Bigfoot Biomedical, a diabetes technology company that makes “smart” insulin pen caps, is in the process of being acquired by longtime partner Abbott Laboratories.
The Milpitas, California-based startup designed its Bigfoot Unity system to pull information from Abbott’s Freestyle Libre CGMs, which can be used with physician input to recommend insulin doses for patients. One feature that sets the technology apart from other smart pens is that it can work with insulin made by the three major manufacturers, including basal insulin and rapid acting insulin.
The company was started in 2014 by Jeffrey Brewer, former CEO of diabetes research nonprofit JDRF, and entrepreneur Bryan Mazlish. In an interview with MedTech Dive, Brewer outlined his hopes for the Abbott acquisition and his long-term vision for diabetes technology.
This interview has been edited for length and clarity.
MEDTECH DIVE: How did you start Bigfoot?
BREWER: Bigfoot was founded by myself and my co-founder, Bryan Mazlish, who happen to be fathers of sons with Type 1 diabetes. Bryan also has a wife [with Type 1]. And we have some particular understanding of the challenges of living with this drug, insulin, that our kids are dependent upon.
It's a tricky drug to live with; it requires a lot of collection of information, things like glucose levels. It requires calculations, formulas, accounting of carbohydrate intake and making decisions essentially around the dosing of this drug, which if given in the wrong amount, can render you unconscious and in the hospital, and people die. If you don't take the right amount of it over time — too little of it — you have all these complications that are associated with Type 1 and Type 2 diabetes that diminish quality and length of life.
So we thought that there had to be some more patient-focused, simpler and more technology-driven approaches.
What thinking went into designing a product that can work with different types and different brands of insulin?
It specifically solves a big problem. Because insurance companies now determine what brand of insulin you're going to be on.
It's not the doctor, unfortunately, or the patient anymore who decides what brand they're going to use. It's the payer. So what happens is payers negotiate deals with the pharma companies that make these insulins, and then they get a better deal with one than the other and they tell all their patients to switch. So a third of patients every year have to switch from one brand of insulin to another.
It creates a big problem for doctors: They have to write new prescriptions. If you only have technologies that work with one brand of insulin, then you have to throw them away.
Supporting all these different types of insulin was absolutely essential — although it's hard because they’re each different pens; they have different shapes, different sizes, and we had to go out and partner with each of the insulin companies to support their individual insulin pens. But it's worth it because it makes a much more usable product.
How did you decide now was a good time to be acquired by Abbott?
It's time to take the solution that we have demonstrated works really well and get it to more people than we could as a small company. The constraints of our ability to finance and to be able to operationally support putting this in the hands of hundreds of thousands or millions of people, that's what Abbott knows how to do. So we're at that inflection point where we need that kind of weight in order to really drive it to benefit all the people who should have it.
You received FDA clearance for your smart pen cap system, Bigfoot Unity, back in 2021. How has uptake been since then?
We did a limited launch back in the second half of 2021 that allowed us to go out and get hundreds of patients and collect a ton of real-world data. So the first step of the journey was to get hundreds of patients using it — mostly people with Type 2 diabetes — and to see how they're doing. And we've recently published data that shows some amazing drops in A1c.
We can see this impact of people taking insulin more often and in more therapeutic doses. Before that, nobody ever had this insulin injection data. Doctors today don't know whether the shot is being given, let alone in what amount.
This is a really powerful opportunity to demonstrate how well this works in a population that many people have frankly written off and said they’re too old or they can't use technology or it's not cost effective enough. We've proved all that wrong with the data that we've generated. And now we're ready to take it to a broader population. And this is what we're going to do with Abbott.
There’s been some recent discussion around the use of insulin pumps for automated insulin delivery systems. Why did you choose to focus on insulin pens?
Pens and pumps are both required to solve the problem, which is to treat a large heterogeneous population of people with Type 1 and Type 2 diabetes. Pumps are great, moreso for Type 1 diabetes, given some of the challenges around using them, supporting them from a clinician standpoint and the insurance required to pay for them.
The fact is that over 90% of people who are dependent upon insulin to live on a daily basis, they inject that insulin. Pumps are growing, but today, still, it's about 35% of people with Type 1 diabetes, and about 5% of people with Type 2 diabetes.
That means that there are millions of people who are on shots, and they're just not doing well. What we're doing is, without them having to change the fundamental way they take insulin, we're giving [them] the final piece of the puzzle that helps them to be successful.
Our solution is less complicated, much less costly, and it is something that a larger population of clinicians and doctors will be able to use, so it complements the pumps.
How far has diabetes technology come since you started Bigfoot?
I think it's come a tremendous way. There are closed-loop systems now, and they work; my son wears one. And yet, there's so much more we could do, because today's systems are still too complicated, and they require too many different pieces.
So for instance, the closed-loop system today, the Omnipod — it’s a great product, but the pump comes from Insulet and the sensor comes from Dexcom. You’ve got to order it from two different places. They're supported by two different places, two different apps on your phone, and the Dexcom sensor doesn't come with the Omnipod when you first get it delivered. So the lack of integration is a complexity and a challenge to effective use. I think you're going to see things [get] more integrated.
All this stuff needs to be more gracefully integrated and presented as a single solution, not as a bunch of pieces that you have to put together.
What else do you want to see from diabetes tech?
Just the recognition of diversity in terms of needs. Some people just want something simple and it works. Other people want something entirely configurable, and one is not better than the other. They're both needed.
Another thing is, when these tools don't work, there's a lot of tendency to blame patients, then blame doctors, and say, “Well, the doctor is not supporting the person or the person isn't committed to their own health.”
We at Bigfoot took the exact opposite perspective from the beginning, as people who came from the patient experience. We put the blame on ourselves. If a person's not using it properly, then it must be too complicated. It must not be as usable as it could be.
I think that what needs to be brought more to the medical device and diabetes [space] is the respect for the patients and understanding that they do want to be successful and that we just need to try harder to help them.