my opinion, at least a five-year head start of what would have happened without COVID just by people being forced. I know that's not the most fun topic in the world, but the industry leaped forward by need or necessity because people suddenly couldn't go into hospitals and so on.

We actually, for example, set up a COVID program here in Iceland to help people track their symptoms if they had infections. Instead of having a phone call from a nurse sometime on Tuesday next week or something like that, you were just reporting daily on body temperature, soreness in the throat, or something like that to help people prioritize who to reach out to and so on.

Robert: Yeah. So many new use cases opened up. One of the ways that we've seen this is that we call velocity matters now I think in particular in space. For example, even in that case, you go into your hospital. You could do all these things that are kind of time lags. Now speed—well, you couldn't go into a hospital, and the solution for that was to allow things to happen in your home, maybe. That's much faster. Now it's getting to higher data integrity, better data that allows us to make better decisions.

We've also seen that generally, the industry seems to want to move a lot faster now because it understands. Speed is important in this industry, which is good because I think it bodes well for companies like you folks and everybody who's coming down the line.

I’m curious, you opened up by saying that it sounds like both our companies are in similar growth paths. Growth is one of the best problems to have. Problems are still problems, and it can be difficult. If you're growing very quickly and you're taking apart, rebuilding processes that did work, I’m curious. As you folks, your team, or your products have been growing that quickly, how has that been? Any interesting learning on the past so far?

Kristinn: Yeah. Well, basically, when I joined, we were 15 employees at Sidekick. We are now over 60 in 18 months or something like that—18 or 19 months. That's been quite a fast curve. But what's been most valuable and most important in all of this is keeping the culture. To give you a little bit of an insight, we use the No Rules Rules Netflix book sort of as a reference, partially at least.

Robert: Great book.

Kristinn: Yeah, it's a great book, and it's a great tool to try and build culture on in companies because there are no stupid questions.

As we alluded to earlier, I’m a lawyer by training, and therefore understanding software infrastructure is not the first day of law school. It's not software infrastructure or something like that. I have to ask a lot of stupid questions, and I can't imagine that the development team is always jumping with joy when I run over to them and go, okay, is this something we can do, or is this something we are doing? To them, it's obviously true or obviously not true.

But the culture we built is that it's all right to ask stupid questions and all right to admit that you don't know anything or know something, you don't know everything. That's something that's been very valuable for us as a company. Basically growing through all of this is okay, just say I don't know instead of going yeah. Fake it until you make it doesn't work in the long run.

Robert: No, it doesn’t scale successfully.

Kristinn: Yeah, it doesn't scale. That's exactly it.

Robert: A lot of similar learnings on our side. I’m curious, getting back to the company and some of this growth, you're probably looking to enter some new markets at the moment. Are you planning that right now? I saw a lot of complexity for companies doing that. I’m curious how you're seeing that as a digital product.

Kristinn: Yeah, absolutely. Obviously, with a CE mark, you gain access to Europe. On top of that, we are looking to the US. I don't think that's a secret. There's no spoiler in that.

Robert: Most companies do so it makes sense.

Kristinn: Yeah, precisely. Well, basically, complexities are obvious that the talent in-house is, as of yet, very Eurocentric. The differences in legislation and regulatory complexities, let's say, there are some differences, although it's pretty much the same when you boil down to it. But there are different requirements.

One of the reasons, to plug Qualio shamelessly a little bit, that we chose Qualio was basically this capability of operating audit-ready at all times with the documentation in Qualio. That's one of the biggest selling points we found was that Qualio focuses on being an eQMS and not being 10 different things to 10 different types of companies. This focus on being an eQMS or QMS in that sense was really the reason and the capabilities of digging into the quality of Qualio regulations on both sides of the pond was one of the biggest selling points.

Robert: I really appreciate that feedback. It's incredibly helpful, Kristinn. Thank you. With the future, I’m curious now that we seem to be coming at the other side of the worst of this pandemic that felt like a dream to some people now I think. As you look back, we're all trying to look forward. How are you folks planning for the next 18 months, 2 years as a company?

Kristinn: For the growth, I would say it’s probably on the horizon. What we want to do more is getting deeper into the relationship with our pharma partners. For example, getting closer to them as partners and basically optimizing. What we obviously don't want to do is be busy laying train tracks when someone flies a plane over our heads. It’s obviously a very cliched way of looking at it, but that's basically our biggest mission these days.

One of the biggest missions for the future is being the guy on the plane or being the people on the plane not on the train. Basically looking for new innovation and being on top of all of that. That's obviously a challenge for everyone in the tech industry, and that's just something we have to be constantly aware of.

Robert: How do you folks do that?

Kristinn: By being agile. I mean, that's probably the biggest thing and that's going back to the quality system. That's not easy being a medical device and being agile. I mean, the regulation is mostly written for [...] or something like that that doesn't change for 10 years. And then you come in with a software solution, we change it twice a week or something like that.

Robert: Twice in the last hour.

Kristinn: Yeah, precisely. That's complex and that takes a lot of work and effort. I mean, we do it and we go through it. I think we see great gains from doing it with a partner like Qualio. I mean, this is obviously not a sales interview or something like that, but it does actually help. Previously we did it by paper, and just coming in and doing the first version of a registration or a quality system by paper is just fine once, but once you add up and add up and add up on various products that are CE-marked or need to be under the quality management system, then it’s a headache. I think I would literally drown in filing cabinets.

Robert: Yeah, we've seen it and I’ve seen the fireproof filing cabinets in any customer’s offices. I’ve seen that firsthand. I think what's interesting is talking about being agile in this space. It feels difficult to do with today's status quo of the industry, it hasn’t worked and there's often this perception that speed and quality in this industry feel like opposing forces, right? To move quickly, to resolve the pressure of quality, and if you want to really focus on doing things right and making things that are safe, effective, and work consistently, you feel like you're sacrificing a lot of speed.

We see that as it's kind of a false choice really. We don't think that needs to be that way. This idea of this agile work feels like it doesn't work in this space. That's often how people first approach it because the traditional ways to solve for building safe, effective, consistent products or high-quality products have always flowed a different way.

Personally at Qualio, we have a strong belief that's a false choice. You shouldn't need to choose one over the other. I think one of the things we've learned from the software world as you folks are like a software company, like a digital company. Actually, I think the speed of iteration is probably one of the highest correlating factors to the quality of the end result. 

We look at it a lot right now, how can we help companies like you move with unconstrained velocity? Because we know if we can help you do that in the right way, that helps you build the highest chance of a product that actually meets the success outcomes you're trying to design for, which will ultimately help the world in the way that you want to do. We see it as an and rather than an or. I think that's going to be one of the big transitions that companies like yourselves are probably writing the playbook for, right? The new playbook. 

Just like in the 1990s, software was built like waterfalls too with these life cycles. Now, companies are changing things three, four times a day depending on the mood and they're split testing things. I think that's a trend we're going to see accelerate here. That gets me excited.

Kristinn: Yeah, absolutely. As you said, the speed of things that there comes the need for discipline though because you need to respect the requirements and so on. But that's just a fundamental cultural thing within the company. We're not building the new Snapchat or something like that.

Robert: Exactly. You’re not moving fast and breaking things.

Kristinn: Yeah. It's not trial and error. It’s basically doing things in a considered way and they should go all right. I think it's obviously difficult, not to dish out to programmers, but they often like to run fast and then basically hit a wall and figure out how to go through the wall instead of actually perhaps considering building a door and going through that. That's discipline, again. 

I mean, we are very lucky to have great programmers who are really disciplined, even though they don't always like the rules that we put in front of them and the hoops they need to jump through for quality sake. But there are developments coming along the way, especially within Qualio. We've been testing out some new features that we're really excited about.

Robert: I’m glad you've had a chance to see that. In a few more months, we'll get your verdict. I’ll make sure to follow up. Thank you for sharing that.

Just in terms of time, I realize I feel like I could chat to you for a long time about some of these items, but I just want to make sure that I get you back to your day.

Kristinn: It's coming into six in the evening here in Iceland. My day is over once this is over so no worries.

Robert: Well, let me help you get back to your evening bit. I think as I follow on, we're still in the very early days. What does it mean to apply software to healthcare and in the life sciences industry? As that's being reimagined in certain ways and new use cases that are novel but also very valuable, what advice would you have for other people or teams who are a bit earlier than you folks and are trying to figure out how to build something special in what is a regulated space?

Kristinn: Basically, I don't have the secret recipe or the secret sauce for this, but I could perhaps help people by saying surround yourself with people who amplify your capabilities who are in some way better than you in some things, some aspects. If you do that enough, even though they are the complete opposite of you, they can help the team move forward. 

That's basically a vision that needs to be adhered to because if you surround yourself with people who are identical to you in the way of thinking and the way they see life, then you're only going to move towards people who are like you. The whole world is far from being like you. 

I could go really philosophical here. That's basically it. I mean, not to lock yourself into something and refuse to consider changing. Even though the whole world is telling you your first idea is not a great one or it's not working as you dreamed it would be, then be agile and be ready to move in a different direction if that works.

Robert: That's really helpful, Kristinn. Thank you for walking us through that. I really appreciate you taking time out of your evening to chat with me today and telling some of your story and the Sidekick Health story. I’ll be excited to watch all of your progress and looking forward to keeping in touch. If there's anything else to add, we'll get it added to the show notes. Thank you so much.

Kristinn: Likewise, it’s been great and I feel really lucky to have stumbled upon Qualio in my search for an eQMS.

Robert: I’m glad you did.