November 10, 2022 • 33 mins
James has more than 25 years of medical device experience and is currently the CEO of Conformal Medical. Prior to joining Conformal, he led Saranas and private companies such as Drawbridge Health, and Aptus Endosystems as their President, CEO, and member of the board of directors. He held a similar role at the publicly traded medical laser company, Cutera from 2017 to 2019. He was part of the management team that led the turn-around at Cyberonics where he was the EVP & Chief Commercial Officer. James spent 17 years at Boston Scientific in various roles and functions including business development, marketing, and general management. Most of his career at Boston Scientific was spent working and living in Europe, Asia, and Latin America. Additionally, Mr. Reinstein has served as a board director for several medical companies, including publicly traded Mainstay Medical in Dublin, Ireland, Pixium-Vision based in Paris, France, and Monteris Medical a privately held company located in Minnesota. James began his professional career with Proctor & Gamble after earning his Bachelor of Arts in Marketing (BA) degree from the Terry College of Business at the University of Georgia in Athens. He also completed graduate studies at INSEAD in Fontainebleau, France.
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Speaker 1 (00:00):
Welcome to the Latin MedTech Leaders podcast, a
conversation with me, Techleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
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Tune in.
I heard radio.
Pandora, or these are
Speaker 2 (00:20):
Welcome to the Latin Metech Leaders podcast, a
conversation with leaders whohave succeeded or plan to
succeed in Latin America.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast, Amazon Music, et cetera
.
Today our guest is JamesWeinstein, CEO Crans.
(00:41):
Hey, James, great to have youhere today in the show.
Thank you for
Speaker 3 (00:44):
Joining us.
Hey, thanks, William.
Great to be with you.
Speaker 2 (00:46):
Awesome, James.
So tell us about you a littlebit, James.
Speaker 3 (00:51):
Uh, so long time, uh, med tech, uh, med device person.
I, uh, spent a number of years,almost 20 years at Boston
Scientific, working, living in,uh, multiple countries, multiple
regions throughout the world.
Uh, started in a sales positionwith a division called Meditech.
We didn't even know BostonScientific was the name of the
parent, but, uh, so basicallyMeditech was their
(01:15):
Peripheralvascular division, Soballoons.
Um, then I moved into a BD roleand actually got the company,
the corporation involved ininterventional oncology, uh,
started that, that, uh, divisionbasically within Boston
Scientific.
They eventually sold it.
Um, but I was, uh, um, thentapped.
(01:35):
We emerged with Sied LifeSystems and Sied had a very
significant, uh, portion oftheir revenue and, and business
were done in, in internationalmarkets.
And Boston Scientific Legacy,Boston didn't really have
anything going on.
So Jim Corbit was leading, uh,international at the time, and,
and he started tapping into thedivisions and saying, Okay, who
(01:56):
is willing and able to take onan expat assignment?
Um, I had always had an interestand, and raised my hand.
Um, my interest stems from myfather-in-law who ran, uh, uh,
Kodak, South America, lived insa Paul and Brazil for, for 10
years.
And, uh, so did a lot ofvisiting there.
And, uh, and I thought, Wow,this, this expat, uh, role could
be pretty interesting.
(02:18):
But, but more importantly, Ithought, if I'm ever gonna lead
a global med device company, you, you gotta have that on the
ground experience.
Uh, so had to convince my wifeto move to Paris, which is where
the European headquarters was,um, and was there for five
years.
And during those five years, weacquired about 15 companies.
Speaker 2 (02:37):
Oh my God.
I mean, amazing.
Speaker 3 (02:39):
And, uh, I integrated about half of them into the
various divisions of BostonScientific, at least the
European organizations, um,which was a great learning
experience, uh, veryinteresting.
And, and the whole concept ofintegrating the last company
that I was involved in wastarget therapeutics and
neurovascular companies.
So did that integration was verysuccessful, at least from
(02:59):
Europe.
And Europe was about 70% of therevenue of target therapeutics.
So it was, it was a critical,uh, integration for, for the
corporation that had just spenta billion dollars on them.
Um, and so that's what, um, uh,started this whole travel
through the expat, uh, life.
And, uh, then I, I did return toBoston.
(03:22):
I was in a meeting and I was, Iwas in a, a role where you, um,
uh, we were sort of regionalsupport for marketing, so we
were called theIntercontinental, some people
call it emerging markets.
And I ran the marketing for thetwo divisions,
Peripheralvascular, and I was ina quarterly business review with
Juan Zeke, who is the VP of, ofLatin America for Boston
(03:44):
Scientific.
And he was lamenting the woes ofthe situation he had in Mexico.
And, um, I was saying, Well,have you thought about this?
Or did you think about this?
And at a certain point, he justkinda get fed up with the, the,
you know, the kid in the cornerkept asking these questions and
he goes, Well, well, why don'tyou do it?
And I looked over at JeffGoodman and Dan Moore, who are
(04:07):
the heading international orintercontinental emerging
markets at the, and I kind ofshrug my shoulders,.
I'm like, Wow, I guess I could.
And, uh, two weeks later my wifeand I were house hunting in
Mexico City,, and uh, shewas seven months pregnant with
our second child,, and wewere there before she had the,
(04:30):
we, we had our second child in,in Mexico City.
Speaker 2 (04:33):
Oh, nice.
Speaker 3 (04:34):
.
We have a, uh, I dunno if thisis, is probably a terrible thing
to say, but we have a chia me do.
.
Speaker 2 (04:41):
I love it.
Yeah.
Speaker 3 (04:43):
Yeah.
So, uh, um, we actually loved itso much.
We, we had a second child inMexico City, so I have Dolans
Speaker 2 (04:49):
Oh my God.
So they have dual citizenshipnow.
Speaker 3 (04:53):
Yeah, yeah.
We've kept up their passports.
They're now, I mean, they're now, uh, 20 and 18, but, uh, yeah,
beautiful.
Speaker 2 (04:59):
Good for them.
Yeah,
Speaker 3 (05:01):
Yeah, yeah.
Yeah.
And that was, I mean, that was,uh, just one heck of an
experience.
Uh, it was my first sort ofgeneral management experience.
So the way we ran countries backthen would be, um, you know, all
functions were autonomous in, inthe country.
We had a regulatory, we had afinance department, and once a
quarter my boss would come totown with his team, and it was
(05:23):
kinda like a board meeting.
Uh, so it was, uh, it was, itwas very interesting.
And, um, a lot of, you know,dynamic, uh, business
opportunities there.
I just, just had a blast.
Five years.
We, we spent, um, and, uh, youknow, we had had just a great
time and, and, um, that allowed,or that that success led to an
(05:46):
offer for me to go run, um, aregion in Asia.
So I basically, instead ofrunning a country, I ran sort of
the area, um, of, uh, Hong Kong,Taiwan, and Korea.
And because Korea was thelargest and most dysfunctional
of, of this, of these countries,um, it was, uh, that's where I
(06:08):
lived.
We lived in Seoul, Korea for,for three years.
Um, and I was on my way to comeback and report to Jim Tobin,
the CEO of Boston Scientific atthe time.
Um, but in the interim, I had acall from a guy, uh, Dan Moore,
who I'd worked for on and offover the years at Boston.
He had just, just become the CEOof Cyberonics, so a neurostim
company based in Houston.
(06:29):
And, um, that was, uh, you know,it was, it was one where I
actually called Tobin and Isaid, Look, I'm not gonna come,
I'm not coming, but I'm gonna godown to to Houston.
Boston Scientific owned 20% ofthe, of the equity.
I was a publicly traded company.
And, uh, Jim said, Well, yourealize that's not a turnaround.
I know you're a turnaround guy,but you know, that's a
(06:50):
reclamation.
And I said, Yeah, I know I got apretty good, uh, you know, Dan
being the honest guy that he is,I said, I got a pretty good idea
what we're facing.
And it was, it was aninteresting, I mean, they, they
had about a hundred million inrevenue with a good margin, you
know, probably solid 70% grossmargin, but, uh, had lost
(07:14):
60,000,002 years in a row.
So they were good at, um, so wecame in and basically, you know,
we had to, they had, they had asignificant number of people on
the team, and we, yeah, I wasChief Commercial Officer.
I think I had an organization ofabout 300 people.
Um, I took it down to 80 andgrew revenue, 18%.
Sure.
Speaker 2 (07:32):
Yeah.
Streamlined the operation.
Speaker 3 (07:34):
Well, I mean, you had five different customer facing
groups.
None of them, not a single oneof them was in charge or
responsible for bringingrevenue.
And it was, you know, so when, Imean, so whenever, you know,
something went wrong, it waslike, Oh, you know, it's this.
Yeah, exactly.
Everybody blamed each other.
Yeah, yeah.
So it was like, okay, well thisis, um, you know, we weren't
(07:56):
splitting Adams.
I mean, it didn't have to bethat smart, but it was just
really good business acumen andputting in place the right
people, getting the right peopleon the bus, maybe getting rid of
a couple buses,.
But, uh, yeah.
So, uh, I was there for, um,almost five years.
Took the market cap up fromabout, it was about 400 million
(08:17):
when I got there, and over 2billion when I left.
Oh my God, James, that's was agreat run.
It was a great run.
And, uh, the, Dan had signed afour year agreement, and he was,
um, he was up coming up on that.
And the, so the board did aprocess and they said, Yeah,
Rheinstein, you're gonna replacehim, but we're gonna try to keep
him, and they succeeded.
So, and I'm like, Well, you guysthink I'm ready to, one of these
(08:38):
things.
I wanna run one, It's not gonnahappen at this company.
And at the time I'm in Houston,I said, Well, it's not gonna
happen in Houston cuz thereisn't a company.
Uh, so that's when I, I left,went out to the area and ran,
uh, APPO Systems, did that for,for three years until Medtronic
bought it.
Um, and then, uh, have kind ofbeen on the CEO run ever since.
(09:00):
And, and, but what I, what Aptuswas, was a, um, adjunctive, um,
it was sort of the, the helicalscrew, uh, the, the endo anchor
they called it, um, that wasadjunctive to stent grafts for
aaa.
And when I looked at Crans, thecompany I'm running now, which
is here in Houston, um, theyfinally, and I'm, I'm here
(09:22):
operating into this incubatorwhere you've got close to a
hundred companies that areincubating in the, uh, they call
the Texas Medical Center, thetmc.
Oh,
Speaker 2 (09:29):
Yes.
Yeah.
I've about
Speaker 3 (09:31):
It just a really great, uh, um, you know,
environment and, uh, a verypositive, uh, place to work.
Um, and so, but when I looked atCrans, I thought, Wow, okay,
adjunctive technology, but it'snot as expensive as the app's
product was.
It can be a join to multipleprocedures, not just triple A,
(09:54):
but, you know, the mechanicalcircuit sports tavr.
And when we get our nextgeneration product, then we're
talking about peripheralvascular, neurovascular, all
kinds of these vascular diseasewe're, we're bleeding
complications do occur.
Um, and, and what we'vediscovered or proven, uh, in a
clinical study do a larger oneis, is, is that if the care team
(10:15):
either para procedurally or postprocedurally is aware that
there's a bleed beginning rightnow, they, they basically feel
for it or look for the hematoma,and it's almost too late.
You're heading into complicationland by then.
Um, our device lets, you know,when you've got about 50 cc of
blood that's, um, you know,extra arterial in the tissue,
(10:37):
uh, and then all the way up to200, you're still less than half
a half a unit of blood.
So it's, it's phenomenal.
Technology works extremely well,a hundred percent sensitivity
and a very high specificity.
So it's, um, really, really goodtechnology.
And we're just now funded andhiring the team, the sales team,
we're gonna do a larger clinicalstudy, uh, and it's, um, yeah,
(10:59):
really excited about it.
We, we just got funded, BAVenture partners led the round.
Uh, so they, they've been,they'll be a great partner for
us going forward.
Speaker 2 (11:08):
Excellent.
James, I mean, quite a right,quite a journey.
And you've had, uh, and it's theLatin American piece of it.
Uh, so let's talk about LatinAmerica in a little more
details.
Uh, James, um, what trends doyou see happening in the world
or in Latin America, political,economical, social, that are
(11:28):
kinda beneficial to ourdiscussion today or for the
business of, uh, doing trials orselling devices in the region?
Speaker 3 (11:36):
Yeah, so I mean, there's, there's, I I would say
definitely opportunities for,for the commercial.
You know, there's commercialopportunities and finding the
right partners.
Um, you know, most companieslike Crans would not be trying
to outfit direct teams.
So it's trying to find thirdparty partners.
Um, and that's, that's prettymuch the norm.
(11:56):
In the past, I've done somehybrid versions of that, uh,
such as Cyberonics, where we hada, we had a small kind of tiger
team on the ground that managedthe distribution network.
And I always thought that thatwas critically important because
you need to have, uh, someone onyour team that speaks the
language, speaks the culture,and is, you know, um, you know,
(12:17):
supporting the, the thirdparties or, or maybe a, you
know, a boot in the tail of thethird parties, which sometimes
is necessary, but, you know,that's, uh, but it's really
about training, support and, andgetting, uh, getting, providing
that to them in, in the best waypossible.
And you really need somebody onthe ground to do that.
I, I believe,
Speaker 2 (12:35):
Yeah, I agree with you.
And I've seen that trend or, orthat, um, structure happening,
um, in the region a lot.
And I, and I think that's,that's the ideal way to enter a
new, a new market, Asia, LatinAmerica, because, uh, the
shooters come and go, but, uh,your people are advancing your
(12:55):
agenda.
They are helping you generatedemand and supporting the work
of the shooter, doingco-marketing activities,
training the shooter and the newshooters, because they don't
always stay with you forfor as long as you want.
So you always have to be lookingfor new shooters, new ways to,
to expand the coverage in thecountry.
(13:17):
So, for example, in Columbia,Mexico, such large countries,
Brazil, you need a fewdistributors, I mean, more than
one certainly to cover the wholecountry.
So,
Speaker 3 (13:27):
Yeah, I mean, even in Mexico, when, when I went there
with Boston, San Diego, we werepredominantly direct, but we
still had to distributor becausethe process to get into military
hospitals or did the es, the Esreally, really needed a third
party to, to do that.
Um, in, in most instances, mostcases.
So, um, but, uh, you know,smaller companies like I'm in
(13:50):
now or even, you know,Cyberonics, we, we did that sort
of hub and spoke, uh, approach.
Uh, we had, we had a group in,in Sao Paulo, and then he had
one or two of his, uh, marketingsupport people, uh, in, you
know, I think one in Mexico, youknow, the larger countries, uh,
Brazil for sure.
He was in, he was in Sao Paulo.
So, yeah, so I see that, um, youknow, the other area, and this
(14:12):
is what we did when I was atCyberonics, Mel Nova is, um,
initiated manufacturing, uh, in,in Costa Rica.
Um, you know, there's a, there'sa whole, you know, center, Uh,
you've got almost every largecompany there.
Um, but you know, the one thingI did while I was at Boston
Scientific, we had about five ofthese Maia dos, uh, you know, on
(14:33):
the frontier in the, on theborder border towns.
Um, and, uh, I was thein-country representative.
I really didn't have much to dowith it and, uh, other than, you
know, quarterly board meetingsand, but I never had to
physically go, which wasinteresting.
But, uh, you know, that was,that was a great, uh, you know,
(14:54):
opportunity for companies, uh,you know, obviously NAFTA driven
at the time, but, um, uh, but,but, you know, putting the, we
were deciding between Costa Ricaand Ireland, uh, to put
manufacturing and, and it reallywasn't even close.
I mean, I had worked veryclosely with Boston Scientifics
Irish manufacturing in Galway,then we even opened up another
(15:14):
one in Cork.
But, um, it really was, it justmade so much more sense, uh,
for, for Costa Rica to be the,the destination for that
manufacturing plant.
Speaker 2 (15:24):
Hmm.
You know, Costa Rica is comingup a lot in colo because
Columbia is now targeting nearassuring, Right.
You know, that term now wherecountries are, where the
relationship between the UnitedStates and China, you know, has
some tension.
So, uh, companies are looking tonearshore their operations, and
(15:48):
Columbia is going after thatmarket.
And, uh, recently the governmentjust announced an initiative to
bring pharmaceutical and medicaldevice near assuring to Columbia
.
And they're looking at CostaRica as one of the examples of a
successful policy, state policyto attract near assuring.
I mean, such a small country,All you hear is the jungle and,
(16:12):
and the, the kids from highschool going on vacations to
Costa Rica.
You never imagine that such asmall country has such a strong
manufacturing, medical devicemanufacturing industry.
I'm very sophisticated, by theway, so
Speaker 3 (16:25):
Oh yeah, no, it's, uh, I mean, concerted effort on
their part to develop it, Idunno when it was decades ago,
maybe.
But, uh, you know, you go tothat region and you've got
every, you know, Boston striker,every, every company, seemingly
Abbot has a huge facility there.
Um, and they have theinfrastructure to support
Speaker 2 (16:44):
It.
Exactly, exactly.
So, uh, they're doing somethingright.
And, and Columbia should getinspiration from, from there.
That's certainly something thatI, that I see happening in the
near future.
Uh, um, in terms of Columbia orother countries in Latin
America.
I, I think countries in LatinAmerica, James, are maturing.
(17:04):
They're realizing that exportingcoffee and avocados, and in the
case of Columbia cocaine and badnews, for Netflix, it's
not gonna cut it.
They need to diversify and getmore, uh, complex in, in what
they export, Right.
Knowledge, Yes.
What we need to export in thecountry.
Speaker 3 (17:24):
So, you know, Columbia keeps coming up for me
as well for, um, doing clinicaltrials.
Yeah.
Uh, as, I guess a couple keycenters there.
Um, you know, we, we are gonnado a post market study, but, you
know, just in, just in UScenters, uh, for, for Crans.
But I know that, uh, there'sactually a company here called
(17:46):
Presi, I believe they're doing,um, they did their initial first
in man in
Speaker 2 (17:50):
Columbia.
Excellent.
I'm, I'm happy to to hear that.
Very good.
Very good.
Yeah, James, uh, you're bringingup a good point.
I, I think, um, I mean, this iswhat I do.
I do clinical trials, earlyvisibility, clinical trials, and
we also help companies sellmedical devices in Latin
America.
And I've seen the regulatoryframework of pretty much all
(18:14):
countries in Latin America,because a lot of my clients, uh,
first come to me thinking aboutBrazil, or thinking about
Argentina or thinking aboutMexico.
So I have to study theregulatory framework and their
environment for clinicalresearch, specifically early
stage.
And it's not that friendly, um,as compared to Columbia.
(18:34):
And Columbia has some, some goodadvantages.
Uh, and, and one of the, theadvantages is the, not only
Columbia lot, Latin America, um,but is the ease of patient
recruitment.
It's a lot easier to recruitpatients because they have, they
don't have as many options aspatients have in the United
States, Right?
You have 20 other FDA approvedoptions that may delay, or you
(18:59):
can do pain management orsomething that can delay, uh,
some, some more drasticintervention.
Um, uh, you're not gonna subjectin the United States yourself to
a, an investigative, uh, devicethat has not been tested in
humans.
They just tested a device in acouple picks, and you wanna be
(19:20):
the first one, right?
At least out in the UnitedStates.
Whereas in Latin America,unfortunately, patients have
delayed access to medicalinnovations.
So if you come with a, with adevice, it can treat your
chronic disease in 15, 20, 30minutes, they will send out for
it, I mean, immediately.
And then you also trust thedoctor.
(19:41):
So if the doctor suggests thatyou get the trial, they will
take the advice of the doctor.
So that's one thing.
And another thing is the, um,it's cost savings.
In the case of colo, theColombian peso James has become
the third one of the, the topthree most devalued currencies
in the world.
(20:02):
And, and so it's really abargain to buy services from
hospital in Colombia now,because is so cheap.
.
So, so yeah.
So those are kind of theadvantages of doing trials.
Speaker 3 (20:14):
Are they gonna move to Bitcoin?
Like, uh,
Speaker 2 (20:19):
I don't think so.
That's kinda a joke.
Speaker 3 (20:22):
,
Speaker 2 (20:24):
I dunno why they're doing that.
I think they're seekingpublicity or something, but, uh,
but is interesting not tryingsomething new.
At least credit credit.
Anyway, so, So James, um, whatdo you think about the e MDR
about that trend happening inEurope and the relationship with
Latin America?
Do you think that will benefitthe region, somehow
Speaker 3 (20:46):
Benefit, uh, Latin America or
Speaker 2 (20:49):
Eu?
No, the, uh, Latin America, Yeah.
More trials, more companieslooking at Latin America to
start their sales airports.
Speaker 3 (20:56):
Yeah, I mean, you could already see this trend
between us, the fda, andnotified bodies in Europe.
Um, even leading up to, to mdr.
I mean, it was the notifiedbodies, you know, I call them,
they're like the airlines.
They really don't care about youas a customer.
(21:17):
Um, and they forget that that'sactually the relationship.
Um, you know, they just, andI've multiple companies that I
was helping, uh, back when I wasconsulting, were just lamenting,
oh, this, this notified bodythat notified body, and it's
just amazing.
And, you know, these are thesmaller companies.
They're not gonna get the BostonScientific attention.
Um, so it's, it's, uh, makingwhat was already, uh, what I
(21:43):
would consider a dubiousopportunity to make money, um,
commercially in Europe, uh, thatmuch more difficult.
Um, now the other side of thecoin is, as a small company like
Crans, you, we really need tohave CE mark, um, if, if nothing
else, not so much for thecommercial benefit, but to be
(22:04):
able to say to a potentialacquire, you know, where you
already have market access.
Um, and, but, you know, havingFDA is irrelevant to, to mdr,
uh, fortunately or unfortunately, uh, but in some Latin American
countries that it's the benefitthat's kind of all you need.
(22:24):
Um, but, uh, you know, it's,it's, it's no, you know, kind of
layout in, in, as you know, insome countries it's, it's, it's
great.
I mean, it's easy access likeChile, but, uh, you know, Brazil
was probably the other extreme.
Maybe even Argentina now I thinkhas gotten more difficult.
Um, Mexico is making some effortthere, from what I understand,
(22:45):
and
Speaker 2 (22:46):
Still is a little convoluted.
Speaker 3 (22:48):
Yeah.
Yeah.
I mean, it's, it's, it's too badthat, you know, with FDA
approval, which isn't, you know,as is isn't that easy, but
actually compared to mdr, it is,
Speaker 2 (23:01):
It's the park
Speaker 3 (23:02):
.
Yeah.
Yeah.
I mean, we were surrounds, ourproduct was a de novo five, 10 K
.
Uh, we did a clinical studyalready for 60 patients.
I guess it was post-market, um,but it wasn't required for, for
approval.
So, um, but you know, this is,this is a pretty arduous, uh,
requirements, You know, the techfile is not necessarily the same
(23:24):
tech file you're gonna give tothe fda.
Um, so, uh, I think it, it couldcreate opportunity for, for
Latin America, but, you know,here's the door, the door is
open, are, are the government'sgonna react and say, Okay, let's
figure out a way, you know,least burdensome path, uh,
approach.
And if they do, then, thencertainly opportunities will
exist.
Speaker 2 (23:44):
Yeah.
Yeah.
I think, uh, going back toColumbia, Columbia is poised to
benefit from it somehow.
Um, cuz by the way, it has thefastest regulatory approval time
for a clinical, uh, uh, trial.
Uh, and also for a commercialdevice, if you already have the
(24:06):
approval of a reference country,reference country being Canada,
the United States, uh, Europe,Japan, and Australia, uh,
getting envi a approval inColumbia is pretty
straightforward by law.
The agency has to reply in 90days, and they do.
So it is considered one of the,the concept with faster, with
(24:26):
the fastest access to mm-hmm.
to,
Speaker 3 (24:28):
So one of the questions we were talking
earlier about, uh, distributorscome and go, right?
So in some countries the licenseis held by the third party, and
some countries you can actuallyas a company, hold it yourself
or appoint it to somebody whoisn't the distributor that you
need to, to change out.
Yeah.
Where, you know, for me, theideal is company can hold it,
(24:52):
but, uh, sometimes that's, mostcases not the case.
Where is it an opportunity tohave it in a third party?
So if you do change out, adistributor is not another
period of time that you're outof the market.
Speaker 2 (25:04):
That's, that's a interesting comment that you're
making here.
And, and going back to Columbia, because is the only
country in Latin America, James,by the way, that allows foreign
entities to be the title holderof their registration.
You don't have to rely on alocal distributor or in a third
(25:24):
party registration holder thatis also a local company and pay
like$300 every month orsomething like that for that
privilege.
So yeah, that's one of thebenefits of Columbia without
mentioning the, the fact thathealthcare is a constitutional
right.
So you get reimbursement prettymuch guarantee in the system,
which is European style, kind ofa universal coverage.
(25:47):
Everything is covered kind ofeasy access to the system, uh,
from the patient standpoint.
And, and, uh, if they don't getyou the device or the diapers
that you need or the medicinethat you need, you can go all
the way up to Supreme Court andget you Right.
Respected and, and, and, andthey get, you.
(26:08):
Are
Speaker 3 (26:08):
There a lot of, are there a lot of diaper cases
heading to the Supreme Court?
,
Speaker 2 (26:13):
There's a gay of a lady that, this is Al case, I'm
not joking.
There's a lady who went througha procedure, James and, uh, is a
famous case in Columbia that exexemplifies my, my point.
And, uh, she couldn't go up tothe second story in her house,
so she needed an elevator, andshe went all the way up to the
Supreme Court to thatelevator Wow.
(26:35):
In her house.
So, yeah, that's the way it's,
Speaker 3 (26:38):
Okay, interesting.
Speaker 2 (26:39):
Yeah.
So anyway, but going back yourpoint, it, it, that little
things like that, like you as aforeign entity, being able to
have total control over yourregistration is, is, is really,
uh, an advantage that makesColumbia a very business
friendly country.
And, and, and, and colo withMexico, with Chile and, and
(27:03):
Costa Rica now are O E C Dcountries.
So they're adopting work classpolicies to attract business.
So Columbia is, is leading thisin, in, in, uh, in the
regulatory framework.
So, so yeah, that, that helps alot.
So, so what are your plans withSato, uh, James?
(27:25):
I mean, how do you see LatinAmerica playing a role in your
company, your future?
Do you have any markets in inmind?
Any next steps in Latin Americanmind?
Speaker 3 (27:36):
Yeah, I mean, our initial focus certainly is, is
getting us traction, uh, gettingsome, uh, getting this
enrollment into our clinicaltrial, which will be a 260
patient, um, trial todemonstrate a reduction in, in
bleed complications when ourproduct is used versus not.
And we'll compare that to, uh,existing published data that's
(27:57):
out there.
Um, with regards to, you know,commercialization would be, uh,
you know, we're, we're hiringthe team up here for, for us,
but, but we'll also startlooking to external markets.
The company never did anythingoutside of us, don't we, You
know, we're gonna start fromground zero with the CE mark,
um, so we've got to go after,but, but what I am looking at is
(28:21):
what can we do in, you know,countries like Latin America,
even countries, you know,regions like Middle East, um, or
countries in Latin America andMiddle East, that, that have
sort of the criteria that I want, um, which is, you know, what's
the status of, of the licenseholder, call it that.
Um, what's the, what's the, youknow, size of market?
(28:43):
There's, there's obviously the,the, you know, ability to sell
into that market, public,private, uh, you know, what was
the process, not just, not justfor approval, but, but what's
the, uh, financial side of thereimbursement,
Speaker 2 (28:56):
Uh, status and
Speaker 3 (28:57):
All that?
So there's, there's kind of aextensive checklist that, that I
operate off of.
So, you know, but we probablywon't start looking to, uh,
Latin America until next yearand more likely second half.
Um, but, but at that time willbe because ideally what I want
is somebody dedicated insideCrans to manage that.
(29:20):
Um, right now I'm the only,right now I'm the only one.
And, uh, I'm, I'm notprioritizing, uh, you know,
Latin America.
However, um, you know, I, I dothink the countries that you
just listed earlier, you know,Mexico, Columbia,
Speaker 2 (29:35):
Chile,
Speaker 3 (29:37):
Chile, certainly mm-hmm.
, and then if, if,uh, you know, Brazil's obviously
a great and large market, greatcountry.
Uh, it's just a, it's aregulatory, uh, um, behemoth.
So it's, it's, uh, pretty,pretty much a barrier.
Yeah.
Speaker 2 (29:57):
Excellent, James.
So it looks like that, like theAmerica innovator, that's what I
wanted to hear, and that's whatI wanted listeners to, to, to
hear directly from you that, uh,you certainly,
Speaker 3 (30:09):
And I definitely have a lot of, uh, a lot of friends,
obviously, particularly inMexico, but, uh, you know,
having, uh, worked in, in theentire region and, uh, you know,
reported to Argentina while Iwas in, uh, certainly have a lot
of friends and, uh, and oldcolleagues that, that are, uh,
in fact, I think a good, goodfriend, uh, Carlos Flores is in,
uh, is in Columbia, or he, Imean, hes Columbia, I think he's
(30:31):
got a business going in Columbia.
So yeah, he reached out to merecently, so
Speaker 2 (30:37):
Excellent, excellent.
And, and Juan, good friend too,too in Columbia.
Speaker 3 (30:43):
Oh yes, of course.
.
Speaker 2 (30:47):
All right, James, it's being a, the delightful
conversation and, uh, we'reclose to the end of the show.
Uh, any final words of wisdom?
Uh, what would you say to theCEO of, uh, newer medical device
company that is just starting tolook at Latin America as a place
to do business trials orcommercialization?
What would be your, your finalwords to
Speaker 3 (31:08):
Him?
Um, yeah, I mean, I, I, I thinkthat there's, there's plenty of
opportunity.
There's, there's plenty ofreason, uh, to want to, to have
activities in Latin America, beit clinical study, uh, certainly
the first in man opportunity is,is presented itself as, as, as
being real.
(31:29):
Uh, the commercial opportunitiesare certainly there, and then
one that we're gonna pursue, uh,for sure.
But then, you know, finally is,is as you get larger and in
wanting to do this offshore,near shore, as you said, um,
manufacturing, uh, it's, there's, there's an industry there, and
it's not even burgeoning.
It's, it's there.
I mean, it exists.
Uh, so it would be one for allthose, um, opportunities exist
(31:53):
for, for certainly medicaldevice companies.
Um, you know, and then, you know, something I've always looked
at.
So people said, Oh, you, you'vedid multiple expat assignments,
you are pretty successful ateach of them, which led to the
next one and the next one.
Um, and, you know, somebodyasked me, how, how did you
approach it?
I said, Well, look, I believethat, um, you know, everyone in
(32:15):
the world is pretty much thesame, maybe 80%, and I don't
even, I'll just make up anumber, say 80% the same.
It's that other 20% that isreally different.
And that's what is the shiny toythat if everyone focuses on, And
that's what you absolutely needto ignore.
It doesn't matter.
Stay where the commonalityexists.
(32:36):
You know, you want to do well inyour job.
You wanna be recognized for thatsuccess you wanna provide for
your families, You know, allthose intangibles that don't
separate us.
You need to focus on ignore
Speaker 2 (32:50):
Words.
good is being, again, a,a fascinating conversation.
I, I learn so much every time Ispeak with somebody of your
caliber, with somebody of yourexperience.
And, uh, I can't thank youenough for being in the show
today.
And I, I'm sure listeners, uh,have learned a lot from, from
(33:14):
you, from your words, from yourwisdom, from your experience.
Speaker 3 (33:18):
That was a pleasure, uh, Julio, I enjoyed it.
And thanks for the invitation.
And then, uh, look forward toworking with you.
Speaker 2 (33:23):
Beautiful.
Bye, James.
All right.
Speaker 3 (33:26):
Take.
Welcome to the Latin MedTech Leaders podcast, a
conversation with me, Techleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast.
Amazon Music is teacher.
Tune in.
I heard radio.
Pandora, or these are
Speaker 2 (00:20):
Welcome to the Latin Metech Leaders podcast, a
conversation with leaders whohave succeeded or plan to
succeed in Latin America.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast, Amazon Music, et cetera
.
Today our guest is JamesWeinstein, CEO Crans.
(00:41):
Hey, James, great to have youhere today in the show.
Thank you for
Speaker 3 (00:44):
Joining us.
Hey, thanks, William.
Great to be with you.
Speaker 2 (00:46):
Awesome, James.
So tell us about you a littlebit, James.
Speaker 3 (00:51):
Uh, so long time, uh, med tech, uh, med device person.
I, uh, spent a number of years,almost 20 years at Boston
Scientific, working, living in,uh, multiple countries, multiple
regions throughout the world.
Uh, started in a sales positionwith a division called Meditech.
We didn't even know BostonScientific was the name of the
parent, but, uh, so basicallyMeditech was their
(01:15):
Peripheralvascular division, Soballoons.
Um, then I moved into a BD roleand actually got the company,
the corporation involved ininterventional oncology, uh,
started that, that, uh, divisionbasically within Boston
Scientific.
They eventually sold it.
Um, but I was, uh, um, thentapped.
(01:35):
We emerged with Sied LifeSystems and Sied had a very
significant, uh, portion oftheir revenue and, and business
were done in, in internationalmarkets.
And Boston Scientific Legacy,Boston didn't really have
anything going on.
So Jim Corbit was leading, uh,international at the time, and,
and he started tapping into thedivisions and saying, Okay, who
(01:56):
is willing and able to take onan expat assignment?
Um, I had always had an interestand, and raised my hand.
Um, my interest stems from myfather-in-law who ran, uh, uh,
Kodak, South America, lived insa Paul and Brazil for, for 10
years.
And, uh, so did a lot ofvisiting there.
And, uh, and I thought, Wow,this, this expat, uh, role could
be pretty interesting.
(02:18):
But, but more importantly, Ithought, if I'm ever gonna lead
a global med device company, you, you gotta have that on the
ground experience.
Uh, so had to convince my wifeto move to Paris, which is where
the European headquarters was,um, and was there for five
years.
And during those five years, weacquired about 15 companies.
Speaker 2 (02:37):
Oh my God.
I mean, amazing.
Speaker 3 (02:39):
And, uh, I integrated about half of them into the
various divisions of BostonScientific, at least the
European organizations, um,which was a great learning
experience, uh, veryinteresting.
And, and the whole concept ofintegrating the last company
that I was involved in wastarget therapeutics and
neurovascular companies.
So did that integration was verysuccessful, at least from
(02:59):
Europe.
And Europe was about 70% of therevenue of target therapeutics.
So it was, it was a critical,uh, integration for, for the
corporation that had just spenta billion dollars on them.
Um, and so that's what, um, uh,started this whole travel
through the expat, uh, life.
And, uh, then I, I did return toBoston.
(03:22):
I was in a meeting and I was, Iwas in a, a role where you, um,
uh, we were sort of regionalsupport for marketing, so we
were called theIntercontinental, some people
call it emerging markets.
And I ran the marketing for thetwo divisions,
Peripheralvascular, and I was ina quarterly business review with
Juan Zeke, who is the VP of, ofLatin America for Boston
(03:44):
Scientific.
And he was lamenting the woes ofthe situation he had in Mexico.
And, um, I was saying, Well,have you thought about this?
Or did you think about this?
And at a certain point, he justkinda get fed up with the, the,
you know, the kid in the cornerkept asking these questions and
he goes, Well, well, why don'tyou do it
And I looked over at JeffGoodman and Dan Moore, who are
(04:07):
the heading international orintercontinental emerging
markets at the, and I kind ofshrug my shoulders,
I'm like, Wow, I guess I could
And, uh, two weeks later my wifeand I were house hunting in
Mexico City,
our second child,
(04:30):
we, we had our second child in,in Mexico City.
Speaker 2 (04:33):
Oh, nice.
Speaker 3 (04:34):
We have a, uh, I dunno if thisis, is probably a terrible thing
to say, but we have a chia me do
Speaker 2 (04:41):
I love it.
Yeah.
Speaker 3 (04:43):
Yeah.
So, uh, um, we actually loved itso much.
We, we had a second child inMexico City, so I have Dolans
Speaker 2 (04:49):
Oh my God.
So they have dual citizenshipnow.
Speaker 3 (04:53):
Yeah, yeah.
We've kept up their passports.
They're now, I mean, they're now, uh, 20 and 18, but, uh, yeah,
beautiful.
Speaker 2 (04:59):
Good for them.
Yeah,
Speaker 3 (05:01):
Yeah, yeah.
Yeah.
And that was, I mean, that was,uh, just one heck of an
experience.
Uh, it was my first sort ofgeneral management experience.
So the way we ran countries backthen would be, um, you know, all
functions were autonomous in, inthe country.
We had a regulatory, we had afinance department, and once a
quarter my boss would come totown with his team, and it was
(05:23):
kinda like a board meeting.
Uh, so it was, uh, it was, itwas very interesting.
And, um, a lot of, you know,dynamic, uh, business
opportunities there.
I just, just had a blast.
Five years.
We, we spent, um, and, uh, youknow, we had had just a great
time and, and, um, that allowed,or that that success led to an
(05:46):
offer for me to go run, um, aregion in Asia
So I basically, instead ofrunning a country, I ran sort of
the area, um, of, uh, Hong Kong,Taiwan, and Korea.
And because Korea was thelargest and most dysfunctional
of, of this, of these countries,um, it was, uh, that's where I
(06:08):
lived.
We lived in Seoul, Korea for,for three years.
Um, and I was on my way to comeback and report to Jim Tobin,
the CEO of Boston Scientific atthe time.
Um, but in the interim, I had acall from a guy, uh, Dan Moore,
who I'd worked for on and offover the years at Boston.
He had just, just become the CEOof Cyberonics, so a neurostim
company based in Houston.
(06:29):
And, um, that was, uh, you know,it was, it was one where I
actually called Tobin and Isaid, Look, I'm not gonna come,
I'm not coming, but I'm gonna godown to to Houston.
Boston Scientific owned 20% ofthe, of the equity.
I was a publicly traded company.
And, uh, Jim said, Well, yourealize that's not a turnaround.
I know you're a turnaround guy,but you know, that's a
(06:50):
reclamation
And I said, Yeah, I know I got apretty good, uh, you know, Dan
being the honest guy that he is,I said, I got a pretty good idea
what we're facing.
And it was, it was aninteresting, I mean, they, they
had about a hundred million inrevenue with a good margin, you
know, probably solid 70% grossmargin, but, uh, had lost
(07:14):
60,000,002 years in a row.
So they were good at, um, so wecame in and basically, you know,
we had to, they had, they had asignificant number of people on
the team, and we, yeah, I wasChief Commercial Officer.
I think I had an organization ofabout 300 people.
Um, I took it down to 80 andgrew revenue, 18%.
Sure.
Speaker 2 (07:32):
Yeah.
Streamlined the operation.
Speaker 3 (07:34):
Well, I mean, you had five different customer facing
groups.
None of them, not a single oneof them was in charge or
responsible for bringingrevenue.
And it was, you know, so when, Imean, so whenever, you know,
something went wrong, it waslike, Oh, you know, it's this.
Yeah, exactly.
Everybody blamed each other.
Yeah, yeah.
So it was like, okay, well thisis, um, you know, we weren't
(07:56):
splitting Adams.
I mean, it didn't have to bethat smart, but it was just
really good business acumen andputting in place the right
people, getting the right peopleon the bus, maybe getting rid of
a couple buses,
But, uh, yeah.
So, uh, I was there for, um,almost five years.
Took the market cap up fromabout, it was about 400 million
(08:17):
when I got there, and over 2billion when I left.
Oh my God, James, that's was agreat run.
It was a great run.
And, uh, the, Dan had signed afour year agreement, and he was,
um, he was up coming up on that.
And the, so the board did aprocess and they said, Yeah,
Rheinstein, you're gonna replacehim, but we're gonna try to keep
him, and they succeeded.
So, and I'm like, Well, you guysthink I'm ready to, one of these
(08:38):
things.
I wanna run one, It's not gonnahappen at this company.
And at the time I'm in Houston,I said, Well, it's not gonna
happen in Houston cuz thereisn't a company.
Uh, so that's when I, I left,went out to the area and ran,
uh, APPO Systems, did that for,for three years until Medtronic
bought it.
Um, and then, uh, have kind ofbeen on the CEO run ever since.
(09:00):
And, and, but what I, what Aptuswas, was a, um, adjunctive, um,
it was sort of the, the helicalscrew, uh, the, the endo anchor
they called it, um, that wasadjunctive to stent grafts for
aaa.
And when I looked at Crans, thecompany I'm running now, which
is here in Houston, um, theyfinally, and I'm, I'm here
(09:22):
operating into this incubatorwhere you've got close to a
hundred companies that areincubating in the, uh, they call
the Texas Medical Center, thetmc.
Oh,
Speaker 2 (09:29):
Yes.
Yeah.
I've about
Speaker 3 (09:31):
It just a really great, uh, um, you know,
environment and, uh, a verypositive, uh, place to work.
Um, and so, but when I looked atCrans, I thought, Wow, okay,
adjunctive technology, but it'snot as expensive as the app's
product was.
It can be a join to multipleprocedures, not just triple A,
(09:54):
but, you know, the mechanicalcircuit sports tavr.
And when we get our nextgeneration product, then we're
talking about peripheralvascular, neurovascular, all
kinds of these vascular diseasewe're, we're bleeding
complications do occur.
Um, and, and what we'vediscovered or proven, uh, in a
clinical study do a larger oneis, is, is that if the care team
(10:15):
either para procedurally or postprocedurally is aware that
there's a bleed beginning rightnow, they, they basically feel
for it or look for the hematoma,and it's almost too late.
You're heading into complicationland by then.
Um, our device lets, you know,when you've got about 50 cc of
blood that's, um, you know,extra arterial in the tissue,
(10:37):
uh, and then all the way up to200, you're still less than half
a half a unit of blood.
So it's, it's phenomenal.
Technology works extremely well,a hundred percent sensitivity
and a very high specificity.
So it's, um, really, really goodtechnology.
And we're just now funded andhiring the team, the sales team,
we're gonna do a larger clinicalstudy, uh, and it's, um, yeah,
(10:59):
really excited about it.
We, we just got funded, BAVenture partners led the round.
Uh, so they, they've been,they'll be a great partner for
us going forward.
Speaker 2 (11:08):
Excellent.
James, I mean, quite a right,quite a journey.
And you've had, uh, and it's theLatin American piece of it.
Uh, so let's talk about LatinAmerica in a little more
details.
Uh, James, um, what trends doyou see happening in the world
or in Latin America, political,economical, social, that are
(11:28):
kinda beneficial to ourdiscussion today or for the
business of, uh, doing trials orselling devices in the region?
Speaker 3 (11:36):
Yeah, so I mean, there's, there's, I I would say
definitely opportunities for,for the commercial.
You know, there's commercialopportunities and finding the
right partners.
Um, you know, most companieslike Crans would not be trying
to outfit direct teams.
So it's trying to find thirdparty partners.
Um, and that's, that's prettymuch the norm.
(11:56):
In the past, I've done somehybrid versions of that, uh,
such as Cyberonics, where we hada, we had a small kind of tiger
team on the ground that managedthe distribution network.
And I always thought that thatwas critically important because
you need to have, uh, someone onyour team that speaks the
language, speaks the culture,and is, you know, um, you know,
(12:17):
supporting the, the thirdparties or, or maybe a, you
know, a boot in the tail of thethird parties, which sometimes
is necessary, but, you know,that's, uh, but it's really
about training, support and, andgetting, uh, getting, providing
that to them in, in the best waypossible.
And you really need somebody onthe ground to do that.
I, I believe,
Speaker 2 (12:35):
Yeah, I agree with you.
And I've seen that trend or, orthat, um, structure happening,
um, in the region a lot.
And I, and I think that's,that's the ideal way to enter a
new, a new market, Asia, LatinAmerica, because, uh, the
shooters come and go, but, uh,your people are advancing your
(12:55):
agenda.
They are helping you generatedemand and supporting the work
of the shooter, doingco-marketing activities,
training the shooter and the newshooters, because they don't
always stay with you for
So you always have to be lookingfor new shooters, new ways to,
to expand the coverage in thecountry.
(13:17):
So, for example, in Columbia,Mexico, such large countries,
Brazil, you need a fewdistributors, I mean, more than
one certainly to cover the wholecountry.
So,
Speaker 3 (13:27):
Yeah, I mean, even in Mexico, when, when I went there
with Boston, San Diego, we werepredominantly direct, but we
still had to distributor becausethe process to get into military
hospitals or did the es, the Esreally, really needed a third
party to, to do that.
Um, in, in most instances, mostcases.
So, um, but, uh, you know,smaller companies like I'm in
(13:50):
now or even, you know,Cyberonics, we, we did that sort
of hub and spoke, uh, approach.
Uh, we had, we had a group in,in Sao Paulo, and then he had
one or two of his, uh, marketingsupport people, uh, in, you
know, I think one in Mexico, youknow, the larger countries, uh,
Brazil for sure.
He was in, he was in Sao Paulo.
So, yeah, so I see that, um, youknow, the other area, and this
(14:12):
is what we did when I was atCyberonics, Mel Nova is, um,
initiated manufacturing, uh, in,in Costa Rica.
Um, you know, there's a, there'sa whole, you know, center, Uh,
you've got almost every largecompany there.
Um, but you know, the one thingI did while I was at Boston
Scientific, we had about five ofthese Maia dos, uh, you know, on
(14:33):
the frontier in the, on theborder border towns.
Um, and, uh, I was thein-country representative.
I really didn't have much to dowith it and, uh, other than, you
know, quarterly board meetingsand, but I never had to
physically go
But, uh, you know, that was,that was a great, uh, you know,
(14:54):
opportunity for companies, uh,you know, obviously NAFTA driven
at the time, but, um, uh, but,but, you know, putting the, we
were deciding between Costa Ricaand Ireland, uh, to put
manufacturing and, and it reallywasn't even close.
I mean, I had worked veryclosely with Boston Scientifics
Irish manufacturing in Galway,then we even opened up another
(15:14):
one in Cork.
But, um, it really was, it justmade so much more sense, uh,
for, for Costa Rica to be the,the destination for that
manufacturing plant.
Speaker 2 (15:24):
Hmm.
You know, Costa Rica is comingup a lot in colo because
Columbia is now targeting nearassuring, Right.
You know, that term now wherecountries are, where the
relationship between the UnitedStates and China, you know, has
some tension.
So, uh, companies are looking tonearshore their operations, and
(15:48):
Columbia is going after thatmarket.
And, uh, recently the governmentjust announced an initiative to
bring pharmaceutical and medicaldevice near assuring to Columbia
.
And they're looking at CostaRica as one of the examples of a
successful policy, state policyto attract near assuring.
I mean, such a small country,All you hear is the jungle and,
(16:12):
and the, the kids from highschool going on vacations to
Costa Rica.
You never imagine that such asmall country has such a strong
manufacturing, medical devicemanufacturing industry.
I'm very sophisticated, by theway, so
Speaker 3 (16:25):
Oh yeah, no, it's, uh, I mean, concerted effort on
their part to develop it, Idunno when it was decades ago,
maybe.
But, uh, you know, you go tothat region and you've got
every, you know, Boston striker,every, every company, seemingly
Abbot has a huge facility there.
Um, and they have theinfrastructure to support
Speaker 2 (16:44):
It.
Exactly, exactly.
So, uh, they're doing somethingright.
And, and Columbia should getinspiration from, from there.
That's certainly something thatI, that I see happening in the
near future.
Uh, um, in terms of Columbia orother countries in Latin
America.
I, I think countries in LatinAmerica, James, are maturing.
(17:04):
They're realizing that exportingcoffee and avocados, and in the
case of Columbia cocaine and badnews,
not gonna cut it.
They need to diversify and getmore, uh, complex in, in what
they export, Right.
Knowledge, Yes.
What we need to export in thecountry.
Speaker 3 (17:24):
So, you know, Columbia keeps coming up for me
as well for, um, doing clinicaltrials.
Yeah.
Uh, as, I guess a couple keycenters there.
Um, you know, we, we are gonnado a post market study, but, you
know, just in, just in UScenters, uh, for, for Crans.
But I know that, uh, there'sactually a company here called
(17:46):
Presi, I believe they're doing,um, they did their initial first
in man in
Speaker 2 (17:50):
Columbia.
Excellent.
I'm, I'm happy to to hear that.
Very good.
Very good.
Yeah, James, uh, you're bringingup a good point.
I, I think, um, I mean, this iswhat I do.
I do clinical trials, earlyvisibility, clinical trials, and
we also help companies sellmedical devices in Latin
America.
And I've seen the regulatoryframework of pretty much all
(18:14):
countries in Latin America,because a lot of my clients, uh,
first come to me thinking aboutBrazil, or thinking about
Argentina or thinking aboutMexico.
So I have to study theregulatory framework and their
environment for clinicalresearch, specifically early
stage.
And it's not that friendly, um,as compared to Columbia.
(18:34):
And Columbia has some, some goodadvantages.
Uh, and, and one of the, theadvantages is the, not only
Columbia lot, Latin America, um,but is the ease of patient
recruitment.
It's a lot easier to recruitpatients because they have, they
don't have as many options aspatients have in the United
States, Right?
You have 20 other FDA approvedoptions that may delay, or you
(18:59):
can do pain management orsomething that can delay, uh,
some, some more drasticintervention.
Um, uh, you're not gonna subjectin the United States yourself to
a, an investigative, uh, devicethat has not been tested in
humans.
They just tested a device in acouple picks, and you wanna be
(19:20):
the first one, right?
At least out in the UnitedStates.
Whereas in Latin America,unfortunately, patients have
delayed access to medicalinnovations.
So if you come with a, with adevice, it can treat your
chronic disease in 15, 20, 30minutes, they will send out for
it, I mean, immediately.
And then you also trust thedoctor.
(19:41):
So if the doctor suggests thatyou get the trial, they will
take the advice of the doctor.
So that's one thing.
And another thing is the, um,it's cost savings.
In the case of colo, theColombian peso James has become
the third one of the, the topthree most devalued currencies
in the world.
(20:02):
And, and so it's really abargain to buy services from
hospital in Colombia now,because is so cheap.
So, so yeah.
So those are kind of theadvantages of doing trials.
Speaker 3 (20:14):
Are they gonna move to Bitcoin?
Like, uh,
Speaker 2 (20:19):
I don't think so.
That's kinda a joke.
Speaker 3 (20:22):
Speaker 2 (20:24):
I dunno why they're doing that.
I think they're seekingpublicity or something, but, uh,
but is interesting not tryingsomething new.
At least credit credit.
Anyway, so, So James, um, whatdo you think about the e MDR
about that trend happening inEurope and the relationship with
Latin America?
Do you think that will benefitthe region, somehow
Speaker 3 (20:46):
Benefit, uh, Latin America or
Speaker 2 (20:49):
Eu?
No, the, uh, Latin America, Yeah.
More trials, more companieslooking at Latin America to
start their sales airports.
Speaker 3 (20:56):
Yeah, I mean, you could already see this trend
between us, the fda, andnotified bodies in Europe.
Um, even leading up to, to mdr.
I mean, it was the notifiedbodies, you know, I call them,
they're like the airlines.
They really don't care about youas a customer.
(21:17):
Um, and they forget that that'sactually the relationship.
Um, you know, they just, andI've multiple companies that I
was helping, uh, back when I wasconsulting, were just lamenting,
oh, this, this notified bodythat notified body, and it's
just amazing.
And, you know, these are thesmaller companies.
They're not gonna get the BostonScientific attention.
Um, so it's, it's, uh, makingwhat was already, uh, what I
(21:43):
would consider a dubiousopportunity to make money, um,
commercially in Europe, uh, thatmuch more difficult.
Um, now the other side of thecoin is, as a small company like
Crans, you, we really need tohave CE mark, um, if, if nothing
else, not so much for thecommercial benefit, but to be
(22:04):
able to say to a potentialacquire, you know, where you
already have market access.
Um, and, but, you know, havingFDA is irrelevant to, to mdr,
uh, fortunately or unfortunately, uh, but in some Latin American
countries that it's the benefitthat's kind of all you need.
(22:24):
Um, but, uh, you know, it's,it's, it's no, you know, kind of
layout in, in, as you know, insome countries it's, it's, it's
great.
I mean, it's easy access likeChile, but, uh, you know, Brazil
was probably the other extreme.
Maybe even Argentina now I thinkhas gotten more difficult.
Um, Mexico is making some effortthere, from what I understand,
(22:45):
and
Speaker 2 (22:46):
Still is a little convoluted
Speaker 3 (22:48):
Yeah.
Yeah.
I mean, it's, it's, it's too badthat, you know, with FDA
approval, which isn't, you know,as is isn't that easy, but
actually compared to mdr, it is
Speaker 2 (23:01):
It's the park
Speaker 3 (23:02):
Yeah.
Yeah.
I mean, we were surrounds, ourproduct was a de novo five, 10 K
.
Uh, we did a clinical studyalready for 60 patients.
I guess it was post-market, um,but it wasn't required for, for
approval.
So, um, but you know, this is,this is a pretty arduous, uh,
requirements, You know, the techfile is not necessarily the same
(23:24):
tech file you're gonna give tothe fda.
Um, so, uh, I think it, it couldcreate opportunity for, for
Latin America, but, you know,here's the door, the door is
open, are, are the government'sgonna react and say, Okay, let's
figure out a way, you know,least burdensome path, uh,
approach.
And if they do, then, thencertainly opportunities will
exist.
Speaker 2 (23:44):
Yeah.
Yeah.
I think, uh, going back toColumbia, Columbia is poised to
benefit from it somehow.
Um, cuz by the way, it has thefastest regulatory approval time
for a clinical, uh, uh, trial.
Uh, and also for a commercialdevice, if you already have the
(24:06):
approval of a reference country,reference country being Canada,
the United States, uh, Europe,Japan, and Australia, uh,
getting envi a approval inColumbia is pretty
straightforward by law.
The agency has to reply in 90days, and they do.
So it is considered one of the,the concept with faster, with
(24:26):
the fastest access to mm-hmm.
Speaker 3 (24:28):
So one of the questions we were talking
earlier about, uh, distributorscome and go, right?
So in some countries the licenseis held by the third party, and
some countries you can actuallyas a company, hold it yourself
or appoint it to somebody whoisn't the distributor that you
need to, to change out.
Yeah.
Where, you know, for me, theideal is company can hold it,
(24:52):
but, uh, sometimes that's, mostcases not the case.
Where is it an opportunity tohave it in a third party?
So if you do change out, adistributor is not another
period of time that you're outof the market.
Speaker 2 (25:04):
That's, that's a interesting comment that you're
making here.
And, and going back to Columbia
country in Latin America, James,by the way, that allows foreign
entities to be the title holderof their registration.
You don't have to rely on alocal distributor or in a third
(25:24):
party registration holder thatis also a local company and pay
like$300 every month orsomething like that for that
privilege.
So yeah, that's one of thebenefits of Columbia without
mentioning the, the fact thathealthcare is a constitutional
right.
So you get reimbursement prettymuch guarantee in the system,
which is European style, kind ofa universal coverage.
(25:47):
Everything is covered kind ofeasy access to the system, uh,
from the patient standpoint.
And, and, uh, if they don't getyou the device or the diapers
that you need or the medicinethat you need, you can go all
the way up to Supreme Court andget you Right.
Respected and, and, and, andthey get, you.
(26:08):
Are
Speaker 3 (26:08):
There a lot of, are there a lot of diaper cases
heading to the Supreme Court?
Speaker 2 (26:13):
There's a gay of a lady that, this is Al case, I'm
not joking.
There's a lady who went througha procedure, James and, uh, is a
famous case in Columbia that exexemplifies my, my point.
And, uh, she couldn't go up tothe second story in her house,
so she needed an elevator, andshe went all the way up to the
Supreme Court
(26:35):
In her house.
So, yeah, that's the way it's,
Speaker 3 (26:38):
Okay, interesting.
Speaker 2 (26:39):
Yeah.
So anyway, but going back yourpoint, it, it, that little
things like that, like you as aforeign entity, being able to
have total control over yourregistration is, is, is really,
uh, an advantage that makesColumbia a very business
friendly country.
And, and, and, and colo withMexico, with Chile and, and
(27:03):
Costa Rica now are O E C Dcountries.
So they're adopting work classpolicies to attract business.
So Columbia is, is leading thisin, in, in, uh, in the
regulatory framework.
So, so yeah, that, that helps alot.
So, so what are your plans withSato, uh, James?
(27:25):
I mean, how do you see LatinAmerica playing a role in your
company, your future?
Do you have any markets in inmind?
Any next steps in Latin Americanmind?
Speaker 3 (27:36):
Yeah, I mean, our initial focus certainly is, is
getting us traction, uh, gettingsome, uh, getting this
enrollment into our clinicaltrial, which will be a 260
patient, um, trial todemonstrate a reduction in, in
bleed complications when ourproduct is used versus not.
And we'll compare that to, uh,existing published data that's
(27:57):
out there.
Um, with regards to, you know,commercialization would be, uh,
you know, we're, we're hiringthe team up here for, for us,
but, but we'll also startlooking to external markets.
The company never did anythingoutside of us, don't we, You
know, we're gonna start fromground zero with the CE mark,
um, so we've got to go after,but, but what I am looking at is
(28:21):
what can we do in, you know,countries like Latin America,
even countries, you know,regions like Middle East, um, or
countries in Latin America andMiddle East, that, that have
sort of the criteria that I want, um, which is, you know, what's
the status of, of the licenseholder, call it that.
Um, what's the, what's the, youknow, size of market?
(28:43):
There's, there's obviously the,the, you know, ability to sell
into that market, public,private, uh, you know, what was
the process, not just, not justfor approval, but, but what's
the, uh, financial side of thereimbursement,
Speaker 2 (28:56):
Uh, status and
Speaker 3 (28:57):
All that?
So there's, there's kind of aextensive checklist that, that I
operate off of.
So, you know, but we probablywon't start looking to, uh,
Latin America until next yearand more likely second half.
Um, but, but at that time willbe because ideally what I want
is somebody dedicated insideCrans to manage that.
(29:20):
Um, right now I'm the only,right now I'm the only one.
And, uh, I'm, I'm notprioritizing, uh, you know,
Latin America.
However, um, you know, I, I dothink the countries that you
just listed earlier, you know,Mexico, Columbia,
Speaker 2 (29:35):
Chile,
Speaker 3 (29:37):
Chile, certainly mm-hmm.
a great and large market, greatcountry.
Uh, it's just a, it's aregulatory, uh, um, behemoth.
So it's, it's, uh, pretty,pretty much a barrier.
Yeah.
Speaker 2 (29:57):
Excellent, James.
So it looks like that, like theAmerica innovator, that's what I
wanted to hear, and that's whatI wanted listeners to, to, to
hear directly from you that, uh,you certainly,
Speaker 3 (30:09):
And I definitely have a lot of, uh, a lot of friends,
obviously, particularly inMexico, but, uh, you know,
having, uh, worked in, in theentire region and, uh, you know,
reported to Argentina while Iwas in, uh, certainly have a lot
of friends and, uh, and oldcolleagues that, that are, uh,
in fact, I think a good, goodfriend, uh, Carlos Flores is in,
uh, is in Columbia, or he, Imean, hes Columbia, I think he's
(30:31):
got a business going in Columbia.
So yeah, he reached out to merecently, so
Speaker 2 (30:37):
Excellent, excellent.
And, and Juan, good friend too,too
Speaker 3 (30:43):
Oh yes, of course.
Speaker 2 (30:47):
All right, James, it's being a, the delightful
conversation and, uh, we'reclose to the end of the show.
Uh, any final words of wisdom?
Uh, what would you say to theCEO of, uh, newer medical device
company that is just starting tolook at Latin America as a place
to do business trials orcommercialization?
What would be your, your finalwords to
Speaker 3 (31:08):
Him?
Um, yeah, I mean, I, I, I thinkthat there's, there's plenty of
opportunity.
There's, there's plenty ofreason, uh, to want to, to have
activities in Latin America, beit clinical study, uh, certainly
the first in man opportunity is,is presented itself as, as, as
being real.
(31:29):
Uh, the commercial opportunitiesare certainly there, and then
one that we're gonna pursue, uh,for sure.
But then, you know, finally is,is as you get larger and in
wanting to do this offshore,near shore, as you said, um,
manufacturing, uh, it's, there's, there's an industry there, and
it's not even burgeoning.
It's, it's there.
I mean, it exists.
Uh, so it would be one for allthose, um, opportunities exist
(31:53):
for, for certainly medicaldevice companies.
Um, you know, and then, you know, something I've always looked
at.
So people said, Oh, you, you'vedid multiple expat assignments,
you are pretty successful ateach of them, which led to the
next one and the next one.
Um, and, you know, somebodyasked me, how, how did you
approach it?
I said, Well, look, I believethat, um, you know, everyone in
(32:15):
the world is pretty much thesame, maybe 80%, and I don't
even, I'll just make up anumber, say 80% the same.
It's that other 20% that isreally different
And that's what is the shiny toythat if everyone focuses on, And
that's what you absolutely needto ignore.
It doesn't matter.
Stay where the commonalityexists.
(32:36):
You know, you want to do well inyour job.
You wanna be recognized for thatsuccess you wanna provide for
your families, You know, allthose intangibles that don't
separate us.
You need to focus on ignore
Speaker 2 (32:50):
Words.
I, I learn so much every time Ispeak with somebody of your
caliber, with somebody of yourexperience.
And, uh, I can't thank youenough for being in the show
today.
And I, I'm sure listeners, uh,have learned a lot from, from
(33:14):
you, from your words, from yourwisdom, from your experience.
Speaker 3 (33:18):
That was a pleasure, uh, Julio, I enjoyed it.
And thanks for the invitation.
And then, uh, look forward toworking with you.
Speaker 2 (33:23):
Beautiful.
Bye, James.
All right.
Speaker 3 (33:26):
Take.
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