Episode #77 | Orthopedics Meets 3D Printing: A Journey Into the Future - The Lattice (Official 3DHEALS Podcast)

Episode Transcript
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Speaker 1 (00:00):
And, okay, let's just make sure everything works.
Okay, I think people aretrickling in.
That's great.
Hello, hello, hello, goodmorning, and some of you guys
are mid-morning now.
My name is Jenny Chen, afounder and CEO of 3D Heels.
I just want to say a couple ofthings about 3D Heels before we

(00:22):
move on to this incredible paneland incredible topic 3D printed
orthopedic for orthopedicdevices.
I started this almost eightyears ago seven or eight years
ago, I can't even count becauseyou know it's more than a
handful and my our mission.
There are three missions.

(00:42):
One is to educate people about3D printing and what it can do
for healthcare, and I think overtime it evolves into this kind
of virtual event.
It's not just educational, butalso conversational.
We want to talk to each otherand we can't afford the plane
ticket anymore.
It's getting more and moreexpensive.
Traveling in general islogistically complicated, so we

(01:05):
want to bring people together.
We can have this kind ofconversation, educating each
other, and also engage ouraudience, because I know we have
a lot of smart people in theaudience who want to have a
conversation and love to engageyou guys, and this is the kind
of conversation we want to have.
And number two is networking.
So in the chat box, feel freeto put your LinkedIn link, your

(01:26):
social media link, and you candirectly message any speakers
you have questions.
And if you have questionsduring the event, feel free to
put them in QA box.
Our moderator Craig today, sohe can manage I can also help,
but still, put it in a QA box ismore organized.
So networking is number two.

(01:47):
We are actually having anin-person event in a couple of
weeks in San Francisco, so ifyou're in town on March 27th in
the evening, please join us.
And number three is we have aprogram called Pitch3D.
I'm really proud of thisprogram because since 2018, we
have hosted more than 70startups and I've seen literally

(02:08):
some of the startups has grownfrom, you know, one employee to
30 and some are raising round Band C now.
So really proud of this group.
So Pitch3D is a program is afree program for early stage
startup, so pre-seed seed toseries A in healthcare, 3d

(02:31):
printing and 3D technology.
So AR, vr or any kind of CADprogram, cad software, design
and any SaaS related to additivemanufacturing in healthcare.
They're all included.
We're not really restrictive tojust 3D printed or 3D printing
the machine, that kind of thing.
So we're actually pretty,pretty wide space.

(02:52):
So that's number three.
So I want to introduce ourmoderator today because he
really is a moderatorextraordinaire.
I know Craig for more than fiveyears now, is that right?
During the pandemic we met eachother.
Virtually.
Only last year we actually meteach other in person and he's
also the community manager forNew York and he's doing a

(03:16):
fantastic job.
And he's also the president ofHyMet and so I'm really happy we
have him as moderator.
He's probably a bettermoderator than me.
He's extraordinary.
But before we move on to thepanel which Craig will introduce
us to, I just have a couple ofslides I want to share with

(03:37):
people, because I'm always kindof curious is where is 3D
printing in healthcare?
Because the numbers put out byanalysts I'm not 100% confident
about those numbers because Iknow there's some numbers
throwing out saying the totalmarket for 3D printing is about
$20 to $30 billion and I'malways curious like, well, okay,

(03:59):
is that number accurate?
And where is healthcare?
And, more importantly, I haveto say I I see orthopedic space
is growing a lot more than manyother spaces we focus on.
That includes bioprinting andprosthetics, you know stuff, and
dental.
But where does this panel stand?

(04:21):
Um?
So I want to share just acouple of slides and let me see
where did my hold on one second?
My PowerPoint presentation wasworking.
Hold on one sec.

(04:45):
Okay, here we go.
There you go, okay, all right.
So a quick market analysis frommy own research.
I have reviewed, basically thepublic company, some of the

(05:09):
largest public company companies, public reports, so their SEC
filing the most recent ones, andlet me just collapse my thing
here and I have noticed somereally interesting trends, since
I am not an orthopedic surgeonand when I was training in
medical school we did not haveany robots.

(05:32):
That should kind of date me howold I am now.
But now almost every largeorthopedic implant companies
have robots and they also have3D printing and they combine
these two technologies togetherto increase efficiency, accuracy
and improve clinical outcome.
So that's a really interestingtrend for me.

(05:53):
I think some of the benefits of3D printing for orthopedic
implants are clearly known tothis audience.
So I don't want to take thataway from the speakers as well,
because they're more expert thanme in this.
But here's a quick comparisonon where is every the larger

(06:13):
companies are going, and wecertainly have some rising
startup like Restore3D in thespeaker panel, who Nathan is
going to tell us more aboutwhere the cutting front frontier
is.
But these are the big playersin the space and, as you can see
, everybody has a robotic systemthat works with a 3D printed

(06:33):
implant and the implant also hasthe engineered surface
geometries to make theseoperations safer and the outcome
better.
Make these operations safer andthe outcome better, which means
the implant lasts in thepatient, maybe even beyond the
stated 10 to 15 years and lesscomplication.

(06:57):
Okay, and so the other thinginteresting is we're also
talking about fully customized,customized, semi-customized
versus fully customized implants, and the companies who are
manufacturing what we alwaysthink 3D printing for is the
patient-specific implants where,you know, every implant is

(07:19):
designed for every singleindividuals and every implant is
different because, you know, wethink we can have complexity
for free.
So, uh, it makes sense thateveryone has their own implant,
but actually the reality is onlya minority of the 3d printed
implants are completely patientspecific and you see some of the

(07:41):
companies who does this hereand the you know.
Restore 3d is one of them,which we will hear more from
nathan soon.
Um, and then I think themajority, the millions of
implants we have, that's 3dprinted year annually, are
actually from our semi um,adapted, so they're adapted 3d
printed implants.

(08:02):
So so they come in differentsizes or they can be modified to
fit a particular patient.
They're not reallypatient-specific, they're
customizable.
So that's another interestingfinding.
And then come down to the moneypart, and these are just
estimates.
So nobody actually specificallycome out because you know the

(08:24):
orthopedic implant industry,they did not come out to grow
the 3D printing industry.
That is not how it goes, theimplant manufacturer, they just
want to make better products andgenerate revenue.
So this is only an estimate.
Nobody in our report says, ok,our 3D printing you know CapEx
is generating this kind of ROI.

(08:44):
There's nobody saying that andsometimes you can't even find
those numbers.
So these are just estimates.
And, as you can see, for most ofthe larger players the
percentage of implants as 3Dprinted is about 15 to about 15%
and J&J, even though we know itas a leader in this space,

(09:08):
percentage-wise, it's also got abigger denominator in terms of
total revenue.
Percentage-wise it's actuallyrelatively less, but if you add
the numbers of the totalestimated 3D printing revenue
it's about $4 billion.
And so if you believe the lowrange number of $20 billion

(09:28):
total market and you know $4billion revenue.
This is annual revenue.
You can see that howsignificant healthcare is.
I mean, just orthopedic implantalone is part of healthcare.
3d printing.
So again, I don't think the 20to $30 billion market size it

(09:49):
depends on how they calculate itis extremely accurate.
I also think that this speaksvolume of how important it is.
3d printed orthopedic implants,or just implants in general, is
in 3D printing.
Okay, so that's all I want tosay.

Speaker 2 (10:15):
Thank you, jenny.
That was an interesting set ofdata to begin the conversation,
and thank you for the kind wordsas well.
You know, let's all acknowledgethe hard work that Jenny does
in putting together great eventslike this, and the timing of
this event was reallyappropriate, given that the
American Academy for OrthopedicSurgery conference is coming up
in San Diego March 10th through14th.

(10:38):
Many of our speakers will be inattendance and we thought it'd
be a good opportunity toestablish conversations,
virtually so for those of usthat are going to be in
attendance, great opportunity tomeet and continue the
conversation.
So again, without further ado,good morning, good afternoon.
We have people from all overthe world, so it's always great
to have these events.

(10:59):
My name is Craig Rosenblum.
I'm the president of HyMed.
We have a great list ofspeakers lined up today and
really the goal of thispresentation is to understand 3D
printing and specificapplications that are up and
coming in orthopedics.
If this was a webinar, say,five, 10 years ago, I think

(11:20):
there would probably be someskepticism as far as the
practical application for 3Dprinting in orthopedics.
But now, as the data that Jennyhas shown you know, really
things are up and coming andthere's so many companies
especially I'm looking at Nathancompanies that depend on 3D
printing and many companies inthe orthopedic field that

(11:41):
probably would not be inexistence if 3D printing was not
a thing.
So, without further ado, I'dlike to introduce our first
speaker, my colleague and friend, garen Njakian.
Garen is sitting literallyright across the room, right
across the hall here at Hymed.
Garen is our engineeringmanager at Hymed.

(12:01):
So Hymed has been in businessfor over 30 years as a global
leader in calcium phosphate.
We manufacture calciumphosphate materials for plasma
spray coatings and surfacetreatments, and were in
existence long before 3Dprinting was a thing.
Garin and his team collaboratedirectly with dental and medical

(12:22):
device manufacturers around theworld to provide innovative
biomaterial solutions.
Drawing on his experience withall three major classes of
medical devices, garen's work inthe medical device industry
over nearly a decade hascentered on process optimization
, root cause analysis,mechanical design and quality

(12:43):
management systems.
He holds a bachelor's degree inbiomedical engineering, with a
minor in robotics from JohnsHopkins University and a
master's degree in biomedicalengineering from Duke University
.
So, garen, the floor is yours.

Speaker 3 (12:59):
Thank you very much, craig, and good morning, good
afternoon, to those in differenttime zones as well, so I will
share my desktop here andhopefully all can see these
slides, all right, so thank youagain for all being here.
I'm going to touch onspecifically 3D-printed devices

(13:19):
in orthopedics, morespecifically bioceramic
post-processing, and, as Craigmentioned, my name is Garen and
happy to be here and hear yourthoughts on the talks today.
So, in brief, himed, what do wedo?
What is our company all about?
Right, so we've been supportingthe orthopedics industry for
over 30 years, supporting 3Dprinting for as long as 3D

(13:42):
printing and orthopedics hasbeen around, so let's say the
last five to 10 years.
And we have three kind of mainfocuses in our organization.
We are, first and foremost, abiomaterials manufacturer, so we
create different calciumphosphate forms that get used
into bone grafts, bone putties,bone void fillers, things like
that.
But then we also take thosematerials and create

(14:03):
biocompatible surfaces withthose.
So things like plasma sprayedhydroxyapatite or things like
resorbable blast media texturingto increase the surface area of
dental and orthopedic implants.
So we do things like contractmanufacturing for different
companies as well as purely R&Dwork for a number of up and

(14:27):
coming and larger, establishedorganizations.
We have things like SEM, xrd,along with other capital
equipment that we use on a dailybasis, not only for our
customers but also for our owninternal engineering and R&D
work.
So to kind of set the stage ofmoving over to additive,
something like Matrix, ti ortitanium plasma spray coating is

(14:47):
something that Hymed has donefor well over a decade now and
that still is a market for that.
But we are seeing this shift inthe industry of creating your
porosity and your controlledporosity through additive
manufacturing.
So you get the porosity thatyou want built into the CAD and
built into the print itself.
It removes steps from thesupply chain and you can scale

(15:10):
it, as you can see from thisimage from Anthropologie.
So we've seen that as anindustry trend as well.
Moving over to additive, talkingabout 3D printed titanium, I'm
sure others on this call aremore well-versed than I am, but
my understanding is that there'sbasically two paths that most
companies go in terms of powderbed fusion technology for

(15:32):
titanium 3D printing.
The first is scanning, lasermelting, or SLM, and the second
is E-beam or electron beammelting, ebm, and what we can
see here is that the startingpowder size is much smaller for
SLM than it is for EBM,depending on the printer and
your settings and things likethat.
But generally speaking, andwhat we see on the untreated
surface after printing is youhave these partially molten or

(15:56):
residual beads left on thesurface.
A takeaway that we found in ourresearch is that the size of
your feedstock or your powderbed to start it actually drives
the size of the residual beadsat the end.
So if you're using an SLMtechnology, you can see on the
scale bar you're going to seesmaller beading and then if you
use the e-beam technology,you'll see larger beading on the

(16:17):
exterior of your parts.
When we look at some finalparts that we've had in-house
here at Hymed, when we look atsome final parts that we've had
in-house here at HiMed, we'vehad parts that are sent to us
for other areas of processingand in the 3D printed area they
were not post-processed at all,even though they were meant to
be final devices.
Moving on to the field.
So, interesting enough, if yousee the top image there where I

(16:40):
put an arrow, that bead I wastrying to take a second picture
on our SEM and by the time thatsecond picture was snapped that
bead was gone.
So it really gives an idea ofhow loosely adhered or cracking,
as you can see in the bottomimage some of these beads really
are.
They're not partially melted orfully adhered.
In some cases they are barelyhanging on.
And other customers have sentus parts as references for us to

(17:02):
work with for us topost-process other parts.
But the parts they sent thatthey said were completely
processed, we saw that there wasstill significant beading on
the parts.
So I think this really showsthat a lot of manufacturers
either don't fully post processor don't post process their
parts at all to remove thoseresidual beads that remain on
the ends of prints residualbeads that remain on the ends of

(17:28):
prints.
This is a little bit of work outin University of College London
and others on threecommercially available
acetabular cups.
If I said the company namesyou'd know them.
You can read the paper.
But this was using SLM andE-beam depending on the part.
And again we can see that thosecommercially available cups had
partially molten looselyadherent beads or even clusters
of had partially molten looselyadherent beads or even clusters
of multiple beads and looselyadherent beads together in the

(17:50):
sample C there.
So I think now that we'veestablished that the beads exist
after printing and some folkskind of don't recognize that yet
that they exist or that theymight need to be post-processed.
We wanted to do a little bit ofresearch on what are the stated
concerns in industry with theresidual beads.
So rather than take my word forit, I ended up pulling a couple

(18:10):
of sources from publicationshere.
So the first one is one concernis that particles falling off
from the surface as wear debrismay cause aseptic loosening of
the bony prosthesis.
We know that aseptic looseningis one of the largest failure
modes for these types ofimplants, so that is a concern.
The second is that the clinicalimpact of these partially
molten beads needs to beunderstood, particularly if this

(18:31):
may increase the release oftitanium for the implants.
So this is something wheremaybe tabor abrasion or other
testing can be performed to seethe level of beads that would be
removed when being placed invivo.
And then the third, which we'lltouch on more in the coming
slides, is in the course ofanalysis of specimens cracking
surface in stress tests orstrength tests.

(18:52):
Rather, they have observedvoids and unmelted powder, and
the crack initiation locationsoccurred in the form of unmelted
or partially melted metalpowder particles.
So these are areas where theremay be different stress
concentrations because of thenon-uniformity of those last
layers of your print which couldbecome crack initiation sites.

(19:13):
And now that we've talked aboutsome of the concerns, what are
some benefits to post-processingand what research and
experiences Hymet had out thereto see what the benefits could
be?
So this was a study done in arat model or multiple rat model,
where they 3D printed implantsusing SLM and then they either
left them untreated so that's Aand B on the pictures there or
used an acid etch to remove theresidual beads, so that's what

(19:36):
we're calling 3DA and that'simages C and D.
And they implanted these intoanimal models and performed
histological analyses at threeand six weeks and they found
that the treated samples had anincreased bone implant contact
that was statisticallysignificant at both three and
six weeks and had bone MSCproliferation and osteogenic

(19:56):
differentiation that was higherthan compared to the as printed
part.
The next is a little bit ofmore research that we found in
our literature view as well assome customer data we have on
file.
So the top is from a paper andthose SEM images are from a
paper as well, where the postsurface treatment imparts a
compressive residual stress onthe surface, increasing fatigue

(20:18):
life by slowing down theinitiation of cracking.
So what they found was thatusing a bead blasting technique,
they could smooth out thissurface, get rid of some or get
rid of those residual beads andany initial crack initiation
sites that may have been formingand impart some compressive
stress and increase theirfatigue life processing.

(20:44):
And normally they'll send usparts that were printed and then
they did hip or hot isostaticpressing on the parts or they
sent us those samples that wentthrough those two actions and we
blasted them afterwards andthey found that the parts that
weren't blasted by Hymed, therewas large variability in number
of cycles and fatigue strengthas compared to the Hymed parts
and that the Hymed parts were50% increase in fatigue life
across the board.

(21:05):
So we've seen this acrossmultiple customers and we've
convinced ourselves there'svalue here based on our customer
data.
Next I want to talk through justa few case studies again of
some work that we've done hereat HyMED.
So this is an image of nodepost-processing.
I don't need to beat the deadhorse on the beads existing.

(21:25):
They were there and we ended uptaking some of these 3D printed
lattices and aluminum oxideblasting it.
That's a common grit blastmedia that's used and when we
did blast we see that it doeseffectively remove those
residual beads.
However, we see embeddedcontaminant remains on the
implant surface.
So all those darker areas there, the dark gray that's aluminum

(21:51):
oxide still embedded in thesurface of the part itself.
But using something like MatrixMCD, our proprietary apatitic
calcium phosphate abrasive, youend up having a biocompatible
post-processing producing aclean and contaminant-free
surface following passivation.
So you get your microtexturingand things like that and you get
rid of those residual beads,but you don't have any embedded
particles and no aluminum oxide,obviously, in your process.

(22:13):
The next this was just a littlebit of fun we had in Python a
couple of months back.
So customer had sent us someparts that we treated and they
had sent us a few parts thatwere aluminum oxide treated in
terms of the blasting, and wewanted to figure out how do you
quantify what percentage of yoursurface is no longer your
osteoconductive titanium alloy,what percentage of your part is

(22:34):
now covered in aluminum oxide?
And so we did some histogrambased and adaptive thresholding
and then you can plot out thepixel intensities based on the
images themselves to say howmuch dark spots am I seeing on
the aluminum oxide as comparedto the matrix MCD treated
surface where you then passivateand remove the calcium
phosphate, leaving the puretitanium alloy.
So I think this next slideshows it a little bit better

(22:58):
where.
Up to 10% of the surface, itdepends on where you put your
thresholding.
But you can kind of see on theright with the red graph of the
aluminum oxide blasted part, youalmost had a bimodal
distribution where you have alarger cluster in that lower
pixel intensity and that's all,the aluminum oxide being the
dark spots in your image.
As compared to over on theright side, that's your titanium

(23:19):
alloy.
As compared to the blue withthe MCD you have a single crisp
peak and that is yourMCD-treated titanium alloy.
That you have left over.
So it depends on where you putyour thresholding.
But anywhere from 5% to 10% ofthe surface, at least in the
samples we've seen in-house hereat Hymed, is really aluminum
oxide.
It would be glass beads.
It would be other materialsthat are not able to be

(23:41):
dissolved afterwards, such assomething like Matrix MCD.
So that's all I have to sharetoday.
Obviously, you know this isjust learning a little bit more
about our experience here atHymed with this topic, as well
as some literature research, butvery excited to hear what
everyone else in this room andthe other panelists have to say
on this topic, so that we canall learn and grow the industry

(24:03):
together.
So with that I will stopsharing and thank you very much.

Speaker 2 (24:09):
Thank you very much, karen.
That was very interesting, butI might be biased, because we
work for the same company.
I see that there's quite a fewchat in the conversation in the
chat room and, just lookingthrough names, there's a lot of
familiar faces or familiar names, and I know the faces that go
with the name.
So it's nice to see so manypeople that have joined.

(24:30):
Um, I think we're going to do qa at the very end of the
meeting.
So, with that being said, weappreciate garen for sharing,
and next I'd like to introduceour next speaker, nathan.
So, nathan, why don't you shareyour screen?

Speaker 4 (24:49):
let me get myself off here.

Speaker 2 (24:54):
So, for a shameless plug, both Hymed and Restore3D
will be exhibiting in adjacentbooths at AAOS next month.
It just so happened to work outthat way.
So if you're interested in whatGaren had to share and
interested in what Nathan isabout to share and would like to
continue those conversations,then please look for us at AAOS.

(25:15):
Restore 3D is exhibiting atbooth number 3439 and HiMed
directly adjacent at boothnumber 3546.
All right.
So, nathan, your screen is up,but let me first introduce you
properly.

Speaker 4 (25:32):
Is it up correctly?

Speaker 2 (25:33):
Yes, it is up correctly.
Thank you, it is up.
But let me first introduce youproperly.
Is it up correctly?
Yes, it is up correctly.
Thank you, it is up correctly.
What happened behind the scenes?
No one has to know.
So Dr Nathan Evans leadsproduct development for
Restore3D.
He joined the company in 2018and has been a part of clearing
and launching numerousadditively manufactured products
in the orthopedic space.

(25:54):
Restore3d's focus is onpersonalized surgery realized
using 3D printing.
Prior to Restore3D, Nathanspent two years at McKinsley
Company as a consultant to largeF500 companies.
He obtained his PhD in materialscience and engineering at
Georgia Tech.
He currently lives in Durham,North Carolina, where Restore3D

(26:17):
is headquartered.
Nathan, the floor is yours.

Speaker 4 (26:20):
Great, thank you for that introduction.
And yeah, as he mentioned, Ilead product development at
Restore3D, a company thatutilizes additive as well as
some other enabling technologiesto deliver personalized
implants, and so what I'm goingto do here is really focus on
the why of utilizing additivefor orthopedics and then touch
briefly on some kind of caseexamples and some where I think

(26:43):
maybe the industry is going alittle bit, but save a lot of
that discussion, I think, maybefor Q&A.
So again, this kind of athree-part talk where I'm going
to mainly focus on part one herewhy use additive in orthopedic
design.
So first I want to present toyou this patient which we would
say previously had no option.
This is a severe trauma casewith a large defect in the

(27:05):
distal tibia.
So it might be hard tounderstand what's going on for
those not used to looking atimages like this, but this is an
ankle of a patient and Ibelieve it might have been a
motor vehicle accident, butsevere trauma like this.
Maybe a surgeon could usetraditional plates and screws to
try to reconstruct this, butthis would be a very, very
difficult surgery without theuse of, maybe, a

(27:25):
patient-specific implant.
A second case same region of thebody but a very different
indication here.
So this patient is a cancerpatient.
So there's an osteosarcomaagain in the distal tibia.
To be able to treat this theyneeded to resect a very, very
large portion of this bone andagain, without the introduction
of additive patient-specificimplants, this patient would

(27:48):
have also historically had nooption and maybe would have been
facing a below-the, below theknee amputation.
So these two cases kind ofhighlight often what people
think about at least with ourcompany of why use additive, and
that's for patient-specificdevices.
But these really really kind ofone-off, unique, very, very
complex spaces.
But I want to show why thatthis is not just for the one-off

(28:11):
complex but it's for youreveryday.
And so one of the things I justdid was did a PubMed search on
the use of patient-specificimplants in the literature.
You can see there's just beenan explosion of activity over
the last 20 to 30 years and thisis not just in the basic
science.
This is translating intocommercial activities.
With a study put out by the FDAthey show how many clearances

(28:32):
they've received that have beenon additives.
So this was in a Nature Reviewof Bioengineering publication
that the FDA did and it showsthe number of devices cleared
over again.
The last kind of call 15 yearshere, I guess at this time of
publication is about 10 yearsand again really showing that
this has been exponential growth.
But I think what's important tomaybe point out here is we often

(28:54):
think about the use of additivebeing implant focused, but a
lot of the clearances you'll seehere are not necessarily
implants.
You have them on things likesoftware, cutting guides, things
that make up a decentpercentage of these clearances
that maybe go underappreciated.
It's some of the enablingtechnology.
Again, cutting guides arecritical to if you're going to
use a patient-specific implant,you need a way to make sure that

(29:15):
you're appropriately preppingthe surrounding bone and you
need a patient-specific cuttingguide to do so.
And then software this isthings like the ability to take
a CT scan and create a segmentthat and create a
three-dimensional reconstructionof the patient's anatomy or
some of the other digitalworkflows that are used to
create patient-specific devices.
There's a lot out there in thesoftware side, particularly as

(29:37):
we start to think aboutautomating some of these
activities as well.
So I want to again make the kindof point, though, that it's not
just for complex cases.
What about kind of the moreeveryday case and so an everyday
case that often you know manyof us are familiar with is a
total knee surgery or total kneereplacement.

(29:57):
Many of us know a family memberor an acquaintance who've had a
total knee, and this just withdwarfism on the left versus an
NBA player on the right.
These are actually two casesthat we as a company have done

(30:19):
and these are not to scale onthe screen but are to scale
relative to each other and againshows you the size disparity
that's out there with differentpatients.
But you might kind of make theargument that these are still
outlier patients.
You said we want to make theargument that it's not just for
kind of complex, one-off casesand these are still fringe cases
, and you're absolutely right.

(30:40):
So what I want to do is kind ofwalk you through a little bit of
the way we think about kneeanatomy and then some
interesting data that'll showyou why it's important to have
patient-specific implants forkind of quote, unquote your
everyday patient.
So these are two different,real, real patients a right knee
and a left knee, and thepatient on the left we would
call bow legged and the patienton the right we would call knock

(31:02):
knee, and the way we define,that is by these angles.
So the LDFA, that's a lateraldistal femoral angle, and then
the ML, that's just your, yourmedial lateral width there.
But on the patient on the leftthat angle is less than 90.
And the patient on the right,that is greater than 90.
So now that we've defined that,I want to show those two

(31:22):
variables on a scatter plot.
So this is a scatter plot of85,000 different patients.
Sorry, I got to move my littlebar here on Zoom so I can see my
full screen.
But what we did, we plottedthese 85,000 CT scans this is in
our database from patients thatwe've treated over time and we
plotted those two variables.
So just looking at the femoralmedial lateral width and again

(31:44):
the AP depth, and then we'lllook at the angle in a second,
you can see this wide, widerange of patient anatomy and
then you can also see howthere's a little bit of a
bifurcation around our male andfemale anatomy.
But then what we did is weactually plotted these two
variables.
We looked at sorry, it's notadvancing here we plotted the

(32:07):
offering of some of the largestcompetitors on the market, so JJ
, stryker, zimmer, biomet, smith, nephew and Medacta, and what
they're doing is trying theirbest to kind of match the
standard scatterplot of the youknow general patient population.
But you can see this leaves alot to be desired.
There's a lot of patients thataren't falling right on this
kind of linear curve.

(32:27):
And what do you do with them?
Well, the surgeons just pickthe best option they have and to
you know, to be fair, theoutcomes are pretty good.
Patients are generally happywith knee surgeries as well as
other procedures like hipreplacement et cetera.
But there's also data that saysthere's a high percent of
patient dissatisfaction and pain, as high as one in five or
about 20%.
And while that might sound likeit's pretty successful, you

(32:50):
know 20%, you know essentiallyfailure rate for a procedure
like this is leaves a lot ofroom for growth here.
So again let's look at thatother variable, that lateral
distal femoral angle plottedagainst the femoral ML, and
again plotting the othercompany's implants on the, and
here you can see the spread is alittle wider.
Most companies only offer asingle angle.

(33:10):
They provide it in 90.
Because again, you people, lessthan 90, greater than 90.
So they just say let's justoffer it in a kind of one size
fit all and they just simplycome in different widths.
There's only one other companythat is offering an angle at 87
degrees there, I believe.
So I want to show you, though,some data that says personalized
implants do result in betterclinical outcomes.

(33:31):
So there's a lot of studieshere.
These are studies published allover.
Some of them we've collaboratedon, others are from other
companies that say that thesetypes of implants, when you have
some personalization to them,result in better fit, better
alignment and then, importantly,the outcomes are better better
range of motion, better function, higher patient satisfaction
and then overall better healtheconomics.
Why is that?

(33:52):
Because there's less chance forhaving a revision surgery, less
shoulder rehab, quicker returnto work, etc.
So this is well studied in theliterature.
And then our specific implant,the Restore3D patient specific
knee, has the lowest revisionrate in the UK database, the UK
registry, at only about 1% at10-year follow-up.

(34:12):
So this is about half ofcompared to kind of standard
off-the-shelf implants.
So we know that the use ofadditive can allow for these
again one-off, complex traumacases, oncology cases.
That I think is fairlyintuitive and obvious.
And then it's also obvious tosay maybe these outlier patients

(34:33):
again, the NBA player or thepatient with dwarfism, maybe
that is an intuitive, obviouscase for where patient specific
matters.
But I want to make the caseagain that even if you fall
within the general bell curvethere, um, you still have a lot
of of opportunity to have abetter outcome with with a
patient specific implant that ismade uniquely for you, and so

(34:54):
that, to me, is is, again, oneof the big advantages of
additive is is it?
What was once an idea,personalized medicine is now a
reality, and this is not justagain in that kind of academic
space, it's actually gettingkind of mainstream press now.
So there was recently a wallstreet journal article as recent
as that this was published inAugust that talked about how

(35:14):
there's younger and youngerpatients getting total knee
replacements down into the 40s,which it would have been unheard
of a decade or two ago, andthey talked about what is
enabling this.
They mentioned robotic surgery,which Jenny highlighted earlier
, as well as custom fitted 3Dprinted prosthetics, which,
again, are getting such betteroutcomes that you don't have to
worry about the need for arevision in 10 or 15 years like

(35:36):
you used to.
These implants are lasting muchlonger, patients are doing much
better and, again, the bigcompanies are highlighting this.
Jenny mentioned earlier some ofthe trends she's seen and some
of the data that suggests whatpercentage of their sales is due
to additive manufacturing.
But I'll kind of highlight onsome of these quotes here.
Stryker is talking about howthey are excited and are growing

(35:57):
their capabilities in the areaof individualized implants.
Zimmer talks about how they aremaking an increased effort into
getting into truepersonalization for each patient
, and then Smith and Nephewtalks about how their total hip
system is moving forward with apersonalized mechanism as well.
So kind of you know it's notjust small startups doing this,

(36:17):
everyone is seeing the benefit.
So that's one of the hugepillars in my mind of why use
additive is patient specificity.
I think Jenny in her intro slidehad another one which is
improved osteointegration, andGaren touched on this a little
bit as well with some of hisstudies, and that is to
introduce porosity for improvedbone ingrowth into implants.

(36:38):
Here's just a histologycross-section of an implant or
of a study that we did with aporous implant versus solid
implant.
Pretty obvious Obviously soliddoesn't have room for ingrowth.
So it may be a boring picturethere, but I think it highlights
the case here that not the onlyreason for additive isn't
patient specificity.
In fact from that same FDAstudy that I highlighted earlier

(37:00):
.
They actually make the pointthat 73% of devices that are
additively manufactured are notpatient specific.
And why do that then?
It is for for porosity, mainlyum, and the the improved
osteointegration and boneingrowth that you get from that.
So there's been a history ofthis for a long time.
I'll just throw all this on theon the screen.

(37:21):
This really kind of started inabout the 1980s with centered
beads, uh, where they weretrying to find ways to get these
metal implants to to betterintegrate with the, with the
bone um, here you really more ofa surface osseointegration
though, because this wasn't bulkporosity and it was also very
challenging manufacturing,costly, et cetera.
Then in the early 2000s youstarted getting porous foam.

(37:42):
This is some pictures of someZimmer trabecular metal.
Again you got improvedosseointegration, because this
is more of a bulk porosity now,but you still have more
challenging manufacturing.
You can't just like easilycreate any shape and again the
cogs are a little higher thanyou'd like to be, particularly
compared to subtractive means.

(38:02):
But, starting about a decadeago, we started to see 3D
printing become more mainstreamfor implants and started to get
the first clearances through theFDA and the first use of these
in commercial applications, andyou know you have more seamless
manufacturing care you get.
You can mix and match where youput porosity, so you can dial
it into regions that arecritical.
You can tune your properties,not only with regards to

(38:25):
osteointegration but things likestrength and fatigue
performance, and so now we'veseen the widespread, and this is
this is hope fairly basic andwell understood at this point.
But I but I think it's worthrevisiting.
Um, smooth implants simplydon't osseone great, and but the
thing is there's been aperception of certain materials
of of being poor and othersbeing more gold standard for

(38:47):
bone and growth.
But I'd like to make theargument here that so much of it
is due to the surface geometry,or even the bulk geometry, and
not the inherent material itself.
So one example that is oftenhighlighted is smooth peak
versus titanium coated peak.
Smooth peak has very, very lowshear strength in a bone pushout
model, and then titanium coatedpeak has obviously an order of

(39:10):
magnitude better there, and sothe conclusion might be titanium
is way better forosteointegration than peak.
But that's not necessarily thecase, because if you look at
porous titanium here you can seethat when you add porosity you
get another order of magnitude.
Jump and smooth titanium isactually quite poor as well.
So when you polish titanium, itperforms basically the same as

(39:30):
peak, and so what the conclusionhere is is, again, it's not
necessarily material, althoughmaterial does have an impact.
There are certain materialsthat are going to elicit, maybe,
a fibrous tissue response andlead to more poor integration,
but structure dominates theresponse compared to the
inherent material itself.
So where are we at today?

(39:54):
Today, spine is clearly themarket leader in 3D printed
implants.
It is ubiquitous in thisindustry.
If you walk the floor atsomething like Academy or at
NASS, which is a large spinemeeting, you will see it's not
an exaggeration to see probablyhundreds of company of spine
companies that offer a 3Dprinted implant, and the reason
why is they were the one of thefirst kind of spaces to realize

(40:16):
again that porosity matters somuch, particularly in a fusion
application and in spine.
What we're often looking forwe're looking at is fusion.
Lower extremity, though, is notfar behind, so in kind of total
ankle and bone wedges forthings like osteotomies, you see
a lot of companies utilizingadditive now as well, and then
upper extremity is slowlygetting into this, like Zimmer

(40:37):
and Stryker have made someefforts into personalized
implants and something like atotal shoulder replacement, but
it's still pretty early.
And then things like trauma arefar behind, even though that
might be an area where you couldhave the most efficacy again
with these patients that justhave large defects and no other
you know solution.
There's just not much out therefor them today.

(40:57):
And so I think there's so muchroom for growth.
Even though we think that 3Dprinting and, you know, the
additive solutions have reallypenetrated orthopedics, it
hasn't.
In some spaces, like spine, yes, it's kind of commonplace, but
in others there's a lot ofopportunities still.
So I'm going to just maybe showyou just there's a lot of
opportunities still.
So I'm going to just maybe showyou just there's a lot more
here and we don't have time togo through it all, so I'm just

(41:18):
going to kind of throw up onemore screen here that'll just
kind of show you I'll clickthrough these the diversity of
implants that we do at Restore3D.
That might be a little bit ofinspiration and lead to maybe
some good discussion at the end,to just show you how this
technology additivemanufacturing and orthopedics
can be just applied across theentire body.
So as I click here, you cankind of just see the range of
implants that we have done as acompany.

(41:39):
These are all restore 3D deviceswhere surgeons bring to us
complex or unique clinical casesand we partner with them
utilizing additive as well assome other digital design tools
to be able to treat thesepatients.
So again, this technology has autility across the entire body

(42:01):
and it's really exciting to kindof see where it's gone in the
last 10 years.
But there's a lot of work aheadand I think we can continue to
offer these solutions to improvesurgeons' ability to treat
these cases, but as well asimprove patient outcomes.
I'm excited to see where theindustry takes us.
So with that, I think I'llpause Again.
I don't want to run over timeand we can save any additional
discussions for later, but thankyou for the opportunity to

(42:22):
present.

Speaker 2 (42:25):
Nathan, really, really interesting.
I'm glad that we're going to betogether at AOS.
I just wrote down about fivequestions.
Maybe we'll have time at theend.
I thought the timeline that youshared was really interesting
and certainly impressing uponthe audience.
The importance for poroussurfaces is quite apparent, so
excellent job.

(42:46):
Next up is going to be Kuntay.
So Kuntay comes to us in Turkey, so why don't you start to
share your screen?
I'm saying, yeah, Perfect, itworks Real quick.
Before you start, for those ofyou that have just joined,
welcome Again.
This is a presentation clearlydedicated to 3D printing and

(43:08):
orthopedics.
We would encourage you tosubmit any questions that you
have for the panelists throughthe Q&A portion.
We'd be happy to address yourquestions and have panel
discussion at the very end ofthe conversation.
Without further ado, please letme allow time to introduce
Kuntai Akhtas.

(43:29):
So Kuntai is a passionateentrepreneur, technology
executive and strategist withexpertise in additive
manufacturing, medical 3Dprinting and additive
manufacturing technologyapplications, With a background
in mechanical engineering and amaster's degree in
bioengineering.
He's co-founded Btech Innovation, TrapTech, Earfit and AdPark

(43:54):
companies that drive innovationand additive manufacturing
across various industries.
He specializes in managingmultidisciplinary projects and
tackling complex challenges,leading teams to develop
cutting-edge additivemanufacturing products and
services that disrupttraditional industries.
But wait, there's more.
He has been recognized threetimes in Fortune's 40 under 40

(44:18):
list.
He has deep technical expertisein SLM and EBM technologies,
along with extensive work inmaterial science.
All of his companies operate atthe intersection of deep tech
and additive manufacturing,collaborating with industry
leaders such as Materialice,Forum Labs and Top to push the

(44:39):
boundaries of innovation.
So we're thrilled to be able tointroduce Kuncai and look
forward to your conversation.

Speaker 5 (44:48):
Thank you very much, greg.
So good morning and goodevening for everyone.
You very much, great.
So good morning and goodevening for everyone.
So my name is Kunzai and I'mcoming from mostly the
engineering part, both in theaerospace and the medical side,
so I have started the medical 3Dprinting business in 2012.
So it's been more than 10 yearsthat I've started the medical

(45:12):
3D printing and over the timetoday I will try to a little bit
explain to you why the additivemanufacturing and medical 3D
printing intersects.
But, on the other hand, we alsohave some challenges to use the
technology in a more efficientway.
So, on the TrapTech side, it'sa spin-off company from the
B-Tech Right.

(45:32):
So on the TrapTech side, it's aspin-off company from the
B-Tech.
So we are actually roughly 50people in the company, based in
Turkey, and we are very muchfocusing on medical applications
with titanium.
We also have a dental unitinside, but we are also making a

(45:55):
lot of research about the newbiomaterials, which I will try
to explain you today.
So, um, as as I mentioned, sowe are a tech company, but we
are collaborating so manyuniversities, both in the us and
the uh and the europe, uh andgermany, finland, uh,
switzerland.
Um, and actually we like towork with this way because we
are learning a lot.
You know, and we know that youcannot be expert of everything.

(46:18):
So, um, our vision actually touse the additive manufacturing
and the biomaterials technologyto make the technology and the
materials more accessible forthe people.
And I remember the dates wherewe started the 3d printing and
then 10 years ago, and designingan implant would take like

(46:38):
custom implant would take liketwo weeks or three weeks.
Now, with the technology, it'smore accessible.
And I was also had a chance towork with the early versions of
concept laser m2.
It was one of the firstinstalled base in in europe uh
on metal editing manufacturingand and I remember how
challenging it was to use a 200kilowatt uh 200 watt laser slm

(47:05):
machine.
I also had a chance to workwith evm machines.
So it's much more complicatedtechnology.
But unfortunately, what we seein the market is that we say
that, okay, it's like a pressand push the button and get the
parts, but it's not working thisway.
So therefore, we also believethat accessing the technology

(47:27):
and using it in a more efficientway also makes a lot of
difference and a personalizedimplants really needs that.
So what we do?
We focus on different areas.
So we are making custom-madeimplants.
So we are.
We have an iso 13485 certifiedprinting center with multiple

(47:49):
metal additive manufacturingunits.
We also have some bioprintingand peak printing and also some
SLS and SLA technologies.
So we are making research on thebiomaterials, mostly the
biodegradable materials which Iwill mention.

(48:09):
They're not commercialized yet,they're still under research,
but we made a lot of progress uh, and we are developing process
for different uh alloys, uh, andof course, the titanium
different different titaniumalloys also uh in our scope and
uh, we're also working with somemedical companies, uh by making

(48:31):
some custom medical models fortraining and education purposes.
So I mean, I want to repeat theinformation that the other
presenter has done earlier,which were really great, and you
know, we are also making somenumber of implants in the market
as a number of implants in themarket, um, and actually what we

(48:59):
see is that each year, um, wesee more and more demands, uh,
but we also see that, um, thatthe manufacturer are not always
aware of the problems that mayoccur in the long run or in the
pulse process or even in theheat treatments.
So therefore, I mean we believethat validation of the process
is also very important, and notonly that.
I mean we know thattitanium-6-4 is one of the most

(49:22):
common material in the market,although it's not coming from
really on the medical side.
It's more aerospace-basedmaterial but it's more easy to.
It's available in the marketand orthopedic industry is using
it for a long time.
But we have aluminum, and themechanical properties are one of

(49:42):
the best, but it's not theideal, uh, and we know that the
the biological behavior of thematerial also, uh, one of the
best, but still it can beimproved, um, so, and it's not a
good material for thatmanufacturing.
What we see is that we arehaving a lot of issues due to
thermal warpage, like, like heat, um, overheating and and also

(50:07):
like geometry change andeverything.
There are a lot of problems ofusing titanium in the additive
manufacturing.
Therefore, there are some othermaterials that are more
suitable for using the SLMtechnology or EBM technology and
they're absorbing energy in abetter way.
So we are making some researchabout the new titanium alloys

(50:27):
and also we are interested withmagnesium material, which is
also another biodegradablematerial.
Magnesium is very explosive.
Even getting the powder is verytricky and using the machine is
also quite dangerous because ithas a lot of crack problem and

(50:49):
also it has a lot of smokeduring the process.
But there are some institutionsthat make some progress and now
we are making some researchabout the fine tuning, the
process optimization and processparameters, and also we are
looking for the applicationareas in the orthopedic area
which could be interesting.

(51:10):
The other one is the polymermaterial that we are working on.
I mean, there are already somepolymers in the market, but the
problem is these polymers areeither on the FFF types of
printer they're working on theFFF types of printers or like a
big carbon dioxide-based SLStechnologies carbon

(51:34):
dioxide-based SLS technologies.
But we believe that thesematerials and technologies will
be part of the point-of-carecenters.
Therefore, they should be usedin the desktop kind of SLS
technologies and today like aFormlabs or there are also some
other brands in the market whichyou can purchase less than 20K
and they're working veryreliable.

(51:55):
But of course, it's tricky touse these materials in these
machines because the lasersource and the wavelength on the
carbon fiber lasers aredifferent than the carbon
dioxide lasers.
Therefore, you need to use somespatial techniques or maybe
nanoparticles to absorb theenergy onto the material and get

(52:16):
the demanded shape.
So we are working with someuniversities, in this case so
from Hungary, switzerland andGermany, and we have made some
progress.
An idea here is, as I mentioned,to make this niche polymers,
biopolymers available andvalidated in the desktop SLS

(52:37):
technologies to be used anywherein the world.
Because the design technologyis also making a lot of progress
.
We see more and more automateddesign processes and when you
have these two tools design andthe manufacturing then you may
not be needing a lot ofexpertise or engineering skills

(52:58):
to be able to print some customdevices in hospitals as well.
So I also mentioned that thenew types of titanium, the new
types of titanium.
So when the market grows, wesee a trend of lower price on

(53:18):
titanium powder.
But still, in terms of themechanical properties, we start
to see variations of so manyalloys in aluminum alloys,
nickel-based alloys or steelalloys for different
applications.
Therefore, we believe that inthe future we will be seeing

(53:43):
more options for trauma cases,cmf cases or orthopedic cases,
and even playing with some heattreatments, parameters or
process parameters, we can alsoend up with various mechanical
properties which that particularapplication needs.

(54:03):
So we are working on anAI-based process optimizer
software.
So this is basically, you know,the process parameter is very
experiment-based uh knowledge,and so many people are doing the
same stuff in the differentlabs and spending the same money
for the same results, althoughthere are now more and more

(54:25):
knowledge and data and theliterature, and now we're trying
to gather this around and makean AI tool to end up with the
demanded properties so you canuse different layer thickness,
laser scan speeds or even youcan play with some alloy
composition in case it fulfillsto medical regulations.

(54:51):
So I think one of the veryinteresting points that we have
seen in the presentation was theexcess powder coming from the
manufacturing.
Many manufacturers are not evenaware of this, I mean, and it's
not visible unless you see itwith an SEM or you do some tests

(55:14):
.
And cleaning the part is achallenge.
And this Estabular cop was oneof our first products and it was
printed with the EBM and if youknow the technology, ebm is a
preheated technology and youhave a lot of unmelted powder

(55:34):
but they're like a cake, they'renot free-floating powder and
removing those powder makes iteven more complicated.
Therefore, I mean, for this cup, we look for so many options
for post-processing, like achemical or mechanical, but also
validating the process, whichmeans that you get end up the

(55:55):
same results for each time.
That's also another challenge.
So, therefore, I thinksolutions that have been
presented are really great inthat regard.
So we are also looking for somealternative waves, and this was
a study that we have done inPolitecnico di Torino in Italy.
So we have made some chemicalprocess for nanotexture titanium

(56:22):
surfaces, and this is aresearch at a PhD research
actually, and it's, of course,the lab scale at the moment.
It's, of course, the lab scaleat the moment.
It's a foreign project, but wesee a lot of difference between
the raw parts and also theprocess parts, post-process
parts, and we believe that thisis something underestimated in

(56:45):
the markets and we will beseeing more and more research
about that in the future.
And I think this is also part ofthe regulations, because on the
MDR side, you need to have aclear validation process about
how you make sure that each partare producing the same

(57:07):
properties and also you cleanthe same way.
You don't have any excess powder.
So this is also, uh, anotherchallenge of the technology has
today.
So, um, as I mentioned, so, um,we will come to a point to
discuss about the mdr.
So we have a c certification,um we received in 2023, 2023, uh

(57:39):
, but um in the last two years,the last three years, europe is
facing a lot of uh problems withthe mdr regulations, since it's
very expensive, you don't haveenough experts all this are
really crazy.
And then we have decided tostop all the activities in in
europe and now we are trying toswitch I mean to US markets.
So we are trying to create somepartnerships and we have a long

(58:00):
history about the research,about the mechanical part and
the bio side of the additivemanufacturing and we are hoping
to find some partners to grow inthe US market.
So thank you very much.
So, again, my name is Kun Taiand I'm one of the co-founders
of TrapTech and if you areinterested what to do or

(58:23):
anything with our companies orin our regions, I will be happy
to help.
And thanks for listening.

Speaker 2 (58:32):
Thank you very much, kuntai.
I'm glad that you spoke aboutvalidation, and it's appropriate
given our next speaker.
I thought that was veryinteresting.
In particular, the nanotexturedchemical process.
I'm sure we'll have somequestions about that.
One person has submittedquestions in the Q&A section of

(58:58):
the Zoom.
Feel free to submit anyquestions that you have.
We have one final speaker, whoI'll be introducing shortly, but
we will be able to address anyquestions.
For those of you that havealready spoken, if you have
ideas for questions that maybeyou think would be useful for
the audience, feel free tosubmit your own questions, and
it'll be a good way to getstarted for our Q&A when that
comes.
So, kyle, feel free to shareyour screen.

(59:22):
Kuntay, what time is it rightnow in Turkey?
Oh, you're on mute.

Speaker 5 (59:31):
Yeah, it's 8 pm, 8 pm .

Speaker 2 (59:34):
Okay, so thanks for staying late with us.

Speaker 5 (59:37):
No worries.

Speaker 2 (59:38):
Kyle's screen.
Okay, it looks very good.
So, again, we were just talkingabout validation, so we
purposely save the best for last.
All of these ideas are excitingand obviously present a lot of
great opportunities fororthopedic advancement, but it's
important in FDA's perspective,of course, for there to be the
proper quality and regulatorysafeguards in place.

(01:00:03):
So I introduced Kyle Kovach.
Kyle is in Cleveland, ohio, andhe serves as the quality and
regulatory manager at JLXMedical.
Jlx specializes in engineeringsupport, specifically in product
development, regulatory affairsand quality management systems.
Jlx serves many types ofclients, including startups,

(01:00:25):
independent inventors, midsizeand large size medical device
companies not just 3D printingcompanies all of these companies
of which are developing classone and class two medical
devices in the medtech industry.
With over 13 years ofexperience in biomedical
research and medical devicequality and regulatory affairs,

(01:00:48):
kyle has played a key role insecuring numerous FDA clearances
for JLX clients.
He has successfully led FDAsubmissions, including 510Ks and
pre-submissions.
I see his colleague Stacey onour call and I'm sure that
there's quite a few other folksthat are very eager to hear from
Kyle.
So, without further ado, kyle,we look forward to your talk.

Speaker 6 (01:01:12):
Great.
Thank you for the introduction.
Appreciate that.
Your talk Great.
Thank you for the introduction.
Appreciate that, like you said,my talk here is going to be a
little different than what we'veheard so far more on the
materials and design side, it'sgoing to be a little higher
level, specifically talkingabout the regulatory
implications for these devices.
So thanks for everyone whojoined the talk.

(01:01:33):
Appreciate you hanging on tothe end here.
Hopefully you learned somethingand find this piece of things
valuable.
So I won't rehash all of theintro, just to give a little
brief background of myself andsort of give you a perspective
of where I'm coming fromrelating to the 3D printing

(01:01:55):
field.
So I do have a biomedicalengineer.
By training at JLEX, Iobviously have focused more on
the medical device quality andregulatory side of things, and
so I do have a lot of directexperience in, like Craig said,
leading FDA submissions like510Ks, de novos and pre-subs.
Again, quickly, just to talkabout what JLX does and sort of

(01:02:22):
the reason that we have a lot ofexpertise on the regulatory
side of things.
We do have an in-houseengineering team that does
design and development.
Again, we have regulatoryaffairs and quality engineers as
well, and so we do work withcompanies of all sizes anyone

(01:02:42):
from single surgeon, inventors,startup companies to obviously
mid and large size corporationsas well that need help with our
services, and we work reallyanywhere in the product
development lifecycle formedical devices, from initial
concepts all the way throughcommercialization.
So in terms of 3D printedimplants, I highlighted sort of

(01:03:11):
three main areas here that we atJLX work a lot with.
The design and specificationpiece of things I'm not going to
focus on in my talk here.
I'm going to be talking moreabout again regulatory affairs
and process validation as well.
You'll see in some of my laterslides here how process
validation really is a key, keypiece of the regulatory

(01:03:34):
submission and clearance processfor these types of devices.
So I guess to start at sort of ahigh level here, I want to talk
a little bit about thedifferent regulatory pathways
that are available for all typesof devices, but obviously
specifically 3D printed ones aswell.

(01:03:55):
I think the first thing that'simportant to note here is that
the type of pre-marketsubmission that ends up getting
submitted to FDA for an additivedevice isn't determined by
whether the device is 3D printedor traditionally machined.
It's determined by theregulatory classification of the

(01:04:16):
device type itself.
So whether that's a spineimplant, a hip implant, an
extremity bone screw, whateverthe specific device type is,
determines the classification,not how it's manufactured.
So the first type of regulatorysubmission that the majority of
class two devices in the USfall under is the 510k pathway,

(01:04:40):
also called pre-marketnotification, and so in this
pathway, you are essentiallyidentifying a device that has
already been cleared on themarket and demonstrating that
your device is substantiallyequivalent to it.
Demonstrating that your deviceis substantially equivalent to
it.
It carries a 90-day FDA reviewtime and again.
This is the pathway that themajority of Class II devices

(01:05:01):
take to market.
The other alternative pathwayis the de novo pathway.
This can also be used for ClassI or Class II devices, and this
is for more novel devices, sothings that are so new to the
market that nothing has everbeen cleared before.
That is exactly like it.

(01:05:21):
In this pathway, fda willactually create a new product
classification.
It is a substantially longer,150-day review time, actually
often longer than that due toall of the questions and
clarifications that FDA needsabout the device.
But that is the other mainpathway to clearance for class 1

(01:05:44):
and class 2 devices in the US.
The last thing that I want totalk about on this slide here is
the Q-Sub program.
So this isn't a pathwaydirectly to market clearance,
but it is a specific programthat FDA offers where submitters

(01:06:06):
can actually get formal FDAfeedback, have an interactive
telecon with FDA before theyspend all the money to actually
submit one of the clearances wetalked about before, so the 510k
or the de novo submission.
There's actually no FDAsubmission fee involved with the

(01:06:27):
Q-Sub program.
So this is something that we doa lot of at JLX.
We encourage our clients totake advantage of it,
specifically if your device oryour development pathway has
specific questions or challengesthat you want to get FDA input
on again before you submit thatregulatory submission.

(01:06:48):
So taking, I guess, a stepforward.

(01:07:12):
Here are a number of differentgeneral topics of information
and documentation that then gointo those submissions to FDA.
This list certainly is notall-inclusive.
I highlighted the ones herewith asterisks that I think are
particularly important to focuson for 3D printed devices.

(01:07:34):
So mechanical testing,obviously key for any orthopedic
implant, but specifically for3D printed ones, I've
highlighted an FDA guidancedocument on the right here this
technical considerations foradditive manufactured devices.
That is a wonderful resourcefor all kinds of 3D printed

(01:07:55):
devices, so multiple materials.
It's not specific to ananatomical region, but that
gives a lot of good informationon FDA's thinking and
expectations when it comes to 3Dprinted devices.
And there are also many devicespecific guidance documents out

(01:08:15):
there that you can look at.
You know, whether, again, it'sa bone screw, a spine implant,
there are guidance documents outthere specific to those types
of devices.
Engineering drawings that youinclude in the submission for 3D
printed devices.

(01:08:36):
There are things like porosity,lattice structure versus solid
printed areas of the device thatare important to call out on
these engineering drawings thataren't a factor at all for
traditionally machine devices.
So that's an importantconsideration.
Material characterization andthe manufacturing process

(01:08:57):
material characterization andthe manufacturing process.
We'll talk more about themanufacturing process, but with
3D printing being a relativelynew technology, again, compared
to traditional machining,details of that manufacturing
process are something that FDApays a lot more attention to in
these submissions.
And then biocompatibility isthe last one I'll end up talking
a little bit more about later,but for 3D printed devices this

(01:09:21):
would involve biocompatibilityboth of the material itself but
also considering the effects ofpost-processing cleaning and
removing of manufacturingresiduals that I think actually
a couple of other presentershave touched on here today, so

(01:09:41):
what I want to move on to hereis talking a little bit more
specifically about some of thepain points that we have seen
with our clients' submissionsour clients' submissions
specifically for 3D printeddevices.
What I want to lead with,though, is that FDA's thinking

(01:10:06):
and outlook on 3D printeddevices is continuing to evolve.
Month by month.
Year by year it changes, andobviously another thing to keep
in mind is that any uniquesubmission to FDA does involve a
degree of reviewer subjectivity.
So I think sort of one of thechallenges that we have at JLX a

(01:10:27):
lot of times is a lot of peopletend to look at FDA as sort of
this machine that you feed asubmission into and it spits out
a clearance on the other side,and obviously that's not the
case.
There's a human review team,there are educated scientists on
the other side that are lookingat your submission, and so it's

(01:10:47):
our job to clearly present sortof the device, the underlying
data and our arguments for it,so that these people on the
other side can look at it,understand it, and it is meeting
the requirements that they havefor a safe and effective
medical device.
So some of the topics here thatwe have found have been a

(01:11:12):
challenge specifically for 3Dprinted devices.
One of them is ensuring thatthere are adequate details of
the manufacturing processdefined in the submission.
So one example would bespecific 3D printing machine
information that you're using.
So FDA wants to know make modelnumber of machines, like the

(01:11:32):
exact details of the machinesthat you're specifically using
and validating to create yourproduction devices.
Worst case manufacturingconditions is another one I've
called out.
One pretty easy example herewould be build plate positioning
.
Obviously there are a hugenumber of different parameters

(01:11:56):
that you would need to consider,but you need to be able to
define your worst casemanufacturing conditions with
data and show that to FDA.
Performance testing another keyone I've called out test coupon
testing.
Here that's something obviouslyspecific to the 3D printing
world that doesn't exist andisn't really relevant in the

(01:12:18):
traditional manufacturing world.
But having test coupon data andhow that relates to your
process validation is importantin regulatory submissions.
Manufacturing residuals thishas been much more of an FDA
focus lately, specifically theremoval of particulates from the
product after it's been printed.

(01:12:40):
So this is again abiocompatibility concern and we
have seen much more FDA focus onthis in the recent years than
perhaps they did maybe a handfulof years prior and the last one
is build process validationthan perhaps they did maybe a
handful of years prior, and thelast one is build process
validation.
So I'll actually dedicate theslide after this to process

(01:13:03):
validation.
But this is sort of, I guess,the overarching theme of needing
to include all of this otherinformation in the submission
include all this otherinformation in the submission.
So process validation issomething that, for a medical

(01:13:24):
device manufacturer, you need tobe validating your processes
anyway per FDA's quality systemregulation, so 21 CFR 820.
But, specific to 3D printing,it's important that you clearly
define all of the buildparameters and are validating
your process.
So, again, you can show FDAwith data that your build

(01:13:47):
process is able to consistentlyreproduce your printed device
across build cycles.
So it's great if you can printone device, mechanically, test
it and it passes.
Your test meets all youracceptance criteria.
But FDA wants to be convincedthat your process is able to
repeat that over timereproducibly and reliably.

(01:14:09):
And so the last thing on thisslide that I want to make note
of is that anytime you have avalidated process, any changes
to your device, changes to theprocess or process deviations
that you see you need to betaking those into account to
then determine if you actuallyneed to revalidate the process

(01:14:31):
later on down the line.
Later on down the line.
So I'll finish up here with aquick case study.
So this is an example of aclient that we worked with at
JLX.
This clearance was very recentin 2025.
It was a 3D printed titaniumspine implant that took the 510K

(01:14:54):
pathway.
So we identified a predicatedevice on the market that we
were substantially equivalent to, and there were a couple, I
think, key success areas thatwere important for this
submission, one being we wereable to get very detailed and
comprehensive process validationrecords from the contract
manufacturer.

(01:15:14):
And also there was a lot of keydiscussion with FDA on the lot
release criteria that weredefined for the 3D printed
devices themselves.
So those were sort of what I'llcall the sort of keys to
success of this submission andgetting it cleared by FDA.
So that's all I have for you.

(01:15:38):
Again, I know this was a littlebit different than the other
presenters here today, but Ihope everyone found it valuable
and I appreciate your time.

Speaker 2 (01:15:52):
Thank you very much, kyle.
So, as I plugged a few times,I'll repeat one more time that
JLEX and Restore and HyMed areall going to be exhibiting at
AAOS in just a few weeks, fromMarch 10th to March 14th.
By coincidence, we're allexhibiting literally a few rows
from one another, right betweenthe large Smith and Nephew booth

(01:16:15):
and the large Zimmer booth.
So for those of you that willbe in San Diego next month, we
hope that we can continue theconversation in person Until
then.
I'm happy to see that a numberof questions have started to
come in through the Q&A.
So, for those participants inthe audience or again for those
speakers, if you have questionsthat you would like to submit,

(01:16:36):
either for yourself or foranother speaker, feel free to do
so.
I'd like to begin theconversation focused on Nathan
and Nathan.
I thought it was interesting.
You know, kind of lookingforward.
I really like the slide thatyou had shared as far as the
different disciplines for porous3D printed implants,

(01:16:57):
acknowledging that spine is mostestablished, extremity is
growing and trauma significantlybehind.
If we were to have this webinar, say, in five years from now,
how much more growth do youexpect in spine?
Do you think that the marketfor spine is more or less
established.
Is there more opportunities anddo you expect for extremity to

(01:17:17):
continue to grow at maybe therate that we all saw spine five
years ago?

Speaker 4 (01:17:22):
Yeah, yeah, great question.
I do think there's stillopportunity for spine to grow.
I think some of the fusionmarket is maybe reaching a point
of saturation with regards tothe use of additive, but there's
some interesting companies outthere.
I'll just highlight one of them, Carlsmed, who is pioneering

(01:17:42):
the use of additivemanufacturing to deliver
patient-specific spinal implants.
So, whereas spine has been theleader in using additive for the
introduction of porosity and topromote fusion, there really
hasn't been a whole lot in spineas far as patient specificity,
whereas the other areas areactually using additive mostly
for the patient specificity.
So I think there is opportunityin spine.
I think Carlsman is doing somereally interesting things.

(01:18:03):
I think there's a few otherstartups that are also looking
at a similar space.
It's something we've taken justa brief look at, but that's an
area, I think, of absolutepotential growth in spine beyond
the fusion market.
It still is the fusion market,but it's kind of a different
angle to it, if that makes sense.
And then the extremitiesabsolutely I think those are
just getting started.
To be honest, particularly inthe large joints If you look at,

(01:18:26):
you know knees and shoulders,the total ankle market.
I think there's a lot of roombecause additive solves two
things.
There Again, the patientspecificity, which I think the
data is pretty compelling of whythat leads to better outcomes.
But then you have implantloosening in some of the large
joints.
That is a big problem and thesurgeons want to get away from
cemented implants oftentimes andutilize porosity to improve

(01:18:49):
fixation.
So I think there's a lot ofreasons why we'll continue to
see the use of additive grow inthe extremities market.

Speaker 2 (01:18:57):
So Garen, who has since joined me, and we now can
prove that we are in fact in thesame building.
We were both at the Hospitalfor Special Surgery last fall
and we got into interestingconversation about
patient-specific implants.
And you know, I could certainlybe convinced that.
You know a customized implantis going to perform better than
an off the shelf model, but atthe same time there's costs that

(01:19:20):
are associated with that.
Maybe as engineers we don't seethat directly, but insurance
companies certainly wouldQuestion.
Both for Nathan and then forKuntai.
I'm curious in your opinion, ifyou're able to comment on
patient-specific implants, atwhat point do you see a patient
being eligible or thatcircumstance warranting that

(01:19:43):
additional customized implant?
Versus when is an off-the-shelfimplant still a viable solution
?

Speaker 4 (01:19:52):
It's a great question .
I'll start and then, kutai,please jump in.
You're right.
The pushback we get on the useof additive in our
patient-specific implants iscost, and then also speed,
because there's a lead timeassociated with it.
Off the shelf by definitionit's sitting there on the shelf,
right, patient-specific.
There's a lead time associatedwith going from a CT scan to an

(01:20:13):
implant, and so both of thosethings I think the last part of
the talk that I kind of justhighlighted, and if I drop my
slides in, you'll see that thoseare two of the biggest areas, I
think, of opportunity, thethird being what Kyle touched on
is improved regulations andconsistent standards, et cetera.
But the point, you know, whereit makes sense, I think it
depends.

(01:20:33):
I think you know, in this spaceof like you're facing, you know
, the patient with truly nooption you're facing, say, an
amputation.
The willingness to pay there isextremely high because the
alternative is so dire and bleak.
Right, then something like atotal joint where it's like off
the shelf versus patientspecific.
The data is compelling but atthe end of the day it's still a

(01:20:54):
total need.
For example, I think thewillingness to pay is a lot
lower and so cost needs to bemore neutral there, like we've
got to find.
But the technology isn't isgrowing so quickly.
The printers are getting faster, the qualifications are getting
better.
On the digital side, there's alot more automation on things
like segmentation, whereas Ithink we're going to see in the
next few years that or we'restarting to realize it now, to

(01:21:15):
be honest where the cost ofgoods are somewhat equivalent
and the buyer will becomeindifferent then and simply is
picking the best technology.
Maybe not quite there yet, butthat's absolutely on the horizon
.

Speaker 2 (01:21:27):
Excellent.

Speaker 5 (01:21:28):
Do you have anything?

Speaker 2 (01:21:29):
else to add?

Speaker 5 (01:21:30):
Yeah, I agree with Nathan.
I think that the cost and thenwho is paying is, I think, yeah,

(01:21:56):
I agree with Nathan.
I think that the cost and whois paying is, I think they are
the most important points todecide about it because it
depends on the market.
But if the conventionalimplants are reimbursed and
custom implants are not, thenthe decision is very clear that
it's only used when it is reallyreally needed or you don't have
an alternative.
It also depends on the, I think, the surgeons.
Some surgeons, um, finds thiseasier.
Some surgeons believes thatit's still, uh, you know, not
matured enough and you knowthere's still uh risky or a
space technology that should beused in the very rare cases, uh.
But I think we're seeing moreand more people, specifically
young surgeons, are showing moreinterest than the very

(01:22:18):
experienced surgeons and,together with the involvement of
technology, I think that willbe a little bit more tricky to
decide.
I think we will be seeing thatmore primary cases will sights
on custom implants in the firstattempt.

Speaker 1 (01:22:39):
Craig, I'm going to add a little bit on the market
growth and also patientspecificity.
Market growth, first of all.
I mean we're hearing that thespine is questionable.
Saturation I don't think it'sgoing to saturate.
Just from the clinicalperspective, we have our aging
population that has more andmore people who not only have

(01:23:01):
bad back but also failed backsurgery.
There's for all those fusionsurgery that we're talking about
.
There is this one case, onedisease called adjacent segment
syndrome, and that's a repeatclient and also means whatever
we have right now aren't working.
We're not really solvingpeople's back pain problem and

(01:23:23):
that, you know, everyone isgoing to experience one time in
their lifetime.
So that's definitely a growingmarket.
But whether or not 3D printingis going to penetrate that, that
is the question.
But whether or not 3D printingis going to penetrate that, that
is the question.
The other thing through myresearch very recently about
patient-specific versus adaptiveimplants is you know these

(01:23:45):
robots, they can actually modifyintraoperatively of how the
bone is cut.
So it's not just the implantthat has to be patient-specific,
the procedure itself canactually adapt.
So the question is how usefulis it?
For a 100% personalized implant?

(01:24:08):
It really isn't necessary andwe actually saw a couple of
startups recently pitchingthrough and one of them actually
is just like restore 3D,complete personalization, and we
have some surgeons in theaudience and this question is
raised again.
I think at some point the costof manufacturing these

(01:24:28):
personalized implants if it goesdown and the benefit the
clinical benefit actually reallyis there, then I think we're at
an intersection where this isgoing to take off.
That's my opinion.
I think the majority of theclinicians, like Conte and some
other speakers, I think they'restill kind of favored off the

(01:24:51):
shelf because we're not at thatintersection yet for many of
these implants.
That's my opinion.

Speaker 2 (01:24:59):
So Jenny just got back from AM Strategies, so I
would imagine that a lot ofthese topics were discussed and
I'm not sure how was that eventthis year?
In that they typically try to,I remember at last year's event
they presented challenges thatall industries face, right
Recognizing that not everyone inthe bio sector is in that

(01:25:19):
audience, and I thought it wasquite interesting to see.
I'm curious in your opinion,how did that event go this year
and were you able to get intoconversation about
patient-specific implants withfolks that were in attendance?

Speaker 1 (01:25:34):
You know it's a biased audience.
Needless to say, everybodyloves 3D printing, including
myself, and the only reason whyI said what I said it was I try
to provide a counterpoint over.
Things can grow and improve.
I think the technology still tobe mass producing and high
penetration and adapted by theclinicians.
There are a lot of technicalimprovements that on our end we

(01:25:57):
need to provide and I thinkwe've seen a lot of technical
advancement in the last coupleof years, including this
conference, but there's still alot of work to do.
That's basic.
I think the conference itselfdidn't address healthcare that
much.
A lot of them is industrial,but obviously if you're in 3D
printing industry, then you'redefinitely a fervent supporter

(01:26:20):
of personalized medicine foreverybody.

Speaker 2 (01:26:24):
Excellent.
Well, I had a question that wasemailed to me to ask to Garen
and I'm about to get to that.
But I want to get back to Kyle,just in the context of
patient-specific andpersonalized implants.
So Ryan Menrath asked aquestion in the chat what would
the qualification look like fora personalized orthopedic
implant?
Does the FDA allow for a partfamily qualification?

(01:26:47):
So personalized implants arenot hampered with many
individual qualification efforts.
Now that question came induring Nathan's talk, but I'm
curious from a qualityperspective, kyle, maybe you're
best suited to address that one.

Speaker 6 (01:27:02):
Sure, I will qualify this by saying this is certainly
a question that the actualanswer is going to be specific
to what device it is.
But I think at a high levelwe've seen that certainly
qualifying or getting clearancefor a family is possible.

(01:27:22):
We've seen for certain types ofdevices, fda wants you to
define sort of a design envelope, so like, what are the bounds
of what you would possibly beprinting for a patient-specific
implant?
And then obviously, like Italked about in my slides, you

(01:27:42):
would need to do a very good jobof defining what exactly is the
worst case device and thenperforming all of your testing
on that worst case design.

Speaker 2 (01:27:54):
Anyone else have anything to add to that?

Speaker 4 (01:27:57):
Yeah, from our experience I think what Kyle
said is right on it's definingthat design envelope.
Even though it'spatient-specific, you are still
operating within the aboundingbox of dimensions from a design
perspective, but then also theconstraints then from the
manufacturing perspective,because they want to ensure that
if you're printing somethingoutside of that range bigger,

(01:28:18):
smaller et cetera that has beenqualified and so you do
establish those envelopes andthe worst case for the actual
physical manufacturing might bea different worst case device
from the device specific testing, and so it can become pretty
complex the device-specifictesting and so it can become
pretty complex.
And the one thing we've noticedwith the FDA is in

(01:28:38):
patient-specific, when you havea lot of dimensions that can
change, it can be very difficultto define what is worst case,
and so you often have more thanone worst case device.
I recently ran a fatigue testand with the FDA we kind of
agreed that it was verydifficult to tell what would be
worst case, and so in ourbounding box we actually
established four different worstcases.
So that adds a lot of cost andtime.
It could become quite expensive, but it's the reality.

(01:29:02):
You can maybe use FEA to try tomodel some of that.
But yeah, there's a lot ofcomplexities, but in a sense
that's the way that we've kindof seen that play out with the
FDA.

Speaker 2 (01:29:13):
Thanks, nathan.
So I want to bring Garen intothe conversation now and, as I
said, there was a question thatcame in from someone that's used
MCD.
They sent it via email so theysaid I'm on the presentation
that, as you mentioned.
Thanks for sharing.
We've been internally testingwith your material.
One thing that we have notreally discussed is with fatigue

(01:29:34):
performance.
You mentioned 50 percent, andthis is directed again to Garen.
He mentioned 50 percentimprovement using high-med
blasting material.
Was this comparing non-HIPT,non-blast product to HIPT and
blasted with high-med material?
He's curious to hear more.

Speaker 3 (01:29:50):
Yeah, yeah.
So thank you for that question.
I guess I can always reply tothis email too, but I'll do it
on the call here.
So those parts that we'vegotten from customers were
printed and hipped versusprinted, hipped and high med
blasted.
So they were SLM printed, whichI think in most cases needs
some type of treatment forstress relief and things like

(01:30:11):
that.
So that is what we've seen.
I'm sure we would also see agreat benefit from purely print
plus blasted versus just print,but the experience we've had so
far has been SLM printed and HIPprocessed and then both sides
of blasted versus non-blasted.

Speaker 2 (01:30:28):
Excellent, thank you.
So, kutai, I'm glad that youwere talking also about a form
of post-processing and I thinkit was in the slide that you
shared also nanotexturing, and Iused that really as a segue to
Kyle when we were talking aboutvalidation.
So, when you discuss validationand reproducibility for that
nanotexturing, what type oftests and sample size would you

(01:30:52):
recommend of tests and samplesize would you recommend?
Is that something that um youestablish on your own?
Or what level of of consulting,perhaps within your
organization or external uh,would you consider or would you
need to consider?

Speaker 5 (01:31:05):
yeah.
So, first of all, this is a phdstudy of a student which
actually uh, warned me to not toreveal so much information for
now.
Uh, so, but it's, it's a I cantell you that it's a little bit
beyond the commercialapplication, yet it's in the lab
scale.
Uh, they have different kind ofum, I think, chemical process

(01:31:27):
that's of um, uh, hip cup.
So we want to have that to, toshow that the you know, the
conformal surface uh to to youknow, make it more realistic,
because we you end up with adifferent results if you have a

(01:31:47):
flat surface around the surface.
So, therefore, we have taken ahip cup and then we cut it and
then, uh, they are using this um, real hip cup for this, you
know, as a specimen in the study.
That's.
At this point I can sayexcellent, let's see.

Speaker 2 (01:32:09):
Um, so a question for kyle.
Uh, kyle, do you question wasreally just as far as JLX's
business strategy.
Gilead is wondering if you needto visit the submitting company
or are you able to prepare asubmittal 100 percent remotely?
And if remotely, how do youlearn and validate what the

(01:32:30):
company is reporting?
What does that arrangement looklike when you're working with
clients on a quality andregulatory project?

Speaker 6 (01:32:38):
Yeah, good question.
We can certainly do it allremotely.
That's actually what we do mostof the time for putting
together a regulatorysubmissions.
That said, we can certainlyvisit on site if that's what the
client prefers.
If there's things that you knowwould be worth seeing in person
you know we've had people shipus part samples.

(01:33:00):
You know we do video calls tosee the device physically, we
can do that on site, but usuallyit's for the regulatory piece
of it.
A lot of it is justdocumentation based, and so it's
really just figuring out what afile share system is.
We can communicate prettyclearly the types of documents

(01:33:21):
that we expect, whether that's,like I said, engineering
drawings, test reports,validation records, all of those
things you know we can shareremotely, view remotely and
communicate back.
You know, if we think there areissues here, gaps that FDA
would need to see filled.
So, yeah, it's a pretty easycollaboration on the regulatory

(01:33:46):
side of things.

Speaker 2 (01:33:48):
Okay, thanks, kyle.
We have a great question fromBrett and I know I'll be seeing
Brett in a few weeks.
I think we've seen each otherevery year when we are at AAOS,
but this question is addressedto Kuntai, I believe.
So.
Is nanoparticle debriscontaminating the bloodstream a
patient risk?
To what level does validationand testing help manage this

(01:34:10):
risk effectively?
And then the second part to thequestion he wants to know how
does FDA regulation for devicemanufacturers help to mitigate
the patient risk?

Speaker 5 (01:34:23):
Well, I think the animal testing.
I believe that's one of thebest methodology that we can
test it.
There are some experts that'schoosing the rights, the
material methodologies and theanimal types that you understand
this to validate it.
It's not actually a part of thevalidation process of MDR or

(01:34:44):
the CE certification.
It's more of, I think, a newdevice or a more I think Kyle
will answer it differently, butit's not a validation of the
certification, but it's aprocess of how safe the device
is.
I believe.

Speaker 2 (01:35:05):
So, kuta, you do a lot of work.
It seems like partnering withacademia, and there's a specific
question Sahin, who I apologizeif I'm mispronouncing your name
wants to know as a candidate ofentrepreneur from Turkey, would
like to ask why do youpartnership with academia so
much instead of conducting allof your R&D studies in-house?

(01:35:28):
What is the benefit of?

Speaker 5 (01:35:34):
this additive manufacturing company groups in
orthopedic?
Probably it's because I do nothave 1,000 people.
So when you get into deep techyou see that there's so many
topics that you need tounderstand and have some
expertise on, but you cannot doeverything by yourself.
So you know it's like a heattreatment is all scientific

(01:35:56):
stuff and the surface is totallya lot of structures is you know
all different area, mechanicalproperties, process.
I mean, you cannot do them alland it's not our job.
So we are not scientists, weare, in the end, entrepreneurs
and what we are doing is thatcollect the right information or
data and people around and tryto make a commercial product.

(01:36:17):
So it's not in our interest toknow everything.
So what we are interested in isto develop a product that works
and competitive.
In order to do that, to getsome people around.

Speaker 2 (01:36:34):
I thought it was a question that needed to be
addressed because there's a lotof students and Jenny, you could
attest to this right.
This is an event that isbroadly produced for orthopedic
3D printing.
Not everyone in the audience,I'm sure, is involved in this
field.
Maybe there's some folks thatare still completing their
studies and they're looking tofind opportunities.

(01:36:54):
But you're absolutely right.
I think the bridge betweenacademia and industry is maybe
the scale, and certainlyacademia as far as being able to
do research that inspireslarger research.
I would really defer to Nathanon that one.
Right.
It seems like Restore3D hasclose ties to university as far

(01:37:15):
as how your company was firstestablished.

Speaker 4 (01:37:18):
Yeah, we do.
We were kind of a little bit ofa spin out out of Duke
University, which I think, garen, you're an alum of right, so
our founders came from there butthen close ties with many
academic institutions, I thinkyou know just that basic science
, collaboration early on, accessto equipment that just we don't
have.
And then, to be honest, there'sa little bit of a marketing
thing to it.

(01:37:38):
There's a maybe a skepticismwith research published by
industry because it's maybeconveyed as being a little
biased or whatnot, versus ifit's coming from academia it
maybe is received with a littlehigher regard, and so I think
that that's a reason as well asjust that kind of credibility
factor to it maybe is receivedwith a little higher regard.
So I think that that's a reason, as well as just that kind of

(01:37:59):
credibility factor to have likethings that are published in the
academic literature fromuniversities.

Speaker 2 (01:38:05):
Jenny, how are we doing on time?
I'm sure you have somequestions.

Speaker 1 (01:38:07):
Time is good, but I actually have a question on my
own.
So I see SLM process is being,you know, the dominant force for
the Meadow implant.
But I've been hearing EBM quitea bit lately, including some of
the pitches I'm hearing.
So I'm kind of curious does EBMreally change the game
significantly from yourperspective?

(01:38:28):
From post-processing to designs, to Nathan, your goal is to
create this whole workflow.
Have you guys thought aboutthese new processes in Kyle, you
know, regulatory-wise, likedoes EBM?
I think there's some newtechnological advancement in EBM
and that's why I've beenhearing a bit for both Europe

(01:38:48):
and US.
So I'm just kind of curiouswhere things are with that
particular process.

Speaker 6 (01:38:53):
Yeah, I guess I can, I can add my perspective on it.
We certainly have seen not asmuch on the EBM side from our
clients that we've been workingwith, so I won't say that it's
unheard of in the regulatoryspace.
As far as what's been clearedout there, you know, I think

(01:39:16):
we'd probably.
I think, like some of thepanelists have talked about,
there have been many moreclearances in spine.
So if we were to start diggingdeeper into that we would
probably look at the spineclearances first to see if that
manufacturing method is moreprevalent there.
But at least in my experienceit doesn't come up as much

(01:39:38):
through the contractmanufacturers at least that
we've been working with.

Speaker 5 (01:39:43):
So Garen maybe you go first Well, maybe I can add a
comment because I started towork with the R-CAM in 2013, and
back in the days the EVM wasvery popular in the orthopedic
industry.
Actually, one of the reasonswas you can use more coarse
powder.
In the days the EBM was verypopular in the orthopedic

(01:40:03):
industry, actually, one of thereasons was you can use more
coarse powder in the EBM, whichwas cheaper back in the day.
It's almost half the price ofan SLM.
But EBM is a very, verycomplicated process.
I mean, the parameters insidethe machines are insane and even
the Arkham.
People don't know what is doingwhat and it's just you change
something and 10 other thingschanging at the same time and

(01:40:24):
nobody knows how to control it.
It's very efficient.
Back in the days, stacking wasreally something new and you
know the powder was veryefficient and you know you don't
need a heat treatmentnormalization.
I mean you see less or pitchbecause, um, the delta between
the preheating and the meltingas is lower.

(01:40:47):
So and the the anotherdifference was uh, you can use a
higher energy because theenergy energy penetration depth
is higher.
Uh, I mean, on on the SLM side,whatever power you have, the
thickness that powder go inefficient is limited.
In the EBM it is higher but youend up with a coarser surface

(01:41:11):
of gas.
But the idea was back in theday is that it's even better for
orthopedic purposes.
But today what I see is thatthe SLM machines are becoming
more and more reliable andthey're easier and the powder
price dropped a lot.
And the Asian players.

(01:41:31):
The machines are veryproductive.
Now we have six 10 lasersworking simultaneously and
they're doing quite good.
And I think after theacquisition of Arcam with GE,
the company's focus shifted alittle bit into the aerospace
and I believe that we will seeless and less EVM in the markets

(01:41:56):
in the future markets in thefuture?

Speaker 2 (01:42:04):
Jenny, I remember this was a topic of discussion
at the in-person 3D Heals eventthat coincided with AAOS last
year and I was going to askGaren, because he presented a
slide that I presented at thatevent and it was sharing some
really interesting data thatRoyal National Orthopedic
Hospital had performed.
And little did I know.
You had invited Johan Henkeland he was sitting in the
audience and that's how we firstcame in contact.

(01:42:25):
But maybe, garen, you couldspeak to the evolution of
apoptotic abrasive at Hymed.
This is a material that was notdeveloped intending for
post-processing and there's beenstudies that Hymed has involved
in both for EBM as well as forother styles of print, but the
goals are not always the same.

(01:42:46):
Maybe you can just speak to theevolution of the abrasive and
by post-processing, just on abroader scale, what are some of
the common requests that youfield?

Speaker 3 (01:42:56):
Yep, yep, great question.
So really, mcd, the apatheticabrasive.
It was well before 3D printingand orthopedics was a thing
right.
So the company really startedwith requests for hydroxyapatite
plasma spray coatings.
And before you do that sprayingyou need to texture the implant
so that you get good mechanicalinterlock with your HA coating
to your part, so that it doesn'tcome off in vivo.

(01:43:18):
And so we needed to texture theparts beforehand, and so the
company developed this MCD, orthis apathetic abrasive for
usage before applying the HAcoating.
Fast forward a little bit.
A lot of our customers willjust use that apathetic abrasive
.
Others will use the apatheticabrasive with the plasma sprayed
HA on top of it, specificallyfor 3D.

(01:43:38):
We've seen in the last five to10 years a lot of growth there
and the requests have beendifferent.
It depends on the customer.
Some recognize these partiallycentered beads and say I need
that all cleaned up across theentire body, and other customers
will come and say, hey, the upface versus side faces versus
other faces on the buildplatform look a little different

(01:43:59):
.
I see some layer lines, I seesome build plate irregularities
and we need those specificallycleaned up, in which case we'll
focus our automation topost-process those areas to get
a more uniform yet texturedsurface over time.

Speaker 2 (01:44:15):
Very good.
So I want to transition theconversation to materials.
I know that quite a few of usin the panel are material
scientists.
There's a question that came inthat I'm going to be addressing
.
I think this is probably bestgeared, maybe, to Kuntai, but I
want to first start off Kuntai.
You were talking aboutmagnesium and I'm really happy.
I think, jenny, you did areally good job finding a proper

(01:44:36):
complement of speakers, notjust for the market within
orthopedic, but the material.
So, kuncai, maybe you can speaka little bit more about
magnesium.
I know you know, as weacknowledge, there's a lot of
work that your company is doingin academia.
Do you see significantopportunities for growth for
magnesium in an industry?

Speaker 5 (01:45:00):
It's hard to say.
I believe it will be still aniche application because it's
not because of the magnesiumitself, it's more about the
process.
I mean, in the past we used tosee more people interested with
the magnesium, but the safetystarted to become a very
important topic.
Even I think right now is no umcompany who are producing

(01:45:22):
magnesium powder in europe.
Uh, so yeah, that they theyrequire very uh strict safety
rules to produce such kind ofmaterials.
So, and historically, um, Imean, was a very interesting
material for a lot of peoplebecause it's the greatest in a

(01:45:43):
level.
But I believe that it will be aniche application where some
specific companies orinstitutions are able to print
in a level, and then maybe thereare some more and more
applications will be visible inthe market, but I do not see

(01:46:04):
that as a mainstream material.

Speaker 2 (01:46:08):
Thank you for your thoughts there.
So Orr's question, continuingalong the materials trajectory
wants to know and I don't knowwho this was addressed to,
because it came in during theQ&A, so we'll consider it a jump
ball whoever wants to feel thisone?
How do you envision the futureof titanium customized implants
in an era where polymers arerapidly advancing in material

(01:46:32):
properties, ease of use and evenin-house manufacturing
capabilities?
So who in our panel feelscomfortable speaking about
polymer versus titanium 3Dprinting?

Speaker 5 (01:46:45):
Maybe I can speak a couple of words.
So clearly, the polymers areinterestingly growing the peak
and some other or some newmaterials are coming.
But it's not just about theproperties of the materials.
It's about how confident is theuser.
Uh, is you know about thematerial?

(01:47:06):
So titanium is in the marketfor a long time.
They know what's happening withthe titanium in 10 years, 20
years, 30 years.
So for surgical applications, Ithink it's not very easy.
A new material come up andeverybody will say that, okay,
this is great, now we will usethis material instead of turning
the material like a titanium orsomething.

(01:47:27):
So it will take time.
Uh, clearly, the the polymershas a lot of potential, but I do
not believe in certain caseswhere really strength is
important, that titanium will bereplaced that easily.
That's still, I think, the beststrength to weight ratio

(01:47:48):
material in the market.

Speaker 2 (01:47:51):
You kept him waiting a long time, but I think it's
really a question that probablyis at the core of this
discussion as it relates toosseointegration right, All of
these materials naturally we'retalking about need to be
biocompatible.
You know, the device could lookcool and the pore size and

(01:48:12):
print style could look quiteappealing from a marketability
perspective.
But the question specificallyrelates to in vitro testing and
he wants to know what are thebest in vitro tests to forecast
ASIO integration.
So what are some materialstests that our panel is involved
in, predicting how compatibleand the level of bony ingrowth

(01:48:37):
that one might see for thesedevices?
It's such a broad question butit's an important question.
Maybe, Garen, we can feel this,perhaps representing HyMed, you
know we manufacture thesecalcium phosphate materials.
So not only are thepost-processing processes things

(01:49:02):
that we're performing with ourautomated systems, but we're
manufacturing these materials.
Our team is in the process ofdoing biocompatibility and
cytotoxicity and bioburdentesting, which we do on a
frequent basis to evaluate howthese materials respond in those
instances.
Maybe you want to speak alittle bit more about material

(01:49:23):
testing that needs to occurbefore a hydroxyapatite product
is released at HyMed.

Speaker 3 (01:49:28):
Yep, yeah, that's a good question.
So we've done many studies.
We talked about the embeddedaluminum oxide or other
materials that may be embeddedas grip blast media in
comparison to an apatiticabrasive, and we've done many
SEM studies, both in-house andwith independent third-party
labs, to prove that no residualsare left on the part afterwards
.
So you have just your puretitanium alloy on the part.

(01:49:51):
Additionally for something likehydroxyapatite coating, we
follow ASTM standards for itemssuch as tensile and shear
testing, and we do that on avery frequent basis, as well as
daily checks of things likecrystallinity of our coatings,
among other tests, to make surethat our surfaces and the
products that we ship out arecontinually meeting and

(01:50:12):
exceeding specifications.

Speaker 2 (01:50:15):
Jenny, do you have anything that you'd like to add?
I know you always have goodquestions and thoughts.

Speaker 1 (01:50:19):
Yeah, I just want to add on the polymer versus metal
set of things.
I think we have hosted quite afew biomaterial conferences and
what I have learned is that itis definitely a growing market
where you can have biodegradablescaffolds that can encourage
bone growth, for example fororthopedic purposes, or
cartilage, both, for example,for orthopedic purposes or
cartilage.
However, the size of these youknow, first of all it takes time

(01:50:42):
for these biodegradation, andalso the size.
So you cannot have largedefects and you cannot do like
any replacement and stuff likethat.
So most of them are actuallyfor smaller size of replacement
or defects.
So the size is a limitation.
But in the polymer side I thinkthat that is the frontier I'm

(01:51:04):
seeing as encouragingbiodegradable scaffolds where
the body heal itself, and thereare a couple of companies
working on it and the otherinteresting company I have seen
last year actually Craig, youwere with Alisa right and then
her company, illuminate,actually has this interesting

(01:51:25):
design of a particular screwwhere you can inject other
materials.
So I think in the future it'sthe design of implants itself
can have other properties, likeyou can have drug illusion or
you can coat it with medicationor something like that.
That would make metalinteresting.

(01:51:45):
So I think that's the materialside of things.

Speaker 2 (01:51:51):
Yeah, that was very interesting.
And then also for those folkson the material side, I just
shared a link related to ceramic3D printing.
Last year at this event in thefall, we heard from folks from
Synaptic and my colleague EstherValiant spoke representing
Hymet and the recentlyestablished Bioceramic Center of
Excellence.
So I thought it was importantto tie in that question for

(01:52:14):
osseointegration once we focusedon the materials, recognizing
that as the underlyingcommonality.
Anyone else in the panel thatwould like to speak?
Maybe there's additionalinformation that you feel is
pertinent, given the directionthat our conversation has gone?

Speaker 6 (01:52:35):
I guess I don't have a specific answer here, but I
would just sort of want toreinforce what I said in my
slides, that FDA's thinking onthis is evolving so quickly.
They put out draft guidancesfrequently and although draft
guidances aren't formally whatthey will be pointing to in

(01:52:56):
reviews, if you read them it canat least give you an idea of
sort of where they plan to go inthe future.
And in many cases the draftguidances, with some edits, end
up becoming formal publishedguidances.
So I would encourage everyoneto sort of keep an eye out on
those as they come out.
They may be device specific.

(01:53:17):
They may be specific toadditive manufacturing.
They may be device specific.
They may be specific toadditive manufacturing.
Other ones may touch onbiocompatibility for all types
of devices.
So even if you see somethingthat maybe the title doesn't
seem completely relevant to whatyou're doing, there may be bits
and pieces in there that youcan draw some important
information from.

Speaker 3 (01:53:37):
Kyle, if I can ask, how do you?
How do you stay abreast ofthose new guidances?
Are you guys just like scouringFDA's website once a week, or
there's like some newslettersign up for?
How do you?
How do you know when anapplicable guidance has come out
for you to review?

Speaker 6 (01:53:51):
Yeah, good question.
So through our work we do endup just seeing a lot of things
through our searches.
But FDA does have some veryhelpful email subscription
updates so you can subscribe toget updates for specifically
medical devices or specificcenters within FDA.
So we subscribe to a lot ofthose and they will just blast

(01:54:13):
out.
You know here are a bunch ofdifferent guidance documents we
published.
You know they have ones aboutrecalls, about all kinds of
topics.
So yeah, that's an easy way todo it, that you don't have to
actually go searching on yourend.
You can get it sent straight toyou.

Speaker 1 (01:54:29):
Kyle, do you see more European implant company coming
to you guys after the MDR isimplemented?

Speaker 5 (01:54:35):
Yes.

Speaker 1 (01:54:38):
Okay, that's a definitive yes okay, that's a
definitive yes.

Speaker 6 (01:54:46):
We certainly see um clients from europe, others from
other international markets.
Um, we have heard the generalsentiment that mdr is
challenging um, I won't say that.
Everybody comes to us and saysyou know, that's the reason
we're entering the us market, um, but I would say the prevailing
sentiment out there is it ischallenging.
I think, like some other peoplehave touched on here today,

(01:55:07):
it's a lot of understaffing, Ithink, on the side of the
notified bodies and you knowthey're just not able to get
through a lot of theseapplications very quickly.
And you know, not placing blameon either side, it's just that
that's the reality of what'sgoing on.

Speaker 4 (01:55:24):
Kyle, can you comment on with the current
administration here in the US,if there, and the changes?
I know there's been cuts to theFDA as well as CDRH.
Do you anticipate challengeswith regulatory submissions or
delays in timelines in the US incoming weeks or months?

Speaker 6 (01:55:44):
Yeah, that's a good question.
Obviously I don't think throughwhat I've read.
I've seen it has the layoffshave hit CDRH.
I don't know anything about rawnumbers or percentages.
You know concretely which is.

(01:56:05):
You know concretely.
If I had to purely speculate Iwould say potentially some
delays.
But it is complicated becauseFDA is held to their you know
performance goals based on law.
So it's hard to say how that'sgoing to shake out.
You know, I don't know ifthey're going to be trying to
hire more to backfill or howthat's going to work.

(01:56:25):
I wouldn't be surprised ifthere are delays.
But again, that's, that's sortof pure speculation.
All I can say is concretely,from the submissions that we've
been working with this year, forexample, we haven't seen any
delays yet.
So that's at least good.
But obviously a small samplesize.

Speaker 1 (01:56:44):
Well, thanks for that I suggest we all go on to
Twitter to tell Elon don't cutthis particular segment of the
government.
I actually think that's goingto work.
You know, we just have to like,group together and be unified
front.

Speaker 5 (01:57:00):
Don't cut this part.

Speaker 3 (01:57:02):
You can cut everything else, but just not 3D
printing, okay, I also justwonder aloud here, kyle if
there's a performance metric tobe met of 90 days or 150 days
and you have less folks to do it, does that mean that the
quality of the review or thedepth that they go to does that
change to still meet theirmetrics right, and what impact
does that end up having todevice manufacturers, patients,

(01:57:24):
surgeons, etc.

Speaker 6 (01:57:27):
Yeah, I agree, and obviously that's a kind of scary
slope.
You can start going down.
You know I, at least ourinteractions with FDA have
always been.
You know, these are likeprofessional scientists on the
other side, right, and like theyare deservedly proud of what
they do and, you know, obviouslyplay such a key role in

(01:57:49):
maintaining public health that Iwould hope that you know that
that depth of review and thequality of their work isn't the
thing that gets sacrificed.
But obviously I guess, I guesswe never know right.

Speaker 1 (01:58:03):
I think the delay is going to be more likely than
decreased stops, which neitheris good.

Speaker 4 (01:58:10):
Right, there might be other mechanisms, kyle, that
they can still meet theirmetrics and yet still have
delays, like using additionalinformation holds more liberally
, or something.
Sure Good point, who knows?
Who knows, though?
I guess that's what we're allsaying, right?

Speaker 2 (01:58:26):
I thought that your 3D Heels interview was really
interesting.
I was reading it while you werepresenting and it made sense
the backstage conversation thatwe were having how you met Jenny
some 10 years ago so 2013,thereabouts is when you started
your company.
Here we are, 12 years later.
What has surprised you, right?

(01:58:47):
I mean just being anentrepreneur, let alone being
nominated three times for aFortune 40s under 40,.
Maybe you could speak aboutyour entrepreneurial experiences
in 3D printing, about yourentrepreneurial experiences in
3D printing.

Speaker 5 (01:59:04):
Well, I mean, I also read when you wrote back to the
chat site that I was young.
I was young and I didn't seethat risks ahead, and then I was
just running out withoutknowing what's expecting in the
future.
So I think 80% that what Iexpected didn't happen.
So, but being an entrepreneuris like being on the road.

(01:59:26):
I guess you find a way at least.
I mean, I had big dreams.
I knew nothing about theregulatory, so back in the days
my thinking was okay, there waslike a product, there was a
buyer, then it should be okay,right.
Then I a product, there is abuyer, then it should be okay,
right.
Then I noticed that, well,there's something called CE
marking and it's verycomplicated and I knew that FDA

(01:59:50):
is a little bit scary back inthe days.
But today, the regulations inEurope, I think it's not
supporting innovation.
So that's the biggest challengeI think that Europe will face.
Nobody, I think, will pushthemselves and spend millions of

(02:00:11):
dollars and years to, you know,make a better product.
They will probably go with theearlier version of the products,
but that's a challenge.
So, um, I wasn't expecting thatto happen.
Uh, that you know that thetechnology is evolving, it's
getting better, it's almost inthe best version, but then there

(02:00:32):
are some other things happeningaround the world and and the
regulations.
That's a little bit slowingdown the market.
And another thing was I thinkright now, at least on the
machine manufacturer side, thereare so many players with the
same claim and for newcomersit's almost impossible to

(02:00:54):
understand the differencebetween the companies and I
think nobody is making the money.
And they all have big shoutsand big claims.
Uh, but it's not like you know,buying a machine and the next
day you're printing hip cupswith the additive manufacturing.
So that's and and design partfile management.

(02:01:16):
I think even a very simplething.
We mentioned about the NTOPright.
So what NTOP does was reallythat the difference is on how
you manage the file size.
With the implicit model you canreally make really interesting
cases with a lot of details andyou can make so many analysis,

(02:01:41):
but still, whatever you have inthe end top, exporting it and
importing it into the magics,that's still a very big
challenge.
Sometimes it's not printablewhat you design.
So people are not aware of this, people does not know that
anything you design doesn'tnecessarily you can print it.

(02:02:05):
So there are so many obstacles.
We are seeing more improvementin this.
You know, integrations betweenthe machines and software and
big players and big players.
And another thing that I wassurprised was I was expecting
big players to make morepositive impact in the market,

(02:02:26):
like GE or Nikon or maybe someothers, orlikon or the others.
They came into industry with abig expectation to industry with
a big expectation, but then Ithink it wasn't the response
that market was expecting fromthe big players.

(02:02:48):
I was expecting for some GE totake over the lead and make the
machines more accessible, betterand everything.
Unfortunately, we've been ableto see it and I'm a little bit
feeling like technology evolvedin a level.
Now it's the customer.
Uh, they'll take the lead andgo to the next step.

(02:03:10):
I think there's not much thetechnology makers can do at this
point yeah, I absolutely agreewith that.

Speaker 1 (02:03:18):
Um and uh.
You know, just looking allthese orthopedic implant, large
public companies bought astartup for 3D printing so they

(02:03:42):
want to bring 3D printingin-house, eroding the revenue
for 3D systems, which basicallyrely on Align for many years now
.
So that is definitely the trend.
3d printing is not going to goaway, but I think, like you said
, other industrial leaders arenow taking the lead, so you know
who is going to be our major.

(02:04:02):
The other huge topic we haven'treally touched upon is China.
The role China is playing ishuge, and I visited China in
2018.
It was already pretty advanced,but it's getting there, so
anyways.
So, craig, I don't want to takeit away, but we are running out
of time.
Why don't you do someconclusion?

Speaker 2 (02:04:24):
Yeah, absolutely no.
So I think this was really avery effective conversation.
I thank all of the panelistsand, once again, jenny, for all
of your hard work assemblingsuch a great list of speakers.
For those of you that are newto 3D Heals, this is not a
standalone event.
We encourage you to visit theirwebsite.
As Jenny had plugged earlier,there'll be an in-person event

(02:04:45):
next month focused onbioprinting for health in San
Francisco.

Speaker 1 (02:04:49):
Not just bioprinting, everything Healthcare printing.

Speaker 2 (02:04:52):
Everything is healthcare printing.
That's right.

Speaker 6 (02:04:54):
Yeah.

Speaker 2 (02:04:55):
Definitely sign up for 3D Heals for future events
throughout the year and we lookforward to meeting those of you
that will be at San Diego nextmonth.
Let's connect through LinkedInand other means to continue the
conversation.

Speaker 1 (02:05:09):
By the way, carl's Met is in San Diego, if you guys
want to hit them up.

Speaker 3 (02:05:14):
Yes.

Speaker 1 (02:05:17):
And they're one of the earliest pitch 3D companies,
so kudos to them doing such agreat job so far.

Speaker 2 (02:05:22):
Absolutely All right.
Well, thanks again everyone.
Thank you everyone.

Speaker 1 (02:05:25):
See you next time.
This will be on demand.
Bye-bye.

Speaker 2 (02:05:28):
Thank you Bye.

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Episode #77 | Orthopedics Meets 3D Printing: A Journey Into the Future

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.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}Episode #77 | Orthopedics Meets 3D Printing: A Journey Into the Future