In the news recently is how Tandem Diabetes Care’s longtime CEO Kim Blickenstaff is stepping down, transitioning to a newly created executive chairman role on the company’s governing board. (Former COO John Sheridan will take over as the new chief exec.)

Don't forget, in the past year, San Diego-based Tandem has come back from the brink in a way that investors have described as a "miracle recovery" unseen in the med tech space. Under Blickenstaff's leadership, they made this turnaround after Tandem came dangerously close to joining the ranks of pump companies that have gone under in the past decade -- within 60 days of that actually happening, he says!

We were privileged to talk with Blickenstaff recently about his experience establishing Tandem, eventually launching the first touchscreen insulin pump in 2012, to where we are today -- with the company's groundbreaking closed loop technology now on the verge of leading the industry (as the only currently available system that works directly with Dexcom CGM tech).

Don't miss our interview with Mr. Blickenstaff:

 

An Interview Tandem's First CEO Kim Blickenstaff

DM) With Tandem on its feet again, can you start by telling us why you’re making this change now?

It’s a two-part answer. First, it’s just good corporate governance. I turned 65 a couple years ago and that’s usually a trigger point. The Board and I have been talking about this for some years, and John (Sheridan) is just a great leader at med tech companies. I’ve known him for 23 years and we got him on board here five years ago. It just seemed like the natural time. John led our annual Analyst Day (in 2018) and after our recovery, all these investors came up to me and said, “Are you retiring and is he your successor?” So it was a natural transition and... part of a good succession plan, so we don’t run into a 'Steve Jobs' problem here at Tandem… We expect to have a long run.

You’ve been leading the company since its founding in 2006. Can you tell us about those early days of passion to design a "next-generation" insulin pump?

I had been involved in diabetes a bit, on alternate site therapy that didn’t really work out and also with Dexcom, recruited by Dexcom founder John Burd as the first independent board member. So I had some diabetes experience on the CGM side and it felt like a puzzle with complexities that I just wanted to figure outs. I got totally immersed and addicted to this puzzle, especially with Dick Allen’s (philanthropist behind the Diabetes Center at Hoag Hospital in Newport Beach) passion from his granddaughter... wanting to see more innovative technology in insulin pumping. I had never met a type 1 in my life, before I got involved in this.

The initial idea was percolating, and then Amy (Tenderich, DiabetesMine Founder & Editor) wrote her Open Letter to Steve Jobs about better design of diabetes devices. It intersected with what we were hearing from focus groups with patients and healthcare professionals, and so I reached out to Amy at the time – she said simply, “make it a simple touchscreen and easy to use.” That kind of stuck and it became our mantra, before the world of apps and the iPhone evolution that we’ve seen over the years.

Our theory was that if we could design an intuitive interface, that you could sit and learn without a manual, we might be able to get patients to actually use advanced features more regularly and get better outcomes. That’s what we found. We did 2,000+ interviews and testing rounds to design the original t:slim interface, which is the heart and soul of what we’re about and what works. We knew we could expand the market and improve health as we moved toward simplicity and ease-of-use. Those were the learnings of the early years. From there, we’ve moved into a different market in today’s age of apps and how fewer pumps exist. Quite a bit has changed since those early years.

Tandem almost went bankrupt a few years ago, looking like it would go the way of failed insulin pump companies Deltec Cozmo, Asante Snap, and JnJ’s Animas...

Yes, we did. If you look at that 2007-08-09 timeframe, healthcare providers would say that lack of control led to insulin pump treatment and they’d pull all these different pumps out of a drawer and say, “You choose.” We’ve gone from that environment to where now you just pull us and Medtronic out, in the traditional durable tubed pump space. There is duopoly. You do have Insulet’s OmniPod (tubeless patch pump) off to the side, but the point is it used to be a very cluttered market and it was tough to get market share and be profitable. Those companies exiting the market donated profit share for us, and that helped us lift us into profitability along with our innovations.

What was the turning point that put Tandem in danger?

A lot of it was timing. There was a United Healthcare decision on Medtronic being a preferred brand in 2016, and the Medtronic 670G got approved in Fall that year, which the FDA called an “Artificial Pancreas,” and Medtronic had clinical trial data that really looked compelling. I had numbers going into that fourth quarter (of 2016) that showed our prospects were trending up, but the market was in throes and all the talk was about Dexcom G5 integration that we just weren’t approved for yet.

Just how close were we to losing Tandem as a pump choice?

Very close. It was absolutely a reality and we were within a couple months of demise. We were within probably 60 days of default... it was perilous. I’ve had investors, young and old, say they’ve never seen anything like this in their careers. Those who had the courage to invest have a career-creating event. It’s quite a story!

What changed?

With 2017 and all the supply and manufacturing issues (for Medtronic’s 670G), the hurricanes, and when the 670G finally got to the marketplace, many felt hoodwinked and that began showing. Many were married into four-year hardware cycles and wanted out of it. I think that was a turning point for us. With our financial strength, Medtronic couldn’t keep telling people we were going out of business.

That was a turning point, and I think it happened mid-way into 2017 when widespread use of the Minimed 670G got out onto the Internet and other pumps were going away (Roche and Animas). There was a presentation at ATTD in Berlin recently where non-company sponsored investors tried to study the device and found with the user interface, only the very dedicated could use it effectively. When that starts coming up, they look at us and say “Wow, Tandem works!” And a big lift to us was the G5 integration that came in mid-2017, and we were able to use our remote updater tool with that. It was surprising to healthcare providers and gave them something they hadn’t experienced before… Because they didn’t have to send the pump back to the manufacturer to update.

How groundbreaking do you think it was to introduce remote updating for an insulin pump device?

Very much so. The whole world has turned for us. We have moved from just a first-generation device into this age of updatable med tech, very much like an iPhone where you can update software from home. Improvements to the software and to algorithms can be pushed out very quickly within a four-year warranty cycle and get innovation immediately on the market. We have gone from basic cell phones to the world of apps and beyond.

When you look at our business model, something that’s so hard to train on and remember how to fully use... and then you throw in the business model with people on phones and hardware replacement cycles, it's challenging. But if you use the iPhone model remotely, the training comes way down and the innovation is out very quick. The whole app concept has materialized that we were talking about in 2007, compared to having to upgrade devices to get to the next piece of hardware that can’t be updated without paying for.

Tandem also launched its first glucose prediction algorithm called Basal-IQ in mid-2018. How has that been received so far?

The early returns are phenomenal. No one really understood the extent to which hypoglycemia in the morning causes a loss of control all day long. You try to get glucose in as much as you can and try to get out of a Low because of all the symptoms, and as a result over-treat… it’s a roller coaster all day long for many people. Those have been some of our learnings so far. One of the other surprising learnings connected to that from Basal-IQ is that if you don’t go low, and don’t ingest all that glucose and then go high, you actually reduce the amount of insulin you use by about 20% and we see anecdotal weight loss – which makes sense. You’re essentially eating too much and taking too much insulin, and storing it and can’t lose weight and can’t get good control.

I’ve just looked at clinical trial data showing that Basal-IQ works as well as the Medtronic 670G, which modulates basal insulin up and down. You see the same Time in Range (TIR), the same High and Low percentages, so it’s comparable. That’s before we even get to our next-generation later this year. And now we have the iCGM designation and our ACE (iPump) designation with the t:slim X2, it’s an exciting time.

What can we expect from your next-gen automated insulin delivery system, Control-IQ?

You’re going to see more improvements, in TIR and fewer hyper and hypo amounts. It also does correction boluses with a bit of manual entry, so it’ll correct high glucose levels with that. We’ll leapfrog the 670G because there are no fingerstick calibrations required with the Dexcom G6. There’s bolus modulation, and improved Time in Range.

Just a few days ago, there was news of a blip in a clinical trial relating to Tandem's remote update feature. What happened there?

We had used our remote updating feature once with Basal-IQ and we’ve now done it with this trial for Control-IQ. The FDA’s been very welcoming about making any needed in-trial improvements to the algorithm. Everything’s been validated through the rules and regs, of course. This wasn’t a serious issue with the software, but if it had been, this (remote update capability) would have prevented the clinical trial from being halted and re-started at a later date. So it was a minor issue, but a major breakthrough because you don’t have these clinical trials stopped and needing to be re-enrolled all over again.

Can you share what’s in Tandem’s pipeline after this next Control-IQ feature?

That algorithm was locked and loaded from the earlier research and tech developed by TypeZero Technologies (now owned by Dexcom). So we didn’t change it. There’s logic in there that limit us and were built into the algorithm. Going forward, we can make some of those changes and make them more dynamic. The concept is to take that bolus-correction concept and eliminate patient input. We can correct to a certain amount now, but if you make that bolus a total correction, you can control the flow more. It’s like cruise-control where you need a little of oomph or lot of oomph to stay at 50 mph. That’s the next series of goals, though we haven’t said specifically how we’re going to do it. But we want to take the patient out of the loop and close this loop.

What do you think the future of diabetes technology looks like?

I believe in the next three to four years we’re breathing down the neck of total system, closed loop control without patient input. I believe when we get to the Tandem t:sport product (see our DiabetesMine coverage here), you can put the whole thing in your pocket while it communicates with the CGM and continues to run with you only glancing at the smartphone or watch to display the data and control interface. It’ll be like looking at the dashboard in your car, where you look at the speed but we have lane correction and distance adjustments being built in. That’s where we are going. Taking the patient responsibility and burden in dosing and thinking about this out of the equation. That’ll be increasing over the next few years. 

So the future of Tandem looks bright... and you’re excited to continue serving on the board, we'd imagine?

Yes, the whole goal was to have a management team in place to take this thing as big as Dexcom’s CGM. I think we’re comparable. That’s where I believe we are going, and we need a team to manage going to that kind of scale. We definitely have it and don’t have to go outside for it.

 

Thank you Kim, for not giving up on Tandem, and for all your contributions!