of a job
I’ve been working for a grad student at
the robotics Institute at Carnegie
Mellon I was a junior and I worked for
him over the summer it was a great
experience I got to sit in the lab and
just crank out code for computers and
robots and I found out that he was
graduating so I was out of work so I
looked up some local opportunities and
fortunately I was able to find another
opening on campus at the Medic robotics
lab it was also called the mr. Cass lab
of course short for medical robotics and
Peter assisted surgery I didn’t have any
particular interest in surgical robotics
or computer aided medicine I was just
looking for a way to keep coding and
instead of working fast food now mr.
Cass lab was founded by Tony to Joya
Tony was a CMU engineer and then ended
up going to Harvard Medical School and
he became really prominent orthopedic
surgery surgeon here in Pittsburgh he
also co-founded the lab because he was
interested in robotics Frank O’Gara
Mathers was a biomedical engineer that
worked at the lab and I found out after
the interview process that I got the job
and wouldn’t be signed to him and our
task was to develop a computer assisted
surgery simulator and range-of-motion
planner for total hip replacement
surgery now total hip replacement for
those of you who don’t know this is your
hip joint usually the way the hip socket
works is you have a layer of cartilage
over your femoral head and you have a
layer of cartilage in your hip socket
and allows the bones to move very freely
relative to one another
unfortunately due to arthritis this
cartilage layer starts to wear down the
bone starts to rub on bone and it starts
to hurt a lot so what we need to do is
we need to replace the diseased surfaces
with metal and plastic bearings this way
you can move freely and there’s no more
pain it’s pretty key though to get the
components in the right orientation you
can imagine if you put these things in
wrong that the implants can start to
bang on one another it can lead to
implant failure but also potentially to
dislocation so how do we avoid
dislocation well the way it was done
before
the advent of computer assisted surgery
we had the type of planning that was
done on app with acetate templates on
top of an x-ray so basically you do the
2d x-ray it gets a front picture of the
joint and then you can use these guys to
kind of roughly align but mostly for
sizing figure out what you were going to
do going into the surgery and then from
there you made your decisions within the
surgery you use really crude mechanical
guides you can see here on the picture
on the right
this mechanical guide essentially was
used to align the tool to the floor of
the operating room it didn’t take into
account any variability in the patient’s
anatomy and you had to make assumptions
about how the patient was aligned on the
operating table and you can imagine if
you have a 300-pound patient on the
operating table it’s pretty difficult to
know exactly where their pelvis might be
so how do we solve this problem well the
project we worked on was called hip nav
and hip nav included a preoperative
planner and a interoperative guidance
system the preoperative planner was my
work what we did is we develop a
cd-based planner that allow us to build
3d shapes of the pelvis and the femur in
order to accurately place and align the
components and we can make adjustments
according to the native patient’s
anatomy and after we did that alignment
we could fine tune things by basically
doing a rate a preoperative range of
motion simulation we can move the
joining through a range of motion and
see how the positions of the components
and the selection of the various
components would affect the range of
motion for the patient so that’s great
we have a great plan for the surgeon its
patient specific how are we going to
make it happen in the operating room
well the first thing we’re going to do
is we’re going to get rid of the
mechanical guides because you can
imagine they don’t work so well then we
help fit the operating room with an
optical tracking camera kind of like
your Microsoft Kinect but this was 10-15
years earlier than that
we attached sensors like motion capture
sensors to the pelvis we attach it to
the tools as well and then what we can
do is we can plug all of that
information into a computer system that
allows us to do all the math for the
surgeon and then basically tell the
surgeon whether or not that his
insertion tools are aligned incorrectly
or correctly according to where the
pelvis is and this is how it worked in
the operating room this is Shadyside
hospital this is doctor the joy on
right he has his sensors equipped to
both his instruments and to the
patient’s pelvis you’ve got the tracking
camera off of the right or off to the
left it’s monitoring the positions of
the tools and he sees his readout in the
operating room now
the capability to track the pelvis and
instruments in the operating room was
unprecedented and what it allowed us to
do is research not about guiding the cup
but actually in measuring current
practice and so our team won the 1998
hip society award and the ability to
show that indeed the assumptions that
were made before the advent of this type
of technology were all wrong the pelvis
was not fixed on the operating room
table you needed to take into account
patient specific Anatomy and you also
needed to track your tools in the
operating room so you can know you did a
good job
in fact the type of research that Tony
and Franco did along with others in the
field kind of revolutionized the
industry and you can see that Tony and
Branco could literally be considered the
authors of the book on computer assisted
surgery now Tony and Branco didn’t want
to stop there they weren’t satisfied
with just writing some research papers
and doing some good work they wanted to
get this out there and so how do you do
that well you make form a company sokka
surgery was spawned out of Carnegie
Mellon and its mission was to fund and
make the FDA approval for this product
happen the idea was that we were going
to place this in all the operating room
we’re going to revolutionize surgery I
had a couple friends at work Frisco
surged again I cans know first hand how
hard they work and trying to prepare the
applications in fact they worked so hard
they hit so many dead ends they pivoted
and what they ended up doing is instead
of trying to build the application
themselves they decide the partner with
an existing navigation system that was
used for sinus surgery and they try to
outfit the hip NAB software on that
system unfortunately that didn’t work
the companies funding run down my
friends got burnout and they shell the
company for at least a little while
later I was taken to lunch by Branco I
was still working for the lab at the
time and he took me off the lunch at the
church brew works Church brew works is
is a fine establishment here in
Pittsburgh and we
I had a lunch of pierogies with a
colleague of his name Craig Markovitz
Craig Markowitz was a local business guy
he was actually instrumental in
establishing to surgically was need
adviser to Tony and Franco and they sat
me down over pierogies and talked to me
about what they wanted to do what they
wanted to do was to give it one last go
with kosaka they were going to fund the
company they were going to shoot for FDA
approval build it sell it take over the
world so they asked me that they want
wanted me to join them after all the
citement of Costa Rica and see my
friends get burnt out and leave the
company I said of course I’m in we work
with the surge ago we worked on the
kidnap project for a number of years we
tried to build the FDA approval packet
we brought in consultants for regulatory
issues we debugged software we did sales
calls we did everything that we could do
couldn’t get it off the ground
didn’t have any major investors didn’t
make any sales we even went further in
doing alternative research trying to get
research grants we provide shoulder
surgery retried ACL reconstruction
surgery we even tried fetal cardiac
interventions which is essentially
operating on unborn babies hearts that
didn’t work either but it helped keep
the company alive fortunately this is
Anika didn’t work out what we do have is
now a sea change in computer assisted
orthopedics if you search for computer
assisted orthopedic surgery this is what
you see today as opposed to nothing
every major implant manufacturer is
associated with computer guidance
there’s robotic systems that will put in
your hip we helped make change in the
industry now mr. casse the lab that we
were working at was medical robotics and
computers of surgery so let’s talk a
little bit about medical robotics if you
think about medical robotics this is
what you think of this is the da Vinci
robot by Intuitive Surgical it is
impressive technology it is extremely
capable it is incredibly accurate it’s
fun to play with if you ever get a
chance to do a demo of a DaVinci robot I
recommend it highly because it’s really
fun it’s also very
large and very expensive back in the
late 90s there was another robot that
was large and expensive this was called
the Robo dock robot this was also used
for a hip replacement surgery but it was
made for reaming out the femoral part of
the surgery the surgeon would basically
sit back and watched the robot do the
work but the robot literally stood
between the surgeon and the patient so
this begs the question why do all these
robots have to be so big robots don’t
have to be big what if you could fit in
the robot in the palm of your hand this
is Gabrus and gate was actually a grad
student with me at CMU while I was
working for the mr. Cass lab I went to
school part-time in the robotics
department gable is a PhD student and he
was also assigned to medical robotics so
this idea was Gabe’s Gabe said what if I
had a robot that I could hold in my hand
as a surgeon but I could control the
robot by moving it around but the
surgeon would make up for my mistakes
the surgeon would improve my precision
and that’s exactly what he proposes his
thesis presentation this was the concept
drawing we have the camera again same
sort of tracking camera off to the right
it’s monitoring the bones it’s
monitoring the surgeons tools but this
time the surgeons tool is smart the
surgeon’s tool knows when it should cut
it knows when it should not cut it can
start it can stop it can slow down it
knows what the plan is and it achieves
that plan by adapting to the surgeons
motions Gabe called it the PFS precision
freehand sculptor I didn’t think it
would work luckily though Tony Franco
and Craig thought it would work they
approached CMU about licensing the
technology and they did and they create
a company called blue belt technologies
it was named for the Beltway that here
in Pittsburgh is closest to Carnegie
Mellon so Craig was my CEO at Caesarea
at the time and it was well within his
right to say hey Kosta you’re going to
work on PFS too so I ended up becoming
the first employee of blue belt and even
though I didn’t think that the
technology would work originally it now
became my job to make it work so I moved
over out of our concern office into a
new office with Craig over on the corner
of Friendship Park and Gabe joined us in
a part-time manner and we started
writing code and we start
building robots so this is the first
blue belt sponsored prototype for PFS
this is called the ugly tool you can see
that it’s fairly aptly named this tool
was great as a proof-of-concept but
would pinch your fingers if you held it
wrong
the next tool is called the TP FS it’s
obviously much more attractive
unfortunately surgeons didn’t like to
use it because it weighed 5 pounds also
if you ran it for more than a couple
minutes it would start to heat up and
burn your hands so we had lots of wet
paper towels wrapping around to try to
get through our experiments so this
wasn’t going to work out but it allowed
us to get the research more advanced it
allowed us to do some cadaver trials and
it allowed Gabe to get his PhD research
completed once Gabe had his PhD he
decided he was going to go and move to
California and work for intuitive and
build the Vinci robots ironically enough
so what we did is we hired some more
engineers and we built some more
prototypes
fortunately Craig was a master at
keeping these small companies funded
through looking at opportunities in
local economic development like the life
sciences greenhouse here in Pittsburgh
but also in sponsored research coming
from companies this is the NP F s tool
this was adapted tool for our technology
that was applied to spine surgery there
are a few doctors at Allegheny general
that were interested in applying this
for spine in order to protect the spinal
cord when you’re doing a laminectomy
procedure we also the found
opportunities working with Johnson &
Johnson and their implant company Depew
building yet another anny prototype that
we called the knee FS but again we still
didn’t have an fda-approved product we
were a small company chasing funding
just trying to stay alive to develop a
technology so we chased other
opportunities we did some work in some
early medical augmented-reality the
project we called image overlaying we
also got some grant funding in order to
develop a computer-assisted hematoma
evacuation tool does it basically suck
the blood clot out of your brain if you
had head trauma we call this one the
you play the video please if you click
oops all right though edit that one out
in post I guess is that can you play
all right sorry about that this was our
last go as a little startup company we
were trying to promote the PFS not as a
end application we just couldn’t get
enough funding enough wherewithal to do
the FDA route to build our own product
and so our idea is we’re going to
promote this as a technology that you
can bolt on to existing navigation
systems so by this point there are a lot
of companies doing computer assisted
surgery and we wanted to provide the
technology we didn’t want to necessarily
build a system from the ground up so
this is our way of demonstrating how PFS
worked you can see that the tool is
extending and retracting starting and
stopping in order to conform to in this
so we worked long and hard we did a lot
of different prototypes we tried to keep
the company lasting as long as we could
but eventually our funding ran out
fortunately Craig was able to find one
more opportunity for us there was a
local super o angel investor that was
able to fund blue belt with an A round
and basically take us out of the
research lab and make us a real company
and here’s that real company back in
2010 our mission was to actually create
PFS as an end-user application get the
approvals that we needed and sell this
now of course the company got bigger
from the three-person group that we
started off with and so with more people
and more resources you need more money
so in 2011 we had to get another round
of funding this time we were actually
purchased by a health point capital
which was a private equity group out of
New York Health Point Capital allow us
to staff up and focus and really
concentrate on getting our FDA
application in so that we could sell
this thing one of the things the health
point did was they brought in a new CEO
that had some more international sales
experience his name was Eric timko Eric
is out of Minneapolis but he was okay
because he was from Pittsburgh he grew
up in saxenburg he’s from Butler County
and he was okay with us because he was
the next year after lots of hard work
getting our European approvals which for
us it was a little easier to do that
first we did our first demand in Belgium
off to the right you see me and Brent go
and Eric and Adam and John are from our
European group and also dr. belham ins
front-and-center who performed the first
live Navia taste on a patient at the end
of that year we did all the paperwork
necessary for our FDA approval and in
fact that FDA approval paperwork
included studies that showed that we
were actually as good if not better than
the big robot competition that was out
there and we were far better than any of
the mechanical instruments that our
technology was intended to replace the
next year we started to blow up our
minneapolis operations we actually had a
manufacturing and sales corporate
operations center in minneapolis and so
we were kind of a two-headed monster
pittsburgh state research and
development
the appleís built and sold the units we
also did our hundredth case the
following year we declined to 500 cases
this is solely the Pittsburgh group here
you can see that we were getting bigger
getting better
we’re in dancing into other areas of
surgery when went back to total hip
replacement surgery we went forward into
total knee replacement surgery and we
finally had enough critical mass to take
the obligatory trip on the Gateway
clipper and by a thousandth case in 2015
we were a real deal in orthopedics
people were starting to talk about us
we’re getting analysts visit us our
booth at the local there at the global
conferences and orthopedics so the only
thing left for Bluebell we were selling
product we were getting surgeries done
on patient was market validation that’s
Craigan Branco and the market validation
came in 2016
Bluebell was purchased by Smith & Nephew
with the nephew was the number four
orthopaedic company in the world and
they’ve assimilated us we are now a year
in but there was still one more personal
milestone that I had to achieve my dad
so this talk is supposed to be about
revolutions I can’t claim to be any kind
of a revolutionary as I said I didn’t
believe in the idea at first but I think
that what you can do is you can identify
a great group of people and if there is
a revolutionary idea out there that you
can glom on to this great group and you
can get together and you can start a
revolution and make it work thank you
very much [Applause]