Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin delivery system since its beginnings in 2014. Just yesterday Bigfoot announced that it is partnering with Abbott, bringing together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin delivery platform. Medical Design & Outsourcing managing editor, Chris Newmarker, spoke with the company’s co-founder & CEO, Jeffrey Brewer, about its efforts to bring a secure, connected device to market.
Newmarker: Where are things right now with Bigfoot’s smart loop system?
Brewer: We are about three years into the journey with Bigfoot Biomedical. We have developed an automated insulin delivery system that we believe is the first class three medical device drug delivery system [for insulin]. It is a true internet-of-things secure device that uses a smartphone as an interface to the system, where you can announce a delivery of insulin from the phone and that phone is connected to the cloud. We created an entire system to simplify insulin administration, to make it as safe and as supported by data science as possible. And to make life easier, for people with Type I diabetes.
We’re going to a pivotal trial, later this year. That will be the final step of our clinical journey, prior to testing and an ambulatory real-world setting at home, for a few hundred people with Type I Diabetes. Then we’ll be onto a PMA with the FDA for the permission to market our system to the public. We’re very excited.
Newmarker: How did your initial trial go last year?
Brewer: That went very well. It was an inpatient trial to test the algorithm for automated insulin delivery. It was the first step in the articulated guidance for the clinical path via these systems. We are successfully through that step.
The first trial is designed to be a series of challenges that try and, for lack of a better word, trick the algorithm. You give it bad information. You have too much insulin, too little insulin, and then the system has to adapt and keep the person safe and ours successfully did so in ten adults adults and in ten children.
Newmarker: Are you expecting that if this does become commercial, it will be totally automated or will patients still have to make entries sometimes?
Brewer: It’s not possible to totally automate this disease. But what you can do, is you can have a feedback loop that is working in real time. If you make a mistake, or if your body isn’t consistent from day to day, then the system’s constantly tuning the amount of insulin you’re getting, and trying to keep you in a safe range. It still does need to get some information from you. For instance, when a person eats a meal, this is one of the things that today is so burdensome about Type I Diabetes. You have to be precise in terms of counting the carbohydrate intake, and then turning that into a corresponding amount of insulin, to cover the meal. The system helps you with that, because it allows you to be less precise. You literally are picking small, medium, and large meals to correspond with a certain amount of insulin, that then will be delivered in a smart way over time, to address the meal but also to keep you at a stable glucose range.
Our system is a partner to the person with this chronic disease. It doesn’t replace all the responsibilities of life with it, but it does the math for you.
Newmarker: Medtronic already has its MiniMed 670G out on the market. How is what you’re doing going to be better than what they’re doing?
Brewer: We’re taking technologies and we’re using them to provide a more consumer-focused experience. The person who lives with this disease is not the doctor, but rather an average person, who doesn’t necessarily read manuals, doesn’t follow all of the doctor’s instructions. This is a real person of varying education levels, income, access to healthcare, access to insurance.
The goal for us is to make it as simple as it possibly can be. To distribute a system broadly across the population of the users who are not the hyper-engaged, affluent, and supported by the world’s best doctors. Those are the only places that the 670G is being prescribed today. In fact, we’re going for a much broader market, which requires that you need to design the system from the standpoint of the consumer.
Brewer: We need things that are easier to train, that don’t have as many switches and knobs, bells and whistles. The existing systems were designed for clinicians.
Newmarker: You’ve mentioned that your 22 year old son, Sean, has Type I diabetes. How many people at Bigfoot Biomedical have diabetes?
Brewer: About 40% of the people at this company of 50 people have a direct connection to Type I Diabetes. About a dozen of them have Type I themselves. This is a company that is very much in touch with the problem we’re solving. Many of us from a deeply personal perspective. I began this journey 15 years ago, because I thought that the technology being used to deliver insulin was completely inadequate.
Brewer: I took another path starting in 2002 when my son was diagnosed, working with non-profits and starting a project at the Juvenile Diabetes Research Foundation to raise money over the last 10 years before founding Bigfoot.
We directly partnered with Medtronic, B. Deedy and Roche, J&J Animas, to the tune of about $35 million in total to try and subsidize their development efforts. I gave up in 2014 working with these medical device companies because I realized they don’t know anything about some of the key aspects of the technology. Namely, integration with a smartphone. And if it wasn’t clear enough based on all the other things we can use in our lives today that make ourselves so efficient, productive, and safe, my co-founder Bryan Mazlish actually hacked into a Medtronic pump and he created the first inroad toward a real-world automated insulin delivery system.
Brewer: It is hard to make simple product. The iPhone is an amazingly simple product. You can pick it up and figure out how to make a phone call pretty quickly. And that took a lot of work. That’s not the way medical devices has historically been done. We took the opportunity to go back to the beginning, examine first principles, and develop a system that is very consumer-focused.
I’m selling an experience that delivers a value proposition of helping a person live with a chronic disease.
Newmarker: How much do you think you’ll be charging per month for the company’s services?
Brewer: If you were to pickup a Medtronics 670G, the sensors, the infusion sets, and the blood glucose meter which is required to use it, the test strips, all that together, you’re talking about $1,200 a month. We’re gonna to it for less than $1,000 a month, and we’re gonna go at risk for doing that, and actually deriving healthcare outcomes that are very motivating to payers.
So, we believe we’re going to be cheaper.
Newmarker: What do you mean by a connected, secure device?
Brewer: No other insulin pumps, and certainly not the 670G, even talks to a phone in real-time. My son once gave himself an accidental overdose of insulin, which the pump was not smart enough to question before it let him do it. The pump and the CGM knew that he was dying, because below a certain threshold of blood glucose a person’s life is at risk, and couldn’t tell anybody, even though we were down the hall. Because these systems don’t talk to anything.
Our system is always online. If for some reason you are in a situation where you are unsafe, it can reach out for help. It would have been very easy to wake us up down the hall, to administer some orange juice, which would have prevented a catastrophic trip to the hospital.
Newmarker: So the flip side, because insulin is so dangerous, how do you make sure that the device is secured if it’s so connected?
Brewer: We have developed a secure paradigm for doing just that.
The systems that exist are not secure. We wanted to go back and develop a secure, authenticatable, cloud-connected system. Things like over the air firmware upgrade are essential to have a secure system, because security is not static. If you try to hack into it long enough, and you’re smart enough, someone will. But, our system is designed so that I can press one button, once the FDA gives permission, and I can propagate an update to the firmware of the insulin pump, every one of which is connected to the network. I can do that overnight.
Newmarker: How are you persuading the FDA that this is safe?
Brewer: We have a hazard analysis of 10,000 different things that could go wrong. Some of them are failures of components, some of them are mistakes users make, some of them are malicious activities that somebody might undertake like a hacker. We have to have a plan for every one of those in the technology, in the design. And the FDA reviews those plans, and if they see the mitigations, then they approve the product.
The FDA just want to make sure it’s done right. The reason nobody else has done it, is because the competencies and understanding of the technologies, don’t exist at these other medical device companies. We’re a unique animal here in Silicon Valley, that we have medical device side, but we also have the advanced cyber-security side.
Newmarker: What kind of security have you guys designed into your system?
Brewer: It is an entire system design that anticipates all the different use cases. In order to do what we’re doing, you have to have a whole bunch of things together. You have to issue a CryptoKey with the insulin pump at the time of manufacture. I need to track that in the cloud and correlate that with a customer name. That CryptoKey is stored on a CryptoChip, which authenticates for firmware downloads.
The first time an app is downloaded and tries to connect and pair with that pump, it checks with the cloud. And there’s a cloud-based authentication system, that knows the name of the one customer in the world that’s supposed to be talking to that insulin pump. We authenticate a connection that goes from the cloud, down to the thin client on the phone, and to the insulin pump itself, and create an unbreakable bond, such as that is the only phone in the world that can talk to and give any command, to that insulin delivery system.
Also, I’ll add, the parent of a child can see that their child is safe in real time at school, intead of being completely blinded from that information. Then we can reach out to healthcare resources if a person ever finds themselves in trouble because they accidentally gave themselves too much insulin.
The FDA understands this is a dangerous disease. Security is about creating a defensible barrier to somebody doing something that would result in patient harm.
None of us can guarantee absolutely, that nothing bad will happen. Once you reach a security threshold that’s defensible, you’re able to do a lot of good with these connected features. And that’s the purpose of connecting things. It’s not just to say that it’s an internet-of-things device, but to rather say that now you are safer from a disease which puts you at great risk.
Newmarker: Any plans to bring the Apple Watch into the loop? I know that there have been reports that Apple is looking at doing glucose monitoring.
Brewer: There’s glucose monitoring and then there’s glucose monitoring. Glucose monitoring for delivering insulin requires a level of accuracy and reliability that non-invasive is not going to support for a while. But, if they prove me wrong and get that approved as an insulin-dosing application, then I’d be happy to use it.
The system we’ve built is a modular architecture. We’re an integrator as much as a hardware company. We do have an insulin pump, and it does have to have certain characteristics to support the security and processing, and the connectivity to the other components, but at the end of the day what we’re really doing is taking existing technologies, ones that are proved to work and be robust, and integrating them into a package which is much more usable.
Newmarker: Why haven’t the big companies like Medtronic caught on to what you guys are doing?
Brewer: Because they don’t have to, that’s why. They make money on the existing model. No one ever got promoted for turning an existing business upside down, in order to position a company for the future, if that was gonna hurt the bottom line in the next 90 days, 180 days, if there’s not competition forcing you to do so.
Newmarker: How does your company navigate the challenges of reimbursement?
Brewer: I recognize that the payer is the customer, in a very fundamental way. We’re building a system to appeal to them by solving the problems that they tell us they have. They don’t want to pay up front a $9,000 fee for an insulin pump that they have to amortize over four years. They hate that because people go to another plan, on average, every two years. They’re sick of being nickel and dimed on all the consumables that need to be used. The infusion sets, and reservoirs, and the actual sensors and transmitters, the blood glucose test strips, and lancets. All that stuff that requires ten prescriptions from the doctor, and then ends up, a lot of it being thrown out. I know this for a fact, because we threw a bunch of it out. The burden is on the patient and the doctor to manage all that complexity, and the insurance company actually gets stuck with the bill, for waste, and for devices that may not even be used.
We’re solving that problem by saying, here’s a fixed price. It’s only gonna be a monthly fee. So as soon as that person is not seeing value in it, or their payer is not, or the doctor is not, you don’t have to pay anymore. And then, more importantly, I’m actually gonna take a portion of my monthly fee, and I’m gonna go at risk, based on some outcomes that you and I as a payer agree upon. Things like, number of hypoglycemic episodes, even the actual cost of those episodes at the hospital.
And you’re paying that monthly fee to one accountable party. Not to 10 different companies that are all providing parts of the solution. One the pump, one the sensor, one the blood glucose monitor, one the infusion sets, one the reservoirs. All this stuff today, they have so much complexity, and nobody’s accountable for the cost of the patient.
We’re not at the government payers yet, but [we are at] the private payers.
One of the challenges with medical devices is that a lot of companies seem to fall in love with a particular technology. They see if they can get it approved. And then only at that point, do they ask who is gonna buy it. Who’s gonna pay for it, and why would they? Baked into the very beginning of this company was, what makes this a big business, so that we can actually pay for those R&D efforts that are gonna deliver this amazing product that’s going to iterate very quickly. How can we make this more like a competitive consumer device business, than a traditional medical device business? And the key to that is, you have to have the goods when it comes to the payer. And, that’s all about costs that are measurable, and can be delivered over a two to three year timeframe.