Article

Looking Back at a Pioneer in DTx and SaMD – Propeller Health in 2013

Ke Li Yew

Published on: January 22nd, 2021

In Orthogonal’s digital archives, we recently came across a presentation and extended Q&A session from 2013 at a Chicago Lean Startup Circle event we helped organize. The event featured David Van Sickle, the co-founder and CEO of Propeller Health. In a talk titled Propeller Health: Fast Feedback Loops in an FDA Regulated Environment, David discussed Propeller Health’s pioneering journey to improve outcomes for people with COPD using software and connected medical devices.

We’ve been long time fans of both David and Propeller Health. But looking back at his talk from seven years ago, we were struck by how many of the issues he addressed then are still incredibly relevant to the Digital Therapeutics (DTx) and Software as a Medical Device (SaMD). We also note how prescient David was with many of his observations and lessons learned.

Two points to illustrate how far we’ve come since 2013.

The first is that the opening paragraph of our original blog post after this event uses language that shows how novel the very concepts we now call SaMD and DTx were a mere 8 years ago: “There’s a big opportunity for wireless devices, as part of systems and services to improve health outcomes and decrease costs among those who suffer from chronic conditions.”

The second point is a codicil to this talk: In 2019, Resmed, a $30B+ medical device firm, bought Propeller Health for $225M. ResMed CEO Mick Farrell explained the value of the acquisition this way: “Propeller’s digital solutions and partnerships strengthen ResMed’s larger suite of products that can treat millions of people at various stages of their COPD and other chronic diseases, all aimed at improving people’s quality of life, while reducing the effects of these diseases, hospitalizations, and the overall cost of healthcare.”

So it’s with pleasure that we now reshare this talk as an early classic of the connected medical device space. If you scroll down this webpage past the following video, we’ve also included a transcript of the talk and the Q&A that came after. (Our apologies that the video and transcript are missing some of David’s beginning and closing remarks.)

David Van Sickle’s Presentation on “Propeller Health: Fast Feedback Loops in an FDA Regulated Environment”

A whole bunch of missed opportunities essentially to capture information about how people are doing and put that to work. Then they started using these questionnaires, which are good, and validated, and so forth, but they basically asked you to recall, “In the last month, how many days did you use your medicine?” These types of recall-driven assessments are fundamentally affected by bias and by heuristics. You think, “Okay, I used it a few times the last three days, and then I multiply that by 10. That’s probably about how much I used it in the last month.”

You’ll solve the problem to answer question four, which is, how often did you use your inhaler in the last four weeks? But you won’t be at all in the realm of accurate or be able to give a reliable answer. I was seeing these kinds of things get popular, and then this happening, where we’re asking people who have a chronic disease that’s already a pain, and requires time, and energy, and household expenditures, and so forth, then we give them this. It’s this horrible Excel sheet, that you have to fill out by hand, and trace, and fill in over and over and over again.

I got fundamentally frustrated by this obliviousness to what the day-to-day burden of managing a disease was like. Then digital health started to come onto the scene. This whole thing started back in 2006, but as I was working in it, you start to see digital health apps and asthma apps get filled. Look what they did. They took the horrible, burdensome, and time-consuming interface of the past, the pen and paper diary, and then they translated it onto the smartphone interface that we have now. A total absolute failure to imagine what was innovative, and what the opportunities were, and how the whole game of self management could be fundamentally re-imagined.

Make sense? Would you ever fill that out? We know people don’t fill those in. Bear with me. I’m just giving you the quick overview of the company. We decided back then that the thing that we could do is, people are carrying around and using inhalers like this. You can see there. They’re carrying around and using these pieces of … They’re actually fairly awesome. Think about it, no power required. They deliver a dose down to the microgram. They’re waterproof. They’re totally rugged and indestructible. Anyway, we’re like, “Hey, let’s jam electronics on there, because people are carrying around and using them at the time and place that they’re having symptoms.”

We had this idea that you could instrument those. You could put chips, and sensors, and radios onto those medicines, and then see what was happening with asthma, and not just among people, but among an individual, but among people. Who, when, where is asthma happening in a community? Then you build this weird individual and public health feedback loop that looks like the bottom-up corollary to the top-down public health of the past. Everybody get it?

(Audience responds: Yeah.)

Cool. This is what it looks like today. You have this sensor, the white part that’s on the inhaler here. This is the part we made. It grabs onto the end of the medicine that somebody uses to relieve their symptoms or takes daily to prevent their symptoms from occurring. The information from that is captured automatically, passively. It goes through smartphone apps on this lovely Qualcomm 2Net Hub that’s like a nightlight that gets plugged into the wall. It requires the person to do virtually nothing. Then the smartphone apps and those hubs get the information on into the server. The app also serves to remind people, to educate them, to alert them to changes in their condition that are relevant, to provide them with a view of what’s happening around them in their community.

Then there’s this online account, obviously, behind it, so that you can see how you’re doing with your medications and so forth. This is just a shot of the site. I think probably the most interesting thing is this, which is played into the big story about the individual, the public health feedback, which is this. You get to see what’s happening around you, which is really the first time that anybody with asthma has ever felt like they’re not alone. You’re part of somebody and an environment, something larger than yourself, and you can contribute a little bit of information about your disease, that is not only relevant to other people around you, but it’s potentially finally helping to push our understanding and our abilities to intervene, and down the road a bit.

The goal is to take the horrendous approaches to self-management from a user experience perspective, and to break them up into little meaningful chunks that can be sent out to a person when and where it’s relevant to them, rather than sending them these giant PDFs and materials and all kinds of things when they get a diagnosis. It was great as an academic project, but when we decided that it was going to come off campus and become a business, this is what happened. We realized that we were very much in a… it was a regulated industry. On the left is a list of all of the standards that we have to adhere to as a business. We’ve got purity, a vast assortment of wireless testing and electrical tests, and biocompatibility testing.

The point isn’t to suggest that it’s overwhelming. In fact, they all make sense. If you take them for what they are, which is that to me, it’s like a preventive medicine. It’s stuff that’s hard to do. It’s a pain. It’s expensive. It doesn’t generate any kind of immediate reward, but over time it actually leads to higher quality products, and has built really strong processes in the business. On the right is actually our FDA filing that went in for our system. It was a 700+ page document that required a team of people, and the vast amount of money to put together, and to get through the agency, and to get cleared. All of that to build that little thing that grabs onto your inhaler, and I’m sure this is actually probably a fairly small one, for medical devices.

I’m going to take you through one of the feedback loops of the business, along that path of getting there, and show you what was fast about it and what was slow about it, and what I think is relevant both to hardware startups and hardware, software, and others. I don’t know if you can see, but I’ll zoom in. This is a timeline. The project was started in 2006. We built that thing on the left as a prototype. Then this is the march over time, over years, through different iterations of the technology, swapping out key components, trying new configurations of radios, trying different ways of powering things, trying to help the dude who wanted to go swimming with it, for example, all these things taking place over this really fairly long span of time.

The point I’m trying to make is that you didn’t have this idea of this perfect product, and then we had to raise capital and go build it. The first iteration would, by any stretch, get you basically locked up at TSA airport, security thing, right now. You would never make it through, I guarantee. It was really just about this slow whittling of the technology and the key parts of it to what was essential about it. Inhalers, as I mentioned earlier, they have this incredible daily life. They’re carried around in purses and bags, in bike baskets, in people’s swim trunks. God knows where.

We’re coming in and wrecking what’s elegant about them and putting electronics on it, and so it’s incumbent on us to make sure that we were building the best thing we could. There was just no way to get there in one go. If we had taken it as like, “This is a game with a few number of innings, instead of a really long horizon.” We would have never made it.

I’m going to tool through some of the photos of the sensor so you can see how it emerged over whatever it’s been, in seven years. This is that first prototype, essentially. You can’t imagine something more funky. This is back in the day too. Getting patients to use this was not an option, but we got it into this case with this giant battery. It has this really ugly, like wires sticking out. You had to plug it into a connector to charge it. It actually worked, and people can carry it around, and we made essentially the first map of inhaler use that’s ever been done.

This was the software back then. It was this flash based program, basically animate inhalations and your medicine over time, and let us look at things we care about, like how much is happening near a school, or how much is happening on different issues, and so fort. It gave us, as physicians, the tools to see what was going on. Then we got better. We made a smaller version, and we spent years under the microscope, not years, but months soldering these things. You get to this… You can feel, “Wow, there’s a panel of batteries and parts, and we’re building them.”

Then it actually gets to a point where it’s usable by a person and can be carried around. We took it to CDC, and asked them to fund a study. We ended up getting about 55 patients enrolled, and they used this for a bunch of months. The goal was just to understand, what could we learn about asthma in this is three or four-month trial? The other thing we did was, we sent them a weekly email report, an HTML formatted email report. We didn’t really have much else to go on, essentially, but we thought, “Hey, we’re building a signal about how somebody’s disease is, what the level of control is, and we can send them a few things, a few tips about how they can do it better.”

We did that. We enrolled them into this trial. They were in it for a month, where they got no feedback at all about how they’re doing, and then we turned on the system. We followed them for two months and basically what we were able to do was shocking. We were able to cut the number of people who have uncontrolled asthma in half, just by providing them with feedback about their current status, and giving them a few tips like, “Whoa. We’re seeing a lot of inhalations at work. Maybe you’re being exposed to something in your job as a hairdresser that you need to be aware of.”

We were able to sustain that over time. It was levels of improvement that we really hadn’t seen.

We decided to form a business then in 2010, brought it off campus, went through another round of engineering. The first box of really manufactured parts, hardware, arrived, and we ran another trial that showed similar results. Here you can see it’s actually now moved up off the side. Here’s the thing. It looked like this. Now, we’ve moved up onto the top of the inhaler. This is the next year, essentially, so a whole seven, eight months went by of engineering. Now, we’ve got it up on top. It’s still square and clunky. For men, especially, who carried inhalers in their pockets, it’s not all the way there, but we’re making big progress.

We started the business after that second trial showed similar results, and thought, “Okay, it’s time to raise capital and build a real commercial version of this.”

The other feedback loop that I want to highlight, that’s been important in our business is… hardware is a different kind of animal. One thing you can do is you can build tools that let you iterate through hardware, before you ever actually cut tools or manufacture things. I think this is becoming more and more widely known now that there’s so many more hardware startups.

In any event, what we did, we have this one on the right, which is the commercial version. Before we did it, we basically wrote software that would allow us to simulate everything, the LEDs for example.

If I could do it, you actually click on the sensor, and the LED pattern happens. We can basically adjust all the firmware parameters in this simulation, and figure out what will people understand, how do they understand the LEDs to work, before we went off and built 5,000 units or 10,000 units or whatever? Once you build them, it was a pain to update firmware. We didn’t want to have to redo the firmware. Software was helping us build better hardware. Make sense? That’s one of the lessons.

Obviously, SLAs have been huge. We can prototype and then tool in a matter of time. This is the newest one, actually, that we have. It’s super small, and we can see the really ugly, black, funky one that we had a few months ago to play with. This thing makes me infinitely happy. When you’re testing, and you’re in a regulated space, you have to have these incredible amounts of bench testing to support what you’re doing. One of my QA Engineers built this thing, which is basically like a slow motion sensor massager. It will just sit there, and run, and just press that button over, and over and over again for days, and days, and days. Then we look back at the number of times it’s incremented, and the number of times we have it on the server, and we can see how we’re doing, tuning our button force and so forth, and all the parameters around that.

Look at that thing. That is a crazy contraption built by a young, hustling QA engineer to make her life easier, but it makes the whole business rally around it and move faster. Now, there’s this thing whirring in the back, and that sensor, we understand how it’s going to work in these different environments. She’s doing all this fantastic work to simulate it. It’s really about, as a heart, because of the investment in hardware, it’s really about how do you get through these cycles quickly with these cut-rate tools?

Then there’s things like the pairing, just the new Bluetooth low-energy pairing process is different. Everything has to change in all of our apps. We work through crazy pairing workflows on the wall, and make sure that the wasteland of Android is somehow wrangled so we can get a release out, because it’s all changing now.

The other lesson for me from the past few years is that we are, over time and you haven’t seen it, but in here in the visual aspect, we’ve been removing things from the radio, from this device. We took the GPS out of the thing because we realized we’re duplicating a lot of electronics that people are already carrying around and using, and it was a huge burden on power. It was a big burden on cost of goods, and it made it giant. Get rid of that because the background patterns of use of technology are changing.

Smartphones did not exist when we started it, and now they are a core part of our business. It’s never going to be a static target you can hit, because the population is always changing. Their familiarity with technology is also changing. I’ll pause there, and just see if there’s any questions about what I’ve covered so far.

This image has an empty alt attribute; its file name is SaMD-White-Paper-Download-CTA.png

Audience Questions and Answers

Question #1: Did you start out thinking this was going to be a long-term issue, or what were your expectations when you started?

David Van Sickle: No, I’m an academic scientist. I thought I was going to do a couple of grants, publish some papers on the space-time dimensions of asthma, and that would be it, pretty much. It’s one of those things that has never finished unraveling for me. I’m sure there’ll be a day where I feel like I’ve turned a corner on it. From that, now, it’s a different challenge to me. How do you build a business that accomplishes it? It used to be, how do you accomplish that outcome that I care about, which is basically crushing asthma? How do you turn that now? How do I build a business that accomplishes that outcome? It’s just a different thing.

Question #2: Hi. Well, first off. Thanks for sharing your story and congrats for making it so far. It’s been such a long journey, it sounds like. What I was wondering is, I know you said it’s very difficult to get anything FDA approved as a medical device. Now, this thing isn’t administering care or medicine or anything. It falls almost by itself data tracking. Why does this even have to get FDA clearance as a medical device?

David Van Sickle: Actually, by the guidelines, it’s very clearly a device. We’re an attachment to the delivery of the medication, the device that’s delivering the medication. For example, you wouldn’t want it to make your inhaler harder to use. You wouldn’t want it to somehow affect the integrity of the aerosol plume. You wouldn’t want us to make it so tall that a kid would put it on their inhaler and their fingers wouldn’t stretch around it, so they couldn’t use their inhaler. There’s a very clear …

When we built the company, we knew from day one that we were going down a regulated path. I partnered with two guys who had a long background in regulated medical software, and we just said, “This is a device, and we’re going to embrace that path.” The first person we hired was a regulatory officer who worked at CareFusion and with some other high concern devices. We steered right into that, and it’s been good, I think, overall, because as I mentioned, I think it’s led us to build better products and better software. It’s also now allowing us to proceed down a path.

We’re actually claiming. We’re going to go back and get another couple of clearances on new sensors that we’re building. We will claim therapeutic benefit. We will now actually start. For us, it’s a little bit of a game of inches.

Question #3: Would you try to sell it as an accessory, or inhalers?

David Van Sickle: Yeah.

Question #4: Would there be a specific regulatory burden on you? Could the company be potentially reprimanded or forced not to get an FDA clearance?

David Van Sickle: Yeah, it happened. A startup came out of MIT, and essentially copied us, put an Indiegogo campaign on, and guess who came knocking? It’s a cat and mouse game, and there is a cat. Let it be very clear. They came, and that got shut down. Part of it is us establishing precedent, and other companies establishing precedent for the agency around what we consider to be appropriate precautions and so forth. Let me show you some data from one of our trials. One of the things that [Bernhard 00:21:06] wanted me to highlight was just, how do you do good evidence building in the context where technology is changing? We built this big randomized trial in California that was launched before we had FDA clearance. We split 500 people into two arms, an intervention arm and a control group. People in the intervention arm get sensors and so did the people in the control group. People in the control group don’t get any feedback on all the info that we collect.

Incidentally, their physicians are the same way. People get split. It’s still going on. It’s been going on for about a year and a half now. This is what struck me, in preparing for this talk, is that when we started this trial, there were 10 people in the business. We had basically zero commercial programs. Essentially, what we do is we come in with our technology that we sell to a payer health system customers and say, “Give us the folks with asthma who are not doing well, and we’ll provide them with technology, and we’ll help coach them to a better outcome, and we’ll share that soon.” We hadn’t done that successfully. We didn’t have marketing clearance to actually be in the world selling it. We haven’t done that.

The company was actually a different name when we started this trial, and this is an IRB approved randomized trial at these two big health systems in California. A little more than a year later, the team is now 28 people. We have 15 commercial programs going on around the country with big health systems and insurance companies. Just since the time that the trial started, till now, we’ve actually run… There’s been 43 software releases, and we’ve updated firmware on the sensor six times, and you can see what the website looked back then to what it looks like now. We have a different name, for God’s sakes, so we started this trial. If you think about the old approach to clinical trial was you would never vary the intervention while it’s going on, it’d be like doing drug development while the drug was in trial.

If you think of these as kinds of new interventions from a business, you would never stop your development at the point you begin a trial, and hold it all the way through to see if it was effective. That would be insane. There’s a precedent for this. What’s happening? The trial starts. People go off in their paths, and then the business is actually iterating. Our software is getting better and smarter. We’re building new educational tools. The whole interface is changed. I’ll show you. Every one of these releases, is this incredible amount of work. We’re iterating through it, and intervention is changing as it’s going on. Marketing materials are changing, and the tools that people are using in the trial are actually changing in front of them while they’re in this study.

The math and the methodology to work out what’s happening in that world is much better known for drugs. The FDA has fantastic guidance about how to do these types of trial designs for drugs and actually for some devices that deliver drugs. We’ve been oblivious to it in digital health. We throw up our arms like, “Oh God, we can’t do a randomized trial in digital health. It takes so long.” It’s really just laziness and a lack of enthusiasm to embrace the science and understand what the drug guidelines say, because you absolutely can do that work, and work out how effective your intervention is. The cool thing is that these types of tools… I got to stop in a second for questions… they generate this incredible amount of data. Every line in here it’s a person in a trial, and every triangle on there is an event.

Unlike most clinical trials we have, maybe an entry survey and exit survey. We actually get real time information about how people are doing. That’s what allows us to build things that are doing better at accomplishing the goal we care about. Make sense?

The thing we’ve been able to do is these are the two groups. How often you use this drug is the most important marker of how you’re doing, what you’re missing. It’s like a vital sign for asthma. What we’ve been able to do is drive those groups apart over time, so that control group gets left behind and regresses back to baseline, and we’re able to virtually cut out inhaler use, rescue inhaler use in the intervention group. And what does this mean for the business? It means these big savings. The health plan is able to save $700 a year per patient in our trial, as a result of the effects that we’ve had on how much health care they consume.

I don’t have time to go into this. This is another project we’re working on with the City of Louisville, which was spearheaded by a mayor, and unfortunately it’s my big feedback loop. Anyway, what we’re doing in Louisville is actually arming citizens, so you can wander in off the street to a Walgreens, get a kit, and go out, and just go on your way for free. And all of that data is used to help you improve, but it also goes to public health, so that they can apply their interventions more effectively, where, when, and among whom they’re needed. We’re seeing the same kinds of results there. I’ll stop. Thanks for your time and attention. I’m certainly happy to do questions.

Question #5: Your clinical trials are a great opportunity for usability data. In this stuff, you got real users using the real device. Are you collecting this information, and using that to iterate your product?

David Van Sickle: Yeah. That’s a part of being a regulated device manufacturer. You have to look at all your incoming support calls, and they go through a process internally where we review all the support. If we see some weird signal, we investigate and try to understand what’s happening. It’s not anything different than you would do, just, as a smart software company, but there is a process around it, and I’ve got to sign papers at the end of the week and say, “Hey, we looked at support. This thing isn’t… and nobody’s eating it, or shocking themselves, or anything like that.”

Question #6: Can you tell us a little bit about your funding, and how that flipped from funding to… It sounds like you’re getting people to pay for these services, or a mayor. How is the financial side of this?

David Van Sickle: Yep, we were started by angel investors, so Mitch Kapor is one of the investors, another angel investor from the Milwaukee area, and then another guy, so three investors. We raised some strategic investment from a retail pharmacy operator, who’s interested in, obviously, down the road, how can you carve out primary care services, and bring them out of the clinic, and into retail clinics, for example, or, just into the new settings? Then we recently closed a Series A round from a firm in Palo Alto, called the Social Capital Partnership, who has made an increasing number of healthcare-related investments. They’re non-profit that came out of the Blues converging. They subsidized that randomized trial that we have started, and then they became an equity investor in post-series A.

Question #7: What was that compared to the income?

David Van Sickle: We’re still venture backed. We’re not profitable yet.

Question #8: How easy or hard is it for you to take commercial work out of the university?

David Van Sickle: Wisconsin has one of the most faculty-friendly or liberal IP policies. My story is not at all applicable to most… 99% of faculty. It’s very easy to take IP out of University of Wisconsin. You have a right to develop it yourself, and you have the option to grant it to the university and have them pursue it, which is basically the case, and I think there’s only one other major university in the US that has that. I think they have a good record, nothing against them. I just chose a different path.

Question #9: Are you partnering with the pharmaceutical companies, for example, that produced Ventolin or some of the other inhalers?

David Van Sickle: Today we have not. I think that’s coming into digital health in a big and fast way, and it will happen at some point. They have scale. Just the units they make of inhalers are on a scale that basically no health plan is anywhere. It’s not even a tenth of the way there. But it’s going to look a lot more collaborative than you might imagine, because pharma side is terrified that Aetna or United is going to show up with a list of seven million members in January 1, and say, “Your drug is not effective in 80% of the population in whom it’s being used.” They don’t have any of the data that they need.

What we’re seeing form, and I can only speak generally to it, is really collaborative kinds of relationships between pharma, payers, providers that are looking more at outcome based models and less at, “I want to sell more drugs.” Makes sense?

Question #10: You mentioned that you were iterating software even during trials. How long… What was the granularity of those iterations, and what was the FDA’s view of those iterations that were happening during your certification?

David Van Sickle: Yeah. They have a supported view but it has to be planned, essentially. It can’t be ad hoc. You can even adjust fundamental parameters of the trial while it’s going on, assuming that you’ve built on an adaptive design. At milestone three, we’re going to review sample size and attrition, and we might have to enroll more, or we might find that Spanish speakers don’t use this. We’re one of the very few digital health tools available in Spanish, and so we’re in this no man’s land. Literally, it’s like digital health, basically, thinks nobody has health issues except for English speakers. I swear it. Go look. You will find zero, or near zero kinds of apps for people who don’t speak English. That was one of the things. We don’t know. Are people going to use this stuff, and how will we adjust it? We define all that stuff up front. We’re not just willy nilly doing stuff, but we have a plan.

Question #11: How far away are you?

David Van Sickle: That’s a good question. There’s been 43 releases since the trial started. That’s what I had them. Somebody I asked yesterday. I’m like, “Hey, I have a job for you. Count the number of releases since the trial.” There’s 43, and that’s across mobile and web, so I don’t know. Maybe, it’s probably happened twice a month type of thing.

Question #12: What about iPhone? Do you upgrade the firmware as well during the trial or just the user interface?

David Van Sickle: We upgrade firmware, six times it’s been upgraded since the trial started, but it goes through the same process. It goes through this long testing labyrinth and verification process before it goes out to the field. Part of it was to address things we’re seeing in the trial, actually, not just things in the business. In the trial we weren’t able to tell whether we didn’t hear from a sensor on a day because the battery was dead. Sorry, this is a terrible explanation, but did the sensor have the opportunity to give us information, or was it just totally haywire? We read firmware, so that every day we would log a little heartbeat no matter what. Now, we have just much more visibility into who’s still alive and available in the trial, versus who’s gone completely dark. It seems like a thing we should have easily anticipated, but we totally missed it. That’s part of it. It’s like you’re a little company with tiny amounts of resources, and you’re trying to build sensors that are coming from God knows where.

The other two founders had built regulated medical software, but we’ve never done hardware aside from the shenanigans you saw me do on campus, these iterations through these things. I still don’t really know how to do hardware, but I now at least have the sense to get the right people around to do it.

Question #13: Did you have goals while you were building this, and you’re looking at everything in the past as what’s happened as milestones, but how did that match up with the goals and expectations that you set going into it? Once you passed the prototype, where was your next milestone for the next prototype? How close or how far off were you from that and so on?

David Van Sickle: It’s basically been unlike annual cycles, where we’ve gone from prototype to prototype. It looks like, roughly, when I was doing this deck, it’s 12 to 14 months between prototypes.

Question #14: Were those planned? Did you have a specific date that you were trying to hit for the next thing, or was it just-

David Van Sickle: No. I would run the trial. I would get to the end of the trial, and be like, “Damn, I missed this super important thing.” If it was only smaller, or if it was only that, it would be way more effective, or I would have been able to reach more people, or what have you. Now, I just fire it all up again, and build another prototype, and then run another trial, and just have done that literally over, and over, and over again for the last seven years. I thought you were going to ask where is it going? That’s a hard question to answer because I can see now we’re building a whole bunch of new sensors. They are vastly smarter and cooler than I could have.

Question #15: I’m just talking more from the startup perspective. How do you measure your success, and how do you make sure that you’re hitting your targets and your goals? And did you? When did you know if you weren’t doing well or you were in trouble? How did your investors respond back?

David Van Sickle: I will say one thing, the goals I have are internal goals. I really want to make a dent in asthma. I periodically have to calibrate that against business imperatives, but the technology, as complicated as it is to be in hardware, and medical device hardware is actually the easiest part of the business. The hardest thing we have is the human thing. You have people and digital health, and should take it on the chin for this right now. The assumption that you can add to the burden of time that’s required for people to log, and track, and all that stuff is just so off base. We see that. It’s such a challenge for us, in a big program in Florida with the Medicaid Managed Care organization. We would have never have gotten that business if we’d gone in and said, “Look, we’ll take on asthma, but we only want the people that have the latest iPhone.” They’d be like, “Get lost. That is not our problem.”

The problem is people who have multiple jobs, and are working hard, and are being exposed to crap in schools or communities, and maybe they don’t even have the internet. Good luck. That’s where you’re going to help us. I think around 20% of the people in that population don’t have the internet at all, but it was like, “Well, that’s what we’re doing.” People want to like, “Let’s just sell the app.” I’m like, “No, you don’t get it. That is where we’re going.” Now is a great time for you to go get a job at American Family. What we’re going to do is, we’re going to figure out how to mail them a report, and how to help them, if it means getting on the phone. I don’t know what it means, but that’s where we’re going. That part of it, the human side of it has always been the biggest challenge we face. Still, people are losing sensors, not charging them. Whatever, all those things are a huge issue.

Question #16: Did you bring up schools? Was there something interesting that happened at schools?

David Van Sickle: No, not necessarily, but we know that a lot of events happen in schools, and so we assume that it’s just been overlooked, as an important source of exposures that cause symptoms. The thing everybody said, this Louisville data basically, there was a lot of concern that basically what we were going to do is just go build a map of where people live. Well, if you actually look at the data from Louisville, the majority of events don’t happen where the person lives. It turned out that, not only did they… we came in and the mayor brought us in. They wanted us to focus on this part of Louisville West, which is called Rubbertown, literally Rubbertown and Smoketown. I was like, “Oh my God, this is the easiest FP outbreak investigation I’ve ever done.” I’m going to show you all the asthmas in Rubbertown and Smoketown. I could do that right now.

We put all these people on these weaponized-assist sensors, and then we recently analyzed it, and just reported it at American Public Health Association. Guess what? It turns out the main risk area for asthma in Louisville is actually the most expensive real estate in the city. It’s in eastern Louisville, and why? Because the air, when the wind blows, all the stuff from Rubbertown and Smoketown come to fancy Bourbonville, or whatever it’s called, and land there and cause all kinds of issues. Now, it’s a really interesting project. Because now, it’s like, well, what do you do? Now that Metro Health and Wellness has this information, now that the Air Pollution Control Board can go over, and take the papers and the maps of our stuff to a discussion with the stationary polluter, and say, “No, we’re not going to permit it and increase the permitting this year.” Or they won’t do that based on our data, but that’s where it’s headed. It’s a different kind of public health that you can do now. It’s a lot more driven by data.

Question #17: Just a question on technical information, based on multiple rescue medication with multiple devices and I have a single device?

David Van Sickle: We don’t change anything about their drugs.

Question #18: How did you handle that conundrum?

David Van Sickle: Yeah. There’s a path that we went down. It’s called an investigational device exemption. You can actually file to say, “Hey, we’re going to try this idea,” and they say, “Fine as long as it’s in the context of a supervised and clinical trial, and that you explain to people that this is not an approved or cleared device, and that there’s all these risks.” If you do that, and you can enroll people into that trial… if you’re not presenting them with such overwhelming risks, that nobody wants to enroll, then people can participate, and you have a responsibility to notify the agency of untoward effects or nonsense that happens. There is a path. It’s the IDE path, and that’s what we’ve done all along.

And just to be clear, we went down the 510(k) path. There’s another pre-market path, which does require clinical evidence. Ours did not require clinical evidence of clinical effectiveness. It does require that you demonstrate that it’s safe, and that it looks or is functionally equivalent to something that had been on the market before.

Question #19: Coming from the technical side of developing and now running the company, how do you find allocating the time from running the business admin side to actually being hands-on technical? Are you mashing the two 50/50, or are you finding you’re being less technical now because you have to run the business? How did that transition happen coming from being a scientist?

David Van Sickle: Yeah. It was getting that way, and then we rebranded the company in September, and are essentially going both broadly to other respiratory diseases. Now, we’re actually in a world with chronic obstructive pulmonary disease, which is asthma like, but later in life. They use a lot of the same medications. It’s changed a bit because now there’s a lot of effort around building, retooling the product for folks with COPD, who are a different demographic group, and have a lot of complex multi-morbid conditions.

I’m back in the science fit and product development more than I’ve ever been, but unfortunately none of the other stuff goes away. We’re at this weird size of the company, where it’s like simultaneously it feels like way too many people and not nearly enough. You feel like you can do great things, but you don’t have enough people to do them, but you’ll have all the personnel problems to run a giant 500 person company without all those people that get stuff done. Makes sense?

It’s just become more and more consuming, I guess. I’ve been able to get great people to do a lot of the work, so right now it’s me just trying to think about what’s new and next, and help build that, and keep the other stuff going.

Question #20: Back to the startup aspect, so you have this idea for this device, there’s a software hardware component. How do you start to make that first partnership, do you go with the pharma company? Do you go with the insurance company? What were some of the behind the scenes aspects. Like, “Here, we’re going to try and target these guys because they have deep pockets or whatever with the goal, okay, we’re trying to get a customer and a revenue stream.” What are some success stories you can share?

David Van Sickle: We actually started out with the business plan focused on self-insured employers. We looked at the economics. We were like, “Oh, self-insured employers have all the economic costs of an event like asthma-related hospitalization, and they also get hit with the issues caused by this work, absenteeism, and people with asthma symptoms on the job being less productive.” There’s all kinds of literature you can draw on. We went down that path for maybe two quarters, and we were getting nowhere. The traction was minimal and for a bunch of complicated reasons. It was really a moment where we were like, “Nobody cares about the hard social ROI here.” There’s economic ROI. But the hard social ROI they’re like, “Yeah we don’t really care.” They were always looking at payers to bring them solutions, rather than have solutions come directly to them. Anyway, we abandoned that and have never gone back to self-insureds. We ended up switching where we were focused and went to an integrated system.

So, we said, “Who’s next?” Who’s next was somebody who has economic interest, economic risk, and clinical interest. An integrated system like a Dignity, or Pfizer, or somebody else. There was this priority list, and they were next. That’s where we went because there, we could make the economic case. Then the physicians who immediately understood what we were trying to do could also support us, and that’s where we found immediate traction, from those folks.

Question #21: You mentioned you were using data from EMRs, and from things like that. Are you getting back data after the facts, and then you’re matching it to your trial later, or you’re integrating directly with their systems? How easy has it been for you?

David Van Sickle: A little bit of both. Generally, I would say in most of our trials we get it monthly. Well, in our clinical trials we get it monthly at the end. In some cases, we get it more real time, if it’s a commercial program, because there’s really no interest in us waiting around. You don’t want your credit card company doing fraud detection at the end of the year. You want them to do it all the time. We follow that model in the commercial world.

Not easy. It’s still a hard problem, I would say. Mainly because there’s a lot of local installations. I’m from Epic land, so every Epic installation is its own animal, which is unfortunate for little companies.

Question #22: You mentioned this investigational device exemption. I’m really curious about how your path went. You showed this timeline of the prototypes, and then that 700 pages of paper work. Was that 700 pages delivered in one chunk?

David Van Sickle: Multiple copies.

Question #23: And then did everything else that was covered under the investigation device, or as you did each prototype redoing new approvals? How’s that for?

David Van Sickle: No, that was our filing. That was our 510(k) filing, and back then they wanted all these four copies of the 700 pages. Literally, it went in a box. God knows where it is right now. Every time we go on prototype, we update the IDE. The big thing of paperwork was actually for formal mandatory claims.

Question #24: And that’s required then for doing commercials?

David Van Sickle: That’s required to market. You can do trials, as long as you’re not being paid for it. And you can do trials galore, right. Technically, you can cover your expenses or something like that. Don’t quote me on that.

Question #25: Just a question about the software documentation. As you went through revisions, what did the FDA want in terms of documentation?

David Van Sickle: Very little, actually. There’s a lot of software documentation that went in the formal filing, in the 510(k), but along the way it was minimal. It was submitted as PDFs.

Question #26: Tell me about the privacy issues. Is that evolved as far as what you guys use? Both for the regulatory and personal sides of privacy?

David Van Sickle: I would say it’s one of the more complicated parts in the business, actually. With HIPAA, which is generally a good rule, actually, despite its reputation. I want to be able to take my medical records wherever I want, I like that about this. From a business side, it’s complicated because you reuse a lot of 3rd party services. We’re built on Amazon Web Services, and for us to work with them, you have to get these business associate agreements to bring you into compliance with the law. It’s hard to get them to sign an agreement. We use all kinds of services, and so getting and keeping track of all those, and even validating and testing through our CRM is part of our tests, because we have patient information in there, so it’s all tested. Then you modify Salesforce, and we actually have test plans for Salesforce.

Privacy is a big deal, and it has tentacles throughout the business. It’s even more complicated if you go overseas. We do a little bit of work in the EU, and there, there’s a directive that personal information can’t leave the EU. Thank God, AWS has a server cluster in Ireland, I think. We can basically spin up an instance over there, and we remain in compliance with the EU directives. It’s never ending essentially.

Then from the patient side, the physician side… The striking thing about privacy to us has always been that, as long as people feel like you’re taking appropriate precautions, and they have controls over what they can share and with whom, which they have in our system, they’re more generous with relaxing their own privacy than you would anticipate. The comment we always here is, “I’m happy to give up a little bit of information about a symptom or an attack, if I think it’s being, A, protected and B, potentially being put to use that will prevent somebody else from having to go through, or God forbid, some of these kids .” That’s the striking thing about privacy. There are always people who suddenly realize that if they haven’t turned it off, that we have tracked the location where they have an event, and they panic, and they shut down their account.

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