Thinking Like a Patient (or Being One!) Can Make Your Company's Device Better

Written By Patrick Kothe
 
 
 
 

In this episode, Chris McAuliffe, CEO of Theragen, shares his extensive journey in the medical device industry with a focus on non-invasive spine fusion. He recounts his personal experience as a patient undergoing spinal fusion surgery and how it has influenced his work and product design. The discussion covers the challenges of spinal fusion, the role of non-invasive electrical stimulation in patient recovery, and the importance of VIP customer service in healthcare. Chris's insights highlight the importance of understanding the end user experience, ensuring patient compliance, and leveraging data for enhanced patient outcomes.

00:00 Introduction and Guest Overview
02:25 Chris McAuliffe's Journey in Medical Devices
03:18 The Fascination with Electrical Stimulation
09:10 Understanding Non-Invasive Spine Fusion
15:06 Chris's Personal Experience with Spine Surgery
20:42 Post-Operative Challenges and Insights
30:17 Theragen's ActaStim-S Device
32:31 Mission and Product Overview
33:35 Challenges of Patient Compliance
35:25 Innovative Features of the Device
37:22 Data and Patient Engagement
41:22 Big Data and Machine Learning in Healthcare
51:54 VIP Customer Care Philosophy
54:16 Customer Testimonials and Impact
01:00:20 Key Takeaways and Conclusion

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Episode Transcript

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

[00:00:29] Patrick Kothe: Welcome! We get so used to presenting our products to clinicians and working through the everyday challenges of a medical device professional that we often lose focus on the end user experience. Also, it can be hard to put yourself into a situation an end user is actually in. There are distractions, emotions, outside thoughts, a lot of different things that they're experiencing, but you don't necessarily know. That's what makes today's conversation really interesting.

Our guest today is Chris McAuliffe, CEO of Theragen, a company that provides products to help patients heal following spine fusion procedures. Chris has spent much of his career in the non invasive spine fusion markets and has contributed at Biomet, Bioelectron, Endius, Paradigm Spine, Spinalign, and Neurotech. What makes this story unique is that Chris has also been a patient in the market segment in which he serves and that experience has helped inform his thoughts on product design and company focus.

In our conversation, we discuss his journey in the medical field and electrical stimulation markets, what spinal fusion is and its challenges, Patient compliance, his personal story of injury and recovery, and how he uses the experience in his business, and a special patient communication. Here's our conversation.

Chris, over 30 years in medical device. That's, that's quite a while. So what brought you to medical device and what keeps you in?

[00:02:35] Chris McAuliffe: Early on I was a life science major in biology. I thought I was going to be a doctor. Didn't do so well in organic chemistry. Not an uncommon story. so I got through and I was mentored, early on in my career to take a look at medical device sales. I started in pharmaceuticals with a company that a lot of people know, Johnson Johnson.

Great training. Um, and, uh, joined their pharmaceutical division. Understood what it takes, to move products. We launched a couple of products while I was there. and then I really wanted to move into something a little bit more tangible than pharmaceuticals. so medical devices were the thing that you sold that you actually saw the results of your efforts because you did something.

So I got involved with the kind of the OG of electrical stimulation, a company called EBI, back in the mid to late 80's. Boy, that was a time when electrical stimulation was not particularly well known. some people called it voodoo. some people didn't really understand the power. but, If you ever saw the movie Matrix, where human beings are batteries, they think they call them copper tops or Duracell batteries, you realize that everything that you and I are doing today, speaking, listening, hearing, seeing, is enabled by electrical signals, bioelectrical, electrochemical. So we are kind of one big battery and I had the great opportunity, to see things like nine month old tibial fractures heal with just the application of noninvasive electricity.

I became a massive advocate and disciple of electricity. I knew we had barely scratched the surface. so that's caught me up there. I did go back into medical devices and Some minimally invasive technologies, implants, heck, we designed a cervical plates, posteriors, cervical fixation. We designed pedicle screw systems that you can deliver through a cannula, kind of like a ship in the bottle.

Those are all very fascinating things, but I was called back into electricity, in 2014, when this company was founded. That's why I'm here, and it took a rather twisty type of a path. I think we all know all of those things add up and hopefully help you face challenges and see opportunities in the future.

[00:05:05] Patrick Kothe: It's interesting from a career standpoint, we can put the pieces together looking backwards, but many times we can't look forward and say, this is how it's going to play out. But when you look backwards, you can see, okay, there's a couple of themes that are running through here and these are the pieces that I've picked up and this is how it all fits together.

So for you, when you look backwards, what is that? What is that theme that that runs through it?

[00:05:30] Chris McAuliffe: The science background and the interest in medicine, and then I was encouraged to get my master's degree in business. and I went to a school called Rensselaer Polytech. They were a, an engineering school. Uh, what the heck do you go to Rensselaer for a business degree? but they were very well known at the time for taking concepts and pushing them through to innovation and then to market.

they were, I think at the cutting edge back in the day, back in the dark ages. so I decided to go for my master's degree that allowed me to understand better, a more global view of business, economics, and finances, organizational development, leadership, and things like that. But then I got to drag along, my passion for medicine and life sciences.

[00:06:16] Patrick Kothe: Like you, I've spent time in the plumbing side of things, working inside, inside arteries. I've spent time in the structural thing with heart valves and structural issues, some carpentry with orthopedics, and some time in the electrical side of things with ECG algorithms. So I've kind of worked the different, the different systems as well.

[00:06:42] Chris McAuliffe: We're brothers! We're brothers! We're brothers!

[00:06:45] Patrick Kothe: but, but to me, I mean, everybody knows their own strengths, their own interests. of those areas, the electrical one was more foreign to me. It didn't fit me as well. And it's, I guess for this, for the same reason that when I tackle household projects, I'll do the carpentry.

I'll even play around with some of the plumbing, but I won't touch the electrical side of things. It's just kind of what we're, what we're comfortable with. So what is it about electricity that fascinates you?

[00:07:18] Chris McAuliffe: if you believe, and I think we should believe that everything we're doing right now is electrically enabled, that's pretty fascinating. and we're all familiar with what you do mechanically, surgically going in and manipulating tissues and putting structures in to support things.

But if you could figure out a way to communicate with cells, hopefully noninvasively, and help them orient themselves to do something. And so my early understanding when I was interviewing at EBI, and doing my research is that there was a lot, there was a lot of research out, but not many commercial products, that were designed to communicate with cells, these pluripotent types of cells, these cells that didn't know what they wanted to be when they grew up.

And we could help them arrange and orient into something helpful. for us, it would be taking cells that had the capability of becoming bone cells, delivering an electrical signal, that helped, kick off a cascade. In our instance, we open voltage gated calcium channels. That's a big, long phrase, right?

But what it does is it allows ionic calcium to stream into a cell and kick off an important cascade that leads to DNA and cell proliferation, more bone. for me, that's just fascinating. I I mean, how many more things can we, solve without necessarily going into the body surgically? And by the way, I'm a big advocate for surgery. I've had procedures myself. Um, but I think if you can stay outside the body and do something or at least come in after a surgery is done and help those cells know what they want to be when they grow up, I think that's a, it's a pretty cool thing to do.

[00:09:10] Patrick Kothe: So you've spent 22 years now in this non invasive spine fusion area. So for the listeners, what is non invasive spine fusion?

[00:09:23] Chris McAuliffe: surgeons spend so many years, a decade plus learning how to diagnose and choose procedures to help patients, many times your nerves, your neural elements are compressed and they have to go in and they need to free them up. Sometimes it's a soft tissue removal like a disc herniation, but sometimes there's stenosis that's caused by bone.

And when a surgeon goes in and removes, the pressure on the nerves, depending on how much bone they have to take away, may require, some stabilization. That often times comes in the form of pedicle screws and rods. Can come in the form of interbody devices that take the place of disc, that was removed.

it's all done, for the purpose of creating space for the nerves and neural elements and then helping them fuse into one motion segment where there was a disc and a little bit of motion between two vertebral bodies. Sometimes you need to fuse that to arrest that motion. And so the patient has symptom resolution, has pain resolution down, down the line.

The surgeons do that and they've got. implant technology, they have instrument technology, they're using navigation, they're using visual assistance, they're using augmented reality. They have all these great technologies to get in there, to navigate, to find out what is likely the pain generator, to address it.

Sometimes they have to take a good amount of bone or alter the soft tissue structure so that they need to fuse. Fusion is pretty simple in concept. It's two vertebral bodies that used to move a little bit with the disc and the facet joints, and you don't want them to move anymore. So you'd like to create bone where there was no longer any bone.

So they do all of this great work. They have access to all of this great technology. And then sometimes, they get in there and the bone quality just isn't what they thought it would be. So they're worried about purchase and stability of their screw and rod construct. Sometimes the stenosis, the pressure on the nerve was from a much larger body, much larger piece of anatomy that they had to remove.

And it created a lot of instability. Sometimes the patient was an active smoker prior to surgery and they promised they weren't, they were going to stop smoking, but we know smoking has a negative impact on the likelihood of how a patient will heal. So there's all these different types of things and there's really only one level one proven technology or therapy that I'm aware of that can have a significant impact on helping all of the hard work, the brilliance, the technical expertise that's gone into that fusion to help it heal at an even higher rate. And that's noninvasive electrical stimulation. We can help all of those cells that were put there, the fusion mass, the orthobiologics, everything aligned. We can then help communicate and drive bone formation once the patient's closed.

Once the surgery is done, once the patient's out of the hospital. Can't do that with any other technology, at least none that I know of.

[00:13:00] Patrick Kothe: So Chris, the spine runs from your skull all the way down, down to your tailbone. What parts of the spine are the most common areas where people have fusion?

[00:13:15] Chris McAuliffe: Historically, the lower back, the lumbar spine area is the most problematic. The reason being it has a curve, a lordosis. It's very important from your sacrum, which attaches to your ilium, which sets up your ability to attach your, your femurs and impacts your gait and your stature and how you move about life.

But that S1 up to L1 area, the lower back, is the most problematic and it's because of gravity in the design. it's where most of your weight presses down at the lower end of the spine. And so depending on, uh, well, some is genetics, some is activity, some is lifestyle. Sometimes it's just some type of an injury or trauma, but there are times when that area, has a significantly higher likelihood of neural impingement.

And that's where A lot of surgeons go in to do their work. Not uncommon to have L5 S1, L4 L5 S1 for a multi level type of effusion. And then as you go up the spine to the thoracic region, anytime you switch the curves from lordosis, up to all the way up to the cervical region, you have these kyphotic curves.

Then it goes back to lordosis. Each juncture from lumbar to thoracic and then thoracic to cervical, those apical regions, those transition regions are particularly problematic when spine surgeons need to go in, perform a decompression and perhaps fuse those motion segments

[00:14:59] Patrick Kothe: We all know people who've had back issues and some of us have had them ourselves. It can be debilitating, not only dealing with the pain, but just the ability to be mobile.You had a, you had an experience, yourself personally.Can you walk us through what you went through? when it happened and what was going on with you?

[00:15:24] Chris McAuliffe: Do I have to, do I

[00:15:25] Patrick Kothe: Ah! ha!

ha, ha, ha!

[00:15:26] Chris McAuliffe: do I have to relive that time? All right. So, um, yeah, I did. I did. And so, um, in the March timeframe of 2020, we know that coincided with COVID.

[00:15:41] Patrick Kothe: else happened out there in the

[00:15:42] Chris McAuliffe: Yeah. I was, doing some work, in trees in my front yard. Manipulating things and sawing branches and stuff. And, that night I felt, some burning and some pain down my right arm.

From my shoulder down to my right arm, but settled in my right elbow. When morning time came, I was reduced to, a useless human being. I had so much pain and stabbing, in my upper right arm. It was starting to get down a little bit towards my middle of my forearm. nothing that I could take, certainly over the counter, was touching it.

The pain was consuming.you would do anything to get rid of that pain. So I've had the blessing of working with a lot of really great surgeons called a couple of them. One of them wrote, orders to get an MRI and a, an x ray. And I got them and I got a digital copy and I sent them out to four surgeons that I respected a great deal.

Every one of them came back and said, I see the problem. Your C5 in your neck is destroyed. It's like a pile of rubble. You have massive impingement on the nerves, especially coming out at the right side and you got a big problem because your cervical spine is now thrown out of balance and there's nothing you can do but have some type of a surgery.

They look at the MRs. They saw the impingement on the nerve reads. So I chose a surgeon, who had a good plan for me. Interestingly, I went to the hospital. I flew all the way out, to San Diego. this, the hospital is closed down. They met me in the parking lot. I put a mask on. They wouldn't let my wife come in and even wait for me.

They led me into the hospital. It's very scary, very surreal. Um, got undressed, put my clothes underneath my head, laid on the gurney. And the anesthesiologist came in and gosh, three or four hours later I was done.I woke up completely pain free, bandages and a little soreness there.

But I could not believe. It was a miracle. I couldn't, I couldn't even, I've been in this business a long time. I've been doing lumbar, thoracic, you know, scoli types of surgeries with really good surgeons. Always hearing about the pain, but never really understanding what you would do to get past that pain.

So, I had to stay in a hotel out there. My wife was there. I was able to walk that afternoon. The next day I walked three and a half miles. Man, I was on cloud nine. Stayed the requisite amount of time. Flew back to Jacksonville, which is where I work. Week and a half goes by. I guess all of the anesthetics and all the systemic things go, you start weaning yourself off and you start to feel a little bit coming back in and a specific to your neck for me, wasn't my arm.

That was done. My right arm was, I could hold a glass of water. But I'll tell you one thing I've been involved in this business. I've spoken to patients not only with electrical stimulation, but when I was involved in IDE trials for different types of products and had to speak with, family members post surgery, I saw the looks on their faces.

I understood what the patients were going through and I was so excited when they got through the surgery. I thought it was done. It's not done. I have this many months ahead of me where the biology, the bone biology in my neck had to heal because they took my C5, my, my Fifth cervical vertebral body out replaced it with a piece of medical plastic that mimicked that body and I had to grow bone up and down.

I was a, you know what, I was a high risk patient. I had a comorbidity. I had a multi level fusion. Um, and so My surgeon did an amazing job. The x rays looked perfect. My symptoms were gone. But I will tell you, now as a patient, as a normal human being, every morning I woke up, if I had a little twinge in my neck, if there was a little twitch in my arm, uh, it wouldn't matter.

No matter how much information I had, and I knew I had this long journey where I wanted to heal. I also, by the way, knew that I wanted to heal before it put too much stress on my hardware, my screws, my plates, piece of plastic. every single time you feel something, you don't know what's going on, without reference to back the way I used to feel or how I felt the first week out of surgery, whatever, didn't really know that I was making progress.

My surgeon, he prescribed a non invasive bone growth stimulator for my neck. Got it just before I left California and wore it routinely because I believed in the importance of electrical stimulation. I actually believe that device was very helpful in helping me come to a really great outcome. As you can see, my neck works fine.

I have C4 through C6. I can do everything. It's a great procedure. But all the way down And through that time, it took many months until I achieved legitimate spine fusion. Every step of the way, there's doubts, there's concerns. I had to fly, I was still working, Did my neck hurt a lot?

Did I break my cervical plate? Did I dislodge screws? There's things that every patient makes up when you don't have information. Actually, it's one of the reasons why we put so much thought into our product. to see if we could help patients during those long journeys, understand that they are in fact making progress.

So as a patient, as a patient that used another product, one, I love electricity too. I think it helped me, but three, I got a real understanding of what it's like to be a patient post operatively. You don't want to bug your surgeon. You don't want to call the office constantly. You don't want to be on pain medication and you don't know what's normal.

You don't know what's normal. So where's my sign markers? Where's my, where my signposts and my markers for progress. So we figured let's, while we're developing this very cool product, let's see if we can add something, to the world that would help spine fusion patients postoperatively understand that they are in fact making good progress.

[00:22:34] Patrick Kothe: Such a gift to be able to see your, see your business, see your product line, from a different viewpoint. I know it, it's, it's not a gift. It's, it was a nightmare, but it is a gift. You know, you, you got to, you got a chance to see something from a different perspective. And it's just, A couple of weeks ago, I had a little, basal cell carcinoma that needed to be taken out, taken off my, uh, my nose from not wearing, uh, you know, sunscreen.

So all your listeners out there, make sure you put your sunscreen on there because if you don't, you'll pay for it as you age. but when I went through that, as a patient, You read all the stuff, you know the stuff, and then you get in there, and what I learned is as much as I think I'm listening, most of the stuff that the doctor was saying to me when I was in that, in the chair, and I was listening to it, and I had all this other stuff going on, so much of it went right, right past me.

I knew she was talking, but I didn't hear her. I didn't hear the instructions. I didn't understand the instructions. and as I came through that, I was thinking, geez,that, that isn't right. now I know why they give you these sheets and you have to read them and reread them because you're not able to accept that information as a patient.

And, and you, as somebody who's in the business and in the spine business, you saw it from a different spot as well. What were some of the things, not just the post-op, but through the whole experience, what were some of the things that you learned that you didn't know?

[00:24:12] Chris McAuliffe: You're a great interviewer. I just want to tell you because you, you, you, you just hit me in a, in a place that was like, like right to my heart. Post operatively, I received my, my bone growth stimulator. I was an hour and a half, two hours away from flying out to come back to Florida. I was told how to use it, et cetera, et cetera.

They are pre programmed to go on or off whenever they're supposed to. I didn't know whether I was supposed to wear it over my neck brace, which I had. I had sheets of paper that said, here's the types of activities that you should avoid. Pat, there's so much inconsistency when they say, you know, don't lift a lot of weight.

lift a lot of weight with my neck. I got no problem with that. Is a jug of milk, a lot of weight on my right arm? Actually, it actually could be depending on how much extension of my arm there was. I had to have a couple of telehealth conferences within the first two weeks, post operatively, to ask.

and this is a stupid question, but I asked it, can I jog? Can I not run, but can I jog? Cause I feel great. Absolutely not. Why not? Cause you're carrying a bowling ball on your neck. You're going to put all of this pressure from all different forces on your neck and you're going to create problems for you in the healing journey.

yeah, you know what? I was, I think I was counseled very clearly. I had all those sheets of paper. and What I had hoped is that our device would end up filling in the void while you're paying attention to your discharge personnel or your nurse and you've got all your sheets. What is it about this journey that gives you this sense that you're making progress?

We used to say it's like watching paint dry, waiting for your fusion to heal. I guess, I think actually watch, watching paint dry is easier because you can see when the paint is dry. This is inside your neck, it's inside your lower back or what have you. So what is it? Well, pain, your pain scores, real time pain scores.

Based on something known as the visual analog scale of pain. Everybody knows about that. Everybody knows, somebody said, what's your pain now? Between one and ten, you can figure that out. But if you, if you respond to that for two or three months in a row, you'll realize that while you think that you still have some problems, and you're three months into your journey, You're mostly a three or a two out of ten now.

When you came out of surgery, you might have been a four. Makes sense, but if you don't have that discipline or you don't have a product that asks you to check in on that, that's pretty important. We also onboarded a three axis accelerometer into our device. Our device, this is our device right here, Pat.

It's so small.

[00:27:16] Patrick Kothe: we'll hold on a second because, uh, our, our viewers are listening , so, we'll, we'll give, give 'em a little, a little bit of a visual, so that, that's okay. But let's, let's talk about. What this device does, and you talk about the recovery period in here, so we're talking about, a spinal fusion and the recovery period.

Some procedures have recovery periods. It's a couple of weeks. You need to do something to, you know, you need to, you know, stay outta the water for a while. You need to stay outta the sun for a while. you can't do it. Spinal fusion is not a couple of weeks, is it?

[00:27:54] Chris McAuliffe: No, it's, it's a really good point. And I think the medical community, surgical community, understands that spine fusion patients probably don't achieve a solid fusion any sooner than four, and that's on the early side, six. My world, our devices treat patients up to nine months post operatively and still surgeons like to see their patients at one year for a confirmatory x rayand they still may have comments. They still may have advice to the patient. You're a bridging bone. There's a lot of fusion mass that's forming, but there's some areas that are still not bridging. You still need to avoid certain activities and give your body that opportunity to heal. I think that's one of the hard parts about a surgery like I had, where you get pain relief so quickly and you feel like a new person.

You immediately start to push it. You start to think about things you can do. I'm not a physicist. I'm not a physiatrist. But when you start thinking about moving your body quickly, or running, or riding a bike on bumps, or trying to play tennis, you realize you're carrying your head on your neck. Or maybe you're carrying a hundred pounds on your lower spine.

And the forces that impact that are very difficult to calculate, and many of those forces work against bone healing.That's why they put rods and screws and plates in. The best way to get them, to get a patient to heal in their spine fusion is to keep that immobile, allow the bone bridging process to happen, and then let it mature.

Before that, you have the opportunity to do away with all that good work that was done.

[00:29:49] Patrick Kothe: So this period of time, so the surgeon does his thing, his or her thing, and then we've got a healing period of time. And if the patient doesn't do their job, the results of that surgery are going to be worse So this is where you guys step in. So let's, let's talk about Theragen and,

your device and how it works and what it entails.

[00:30:17] Chris McAuliffe: So Theragen is a specialist in non-invasive electrical stimulation devices, and our flagship product is something called Actastim SIt utilizes a technology known as capacitive coupling. It's like the most efficient way to get electricity into the body because it, if you will, it ports electricity directly in.

It doesn't. Secondarily, induced electrical flow like through a pulsed electromagnetic field or something like that. So our device is very, very small. It was designed and purpose built to be worn around the clock. Most of the, um, good research demonstrates that. There's a bit of a dose dependency when it comes to bone stimulation.

The more you get, the better off you are. So we believe in getting as much in as you can. So the device has to be very small. If you can imagine, a device that's half the size of your smartphone. Has two little wires in one inch electrodes that go on either side of the back at the level of the spine fusion.

It uses a very high frequency, low volt, low amperage signal to communicate with cells in and around the fusion site. And it helps cells that are supposed to and want to be solid bone, it helps give them, that capacity. It accelerates healing and it actually increases, the likelihood of a successful spine fusion.

Our, Our level one, double blind, randomly allocated, placebo controlled study says that for any type of spine fusion, regardless of the comorbidities, you can expect a 31 percent increase in Spine Fusion Success, and that translates into a 56 percent reduction. in spine fusion failure. And many surgeons are just as concerned about a revision, having to take a patient back into hospitals.

The landmarks have been oftentimes altered. The landscape looks different. It's harder to find your way around. And quite frankly, the literature says on a revision surgery, success rates are significantly less likely than on a first time in on the spine infusion. So if you wanted to encapsulate our mission.

Our mission is to help patients heal quicker and at a higher rate after all of the great things that spine surgeons did during the operative procedure. They saw it, they decompressed it, they figured out what the best implants should be, what the best approach could be from the back, from the side, from the front.

They do all of that great work. They know what to do. And then we add that extra measure of likely success to that spine fusion patient.

[00:33:17] Patrick Kothe: So as you said, the product is like two little ECG electrodes on either side of the spine, uh, where, you know, where that problem occurred. And then it's wired to a small cell phone, a small device, like that. And you can put it in your pocket or whatever. Now it sounds simple, but patients are not always compliant.

You know, physicians do something and say, okay, take these,pills twice a day and patients forget about it. They're not compliant. in your instance, where you felt better right away. You knew that you needed to continue to do this, but patients forget. So tell me about compliance with the patients with something that they would need to have long term four to nine months that they're going to need to need to have this,therapy, on them.and at what point do they start saying, well, I'm feeling better. Do I really need this anymore? And stop doing it. so what about patient compliance?

[00:34:26] Chris McAuliffe: Boy. Uh, so you're asking me to solve the issue of patient compliance. You know, that has plagued medicine, right? From pharmaceuticals to physical therapy and even in our device. So we started off with the first thing that seems to make a lot of sense. None of these devices work if you can't wear them or if you don't want to wear them.

Or if they're large and they call attention to you. And as a patient, what I will tell you is one of the things that you don't want to be reminded of is your fragility, your impact in health. You don't, you're already dealing with all these questions, right? So you'd like to have a device that's discreet.

Ours is, it's worn underneath your clothing. It's clipped to your belt or put in a pocket or what have you. So nobody can see it. So nobody's asking you all day long, what is that device? That's number one. So it's very small. The ultimate and compact wearable medical device. The next thing is when you're watching paint dry, when you want that fusion to heal, you'd like to have some data, you'd like to have some indication that you are indeed making progress.

Months and months of adherence to a therapy is very, very difficult. Well, one, you knew the pain you had. Some people go through, six to seven months worth of PT and epidural injections and all that, trying to get to a non invasive, non surgical thing. You know what you felt like, you know, the fear that you had before you went in, you know, it felt like after, and you know, all the concerns that you have afterward, you don't ever want to go back.

So you're looking for help. So our device, um, demonstrates to patients, one, it takes their compliance, ratings down to the second, the minute, the hour, the day, et cetera. And that's important because the literature says the more you wear it, the better off you are. Secondarily, with an onboarded accelerometer, our device measures relative patient activity.

Why is that important? Because quite frankly, besides eliminating pain, mobility and activity, return to activities of daily living are the number one goal of all spine fusion patients. Everybody wants to get back to the things that they love. It doesn't matter whether it's walking in the mall, getting your newspaper in your mailbox, picking up your grandchildren. Doesn't matter. So we just said, what indicates or how can we tell patients that they're actually getting better? What's really cool is that when our patients are using the device, not uncommon for them to be pretty sedentary, postoperatively. A week, maybe a couch potato, I don't know. but then all of a sudden they see that they move from low to mid to high activity levels, a proportion of movement that they have during the day.

Regardless of that activity is measured. And then we take that information, we send it to an app called ActiStim Sync on their phone, and it produces these amazing graphic representations of their daily, monthly, weekly, activities and you see this up and to the right, this movement, increase and improvement that says, you know what?

I had a bad day yesterday. My lower back hurt, but no, I'm so much better than it was pre op and I'm definitely better than the first couple of weeks when I was post op. That helps patients stay on track. It's, it's like when you're on a diet. If you can start to lose two pounds on the first week, you're motivated to stay.

If you can walk to your mailbox and then walk around the block in the first month. You feel pretty darn good. The last thing that we do is we, we, um, remind patients to input real time pain scores. That is one of the number one metrics for Spine Fusion success, is the pain being reduced. And postoperatively, a lot of people don't have that immediate pain release that I had when I had my cervical fusion.

Lower back can usually take a lot longer. You have residual radiculopathies and pain signals going down your legs. There's a lot of PT, there's a lot of therapy that has to go on. So, if you're taking your pain scores, you can take it up to three times a day. And you're noting, and we have this really cool, menu drop down in our app.

You can put your pain score in, and then you can say it was due to household chores, or it was painful when I was sitting, painful when I was driving in my car, painful when I was bending over, lifting up a laundry basket, and you can note those things. guess what? One, you watch where your pain goes, your doctor's gonna ask, that's the number one thing that a surgeon's gonna ask their patient.

How do you feel? How's the pain? Secondly, if you have pain, you can say, I've been keeping score the last three months. I noted Interestingly enough, I would never would have expected. I have pain sittingnot just as simple as saying then don't sit because you have to sit. But now that doctor might say I have physical therapists that can help you with the muscles with a rehabilitation regiment that's going to help you build up your strength in the soft tissues or stretching or whatever you have to.

That information is so hard to get if you're a patient and you see some of your doctor every 90 days. I think I'm pretty, uh, well educated medical consumer, but when I go in for my annual physical, I write all these things down and I get in there and the surgeon and my doctor's going to give me a full 10 minutes.

How are you feeling, Chris? Okay, you sleeping okay? I've had some difficulty sleeping. When? I don't remember. Okay, next subject. Our device fills in and makes those dialogues between the patient and the surgeon, the support staff at the office, so much more productive. So anyways, I'm proud. Those are the things that we thought about.

Those are the things that patients and surgeons, while we were developing this product said that might be, a real help. We talked to people who had used the other devices that were on the market previous to ours, which included things that I developed and launched. and they told us what they wish they could see and feel and hear.

And so we've given them a bunch of information. You know, what's really cool. As a DME provider, a durable medical equipment provider, we know a lot about our patients. It's the requirement for insurance and reimbursement. So I know patient demographics. I know the preoperative diagnosis. I know the intraoperative because most insurance companies and things like Medicare require op reports.

And then we have all this data post op many months of compliance, motion, a relative activity of pain. Pat, can you imagine when people start talking about big data, machine learning and all that? We have no dog in the fight when it comes to implants or a new way to approach the spine or an orthobiologic.

We're like a dispassionate observer. We're collecting all this information. At some point, we'll be able to apply machine learning. AI. And then we'll be able to understand, is there a combination of best practices? So if you have a male who has a body mass index of 35, little heavy, ex smoker, Maybe a prednisone, steroid user for a long time, and we have 200 of those types. And some of them had a posterior approach. Some had far laterals. Some had a 360. Some of them had titanium implants. Some of them had unilateral screw fixation. All those technical things we'll be able to put into the stew. We'll be able to analyze it and we'll be able to say to surgeons, if you have this type of a patient coming up, our data shows, here's the combination that has worked best, especially when they've been using the ActiStim device.

I think that information from what surgeons have told us, from what editors and publications have told us is going to be really interesting. I don't think there's any other company out there right now that has this much device based data, along with all of the pre and the post op stuff, that's going to be able to provide a an unbiased eye as to what all this means.

[00:43:03] Patrick Kothe: Tremendous amount of, clarity could come out of analyzing that data. It's not only, it's not like only compliance, it's how long should it be done, how long, you know, based on what procedure is done. It's performance of physicians. I mean, not, not all physicians are equal. some will have better clinical results than others.

You'll be able to. look at that, be able to look at implant types, or as you said, technique, differences between,different surgeons. So a tremendous amount of data provided that it's analyzed in the correct way. So getting, getting, uh, people to help you, to really discern all that is going to be a really, a really critical piece is to make sure that you're guided by the right people to start making those, those cuts as

well.

[00:43:55] Chris McAuliffe: Yes, that's thank you for that comment. I totally agree with you You know in the age of information. I'm really excited about what we're doing because we're using data today that comes off the device that goes through the app that allows us to bridge between the patient and the surgeon and then the plans are certainly down the road for the big data analysis and trying to understand that the correlations between all these different pieces of data and we need a large enough N, a large enough number to make those statistical analyses mean something, um, but I'm, I'm encouraged and I do, I, we can already see trend analyses that, um, that I think will probably end up in being, statistically significant.

Exciting times, Pat.

[00:44:43] Patrick Kothe: Yeah. So I want to go back for a second because what we, what you were describing with, the system and the data coming off of the Sync product,it almost, it's almost like you're gamifying the system, gamifying it for the patient to keep them engaged. We know that, the trend is, Patients, when they have a say in their own health care, they're generally more compliant, uh, when, and they want to have more of a direct, impact on their own health care.

So by providing that vehicle,it keeps them in, engaged. When you, you said that you, you, you know, your team started gathering this data on how to do that from a variety of different clinicians and inside as well. Was this before or after your patient experience?

[00:45:39] Chris McAuliffe: It was in the middle because my surgery happened in early 20, 2020. We received our PMA clearance in December of 2020, but the design and the development of ActiStem Sync, our app, benefited greatly. Because I was here every day trying to figure out how I was doing when it came to my fusion, and you're right.

It is every single person now who wears a fitness tracker or carries their iPhone or their Android and they have health data that comes off of that. We all expect to have and to understand data. We love to go to the internet to find answers. When you can look at a device and an app that directly reflects how well you're doing in your, your therapy, that may take many months.

You have that sense of ownership, probably the most important stakeholder. This whole thing is the patient and so often the patient is forgotten when it comes to active participation in the post op. I'll get, I'll bet you a million dollars, that if you asked a hundred spine surgeons, what is the biggest negative impact on their success rate when it comes to fusion? I bet you 99 say it's what the patients do postoperatively. So if we could have an impact, if we could harness the patient, and helping them understand that they're making progress, the things to avoid to make patient surgeon discussions that much more productive and getting to the point. Uh, we feel like we're, I guess, gamifying, um, the system, keeping people engaged.

yeah, I think it's a good observation and I, I know that my experience and the questions I had certainly had impact on how we developed it.

[00:47:46] Patrick Kothe: So this is a prescription device

[00:47:49] Chris McAuliffe: They are, all of the bone growth stimulators approved are by prescription only.

[00:47:55] Patrick Kothe: and who is your customer? Who is prescribing it?

[00:47:58] Chris McAuliffe: Um, mostly, orthopedic spine and neurosurgeons. There are some ancillary surgeons that we appreciate their business, but our market, quite frankly, is those people that are doing surgeries. They understand and they mark in advance those that have high risk, that have a comorbidity profile, that might give them some trouble down the road and they want to add some extra.

success.

[00:48:28] Patrick Kothe: And. Is the product reimbursed?

[00:48:31] Chris McAuliffe: It is widely reimbursed. In fact, I've been doing this for so long. I can't, there's never been a time in my life when reimbursement has gone backward. Medicare, you would think that Medicare population is, the vast majority of our patients. It isn't, but they are some of our most treasured customers and patients.

Uh, they deserve the best. But Medicare has been a very good partner, for the bone growth stimulator industry. They recognize the value. And so while you hear year after year, that Medicare is cutting reimbursement, for bone growth stimulation, and it's not, believe me, it's not over the moon, but they just keep increasing it.

Because when you add bone growth stimulation to difficult patient, you more often come up with a success than not.

[00:49:20] Patrick Kothe: So I assume there's a few competitors in this space.

[00:49:24] Chris McAuliffe: They're really good competitors. We entered a market when there were three. It seemed like a deja vu for me because when when I worked at a company called Bioelectron, we were the first company that launched a product that used capacitive coupling for spine. It was a great product, by the way, but it didn't have any of the digital or connectivity capabilities that ours did.

But we went into the market, There's a company called OrthoFix, an outstanding company, probably the longest standing kind of pure bone growth stimulator, OG, because EBI got sold off to Biomet and Zimmer and all that. Uh, when we launched, we came out against OrthoFix. We came out against, my old company, Zimmer Biomet, uh, with my product, SpinalPak, and then with DJ Global, with a combined magnetic field product.

So it literally was identical to when we exited back in 2000.Pat, I think that's one of the things that people should know is that PMA products are difficult to change. They certainly need clinical data to make any real changes. So essentially all the people that I competed with, and the product with which we competed, SpinalPAC, which is now with a company called High Ridge Medical, they're identical. They're the same, been a little modifications, maybe some power pack changes, et cetera, but their form factor and their capabilities and what they provide the patient is limited. They're great products. Let me just say that. I used one of them. They're great. products. I am a massive believer that all of them work, but there are issues like compact design, form factor, throwing data off that helps your patients understand where they are, helping patients stay engaged in a many months long, treatment. That's where ActiStim came out as kind of like a best of the class, right? from the word go.

[00:51:25] Patrick Kothe: So when you've got a market that has multiple players and, and, uh, quality multiple players, every company is searching for a strategic competitive advantage. And sometimes it comes in a form of products. And sometimes, there's, you know, depending on the products, there'll be significant differences or not as significant differences, but there's other things that we do to differentiate ourselves as a company. You, you. I've talked about something called VIP customer care and I wanted to ask you about that and how that, how that came about and how it's been embodied within your company.

[00:52:08] Chris McAuliffe: Uh, wow. VIP customer care. I mean, that, that's essentially our DNA. Uh, it is a patient first attitude.We believe if when solving any problem, we ask what's the right thing for our patients, our prescribers that will usually lead us to the right answer and the business will take care of itself.

if you took every single person in this company and took them into separate corners and asked them the two things that have helped us be successful, through a lot of difficult times one is the focus on patient and prescriber. We all know that our customers first as a patient followed by the prescriber, the reimbursement community. And we believe in that. our sales network, because they are the interface with prescribers, is the fourth customer, if you will. The second issue, or the second quality, is collaboration.

we truly, have a direct communication. philosophy, it's cultural. Um, you provide feedback and you, and you receive feedback routinely. You leave your ego checked at the door. and that also, quite frankly, has, has spawned a culture of leadership that doesn't come by way of title. Doesn't come by way of how many people you're responsible for.

Leadership is an individual thing. but VIP customer care, that is our ethos. that is in our blood. When you pick up the phone and somebody needs something, the very first thing we're all trained here, myself included, is how can I make this a one contact event. So I can solve something. Um, so anyways, that, that's how we built the company.

[00:54:01] Patrick Kothe: So right before I hit the recording button, today, you were flashing a piece of paper

[00:54:06] Chris McAuliffe: Uh,

[00:54:07] Patrick Kothe: and I said, and I said, hold on to it. I don't want to hear it right now, but you said you heard, heard, heard from a customer. So, so tell me what the, what the customer had to say.

[00:54:16] Chris McAuliffe: yeah. So to give this some authenticity, it came in on a text for me at 9:12 PM last night, um, completely, I promise you separate and distinct from this event that we're having now, I know this patient. Um, I, we've had contact. He was seven months post operative, spine fusion. He had residual pain.

There was a fear of hardware failure because he wasn't fusing. The surgeon told him, that he had some bridging bone, but it wasn't fusing and it wasn't stabilizing. There were concerns. He had a number of comorbidities that did not set well when it came to thinking about a revision surgery, but of course he could have gone.

So what do you do? So my experience when I was back in the old days of EBI, when we use pulse electromagnetic fields for tibia fractures that wouldn't heal on their own. I mean, this is before dynamic nailings, before all these great technologies, we used to put electrical signals on fractures that wouldn't heal.

It's Surgeons would say back in the day back in the mid and late 80s. What's the electricity gonna do? This is 9 12 months. I have to take the patient back. This is a second surgery And you know what three four months later. We'd see bridging bones six months later patient was healed. It's like almost miraculous so this text really hits home because it literally completes a circle for me.

and so I'm going to read it exactly as it's, if there's typos in here, please excuse me. It says, Gentlemen, hope this note finds you in Find you and find you both well, said to me another person. The reason for my note today is to let you know that I saw Dr. E, I'm leaving the doctor's name out and we went over my data and x ray.

The synopsis is good. I have fused. I am so happy. I am so grateful for you all coming into my life and helping me heal with state of the art equipment. May God bless you all in every department of your facility. And my hope is that you prosper and remember always you are caregivers. You are blessed. And finally, you made a difference in my life. Thank you. Thank you. Thank you. So let me tell you that, just reading that gave me goosebumps again. That's emotional for me. Um, having come full circle and have had the good fortune and blessing of seeing a lot of patients spared a revision surgery or a, or prolonged healing periods or people can't, you know, get back into activities of daily living, that was an not a typical patient. Because we usually treat patients when the surgeons identify them post operatively because they have different types of aspects to their health profile, but to be able to step in with a patient who wasn't healing as well as they wanted to, when there was real fear of the hardware failing and perhaps having to go back in, and because the patient had comorbidities to start with, it wasn't going to be nearly as smooth sledding as it was the first time, we stepped in.

And with capacitive coupling, with electrical stimulation, with a little tiny device with two little electrodes that the patient wore. and I can tell you they wore, many hours a day. They probably got in 17 to 18 hours a day on average. Uh, they love the data. They love the fact that they could put their pain scores in.

And this gentleman ended up healing. I'm not going to tell you he's pain free. Um, I know a little bit behind the scenes, he's still. You know, isn't completely, but he's only a thousand percent better than he was, you know, before he started using ActiveStim. So that's really cool, man.

I mean, that is, um, that's what, that's why we do these things. I don't know how many people at Boeing or GM or X or Nvidia get texts like that from customers. They all make great products. They're all very important. I use them, I fly in them, but really when your company makes that kind of an impact on a patient, on one life, and we treat thousands of patients a year, we have the potential of having those types of experiences and those types of outcomes literally thousands of times a year.

That's what gets us up in the morning. That's what drives VIP customer care. And that knowledge, that, that text is going to be shared in a little bit of a, like a town hall that we're gonna do. I'm gonna be very excited to share that with the entire company. Because people are remote. People are selling and marketing and supporting our customers all over the country and in two different offices.

I'm in Jacksonville, one in Manassas. Everybody needs to know that. If you ever wonder why you're driving into work, if you ever wonder if you're making a difference, yeah, yes you, we are. And by the way, I believe my competitors are. I believe non invasive electricity helps many thousands of patients all across the country.

I have a bias in favor of mine, but if, my, any of my family members, had to go through what I had to go through, And they said their doctor prescribed a non invasive electrical stem. I'd say you bet. And if they didn't get that prescription, I say, why don't you suggest it? Because you can get texts like that that validate what you're doing.

[01:00:05] Patrick Kothe: Chris is passionate about the customers they serve. I suspect he always had that passion, but I'll bet it went up a notch or two following his own journey in recovery.

A few of my takeaways. First, think like an end user. Not only why they buy, but why and what are they going through at the time they use their product. You may not get an experience like Chris. But ask the questions, observe the behavior that's going on around the environment when your product is being used. And dig down below the surface. Don't just look at what's on the surface, but try and dig down as far as you can to get the full experience of what an end user is going through.

The second thing is VIP customer service. And a lot of us like to think, yeah, we provide great customer service. And, you know, we have the white glove treatment, the VIP customer service. Do you really, is that how you do everything in your business? You know, a couple of things that. Chris talked about focusing on the customer.

You know, a lot of us think that's what, that's what we're, we're doing, but you start to dig down into it a little bit, a little bit further. How can I solve the problem in one call? How can I think through the product and how the product is going to affect that end customer in all aspects? And then how do you make sure that your company has that as an ethos? What is, you know, how do you collaborate? How do you make sure that everyone is doing the exact same thing and has the exact same view on what VIP customer service is?

The last thing that kind of stood out was when he talked about his competitors. A great amount of respect for his competitors. And one of the reasons is he believes in his category of products. He believes that that category is so valuable to the end customers. And he's one of those, those choices, but there are other choices there too. You will compete. You will look for that strategic competitive advantage to make sure that yours is the top of that category, but respect your competitors. You're all providing valuable services to the customers.

Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the Mastering Medical Device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the Mastering Medical Device podcast as interviews like today's can help you become a more effective medical device leader.

Work hard. Be kind.

 
Patrick Kothe
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