December 15, 2022 • 24 mins
Dave is the Co-Founder & Executive Chairman at MultiFunctional Imaging, a University of Utah startup company that provides software solutions for improving the efficiency and accessibility of multi-tracer imaging with PET, PET/CT, and PET/MRI scanners. Dolan’s career has been built on successes centering around the commercialization and customer adoption of innovative MedTech products/services. Spanning from Fortune 500 corporations through startups, businesses have benefitted from his track record of success in turning medical device innovation into record growth, high market share, and attractive market valuations. He is a trusted business leader who draws upon an analytical and data-driven approach with KOLs, advising boards of directors, investors, C-level executives, and other stakeholders in identifying and capitalizing on opportunities to advance each organization’s strategic vision.
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Episode Transcript
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Speaker 1 (00:00):
Welcome to the Latin MedTech Leaders podcast, a
conversation with MedTechleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast.
Amazon Music is teacher tuning.
I heard radio, Pandora, or theseare welcome to the Metech
(00:22):
Leaders podcast, a conversationwith leaders who have succeeded
or plan to succeed in LatinAmerica Today.
Our guest is Dave Dolan,co-founder and chairman at
Multi-Functional Imaging, acompany that provides software
solutions for improving theefficiency and accessibility of
pet, pet CT and PET MRIsscanners.
(00:45):
Dave has a track record ofsuccess in ge, bd and j and j
among other companies.
So, Dave, it's great to have youhere today.
Welcome to the show.
Speaker 2 (00:55):
Oh, Julio, thank you so much.
It was great to get thisinvitation.
Speaker 1 (00:59):
Awesome, Dave.
All right, so let's get startedtalking about your journey.
How is it you got to where youare today?
Uh, what's your journey to LatinAmerica?
How is it you got involved withthe region?
Speaker 2 (01:10):
Yeah.
Uh, well, uh, I'm a med techveteran.
I, I started up my career at,uh, at GE Healthcare, like you,
uh, brought up earlier.
And, uh, I was very fortunate tobe exposed to quite a few
international roles andresponsibilities.
And, uh, Latin America was, uh,was one of those.
Um, I've, uh, spent some timedoing some business development
work in, uh, in Mexico City, uh,Columbia, as well as, uh,
(01:32):
Brazil.
And so, uh, I, I can't, um, Ican't say that, uh, I'm a, a,
uh, long term veteran of doingbusiness in Latin America, but
have come to strongly respectthe, uh, the marketplace.
Speaker 1 (01:45):
Good, good, good.
And, um, let's talk about trendsin Latin America.
Dave, what are you seeing in thenews of what do you know from
experience about the region interms of changes or trends or
happening, political, economic,social disease trends, whatever,
anything you can tell us aboutit?
Speaker 2 (02:04):
Yeah.
Well, I, all of it's quitepositive.
Um, you know, I think, uh, whenyou're, uh, in terms of, uh, an
early company, uh, which, youknow, technically multi
multifunctional is a common, um,commercialization or regulatory
oftentimes would be to gothrough Europe and, uh, able to
do your, your trials over there.
But with, uh, mdr, that'sbecoming, um, untenable, you
(02:28):
know, quite frankly, in a lot ofarenas.
And, uh, you know, I, I'm, I'mprobably sharing nothing that
the listeners to this, uh, showdon't already know, in that
there's a lot of first inhumanstudies that are going on.
I know in Intuitive is doingquite a bit of work in, uh,
Chile right now.
Uh, you know, and the regulatoryenvironment is, uh, is much more
favorable in Latin America.
(02:49):
And you're seeing a, a, a, not asubtle shift from people trying
to commercialize or at least dothe early regulatory work in the
EU or Eastern Europe, um,getting away from that and
getting away from the US anddoing a lot of this work in
Latin America.
And so it's something that is,uh, that is out there, and I
don't think it's much of asurprise to anybody right now.
Speaker 1 (03:11):
That's an interesting point.
I wrote an article about thatspecific topic, Dave, uh, about
a year and a half ago before theU M D R was going to take, um,
effect.
It was supposed to take, effector become, uh, active or a law
in May before the pandemic.
Right.
(03:31):
And it was pushed a year, but Iinterview about 30, uh, CEOs of
medical device companies aboutthis specific trend that you're
referring to.
And, and, and I, and I thinkyou're right on, on, on, on, on
point.
I mean, it's, uh, it's certainlya, uh, um, uh, a trend that will
(03:54):
benefit Latin America in one wayor another with clinical
research and commercialization,because the, the old strategy of
EU first and then the UnitedStates is being reevaluated now,
I think, uh, because, uh, of the, um, the stringent
requirements, and you don't havenotified bodies anymore.
(04:16):
I mean, just a few havesurvived, for example, and it's
getting tougher and tougher todo trials.
So, so yeah, we've seen a trend,um, in, in terms of the number
of, of companies interested indoing first in human work in
Latin America.
Uh, we're being busier thanever.
And, uh, we've also seen a trendof companies looking at Latin
America to startcommercialization after the
(04:39):
United States, of course, and,and some other markets in, in
Europe.
But, um, but they're now lookingat Latin America more favorably,
Speaker 2 (04:47):
So, yeah.
Yeah.
And it's changed so much.
I mean, when I first started,you know, working in the med
tech field 20 years ago, youknow, a lot of people view Latin
America as, geez, it's such avibrant, you know, market, but
boy, there's so many differentregulatory fys, uh, within Latin
America.
It, it, it, it just didn't lookattractive at the time.
(05:08):
Um, and now the shift is goingthe other way where there's a
lot of commonality in terms ofregulatory pathways in, in Latin
America, and like in our case,multifunctional imaging.
We've got a five 10 K and a 5Kis accepted in Latin America, in
, in a lot, in a lot of LatinAmerica, uh, territories.
And so we're actually thetiming of our, of our discussion
(05:30):
is, uh, is, is, uh, prettycompelling in that we're having
a board meeting the end of thisweek where, hey, we need a
America strategy.
You know, we need this marketbecause we think we could add a
tremendous amount of value.
And that's something that, youknow, hey, five years ago, I
don't think people like mewould've said.
Speaker 1 (05:49):
Hmm.
That's, that's quiteinteresting.
All right.
So let's talk about, um,specific countries or, or your
plans.
Let's begin with your plans inLatin America.
Do you have any specificcountries in mind?
Of course, you don't have todisclose confidential
information, but, uh, any, anydirection that you have in Latin
America?
Are you gonna pick specificcountries first, uh, or are you
(06:10):
gonna go for, for the big onesfirst and then the smaller ones?
Or, you know, go for middlecountries first and then the big
ones?
What do you have in mind termsof
Speaker 2 (06:18):
Yeah, we're pretty unique in that we're, we're
gonna, we're gonna approach thisfrom how our technology can best
serve, uh, the markets.
Um, what we do in essence is wemake pet scanners or pet CT
scanners and pet MRI scannersrun faster.
And oftentimes it's, um, oldersystems that our software
actually delivers the most valuefor, because we can make older
systems operate much faster.
(06:40):
And so rather than sort of like,um, oh, we're gonna focus on
Columbia because we knowphysicians there, or we're gonna
focus on Brazil, um, we're gonnabe no, where actually is the
installed base available that wecan take our products to?
And yeah, there might, there'sstill, I'm sure there's still
some regulatory pathwaydifferences between, uh, the
different countries, but, uh,we're gonna approach it more in
(07:03):
terms of work.
Where can we provide the bestvalue?
And where could we commercializeas quickly as possible?
Speaker 1 (07:09):
Yeah, yeah.
Good approach.
Yeah, I think that's, in yourcase, that's probably the best,
uh, strategy and, um, going backto the issue of, um,
fragmentation in Latin America.
But that's because that's alwaysbeen, uh, a problem.
I don't know how much you knowabout the Pacific Alliance.
You don't know, I don't know howmuch you know about the, the
(07:30):
initiatives of all, well, thetop countries, at least, uh, to
homogenize the regulations tomake them more similar in, in
all these countries.
And, and, uh, go, just for thelisteners, um, as you correctly
said, if you have CE mark or,uh, f d a approval, five
(07:54):
[inaudible] approval in yourcase, uh, the pathway for
approval is pre straightforward.
Uh, and Columbia seems to havethe fastest regulatory approval
time in Latin America except forChile.
Mm-hmm.
.
Cause Chile doesn't have any.
Right.
So, uh, not many people knowthis.
Uh, a lot of my clients get likeshocked when I tell them this.
(08:15):
Uh, Chi Chile is quite a uniquecountry in the region.
Um, but it's gonna change.
And, and, and specificallybecause the reasons I just
mentioned, which is the PacificAlliance, Latin America's going
through a transformation, um,where the countries are going,
are becoming more mature, uh,countries are becoming O E C D
(08:36):
members.
Every year there's a new O E C Dmember which says a lot about
countries being serious, aboutimplementing best practices,
best international policies andbest practices on how to do
business, how to do regulatoryapprovals, how to do social, uh,
uh, uh, strategies, whatever,uh, healthcare, et cetera.
(08:58):
So we definitely see a trend,uh, of, of having more uniform
regulatory, uh, requirements andaccepting reference countries,
uh, Columbia, for example, andthat's the case in Brazil and
Mexico.
They accept reference countrieslike the United States, Europe,
(09:20):
uh, some of them accept Canada,some of them accept Australia,
uh, Japan.
So that makes things easier forforeign companies to do business
in Latin America.
Speaker 2 (09:29):
Yeah, no, it's tremendously exciting cuz uh,
you know, boy, you know, youknow, 10 years ago, um, you
know, people like myself sawLatin America as, as, hey, it's
a, it's a, it's a excellentplace to manufacture your
products at, whether it be Tianaor Nogales or in Costa Rica.
And now the table has completelyturned up.
No, actually this is amarketplace for a company as
(09:52):
like multifunctional imaging.
Speaker 1 (09:55):
Yeah, yeah.
And that's, and I think they've,that's how the countries in the
Pacific Alliance want the blockto be portrayed as, as a
marketplace, if you see whatthey're doing for the Pacific
Alliance, which is somethinghistorical, I think, because,
(10:16):
uh, the medical sewer, do youknow what that is, right?
Mm-hmm.
.
Yep.
Uh, in the south, uh, Argentina,Brazil, Uruguay, and Paraguay,
they haven't really made anytraction in terms of, of,
of creating a, a, a, anattractive business friendly
marketplace.
Whereas the Pacific Alliance,since they have O A C D member
(10:37):
countries, Chile was the firstone about 10 years ago.
Uh, then Colombia, then Mexico,uh, in Costa Rica, just joined
in May, I think.
Uh, and, uh, their Peru willjoin very soon.
And so Panama is also, uh, in,in, in the path to, to join the,
(11:00):
uh, alliance, but for now isonly officially is Mexico,
Columbia, Peru, and Chile.
And the marketplace that they'recreating is about 260, 200 70
million people.
So they really wanna compete
Speaker 2 (11:18):
Just those handful of countries.
That's a very big market.
Speaker 1 (11:21):
It is.
It is.
It is.
Exactly.
So, and the idea is to have, andI was speaking with, uh,
somebody, uh, from, from thatorganization, um, a couple years
ago.
I was interviewing her, uh, in,in the adas to have a single
regulatory market where if youget approval in Mexico, you
gonna get instant recognition inColumbia.
(11:41):
And that's already happening.
Speaker 2 (11:43):
Absolutely.
It's incredibly attractive.
Speaker 1 (11:46):
Its, yeah, it's, it's , there's another trade block
that not many people talk about.
I don't know why.
It's probably because they aresmaller countries, but it's
called the Indian Pact.
The Indian P the Indian Pact areof course, the Indian countries.
Uh, Colombia used to beVenezuela, not anymore, for
(12:06):
obvious reasons.
So it's Colombia, Ecuador, Peru,and Bolivia, I believes.
And they're, they're, they havemade it so similar to Europe,
Davis, they're probably behindlike 10 years.
But, uh, just, uh, a coupleweeks ago, I, I've read the news
where a Colombian citizen caneasily move to Bolivia or
(12:27):
Ecuador and live and work andstudy and, and, and get a job
and everything.
So it is just, uh, amazing whatthey're doing.
So they're already integratingthe regulatory environment for
cosmetics, for some, for food.
So they're starting with, youknow, low risk products, but
eventually they're gonna go upto drugs and medical devices.
(12:49):
Mm-hmm.
Speaker 2 (12:50):
.
Yeah.
No, it's an incrediblyattractive market.
And like you said, you know,just a handful of countries
right now you said 270 million.
Oh, by the way, that's about thesize of the US market.
That's pretty
Speaker 1 (13:00):
Exactly.
.
Yeah.
Yeah.
So imagine if, uh, we all getour act together in Latin
America.
Um, Colombian of course.
And, and, uh, we as a, as aregion, we are 30 something
countries, over 600 millionpeople double the size of the
United States, but we have toget our act together.
(13:20):
Come on.
I mean, it is about time that weall join forces and move in the
same direction.
Not
Speaker 2 (13:24):
Everybody.
Well, well, I mean, in, in, inthe defense of Latin America,
there's been tremendous progressover the last five years.
Speaker 1 (13:30):
Yeah, yeah.
I agree with you.
Yeah.
Yeah.
The countries are becoming moremature.
Absolutely.
Yeah.
Middle class is, is growing and,and, and all that.
Anyway, so going back to yourexperience, Dave, I'd like to
dig a little, a little deeperinto, into your life in Mexico
or your experience in othercountries.
Uh, can we talk about that?
I mean, what is it to be doingbusiness in Mexico or elsewhere
(13:52):
in, in the region?
Mm-hmm.
Speaker 2 (13:53):
.
Yeah.
No, my, my, my experience hasbeen, uh, typically with, uh,
either capital equipment or with, uh, disposable products,
specifically.
Most of my experience in LatinAmerica came during my tenure at
, uh, Beckon Dickinson.
Cause, uh, we did have amanufacturing facility, um, just
outside of, uh, of, uh, Rio.
And so there was, there was some, um, there were some, um,
(14:16):
strategy meetings and, and some,uh, and some, uh, interactions
that I had, uh, you know, inthat area.
You know, again, it was, it wasalways just challenging meeting
with the country leaders wherethere was just not a lot of
commonality between themarketplaces.
And I'm talking, you know, thisis 10, 12 years ago, there just
wasn't a lot of commonality whenI've would talk to the country
(14:36):
managers and I'd be saying, geez, we have the same product.
You know, why is the product,you know, priced, um, this much
per piece in Columbia versusPeru?
And it was, it was always achallenge where it was just, you
know, geez, it's, it's difficultto have the country managers and
find synergies amongstthemselves, even though our
(14:57):
product was exactly the same indelivering the exact same
clinical value no matter whatcountry it was being, being, uh,
sent to.
And so, uh, that was always,again, you know, the big
challenge, you know, for us as a, as a mass producer of, uh, of
medical devices is, you know,geez, getting to the final mile,
you know, you know, to the, thefacilities was always a
(15:18):
challenge.
It was never a clinicalchallenge.
It was really more of a, of abusiness development challenge
to be able to effectively marketproducts, uh, correctly over
there.
Speaker 1 (15:27):
Hmm, interesting.
Did you ever have to deal withdistributors or find
distributors or managedistributors in the region?
Speaker 2 (15:34):
Yeah, it was, it was, again, it was by country because
, you know, in some countries,um, you know, distribution was
really the only effective way togo.
Um, you know, there were, youknow, countries like Brazil
where we had to have a directSalesforce, you know, because
the market there expected arepresentative to be there upon,
(15:56):
uh, adopting a new product,doing the in servicing and what
have you.
So, you know, again, ithighlights what you're talking
about.
It was highly variable andfragmented, um, in terms of, uh,
which country you're workingwith in Latin America.
Speaker 1 (16:06):
Yeah, yeah.
In experience in Argentina, forexample.
Speaker 2 (16:11):
No, actually very limited.
Very limited in, in Argentina.
Speaker 1 (16:15):
And, and the reason I ask is because, uh, it's such a,
such a difficult market, such a,uh, it's ups and downs, economic
ups and downs.
It's just impressive.
I mean, the inflation, uh, it'sjust, uh, every time I have an
interview like this, Argentinacomes up, uh, because, uh,
that's the, like, the primeexample of challenges in Latin
(16:35):
America, political changes,left, right center.
Speaker 2 (16:40):
Yeah.
Our, our Argentina was alwaysjust a really quick discussion
whenever we spoke with ourcountry leaders, because
literally the average price soldlooked like our scale because of
the inflation issues that you,you're speaking of.
And, uh, so it was, it was just,whoa, this is really difficult
for us to get our hands on.
And so, uh, yeah, we, it itwasn't a strategic imperative,
(17:03):
at least Dickinson's part to,uh, focus on that country.
Speaker 1 (17:07):
Yeah, yeah.
Yeah.
It's really a shame because it'ssuch a developed country.
Um, culturally speaking, uh,socially speaking, educationally
speaking, there used to be a, avery powerful country in, in the
twenties, in the thirties,absolutely.
Forties.
Absolutely right.
Yeah.
Yeah.
So it's, it's really a shame.
(17:29):
Uh, and, and Buenos Aires is oneof my top places to visit in
Latin America.
It's a beautiful, beautifulcity.
Speaker 2 (17:34):
Yeah.
Well, that's, uh, that's abucket list place for me.
Cause everybody I know that hasbeen to bu rs, uh, does nothing
but rape about it.
Speaker 1 (17:42):
Yeah, yeah.
Yeah.
It's, it's a country full ofItalians who speak Spanish
.
Speaker 2 (17:48):
And I, I hear the best steaks in the world, is
what I hear.
Speaker 1 (17:53):
Yeah, exactly.
Yeah.
Bueno Air is a beautiful mixbetween Madrid and Paris,
actually.
Yeah.
And a little bit of Rome,so,
Speaker 2 (18:01):
Yeah.
And, and, uh, multifunctionalimaging we're headquartered in,
uh, in, uh, salt Lake City, Utah.
And so, um, as you're probablyaware there, there's a, uh, a
church of latter day Saints, um,Mormon, uh, culture here.
And, uh, so I have a lot offriends or associates that did
mission work down there.
Oh, yes.
Graves about Argentina.
Speaker 1 (18:21):
Beautiful.
Yeah.
I'm glad to hear that.
Yeah.
Yeah.
Yeah.
So you have to go,
Speaker 2 (18:26):
The bucket is,
Speaker 1 (18:28):
And what about Columbia and experiencing
Columbia doing business in, inthe country or
Speaker 2 (18:33):
Anything?
Yeah, actually, uh, Columbia wasa pretty big and strategic, uh,
um, um, country for BeckDickinson when I was there, uh,
because, uh, they, even backthen, um, they adhere to Thek,
um, back then.
And, uh, you know, obviouslyit's a, it's a highly, you know,
developed country with, uh, avery good healthcare system.
(18:55):
And, uh, so yeah, in, in spitethe, the fact that it's, it's
not the, uh, and from apopulation standpoint, it's not
the largest marketplace.
It's a highly developedmarketplace.
And, uh, yeah.
And, uh, you know, like I said,we're gonna be meeting as a
board, uh, this coming Friday.
And, uh, not only are we gonnawalk out with the Latin America
strategy, I wanna hear what ourColumbia strategy's gonna be.
Speaker 1 (19:15):
Beautiful.
I'm really happy to hear that asa Columbian.
And, and, and, and just to add,uh, to that, uh, I'm not, uh,
um, this is not a commercial forColumbia.
It's a fact.
Uh, just like Chile is so easyto get into, Dave.
Uh, I'm sure you know, as I saidinitially, you don't really need
a regulatory registration inChile.
(19:36):
All you need is an importer, andyou're good to go.
You're in business.
Uh, there is a voluntaryregistration process that needs
to happen.
What doesn't need to happen thatyou could do, if you wanna
prepare yourself for the future,probably in the next year or so,
the Congress will pass a new lawwhere they're gonna make
mandatory the regulatoryregistration process.
The other countries of thePacific Alliance, Chile is just
(19:59):
getting in the same train as theother countries so that they
have, uh, uh, unified sale oflaws.
Anyway, my point with, uh, thisis that, um, uh, just as
friendly as Chile is, I will saythe second country in Latin
America in terms of friendlinessand market, ease of market
access is Columbia.
(20:20):
Just to give you a hint, theColumbia, the regulatory agency
in Columbia in Vima is the onlyagency in Latin America that
allows foreign entities to bethe owners of the title holders
of the registration certificateor the market clearance
certificate.
No other country does that.
They all mandate, they all forceyou to have a, either a local
(20:44):
entity or contract the servicesof a, what is called a
registration holder, and youhave to pay hefty prices for
that monthly prices for otherannual prices.
Or even worse, they make you,uh, have the distributor as your
title holder, which is notalways a good idea because the
distributor today may not be theshooter tomorrow, you know, that
(21:07):
, uh, you have to probably gothrough two or three the
shooters first before you findthe, the guy, the right guy.
So, um, so yeah, that says a lotabout how much this country is
one business, how much they want, uh, to make it easier for
companies to, to enter themarket, to, um, have access to
(21:29):
patients, have access toinnovative technologies faster
than other countries.
Right.
Um, I mean, we're
Speaker 2 (21:35):
Panama also.
Yeah.
And also these countries, youknow, they respect the
intellectual property that, uh,technologies like
multifunctional imagery bring tothe table, you know?
Yeah.
We've made a strategic choicenot to go into China, for
instance.
Uh, yeah.
Cause we have to share some ofour ip, you know, with, with
their regulatory board.
And, you know, quite frankly,we're, we're not quite
(21:55):
comfortable with that.
Cause we've written a lot ofproprietary code, and we
prefer that to be a tradesecret.
And, uh, and Latin America, uh,is, is is very respectful of,
uh, companies like ourselves,um, in terms of that aspect.
Speaker 1 (22:12):
Yes.
That's a, that's a great point,Dave.
And the reason for that, one ofthe reasons for that is first
the E C D, right?
They, they require you to enactcertain laws to protect
intellectual property and othertype of protections, et cetera.
And second, free tradeagreements, right?
If you wanna have a free tradeagreement with the us you, you
(22:34):
have to comply with certainguidelines or mandates, or, or,
or you agree to respect, uh, orto have a way for companies to,
to, to have access to a coresystem in case of infringement
or, or things of that nature.
So,
Speaker 2 (22:48):
Mm-hmm.
.
Yeah.
Yeah.
Again, it's, uh, we're gonnahave a Latin America strategy
come this Monday.
Speaker 1 (22:56):
, I'm, I'm so
happy to hear that, Dave.
It's that it's great new for theregion, it's great new for
patients, it's great new for thehealthcare systems of these
countries.
And, um, well, we're close tothe end of the show.
I usually keep it short to about30 minutes.
I think we covered so much inonly 20 something minutes.
, is there any finalwords of wisdom do you wanna
(23:17):
share with the audience?
If you had the ceo, e o of amedical device company in front
of you, what would you say tohim or her, uh, if he or she
were just starting to exploreLatin America?
Speaker 2 (23:27):
Oh, there's a fantastic opportunity in Latin
America right now.
My company recognizes that.
And, and we're not the first,and we're not gonna be the last
to, to recognize that.
Um, I think that, uh, with anynew market you go into, it's,
it's important to identify andbuild tight relationships with
partners that can help you.
You get access to those markets,and that's where we're at right
(23:48):
now.
And it's folks like yourself,Julio, that we wanna, uh,
partner with, uh, and able to,uh, take our technologies, uh,
moving forward to Latin America.
It's a fantastic opportunity.
And, uh, you know, I think, uh,if, if you're thinking that it's
gonna be a aeu strategy first, Ithink you need to rethink that
right now.
I think you need to, you know,cast your eyes upon Latin
(24:08):
America, uh, especially forearly stage companies like
Multifunctional Engine.
Speaker 1 (24:13):
Excellent.
Dave, I'm, I'm so happy to hearthose words coming from you.
All right, Dave, thank you againfor being the show.
It's being a delightfulconversation.
I'm sure listeners got a lot,uh, from your insights and your
wisdom and your experience, andI look forward to seeing you
succeed in Latin America.
Speaker 2 (24:32):
Oh, I look forward to , uh, speaking with you again.
If there's way that we can ofassistance to yourself, lu,
please let us know.
Speaker 1 (24:38):
All excellent.
All right, Dave.
Thank.
Welcome to the Latin MedTech Leaders podcast, a
conversation with MedTechleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast.
Amazon Music is teacher tuning.
I heard radio, Pandora, or theseare welcome to the Metech
(00:22):
Leaders podcast, a conversationwith leaders who have succeeded
or plan to succeed in LatinAmerica Today.
Our guest is Dave Dolan,co-founder and chairman at
Multi-Functional Imaging, acompany that provides software
solutions for improving theefficiency and accessibility of
pet, pet CT and PET MRIsscanners.
(00:45):
Dave has a track record ofsuccess in ge, bd and j and j
among other companies.
So, Dave, it's great to have youhere today.
Welcome to the show.
Speaker 2 (00:55):
Oh, Julio, thank you so much.
It was great to get thisinvitation.
Speaker 1 (00:59):
Awesome, Dave.
All right, so let's get startedtalking about your journey.
How is it you got to where youare today?
Uh, what's your journey to LatinAmerica?
How is it you got involved withthe region?
Speaker 2 (01:10):
Yeah.
Uh, well, uh, I'm a med techveteran.
I, I started up my career at,uh, at GE Healthcare, like you,
uh, brought up earlier.
And, uh, I was very fortunate tobe exposed to quite a few
international roles andresponsibilities.
And, uh, Latin America was, uh,was one of those.
Um, I've, uh, spent some timedoing some business development
work in, uh, in Mexico City, uh,Columbia, as well as, uh,
(01:32):
Brazil.
And so, uh, I, I can't, um, Ican't say that, uh, I'm a, a,
uh, long term veteran of doingbusiness in Latin America, but
have come to strongly respectthe, uh, the marketplace.
Speaker 1 (01:45):
Good, good, good.
And, um, let's talk about trendsin Latin America.
Dave, what are you seeing in thenews of what do you know from
experience about the region interms of changes or trends or
happening, political, economic,social disease trends, whatever,
anything you can tell us aboutit?
Speaker 2 (02:04):
Yeah.
Well, I, all of it's quitepositive.
Um, you know, I think, uh, whenyou're, uh, in terms of, uh, an
early company, uh, which, youknow, technically multi
multifunctional is a common, um,commercialization or regulatory
oftentimes would be to gothrough Europe and, uh, able to
do your, your trials over there.
But with, uh, mdr, that'sbecoming, um, untenable, you
(02:28):
know, quite frankly, in a lot ofarenas.
And, uh, you know, I, I'm, I'mprobably sharing nothing that
the listeners to this, uh, showdon't already know, in that
there's a lot of first inhumanstudies that are going on.
I know in Intuitive is doingquite a bit of work in, uh,
Chile right now.
Uh, you know, and the regulatoryenvironment is, uh, is much more
favorable in Latin America.
(02:49):
And you're seeing a, a, a, not asubtle shift from people trying
to commercialize or at least dothe early regulatory work in the
EU or Eastern Europe, um,getting away from that and
getting away from the US anddoing a lot of this work in
Latin America.
And so it's something that is,uh, that is out there, and I
don't think it's much of asurprise to anybody right now.
Speaker 1 (03:11):
That's an interesting point.
I wrote an article about thatspecific topic, Dave, uh, about
a year and a half ago before theU M D R was going to take, um,
effect.
It was supposed to take, effector become, uh, active or a law
in May before the pandemic.
Right.
(03:31):
And it was pushed a year, but Iinterview about 30, uh, CEOs of
medical device companies aboutthis specific trend that you're
referring to.
And, and, and I, and I thinkyou're right on, on, on, on, on
point.
I mean, it's, uh, it's certainlya, uh, um, uh, a trend that will
(03:54):
benefit Latin America in one wayor another with clinical
research and commercialization,because the, the old strategy of
EU first and then the UnitedStates is being reevaluated now,
I think, uh, because, uh, of the, um, the stringent
requirements, and you don't havenotified bodies anymore.
(04:16):
I mean, just a few havesurvived, for example, and it's
getting tougher and tougher todo trials.
So, so yeah, we've seen a trend,um, in, in terms of the number
of, of companies interested indoing first in human work in
Latin America.
Uh, we're being busier thanever.
And, uh, we've also seen a trendof companies looking at Latin
America to startcommercialization after the
(04:39):
United States, of course, and,and some other markets in, in
Europe.
But, um, but they're now lookingat Latin America more favorably,
Speaker 2 (04:47):
So, yeah.
Yeah.
And it's changed so much.
I mean, when I first started,you know, working in the med
tech field 20 years ago, youknow, a lot of people view Latin
America as, geez, it's such avibrant, you know, market, but
boy, there's so many differentregulatory fys, uh, within Latin
America.
It, it, it, it just didn't lookattractive at the time.
(05:08):
Um, and now the shift is goingthe other way where there's a
lot of commonality in terms ofregulatory pathways in, in Latin
America, and like in our case,multifunctional imaging.
We've got a five 10 K and a 5Kis accepted in Latin America, in
, in a lot, in a lot of LatinAmerica, uh, territories.
And so we're actually
(05:30):
is, uh, is, is, uh, prettycompelling in that we're having
a board meeting the end of thisweek where, hey, we need a
America strategy.
You know, we need this marketbecause we think we could add a
tremendous amount of value.
And that's something that, youknow, hey, five years ago, I
don't think people like mewould've said.
Speaker 1 (05:49):
Hmm.
That's, that's quiteinteresting.
All right.
So let's talk about, um,specific countries or, or your
plans.
Let's begin with your plans inLatin America.
Do you have any specificcountries in mind?
Of course, you don't have todisclose confidential
information, but, uh, any, anydirection that you have in Latin
America?
Are you gonna pick specificcountries first, uh, or are you
(06:10):
gonna go for, for the big onesfirst and then the smaller ones?
Or, you know, go for middlecountries first and then the big
ones?
What do you have in mind termsof
Speaker 2 (06:18):
Yeah, we're pretty unique in that we're, we're
gonna, we're gonna approach thisfrom how our technology can best
serve, uh, the markets.
Um, what we do in essence is wemake pet scanners or pet CT
scanners and pet MRI scannersrun faster.
And oftentimes it's, um, oldersystems that our software
actually delivers the most valuefor, because we can make older
systems operate much faster.
(06:40):
And so rather than sort of like,um, oh, we're gonna focus on
Columbia because we knowphysicians there, or we're gonna
focus on Brazil, um, we're gonnabe no, where actually is the
installed base available that wecan take our products to?
And yeah, there might, there'sstill, I'm sure there's still
some regulatory pathwaydifferences between, uh, the
different countries, but, uh,we're gonna approach it more in
(07:03):
terms of work.
Where can we provide the bestvalue?
And where could we commercializeas quickly as possible?
Speaker 1 (07:09):
Yeah, yeah.
Good approach.
Yeah, I think that's, in yourcase, that's probably the best,
uh, strategy and, um, going backto the issue of, um,
fragmentation in Latin America.
But that's because that's alwaysbeen, uh, a problem.
I don't know how much you knowabout the Pacific Alliance.
You don't know, I don't know howmuch you know about the, the
(07:30):
initiatives of all, well, thetop countries, at least, uh, to
homogenize the regulations tomake them more similar in, in
all these countries.
And, and, uh, go, just for thelisteners, um, as you correctly
said, if you have CE mark or,uh, f d a approval, five
(07:54):
[inaudible] approval in yourcase, uh, the pathway for
approval is pre straightforward.
Uh, and Columbia seems to havethe fastest regulatory approval
time in Latin America except forChile.
Mm-hmm.
Cause Chile doesn't have any.
Right.
So, uh, not many people knowthis.
Uh, a lot of my clients get likeshocked when I tell them this.
(08:15):
Uh, Chi Chile is quite a uniquecountry in the region.
Um, but it's gonna change.
And, and, and specificallybecause the reasons I just
mentioned, which is the PacificAlliance, Latin America's going
through a transformation, um,where the countries are going,
are becoming more mature, uh,countries are becoming O E C D
(08:36):
members.
Every year there's a new O E C Dmember which says a lot about
countries being serious, aboutimplementing best practices,
best international policies andbest practices on how to do
business, how to do regulatoryapprovals, how to do social, uh,
uh, uh, strategies, whatever,uh, healthcare, et cetera.
(08:58):
So we definitely see a trend,uh, of, of having more uniform
regulatory, uh, requirements andaccepting reference countries,
uh, Columbia, for example, andthat's the case in Brazil and
Mexico.
They accept reference countrieslike the United States, Europe,
(09:20):
uh, some of them accept Canada,some of them accept Australia,
uh, Japan.
So that makes things easier forforeign companies to do business
in Latin America.
Speaker 2 (09:29):
Yeah, no, it's tremendously exciting cuz uh,
you know, boy, you know, youknow, 10 years ago, um, you
know, people like myself sawLatin America as, as, hey, it's
a, it's a, it's a excellentplace to manufacture your
products at, whether it be Tianaor Nogales or in Costa Rica.
And now the table has completelyturned up.
No, actually this is amarketplace for a company as
(09:52):
like multifunctional imaging.
Speaker 1 (09:55):
Yeah, yeah.
And that's, and I think they've,that's how the countries in the
Pacific Alliance want the blockto be portrayed as, as a
marketplace, if you see whatthey're doing for the Pacific
Alliance, which is somethinghistorical, I think, because,
(10:16):
uh, the medical sewer, do youknow what that is, right?
Mm-hmm.
Yep.
Uh, in the south, uh, Argentina,Brazil, Uruguay, and Paraguay,
they haven't really made anytraction
of creating a, a, a, anattractive business friendly
marketplace.
Whereas the Pacific Alliance,since they have O A C D member
(10:37):
countries, Chile was the firstone about 10 years ago.
Uh, then Colombia, then Mexico,uh, in Costa Rica, just joined
in May, I think.
Uh, and, uh, their Peru willjoin very soon.
And so Panama is also, uh, in,in, in the path to, to join the,
(11:00):
uh, alliance, but for now isonly officially is Mexico,
Columbia, Peru, and Chile.
And the marketplace that they'recreating is about 260, 200 70
million people.
So they really wanna compete
Speaker 2 (11:18):
Just those handful of countries.
That's a very big market.
Speaker 1 (11:21):
It is.
It is.
It is.
Exactly.
So, and the idea is to have, andI was speaking with, uh,
somebody, uh, from, from thatorganization, um, a couple years
ago.
I was interviewing her, uh, in,in the adas to have a single
regulatory market where if youget approval in Mexico, you
gonna get instant recognition inColumbia.
(11:41):
And that's already happening.
Speaker 2 (11:43):
Absolutely.
It's incredibly attractive.
Speaker 1 (11:46):
Its, yeah, it's, it's , there's another trade block
that not many people talk about.
I don't know why.
It's probably because they aresmaller countries, but it's
called the Indian Pact.
The Indian P the Indian Pact areof course, the Indian countries.
Uh, Colombia used to beVenezuela, not anymore, for
(12:06):
obvious reasons.
So it's Colombia, Ecuador, Peru,and Bolivia, I believes.
And they're, they're, they havemade it so similar to Europe,
Davis, they're probably behindlike 10 years.
But, uh, just, uh, a coupleweeks ago, I, I've read the news
where a Colombian citizen caneasily move to Bolivia or
(12:27):
Ecuador and live and work andstudy and, and, and get a job
and everything.
So it is just, uh, amazing whatthey're doing.
So they're already integratingthe regulatory environment for
cosmetics, for some, for food.
So they're starting with, youknow, low risk products, but
eventually they're gonna go upto drugs and medical devices.
(12:49):
Mm-hmm.
Speaker 2 (12:50):
Yeah.
No, it's an incrediblyattractive market.
And like you said, you know,just a handful of countries
right now you said 270 million.
Oh, by the way, that's about thesize of the US market.
That's pretty
Speaker 1 (13:00):
Exactly.
Yeah.
Yeah.
So imagine if, uh, we all getour act together in Latin
America.
Um, Colombian of course.
And, and, uh, we as a, as aregion, we are 30 something
countries, over 600 millionpeople double the size of the
United States, but we have toget our act together.
(13:20):
Come on.
I mean, it is about time that weall join forces and move in the
same direction.
Not
Speaker 2 (13:24):
Everybody.
Well, well, I mean, in, in, inthe defense of Latin America,
there's been tremendous progressover the last five years.
Speaker 1 (13:30):
Yeah, yeah.
I agree with you.
Yeah.
Yeah.
The countries are becoming moremature.
Absolutely.
Yeah.
Middle class is, is growing and,and, and all that.
Anyway, so going back to yourexperience, Dave, I'd like to
dig a little, a little deeperinto, into your life in Mexico
or your experience in othercountries.
Uh, can we talk about that?
I mean, what is it to be doingbusiness in Mexico or elsewhere
(13:52):
in, in the region?
Mm-hmm.
Speaker 2 (13:53):
Yeah.
No, my, my, my experience hasbeen, uh, typically with, uh,
either capital equipment or with, uh, disposable products,
specifically.
Most of my experience in LatinAmerica came during my tenure at
, uh, Beckon Dickinson.
Cause, uh, we did have amanufacturing facility, um, just
outside of, uh, of, uh, Rio.
And so there was, there was some, um, there were some, um,
(14:16):
strategy meetings and, and some,uh, and some, uh, interactions
that I had, uh, you know, inthat area.
You know, again, it was, it wasalways just challenging meeting
with the country leaders wherethere was just not a lot of
commonality between themarketplaces.
And I'm talking, you know, thisis 10, 12 years ago, there just
wasn't a lot of commonality whenI've would talk to the country
(14:36):
managers and I'd be saying, geez, we have the same product.
You know, why is the product,you know, priced, um, this much
per piece in Columbia versusPeru?
And it was, it was always achallenge where it was just, you
know, geez, it's, it's difficultto have the country managers and
find synergies amongstthemselves, even though our
(14:57):
product was exactly the same indelivering the exact same
clinical value no matter whatcountry it was being, being, uh,
sent to.
And so, uh, that was always,again, you know, the big
challenge, you know, for us as a, as a mass producer of, uh, of
medical devices is, you know,geez, getting to the final mile,
you know, you know, to the, thefacilities was always a
(15:18):
challenge.
It was never a clinicalchallenge.
It was really more of a, of abusiness development challenge
to be able to effectively marketproducts, uh, correctly over
there.
Speaker 1 (15:27):
Hmm, interesting.
Did you ever have to deal withdistributors or find
distributors or managedistributors in the region?
Speaker 2 (15:34):
Yeah, it was, it was, again, it was by country because
, you know, in some countries,um, you know, distribution was
really the only effective way togo.
Um, you know, there were, youknow, countries like Brazil
where we had to have a directSalesforce, you know, because
the market there expected arepresentative to be there upon,
(15:56):
uh, adopting a new product,doing the in servicing and what
have you.
So, you know, again, ithighlights what you're talking
about.
It was highly variable andfragmented, um, in terms of, uh,
which country you're workingwith in Latin America.
Speaker 1 (16:06):
Yeah, yeah.
In experience in Argentina, forexample.
Speaker 2 (16:11):
No, actually very limited.
Very limited in, in Argentina.
Speaker 1 (16:15):
And, and the reason I ask is because, uh, it's such a,
such a difficult market, such a,uh, it's ups and downs, economic
ups and downs.
It's just impressive.
I mean, the inflation, uh, it'sjust, uh, every time I have an
interview like this, Argentinacomes up, uh, because, uh,
that's the, like, the primeexample of challenges in Latin
(16:35):
America, political changes,left, right center.
Speaker 2 (16:40):
Yeah.
Our, our Argentina was alwaysjust a really quick discussion
whenever we spoke with ourcountry leaders, because
literally the average price soldlooked like our scale because of
the inflation issues that you,you're speaking of.
And, uh, so it was, it was just,whoa, this is really difficult
for us to get our hands on.
And so, uh, yeah, we, it itwasn't a strategic imperative,
(17:03):
at least Dickinson's part to,uh, focus on that country.
Speaker 1 (17:07):
Yeah, yeah.
Yeah.
It's really a shame because it'ssuch a developed country.
Um, culturally speaking, uh,socially speaking, educationally
speaking, there used to be a, avery powerful country in, in the
twenties, in the thirties,absolutely.
Forties.
Absolutely right.
Yeah.
Yeah.
So it's, it's really a shame.
(17:29):
Uh, and, and Buenos Aires is oneof my top places to visit in
Latin America.
It's a beautiful, beautifulcity.
Speaker 2 (17:34):
Yeah.
Well, that's, uh, that's abucket list place for me.
Cause everybody I know that hasbeen to bu rs, uh, does nothing
but rape about it.
Speaker 1 (17:42):
Yeah, yeah.
Yeah.
It's, it's a country full ofItalians who speak Spanish
Speaker 2 (17:48):
And I, I hear the best steaks in the world, is
what I hear.
Speaker 1 (17:53):
Yeah, exactly.
Yeah.
Bueno Air is a beautiful mixbetween Madrid and Paris,
actually.
Yeah.
And a little bit of Rome
Speaker 2 (18:01):
Yeah.
And, and, uh, multifunctionalimaging we're headquartered in,
uh, in, uh, salt Lake City, Utah.
And so, um, as you're probablyaware there, there's a, uh, a
church of latter day Saints, um,Mormon, uh, culture here.
And, uh, so I have a lot offriends or associates that did
mission work down there.
Oh, yes.
Graves about Argentina.
Speaker 1 (18:21):
Beautiful.
Yeah.
I'm glad to hear that.
Yeah.
Yeah.
Yeah.
So you have to go,
Speaker 2 (18:26):
The bucket is,
Speaker 1 (18:28):
And what about Columbia and experiencing
Columbia doing business in, inthe country or
Speaker 2 (18:33):
Anything?
Yeah, actually, uh, Columbia wasa pretty big and strategic, uh,
um, um, country for BeckDickinson when I was there, uh,
because, uh, they, even backthen, um, they adhere to Thek,
um, back then.
And, uh, you know, obviouslyit's a, it's a highly, you know,
developed country with, uh, avery good healthcare system.
(18:55):
And, uh, so yeah, in, in spitethe, the fact that it's, it's
not the, uh, and from apopulation standpoint, it's not
the largest marketplace.
It's a highly developedmarketplace.
And, uh, yeah.
And, uh, you know, like I said,we're gonna be meeting as a
board, uh, this coming Friday.
And, uh, not only are we gonnawalk out with the Latin America
strategy, I wanna hear what ourColumbia strategy's gonna be.
Speaker 1 (19:15):
Beautiful.
I'm really happy to hear that asa Columbian
And, and, and, and just to add,uh, to that, uh, I'm not, uh,
um, this is not a commercial forColumbia.
It's a fact.
Uh, just like Chile is so easyto get into, Dave.
Uh, I'm sure you know, as I saidinitially, you don't really need
a regulatory registration inChile.
(19:36):
All you need is an importer, andyou're good to go.
You're in business.
Uh, there is a voluntaryregistration process that needs
to happen.
What doesn't need to happen thatyou could do, if you wanna
prepare yourself for the future,probably in the next year or so,
the Congress will pass a new lawwhere they're gonna make
mandatory the regulatoryregistration process.
The other countries of thePacific Alliance, Chile is just
(19:59):
getting in the same train as theother countries so that they
have, uh, uh, unified sale oflaws.
Anyway, my point with, uh, thisis that, um, uh, just as
friendly as Chile is, I will saythe second country in Latin
America in terms of friendlinessand market, ease of market
access is Columbia.
(20:20):
Just to give you a hint, theColumbia, the regulatory agency
in Columbia in Vima is the onlyagency in Latin America that
allows foreign entities to bethe owners of the title holders
of the registration certificateor the market clearance
certificate.
No other country does that.
They all mandate, they all forceyou to have a, either a local
(20:44):
entity or contract the servicesof a, what is called a
registration holder, and youhave to pay hefty prices for
that monthly prices for otherannual prices.
Or even worse, they make you,uh, have the distributor as your
title holder, which is notalways a good idea because the
distributor today may not be theshooter tomorrow, you know, that
(21:07):
, uh, you have to probably gothrough two or three the
shooters first before you findthe, the guy, the right guy.
So, um, so yeah, that says a lotabout how much this country is
one business, how much they want, uh, to make it easier for
companies to, to enter themarket, to, um, have access to
(21:29):
patients, have access toinnovative technologies faster
than other countries.
Right.
Um, I mean, we're
Speaker 2 (21:35):
Panama also.
Yeah.
And also these countries, youknow, they respect the
intellectual property that, uh,technologies like
multifunctional imagery bring tothe table, you know?
Yeah.
We've made a strategic choicenot to go into China, for
instance.
Uh, yeah.
Cause we have to share some ofour ip, you know, with, with
their regulatory board.
And, you know, quite frankly,we're, we're not quite
(21:55):
comfortable with that.
Cause we've written a lot ofproprietary code
prefer that to be a tradesecret.
And, uh, and Latin America, uh,is, is is very respectful of,
uh, companies like ourselves,um, in terms of that aspect.
Speaker 1 (22:12):
Yes.
That's a, that's a great point,Dave.
And the reason for that, one ofthe reasons for that is first
the E C D, right?
They, they require you to enactcertain laws to protect
intellectual property and othertype of protections, et cetera.
And second, free tradeagreements, right?
If you wanna have a free tradeagreement with the us you, you
(22:34):
have to comply with certainguidelines or mandates, or, or,
or you agree to respect, uh, orto have a way for companies to,
to, to have access to a coresystem in case of infringement
or, or things of that nature.
So,
Speaker 2 (22:48):
Mm-hmm.
Yeah.
Yeah.
Again, it's, uh, we're gonnahave a Latin America strategy
Speaker 1 (22:56):
It's that it's great new for theregion, it's great new for
patients, it's great new for thehealthcare systems of these
countries.
And, um, well, we're close tothe end of the show.
I usually keep it short to about30 minutes.
I think we covered so much inonly 20 something minutes.
(23:17):
share with the audience?
If you had the ceo, e o of amedical device company in front
of you, what would you say tohim or her, uh, if he or she
were just starting to exploreLatin America?
Speaker 2 (23:27):
Oh, there's a fantastic opportunity in Latin
America right now.
My company recognizes that.
And, and we're not the first,and we're not gonna be the last
to, to recognize that.
Um, I think that, uh, with anynew market you go into, it's,
it's important to identify andbuild tight relationships with
partners that can help you.
You get access to those markets,and that's where we're at right
(23:48):
now.
And it's folks like yourself,Julio, that we wanna, uh,
partner with, uh, and able to,uh, take our technologies, uh,
moving forward to Latin America.
It's a fantastic opportunity.
And, uh, you know, I think, uh,if, if you're thinking that it's
gonna be a aeu strategy first, Ithink you need to rethink that
right now.
I think you need to, you know,cast your eyes upon Latin
(24:08):
America, uh, especially forearly stage companies like
Multifunctional Engine.
Speaker 1 (24:13):
Excellent.
Dave, I'm, I'm so happy to hearthose words coming from you.
All right, Dave, thank you againfor being the show.
It's being a delightfulconversation.
I'm sure listeners got a lot,uh, from your insights and your
wisdom and your experience, andI look forward to seeing you
succeed in Latin America.
Speaker 2 (24:32):
Oh, I look forward to , uh, speaking with you again.
If there's way that we can ofassistance to yourself, lu,
please let us know.
Speaker 1 (24:38):
All excellent.
All right, Dave.
Thank.
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