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From YouTube: e-NABLEcon 2019 - U.S. Food and Drug Administration - 3D Printing and the State of Medical Devices
Description
Matthew Di Prima, Ph.D.
U.S. Food and Drug Administration
Overview of 3D Printing and State of Medical Devices
Daniel Porter, Ph.D.
U.S. Food and Drug Administration
Lattice Design Parameter Effects on AM Structure Performance
More information and discussion about EnableCon 2019 here: https://hub.e-nable.org/s/e-nablecon-2019/
More information about e-NABLE here: https://enablingthefuture.org
A
A
He
created
the
first
interview
from
labs
at
the
FDA
and
when
volunteers
come
to
visit
here
in
DC,
one
of
the
things
I
try
to
do
as
a
way
of
thanking
them,
since
you
campaign
is
to
create
those
opportunities
so
we're
rather
frequent
visitors
at
the
FDA
and
I
think
that
when
we
go
it
gives
you
a
chance
for
guerrillas
because
they
inevitably,
especially,
they
can't
bring
the
devices
that
they're
working
on,
and
they
talk
about
the
things
that
they're
doing.
They
try
to
understand
the
3d
printing
guidelines
that
were
issued
on
medical
devices.
A
You
inevitably
end
up
letting
them
disclose
everything
they
could
possibly
say
about
themselves
and
I
just
watch
the
gears
turns
it's
really
almost
elegant
the
way
he
did
not
become
a
prosecutor
so
but
I
think
that
we've
always
stayed
in
touch
from
the
very
first
conference.
They
spent
three
days
with
us
outside
of
that
just
to
understand
their
process,
and
so
each
year.
I
am
grateful
that
we
we
knew
that
relationship
publicly
and
I'm
gonna
turn
this
over
to
you.
Thank
you.
B
C
B
Take
over
so
with
that,
I
would
like
to
introduce
you
all
to
dr.
Daniel
Porter
who's,
a
fairly
new
hire
for
the
FDA.
He
has
a
background
in
additive
manufacturing
and
in
his
spare
time,
he's
a
maker
so
he's
going
to
fit
in
really
well
with
all
of
you
guys
and
I'm
really
excited
to
have
him
here
to
sort
of
co-present
and
we're
going
to
cover
some
of
the
cool
work
he's
doing
at
that.
Yeah.
D
B
A
B
B
And
we
do
have
plenty
of
time
for
questions
at
the
end.
That
being
said,
if
either
of
us
use
any
terms
or
phrases
or
FDA
regulatory
talk
that
confuses
you.
Please
raise
your
hand.
Let
us
know
we'll
personally
explain
it.
I've
been
at
the
FDA
at
almost
nine
years
now
so
FDA
Twingo
doesn't
sound
different
from
everyday
language
to
me.
So.
B
C
E
B
Also,
kill
printing
there's
some
really
cool
things
on
the
bio
printing
side
that
we'll
touch
on
later,
but
there's
this
huge
range
of
technologies
and
applications
you
can
use
using
the
underlying
technology.
Now
the
same
issues
you're
going
to
have
on
your
material
extrusion
system,
you're
going
to
have
on
a
metal
product
you're
just
going
to
be
magnified
in
a
lot
more
complex.
B
So
why
do
we
use
3d
crane
right?
Well,
it's
an
easy
way
of
manufacturing
locally.
You
know
what
I'm
gonna
have
to
go
and
buy
an
entire
machine
shop
worth
of
equipment.
You
don't
have
to
get
a
massive
injection.
Molding
setup
with
the
printer
makes
me
actually
an
easier
gives
you
a
lot
of
design
freedom.
It's
easy
to
iterate,
sometimes
a
little
too
easy,
because
I'll
go
back
to
my
design,
guys
and
like
yeah.
We
move
that
just
a
little
bit.
Can
we
change
that?
B
C
E
C
B
To
take
weeks
right,
I
don't
have
to
generate
a
full
set
of
engineering
drawings
anymore
and
talk
to
someone
right
throw
into
the
computer
a
few
clicks.
You
have
a
new
design
and
for
the
medicine
you
can
do
some
really
cool
things.
Now,
with
patient
specific
medicine,
we
can
make
implants
and
devices
tailored
to
your
Anatomy
with
potential
to
print
a
pill.
That's
going
to
be
specific
for
your
biology
in
your
body
mass.
B
C
E
B
Who's
no
longer
breathing,
actually
anymore,
he's
suffering
from
bronchial,
tracheal,
Malaysia
right,
so
his
bronchial
tube
is
underdeveloped.
Has
ten
seat
collapse
under
his
own
weight,
very
high
mortality
rate,
no
good
solutions,
because
these
are
instants
and
we
can't
put
anything
that's
going
to
be
permanent
in
there
because
then
you're
going
to
constrict
the
growth,
so
what
they
were
able
to
do
is
3d
print
out
of
a
horrible
material.
B
A
splint
that's
going
to
be
specific
to
his
Anatomy
right,
so
their
parents
CT
scanning
with
the
design
to
make
this
point
that
will
perfectly
fit
to
his
anatomy
and
then
resorb
over
time.
So
once
it
no
longer
needs
to
hold
it
open
right,
it's
no
longer
going
to
be
constructing
that
bronchus
as
it
grows
and
develops.
B
B
B
B
C
B
E
C
B
Realized
that
this
can
be
a
challenge
in
some
spaces,
but
this
is
how
the
regulations
work,
and
this
is
why
they
work
this
way,
so
medical
devices
are
broken
and
when
we
caveat
this
in
the
US
I
just
spent
last
week
with
fellow
regulators
from
across
the
world
and
I
discovered,
some
people
have
four
or
five
device
glasses.
The
u.s.
has
three:
we
have
class
one.
These
are
generally
exempt
from
what
we
consider
a
free
market
review.
B
B
So
if
you
register
your
factory
where
you're
making
tongue
depressors-
and
you
follow,
what's
called
Good
Manufacturing
procedures
for
making
a
tongue
depressor
theft
cases,
you
can
make
a
tongue
depressor
so
generally,
what
you
do
is
have
to
do
registration
and
listing,
and
you
have
to
make
sure
that
you
have
a
sufficient
quality
system
regulations
in
place.
Now,
it's
important
to
note.
B
So
a
lot
of
times
people
hear
about
the
510
k,
pathway,
510
k
refers
to
a
section
in
the
1976
for
drug
and
cosmetic
act,
amendment
that
allows
medical
devices
to
be
regulated,
and
this
requires
that
you
can
demonstrate
that
your
product
is
no
worse
than
an
existing
product
on
market.
So
that's
what.
B
Equivalence,
usually
in
life,
we
do
what's
called
a
security
test
and
you
have
to
show
your
product
is
better
than
something
else
for
510
K.
It's
called
non-inferiority
right,
you're,
not
worse
than
what's
already
on
market.
You
still
have
your
general
controls
self
manufactured
appropriately,
but
now
we
have
sort
of
device
specific
requirements.
So
a
good
way
to
think
of
it
is
if
you're
going
to
make
the
device.
Where
you
have
to
do
some
testing
to
show
it's
going
to
work,
then
it's
going
to
be
a
class
2
device.
B
So
just
about
anything
implantable
is
going
to
be
a
class
2
you're
going
to
have
to
show
its
back
up
at
home.
You're
gonna
have
to
show
it
can
be
sterilized.
If
you
have
an
orthopedic
implant,
you
want
to
make
sure
it
doesn't
break
when
someone's
walking
or
moving
all
right.
So
the
second
you
have
those
sort
of
test
requirements.
It
goes
into
a
class
2
bucket
now.
B
Of
exemptions
and
weirds
of
regulations
around
certain
products,
so
you
really
have
to
go.
Read
this
giant
book
and
Code
of
Federal
Regulations
to
see
where
everything
falls,
then
the
last
category
for
the
u.s.
is
class
3.
So
these
are
high-risk
devices.
The
regulations
say
if
they're
life
sustaining
life
supporting
or
if
something
fails,
there's
a
high
risk
of
injury
or
death
to
the
patient
so
think
some
stents,
if
you're
getting
a
heart
valve
just
about
anything
going
into
the
brain,
is
going
to
be
a
class
three
device
and
class.
B
Three
devices
require
a
clinical
trial
right
and
the
way
you
like
one
thing
about
it's
just
because
it
worked
on
the
bench
right.
You
did
some
careful
testing
get
back
to
that
ability.
That's
still
not
enough
evidence
to
make
sure
that
this
products
gonna
be
safe
and
effective.
So
you
have
to
do
a
clinical
trial
yeah.
If
you're
going
to
be
doing
things,
you.
B
Millions
of
dollars
and
years
so
for
a
drug,
you
might
have
to
enroll
a
couple
thousand
patients
to
get
enough
population
to
understand
how
it's
going
to
work.
Medical
device
trials
were
generally
looking
in
the
low
hundreds,
so
120,
maybe
130
patients
enrolled
one
two,
maybe
three
years
of
follow-up
based
off
of
what
you're.
Looking
at
what
your
endpoints
are.
So
it's
a
lot
shorter
than
two
drug
trials.
B
C
B
You
can
see
from
2010
to
2015,
there's
been
a
significant
increase
in
510
K
clearance
is
I,
can
promise
you
that
trends
actually
accelerating
in
terms
of
what
we're
seeing
this
is
a
bit
of
the
busy
chart,
but
on
the
outside
of
the
Ring,
we're
looking
at
the
and
technology
for
what
we've
cleared.
83%
of
the
technology
that
come
in
for
clearance
has
been
powdered
by
diffusion.
We've
broken
that
between
a
beam
and
laser
extrusion,
which
is
what
you
guys
are
doing.
B
Three
percent
so
in
terms
of
the
clear
devices,
were
not
seeing
a
lot
of
parallel
extrusion
in
terms
of
applications,
most
of
its
orthopedic
53%
surgical
guides
thirty-four
percent.
We
have
some
dental
and
cranial
if
you're
looking
at
the
orthopedic
implants,
hips
knees
are
the
biggest
spine
and
shoulder
are
also
they're.
More
interesting
for
us
is
going
to
be
2/3
of
the
implanted
devices,
have
some
sort
of
floor,
lattice
or
porous
structure
to
them
and
we're
going
to
be
presenting
some
really
interesting.
B
B
B
Like
it,
because
you
can
very
easily
patient
match
it,
so
on
the
left,
you
have
a
cranial-facial
plate,
that's
been
3d
printed
out
of
a
poly
ether,
ketone
ketone
and
then
on
sri
your
left.
This
is
a
mock,
tibial
trainer.
This
is
it
going
to
me
and
I,
really
like
this,
because
you
can
see
that
some
really
interesting
features
where
you
have
this
lattice
structure
directly
connected
with
some
solid
pieces.
You
can't
machine
this.
It's
it's
impossible.
Michigan.
B
C
B
Have
a
3d
printer
doesn't
mean
everything's
going
to
work
right,
so
you
have
to
look
at
what
you're
doing
for
the
patient
specific
implants
where
your
scans
coming
from,
whose
threshold
Ingham
there's
a
lot
of
interesting
research,
where,
if
you
are
trying
to
use
the
software
and
you
change
the
setting
a
little,
you
can
get
a
millimeter
or
worth
of
difference
in
phone
for
some
applications
that
millimeter
of
bone
may
be
really
important.
So
there
are
a
lot
more
questions
we
have
to
look
at
beyond.
B
Just
you
know
the
printing,
the
design
for
use
there's
been
some
cool
things
where
the
bone
plate
might
be
the
same
for
vacation,
but
you
can
talk
to
the
surgeon
and
say:
do
you
want
to
suture
the
plate
in
how
many
screws
do
you
want
to
put
in?
Where
do
you
want
the
holes
to
attach
this?
So
you
can
do
some
really
cool
things
with
that
technology
as
well,
then
you
have
to
make
sure
that
those
features
aren't
going
to
adversely
affect
the
facts
of
the
device.
B
There's
been
a
lot
of
work
on
visualization
for
anatomy,
so
lots
of
schools
are
3d
printing
anatomical
models
both
for
education
for
the
patient
and
their
parents,
but
as
well
as
training
and
sort
of
diagnostic
decision-making
for
the
clinicians.
Complex
structures
are
I've
already
touched
on
as
well,
and
so
just
some
minor
sorts
I'd
say
in
the
news
thing.
So
I
do
yourself,
dentistry,
which
is
not
fda-approved
clear
and
are
really
recommended,
but
you
can't
really
print
your
own
braces.
If
you
want
technology.
B
The
downside
is,
is
the
person
doing
this?
Isn't
a
dentist
doesn't
know
how
to
decide
where
they're
going
to
move
their
teeth
or
how
much
they
should
move
their
teeth
in
each
one.
So,
even
though
we
have
the
technology,
we
still
want
to
make
sure
that
we're
using
it
responsibly.
What
I
like
to
tell
everyone
is
we
don't
want
anything
to
go
so
wrong.
B
B
The
community
can
sort
of
behave
as
responsibly
as
possible.
We
can
keep
anything
bad
from
happening
and
speaking
of
bad
things
happening.
This
also
came
out
just
about
a
year
and
half
ago,
which
is
a
dy
I
cyborg.
So
this
person
made
this
device
that
could
check
their
temperature
pulse.
They
3d
printed
the
canister
for
it,
and
then
they
had
it
at
me,
planted
I'm
quite
happy
wearing
my
stuff.
It,
which
gives
me
most
of
that
information.
C
B
You
to
do
this
right.
The
better
question
is:
should
you
and
I'm
going
to
leave
that
up
to
everyone
here
to
decide
if
they
want
to
3d
print
or
anything
that
they're
going
to
have
a
tattoo
artist?
I
implant
under
their
skin
I
would
highly
recommend
against
it
right
because
there's
been
no
back
pad
ability,
there's
been
no
long-term
leachability
studies,
hopefully.
B
Ones
we're
dealing
with
right
now
is
how
old
can
this
data
be
for
adults?
Most
people
agree.
You
have
about
six
months
before
those
scans
stop
being
medically
relevant.
So
a
great
question
is
great.
I
have
a
three-year-old
of
a
four
year
old
lab
of
five
year
old
they're,
all
growing
at
different
rates
right
now,
so
we
move
into
Pediatrics
how
you
adjust
that
timeframe
with
one
of
these
scans
are
good
for
right.
Those
are
Sullivan
questions
that
we're
having
they
move
on
to
digital
design.
B
I've
been
doing
a
lot
with
different
software's
to
make
complex
a
lot
of
structures
that
Daniels
going
touch
on.
They
each
do
it
differently.
How
do
we
make
sure
that
we
understand
what
those
differences
are?
And,
lastly,
when
it
comes
to
printing
your
finest
and
great
something
that
we
all
know
right,
printing
isn't
as
easy
as
just
hitting
the
button
having
a
perfect
heart
coming
out.
I
wish
it
was
true.
That'd,
be
great.
B
It'd
save
us
a
lot
of
time
in
the
lab
right,
put
3d
printing
there's
a
lot
that
can
go
wrong,
so
making
sure
your
printer
is
properly
tuned.
You
know
what
the
parameters
are.
You
have
the
right
material
selected,
give
the
right
post-processing
and
then
for
the
big
one
for
us
as
I'm.
Sure
you
guys
is
how
you
finish
the
part,
and
how
do
you
remove
that
support
structure?
Are
you
going
to
ask
home
vapor
to
clean
it
up
for
us?
B
How
do
you
make
sure
all
the
metal
powder
is
out
of
that
complex
force,
device
of
the
forças
and
the
patient?
So
there's
a
lot
of
questions
beyond
just
the
hit
the
button
to
make
the
part
come
out
so
I'm
going
to
do
a
brief,
high-level
overview
of
the
research
and
then
I'm
going
like
Daniel
talked
about
some
of
these
projects?
B
Okay,
so
the
first
one,
that's
always
a
challenge
is
you
know,
what's
happening
in
the
printer?
Thank
you
for
conventional
medical
devices.
You
either
fully
mount
something
fully
hardened,
so
you
have
final
part
or
you're,
given
a
block
of
metal
and
someone's
removing
Metiria
right,
we're
not
fundamentally
changing
what
the
material
is.
3D,
printing
that
goes
out
window
right
for
the
extrusion
you're,
repeatedly
heating
and
re
melting,
the
material
right
you
can
get
warping.
B
If
you
don't
have
the
part
design
properly,
if
you
don't
have
a
strong
enough
wrap
all
that
can
change
the
performance
of
a
material.
So
you
have
to
understand
the
physics
when
we
start
using
stereo,
lithography
and
you're
curing
the
material
Institute,
there's
chemistry
happening
when
you're
heating
up
your
metal
powder,
700
degrees,
Celsius
and
then
hitting
it
with
an
electron
beam
to
melt
it
about
1,200
degrees,
Celsius
right,
there's
a
lot
going
on
you
have
that
repeated
changes.
So
those
are
all
things
we
have
to
worry
about
in
terms.
E
B
B
Fda
for
needing
this
data
and
I
tried
not
to
curse
that
poor
intern
as
I'm
looking
through
600
pages
of
humidity
data.
In
case
something
went
wrong
because
if
the
company
supplied
it
to
the
FDA-
and
we
missed
it-
that's
on
us
right.
So
we
want
to
make
sure
that
we
know
what
is
important,
because
that's
going
save
time
for
everyone
and
the.
B
B
If
a
company
comes
and
says
we
think
we
ran
the
right
tests,
the
FDA
says:
ooh
ooh,
you
almost
ran
the
right
tests,
here's
how
we
wanted
to
do
it
and
then
they
come
back
and
we
said
well,
we
got
this
number
and
we
said
we
wanted
a
slightly
different
number
right,
slows
it
down.
If
everyone
knows
what
they're
supposed
to
do
and
what
acceptable
results
are
beforehand,
much
easier
for
all
parties,
alright,
so
the
impact
from
public
health
right
I'm,
a
scientist
I,
will
look
at
things
generally
through
the
technical
and
scientific
lines.
B
With
end
of
the
day.
We
want
to
make
sure
that
we
get
innovative
products
that
are
safe
and
effective
to
the
American
public.
So
we
want
the
clarity
and
direction
to
speed
that
up
the
metric
and
tools
again
are
going
to
help
people
better
use.
The
technology
make
sure
things
don't
go
wrong
and
these
are
least
burdensome
and
regulatory
process
and,
more
importantly,
to
everyone
here.
This
means
hopefully
we're
getting
better
products
to
the
clinicians
and
patients
as
quickly
as
we
can.
B
Okay.
So
most
of
the
work
we've
done
today,
it
has
been
an
understanding,
3d,
printing
process.
Actually
I
should
say
processes
again.
I
mentioned
there.
Seven
AM
technology
types
of
those
five
currently
are
being
used
to
make
medical
devices,
so
we
need
to
have
at
least
a
decent
understanding
of
what
can
go
wrong
with
all
those
processes
to
make
sure
companies
are
doing
everything
that
they're
supposed
to
do
what,
if
in
terms
of
Quality,
Assurance
or
eight,
what's
important
for
printing
accuracy.
What
come
up
with
peat
ability?
How
about
reliability?
B
B
B
B
Fda,
this
is
sort
of
at
the
end
of
the
day.
What
we
really
care
about,
does
your
medical
device
work?
Hey
you
can
skip
over
a
lot
of
my
printer
was
sort
of
okay.
If
you
can
demonstrate
you
know,
we
tested
thirty
devices
they'll
passed,
because
that
means,
even
if
your
printing
process
isn't
great,
your
design
controls,
give
you
sort
of
sufficient
have
sufficient
give
you
have
enough
safety
factor,
things
will
work
out.
B
I
have
so
through
doing
all
of
this
FDA
does
collaborate
with
quite
a
few
standards
organizations-
and
this
is
just
some
cool
things-
we've
been
doing.
I
talked
earlier
about
the
importance
of
imaging
accuracy.
So
on
your
left,
this
is
a
CT
slice
and
we've
highlighted
two
lines
based
on
how
we
do
the
threshold
in
so
both
of
these
thresholds
are
perfectly
sort
of
appropriate,
but
you
can
see
a
significant
difference
in
where
those
lines
are
all
right.
So
the.
B
B
Study
here
where
we
gave
a
whole
bunch
of
surgical
students,
these
patient
managed
cutting
guides
and
have
them
go
ahead
and
do
cuts
and
we've
said
great,
it
should
work
out
amazingly
well.
It
turns
out
that
the
surgeon
still
has
to
make
sure
the
cutting
guide
is
placed
properly.
So
if
you
can
see
this
wedge
here
right,
this
is
the
difference
between
where
the
cuts
should
have
been
on
the
first
cut
and
where
they
made
it.
B
B
Over
there,
so
another
cool
thing
that
this
technology
allows
is
the
use
of
phantoms,
and
we
have
a
couple
of
cool
slides
on
us,
so
we
can
now
make
using
3d
printing
structures
that
are
relevant
to
the
biology.
So
what
you're
looking
at
is
actually
the
arteries
inside
your
eye.
So
this
is
a
optical
image
of
those
arteries.
B
This
is
when
we
process
it
and
then
we
3d
printed
and
now
we
can
inject
a
dye
through
that
structure
and
we
can
actually
get
a
blood
flow
that
mimics
the
organic
structure,
and
this
is
important,
because
if
we're
going
to
be
doing
scanning
of
these
blood
vessels,
it's
really
important
that
we
can
figure
out
how
to
properly
scan
them.
A
lot
of
people
make
straight
channels
and
say:
look
my
system
can
detect
blood
flowing
through
a
straight
channel.
Computers
are
really
good
at
deciding
if
something's
going
through
a
straight
channel
or
not,
it.
B
B
It
very
easy
for
us
to
make
these
incredibly
complex
structures
for
a
diagnostic
use.
Alright,
so
next
generation
we
talked
about
pills
and
drugs.
There
is
currently
one
approved
3d
printed
pill
by
the
FDA
on
the
market
that
was
approved
in
2015
I'm,
going
to
be
very
excited
when
I
get
to
talk
about
a
second
one,
we're
not
totally
sure
why
more
people
aren't
printing
pills.
You
know,
FDA
approved
it,
the
proof
that
you
can
make
it
through
the
regulatory
pathway
using
that
technology.
B
B
B
B
D
D
So
just
a
quick
overview
of
my
presentation,
I'll
start
with
an
introduction.
You
know
what
lattices
are
used
for
in
medical
devices
of
oversold
motivations.
Why
we're
doing
the
research
that
we're
doing
we
have
some
project
aims
that
we
started
off
and
I'll
discuss
for
those
projects.
We
did
it
put
in
the
Maneri
investigation.
So
before
you
start
a
big
research
project,
you
want
to
kind
of
know
where
it's
gonna
go,
so
you
can
sell
it
to
management.
Then
I'll
go
over
future
works
and
some
conclusions
that
we
had
found.
D
So
what
are
lattice
structures
used
for
and
medical
devices?
Well
a
lot
of
the
times.
People
like
to
propose
biological
fixation,
so
they'll
have
a
lattice
structure
on
a
medical
device
say
it's
your
acetabular,
where,
for
a
total,
hip
replacement,
they'll
put
the
lattice
structure
next
to
your
bone
and
the
ideas
that
bone
grows
into
the
lattice
structure
and
kind
of
anchors
it
to
your
muscular
skeletal
system.
D
They
also
do
it
for
mechanical
compliance
and
matching,
and
the
idea
here
is,
if
you
put
a
like
titanium
of
solid
titanium
implants
into
a
hip,
and
it
takes
too
much
of
the
load
instead
of
your
bone.
Taking
the
load,
the
bone
tends
to
kind
of,
if
you
guys
ever
seen
the
movie
wall-e
Frank
what
happened
when
people
stay
in
space
too
long
and
their
bones
in
filler,
they
kind
of
died
off,
but.
D
It
for
weight
reduction,
so
that's
kind
of
an
obvious.
You
know
if
you
have
a
heavy
component,
you
want
to
make
it
lighter,
for
maybe
a
certain
patient.
You
can
do
that
too.
How
do
you
apply
these
lapses?
You
can
say
at
the
end
of
spare,
you
can
apply
it
on
the
surface
of
a
sphere
or
you
can
make
the
whole
thing
a
lattice
or
you
can
actually
put
the
lattice
on
the
inside
and
if
anybody's
curious.
This
is
what
an
S
Tabler
shell
looks
like.
D
D
What
kind
of
lattice
structures
do
we
see?
We
see
quite
a
bit,
but
there's
even
more
I
think
that
we
haven't
seen
medical
device,
and
this
is
just
a
small
selection,
and
this
is
a
small
selection
in
a
certain
region.
This
doesn't
involve
any
like
stochastic
last
anything.
Those
were
stochastic
means
kind
of
chaos,
random,
and
so
computers
can
generate
these
things.
They
just
go
all
over
the
place.
There's
no
warming
that
organization
to
it.
D
D
There
have
been
some
unexpected
preclinical
results
that
we've
seen
a
lot
of
the
as
I'll
show
you
the
same
chart,
and
that
showed
you
the
chart,
the
the
printing
technologies,
that
we
see
a
lot
our
powder
bed
fusion
and
they
incorporate
lattice
structures
which
are
pores
and
if
we
can
so
gray
area.
Huge
percent,
of
course,
we'd
like
to
actually
create
some
standards,
because
it's
kind
of
difficult
to
compare
apples
to
apples
of
some
of
the
tests
we
have
now
so
we're
trying
to
create
things
where
we
can
say.
D
D
Some
project
aims
we
had.
We
want
to
start
off
by
getting
a
mechanical
response
of
some
of
these
lattice
structures.
So
we
want
to
put
them
in
a
very
strong
machine
and
crush
them,
pull
them
and
shear
them
to
see.
If
we
can
back
out
low
displacement
curves,
we
also
want
to
do
some
experiments
and
evaluate
the
fatigue
so
the
long
term.
So
if
you're
loaded
for
like
five
million
cycles,
will
it
start
to
crack
and
when
it
does,
what
load
does
it
crack
at?
D
Since
we
have
a
nice
powder
bed
fusion
system
at
the
FDA,
you
can
print
a
nylon,
we're
going
to
start
with
printing
some
nylon
samples
better,
then,
eventually,
we're
actually
gonna
go
to
something
more
medically
I
feel
like
titanium
six
for
the
titanium
alloy
that
we
see
a
lot
and
then
we
will
kind
of
compare
anything
we
see
in
the
nylon
samples
to
the
titanium
samples
we
want
to
see
if
there's
any
trend.
So
if
somebody
prints
a
lattice
in
a
different
material,
you
know
is
it
comparable
or
do
we
have
to
think?
D
Well,
you
know,
there's
got
to
be
a
difference
and
the
idea
here
is,
you
know,
kind
of
how
we
sell
it.
You
know
say
if
you
had
evidence
that
a
porosity,
a
service
and
it
gave
you
some
benefit
right
if
you
were
to
use-
and
we
see
there's
a
lot
of
simulations
like
computer
simulations
of
the
performance
of
that
lattice
and
give
you
certain
value.
But
if
you
actually
printed
the
device
and
tested
it,
you
know
across
all
different
ways.
You
can
create
that
porosity.
D
D
The
discrepancy
between,
like
these
numerical
simulations
people
like
to
submit
to
us
all
the
time
and
what
would
actually
happen
if
you
actually
test
it
on
the
dish
and
then
we
want
to
know
and
what
realm
of
geometrical
choices
you
make
us
there
may
be
stress
sizes.
You
know,
is
this
realm,
maybe
we
don't
have
so
many
questions,
but
if
you
start
deciding
things
really
small,
then
maybe
we
have
some
more
questions
to
ask
so
preliminary
investigation,
we
start
off
really
quick.
D
We
designed
some
what
they
call
primitive
lattices,
the
body
centered
cubic
anybody,
who's
taken
a
class
on
materials
will
know
what
that
looks.
Like
and
I've
got
a
picture
for
you.
We
did
some
compression
and
tension
test,
so
we
crushed
them.
We
tend
them
and
we
also
pulled
them
and
just
measured
the
load.
D
This
place
made
a
forced,
sell,
underware
that
was
actually
read
out
the
the
load,
and
then
we
also
simulated
them
in
a
computer
or
computer
program
called
ANSYS,
and
then
we
compared
the
simulation
and
experimental
results,
and
so
this
is
what
a
body
centered
cubic,
primitive
lattice
looks
like.
We
designed
it
in
a
software
called
elements
for
in
topology,
and
this
is
the
body
centered
cubic
unit
cell
after
we
design
and
printed
our
samples,
their
cylinders.
D
D
These
are
some
of
the
failure
modes
that
we
obtained
after
we
applied
our
tension
and
compression
test.
You
can
see
the
compression
you
can
crush
it
and
it
kind
of
springs
back
and
that's
kind
of
failure
mode
you
see
for
those,
but
in
tension
you
have
you
actually
wrote
them
apart
and
they
all
rip
apart
it
at
different
places
and.
D
Due
to
the
scope
of
this
talk,
but
we
we
model
these
and
computer
program
an
interesting
aspect,
if
any
of
you
guys
ever
designed
anything
with
the
lattice,
the
process
actually
be
cumbersome.
So
if
you
ever
worked
an
STL
file,
these
have
lots
of
faces
and
tilt
that
first
student
has
to
work
with
these
it'sit's.
He
wants
to
move
apart
on
a
build
platform
and
he
has
to
click
a
button
and
wait
like
a
minute
for
it
to
move
and
they
have
to
go
and
do
50
of
them.
So
it's
it's
interesting
anyway.
C
D
I'll
go
over
this
data,
the
best
I
can
so
we
simulated
and
what
we
found
is
on
a
graph
of
force
versus
displacement
kind
of
the
stiffness
response
of
this
material.
If
you
simulated
it
using
an
average
person's
simulation
technique,
we
have
to
take
that
per
view
because
everybody
was
semester,
us
isn't
the
top
not
to
PhD
that
simulates
just
an
average
simulation.
We
get
these
responses
for
all
those
three
lattice
samples.
They
they
about
line
up,
and
so
we
kind
of
expect
the
day.
So
you
have
the
same
relative
density.
You
have
roughly.
D
Amount
of
material
support
in
that
load,
but
if
you
actually
go
and
test
these
you'll
see
that
for
the
thick
struts,
the
really
big
ladder
struts
you
get
kind
of
a
higher
performance,
but
it's
still
lower
than
our
simulation.
And
then
once
we
start
going
lower
and
lower
instruct
I
have
a
sample.
Guess
we
can
leave
the
link,
it
becomes
pretty
brutal
and.
B
So
this
is
the
really
important
part
for
the
FDA
right
right.
We
need
to
know
when
do
you
go
from
here
to
here,
because
if
you're
trying
to
convince
left
in
that
your
device
is
not
worse
than
someone
else's
and
their
design
puts
on
my
peer,
but
for
some
reason
your
designs
down
here,
there's
going
to
be
a
lot
more
flash
space
right.
If
you
didn't
test.
D
It
maybe
not
adequately
enough
right
that
this
might
not
be
exposed
in
your
test
case,
so
this
is.
This
is
a
kind
of
important
outcome
for
us,
and
so
that
that
was
pretty
good
and
we
wanted
to
investigate
more.
So
we
created
a
bigger
matrix
of
experiments
and
wanted
to
dive
deeper
into
this,
and
so
this
is
a
lot
of
busy
work.
But
we
we
designed
a
new
cube,
a
new
kind
of
square
volume
that
we
worked
with.
We
also
added
stochastic
lattices
to
the
experiment.
D
We
added
compression
tension
engineer
so
we're
adding
shear
I'll
show
you
what
that
kind
of
test
looks
like
later
on
and
then
same
thing
we're
doing
an
FAA
or
a
simulation,
so
tension
air
tension
compression
where
you're,
crushing
it
and
then
shear
we've
got
this
little
design.
We've
got
these
little
arms,
so
when
you
compress
it
actually
shears
the
latter
cell
and
as
I
was
talking
about
when
you're,
creating
these
parts
and
you're
trying
to
move
them
on
a
build
platform,
you
actually
want
to
3d
print
them.
D
D
The
samples
look
like
there's
some
acronym
terminology,
I,
don't
think
it's
memorize
it
if
you
want
or
don't
so
the
important
things
here,
relative
density,
your
cell
length
in
your
strut
diameter,
we
used
our
powder
bed
fusion
machine
and
we
actually
fabricated
a
bunch
of
samples.
These
aren't
all
of
them,
but
this
gives
you
an
idea
what
they
look
like
and
the
stochastic
lattice
kind
of
a
view.
D
Big
Wallach
texts.
Don't
worry
about
this
interesting
thing,
about
powdered
med,
fusion
technology
versus,
say
your
filament
technologies
is
you
can
build
really
cool
stuff?
Sometimes
the
hard
part
is
getting
the
powder
out
of
the
part
expect
with
these
lattice
structures,
I'm
glad
I've
delegated
somebody
else
to
do
this.
When
you
print,
we
would
air
blast
these
parts
and
then
do
a
bead
blast.
It
just
try
to
to
get
the
powder
out
them.
There
was
nothing
we
could
do
to
actually
remove.
So
when
we
actually
go
to
test
these.
D
This
would
apply
our
effect,
our
mechanical
response,
we
kind
of
knew
that
so
it
would
deter
of
any
outcomes
we
had,
and
so
we
actually
had
to
do
kind
of
a
preliminary
investigation
and
see
what
was
the
capabilities.
Could
we
build
that?
We
could
at
least
feasibly
get
the
powder
out
of
so
that
that
was
a
purpose.
That's
like
something
to
keep
in
mind.
Testing
used
a
servo
hydraulic
load
frame.
We
moved
about
five
millimeters
per
minutes
of
our
question.
D
D
And
this
is
I
think
this
is
one
of
our
oldest
hydraulic
anyway.
This
is
what
the
kind
of
top
test
looks
like
it
spins,
so
you
pin
these
and
both
in
it
pull
the
last
part
and
then
for
the
shear
test.
We
put
it
back
into
the
compression
testing
and
compressive
and
shear
slice
the
failure
modes
of
the
sample
and
is
going
to
show
a
few
of
these
with
the
time-lapse
is
interesting,
but
it
also
gives
you
an
idea
of
when
you
go
to
simulate.
These
are
some
of
the
assumptions
and
simulation
valid.
You
notice.
C
E
D
Able
to
make
the
same
argument
for
the
stochastic
ladder
says
it
crushes.
So
if
I
was
to
take
this
Manos,
like
oh
man,
this
thing's,
a
gigabyte,
maybe
I'll
just
quarter
this
thing
and
we
run
a
simulation-
a
quarter
cuz
it's
much
faster.
Maybe
that's
not
a
good
assumption,
but
here's
some
gifts
of
just
some
samples
tension
compression,
so
you
can
kind
of
see
how
they
fail.
What
was
interesting
is
the
ones
we
pull
intention
and
the
ones
we
do
and
sheer
the
failure
modalities
are
the
different
ways.
These
things
can
fail
are
all
different.
D
Here
and
here
and
the
thing
would
just
lop
and
willfully
fail,
you
know
high
energy,
all
right
data
kind
of
hard
to
go
over
to
accommodate
everybody's
understanding
of
mechanics.
The
general
idea
here
is:
we
saw
these
same
trends
that
we
did
in
the
preliminary
test.
Big
struts
higher,
look
response
and
then
again
as
we
got
smaller,
it
really
start
to
fall
off
the
stochastic
lattices
at
the
relative
density
or
testing,
which
is
a
smaller
relative
density,
had
about
the
same
response,
the
thicker
struts,
pretty
stiff.
D
B
A
finer
point
here
is
the
two
2.5
millimeter:
that's
the
same
relative
density,
the
same
strut
size,
so
lots
of
sort
of
high-level
mechanics
would
assume
it
has
comparable
performance.
So
the
fact
we've
gone
from
that
uniform,
regular
structure
to
that
just
non
uniform
irregular
structure
had
a
significant
effect
on
the
mechanics
without
changing
the
material,
the
relative
density
or
the
strut
size.
So
there's
some
walking
mechanics
going
on.
That's
worth
understanding.
G
D
D
G
D
And
so
in
Fe,
a
right
that
should
is
assuming
your
you've
measured.
It
really
good
and
you've
accommodated
some
of
the
quirks
that
happen
in
the
simulation
that
would
bring
that
out
or
what
else
would
bring
it
out
is
actually
experimental.
A
testament
I
mean
I,
agree
of
doing
a
back
of
the
envelope
calculation,
for
these
I
mean
it's
easy
for
a
dog
bone
structure,
because
then
you
just
measure
the
cross
section
area
and
you
could
play
an
equation,
can't
do
that
here.
B
Ie,
the
challenge
to
is
you:
each
node
dictates
what
the
load
transfer
is
going
to
be,
so
he
can't
just
take
the
one
slice,
and
so
you
know
I
kind
of
slice.
All
my
stress
everything
you
know,
first
of
all
right
because
that
load
has
to
be
transferred
through
the
notes.
Okay
gets
complicated,
hence
the
FE,
a
against
the
bench
testing.
Okay
in.
H
D
H
D
Question
there
are
a
lot
of
lattice
structures,
you
can
have
I
mean
we
have
a
general
idea
of
certain
performance
metrics
of
certain
lattice
structures.
What's
interesting
is
from
our
point
of
view,
I
mean
we
could
go
test,
the
strongest
lattice
structure,
but
from
a
regulatory
sense.
We
don't
want
to
do
that.
We
want
to
know
what's
the
worst,
when.
D
You
know
what
what
what
questions
have
you
used,
something?
Maybe
it's
for
a
novel
application
or
whatever,
but
if
it's
has
certain
modalities
that
show
up
in
intestines,
maybe
it's
a
little
bit
weaker.
We
want
to
know
what
questions
asked,
but
yeah
some
perform
better.
Some
are
bending
dominant
and
some
handle
loads
just
differently.
So
is
there
a
big
difference
between
desolation.
B
D
So
what
was
interesting
from
these
experiments
when
we
go
from
a
point
to
relative
density-
and
maybe
we
jump
to
point
three
here-
the
BCC
is
performed
like
expected,
thicker,
struts,
bigger
response
and
then
lower
lower
diameter,
struts
lower
response.
We
had
an
interesting
outcome
where
now
the
stiffer
response
for
the
stochastic
lattices
was
the
four
and
the
two
point
five.
D
So
now
the
two
point:
five
was
a
lot
different
that
we
didn't
expect
that
and
that
wasn't
what
we
saw
at
the
point
to
what
had
happened
was
that
powder
removal
that
I
was
talking
about
before.
Since
these
are
stochastic,
you
can't
hold
them
up
and
look
through
and
so
evaluating
how
much
powder
and
those
is
actually
kind
of
complicated,
probably
to
do
what's
called
a
micro,
CT
and
kind
of-
and
you
know,
x-ray
it
and
get
to
keep
it
volume.
You
can
measure
things
that
are
in
there
that
you
wouldn't
be
able
to.
D
We
tried
its
hydrophilic,
so
you
don't
really
want
to
put
this
in
water
and
kind
of
compact
it.
What
we
tried
is
put
in
like
isopropyl
seal
it
up
put
it
on
for
sonication
bath,
and
we
had
a
student
do
that
he
he
even
had
some
very
strong
stainless
steel
wire.
That
was
just
enough
to
bend
the
lattice
and
he
couldn't
push
the
powder
out.
It
wouldn't
do
anything,
so
it
was
maybe
or
maybe
just
the
mechanics
of
the
poor
scientist
right.
If
you
just
couldn't
push
it
out,
I
think
our
particle
sizes,
so
there's.
C
D
Limits
the
other
interesting
thing
was
now
the
thicker
strut
and
our
stochastic
lattice
was
a
lot
weaker,
and
so
we
have
some
hypotheses
for
this.
Since
it's
random,
you
know
if
you
do
only
a
few
small
struts
depending
on
the
orientation.
You
know.
Maybe
you
get
beams
like
this.
It
holds
more
load,
but
if
you
get
beams,
you
know
more
slanting
over
it's
a
little
bit
weaker,
so
we
won't
look
into
that
later.
Compression
results,
kind
of
the
same
thing,
just
in
the
sake
of
time,
same
outcome,
model
more
data.
It's
funny.
D
We
used
a
spec
sheet
value
for
our
stiffness
modulus,
but
we
have
to
kind
of
validate
that
with.
If
we're
gonna
like
publish
this,
we
don't
wanna
use
some
nice
spec
sheet.
As
a
mat.
My
colleague
admitted
before.
All
these
machines
are
different.
You
can
have
the
same
machine
installed
right
next
to
each
other
and
they
have
different
performances,
kind
of
an
overview
it.
Some
of
our
modeling
looks
like
and
we
did
do
mesh
refinement
studies.
You
know
why
has
done
a
simulation.
D
You
have
to
make
sure
that
the
results
you
obtain
are
independent
of
your
mesh
size.
So
you
want
to
make
sure
if
you
like
double
the
mesh,
the
answer
doesn't
change
and
again
we
obtain
the
same
results.
We
simulated
these
and
you
can
see
this
is
only
for
the
BCC.
We
don't
have
any
data
for
the
stochastic
lattices
right
now.
Those
take
some
time
so
an
example
compression
versus
displacement,
curve,
force
versus
displacement.
D
D
So
this
had
actually
been
done
in
somebody
else's
master's
thesis.
We
can
100%
attribute
the
same
kind
of
phenomena,
but
when
you
get
to
these
smaller
struts
sizes,
the
laser
power
going
into
the
powder
it
has
to
go
out
of
this
stuff
has
to
cool
it.
So
you
have
to
have
heat,
transfer,
mechanics
that
go
out
and
so
for
bigger
parts.
It's
easy
because
it
can
just
conduct
out
and
things
will
cool
off.
D
Well
here,
if
I
recall
correctly,
Neff
is
2015
paper,
the
effective
diameter
was
different,
and
so,
if
you
go
in
there
and
actually
measure
the
diameter,
you
probably
get
a
solid
core
where
your
bulk
properties,
your
bolts,
stiffnesses,
you
have
for
a
pretty
valid,
but
everything
on
the
outside
was
different,
and
so
what
he
had
to
do
was
go
back,
use
an
SEM
microscope
and
measure
the
cross-section
doing
a
correction
factor,
and
then
he
was
able
to
improve
simulations.
But
not
everybody
who
comes
to
FDA
is
gonna.
Do
that
so
that's
anyway
conclusions.
D
The
simulations
all
showed
reasonable
similarities,
as
that
one
graphic
shows,
so
they
all
overlapped
the
DCCC
structures.
Sorry,
the
preliminary
and
current
nylon.
Twelve
structures
and
revealed
a
discrepancy
like
we
were
talking
about,
so
we
are
kind
of
knowledgeable
about
that.
So
if
somebody
comes
in
and
simulates
a
lattice
and
doesn't
do
any
bench
testing
it's
like,
but
we
don't
know
if
this
is
good
enough,
because
you
know
it's
just
a
simulation.
We
know
that
it
falls
off.
Probably
powder
removal
capabilities
are
important
when
people
do
the
tests
on
these.
D
So
if
somebody
comes
in
with
a
Veroni
mesh
and
it's
really
big
and
they
can't
see
into
it-
maybe
we'll
have
a
question
like
how
sure
are
you
that
you
removed
all
the
powder
and
the
Baroni
tessellation
method
also
gives
interesting
variable
results
at
certain
conditions.
So
if
you
use
a
certain
number
of
layers,
if
you
were
to
regenerate
that
lattice,
as
some
people
do,
if
they
make
a
spec
change
to
their
part
in
just
the
way
you
actually
create
lattices
and
structures,
you
know,
maybe
we
we
have
some
questions
like.
D
D
Future
work
and
I've
got
a
few
minutes.
I'll
just
quickly
go
over
this,
so
we're
going
to
take
this
study
and
some
of
the
the
results
we
get
out
of
this.
We
have
a
colleague
who's
doing
spine
cages,
and
so,
if
you
ever
have
a
spinal
surgery,
the
way
they
do
is
they
take
the
spine
cage
and
the
orthopedic
surgeon.
We
literally
pound
it
into
your
back
with
the
lattice.
D
A
lot
of
these
have
lattice
structures,
and
the
concern
is,
though,
that
impact
force
the
impulses
and
not
many
people,
actually
investigate
and
do
research
on,
like
the
impact
mechanics,
you
know
we
want
to
know
if
some
of
these
weaker
lattice
structures,
you
know
if
they
show
those
very
modalities,
we
want
to
be
able
to
tell
people's
like.
Maybe
you
know
you
should
change
this
right
or
maybe
should
hit
this
list.
D
So
we've
got
some
interesting
things
lining
up.
We
got
spine
cages
printed
in
Thai,
six,
four
and
I'll
go
over
what
these
look
like
modeled
these
up,
they're,
not
for
implant.
There
testing
coupons
about
that.
So
we've
got
a
whole
set
of
coupons
that
we're
gonna
hand
our
colleague
and
he's
going
to
do
what's
called
drop,
our
testing
stock
simulate
impacting
them
enjoy
spy.
D
B
D
B
B
We
had
some
surgeons
come
and
a
bunch
of
them,
and
we
said
okay
guys.
We
want
you
to
hit
this
hammer
that
we
could
have
load
so
on
so
I
think
we
looked
at
three
or
four
surgeons
and
then
we
said:
okay,
so
what's
a
reasonable
impact
load
for
us
to
try
now
right,
you
might
have
the
massive
guy
who
like
lifts
all
the
time,
or
you
might
have
a
really
small
guy
right
and
if
he
hips
it's
actually
promised
they
don't
hit
it
hard
enough.
B
So
again
we
start
getting
all
the
surgeon
effects
and
things
that
gets
tricky
so
we're
trying
to
come
up
with
a
test
that
will
give
us
a
reasonable
assurance
that
when
the
surgeon
hits
the
spine
kitchens,
not
gonna,
break
based
off
of
the
spine
cage
design.
Okay,
so
I
do
believe
we
have
about
ten
more
questions.
H
E
D
A
good
question,
so
when
people
come
in,
we
do
it
ask
them
to
address
their
biological
endpoints.
You
know
all
the
things
that
you
should
test
to
make
sure
your
material
is
biologically
safe.
Most
people,
always
they
address
that
in
some
way.
Titanium
is
expensive.
This
titanium
alloy,
if
you
pass,
evade
it,
and
you
know,
there's
certain
things.
You
just
make
sure
you
have
in
line
the
concerns,
usually
not
too
big.
Exactly
thank
you
saw
titanium
if.
B
You
don't
process
it
right,
it's
a
it's
a
problem,
so
the
other
thing
is,
and
we
were
we
didn't
make
a
big
deal
out
of
this.
Is
most
people
don't
make
any
claims
about
what
that
lattice
structure
does
right?
If
you
were
to
claim
it
was
to
promote
osseointegration
so
bone
growing
in
you'd
then
have
to
prove
to
the
FDA
that
bone
does
grow
into
your
device.
Most
of
these
devices
don't
make
those
claims.
It's.
C
B
Of
these
structures,
so
long
as
you
have
about
750
microns
worth
of
gap
between
your
struts,
you
will
get
tissue
and
grow
lots
of
studies
have
shown
you
get
tissue
ingrowth,
you
actually
get
bone
for
a
little
bit
and
after
that,
just
random
tissue
grows
it
well.
We
don't
ask
those
questions
unless
someone
makes
the
claim
and
the
other
part
is
clinically
we're
not
seeing
any
failures
from
the
interface
between
these
lattice
structures.
B
So
without
a
strong
signal
saying
something
is
going
wrong,
we
don't
have
a
lot
of
grounds
to
ask
additional
questions
and
you
guys
actually
want
that.
The
more
questions
we
ask
about
things
that
aren't
important:
the
slower
it
takes
for
products
to
get
to
the
market.
So
we
want
to
make
sure
we're
only
asking
the
questions
that
are
important,
because
other
thing
is,
is
we
ask
to
make
questions
that
are
important?
Someone
might
miss
something
that
is
so
a
lot
of
the
research.
We're
doing
right
now
is
to
say
look.
B
B
H
B
A
yes-
and
you
know
that
makes
it
easy
for
us
to
justify
to
our
management
the
time
and
effort
we're
doing
in
the
early
days
of
our
work.
There
was
a
lot
of
this
is
where
the
gaps
in
the
science
are.
This
is
where
we
think
the
concerns
are
and
I'd
like
to
think.
We've
done
a
good
job,
because
I've
absolutely
been
a
lot
of
gross
failures
of
these
3d
printing
devices.
B
C
B
I
Really
appreciate
the
the
sensible
and
yet
methodical
way
you
guys
go
about
doing
that.
It's
really
very
nice,
but
I
have
a
question
about
the
regulatory
framework
issue.
Can
you
review
for
much,
if
not
all,
but
for
much
of
what
we
do?
The
sweet
spot
is
in
that
exempt
category
one.
Can
you
review
the
boundaries
of
exempt
category
one
as
it
applies
to
us
back.
B
So
that's
a
good
question.
I
was
actually
looking
at
the
rights
this
morning.
Preparing
for
that
question.
So
for
the
classification
of
the
prosthetic
devices
you
guys
fall
in,
you
are
exempt
from
everything
except
for
record-keeping
and
report
annex
man.
So
if
there
is
a
failure,
you
have
to
have
a
mechanism
in
place,
sir
you're
supposed
to
have
a
mechanism
in
place
to
be
able
to
track
that
and
you're
supposed
to
be
able
to
know
how
many
devices
you're
making
right.
I
F
B
Is
a
tissue
product
that
has
been
more
than
minimally
manipulated
and
that
kicks
it
into
a
FDA
regulatory
regulated
product
right?
So
if
for
tissue
bank,
if
you're
not
manipulating
the
tissue,
that's
outside
the
FDA
purview,
our
view
kicks
in
when
it
steps
beyond
then
way
manipulated.
Now,
my
colleagues
in
the
Center
for
biologics
can,
I'm
sure,
explain
all
the
joys
of
having
a
phrasing
and
when
we
manipulate.