EPISODE 2 – Wamis Singhatat and Active Protective

We’re joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action below. 

Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product to market. 

Episode Transcript

Dan Henrich: Welcome to Medtech Mindset. I’m your host Dan Henrich and I’m Director of Marketing at Smithwise. Recently one of our Smithwise clients and friends from the industry, Wamis Singhatat stopped by our office to be a guest on this show. Wamis is VP of Product Development and CTO of Active Protective, a Philly area medtech company working to bring a really cool product to market. A smart belt that can sense a fall in progress and deploy airbags to shield the hips of the wearer. Our team at Smithwise has had the opportunity to be part of this development process and it’s been fantastic to be along for that journey. You can see a video of the deployment in action by visiting our smithwise.com blog and finding the post for this episode.

I’ll mention before we jump into the conversation that we had a problem with our original audio recording file. So we had to fall back on the audio from a video camera we had running. It’s a bit echoey. We’ll get right back to better audio quality with real mics next episode.

Wamis sat down with our president, Eric Sugalski to talk about the Active Protective product journey and some of the issues they thought through as they planned their path to market.

Eric Sugalski: So first of all, Wamis, thanks so much for taking time to be part of this podcast. Really appreciate it.

Wamis Singhatat:      Yeah, happy to be here. Thanks for inviting me.

Eric:    So I wanted to start with … you had a really interesting career at J&J in the orthopedics space and you decided to move on from J&J, which probably had a lot of benefits, a lot of great things about it, and move into this startup, that had a certain amount of risk. Take us back to that place where you were, tell us a little bit about what was happening at J&J and how you made this decision to join Active Protective.

Wamis:           So it was probably the scariest decision I’ve ever made in my professional life. And maybe twice as scary to my wife when I went home and told her that I’d be leaving J&J, because people just don’t do that. It’s a great company.

I was actually with a company that J&J acquired, Synthes. Synthes was a major orthopedic player and once J&J acquired us, I had landed in the trauma business unit. So trauma meaning orthopedic trauma, so broken bones and I was on the franchise marketing team. I actually ran the portfolio that was responsible for knee and paraprosthetics … fractures. So implants that would go to fix knee and fractures that were happening around, like a total hip, for example.

Interestingly, as we were looking at portfolio opportunities, I came across Active Protective. Active Protective was not in the business of, obviously fixing fractures, they were in the business of preventing fractures, but it was an interesting sort of rehab play for us. The more I learned about Active Protective … it was super early stage at that time, there was only just the CEO working with some external development partners, Smithwise being one of them. But the more I learned about them, the more I realized that I had to come and help them make this a reality. And it was probably the toughest decision that I’ve made … one of the toughest conversations I’ve had with my wife.

Eric:    So let’s talk a little bit about Active Protective. Super compelling opportunity for you to convince you to leave J&J. What exactly is Active Protective doing?

Wamis:           So it’s really an amazing technology, the company was founded by Dr. Bob Buckman, former Chief of Trauma from Temple University. He had a long career in the inner city Philadelphia, like knife and gunshot; really bad traumas. And then later in his career, he moved out into the suburbs at St. Mary’s Hospital and he saw a really big shift in his cases. They were all really hip fractures. Little old ladies falling down, breaking their hips and struggling for their lives. He really thought there has to be a different way and after wracking his brain, he came up with a wearable form that actively protected the hips. And that really was the genesis of Active Protective.

So Active Protective, our mission is really to make hip fractures a preventable condition. And it’s through this smart belt that can very accurately monitor a user’s motions and detect when there is a serious hip-impacting fall and then deploy airbags over the hips prior to impact. And it’s also a connected device so it sends caregiver alerts, as well. And it records all the motion data. We, then can analyze that in the cloud. We developed our own cloud application and we can present that motion data and user activity data back to caregivers and therapists, anybody on the care team to really help inform the care that the user is receiving.

Eric:    So who specifically is this product intended to be used for? There’s a lot of, obviously elderly people that might be prone to hip fractures, but there are people in nursing homes, there are people in assisted living facilities, there’s some people that are living independently, where this product might be applicable. Tell us about how you evaluated those different customer segments and if there’s one in particular that you’ve really honed in on.

Wamis:           Yeah, sure. In general, I think the most broadest category would be a high fall risk individual. So an older adult that is predisposed to falling, whether it’s through some gait abnormalities or through sort of balance issues. It’s really just a normal function of aging that your balance degrades to the point where there is a threshold where you’re then a high fall risk.

When we look at high fall risk individuals, the market can be really cut in two halves. One is aging at home and one is what we sort of generically refer to as the supervised care market. The supervised care market, it’s really big. It includes this entire continuum from really the acute setting to post-acute. So if you’re just discharged from the hospital into say, a rehab facility, which is also a skilled nursing facility. The next level of acuity would be assisted living. So that kind of takes you into these retirement communities and there’s this whole world around what’s called, CCRC’s, Continuing Care Retirement Communities that have assisted living, skilled nursing, and then independent living, all on the same campus. That is what we consider the supervised care community, even though you may have very different use settings on the same campus.

So for example, on a CCRC you’ll find one side, like I said, is independent living. It’s essentially like an apartment complex. The residents there can come and go as they please. But on the same campus they do have nursing, they do have medical assistance, if and when they need it. So for us that poses a great opportunity that we can get a belt onto campus like that where we can have the IT department involved to connect all this to wifi. We can have a fall risk assessment done because there’s nursing staff or therapists on sight.

And then transition from that kind of setting all the way to, say like a skilled nursing on the same campus. So as these residents come in they typically come in to independent living and then as their health degrades they transition into these higher acuity care settings on the same campus. So it’s a really nice market for us because you really can capture a wide variety of users.

Eric:    Right and like you said the infrastructure is already in place to facilitate usage of this system. So building on that, when you’re trying to get products into that type of environment, there’s probably a lot of stakeholders, there’s a lot of people that could be influencers in terms of adopting this type of product. Who is the buyer in that case and who are some of the other stakeholders you need to be thinking about in order to get your product into that type of a market?

Wamis:           Yeah, sure. So the buyer is really primarily the facility owners. So the facility owners, they are financially on the hook, so to speak for risk and liability. So, if someone, maybe a resident for example, falls and breaks their hip on their campus, then they’re liable for that. These facilities face enormous lawsuit, liability exposure and it varies by state, depending on the states, whether they have tort reform or not. But for example, in California, the average liability, sort of lawsuit is five to six hundred thousand dollars per infraction. You go to the state of Kentucky, where there is no tort reform, it’s $1.7 million per infraction and everywhere in between.

So they are incredibly interested in pursuing any technologies that can try to minimize that risk, that liability exposure that they have. So they are a very motivated buyer for us. But then we also see that there are, again, like in the CCRC campus because there are these different care settings, there are opportunities to do some cost sharing or pass some of the costs down to, say an independent living resident. Who may not be as high of a fall risk, but they may still be motivated to wear the belt and in that case, a facility may buy the belt from us and then actually pass some of that cost to the resident.

Eric:    You mentioned that these facility administrators, they’re looking at this from the standpoint of reducing their liability. I would assume they’d want some type of evidence that your device, your product is actually going to that before they invest in this new technology. Is that true and if so, how does Active Protective provide that compelling evidence to those buyers.

Wamis:           Yeah, absolutely, they’re looking for evidence. I think the good thing we have going for us is that we are essentially repurposing known technologies. We’ve got automotive grade airbags and automotive grade inflation, inflaters within the belt. Pretty much the population trusts that airbags work. Airbags have saved lives for decades within automotive applications and they’ll save lives in our product as well. So we don’t have to convince them that an airbag will work if deployed properly.

Things we have to convince people around are typically compliance, so will people actually wear the belt. And that’s a big one, right? It’s wearable. Look at the evidence around wearables and how they’ve been adopted into population at large. It’s not great. It’s the worried well and it’s the fitness buffs, right? Going outside of that to an older adult population with a wearable, it’s a very reasonable question to ask. So we get that question. It’s probably the most common question that we get.

Eric:    To that point, is being in a supervised setting, does that make compliance with the product simpler?

Wamis:           It helps. It helps, no question, but the primary way to really promote and enable compliance is really through the design of the product. So you’ve gotta design the product that is highly usable, that blends into the user’s lifestyle and that you’ve got to target the right users as well. So we’re targeting those users that are highly motivated and that’s how we’ll get compliance with sort of this niche or beachhead strategy, in terms of targeting and good design.

Eric:    Got it. So, you said that airbags are a well known technology, but the evidence … these facilities that you’re getting the product into, they’re not looking for clinical studies that are showing that your product is reducing the incidence of the infraction?

Wamis:           Not these facility providers, no. Not all stakeholders are going to have a level, an evidence bar that’s that low. An insurer, for example, or a hospital network, they will probably have a little bit higher bar, in terms of the efficacy, if you will of the technology. And in time we’ll generate that efficacy to show that we are actually protecting the hip, potentially changing the injury rate. That our algorithm is very accurate and it deploys when it should and it doesn’t deploy when it shouldn’t. Those kind of things we’ll actually be able to generate, but it’ll be a longer effort, it’ll be a longer timeframe to get to that.

Eric:    What is the regulatory process look like for this product?

Wamis:           Yeah, there’s so many conversations that we had internally early on of what was the right pathway to go down. Obviously, we could have developed it as a medical device. That’s the world that I came from, as you said. We’ve got some others within the company who have med device backgrounds. Or we could’ve developed it as a just purely consumer electronic device or consumer product, that wasn’t subject to all these additional regulatory hurdles.

We actually at the end, after really looking through the pros and cons of each pathway, we actually chose a sort of hybrid approach. So we’re developing it as a personal safety product … and a personal safety product, it’s not a medical device, but we are of course going to be subjecting it to some standards, if you will, and best practices from, like the automotive industry, for example. We’re pulling the best bits out of the med device space to really result in a better and safer personal safety product.

Eric:    Got it. So with the hybrid approach, when you’re presumably developing a lot of the documentation that’s going to eventually be needed to meet that medical device requirement, why not just take the medical device route right from the get go? What’s the reason to not do that?

Wamis:           There are many examples of companies that have just really faced these shifting and very onerous regulations and have never made it through, across the finish line. We were incredibly conservative in our approach. Like I said, when we really sat down and looked at the best approach, it’s really one where we feel we can make it the safest and the best product. It’s not really encumbered by unnecessary restrictions.

I’ll give you an example, so we decided to develop a quality management system within the company. It’s a quality management system that is essentially a hybrid between a 9001, which would be your typical consumer product company and ISO 13485, which would be your typical med device company’s quality management system. We’ve bolted on the best parts of med device being, for example design control. Design control, really important to making a good product, having good documentation, showing that your product actually meets its requirements. Then, risk management, my time in the med device space … engineers have conflicting views of risk management, but my personal view is that risk management when applied correctly really will result in a better product and a safer product. Obviously being a personal safety product, that’s important to us.

Eric:    So a lot of these things, quality management, design control, risk management they’re required for medical devices, but they could be considered just good engineering practice for all products, regardless of the regulatory pathway.

Wamis:           Absolutely. Yeah, I think quality by design is a really important thing, like you said, could be applied regardless of what category the product falls in.

Eric:    So down the road do you see a reason to become a regulated device for certain indications?

Wamis:           Perhaps. I think perhaps. What we can say as a personal safety product is, for example, we protect the hips in the event of a fall. We have to be careful not to make any medical claims, just like any other nonmedical product. We can’t or wouldn’t say something like, we reduce the incidence of hip fracture by 23%. Those are clearly making some medical claims. At some point down the road, for marketing purposes, we might want to go down that path and if we do, then we’re not starting from scratch, so to speak. We’ve got these parts of the med device regulations already ingrained within our development.

Eric:    It’s already there, okay, that makes sense. So when you have a processor inside of this system that’s collecting all kinds of motion data, potentially fall data, this data’s going up into the cloud, where this could be really valuable data for your company also for other companies. How does this fit into the equation? Are you looking at this as real world evidence that could help you with convincing insurance companies or others that this product is of high value? Or how are you using data with this product?

Wamis:           Absolutely. I think data is playing a more and more important role in the value proposition, our value proposition of what we provide. It’s not that we didn’t really realize that outta the gate. We would sit down with facility owners and they’d bring in their clinical team into meetings and we’d present a product. It’s our mission is to make hip fractures a preventable condition and here’s this amazing technology that will very accurately detect serious hip impacting fall, etc. etc. And then midway through our pitch they’d say, “Okay, that’s great. We get that and that’s amazing. We have needs there, but you know what this really does for us? Is it gives our patients and our residents a sense of confidence that will enable mobility.”

And that’s a whole other piece of our value proposition that’s really become as important almost as the hip fracture prevention or hip protection in the event of a fall. It’s because its what they struggle with on a daily basis. The need to get people up and moving. Especially those are that higher acuity patients. Especially those that are a higher fall risk. There’s this vicious cycle where those residents and patients that are fearful of falling, they move less and when they move less, their strength decreases and their balance gets worse and counterintuitively, they actually fall more.

So there’s this sort of need to short circuit this vicious downward spiral with a product that can sort of inject confidence into these people and get them up and moving. Then hopefully then they get all the health benefits that come from that mobility. So the data … wrapping all of this back to the data piece, the data pieces is really key to providing evidence of that. It’s essentially a very sophisticated activity tracker if you will. We can measure things that a Fitbit or an Apple watch couldn’t measure, such as very accurately measure postural sway.

So if you put a Fitbit … and I’m showing you the one I have … it’s subject to all this artifact from your extremities moving around and I talk with my hands, so I probably look like I’ve taken a hundred steps [crosstalk 00:23:13] in this interview. But our belt, is mounted, the motion sensor is mounted on the user’s lower lumbar spine. So that can very accurately detect these changes in gait and sway and postural control that are very important to a clinical team, a therapist that’s caring for somebody and really wanting to enable their reaching their rehab goals.

Eric:    So we talked a little bit earlier about compliance being an issue. I know a lot of medical devices and consumer wellness products, whether it’s drug delivery devices or diagnostic wearables. There’s this notion of using data to try to improve compliance with new technology. Is that factoring in to how you were looking at things for your user base continuing to use the product?

Wamis:           Yeah, for sure. The belt is a connected device. The nice thing, that we get this daily snapshot of who’s wearing the belt and how long they’re wearing the belt. We have the ability through this connected element to actively target users who should be wearing the belt more. Particularly these high fall risk individuals that facilities have identified should be wearing the belt for protection. So that’s sort of one piece.

The other piece, like I’d said, the data, when presented in the right manner back to a clinical team can really do a lot in terms of informing the care that a person gets or really documenting progress. I know this is a little bit of a tangent, but there is this shift of value base reimbursement, instead fee for service. Value base reimbursement is largely going to be based on outcomes. You’ve gotta show that your actually improving functional outcomes for these patients and there aren’t great ways to do that in many of these care settings. If you can give the clinical team a nice documented record of how a user has, for example, improved their postural sway or their distance over surface or other mobility and activity measures during the length of their stay within the facility. It’s really doing them a great service. It’s allowing them to document the effect of their therapies and how much the patient has improved.

Eric:    So you’re into Active Protective now, three, four years? [crosstalk 00:26:37]

Wamis:           Going on three years and three months.

Eric:    Okay. Great. So knowing what you know now, if you were to think back to when you started, three and a half years ago, is there anything that you would’ve done differently?

Wamis:           Oh man, is there anything that I would’ve done differently? You know, we’ve really taken a very measured, strategic approach to how we’ve developed this product and the company as well. We’ve kept the company very lean. We used development partners, like I need to mention obviously, Smithwise has been great and the partnership that we have with, not only Smithwise, but we’ve got an automotive safety company, Joyson safety systems. We’ve got an algorithm development team.

I would absolutely repeat that time and time again. Its a very, I think, smart approach to keep your internal core team lean until you’ve reach this sort of critical mass. Then once you get the product into the marketplace and then you’ve got things like sustaining engineering and obviously pipeline products that need to be developed, that’s sort of when you start to bolt on some additional capabilities internally and we’ve done just that. So, hard to actually think of big things that we would do differently. I’m sure there’s a bunch of little things here and there, but I think we’ve done a pretty good job so far.

Eric:    Cool. Awesome. So one last question for you. What’s Active Protective look like five years out? Where do you see the future for the company?

Wamis:           Our dream is really that we develop the product that becomes normalized. Any new technology, you invent it and you put it out into the world, it’s different. It really requires … it goes through this process of normalization until it can really get adopted by the masses. So in five years from now, if we are successful, then this is gonna be a product that you will see on your older loved ones. We’re all a very mission driven company. That’s really why we work so hard, is to actually get this product on to as many older adults as we can. Starting in supervised care settings and then moving into aging at home and then expanding outside of the U.S. into global markets.

Pretty exciting time for us and who knows what’s beyond that. There’s a lot of different areas where we can take personal protection, high risk occupation, we can take it into other parts of the body, to protect the head, for example, not just the hip. But really our focus is on hip fractures because it is one of the most, if not the most devastating injuries on an older adult can sustain. We’re gonna start with the big one and address that first.

Eric:    Great. Great mission, great product. Really appreciate you taking the time to chat with us here, Wamis.

Wamis:           It was great. Glad to be here. Thanks, Eric.