Thank you very much a real
pleasure to be here.

And so what I want to do tonight
is kind of go through there and

all of you if you're interested in
medical devices how you proceed.

How you would come up with an idea.

So I started out after my graduate degree
in mechanical engineering I was tired

of school so I went to law space and
it only took me

a couple of weeks or
months to realize really so

I got interested and find that I had
no background no biology chemistry so

I had to go back for two years and
pick up my medical and

then because my marginal
a lot of fun last spring

I said well I better do something pretty
spectacular to get into medical school so

I started calling surgeons because
I figured I would have them use and

if I was doing mechanical design.

Perhaps I could solve a problem.

So I got hooked up with free.

Thanks.

So I started working with them all the way
through medical school during surgical

residency and then at some point I
want to go into clinical practice and

if I design an instrument users
that has tremendous impact

design and absolutely not.

We have about forty five engineers
in our company on California and

I teach every engineer how to do surgery.

So I go in the pink lab on Fridays and
they'll learn for

a specific instrument the anatomy and
the physiology behind that instrument.

And if they can do the procedure
themselves then they've got really a leg

up on improving the instrumentation
are doing a new design

now to start out with you know
identifying a clinical opportunity

may almost be as important as
the actual design of the device.

And I let you out of school out west and

they're not number two in biomedical
engineering at Georgia Tech and

Emory are but
still we can learn something from them.

So when the staff
are bille design program.

They take a holistic clinical needs and
then you filter it through by looking at

three things the incidence of
a clinical need to some very and

perhaps your company if you're
working with these two and

then you have a shorter list and
then you see.

OK can we design a device to fit that and

then at the end when you filter through
you have just several opportunities.

So now if you take some needs.

Why is incidents important if
you're doing something for

say example pediatric cardiac surgery
have maybe a couple hundred cases a year.

It's going to be hard for

you to design for that need because if you
have a team of say four or five engineers.

You're going to burn probably
a million dollars in one year trying

to develop a device and
if you don't have enough.

To support that afterwards.

It doesn't make sense to design for that.

So Verity is also important because
if it's life threatening then it's

a much more needed design.

So these are some of the criteria and
once you come up with a list a short list

of needs then you go ahead and brainstorm
and try to find solutions for that.

And so
that's where the design process comes in.

So again looking at clinical need you can

always look at the background you can go
into surgeries you can see what these are.

And then what they do after they take
a look at the details of procedure and

you try to see.

Lots of times if you asked
surgeons about a clinical need.

They may not be able to identify
themselves because they're so conservative

in their training so specially for
something like cardiac surgery.

You can't very much from the norm or
else you could have disasters and so

as a consequence the surgeons even though
you may not be able to recognize that

something sometimes it helps to persist in
an idea that you know be an improvement.

You think of a level in tension in
the operating room increases and

you know this procedure is difficult and
if a procedure is too difficult.

There's room for improvement.

So these are some of the things to look
for and you've got a great opportunity

here because here you
have a collaboration and

I think you probably have the best
cardiology cardiac surgery.

In the United States here in Atlanta.

At Emory and they really
are innovative and forward thinking.

So once you go and have the screening.

If you can be at the right
side of the curve then that

particular design is probably
worthwhile going after.

So what next.

After you choose a design.

I would urge you to go ahead and

become as practical as you can
be in your education here.

So as I told some students earlier today.

If you have machine shop courses go
take them learn how to use a lathe and

milling machine because if you're
able to prototype your own

design if you feel that.

You can make a much better device.

Or if you go.

Tronics.

So you go ahead and
try to prototype and then test it

first of all you do a bench testing and
then if that concept looks good.

Then I always go into the animal
the test because living tissue kind of

a perspective as to when the device will
actually work in a human now prototyping.

The reason for prototyping is to
demonstrate function and you want to be

able to do it fast and so I always do ugly
prototyping I mean take a look at some

of these and you can see that I've cut out
parts from actual surgical instruments.

Sometimes I'll go to Hobby shops or
toy stores so

that if you have parts of different
devices that you can take and cobbled

together then you can make prototypes and
try out to see whether they're functional.

So sometimes it's only takes hand
instruments to do so again I urge

you go ahead and just start working with
your hands and trying to make prototypes.

Once you have a device that
you know that's workable

then you have to think about
intellectual property.

So in the US you can have
not only a device but

a technique for example of doing surgery.

So you know a step of maybe
doing something else and

extracting an organ you can hand them the
only country in the world that you can do

that but that could be very important
because if you have early dating if you do

a technique before anybody else does.

You actually own that technique and you
could probably license it off to companies

that are doing things and
I personally experience with them.

So hand protection always documents.

You know like in chemistry where you have

different numbered pages that are bound
together and just write your ideas.

It can be very.

Cursory.

Rough sketches and so
on and have somebody else

a family member witnessed and
understood and sign and date that.

So now you've got a date
of conception then

it's a porn especially with
your ideas be not to disclose

even if you're doing laboratory
work if you have people in there.

They have to be under confidentiality.

So you have to put agreement together and

you yourself were just SES says
I will keep this information.

Why because you have rights immediately
if you aren't if you show a new device or

new concept not a confidentiality
in the United States you have

to be able to file a patent and
apparently is an expensive it's probably

cost about fifteen thousand
dollars in attorney's fees.

To file even a simple.

So at least document things and
get a date of conception.

And the strategy and design.

You can see two different
type of designs here.

My partner there are three of us.

I start our company
originally called Origin.

One of my partners also general surgeon.

He went off and started a robotic
surgical company called intuitive and

they've seen it on the T.V.
news or so on that sits at a console and

there's a large mainframe computer that Dr
Campbell arms over the operating table so

that you can even do remote surgery.

Asked me to join him
there at intuitive and

I was not really interested in
that type of design I rather would

like to design simple
instruments that could be easily

trained to other surgeons and so I just
try to do more the people with design.

However there's a lot to be said for
a simple elegant design.

I'll show you the other thing is you
have to understand the anatomy and

physiology so if you take the hard
cornering obstruction that could cause

a cardio in fact and then heart muscle
you have congestive heart failure where

the heart doesn't win the heart gets
large or you can have a read me as where

you electrophysiological problems
with the heart average conduction and

so on or sudden death relation.

And then also take a look at what
the conventional treatment for

example corner in our disease
we have a balloon angioplasty.

What a stent in their brain.

Or the alternative is to open
the chest and put in a corner graph.

Where you wrap onto
the sending in order and

then hook it on to the corner
an artery has a point of obstruction.

So some of the conventional treatments and

then when you design again try
to be way off so that if you can

think about something and again persist
even though people say that will work

shown they're wrong make a prototype and
demonstrate yourself and if in your gut.

You know it works.

Keep on persisting and it could.

So I'm going to show you kind
of a different concept that

I've come up with over the years.

My very first design with a doctor for
a loon angioplasty.

And at that time.

There was only two classes that
had been performed in the US.

Doctors Myler and structure and so

Dr if you have to put
them into an area that is

probably going to show why I can apply it
to go downstream and large someplace else.

So you can actually cause an end far.

So he said Is there any way
soft into that area and

then after you get increase
the pressure and the dilated.

So the song has less chance.

Than a plastic catheters
sharing all black and

I knew that because the properties of
material are such that if a large diameter

is also long at the same time so
it's hard to keep it from

getting in large so I came up with
this design where there's a floppy.

Here and a sock back into the two so
that when you play with

rolls that area through and so
this is my first design and I

thought of this concept probably a couple
about three days after meeting Dr and

it was actually at the market
under Edwards laboratory.

And then back about nineteen years
ago I started my own company called

The first problem there was
an orthopedic surgery so

that when you do a total hip replacement
you have this prosthetic stem and

you hold it into the patient's
femur using cement back lace match.

The power and liquid together and there's
an actual reaction it gets extremely hard.

So the cement holds the prosthesis and

then after about ten years there starts
to be a reaction between the bone and

cement so the processes loosens and
the patient has pain again.

Then you have to extract and
put in a new hip prosthesis

where the processes comes out
with some man is extremely hard.

So if a surgeon has a chip about that
cement thirty percent of the time

you fracture in the femur
because that's like porcelain.

So I had this orthopedic
surgical resident contact me and

said well there's got to be some way of
dissolving that we start calling up so

many manufacturers said
you have a fluid that

could soften the cement they laughed and
said well this stuff is so hard.

The only thing that softens and that is a.

Mix up a new batch.

At the interface between the old and
new cement softens a little bit and so

you guys are stuck.

But in my mind when I heard that
immediately I thought OK wait a minute.

If it was so hard and
they're softening at the interface.

There must be a chemical reaction.

And if cement is so large.

Why don't we fill the tub with new
Samantha who didn't like a threaded rod

and use a slide hammer and slap it out.

And so current and so

we fill the cement and
then use a slide hammer without well

this concept all this is a bunch of
threaded rod and standard hammer.

But hand application when it went
through the pan takes several years to

get this month's Live
through a nine months and

not a single word in
the application was changed.

Usually when you do an application

claims twenty forty five
because it's already been done.

Plus you have a modified so
this is a pretty unusual idea and

it's still used out there in the market.

Another problem when we started
going into general surgery.

So in order to do general
surgery to reach our

before they used to make a large incision
mid-line incision then we started doing

laparoscopy where you put in
ten millimeters of diameter.

We have to inflate the belly with C O
two and then use an endoscope to see.

We're doing so
as we're doing hernia repair

like going into the belly and
then putting in a piece of MASH.

Well you have to go into
the belly open up the parrot and

then put in a piece of mash and
there's more in there and

then I came up with
this slide it into the.

Just underneath the belly button.

And then just with a little hand so

I formed one leader cavity and
then that's the operating.

So again another very simple concept and
the scope inside the blind to see.

I started using the blue and also.

In the back of a patient and

what's back there you have it in
the back there you have the spine and

you have the border so one of
the largest procedures you can ever.

Repair is if you have to go through
the belly of the get rid of all the bow

retract the bow make an incision and
work way back here.

Well if I could use a form of Kaminey I
might be able to easily reach.

This is a video this is
an animal is what I'm doing

with this as you can see
up started to inflate it.

So you can see.

I have a ten millimeter diameter telescope
in there since it's transparent.

I deflated take it out and
then I guess to hold it open and

it just takes about four or
five minutes and

there you see the polls and
there's a kidney.

There's the order.

So instead of having a very large
I can just go in with a couple

more and then the other thing is.

So instead of going in a graph.

State were put in tact and
returned the order.

My favorite device over the years
was probably this one and it's for

this indication when you
bypass you generally have to

autologous graph your own body's vein or
artery.

The reason is that you're going into
small diameter coronary arteries and

the flow is so
low that if you put in a prosthetic gram.

It's going to clot off the wall
in order to get the vein out.

The entire skin over the patient's leg so
use a sap

along this vein in the body that
runs all the way to the ankle.

Well this actually hurts more patient
more cracking their chest open.

So after open heart surgery as a patient
well where does it hurt the leg

more sensitive there.

In addition thirty percent of patients
that come from corner bypass are diabetic

and they do not and
that they don't feel well if they're

yes in fact they could lose
their leg could be amputated.

So this is a big problem.

What's interesting is the first people
to work on that we're here at Emory.

So Dr labs were here at Emory and
what they did was they took a long

patient and they ought to play and
use it as a retractors

they made a little incision held up
the skin bridge and took out the vein.

They actually had them remember
talking about the patent so

they can do that and
sold it to Johnson and Johnson.

So I took a look at that design and
said Well you know the face of that is

pretty broad so there's probably a dozen
branches on the brain as you go in and

out up and down the leg.

If I try to use this as a red tractor
to plow through some branches and

cause bleeding.

So because of my earlier
I experience with scopes.

This is a prototype so I have a very tiny
fiber optic scope here one point six

five millimeters.

So I'm just sliding this little probe
back in front of me to do as I look at it

with my endo still and so I thought this
is my device and actually work pretty well

in animal and testing until I got to
the five a patient where there was so

much of that there that even though when I
inflated these balloons will stay open so

I go back to the drawing board.

Now maybe because I had done that a little
earlier but I started thinking about other

designs the other problem is
if you have it and the skull.

If you go into tissue and if you get
the skull wet with either fluid or blood.

You're going to have a blurred image.

So you can't see anything at all.

You're in just go about.

So this idea popped into my
head that if I have a skull.

If I let the little transparent
in front of the end the skull

anything that lays along the long axis
of that cone I'll be able to see.

So this is the image you get of a natural.

So as you can see here that dot
corresponds to just a lead and

then it's valid eighteen millimeter
length here on the vessel that we see.

So again prototyping when I thought about

this idea I went to a chemistry
store in San Jose and

I bought a glass pipe that broke off
the snout and sealed it with flying.

Inside and I went to the.

They're going to work very well so I see.

Well that it should be
useful as an instrument.

And then the first place.

I perform was disciplined or
in one thousand nine hundred five.

And as we went along.

We improved the device so that now I've
got a skull and a way of kata rising.

Branches pull it out and

figuration allows me to coordinate
because the branches always

come at right angles to the vein.

So that this coordination decrease the
time of our harvesting in one hand this

is surgical so you can see on
the Harvester here is running along with.

The harvesters of the United States
tend to be physician assistance and

then you really.

Well with this this particular
physician at five thousand cases.

Now notice there's no bleeding or
very little bleeding and so

you can tell that this is a very
dramatic procedure in fact after we

do the procedure the patients don't
even know the baby has been extracted.

So this makes a big difference.

So this is that cone is used to
form a county around the brain and

after that we put in a second life and

this device as you can see we have
a retractable hold off to one side and

then any branches that we
run into we use a card or

a device to seal and then cut branches.

So at the length.

You'll see here with
the scissors coming out.

So little cotton right between
the places that seals the branches.

What's another.

A regular guy.

When I would go in

a place to look at me.

These are some

of the images what's important
here is to be able to

hear

this is able

to move because

we're not able to see the corner real well

every

well were able to reach all the.

I think precisely because
we were going there.

There was another problem

trying to visualize the last images so

you're looking at black and white images
and the resolution is not there yet.

So if I can see the me

go inside through the end of this
interesting was years ago I wrote in

Japanese used to put a purse

strings into the ventricle and

they would blow up a condom or
somehow to push the blood away.

So it's not really that I want to

plant would I be able to so
I did that only prototype with

my first through

this again is it because
it's very similar to

what I think when I come
in contact with a bank.

Here this is so
I left like there's no black

looks like more than

one way.

Now and

then later I started

going to

play with what about it

so what else can we

hope your life.

I think is going to blather.

Well maybe it's because you know there's

going to still being

a company that later.

And now we've got a life that

we can hold still

being this is another

this

is the kind of really we're going to go

out and here is

what

I think I was talking about

this

is this is where

the you know what a song.

You want to know what you know what

you know what you want as a blood

you want to know

there's a northern You know what I

want to thank

you so I came up with this idea

into a shame it was true

and it was going to

get this in a very well

you know if you want to this revolution

has to business.

Yes.

There is no sign.

We can which

is what I was going to

ask

you in a place not

as nice as it is without

anyone would

think that was a.

Kind of make something out of something.

Sometimes they want to

hang on

because there's lots of

red and anytime

now.

One thing you do is interesting because
you hear about other people working on

an area and all those people
other people recognize that and

so sometimes even the newspapers
you hear about you start a company

that's one thing you can
do is that if you have

several people are working in sort of
clinical area there must be a need.

You could be there out design them and

make something that works it's
easier to use or works better.

Or you can just look at another area
where there is no solution whatsoever.

And again severity and incidence.

Or yes.

There's a lot.

I think not only by a result of
material the product biologic blues.

You think about doing and
ask the most as we have to.

So a graph on to a coronary artery or
do you want to take a lot of manipulation.

There should be a what a better way to do
that was companies working on one shot

as to my device which is like a stapler
with one application you can do this.

The work of suturing.

However this still in development.

I mean they have some devices that
are out there is not quite good enough.

So where you do through a small and
sponsorship technology reporter so on.

You know materials are always good.

There's a lot of things you can do.

For repair.

Well

since we're on Generation eight.

I think about so many people we just
had a patient day at our company

where a couple of patients came in
who had been treated with my devices.

So we could have the all the employees
see as well as the surgeons.

And I think our Chief Operating Officer

asked everybody to stand up that had
worked on this device and almost the whole

room did because it takes all different
disciplines not only the engineers but

you have the regulatory people finance
people customer service people all these

functions of the company after you
know acting or to get product out and

that's that's why I made medical device
design my career is because it's so

gratifying because if you think
about it if I'm a surgeon.

Practicing surgeon.

I could reach maybe five thousand
seven thousand patients in a lifetime.

However if we've done a million cases with

something I designed that
is that's really huge.

Yes.

That's a really good question.

That's part of the design process and
what I try to do.

There is to do something
that's simple enough.

And so that you have to you
can see the efficacy and

the safety in that device so
that more what's called a five ten K.

device where you say OK you
can be grandfathered in.

That is similar enough to existing devices
so that you tell the F.D.A. I have

this device here and it's pretty similar
to another device that's been marketed for

ten years and they have ninety days to
respond as to whether they agree or not.

Now it helps because
I'm a surgeon myself so

that some of these devices for
example the values of you where I can tell

you have to say Well I think in my
estimation it's pretty similar.

And we'll agree.

The heartstring device I went to
Washington and talked to the F.D.A. and

they said well we we were discussing
how many clinical cases we

think you need or demonstrate advocacy and
when I explain to them.

Well this is a procedure.

I use to use a device and

then they know I'm a surgeon they actually
change your stance and say well we

understand what you're trying to do we
don't think you need any clinical cases.

Just go ahead and do some animal studies
on the bench test to make sure that you

know materials and everything are safe.

So that's an important part

of your design is to see if you
can simplify things and make it.

So that if you know yourself
that's very say that the F.D.A.

agrees and then a short time a market.

For

example the values of you that wise when
I showed you the last year I do that

last year.

Brown.
My second one thousand nine hundred five.

I did the first case September twenty
ninth one thousand nine hundred five and

then it hit the market.

July one thousand nine hundred six.

So we're talking about what
year from conception to market.

And that's pretty quick.

Although I think now things have
slowed down quite a bit because

my company has grown.

It was orginally it was quite body like
we became guidance cardiac surgery and

then Boston Scientific and now by today so

over those years when you start to get
more employees things start to slow down.

If you have a really good idea.

I advise you try to form your own company
because then you get something out.

That first design where I had
the cement extract in system.

I came up with that design did the F.D.A.
filing myself.

We used to form the company and

got on the market ten months
after our initial funding.

So that's pretty quick.

You.

Again if you've got a really good idea and
you know what.

Try to bring it to market yourself
by doing a little start a company.

Start a company you get four or five
people and their one guy's a marketing guy

another guy is a business guy and you are
funding the idea guy or a technology guy.

That's really all you need.

If you try to if you have a good idea and
you try to license it out to a company

your pride take a year
a year to negotiate that and

then you lose control with that idea.

They may license your idea and

shelve it because they already
have something in there.

Generally companies will have like five or
six projects in line already.

That they have going forward in
the future in their time timetable and so

your idea has to be so good.

It'll knock out something that
they are you decided and I said.

Sometimes they'll buy your
idea because it may be

competitive with what
they're planning to do.

And yes.

I know I will tell people.

I'm very honest when somebody tells me and
says I've got this new idea.

I say Well frankly we already have
these four projects going and

I don't think we were going to develop
it so I'll tell the same thing.

And there are several startups here.

I'm not on the board of
the advisory board behind me and so

I've seen a lot of good ideas come through
from students and junior faculty and

you have a mechanism for getting these
ideas out there so we get an idea

also the other thing you do is that
you go through the tech transfer and

they'll go ahead and
file a patent application for you.

Although you've got to check to see
whether you as a student have any

rights to the idea.

That's something you have to check out.

Our.

Thank you.

All right thank you.