We recently caught up with Sean Saint, the CEO of Companion Medical, which sold to Medtronic in August of 2020. Sean has more than 20 years of engineering experience in medical devices and various start-ups. He’s also living with Type 1 diabetes and is well-known within the diabetes community.
Prior to starting Companion, Sean worked as Director of Advanced Technology and Mechanical Engineering at Tandem Diabetes Care, Co-Founder and Vice President of R&D at Alure Medical, Engineering Manager at Dexcom, and Senior Engineer at Medtronic/AVE. He has 175 issued and pending patent applications.
Sean holds a Bachelor of Science in Mechanical Engineering with a minor in Computer Science from California Polytechnic State University, San Luis Obispo, and is a registered Professional Engineer in the state of California.
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Sean, please tell us a little about your personal background as well as Companion Medical.
I am a mechanical engineer by training. I ended up in the medical device space, and then the diabetes arena, almost by accident. After 10 years of designing continuous glucose monitors (CGMs) with Dexcom and insulin pumps with Tandem Diabetes Care, I was diagnosed with Type 1 diabetes myself. That diagnosis caused me to think differently. Instead of being frustrated that more people weren’t using the great technology that is designed into insulin pumps, I tried to understand why.
How did you come up with the idea for the Companion Medical InPen?
Since most people were using insulin pens and not insulin pumps, instead of asking, “How do we make insulin pumps better?”, I asked, “How do we combine the benefits of insulin pumps in the form factor of a pen?” I'm not the first guy to think about smart pens, but that is what led me in that direction. From there, I realized there wasn’t a solution like I envisioned. But there definitely should be. So we set about designing a bluetooth insulin pen that transmits doses and other info to your phone where an app could provide many of the features of an insulin pump that are so important.
Sean, can you take us through the process of designing, prototyping, and manufacturing the alpha and beta versions of the InPen?
The early versions of the pen were terrible, and I’m glad. We moved very fast. We prototyped, we changed, we evolved, we redesigned. Most importantly, we learned. We knew that what we were making was never going to see the light of day in its current form, and that’s okay. We gave ourselves the ability to be wrong. In fact, we expected it. We didn’t even have a manufacturing line -- why bother if everything was going to change anyway? But, these early versions were “good enough” for us to realize we were onto something -- that people wanted it and we needed to raise the money to go build it the right way.
How did you go about navigating the regulatory environment? In other words, what key regulatory challenges did you have to solve for?
We always knew that the pen would require FDA clearance. We all have medical device backgrounds, so we respected what that meant, and what it required. Sometimes, start-ups in Silicon Valley do things better and/or faster, but in the medical device space, I think it’s important to respect the regulatory environment we live in. Our Head of Regulatory was employee number 4 or 5 and was pivotal to our success. It helped that the team had experience in diabetes, pumps, active implantables, etc.
Sean, can you tell us more about your approach to clinical evidence for the InPen.
We didn’t need traditional clinical studies, but we did need human factors studies. In regards to that, we had to learn. The first thing we picked up on is that engineers don’t always make a user interface that everybody likes. We learned that by doing formative human factors testing early and by making the designers do the testing themselves. It is very hard to support a design after you watch somebody struggle to use it. So design, test, iterate, rinse and repeat until it works. But do it fast!
In terms of raising money for Companion Medical, what is the most important piece of advice you’d give to other medtech or healthcare entrepreneurs?
Raising money is, without question, the hardest thing you need to do. Investors are skeptics, as they should be. And, as an innovator, you are fundamentally trying to do something new -- something that most people disagree with -- or at a minimum, haven't thought of. So my advice is never stop talking -- talk to everyone, all the time. And never, ever get discouraged. It only takes one investor and it's your job to find them, and convince them. That is the job -- embrace it. And one more thing -- accept the fact that investors may get a better deal than you might otherwise expect. If you don't like it, find a better investor. If you can't accept that it's the best deal YOU were able to find, it's not their fault. They enable everything you do -- respect them for that.
When it comes to insurance coverage and reimbursement , Sean, was your strategy with the InPen?
We did a lot of work prior to launch ensuring that the larger insurance companies were aware of us. Lots of miles in planes. And partially because of that, we launched with pretty good coverage. But we learned pretty quickly that isn’t enough. Most of our customers were getting charged reasonable amounts, but some didn’t have any coverage at all. The issue this caused is that the doctors who are understandably skeptical of new technologies would be afraid to write prescriptions for the InPen because they didn’t want upset patients. We decided that nobody should ever experience a high cost for the device and we made it our problem to either have good coverage or cover it ourselves. This was key to our early success because we were able to tell the doctors, “Don’t worry, your patient will never have to pay more than $35 per year for the device.” And that really removed a lot of fear.
In terms of commercialization, what worked for acquiring and retaining your first customers?
The beauty of the InPen system is that when you see it, you understand it. Maybe it’s not what you would have expected when someone said “smart pen”, but most of our customers intuitively understood it. In that regard, to the right person, it sells itself. So, we followed a two-pronged approach early, and still follow it today. We relied on the traditional path of direct to healthcare provider sales, but in addition, we did some direct to consumer outreach and it worked amazingly well. Of course, early on, we still had a lot to learn in terms of making a system that people want to stick with.
How did the acquisition by Medtronic come about and what are you most excited about over the next few years?
Medtronic and Companion Medical have been very aware of each other for years. They have always been interested and supportive. Medtronic has consistently been very innovative, having created the first CGM, the first pump, the first sensor-augmented pump, low-glucose suspend pump, and now a fully control-to-target system. They were able to see our vision. Once we had commercial traction, we all felt it was time to combine the two most important categories of insulin delivery into one insulin delivery company rather than a pump or pen company. Medtronic brings some technologies that we find very interesting -- and certainly -- an amazing commercial team both domestically as well as globally. Together, I think we will have the world’s most widely used methods of insulin delivery.
Sean, where can readers or listeners go to learn more about you and Companion Medical?
Our website -- CompanionMedical.com -- is certainly the best place to learn about the product. You can also find some of our early-stage presentations on the internet. They seem like so long ago, but they really aren’t. The fact of the matter is, companies can grow up quickly and we certainly did.
Let’s transition to some fun and personal questions, Sean. What is the most important piece of advice you’d give to someone that is starting their entrepreneurial journey in the medtech or healthcare arenas?
I almost want to say don’t do it. But really, if you have a truly good idea, it probably means you are one of the very few people doing it. Of course, that happens with dumb ideas, too. It’s your job to convince the world you are right. Never stop talking! Talk to everyone, every chance you get. Make it real! By sheer force of will if you have to.
What influential books, podcasts, or resources have been most helpful in your entrepreneurial adventures?
I love the typical entrepreneurial books. Lean Startup, Zero to One, Innovator’s Dilemma, all of them. But they are not lessons on what to do, they are just stories -- some to be copied, some to be avoided. It depends on your particular situation. I also really love the, “How I Built This” podcast.
Sean, what business leader(s) are you closely following right now?
There are a bunch, but near and dear to my own life right now is Sean Salmon, the new President of Medtronic Diabetes. I expect Medtronic Diabetes to really thrive under his leadership and I’m excited to be a part of that. The other fun one is Elon Musk, but like the entrepreneurship books, there are plenty of lessons to emulate, and some to avoid at all costs. It’s your job to figure out which is which.
If you could put a billboard anywhere, what would it say and where would you put it?
Wow, no idea. But I would say that if you can look at things from other peoples’ perspective, the whole world seems to make a lot more sense. Maybe something like this: “Remember to ask why they think that.”
If you had to teach a class on one thing, what would the topic be?
The easy answer is something around the topic of entrepreneurship, but I don’t think that’s right. There is something about a good entrepreneur -- they learn, but they can’t be taught. Something like that. Those people scare me!
Sean, starting over in your early- to mid-20’s, knowing everything you know now, what would you do differently?
I would find my self-confidence. It impacts everything you do in life, or more importantly, what you don’t do. Don’t confuse this with egomania. Always remember you can be wrong, but don’t let that stop you from trying.