November 2, 2024 • 63 mins
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
Links from this episode:
- Chris McAuliffe LinkedIn https://www.linkedin.com/in/jcmcauliffe/
- Theragen https://actastim.com/
Connect with Mastering Medical Device:
- Website: https://www.masteringmedicaldevice.com
- LinkedIn: https://www.linkedin.com/company/mastering-medical-device
- Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
- Patrick Kothe Twitter: https://twitter.com/patrickkothe
Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support
Thanks for listening!
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Patrick Kothe (00:30):
Welcome.
We get so used to presenting ourproducts to clinicians and
working through the everydaychallenges of a medical device
professional that we often losefocus on the end user
experience.
Also, it can be hard to putyourself into a situation an end
(00:53):
user is actually in.
There are distractions,emotions, outside thoughts, a
lot of different things thatthey're experiencing, but you
don't necessarily know.
That's what makes today'sconversation really interesting.
(01:13):
Our guest today is ChrisMcAuliffe, CEO of Theragen, a
company that provides productsto help patients heal following
spine fusion procedures.
Chris has spent much of hiscareer in the non invasive spine
fusion markets and hascontributed at Biomet,
Bioelectron, Endius, ParadigmSpine, Spinalign, and Neurotech.
(01:40):
What makes this story unique isthat Chris has also been a
patient in the market segment inwhich he serves and that
experience has helped inform histhoughts on product design and
company focus.
In our conversation, we discusshis journey in the medical field
(02:03):
and electrical stimulationmarkets, what spinal fusion is
and its challenges, Patientcompliance, his personal story
of injury and recovery, and howhe uses the experience in his
business, and a special patientcommunication.
(02:24):
Here's our conversation.
Chris, over 30 years in medicaldevice.
That's, that's quite a while.
So what brought you to medicaldevice and what keeps you in?
Chris McAuliffe (02:35):
Early on I was a life science major in biology.
I thought I was going to be adoctor.
Didn't do so well in organicchemistry.
Not an uncommon story.
so I got through and I wasmentored, early on in my career
to take a look at medical devicesales.
I started in pharmaceuticalswith a company that a lot of
people know, Johnson Johnson.
(02:55):
Great training.
Um, and, uh, joined theirpharmaceutical division.
Understood what it takes, tomove products.
We launched a couple of productswhile I was there.
and then I really wanted to moveinto something a little bit more
tangible than pharmaceuticals.
so medical devices were thething that you sold that you
actually saw the results of yourefforts because you did
(03:17):
something.
So I got involved with the kindof the OG of electrical
stimulation, a company calledEBI, back in the mid to late
80's.
Boy, that was a time whenelectrical stimulation was not
particularly well known.
some people called it voodoo.
some people didn't reallyunderstand the power.
(03:37):
but, If you ever saw the movieMatrix, where human beings are
batteries, they think they callthem copper tops or Duracell
batteries, you realize thateverything that you and I are
doing today, speaking,listening, hearing, seeing, is
enabled by electrical signals,bioelectrical, electrochemical.
So we are kind of one bigbattery and I had the great
(04:01):
opportunity, to see things likenine month old tibial fractures
heal with just the applicationof noninvasive electricity.
I became a massive advocate anddisciple of electricity.
I knew we had barely scratchedthe surface.
so that's caught me up there.
(04:22):
I did go back into medicaldevices and Some minimally
invasive technologies, implants,heck, we designed a cervical
plates, posteriors, cervicalfixation.
We designed pedicle screwsystems that you can deliver
through a cannula, kind of likea ship in the bottle.
(04:43):
Those are all very fascinatingthings, but I was called back
into electricity, in 2014, whenthis company was founded.
That's why I'm here, and it tooka rather twisty type of a path.
I think we all know all of thosethings add up and hopefully help
you face challenges and seeopportunities in the future.
Patrick Kothe (05:06):
It's interesting from a career standpoint, we can
put the pieces together lookingbackwards, but many times we
can't look forward and say, thisis how it's going to play out.
But when you look backwards, youcan see, okay, there's a couple
of themes that are runningthrough here and these are the
pieces that I've picked up andthis is how it all fits
together.
So for you, when you lookbackwards, what is that?
(05:28):
What is that theme that thatruns through it?
Chris McAuliffe (05:30):
The science background and the interest in
medicine, and then I wasencouraged to get my master's
degree in business.
and I went to a school calledRensselaer Polytech.
They were a, an engineeringschool.
Uh, what the heck do you go toRensselaer for a business
degree?
but they were very well known atthe time for taking concepts and
(05:51):
pushing them through toinnovation and then to market.
they were, I think at thecutting edge back in the day,
back in the dark ages.
so I decided to go for mymaster's degree that allowed me
to understand better, a moreglobal view of business,
economics, and finances,organizational development,
leadership, and things likethat.
(06:11):
But then I got to drag along, mypassion for medicine and life
sciences.
Patrick Kothe (06:16):
Like you, I've spent time in the plumbing side
of things, working inside,inside arteries.
I've spent time in thestructural thing with heart
valves and structural issues,some carpentry with orthopedics,
and some time in the electricalside of things with ECG
(06:37):
algorithms.
So I've kind of worked thedifferent, the different systems
as well.
Chris McAuliffe (06:42):
We're brothers! We're brothers! We're brothers!
Patrick Kothe (06:46):
but, but to me, I mean, everybody knows their own
strengths, their own interests.
of those areas, the electricalone was more foreign to me.
It didn't fit me as well.
And it's, I guess for this, forthe same reason that when I
tackle household projects, I'lldo the carpentry.
(07:07):
I'll even play around with someof the plumbing, but I won't
touch the electrical side ofthings.
It's just kind of what we're,what we're comfortable with.
So what is it about electricitythat fascinates you?
Chris McAuliffe (07:18):
if you believe, and I think we should believe
that everything we're doingright now is electrically
enabled, that's prettyfascinating.
and we're all familiar with whatyou do mechanically, surgically
going in and manipulatingtissues and putting structures
in to support things.
But if you could figure out away to communicate with cells,
(07:39):
hopefully noninvasively, andhelp them orient themselves to
do something.
And so my early understandingwhen I was interviewing at EBI,
and doing my research is thatthere was a lot, there was a lot
of research out, but not manycommercial products, that were
designed to communicate withcells, these pluripotent types
(08:01):
of cells, these cells thatdidn't know what they wanted to
be when they grew up.
And we could help them arrangeand orient into something
helpful.
for us, it would be taking cellsthat had the capability of
becoming bone cells, deliveringan electrical signal, that
helped, kick off a cascade.
(08:23):
In our instance, we open voltagegated calcium channels.
That's a big, long phrase,right?
But what it does is it allowsionic calcium to stream into a
cell and kick off an importantcascade that leads to DNA and
cell proliferation, more bone.
for me, that's just fascinating.
I I mean, how many more thingscan we, solve without
(08:47):
necessarily going into the bodysurgically?
And by the way, I'm a bigadvocate for surgery.
I've had procedures myself.
Um, but I think if you can stayoutside the body and do
something or at least come inafter a surgery is done and help
those cells know what they wantto be when they grow up, I think
(09:07):
that's a, it's a pretty coolthing to do.
Patrick Kothe (09:10):
So you've spent 22 years now in this non
invasive spine fusion area.
So for the listeners, what isnon invasive spine fusion?
Chris McAuliffe (09:23):
surgeons spend so many years, a decade plus
learning how to diagnose andchoose procedures to help
patients, many times yournerves, your neural elements are
compressed and they have to goin and they need to free them
(09:43):
up.
Sometimes it's a soft tissueremoval like a disc herniation,
but sometimes there's stenosisthat's caused by bone.
And when a surgeon goes in andremoves, the pressure on the
nerves, depending on how muchbone they have to take away, may
require, some stabilization.
That often times comes in theform of pedicle screws and rods.
(10:06):
Can come in the form ofinterbody devices that take the
place of disc, that was removed.
it's all done, for the purposeof creating space for the nerves
and neural elements and thenhelping them fuse into one
motion segment where there was adisc and a little bit of motion
between two vertebral bodies.
(10:26):
Sometimes you need to fuse thatto arrest that motion.
And so the patient has symptomresolution, has pain resolution
down, down the line.
The surgeons do that and they'vegot.
implant technology, they haveinstrument technology, they're
using navigation, they're usingvisual assistance, they're using
(10:51):
augmented reality.
They have all these greattechnologies to get in there, to
navigate, to find out what islikely the pain generator, to
address it.
Sometimes they have to take agood amount of bone or alter the
soft tissue structure so thatthey need to fuse.
Fusion is pretty simple inconcept.
(11:12):
It's two vertebral bodies thatused 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 bonewhere there was no longer any
bone.
So they do all of this greatwork.
They have access to all of thisgreat technology.
And then sometimes, they get inthere and the bone quality just
(11:33):
isn't what they thought it wouldbe.
So they're worried aboutpurchase and stability of their
screw and rod construct.
Sometimes the stenosis, thepressure on the nerve was from a
much larger body, much largerpiece of anatomy that they had
(11:53):
to remove.
And it created a lot ofinstability.
Sometimes the patient was anactive smoker prior to surgery
and they promised they weren't,they were going to stop smoking,
but we know smoking has anegative impact on the
likelihood of how a patient willheal.
So there's all these differenttypes of things and there's
(12:14):
really only one level one proventechnology or therapy that I'm
aware of that can have asignificant impact on helping
all of the hard work, thebrilliance, the technical
expertise that's gone into thatfusion to help it heal at an
(12:35):
even higher rate.
And that's noninvasiveelectrical stimulation.
We can help all of those cellsthat were put there, the fusion
mass, the orthobiologics,everything aligned.
We can then help communicate anddrive bone formation once the
patient's closed.
Once the surgery is done, oncethe patient's out of the
hospital.
(12:55):
Can't do that with any othertechnology, at least none that I
know of.
Patrick Kothe (13:00):
So Chris, the spine runs from your skull all
the way down, down to yourtailbone.
What parts of the spine are themost common areas where people
have fusion?
Chris McAuliffe (13:16):
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 yoursacrum, which attaches to your
ilium, which sets up yourability to attach your, your
femurs and impacts your gait andyour stature and how you move
(13:36):
about life.
But that S1 up to L1 area, thelower back, is the most
problematic and it's because ofgravity in the design.
it's where most of your weightpresses down at the lower end of
the spine.
And so depending on, uh, well,some is genetics, some is
(13:59):
activity, some is lifestyle.
Sometimes it's just some type ofan injury or trauma, but there
are times when that area, has asignificantly higher likelihood
of neural impingement.
And that's where A lot ofsurgeons go in to do their work.
Not uncommon to have L5 S1, L4L5 S1 for a multi level type of
(14:24):
effusion.
And then as you go up the spineto the thoracic region, anytime
you switch the curves fromlordosis, up to all the way up
to the cervical region, you havethese kyphotic curves.
Then it goes back to lordosis.
Each juncture from lumbar tothoracic and then thoracic to
(14:45):
cervical, those apical regions,those transition regions are
particularly problematic whenspine surgeons need to go in,
perform a decompression andperhaps fuse those motion
segments
Patrick Kothe (15:00):
We all know people who've had back issues
and some of us have had themourselves.
It can be debilitating, not onlydealing with the pain, but just
the ability to be mobile.
You had a, you had anexperience, yourself personally.
Can you walk us through what youwent through?
(15:22):
when it happened and what wasgoing on with you?
Chris McAuliffe (15:24):
Do I have to, do I
Patrick Kothe (15:25):
Ah! ha! ha, ha, ha!
Chris McAuliffe (15:26):
do I have to relive that time?
All right.
So, um, yeah, I did.
I did.
And so, um, in the Marchtimeframe of 2020, we know that
coincided with COVID.
Patrick Kothe (15:41):
else happened out there in the
Chris McAuliffe (15:42):
Yeah.
I was, doing some work, in treesin my front yard.
Manipulating things and sawingbranches and stuff.
And, that night I felt, someburning and some pain down my
right arm.
From my shoulder down to myright arm, but settled in my
right elbow.
(16:04):
When morning time came, I wasreduced to, a useless human
being.
I had so much pain and stabbing,in my upper right arm.
It was starting to get down alittle bit towards my middle of
my forearm.
nothing that I could take,certainly over the counter, was
touching it.
(16:25):
The pain was consuming.
you would do anything to get ridof that pain.
So I've had the blessing ofworking with a lot of really
great surgeons called a coupleof them.
One of them wrote, orders to getan MRI and a, an x ray.
And I got them and I got adigital copy and I sent them out
(16:45):
to four surgeons that Irespected a great deal.
Every one of them came back andsaid, I see the problem.
Your C5 in your neck isdestroyed.
It's like a pile of rubble.
You have massive impingement onthe nerves, especially coming
(17:05):
out at the right side and yougot a big problem because your
cervical spine is now thrown outof balance and there's nothing
you can do but have some type ofa surgery.
They look at the MRs.
They saw the impingement on thenerve reads.
So I chose a surgeon, who had agood plan for me.
Interestingly, I went to thehospital.
(17:29):
I flew all the way out, to SanDiego.
this, the hospital is closeddown.
They met me in the parking lot.
I put a mask on.
They wouldn't let my wife comein and even wait for me.
They led me into the hospital.
It's very scary, very surreal.
Um, got undressed, put myclothes underneath my head, laid
on the gurney.
(17:50):
And the anesthesiologist came inand 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.
(18:10):
I've been doing lumbar,thoracic, you know, scoli types
of surgeries with really goodsurgeons.
Always hearing about the pain,but never really understanding
what you would do to get pastthat pain.
So, I had to stay in a hotel outthere.
My wife was there.
I was able to walk thatafternoon.
(18:32):
The next day I walked three anda half miles.
Man, I was on cloud nine.
Stayed the requisite amount oftime.
Flew back to Jacksonville, whichis where I work.
Week and a half goes by.
I guess all of the anestheticsand all the systemic things go,
you start weaning yourself offand you start to feel a little
bit coming back in and aspecific to your neck for me,
(18:54):
wasn't my arm.
That was done.
My right arm was, I could hold aglass of water.
But I'll tell you one thing I'vebeen involved in this business.
I've spoken to patients not onlywith electrical stimulation, but
when I was involved in IDEtrials for different types of
products and had to speak with,family members post surgery, I
(19:15):
saw the looks on their faces.
I understood what the patientswere going through and I was so
excited when they got throughthe surgery.
I thought it was done.
It's not done.
I have this many months ahead ofme where the biology, the bone
biology in my neck had to healbecause they took my C5, my, my
(19:37):
Fifth cervical vertebral bodyout replaced it with a piece of
medical plastic that mimickedthat body and I had to grow bone
up and down.
I was a, you know what, I was ahigh risk patient.
I had a comorbidity.
I had a multi level fusion.
Um, and so My surgeon did anamazing job.
(19:58):
The x rays looked perfect.
My symptoms were gone.
But I will tell you, now as apatient, as a normal human
being, every morning I woke up,if I had a little twinge in my
neck, if there was a littletwitch in my arm, uh, it
wouldn't matter.
No matter how much information Ihad, and I knew I had this long
journey where I wanted to heal.
I also, by the way, knew that Iwanted to heal before it put too
(20:22):
much stress on my hardware, myscrews, my plates, piece of
plastic.
every single time you feelsomething, you don't know what's
going on, without reference toback the way I used to feel or
how I felt the first week out ofsurgery, whatever, didn't really
know that I was making progress.
My surgeon, he prescribed a noninvasive bone growth stimulator
(20:46):
for my neck.
Got it just before I leftCalifornia and wore it routinely
because I believed in theimportance of electrical
stimulation.
I actually believe that devicewas very helpful in helping me
come to a really great outcome.
As you can see, my neck worksfine.
(21:07):
I have C4 through C6.
I can do everything.
It's a great procedure.
But all the way down And throughthat time, it took many months
until I achieved legitimatespine fusion.
Every step of the way, there'sdoubts, there's concerns.
I had to fly, I was stillworking, Did my neck hurt a lot?
(21:30):
Did I break my cervical plate?
Did I dislodge screws?
There's things that everypatient makes up when you don't
have information.
Actually, it's one of thereasons why we put so much
thought into our product.
to see if we could help patientsduring those long journeys,
understand that they are in factmaking progress.
(21:51):
So as a patient, as a patientthat 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 patientpost operatively.
You don't want to bug yoursurgeon.
You don't want to call theoffice constantly.
You don't want to be on painmedication and you don't know
(22:12):
what's normal.
You don't know what's normal.
So where's my sign markers?
Where's my, where my signpostsand my markers for progress.
So we figured let's, while we'redeveloping this very cool
product, let's see if we can addsomething, to the world that
would help spine fusion patientspostoperatively understand that
(22:32):
they are in fact making goodprogress.
Patrick Kothe (22:36):
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 agift.
It's, it was a nightmare, but itis a gift.
You know, you, you got to, yougot a chance to see something
from a different perspective.
(22:57):
And it's just, A couple of weeksago, I had a little, basal cell
carcinoma that needed to betaken out, taken off my, uh, my
nose from not wearing, uh, youknow, 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, asa patient, You read all the
stuff, you know the stuff, andthen you get in there, and what
(23:19):
I learned is as much as I thinkI'm listening, most of the stuff
that the doctor was saying to mewhen I was in that, in the
chair, and I was listening toit, and I had all this other
stuff going on, so much of itwent right, right past me.
I knew she was talking, but Ididn't hear her.
I didn't hear the instructions.
(23:40):
I didn't understand theinstructions.
and as I came through that, Iwas thinking, geez, that, that
isn't right.
now I know why they give youthese sheets and you have to
read them and reread thembecause you're not able to
accept that information as apatient.
And, and you, as somebody who'sin the business and in the spine
business, you saw it from adifferent spot as well.
(24:04):
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'tknow?
Chris McAuliffe (24:14):
You're a great interviewer.
I just want to tell you becauseyou, 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, twohours away from flying out to
come back to Florida.
I was told how to use it, etcetera, et cetera.
They are pre programmed to go onor off whenever they're supposed
(24:37):
to.
I didn't know whether I wassupposed 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 muchinconsistency when they say, you
know, don't lift a lot ofweight.
(24:59):
lift a lot of weight with myneck.
I got no problem with that.
Is a jug of milk, a lot ofweight on my right arm?
Actually, it actually could bedepending on how much extension
of my arm there was.
I had to have a couple oftelehealth conferences within
(25:19):
the first two weeks, postoperatively, 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 bowlingball on your neck.
You're going to put all of thispressure from all different
forces on your neck and you'regoing to create problems for you
(25:42):
in the healing journey.
yeah, you know what?
I was, I think I was counseledvery clearly.
I had all those sheets of paper.
and What I had hoped is that ourdevice would end up filling in
the void while you're payingattention to your discharge
personnel or your nurse andyou've got all your sheets.
(26:04):
What is it about this journeythat gives you this sense that
you're making progress?
We used to say it's likewatching paint dry, waiting for
your fusion to heal.
I guess, I think actually watch,watching paint dry is easier
because you can see when thepaint is dry.
This is inside your neck, it'sinside your lower back or what
(26:25):
have you.
So what is it?
Well, pain, your pain scores,real time pain scores.
Based on something known as thevisual analog scale of pain.
Everybody knows about that.
Everybody knows, somebody said,what's your pain now?
Between one and ten, you canfigure that out.
But if you, if you respond tothat for two or three months in
(26:48):
a row, you'll realize that whileyou think that you still have
some problems, and you're threemonths into your journey, You're
mostly a three or a two out often now.
When you came out of surgery,you might have been a four.
Makes sense, but if you don'thave that discipline or you
don't have a product that asksyou to check in on that, that's
pretty important.
We also onboarded a three axisaccelerometer into our device.
(27:13):
Our device, this is our deviceright here, Pat.
It's so small.
Patrick Kothe (27:16):
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 youtalk about the recovery period
in here, so we're talking about,a spinal fusion and the recovery
(27:37):
period.
Some procedures have recoveryperiods.
It's a couple of weeks.
You need to do something to, youknow, you need to, you know,
stay outta the water for awhile.
You need to stay outta the sunfor a while.
you can't do it.
Spinal fusion is not a couple ofweeks, is it?
Chris McAuliffe (27:55):
No, it's, it's a really good point.
And I think the medicalcommunity, surgical community,
understands that spine fusionpatients probably don't achieve
a solid fusion any sooner thanfour, and that's on the early
side, six.
(28:17):
My world, our devices treatpatients up to nine months post
operatively and still surgeonslike to see their patients at
one year for a confirmatory xray and they still may have
comments.
They still may have advice tothe patient.
You're a bridging bone.
There's a lot of fusion massthat's forming, but there's some
(28:40):
areas that are still notbridging.
You still need to avoid certainactivities and give your body
that opportunity to heal.
I think that's one of the hardparts about a surgery like I
had, where you get pain reliefso quickly and you feel like a
new person.
You immediately start to pushit.
You start to think about thingsyou can do.
(29:01):
I'm not a physicist.
I'm not a physiatrist.
But when you start thinkingabout moving your body quickly,
or running, or riding a bike onbumps, or trying to play tennis,
you realize you're carrying yourhead on your neck.
Or maybe you're carrying ahundred pounds on your lower
spine.
And the forces that impact thatare very difficult to calculate,
(29:25):
and many of those forces workagainst bone healing.
That's why they put rods andscrews and plates in.
The best way to get them, to geta patient to heal in their spine
fusion is to keep that immobile,allow the bone bridging process
to happen, and then let itmature.
Before that, you have theopportunity to do away with all
(29:47):
that good work that was done.
Patrick Kothe (29:49):
So this period of time, so the surgeon does his
thing, his or her thing, andthen we've got a healing period
of time.
And if the patient doesn't dotheir job, the results of that
surgery are going to be worse Sothis is where you guys step in.
So let's, let's talk aboutTheragen and, your device and
(30:14):
how it works and what itentails.
Chris McAuliffe (30:17):
So Theragen is a specialist in non-invasive
electrical stimulation devices,and our flagship product is
something called Actastim S Itutilizes a technology known as
capacitive coupling.
It's like the most efficient wayto get electricity into the body
because it, if you will, itports electricity directly in.
(30:39):
It doesn't.
Secondarily, induced electricalflow like through a pulsed
electromagnetic field orsomething like that.
So our device is very, verysmall.
It was designed and purposebuilt to be worn around the
clock.
Most of the, um, good researchdemonstrates that.
(30:59):
There's a bit of a dosedependency when it comes to bone
stimulation.
The more you get, the better offyou are.
So we believe in getting as muchin as you can.
So the device has to be verysmall.
If you can imagine, a devicethat's half the size of your
smartphone.
Has two little wires in one inchelectrodes that go on either
(31:21):
side of the back at the level ofthe spine fusion.
It uses a very high frequency,low volt, low amperage signal to
communicate with cells in andaround the fusion site.
And it helps cells that aresupposed to and want to be solid
bone, it helps give them, thatcapacity.
(31:43):
It accelerates healing and itactually increases, the
likelihood of a successful spinefusion.
Our, Our level one, doubleblind, randomly allocated,
placebo controlled study saysthat for any type of spine
fusion, regardless of thecomorbidities, you can expect a
(32:04):
31 percent increase in SpineFusion Success, and that
translates into a 56 percentreduction.
in spine fusion failure.
And many surgeons are just asconcerned about a revision,
having to take a patient backinto hospitals.
The landmarks have beenoftentimes altered.
(32:27):
The landscape looks different.
It's harder to find your wayaround.
And quite frankly, theliterature says on a revision
surgery, success rates aresignificantly less likely than
on a first time in on the spineinfusion.
So if you wanted to encapsulateour mission.
Our mission is to help patientsheal quicker and at a higher
(32:51):
rate after all of the greatthings that spine surgeons did
during the operative procedure.
They saw it, they decompressedit, they figured out what the
best implants should be, whatthe best approach could be from
the back, from the side, fromthe front.
They do all of that great work.
They know what to do.
(33:11):
And then we add that extrameasure of likely success to
that spine fusion patient.
Patrick Kothe (33:19):
So as you said, the product is like two little
ECG electrodes on either side ofthe spine, uh, where, you know,
where that problem occurred.
And then it's wired to a smallcell phone, a small device, like
that.
And you can put it in yourpocket or whatever.
Now it sounds simple, butpatients are not always
(33:42):
compliant.
You know, physicians dosomething and say, okay, take
these, pills twice a day andpatients forget about it.
They're not compliant.
in your instance, where you feltbetter right away.
You knew that you needed tocontinue to do this, but
patients forget.
(34:03):
So tell me about compliance withthe patients with something that
they would need to have longterm four to nine months that
they're going to need to need tohave this, therapy, on them.
and at what point do they startsaying, well, I'm feeling
better.
Do I really need this anymore?
(34:23):
And stop doing it.
so what about patientcompliance?
Chris McAuliffe (34:26):
Boy.
Uh, so you're asking me to solvethe issue of patient compliance.
You know, that has plaguedmedicine, right?
From pharmaceuticals to physicaltherapy and even in our device.
So we started off with the firstthing that seems to make a lot
of sense.
None of these devices work ifyou can't wear them or if you
(34:50):
don't want to wear them.
Or if they're large and theycall attention to you.
And as a patient, what I willtell you is one of the things
that you don't want to bereminded of is your fragility,
your impact in health.
You don't, you're alreadydealing with all these
questions, right?
So you'd like to have a devicethat's discreet.
Ours is, it's worn underneathyour clothing.
(35:12):
It's clipped to your belt or putin a pocket or what have you.
So nobody can see it.
So nobody's asking you all daylong, what is that device?
That's number one.
So it's very small.
The ultimate and compactwearable medical device.
The next thing is when you'rewatching paint dry, when you
want that fusion to heal, you'dlike to have some data, you'd
like to have some indicationthat you are indeed making
(35:35):
progress.
Months and months of adherenceto a therapy is very, very
difficult.
Well, one, you knew the pain youhad.
Some people go through, six toseven months worth of PT and
epidural injections and allthat, trying to get to a non
invasive, non surgical thing.
You know what you felt like, youknow, the fear that you had
(35:58):
before you went in, you know, itfelt like after, and you know,
all the concerns that you haveafterward, you don't ever want
to go back.
So you're looking for help.
So our device, um, demonstratesto patients, one, it takes their
compliance, ratings down to thesecond, the minute, the hour,
the day, et cetera.
And that's important because theliterature says the more you
(36:18):
wear it, the better off you are.
Secondarily, with an onboardedaccelerometer, our device
measures relative patientactivity.
Why is that important?
Because quite frankly, besideseliminating pain, mobility and
activity, return to activitiesof daily living are the number
(36:39):
one goal of all spine fusionpatients.
Everybody wants to get back tothe things that they love.
It doesn't matter whether it'swalking in the mall, getting
your newspaper in your mailbox,picking up your grandchildren.
Doesn't matter.
So we just said, what indicatesor how can we tell patients that
they're actually getting better?
(37:01):
What's really cool is that whenour patients are using the
device, not uncommon for them tobe pretty sedentary,
postoperatively.
A week, maybe a couch potato, Idon't know.
but then all of a sudden theysee that they move from low to
mid to high activity levels, aproportion of movement that they
have during the day.
Regardless of that activity ismeasured.
(37:22):
And then we take thatinformation, we send it to an
app called ActiStim Sync ontheir phone, and it produces
these amazing graphicrepresentations of their daily,
monthly, weekly, activities andyou see this up and to the
right, this movement, increaseand improvement that says, you
know what?
(37:42):
I had a bad day yesterday.
My lower back hurt, but no, I'mso much better than it was pre
op and I'm definitely betterthan the first couple of weeks
when I was post op.
That helps patients stay ontrack.
It's, it's like when you're on adiet.
If you can start to lose twopounds on the first week, you're
motivated to stay.
(38:03):
If you can walk to your mailboxand 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 onemetrics for Spine Fusion
success, is the pain beingreduced.
(38:24):
And postoperatively, a lot ofpeople don't have that immediate
pain release that I had when Ihad my cervical fusion.
Lower back can usually take alot longer.
You have residualradiculopathies and pain signals
going down your legs.
There's a lot of PT, there's alot of therapy that has to go
on.
So, if you're taking your painscores, you can take it up to
(38:45):
three times a day.
And you're noting, and we havethis 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 waspainful when I was sitting,
painful when I was driving in mycar, painful when I was bending
over, lifting up a laundrybasket, and you can note those
(39:06):
things.
guess what?
One, you watch where your paingoes, your doctor's gonna ask,
that's the number one thing thata surgeon's gonna ask their
patient.
How do you feel?
How's the pain?
Secondly, if you have pain, youcan say, I've been keeping score
the last three months.
I noted Interestingly enough, Iwould never would have expected.
I have pain sitting not just assimple as saying then don't sit
(39:28):
because you have to sit.
But now that doctor might say Ihave physical therapists that
can help you with the muscleswith a rehabilitation regiment
that's going to help you buildup your strength in the soft
tissues or stretching orwhatever you have to.
That information is so hard toget if you're a patient and you
see some of your doctor every 90days.
(39:50):
I think I'm pretty, uh, welleducated medical consumer, but
when I go in for my annualphysical, I write all these
things down and I get in thereand the surgeon and my doctor's
going to give me a full 10minutes.
How are you feeling, Chris?
Okay, you sleeping okay?
I've had some difficultysleeping.
When?
I don't remember.
Okay, next subject.
(40:12):
Our device fills in and makesthose dialogues between the
patient and the surgeon, thesupport staff at the office, so
much more productive.
So anyways, I'm proud.
Those are the things that wethought about.
Those are the things thatpatients and surgeons, while we
were developing this productsaid that might be, a real help.
We talked to people who had usedthe other devices that were on
(40:34):
the market previous to ours,which included things that I
developed and launched.
and they told us what they wishthey could see and feel and
hear.
And so we've given them a bunchof information.
You know, what's really cool.
As a DME provider, a durablemedical equipment provider, we
know a lot about our patients.
(40:56):
It's the requirement forinsurance and reimbursement.
So I know patient demographics.
I know the preoperativediagnosis.
I know the intraoperativebecause most insurance companies
and things like Medicare requireop reports.
And then we have all this datapost op many months of
(41:17):
compliance, motion, a relativeactivity of pain.
Pat, can you imagine when peoplestart talking about big data,
machine learning and all that?
We have no dog in the fight whenit comes to implants or a new
way to approach the spine or anorthobiologic.
We're like a dispassionateobserver.
(41:40):
We're collecting all thisinformation.
At some point, we'll be able toapply machine learning.
AI.
And then we'll be able tounderstand, is there a
combination of best practices?
So if you have a male who has abody mass index of 35, little
(42:00):
heavy, ex smoker, Maybe aprednisone, steroid user for a
long time, and we have 200 ofthose types.
And some of them had a posteriorapproach.
Some had far laterals.
Some had a 360.
Some of them had titaniumimplants.
Some of them had unilateralscrew fixation.
(42:21):
All those technical things we'llbe able to put into the stew.
We'll be able to analyze it andwe'll be able to say to
surgeons, if you have this typeof a patient coming up, our data
shows, here's the combinationthat has worked best, especially
when they've been using theActiStim device.
I think that information fromwhat surgeons have told us, from
(42:43):
what editors and publicationshave told us is going to be
really interesting.
I don't think there's any othercompany out there right now that
has this much device based data,along with all of the pre and
the post op stuff, that's goingto be able to provide a an
unbiased eye as to what all thismeans.
Patrick Kothe (43:03):
Tremendous amount of, clarity could come out of
analyzing that data.
It's not only, it's not likeonly compliance, it's how long
should it be done, how long, youknow, based on what procedure is
done.
It's performance of physicians.
I mean, not, not all physiciansare equal.
(43:23):
some will have better clinicalresults than others.
You'll be able to.
look at that, be able to look atimplant types, or as you said,
technique, differences between,different surgeons.
So a tremendous amount of dataprovided that it's analyzed in
the correct way.
So getting, getting, uh, peopleto help you, to really discern
(43:47):
all that is going to be areally, a really critical piece
is to make sure that you'reguided by the right people to
start making those, those cutsas well.
Chris McAuliffe (43:55):
Yes, that's thank you for that comment.
I totally agree with you Youknow in the age of information.
I'm really excited about whatwe're doing because we're using
data today that comes off thedevice that goes through the app
that allows us to bridge betweenthe patient and the surgeon and
then the plans are certainlydown the road for the big data
(44:16):
analysis and trying tounderstand that the correlations
between all these differentpieces of data and we need a
large enough N, a large enoughnumber to make those statistical
analyses mean something, um, butI'm, I'm encouraged and I do, I,
we can already see trendanalyses that, um, that I think
(44:38):
will probably end up in being,statistically significant.
Exciting times, Pat.
Patrick Kothe (44:43):
Yeah.
So I want to go back for asecond because what we, what you
were describing with, the systemand the data coming off of the
Sync product, it almost, it'salmost like you're gamifying the
system, gamifying it for thepatient to keep them engaged.
We know that, the trend is,Patients, when they have a say
(45:05):
in their own health care,they're generally more
compliant, uh, when, and theywant to have more of a direct,
impact on their own health care.
So by providing that vehicle, itkeeps them in, engaged.
When you, you said that you,you, you know, your team started
gathering this data on how to dothat from a variety of different
(45:29):
clinicians and inside as well.
Was this before or after yourpatient experience?
Chris McAuliffe (45:39):
It was in the middle because my surgery
happened in early 20, 2020.
We received our PMA clearance inDecember of 2020, but the design
and the development of ActiStemSync, our app, benefited
(46:02):
greatly.
Because I was here every daytrying to figure out how I was
doing when it came to my fusion,and you're right.
It is every single person nowwho wears a fitness tracker or
carries their iPhone or theirAndroid and they have health
(46:22):
data that comes off of that.
We all expect to have and tounderstand data.
We love to go to the internet tofind answers.
When you can look at a deviceand an app that directly
reflects how well you're doingin your, your therapy, that may
take many months.
(46:43):
You have that sense ofownership, probably the most
important stakeholder.
This whole thing is the patientand so often the patient is
forgotten when it comes toactive participation in the post
op.
I'll get, I'll bet you a milliondollars, that if you asked a
hundred spine surgeons, what isthe biggest negative impact on
(47:06):
their success rate when it comesto fusion?
I bet you 99 say it's what thepatients do postoperatively.
So if we could have an impact,if we could harness the patient,
and helping them understand thatthey're making progress, the
things to avoid to make patientsurgeon discussions that much
(47:28):
more productive and getting tothe point.
Uh, we feel like we're, I guess,gamifying, um, the system,
keeping people engaged.
yeah, I think it's a goodobservation and I, I know that
my experience and the questionsI had certainly had impact on
how we developed it.
Patrick Kothe (47:47):
So this is a prescription device
Chris McAuliffe (47:50):
They are, all of the bone growth stimulators
approved are by prescriptiononly.
Patrick Kothe (47:55):
and who is your customer?
Who is prescribing it?
Chris McAuliffe (47:58):
Um, mostly, orthopedic spine and
neurosurgeons.
There are some ancillarysurgeons that we appreciate
their business, but our market,quite frankly, is those people
that are doing surgeries.
They understand and they mark inadvance those that have high
risk, that have a comorbidityprofile, that might give them
(48:23):
some trouble down the road andthey want to add some extra.
success.
Patrick Kothe (48:28):
And.
Is the product reimbursed?
Chris McAuliffe (48:31):
It is widely reimbursed.
In fact, I've been doing thisfor so long.
I can't, there's never been atime in my life when
reimbursement has gone backward.
Medicare, you would think thatMedicare population is, the vast
majority of our patients.
It isn't, but they are some ofour most treasured customers and
patients.
Uh, they deserve the best.
(48:54):
But Medicare has been a verygood partner, for the bone
growth stimulator industry.
They recognize the value.
And so while you hear year afteryear, that Medicare is cutting
reimbursement, for bone growthstimulation, and it's not,
believe me, it's not over themoon, but they just keep
increasing it.
Because when you add bone growthstimulation to difficult
(49:16):
patient, you more often come upwith a success than not.
Patrick Kothe (49:21):
So I assume there's a few competitors in
this space.
Chris McAuliffe (49:24):
They're really good competitors.
We entered a market when therewere three.
It seemed like a deja vu for mebecause when when I worked at a
company called Bioelectron, wewere the first company that
launched a product that usedcapacitive coupling for spine.
It was a great product, by theway, but it didn't have any of
the digital or connectivitycapabilities that ours did.
(49:46):
But we went into the market,There's a company called
OrthoFix, an outstandingcompany, probably the longest
standing kind of pure bonegrowth stimulator, OG, because
EBI got sold off to Biomet andZimmer and all that.
Uh, when we launched, we cameout against OrthoFix.
We came out against, my oldcompany, Zimmer Biomet, uh, with
(50:09):
my product, SpinalPak, and thenwith DJ Global, with a combined
magnetic field product.
So it literally was identical towhen we exited back in 2000.
Pat, I think that's one of thethings that people should know
is that PMA products aredifficult to change.
They certainly need clinicaldata to make any real changes.
(50:34):
So essentially all the peoplethat I competed with, and the
product with which we competed,SpinalPAC, which is now with a
company called High RidgeMedical, they're identical.
They're the same, been a littlemodifications, maybe some power
pack changes, et cetera, buttheir form factor and their
capabilities and what theyprovide the patient is limited.
(50:55):
They're great products.
Let me just say that.
I used one of them.
They're great.
products.
I am a massive believer that allof them work, but there are
issues like compact design, formfactor, throwing data off that
helps your patients understandwhere they are, helping patients
(51:15):
stay engaged in a many monthslong, treatment.
That's where ActiStim came outas kind of like a best of the
class, right?
from the word go.
Patrick Kothe (51:27):
So when you've got a market that has multiple
players and, and, uh, qualitymultiple players, every company
is searching for a strategiccompetitive advantage.
And sometimes it comes in a formof products.
And sometimes, there's, youknow, depending on the products,
there'll be significantdifferences or not as
significant differences, butthere's other things that we do
(51:49):
to differentiate ourselves as acompany.
You, you.
I've talked about somethingcalled VIP customer care and I
wanted to ask you about that andhow that, how that came about
and how it's been embodiedwithin your company.
Chris McAuliffe (52:08):
Uh, wow.
VIP customer care.
I mean, that, that's essentiallyour DNA.
Uh, it is a patient firstattitude.
We believe if when solving anyproblem, we ask what's the right
thing for our patients, ourprescribers that will usually
lead us to the right answer andthe business will take care of
(52:31):
itself.
if you took every single personin this company and took them
into separate corners and askedthem the two things that have
helped us be successful, througha lot of difficult times one is
the focus on patient andprescriber.
We all know that our customersfirst as a patient followed by
(52:52):
the prescriber, thereimbursement community.
And we believe in that.
our sales network, because theyare the interface with
prescribers, is the fourthcustomer, if you will.
The second issue, or the secondquality, is collaboration.
we truly, have a directcommunication.
(53:14):
philosophy, it's cultural.
Um, you provide feedback andyou, and you receive feedback
routinely.
You leave your ego checked atthe door.
and that also, quite frankly,has, has spawned a culture of
leadership that doesn't come byway of title.
(53:35):
Doesn't come by way of how manypeople you're responsible for.
Leadership is an individualthing.
but VIP customer care, that isour ethos.
that is in our blood.
When you pick up the phone andsomebody needs something, the
very first thing we're alltrained here, myself included,
is how can I make this a onecontact event.
(53:56):
So I can solve something.
Um, so anyways, that, that's howwe built the company.
Patrick Kothe (54:01):
So right before I hit the recording button, today,
you were flashing a piece ofpaper
Chris McAuliffe (54:07):
Uh,
Patrick Kothe (54:07):
and I said, and I said, hold on to it.
I don't want to hear it rightnow, but you said you heard,
heard, heard from a customer.
So, so tell me what the, whatthe customer had to say.
Chris McAuliffe (54:16):
yeah.
So to give this someauthenticity, it came in on a
text for me at 9:12 PM lastnight, um, completely, I promise
you separate and distinct fromthis event that we're having
now, I know this patient.
Um, I, we've had contact.
He was seven months postoperative, spine fusion.
(54:39):
He had residual pain.
There was a fear of hardwarefailure because he wasn't
fusing.
The surgeon told him, that hehad some bridging bone, but it
wasn't fusing and it wasn'tstabilizing.
There were concerns.
He had a number of comorbiditiesthat did not set well when it
came to thinking about arevision surgery, but of course
he could have gone.
(55:00):
So what do you do?
So my experience when I was backin the old days of EBI, when we
use pulse electromagnetic fieldsfor tibia fractures that
wouldn't heal on their own.
I mean, this is before dynamicnailings, before all these great
technologies, we used to putelectrical signals on fractures
that wouldn't heal.
(55:21):
It's Surgeons would say back inthe 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 youknow what three four months
later.
We'd see bridging bones sixmonths later patient was healed.
It's like almost miraculous sothis text really hits home
(55:44):
because it literally completes acircle for me.
and so I'm going to read itexactly as it's, if there's
typos in here, please excuse me.
It says, Gentlemen, hope thisnote finds you in Find you and
find you both well, said to meanother person.
The reason for my note today isto let you know that I saw Dr.
E, I'm leaving the doctor's nameout and we went over my data and
(56:05):
x ray.
The synopsis is good.
I have fused.
I am so happy.
I am so grateful for you allcoming into my life and helping
me heal with state of the artequipment.
May God bless you all in everydepartment of your facility.
And my hope is that you prosperand remember always you are
(56:25):
caregivers.
You are blessed.
And finally, you made adifference in my life.
Thank you.
Thank you.
Thank you.
So let me tell you that, justreading that gave me goosebumps
again.
That's emotional for me.
Um, having come full circle andhave had the good fortune and
(56:49):
blessing of seeing a lot ofpatients spared a revision
surgery or a, or prolongedhealing periods or people can't,
you know, get back intoactivities of daily living, that
was an not a typical patient.
Because we usually treatpatients when the surgeons
identify them post operativelybecause they have different
types of aspects to their healthprofile, but to be able to step
(57:13):
in with a patient who wasn'thealing as well as they wanted
to, when there was real fear ofthe hardware failing and perhaps
having to go back in, andbecause the patient had
comorbidities to start with, itwasn't going to be nearly as
smooth sledding as it was thefirst time, we stepped in.
(57:34):
And with capacitive coupling,with electrical stimulation,
with a little tiny device withtwo little electrodes that the
patient wore.
and I can tell you they wore,many hours a day.
They probably got in 17 to 18hours a day on average.
Uh, they love the data.
They love the fact that theycould put their pain scores in.
And this gentleman ended uphealing.
(57:57):
I'm not going to tell you he'spain free.
Um, I know a little bit behindthe scenes, he's still.
You know, isn't completely, buthe'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'swhat, that's why we do these
things.
I don't know how many people atBoeing or GM or X or Nvidia get
(58:29):
texts like that from customers.
They all make great products.
They're all very important.
I use them, I fly in them, butreally when your company makes
that kind of an impact on apatient, on one life, and we
treat thousands of patients ayear, we have the potential of
(58:49):
having those types ofexperiences and those types of
outcomes literally thousands oftimes a year.
That's what gets us up in themorning.
That's what drives VIP customercare.
And that knowledge, that, thattext is going to be shared in a
little bit of a, like a townhall that we're gonna do.
I'm gonna be very excited toshare that with the entire
(59:11):
company.
Because people are remote.
People are selling and marketingand supporting our customers all
over the country and in twodifferent offices.
I'm in Jacksonville, one inManassas.
Everybody needs to know that.
If you ever wonder why you'redriving into work, if you ever
wonder if you're making adifference, yeah, yes you, we
(59:33):
are.
And by the way, I believe mycompetitors are.
I believe non invasiveelectricity helps many thousands
of patients all across thecountry.
I have a bias in favor of mine,but if, my, any of my family
members, had to go through whatI had to go through, And they
said their doctor prescribed anon invasive electrical stem.
(59:55):
I'd say you bet.
And if they didn't get thatprescription, I say, why don't
you suggest it?
Because you can get texts likethat that validate what you're
doing.
Patrick Kothe (01:00:07):
Chris is passionate about the customers
they serve.
I suspect he always had thatpassion, but I'll bet it went up
a notch or two following his ownjourney in recovery.
A few of my takeaways.
First, think like an end user.
Not only why they buy, but whyand what are they going through
(01:00:33):
at the time they use theirproduct.
You may not get an experiencelike Chris.
But ask the questions, observethe behavior that's going on
around the environment when yourproduct is being used.
And dig down below the surface.
(01:00:56):
Don't just look at what's on thesurface, but try and dig down as
far as you can to get the fullexperience of what an end user
is going through.
The second thing is VIP customerservice.
And a lot of us like to think,yeah, we provide great customer
service.
And, you know, we have the whiteglove treatment, the VIP
(01:01:17):
customer service.
Do you really, is that how youdo everything in your business?
You know, a couple of thingsthat.
Chris talked about focusing onthe customer.
You know, a lot of us thinkthat's what, that's what we're,
we're doing, but you start todig down into it a little bit, a
little bit further.
How can I solve the problem inone call?
(01:01:38):
How can I think through theproduct and how the product is
going to affect that endcustomer in all aspects?
And then how do you make surethat your company has that as an
ethos?
What is, you know, how do youcollaborate?
How do you make sure thateveryone is doing the exact same
thing and has the exact sameview on what VIP customer
(01:02:02):
service is?
The last thing that kind ofstood out was when he talked
about his competitors.
A great amount of respect forhis competitors.
And one of the reasons is hebelieves in his category of
products.
He believes that that categoryis so valuable to the end
customers.
And he's one of those, thosechoices, but there are other
(01:02:25):
choices there too.
You will compete.
You will look for that strategiccompetitive advantage to make
sure that yours is the top ofthat category, but respect your
competitors.
You're all providing valuableservices to the customers.
Thank you for listening.
(01:02:45):
Make sure you get episodesdownloaded to your device
automatically by liking orsubscribing to the Mastering
Medical Device podcast whereveryou get your podcasts.
Also, please spread the word andtell a friend or two to listen
to the Mastering Medical Devicepodcast as interviews like
today's can help you become amore effective medical device
leader.
Work hard.
Be kind.
Welcome.
We get so used to presenting ourproducts to clinicians and
working through the everydaychallenges of a medical device
professional that we often losefocus on the end user
experience.
Also, it can be hard to putyourself into a situation an end
(00:53):
user is actually in.
There are distractions,emotions, outside thoughts, a
lot of different things thatthey're experiencing, but you
don't necessarily know.
That's what makes today'sconversation really interesting.
(01:13):
Our guest today is ChrisMcAuliffe, CEO of Theragen, a
company that provides productsto help patients heal following
spine fusion procedures.
Chris has spent much of hiscareer in the non invasive spine
fusion markets and hascontributed at Biomet,
Bioelectron, Endius, ParadigmSpine, Spinalign, and Neurotech.
(01:40):
What makes this story unique isthat Chris has also been a
patient in the market segment inwhich he serves and that
experience has helped inform histhoughts on product design and
company focus.
In our conversation, we discusshis journey in the medical field
(02:03):
and electrical stimulationmarkets, what spinal fusion is
and its challenges, Patientcompliance, his personal story
of injury and recovery, and howhe uses the experience in his
business, and a special patientcommunication.
(02:24):
Here's our conversation.
Chris, over 30 years in medicaldevice.
That's, that's quite a while.
So what brought you to medicaldevice and what keeps you in?
Chris McAuliffe (02:35):
Early on I was a life science major in biology.
I thought I was going to be adoctor.
Didn't do so well in organicchemistry.
Not an uncommon story.
so I got through and I wasmentored, early on in my career
to take a look at medical devicesales.
I started in pharmaceuticalswith a company that a lot of
people know, Johnson Johnson.
(02:55):
Great training.
Um, and, uh, joined theirpharmaceutical division.
Understood what it takes, tomove products.
We launched a couple of productswhile I was there.
and then I really wanted to moveinto something a little bit more
tangible than pharmaceuticals.
so medical devices were thething that you sold that you
actually saw the results of yourefforts because you did
(03:17):
something.
So I got involved with the kindof the OG of electrical
stimulation, a company calledEBI, back in the mid to late
80's.
Boy, that was a time whenelectrical stimulation was not
particularly well known.
some people called it voodoo.
some people didn't reallyunderstand the power.
(03:37):
but, If you ever saw the movieMatrix, where human beings are
batteries, they think they callthem copper tops or Duracell
batteries, you realize thateverything that you and I are
doing today, speaking,listening, hearing, seeing, is
enabled by electrical signals,bioelectrical, electrochemical.
So we are kind of one bigbattery and I had the great
(04:01):
opportunity, to see things likenine month old tibial fractures
heal with just the applicationof noninvasive electricity.
I became a massive advocate anddisciple of electricity.
I knew we had barely scratchedthe surface.
so that's caught me up there.
(04:22):
I did go back into medicaldevices and Some minimally
invasive technologies, implants,heck, we designed a cervical
plates, posteriors, cervicalfixation.
We designed pedicle screwsystems that you can deliver
through a cannula, kind of likea ship in the bottle.
(04:43):
Those are all very fascinatingthings, but I was called back
into electricity, in 2014, whenthis company was founded.
That's why I'm here, and it tooka rather twisty type of a path.
I think we all know all of thosethings add up and hopefully help
you face challenges and seeopportunities in the future.
Patrick Kothe (05:06):
It's interesting from a career standpoint, we can
put the pieces together lookingbackwards, but many times we
can't look forward and say, thisis how it's going to play out.
But when you look backwards, youcan see, okay, there's a couple
of themes that are runningthrough here and these are the
pieces that I've picked up andthis is how it all fits
together.
So for you, when you lookbackwards, what is that?
(05:28):
What is that theme that thatruns through it?
Chris McAuliffe (05:30):
The science background and the interest in
medicine, and then I wasencouraged to get my master's
degree in business.
and I went to a school calledRensselaer Polytech.
They were a, an engineeringschool.
Uh, what the heck do you go toRensselaer for a business
degree?
but they were very well known atthe time for taking concepts and
(05:51):
pushing them through toinnovation and then to market.
they were, I think at thecutting edge back in the day,
back in the dark ages.
so I decided to go for mymaster's degree that allowed me
to understand better, a moreglobal view of business,
economics, and finances,organizational development,
leadership, and things likethat.
(06:11):
But then I got to drag along, mypassion for medicine and life
sciences.
Patrick Kothe (06:16):
Like you, I've spent time in the plumbing side
of things, working inside,inside arteries.
I've spent time in thestructural thing with heart
valves and structural issues,some carpentry with orthopedics,
and some time in the electricalside of things with ECG
(06:37):
algorithms.
So I've kind of worked thedifferent, the different systems
as well.
Chris McAuliffe (06:42):
We're brothers! We're brothers! We're brothers!
Patrick Kothe (06:46):
but, but to me, I mean, everybody knows their own
strengths, their own interests.
of those areas, the electricalone was more foreign to me.
It didn't fit me as well.
And it's, I guess for this, forthe same reason that when I
tackle household projects, I'lldo the carpentry.
(07:07):
I'll even play around with someof the plumbing, but I won't
touch the electrical side ofthings.
It's just kind of what we're,what we're comfortable with.
So what is it about electricitythat fascinates you?
Chris McAuliffe (07:18):
if you believe, and I think we should believe
that everything we're doingright now is electrically
enabled, that's prettyfascinating.
and we're all familiar with whatyou do mechanically, surgically
going in and manipulatingtissues and putting structures
in to support things.
But if you could figure out away to communicate with cells,
(07:39):
hopefully noninvasively, andhelp them orient themselves to
do something.
And so my early understandingwhen I was interviewing at EBI,
and doing my research is thatthere was a lot, there was a lot
of research out, but not manycommercial products, that were
designed to communicate withcells, these pluripotent types
(08:01):
of cells, these cells thatdidn't know what they wanted to
be when they grew up.
And we could help them arrangeand orient into something
helpful.
for us, it would be taking cellsthat had the capability of
becoming bone cells, deliveringan electrical signal, that
helped, kick off a cascade.
(08:23):
In our instance, we open voltagegated calcium channels.
That's a big, long phrase,right?
But what it does is it allowsionic calcium to stream into a
cell and kick off an importantcascade that leads to DNA and
cell proliferation, more bone.
for me, that's just fascinating.
I I mean, how many more thingscan we, solve without
(08:47):
necessarily going into the bodysurgically?
And by the way, I'm a bigadvocate for surgery.
I've had procedures myself.
Um, but I think if you can stayoutside the body and do
something or at least come inafter a surgery is done and help
those cells know what they wantto be when they grow up, I think
(09:07):
that's a, it's a pretty coolthing to do.
Patrick Kothe (09:10):
So you've spent 22 years now in this non
invasive spine fusion area.
So for the listeners, what isnon invasive spine fusion?
Chris McAuliffe (09:23):
surgeons spend so many years, a decade plus
learning how to diagnose andchoose procedures to help
patients, many times yournerves, your neural elements are
compressed and they have to goin and they need to free them
(09:43):
up.
Sometimes it's a soft tissueremoval like a disc herniation,
but sometimes there's stenosisthat's caused by bone.
And when a surgeon goes in andremoves, the pressure on the
nerves, depending on how muchbone they have to take away, may
require, some stabilization.
That often times comes in theform of pedicle screws and rods.
(10:06):
Can come in the form ofinterbody devices that take the
place of disc, that was removed.
it's all done, for the purposeof creating space for the nerves
and neural elements and thenhelping them fuse into one
motion segment where there was adisc and a little bit of motion
between two vertebral bodies.
(10:26):
Sometimes you need to fuse thatto arrest that motion.
And so the patient has symptomresolution, has pain resolution
down, down the line.
The surgeons do that and they'vegot.
implant technology, they haveinstrument technology, they're
using navigation, they're usingvisual assistance, they're using
(10:51):
augmented reality.
They have all these greattechnologies to get in there, to
navigate, to find out what islikely the pain generator, to
address it.
Sometimes they have to take agood amount of bone or alter the
soft tissue structure so thatthey need to fuse.
Fusion is pretty simple inconcept.
(11:12):
It's two vertebral bodies thatused 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 bonewhere there was no longer any
bone.
So they do all of this greatwork.
They have access to all of thisgreat technology.
And then sometimes, they get inthere and the bone quality just
(11:33):
isn't what they thought it wouldbe.
So they're worried aboutpurchase and stability of their
screw and rod construct.
Sometimes the stenosis, thepressure on the nerve was from a
much larger body, much largerpiece of anatomy that they had
(11:53):
to remove.
And it created a lot ofinstability.
Sometimes the patient was anactive smoker prior to surgery
and they promised they weren't,they were going to stop smoking,
but we know smoking has anegative impact on the
likelihood of how a patient willheal.
So there's all these differenttypes of things and there's
(12:14):
really only one level one proventechnology or therapy that I'm
aware of that can have asignificant impact on helping
all of the hard work, thebrilliance, the technical
expertise that's gone into thatfusion to help it heal at an
(12:35):
even higher rate.
And that's noninvasiveelectrical stimulation.
We can help all of those cellsthat were put there, the fusion
mass, the orthobiologics,everything aligned.
We can then help communicate anddrive bone formation once the
patient's closed.
Once the surgery is done, oncethe patient's out of the
hospital.
(12:55):
Can't do that with any othertechnology, at least none that I
know of.
Patrick Kothe (13:00):
So Chris, the spine runs from your skull all
the way down, down to yourtailbone.
What parts of the spine are themost common areas where people
have fusion?
Chris McAuliffe (13:16):
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 yoursacrum, which attaches to your
ilium, which sets up yourability to attach your, your
femurs and impacts your gait andyour stature and how you move
(13:36):
about life.
But that S1 up to L1 area, thelower back, is the most
problematic and it's because ofgravity in the design.
it's where most of your weightpresses down at the lower end of
the spine.
And so depending on, uh, well,some is genetics, some is
(13:59):
activity, some is lifestyle.
Sometimes it's just some type ofan injury or trauma, but there
are times when that area, has asignificantly higher likelihood
of neural impingement.
And that's where A lot ofsurgeons go in to do their work.
Not uncommon to have L5 S1, L4L5 S1 for a multi level type of
(14:24):
effusion.
And then as you go up the spineto the thoracic region, anytime
you switch the curves fromlordosis, up to all the way up
to the cervical region, you havethese kyphotic curves.
Then it goes back to lordosis.
Each juncture from lumbar tothoracic and then thoracic to
(14:45):
cervical, those apical regions,those transition regions are
particularly problematic whenspine surgeons need to go in,
perform a decompression andperhaps fuse those motion
segments
Patrick Kothe (15:00):
We all know people who've had back issues
and some of us have had themourselves.
It can be debilitating, not onlydealing with the pain, but just
the ability to be mobile.
You had a, you had anexperience, yourself personally.
Can you walk us through what youwent through?
(15:22):
when it happened and what wasgoing on with you?
Chris McAuliffe (15:24):
Do I have to, do I
Patrick Kothe (15:25):
Ah! ha! ha, ha, ha!
Chris McAuliffe (15:26):
do I have to relive that time?
All right.
So, um, yeah, I did.
I did.
And so, um, in the Marchtimeframe of 2020, we know that
coincided with COVID.
Patrick Kothe (15:41):
else happened out there in the
Chris McAuliffe (15:42):
Yeah.
I was, doing some work, in treesin my front yard.
Manipulating things and sawingbranches and stuff.
And, that night I felt, someburning and some pain down my
right arm.
From my shoulder down to myright arm, but settled in my
right elbow.
(16:04):
When morning time came, I wasreduced to, a useless human
being.
I had so much pain and stabbing,in my upper right arm.
It was starting to get down alittle bit towards my middle of
my forearm.
nothing that I could take,certainly over the counter, was
touching it.
(16:25):
The pain was consuming.
you would do anything to get ridof that pain.
So I've had the blessing ofworking with a lot of really
great surgeons called a coupleof them.
One of them wrote, orders to getan MRI and a, an x ray.
And I got them and I got adigital copy and I sent them out
(16:45):
to four surgeons that Irespected a great deal.
Every one of them came back andsaid, I see the problem.
Your C5 in your neck isdestroyed.
It's like a pile of rubble.
You have massive impingement onthe nerves, especially coming
(17:05):
out at the right side and yougot a big problem because your
cervical spine is now thrown outof balance and there's nothing
you can do but have some type ofa surgery.
They look at the MRs.
They saw the impingement on thenerve reads.
So I chose a surgeon, who had agood plan for me.
Interestingly, I went to thehospital.
(17:29):
I flew all the way out, to SanDiego.
this, the hospital is closeddown.
They met me in the parking lot.
I put a mask on.
They wouldn't let my wife comein and even wait for me.
They led me into the hospital.
It's very scary, very surreal.
Um, got undressed, put myclothes underneath my head, laid
on the gurney.
(17:50):
And the anesthesiologist came inand 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.
(18:10):
I've been doing lumbar,thoracic, you know, scoli types
of surgeries with really goodsurgeons.
Always hearing about the pain,but never really understanding
what you would do to get pastthat pain.
So, I had to stay in a hotel outthere.
My wife was there.
I was able to walk thatafternoon.
(18:32):
The next day I walked three anda half miles.
Man, I was on cloud nine.
Stayed the requisite amount oftime.
Flew back to Jacksonville, whichis where I work.
Week and a half goes by.
I guess all of the anestheticsand all the systemic things go,
you start weaning yourself offand you start to feel a little
bit coming back in and aspecific to your neck for me,
(18:54):
wasn't my arm.
That was done.
My right arm was, I could hold aglass of water.
But I'll tell you one thing I'vebeen involved in this business.
I've spoken to patients not onlywith electrical stimulation, but
when I was involved in IDEtrials for different types of
products and had to speak with,family members post surgery, I
(19:15):
saw the looks on their faces.
I understood what the patientswere going through and I was so
excited when they got throughthe surgery.
I thought it was done.
It's not done.
I have this many months ahead ofme where the biology, the bone
biology in my neck had to healbecause they took my C5, my, my
(19:37):
Fifth cervical vertebral bodyout replaced it with a piece of
medical plastic that mimickedthat body and I had to grow bone
up and down.
I was a, you know what, I was ahigh risk patient.
I had a comorbidity.
I had a multi level fusion.
Um, and so My surgeon did anamazing job.
(19:58):
The x rays looked perfect.
My symptoms were gone.
But I will tell you, now as apatient, as a normal human
being, every morning I woke up,if I had a little twinge in my
neck, if there was a littletwitch in my arm, uh, it
wouldn't matter.
No matter how much information Ihad, and I knew I had this long
journey where I wanted to heal.
I also, by the way, knew that Iwanted to heal before it put too
(20:22):
much stress on my hardware, myscrews, my plates, piece of
plastic.
every single time you feelsomething, you don't know what's
going on, without reference toback the way I used to feel or
how I felt the first week out ofsurgery, whatever, didn't really
know that I was making progress.
My surgeon, he prescribed a noninvasive bone growth stimulator
(20:46):
for my neck.
Got it just before I leftCalifornia and wore it routinely
because I believed in theimportance of electrical
stimulation.
I actually believe that devicewas very helpful in helping me
come to a really great outcome.
As you can see, my neck worksfine.
(21:07):
I have C4 through C6.
I can do everything.
It's a great procedure.
But all the way down And throughthat time, it took many months
until I achieved legitimatespine fusion.
Every step of the way, there'sdoubts, there's concerns.
I had to fly, I was stillworking, Did my neck hurt a lot?
(21:30):
Did I break my cervical plate?
Did I dislodge screws?
There's things that everypatient makes up when you don't
have information.
Actually, it's one of thereasons why we put so much
thought into our product.
to see if we could help patientsduring those long journeys,
understand that they are in factmaking progress.
(21:51):
So as a patient, as a patientthat 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 patientpost operatively.
You don't want to bug yoursurgeon.
You don't want to call theoffice constantly.
You don't want to be on painmedication and you don't know
(22:12):
what's normal.
You don't know what's normal.
So where's my sign markers?
Where's my, where my signpostsand my markers for progress.
So we figured let's, while we'redeveloping this very cool
product, let's see if we can addsomething, to the world that
would help spine fusion patientspostoperatively understand that
(22:32):
they are in fact making goodprogress.
Patrick Kothe (22:36):
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 agift.
It's, it was a nightmare, but itis a gift.
You know, you, you got to, yougot a chance to see something
from a different perspective.
(22:57):
And it's just, A couple of weeksago, I had a little, basal cell
carcinoma that needed to betaken out, taken off my, uh, my
nose from not wearing, uh, youknow, 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, asa patient, You read all the
stuff, you know the stuff, andthen you get in there, and what
(23:19):
I learned is as much as I thinkI'm listening, most of the stuff
that the doctor was saying to mewhen I was in that, in the
chair, and I was listening toit, and I had all this other
stuff going on, so much of itwent right, right past me.
I knew she was talking, but Ididn't hear her.
I didn't hear the instructions.
(23:40):
I didn't understand theinstructions.
and as I came through that, Iwas thinking, geez, that, that
isn't right.
now I know why they give youthese sheets and you have to
read them and reread thembecause you're not able to
accept that information as apatient.
And, and you, as somebody who'sin the business and in the spine
business, you saw it from adifferent spot as well.
(24:04):
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'tknow?
Chris McAuliffe (24:14):
You're a great interviewer.
I just want to tell you becauseyou, 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, twohours away from flying out to
come back to Florida.
I was told how to use it, etcetera, et cetera.
They are pre programmed to go onor off whenever they're supposed
(24:37):
to.
I didn't know whether I wassupposed 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 muchinconsistency when they say, you
know, don't lift a lot ofweight.
(24:59):
lift a lot of weight with myneck.
I got no problem with that.
Is a jug of milk, a lot ofweight on my right arm?
Actually, it actually could bedepending on how much extension
of my arm there was.
I had to have a couple oftelehealth conferences within
(25:19):
the first two weeks, postoperatively, 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 bowlingball on your neck.
You're going to put all of thispressure from all different
forces on your neck and you'regoing to create problems for you
(25:42):
in the healing journey.
yeah, you know what?
I was, I think I was counseledvery clearly.
I had all those sheets of paper.
and What I had hoped is that ourdevice would end up filling in
the void while you're payingattention to your discharge
personnel or your nurse andyou've got all your sheets.
(26:04):
What is it about this journeythat gives you this sense that
you're making progress?
We used to say it's likewatching paint dry, waiting for
your fusion to heal.
I guess, I think actually watch,watching paint dry is easier
because you can see when thepaint is dry.
This is inside your neck, it'sinside your lower back or what
(26:25):
have you.
So what is it?
Well, pain, your pain scores,real time pain scores.
Based on something known as thevisual analog scale of pain.
Everybody knows about that.
Everybody knows, somebody said,what's your pain now?
Between one and ten, you canfigure that out.
But if you, if you respond tothat for two or three months in
(26:48):
a row, you'll realize that whileyou think that you still have
some problems, and you're threemonths into your journey, You're
mostly a three or a two out often now.
When you came out of surgery,you might have been a four.
Makes sense, but if you don'thave that discipline or you
don't have a product that asksyou to check in on that, that's
pretty important.
We also onboarded a three axisaccelerometer into our device.
(27:13):
Our device, this is our deviceright here, Pat.
It's so small.
Patrick Kothe (27:16):
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 youtalk about the recovery period
in here, so we're talking about,a spinal fusion and the recovery
(27:37):
period.
Some procedures have recoveryperiods.
It's a couple of weeks.
You need to do something to, youknow, you need to, you know,
stay outta the water for awhile.
You need to stay outta the sunfor a while.
you can't do it.
Spinal fusion is not a couple ofweeks, is it?
Chris McAuliffe (27:55):
No, it's, it's a really good point.
And I think the medicalcommunity, surgical community,
understands that spine fusionpatients probably don't achieve
a solid fusion any sooner thanfour, and that's on the early
side, six.
(28:17):
My world, our devices treatpatients up to nine months post
operatively and still surgeonslike to see their patients at
one year for a confirmatory xray and they still may have
comments.
They still may have advice tothe patient.
You're a bridging bone.
There's a lot of fusion massthat's forming, but there's some
(28:40):
areas that are still notbridging.
You still need to avoid certainactivities and give your body
that opportunity to heal.
I think that's one of the hardparts about a surgery like I
had, where you get pain reliefso quickly and you feel like a
new person.
You immediately start to pushit.
You start to think about thingsyou can do.
(29:01):
I'm not a physicist.
I'm not a physiatrist.
But when you start thinkingabout moving your body quickly,
or running, or riding a bike onbumps, or trying to play tennis,
you realize you're carrying yourhead on your neck.
Or maybe you're carrying ahundred pounds on your lower
spine.
And the forces that impact thatare very difficult to calculate,
(29:25):
and many of those forces workagainst bone healing.
That's why they put rods andscrews and plates in.
The best way to get them, to geta patient to heal in their spine
fusion is to keep that immobile,allow the bone bridging process
to happen, and then let itmature.
Before that, you have theopportunity to do away with all
(29:47):
that good work that was done.
Patrick Kothe (29:49):
So this period of time, so the surgeon does his
thing, his or her thing, andthen we've got a healing period
of time.
And if the patient doesn't dotheir job, the results of that
surgery are going to be worse Sothis is where you guys step in.
So let's, let's talk aboutTheragen and, your device and
(30:14):
how it works and what itentails.
Chris McAuliffe (30:17):
So Theragen is a specialist in non-invasive
electrical stimulation devices,and our flagship product is
something called Actastim S Itutilizes a technology known as
capacitive coupling.
It's like the most efficient wayto get electricity into the body
because it, if you will, itports electricity directly in.
(30:39):
It doesn't.
Secondarily, induced electricalflow like through a pulsed
electromagnetic field orsomething like that.
So our device is very, verysmall.
It was designed and purposebuilt to be worn around the
clock.
Most of the, um, good researchdemonstrates that.
(30:59):
There's a bit of a dosedependency when it comes to bone
stimulation.
The more you get, the better offyou are.
So we believe in getting as muchin as you can.
So the device has to be verysmall.
If you can imagine, a devicethat's half the size of your
smartphone.
Has two little wires in one inchelectrodes that go on either
(31:21):
side of the back at the level ofthe spine fusion.
It uses a very high frequency,low volt, low amperage signal to
communicate with cells in andaround the fusion site.
And it helps cells that aresupposed to and want to be solid
bone, it helps give them, thatcapacity.
(31:43):
It accelerates healing and itactually increases, the
likelihood of a successful spinefusion.
Our, Our level one, doubleblind, randomly allocated,
placebo controlled study saysthat for any type of spine
fusion, regardless of thecomorbidities, you can expect a
(32:04):
31 percent increase in SpineFusion Success, and that
translates into a 56 percentreduction.
in spine fusion failure.
And many surgeons are just asconcerned about a revision,
having to take a patient backinto hospitals.
The landmarks have beenoftentimes altered.
(32:27):
The landscape looks different.
It's harder to find your wayaround.
And quite frankly, theliterature says on a revision
surgery, success rates aresignificantly less likely than
on a first time in on the spineinfusion.
So if you wanted to encapsulateour mission.
Our mission is to help patientsheal quicker and at a higher
(32:51):
rate after all of the greatthings that spine surgeons did
during the operative procedure.
They saw it, they decompressedit, they figured out what the
best implants should be, whatthe best approach could be from
the back, from the side, fromthe front.
They do all of that great work.
They know what to do.
(33:11):
And then we add that extrameasure of likely success to
that spine fusion patient.
Patrick Kothe (33:19):
So as you said, the product is like two little
ECG electrodes on either side ofthe spine, uh, where, you know,
where that problem occurred.
And then it's wired to a smallcell phone, a small device, like
that.
And you can put it in yourpocket or whatever.
Now it sounds simple, butpatients are not always
(33:42):
compliant.
You know, physicians dosomething and say, okay, take
these, pills twice a day andpatients forget about it.
They're not compliant.
in your instance, where you feltbetter right away.
You knew that you needed tocontinue to do this, but
patients forget.
(34:03):
So tell me about compliance withthe patients with something that
they would need to have longterm four to nine months that
they're going to need to need tohave this, therapy, on them.
and at what point do they startsaying, well, I'm feeling
better.
Do I really need this anymore?
(34:23):
And stop doing it.
so what about patientcompliance?
Chris McAuliffe (34:26):
Boy.
Uh, so you're asking me to solvethe issue of patient compliance.
You know, that has plaguedmedicine, right?
From pharmaceuticals to physicaltherapy and even in our device.
So we started off with the firstthing that seems to make a lot
of sense.
None of these devices work ifyou can't wear them or if you
(34:50):
don't want to wear them.
Or if they're large and theycall attention to you.
And as a patient, what I willtell you is one of the things
that you don't want to bereminded of is your fragility,
your impact in health.
You don't, you're alreadydealing with all these
questions, right?
So you'd like to have a devicethat's discreet.
Ours is, it's worn underneathyour clothing.
(35:12):
It's clipped to your belt or putin a pocket or what have you.
So nobody can see it.
So nobody's asking you all daylong, what is that device?
That's number one.
So it's very small.
The ultimate and compactwearable medical device.
The next thing is when you'rewatching paint dry, when you
want that fusion to heal, you'dlike to have some data, you'd
like to have some indicationthat you are indeed making
(35:35):
progress.
Months and months of adherenceto a therapy is very, very
difficult.
Well, one, you knew the pain youhad.
Some people go through, six toseven months worth of PT and
epidural injections and allthat, trying to get to a non
invasive, non surgical thing.
You know what you felt like, youknow, the fear that you had
(35:58):
before you went in, you know, itfelt like after, and you know,
all the concerns that you haveafterward, you don't ever want
to go back.
So you're looking for help.
So our device, um, demonstratesto patients, one, it takes their
compliance, ratings down to thesecond, the minute, the hour,
the day, et cetera.
And that's important because theliterature says the more you
(36:18):
wear it, the better off you are.
Secondarily, with an onboardedaccelerometer, our device
measures relative patientactivity.
Why is that important?
Because quite frankly, besideseliminating pain, mobility and
activity, return to activitiesof daily living are the number
(36:39):
one goal of all spine fusionpatients.
Everybody wants to get back tothe things that they love.
It doesn't matter whether it'swalking in the mall, getting
your newspaper in your mailbox,picking up your grandchildren.
Doesn't matter.
So we just said, what indicatesor how can we tell patients that
they're actually getting better?
(37:01):
What's really cool is that whenour patients are using the
device, not uncommon for them tobe pretty sedentary,
postoperatively.
A week, maybe a couch potato, Idon't know.
but then all of a sudden theysee that they move from low to
mid to high activity levels, aproportion of movement that they
have during the day.
Regardless of that activity ismeasured.
(37:22):
And then we take thatinformation, we send it to an
app called ActiStim Sync ontheir phone, and it produces
these amazing graphicrepresentations of their daily,
monthly, weekly, activities andyou see this up and to the
right, this movement, increaseand improvement that says, you
know what?
(37:42):
I had a bad day yesterday.
My lower back hurt, but no, I'mso much better than it was pre
op and I'm definitely betterthan the first couple of weeks
when I was post op.
That helps patients stay ontrack.
It's, it's like when you're on adiet.
If you can start to lose twopounds on the first week, you're
motivated to stay.
(38:03):
If you can walk to your mailboxand 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 onemetrics for Spine Fusion
success, is the pain beingreduced.
(38:24):
And postoperatively, a lot ofpeople don't have that immediate
pain release that I had when Ihad my cervical fusion.
Lower back can usually take alot longer.
You have residualradiculopathies and pain signals
going down your legs.
There's a lot of PT, there's alot of therapy that has to go
on.
So, if you're taking your painscores, you can take it up to
(38:45):
three times a day.
And you're noting, and we havethis 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 waspainful when I was sitting,
painful when I was driving in mycar, painful when I was bending
over, lifting up a laundrybasket, and you can note those
(39:06):
things.
guess what?
One, you watch where your paingoes, your doctor's gonna ask,
that's the number one thing thata surgeon's gonna ask their
patient.
How do you feel?
How's the pain?
Secondly, if you have pain, youcan say, I've been keeping score
the last three months.
I noted Interestingly enough, Iwould never would have expected.
I have pain sitting not just assimple as saying then don't sit
(39:28):
because you have to sit.
But now that doctor might say Ihave physical therapists that
can help you with the muscleswith a rehabilitation regiment
that's going to help you buildup your strength in the soft
tissues or stretching orwhatever you have to.
That information is so hard toget if you're a patient and you
see some of your doctor every 90days.
(39:50):
I think I'm pretty, uh, welleducated medical consumer, but
when I go in for my annualphysical, I write all these
things down and I get in thereand the surgeon and my doctor's
going to give me a full 10minutes.
How are you feeling, Chris?
Okay, you sleeping okay?
I've had some difficultysleeping.
When?
I don't remember.
Okay, next subject.
(40:12):
Our device fills in and makesthose dialogues between the
patient and the surgeon, thesupport staff at the office, so
much more productive.
So anyways, I'm proud.
Those are the things that wethought about.
Those are the things thatpatients and surgeons, while we
were developing this productsaid that might be, a real help.
We talked to people who had usedthe other devices that were on
(40:34):
the market previous to ours,which included things that I
developed and launched.
and they told us what they wishthey could see and feel and
hear.
And so we've given them a bunchof information.
You know, what's really cool.
As a DME provider, a durablemedical equipment provider, we
know a lot about our patients.
(40:56):
It's the requirement forinsurance and reimbursement.
So I know patient demographics.
I know the preoperativediagnosis.
I know the intraoperativebecause most insurance companies
and things like Medicare requireop reports.
And then we have all this datapost op many months of
(41:17):
compliance, motion, a relativeactivity of pain.
Pat, can you imagine when peoplestart talking about big data,
machine learning and all that?
We have no dog in the fight whenit comes to implants or a new
way to approach the spine or anorthobiologic.
We're like a dispassionateobserver.
(41:40):
We're collecting all thisinformation.
At some point, we'll be able toapply machine learning.
AI.
And then we'll be able tounderstand, is there a
combination of best practices?
So if you have a male who has abody mass index of 35, little
(42:00):
heavy, ex smoker, Maybe aprednisone, steroid user for a
long time, and we have 200 ofthose types.
And some of them had a posteriorapproach.
Some had far laterals.
Some had a 360.
Some of them had titaniumimplants.
Some of them had unilateralscrew fixation.
(42:21):
All those technical things we'llbe able to put into the stew.
We'll be able to analyze it andwe'll be able to say to
surgeons, if you have this typeof a patient coming up, our data
shows, here's the combinationthat has worked best, especially
when they've been using theActiStim device.
I think that information fromwhat surgeons have told us, from
(42:43):
what editors and publicationshave told us is going to be
really interesting.
I don't think there's any othercompany out there right now that
has this much device based data,along with all of the pre and
the post op stuff, that's goingto be able to provide a an
unbiased eye as to what all thismeans.
Patrick Kothe (43:03):
Tremendous amount of, clarity could come out of
analyzing that data.
It's not only, it's not likeonly compliance, it's how long
should it be done, how long, youknow, based on what procedure is
done.
It's performance of physicians.
I mean, not, not all physiciansare equal.
(43:23):
some will have better clinicalresults than others.
You'll be able to.
look at that, be able to look atimplant types, or as you said,
technique, differences between,different surgeons.
So a tremendous amount of dataprovided that it's analyzed in
the correct way.
So getting, getting, uh, peopleto help you, to really discern
(43:47):
all that is going to be areally, a really critical piece
is to make sure that you'reguided by the right people to
start making those, those cutsas well.
Chris McAuliffe (43:55):
Yes, that's thank you for that comment.
I totally agree with you Youknow in the age of information.
I'm really excited about whatwe're doing because we're using
data today that comes off thedevice that goes through the app
that allows us to bridge betweenthe patient and the surgeon and
then the plans are certainlydown the road for the big data
(44:16):
analysis and trying tounderstand that the correlations
between all these differentpieces of data and we need a
large enough N, a large enoughnumber to make those statistical
analyses mean something, um, butI'm, I'm encouraged and I do, I,
we can already see trendanalyses that, um, that I think
(44:38):
will probably end up in being,statistically significant.
Exciting times, Pat.
Patrick Kothe (44:43):
Yeah.
So I want to go back for asecond because what we, what you
were describing with, the systemand the data coming off of the
Sync product, it almost, it'salmost like you're gamifying the
system, gamifying it for thepatient to keep them engaged.
We know that, the trend is,Patients, when they have a say
(45:05):
in their own health care,they're generally more
compliant, uh, when, and theywant to have more of a direct,
impact on their own health care.
So by providing that vehicle, itkeeps them in, engaged.
When you, you said that you,you, you know, your team started
gathering this data on how to dothat from a variety of different
(45:29):
clinicians and inside as well.
Was this before or after yourpatient experience?
Chris McAuliffe (45:39):
It was in the middle because my surgery
happened in early 20, 2020.
We received our PMA clearance inDecember of 2020, but the design
and the development of ActiStemSync, our app, benefited
(46:02):
greatly.
Because I was here every daytrying to figure out how I was
doing when it came to my fusion,and you're right.
It is every single person nowwho wears a fitness tracker or
carries their iPhone or theirAndroid and they have health
(46:22):
data that comes off of that.
We all expect to have and tounderstand data.
We love to go to the internet tofind answers.
When you can look at a deviceand an app that directly
reflects how well you're doingin your, your therapy, that may
take many months.
(46:43):
You have that sense ofownership, probably the most
important stakeholder.
This whole thing is the patientand so often the patient is
forgotten when it comes toactive participation in the post
op.
I'll get, I'll bet you a milliondollars, that if you asked a
hundred spine surgeons, what isthe biggest negative impact on
(47:06):
their success rate when it comesto fusion?
I bet you 99 say it's what thepatients do postoperatively.
So if we could have an impact,if we could harness the patient,
and helping them understand thatthey're making progress, the
things to avoid to make patientsurgeon discussions that much
(47:28):
more productive and getting tothe point.
Uh, we feel like we're, I guess,gamifying, um, the system,
keeping people engaged.
yeah, I think it's a goodobservation and I, I know that
my experience and the questionsI had certainly had impact on
how we developed it.
Patrick Kothe (47:47):
So this is a prescription device
Chris McAuliffe (47:50):
They are, all of the bone growth stimulators
approved are by prescriptiononly.
Patrick Kothe (47:55):
and who is your customer?
Who is prescribing it?
Chris McAuliffe (47:58):
Um, mostly, orthopedic spine and
neurosurgeons.
There are some ancillarysurgeons that we appreciate
their business, but our market,quite frankly, is those people
that are doing surgeries.
They understand and they mark inadvance those that have high
risk, that have a comorbidityprofile, that might give them
(48:23):
some trouble down the road andthey want to add some extra.
success.
Patrick Kothe (48:28):
And.
Is the product reimbursed?
Chris McAuliffe (48:31):
It is widely reimbursed.
In fact, I've been doing thisfor so long.
I can't, there's never been atime in my life when
reimbursement has gone backward.
Medicare, you would think thatMedicare population is, the vast
majority of our patients.
It isn't, but they are some ofour most treasured customers and
patients.
Uh, they deserve the best.
(48:54):
But Medicare has been a verygood partner, for the bone
growth stimulator industry.
They recognize the value.
And so while you hear year afteryear, that Medicare is cutting
reimbursement, for bone growthstimulation, and it's not,
believe me, it's not over themoon, but they just keep
increasing it.
Because when you add bone growthstimulation to difficult
(49:16):
patient, you more often come upwith a success than not.
Patrick Kothe (49:21):
So I assume there's a few competitors in
this space.
Chris McAuliffe (49:24):
They're really good competitors.
We entered a market when therewere three.
It seemed like a deja vu for mebecause when when I worked at a
company called Bioelectron, wewere the first company that
launched a product that usedcapacitive coupling for spine.
It was a great product, by theway, but it didn't have any of
the digital or connectivitycapabilities that ours did.
(49:46):
But we went into the market,There's a company called
OrthoFix, an outstandingcompany, probably the longest
standing kind of pure bonegrowth stimulator, OG, because
EBI got sold off to Biomet andZimmer and all that.
Uh, when we launched, we cameout against OrthoFix.
We came out against, my oldcompany, Zimmer Biomet, uh, with
(50:09):
my product, SpinalPak, and thenwith DJ Global, with a combined
magnetic field product.
So it literally was identical towhen we exited back in 2000.
Pat, I think that's one of thethings that people should know
is that PMA products aredifficult to change.
They certainly need clinicaldata to make any real changes.
(50:34):
So essentially all the peoplethat I competed with, and the
product with which we competed,SpinalPAC, which is now with a
company called High RidgeMedical, they're identical.
They're the same, been a littlemodifications, maybe some power
pack changes, et cetera, buttheir form factor and their
capabilities and what theyprovide the patient is limited.
(50:55):
They're great products.
Let me just say that.
I used one of them.
They're great.
products.
I am a massive believer that allof them work, but there are
issues like compact design, formfactor, throwing data off that
helps your patients understandwhere they are, helping patients
(51:15):
stay engaged in a many monthslong, treatment.
That's where ActiStim came outas kind of like a best of the
class, right?
from the word go.
Patrick Kothe (51:27):
So when you've got a market that has multiple
players and, and, uh, qualitymultiple players, every company
is searching for a strategiccompetitive advantage.
And sometimes it comes in a formof products.
And sometimes, there's, youknow, depending on the products,
there'll be significantdifferences or not as
significant differences, butthere's other things that we do
(51:49):
to differentiate ourselves as acompany.
You, you.
I've talked about somethingcalled VIP customer care and I
wanted to ask you about that andhow that, how that came about
and how it's been embodiedwithin your company.
Chris McAuliffe (52:08):
Uh, wow.
VIP customer care.
I mean, that, that's essentiallyour DNA.
Uh, it is a patient firstattitude.
We believe if when solving anyproblem, we ask what's the right
thing for our patients, ourprescribers that will usually
lead us to the right answer andthe business will take care of
(52:31):
itself.
if you took every single personin this company and took them
into separate corners and askedthem the two things that have
helped us be successful, througha lot of difficult times one is
the focus on patient andprescriber.
We all know that our customersfirst as a patient followed by
(52:52):
the prescriber, thereimbursement community.
And we believe in that.
our sales network, because theyare the interface with
prescribers, is the fourthcustomer, if you will.
The second issue, or the secondquality, is collaboration.
we truly, have a directcommunication.
(53:14):
philosophy, it's cultural.
Um, you provide feedback andyou, and you receive feedback
routinely.
You leave your ego checked atthe door.
and that also, quite frankly,has, has spawned a culture of
leadership that doesn't come byway of title.
(53:35):
Doesn't come by way of how manypeople you're responsible for.
Leadership is an individualthing.
but VIP customer care, that isour ethos.
that is in our blood.
When you pick up the phone andsomebody needs something, the
very first thing we're alltrained here, myself included,
is how can I make this a onecontact event.
(53:56):
So I can solve something.
Um, so anyways, that, that's howwe built the company.
Patrick Kothe (54:01):
So right before I hit the recording button, today,
you were flashing a piece ofpaper
Chris McAuliffe (54:07):
Uh,
Patrick Kothe (54:07):
and I said, and I said, hold on to it.
I don't want to hear it rightnow, but you said you heard,
heard, heard from a customer.
So, so tell me what the, whatthe customer had to say.
Chris McAuliffe (54:16):
yeah.
So to give this someauthenticity, it came in on a
text for me at 9:12 PM lastnight, um, completely, I promise
you separate and distinct fromthis event that we're having
now, I know this patient.
Um, I, we've had contact.
He was seven months postoperative, spine fusion.
(54:39):
He had residual pain.
There was a fear of hardwarefailure because he wasn't
fusing.
The surgeon told him, that hehad some bridging bone, but it
wasn't fusing and it wasn'tstabilizing.
There were concerns.
He had a number of comorbiditiesthat did not set well when it
came to thinking about arevision surgery, but of course
he could have gone.
(55:00):
So what do you do?
So my experience when I was backin the old days of EBI, when we
use pulse electromagnetic fieldsfor tibia fractures that
wouldn't heal on their own.
I mean, this is before dynamicnailings, before all these great
technologies, we used to putelectrical signals on fractures
that wouldn't heal.
(55:21):
It's Surgeons would say back inthe 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 youknow what three four months
later.
We'd see bridging bones sixmonths later patient was healed.
It's like almost miraculous sothis text really hits home
(55:44):
because it literally completes acircle for me.
and so I'm going to read itexactly as it's, if there's
typos in here, please excuse me.
It says, Gentlemen, hope thisnote finds you in Find you and
find you both well, said to meanother person.
The reason for my note today isto let you know that I saw Dr.
E, I'm leaving the doctor's nameout and we went over my data and
(56:05):
x ray.
The synopsis is good.
I have fused.
I am so happy.
I am so grateful for you allcoming into my life and helping
me heal with state of the artequipment.
May God bless you all in everydepartment of your facility.
And my hope is that you prosperand remember always you are
(56:25):
caregivers.
You are blessed.
And finally, you made adifference in my life.
Thank you.
Thank you.
Thank you.
So let me tell you that, justreading that gave me goosebumps
again.
That's emotional for me.
Um, having come full circle andhave had the good fortune and
(56:49):
blessing of seeing a lot ofpatients spared a revision
surgery or a, or prolongedhealing periods or people can't,
you know, get back intoactivities of daily living, that
was an not a typical patient.
Because we usually treatpatients when the surgeons
identify them post operativelybecause they have different
types of aspects to their healthprofile, but to be able to step
(57:13):
in with a patient who wasn'thealing as well as they wanted
to, when there was real fear ofthe hardware failing and perhaps
having to go back in, andbecause the patient had
comorbidities to start with, itwasn't going to be nearly as
smooth sledding as it was thefirst time, we stepped in.
(57:34):
And with capacitive coupling,with electrical stimulation,
with a little tiny device withtwo little electrodes that the
patient wore.
and I can tell you they wore,many hours a day.
They probably got in 17 to 18hours a day on average.
Uh, they love the data.
They love the fact that theycould put their pain scores in.
And this gentleman ended uphealing.
(57:57):
I'm not going to tell you he'spain free.
Um, I know a little bit behindthe scenes, he's still.
You know, isn't completely, buthe'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'swhat, that's why we do these
things.
I don't know how many people atBoeing or GM or X or Nvidia get
(58:29):
texts like that from customers.
They all make great products.
They're all very important.
I use them, I fly in them, butreally when your company makes
that kind of an impact on apatient, on one life, and we
treat thousands of patients ayear, we have the potential of
(58:49):
having those types ofexperiences and those types of
outcomes literally thousands oftimes a year.
That's what gets us up in themorning.
That's what drives VIP customercare.
And that knowledge, that, thattext is going to be shared in a
little bit of a, like a townhall that we're gonna do.
I'm gonna be very excited toshare that with the entire
(59:11):
company.
Because people are remote.
People are selling and marketingand supporting our customers all
over the country and in twodifferent offices.
I'm in Jacksonville, one inManassas.
Everybody needs to know that.
If you ever wonder why you'redriving into work, if you ever
wonder if you're making adifference, yeah, yes you, we
(59:33):
are.
And by the way, I believe mycompetitors are.
I believe non invasiveelectricity helps many thousands
of patients all across thecountry.
I have a bias in favor of mine,but if, my, any of my family
members, had to go through whatI had to go through, And they
said their doctor prescribed anon invasive electrical stem.
(59:55):
I'd say you bet.
And if they didn't get thatprescription, I say, why don't
you suggest it?
Because you can get texts likethat that validate what you're
doing.
Patrick Kothe (01:00:07):
Chris is passionate about the customers
they serve.
I suspect he always had thatpassion, but I'll bet it went up
a notch or two following his ownjourney in recovery.
A few of my takeaways.
First, think like an end user.
Not only why they buy, but whyand what are they going through
(01:00:33):
at the time they use theirproduct.
You may not get an experiencelike Chris.
But ask the questions, observethe behavior that's going on
around the environment when yourproduct is being used.
And dig down below the surface.
(01:00:56):
Don't just look at what's on thesurface, but try and dig down as
far as you can to get the fullexperience of what an end user
is going through.
The second thing is VIP customerservice.
And a lot of us like to think,yeah, we provide great customer
service.
And, you know, we have the whiteglove treatment, the VIP
(01:01:17):
customer service.
Do you really, is that how youdo everything in your business?
You know, a couple of thingsthat.
Chris talked about focusing onthe customer.
You know, a lot of us thinkthat's what, that's what we're,
we're doing, but you start todig down into it a little bit, a
little bit further.
How can I solve the problem inone call?
(01:01:38):
How can I think through theproduct and how the product is
going to affect that endcustomer in all aspects?
And then how do you make surethat your company has that as an
ethos?
What is, you know, how do youcollaborate?
How do you make sure thateveryone is doing the exact same
thing and has the exact sameview on what VIP customer
(01:02:02):
service is?
The last thing that kind ofstood out was when he talked
about his competitors.
A great amount of respect forhis competitors.
And one of the reasons is hebelieves in his category of
products.
He believes that that categoryis so valuable to the end
customers.
And he's one of those, thosechoices, but there are other
(01:02:25):
choices there too.
You will compete.
You will look for that strategiccompetitive advantage to make
sure that yours is the top ofthat category, but respect your
competitors.
You're all providing valuableservices to the customers.
Thank you for listening.
(01:02:45):
Make sure you get episodesdownloaded to your device
automatically by liking orsubscribing to the Mastering
Medical Device podcast whereveryou get your podcasts.
Also, please spread the word andtell a friend or two to listen
to the Mastering Medical Devicepodcast as interviews like
today's can help you become amore effective medical device
leader.
Work hard.
Be kind.
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