Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider and Partnership Lead at Touch Surgery. We hope you enjoy them.
When most people think of the wearable space, devices like the Fitbit or the Apple Watch come to mind. But over the past few years, there’s been a lot of development with respect to wearable devices that were designed for the traditional healthcare market.
Medtronic launched the SEEQ device. Although implantable, St. Jude commercialized the CardioMEMS device. And startups like AliveCor and AUM Cardiovascular have developed some innovative monitoring devices as well.
But there’s some major differences between consumer wearables (like the Fitbit) and wearable devices that are designed for remote monitoring within the traditional healthcare setting. In order to get a better picture of this market, I recently interviewed Darrel Drinan, one of the prominent thought leaders within the wearable (remote monitoring) arena.
In this interview with Darrel Drinan, we cover his broad experience developing novel monitoring devices and what he’s learned along the way through deals with DARPA, Medtronic, and his new startup, BioRibbon Health.
The following conversation is based on an audio interview with Scott Nelson and Darrel Drinan. Scott is the Founder of Medsider and leads partnerships at Touch Surgery.
Scott Nelson: Let’s start with Corventis because it was affiliated with your accelerator, PhiloMetron. That was your first spin-out back in 2005, right?
Darrel Drinan: That’s correct. The origins of the research behind Corventis started back when we created PhiloMetron in 2001. DARPA funded us to develop patches for soldiers to monitor various physiological parameters and we were successful in doing that through 2003. We then started to focus on how we would commercialize it to the military and realized that was a significant challenge, so we looked at the healthcare applications and found the cardiovascular region market specifically to be the one that was going to be most receptive to the platform. And we met with Caufield and Byers first and they wanted to do a deal with Kleiner Perkins. So we all got together and decided to create a spinout because at the time we had a bunch of different research projects in various categories and Kleiner and Perkins only wanted to focus on this cardiovascular application. So we created a company called Amigo Therapy, which was the first name, the undercover name, for Corventis, and closed the deal with those two groups in November of 2005.
Scott Nelson: And that’s what became Corventis, as we knew it, before the Medtronic acquisition.
Darrel Drinan: That is correct.
Scott Nelson: Corventis was acquired by Medtronic in 2014 for a reported 150 million. When you think about that acquisition, especially considering how well Medtronic is doing with the two devices (SEEQ and LINQ), how does that make you feel?
Darrel Drinan: Well, of course you’re always proud to be involved with a success, but as the old saying goes. successes have many parents and the failures are orphans. So we’re one of the many parents that created the Corventis spot but we weren’t the only group. There’s a great group of guys there in Minneapolis as well as in San Jose that did some of the heavy lifting on the application that ultimately led to Medtronic acquiring the company.
Scott Nelson: Before we go back to the pre-2005 era with Corventis and how that technology came to fruition, let’s talk about wearables in general because it’s certainly a hot space. Seems to be, if you keep up with the healthcare scene or medtech in general, there’s lots of investment, a lot of M&A activity. Even consumer brands like Apple and Under Armour are making significant investments in wearables. I think Fitbit’s IPO was last year in 2015, if my memory serves me right. So when you think about wearables, is the interest level justified?
Darrel Drinan: Well, I think that a broad way to look at that is in the healthcare space, wearables are yet to emerge other than a couple of small applications such as diabetes and cardiovascular ECG monitoring. In the consumer side of the business, it’s a different approach, whereas life sciences typically have a very narrow vertical focus on an application. In the consumer side of the system like Fitbit, for example, or Jawbone, etc., they’re trying to reach a large, large audience and there’s very few applications that meet that size of an audience. And so they’ve started with fitness, and as we all see now that there are some challenges to that focus in terms of clinical efficacy, the relevance to using something, and then of course the device itself. The wristband devices are going to have some challenges picking up clinically-relevant parameters. So I think all of those will be constraints on the consumer side of the market.
I don’t believe the technology guys really understand healthcare, so they stuck with things that they do understand and fitness is one of them. So if you look at it in that context, I think there’s challenges in that market in terms of future growth opportunities, incremental value, price point, etc. Whereas in the healthcare market, it’s very clear there are needs. There are very clear opportunities, as I mentioned. When we look at the continuous glucose-sensing capabilities and mobile cardiac telemetry, like Corventis, are two of the early vertical applications and have very high value to not only the patient, but to the payer and the provider as well. So if you look at it in the context, the margins are obviously going to be higher in the healthcare side of the market.
Scott Nelson: And when you think about the healthcare side of the market versus the consumer play, are there other areas that you think wearables will make a lot of sense or will make a big impact?
Darrel Drinan: Again, I think we should try to keep wearables in those two categories. If you start to get into this middle category (or gray area), you know some people have talked about wearables for wellness or population health programs, you have to ask yourself, is the data clinically relevant and is it actionable? So on the fitness side, it’s self-actionable; you could do it yourself. Whereas in the healthcare side, you typically need a clinician of some sort to help you understand the value and begin monitoring it.
Darrel Drinan: I think an area that is severely underserved, but challenged in terms of a price point, is the weight loss category because weight loss or weight management is simply a behavioral issue. You need a diagnostic that tells you the problem. And for the most part, the problem is very simple in terms of eating too much or exercising too little. So if you are able to monitor those two parameters, you probably could then create some type of effective interventions or behavioral modifications. But the challenge to date has been on the calorie intake side, and that is the ability to determine how many calories a person has consumed. It is very difficult to do because of compliance and estimation errors as well as the variance in what we eat. The calorie expenditure side is very clear and there are devices, including wristbands, that will get you to a certain level of accuracy that’s more than adequate. There’s a group that attempted to do that with a wrist-based device telling you how many calories you burn, but I think from what we’re reading, it looks like the values they’re providing to their customers are suspect in terms of how they’re actually measuring it through a wrist-based device.
With our next spinout, we spent the last six years developing algorithms and technology, patch technology, to actually measure that particular parameter, or calorie intake, and we’ve gotten it to what we call a “two-Snickers-bar” error and that’s more than adequate in the market right now. That’s not a cumulative error. That’s just an error. So on day one, most people burn between 2000 and 3000 calories a day and as a result, none of us are rapidly expanding or rapidly contracting. So on day two then, if you’re looking at it as a trend over time, you’re at 2000 to 4000 calories and so on and so forth. So our error of a Snickers bar is well within the accuracy needs of the market to drive a behavioral change over a two- to three-month period. The whole premise of Weight Watchers is to count points that are assigned to a food group to give you the number of calories you consume. But if you take that responsibility away, just take that compliance component completely away, take the technique component completely away, and have the patient focus not on the counting of calories but on their behavior, suddenly you have a much more focused system and perhaps a far more effective system.
Scott Nelson: And that’s what you’re doing at BioRibbon Health today?
Darrel Drinan: At BioRibbon, we have 12 different families of parameters. It will be the most comprehensive monitoring platform in a single device out there today and it’ll be useful in both health and healthcare applications. So it could measure the usual suspects of heart rate, ECG,respiration, temperature, and motion. But on top of that, we can monitor your body fat, lean mass, hydration, net weight, emotional status, calorie expenditure, calorie intake, net calorie balance, etc. And it’s in a small chest-worn patch that uses Bluetooth to go through your phone into the cloud.
Scott Nelson: Very cool. Sounds incredibly promising. Before we dig into BioRibbon, let’s rewind the clock even further to earlier in your career. Because I would imagine there were some key lessons you learned throughout your experiences at Gillette ThermoScan as well as the programs you were involved with at UCSD.
Darrel Drinan: Yeah, I think there are some that stand out in my mind through all of these programs, whether it’s my Gillette Braun days or the work we did at UCSD. What I found consistently, and problematic, is that people were developing technology in absence of a focus on the problem, and that creates a number of problems as you move forward. So if you start with a clinical problem or a healthcare-related problem and understand it well and focus on that, your intellectual property portfolio is going to be far deeper because you’re going to identify not one, but many different potential solutions. Your IP is going to be broader and more robust. You’ll be able to capture a field of use that is meaningful to the market and you’ll be better able to understand all of the challenges that others have had.
So when we were at Gillette, we were studying this category of body composition very heavily and we developed a mindset of, “Don’t drink your own Kool-Aid.” That came from my design teams in San Diego and Germany. We started to do focus groups and the feedback we received was completely different from the device that we were developing. So I made my guys go to these focus groups and, for the most part, they were stunned because the market for those types of devices at the time was predominantly women who were making the purchase decisions. Within those focus groups, we were looking for specific feedback of why they would buy it and why they wouldn’t buy it. And to be candid, some of the design options that we had to implement weren’t even in the same universe. So drinking your own Kool-Aid is a huge problem. If you don’t talk to your customer, you very well could be developing your product for the wrong customer.
The other thing that we implemented at Gillette was a rule that if your end user had to do three things in a device, a diagnostic home-based device, your product would fail. Those 3 things were technique, compliance, and knowledge.
So let me give you an example of that. Let’s look at a blood pressure cuff. On a wrist-based cuff, if you don’t have your wrist above your heart, you can have 10 points of mercury or more of air injected into the value. So as a result, you’re not going to have an accurate device. That’s technique.
There’s a compliance component to that too. If I’m a patient, and I have to remember to do this at 8 o’clock every day or 5 p.m. every day, I have to be mindful of that in order to be compliant.
The third component that makes blood pressure possible is people understand what normal is…120/80. They don’t need to be taught this.
But a lot of these emerging categories don’t meet the rule of 3. For example, let’s look at the headband device called Zeo. When that came out, there was a compliance issue in that you had to put it on. There was a technique issue because if you didn’t put it on the right spot of your forehead, it wouldn’t work. And third, they created a brand new value called a ZQ score, which was related to the quality of your sleep. People didn’t understand what a normal value was. So as a result, the device failed. They weren’t able to penetrate the market because the device didn’t meet the rule of 3. And that’s a good example of how you can fail in the consumer side of the market.
However, with a prescriptive device, there’s a little bit more complication because you’re going to have somebody help you understand those values and guide you. And I think with the way that digital health is going now with these automated feedback loops, it’s becoming more and more possible to create values based off data that the patient may or may not understand.
Scott Nelson: That’s great stuff. I’m going to nickname that the “Drinan rule of 3”. In essence, what you’re saying is that you can’t ask the end user or the end customer to take three steps, especially if one of the steps forces them to learn something new altogether. But when looking at the three issues that you mentioned, can you get away with two? Or can you only really ask the end user to make one adjustment on their end?
Darrel Drinan:I think you can get away with only two of them. So how about standing on a bathroom scale? You understand what weight is, so there’s no education component. There is definitely a compliance component. And there is potentially a technique component because if you rock around on the scales or you don’t have the scale properly on the floor, that could influence the reading of the scale.
Scott Nelson: I can see your point about why it’s not as big of a deal in the traditional healthcare setting because there’s a provider involved to sort of coach that patient along. But it’s good advice for any product development team, even outside of consumer-based healthcare. Once you’re asking a patient to do all three steps, that may present quite a few challenges even with a provider or coach to help out.
Let’s go back to your comment about focus groups. You probably recall the famous Steve Jobs quote about focus groups. It was something along the lines of not relying on focused groups when designing products because people don’t always know what they want. So how do you go about balancing the feedback you get from focus groups in light of this fact?
Darrel Drinan: I think we should go back to the differences between a device for the consumer market vs. the healthcare market. If you have a Steve Jobs that wants to create a market for a new solution, how do you get people to use that? Well, you have to tell them what the problem is that you’re solving for them. You also have to make it appealing. So the cool factor is a way to market that. “I have to have that. It’s cool.” Clothing is a good example. Do I really need a new shirt with a new logo? Perhaps not. But if it’s part of the cool trend, then I think you can introduce it and solve a problem they didn’t know they had.
On the healthcare side, it’s a different animal. When you have diabetes, you have to solve it. Otherwise, you die. And so there is a clear difference on the healthcare side in that there is typically an urgent need. You’re bleeding, you have high blood pressure, your glucose is out of control, you’re obese, your hair is falling out, etc., etc. There are so many and they’re very concisely defined. That’s why the pharmaceutical side of the world is so narrowly focused on a drug where as medtech is narrowly focused on a problem. When you go to the consumer side of the market, you have to create the demand for some of those needs. And that’s very, very challenging to do. I mean, how long has it taken the Internet to become such an integral part of our life that we can’t live without it? 25 years and trillions of dollars?
Scott Nelson: As we close out this interview, let’s focus on Corventis vs. BioRibbon. At Corventis, it seemed like you really honed in on cardiac monitoring. But with BioRibbon it seems like you’re expounding a lot further in terms of what you’re monitoring. So what did you learn at Corventis that you’re now applying to BioRibbon.
Darrel Drinan: Remember, when we started to commercialize the underlying technologies for Corventis in 2004, there was no iPhone. There was no iOS. There was no Android. The “cloud” wasn’t there. Amazon Web Services didn’t exist. All of that exists now. So now we can make it invisible. When talking about this, I often ask the question, “Do you really know if your phone is a CDMA or a GSM phone? Do you really care?” Well, no.
I see the fitness market doing one thing, staying on the wrist. Those companies will try to figure out if they can get any meaningful clinical data off of your wrist or those types of devices. But I think the healthcare wearable market is going vertical and those verticals are going to be very problem-focused like we talked about before with a particular solution in mind. But to do that across a large population, you need many different sensors to mitigate variances in physiology, variances in use patterns, variances in body motion and what we call noise artifacts. So by adding more sensors to mitigate that noise, you now have the ability to provide a more robust value than a single-sensor platform such as the Corventis technology or even the MC10 stuff that they introduced at CES.
In contrast, with our platform at BioRibbon, we’re able to provide all of that data so that new observations can be made on things that we never knew about. We have a number of different trials that will be utilizing the platform for things that we couldn’t have even imagined. But the clinician or the researcher has said, “Hey, I need to figure out if this particular parameter has some influence on the underlying condition.”
I can’t go into too much detail, but I’ll give you an example. At around age 55 to 60, most humans lose their thirst complex. So they’re unable to tell whether or not they’re hydrated. Well, what are the clinical manifestations of that? Could it be the effectiveness of drugs when you take them if you’re chronically dehydrated or acutely dehydrated? Perhaps. Could that cause dizziness in elderly patients, ultimately resulting in them going to the hospital for an IV? Perhaps. So there’s a whole bunch of applications yet to be discovered.
We’re not suggesting that someone look at all this data “naked” as we would call it. We’re developing what we call BioRibbon signatures and these are the combinations of different parameters as they’re correlated to a particular end point. And those data points will allow an individual or a group of individuals to make decisions based on that data. We think that’s going to address a huge market in an underserved population. And that is the population that’s not in the hospital, but also isn’t healthy. It’s the unhealthy group that hasn’t visited the ER, are living with comorbidities that are driving the health expenditures in the US.
Scott Nelson: As a follow-up, when you think about product development and corresponding clinical trials at BioRibbon, contrast that to your experiences at Corventis. Is there one thing you recall at Corventis that you’re doing differently at BioRibbon?
Darrel Drinan: Yeah, I think the number of sensing parameters is going to be the difference between us and what Corventis is doing. Same thing with Vital Connect and MC10. This is a more complex platform because the data needed to mitigate beyond just positional changes, temperature changes, or seasonal changes.
For example, grandma’s heart rate is 62 in San Diego on Tuesday and she’s at 91 on Wednesday when she’s in Denver. As it turns out, she went to fly to see her kids. How do I know that? Well, I have data from the device and the phone that I can calculate. And I can mitigate any intervention if grandma is really traveling, or I can intervene if necessary.
Scott Nelson: Let’s now transition to the last 3, more personal questions. What’s your favorite nonfiction business book?
Darrel Drinan: The Lean Startup Series. I think any of Steve Blank’s books are great. If you’re an entrepreneur and you haven’t read them, you are going to fail. The concepts are not just close or nearly accurate. No, they’re perfectly accurate. They have such relevance to what I described early about the problem-focus, talk to your customer, don’t drink your Kool-Aid, etc. I think they’re brilliant.
Scott Nelson: Great. And there is CEO or a business leader that you’re following right now? Or one that really inspires you?
Darrel Drinan: In terms of a business leader, Steve Blank is pretty far up there on the pecking list of people that have solved some really, really, challenging problems.
Scott Nelson: Okay, last question. When thinking about your career in healthcare, what’s the one piece of advice that you’d tell your 30-year-old self if we had to rewind the clock that far?
Darrel Drinan: That’s a good question. I would say don’t drink your own Kool-Aid. Don’t presume you understand the problem. And don’t be enamored with technology for the purpose of technology because technology is hard. But if you focus on a problem and you understand it, you’re more valuable. Becoming an expert and then becoming a KOL in a particular category is very valuable. Being a generalist has marginal value.
I would also say the greatest percentage gain in value happens from creation to the first prototype or first in-human use. After that, it becomes a grind. So manufacturing stuff, hardware especially, is a really tough business. You can’t be faint of heart to be in the hardware side of the business.
Scott Nelson: Darrel, thanks so much for your time. It’s greatly appreciated!