February 16, 2023 • 36 mins
Ruben is the CEO of Alandra Medical. He has dual qualifications in engineering and technology entrepreneurship combined with 16 years of experience in medical device development. Self-motivation, adaptability, trainability, and entrepreneurial drive are his key tools for achieving personal and business goals. Ruben started his career developing hardware and software for medical devices, spending countless hours reading scientific papers, twitching circuits, refining algorithms, and preparing technical reports to deliver products right on time. In a nutshell, his experience as an engineer revolves around developing Class I and II active and sterile medical devices (bio-instrumentation and software); this includes defining design inputs and producing design outputs following state-of-the-art industry standards such as ISO 13485, ISO 14971, IEC 62304 and the IEC 60601 series.
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Episode Transcript
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Speaker 1 (00:01):
Welcome to
the Latin MedTech Leaders
podcast, a conversation withMedTech leaders who have
succeeded or plan to succeed inLatin America. Please subscribe
on your favorite podcastingplatform, apple Podcast,
Spotify, Google Podcast. AmazonMusic is teacher. Tune in
iHeart Radio, Pandora or Deezer.
Speaker 2 (00:20):
Welcome back to the Latin MedTech Leaders podcast,
a conversation with leaders whohave succeeded or plan to
succeed in Latin America.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, 45 , GooglePodcast, et cetera . Today our
guest is Rue Gaitan Ortiz, c eo. At Allandra Medical, Ang is
(00:43):
developing novel monitoringtechnologies to save the most
vulnerable patients from direcomplications in cardiac
surgery and critical care. So,Rue , welcome to the show.
Speaker 3 (00:54):
Thank you very much for having me.
Speaker 2 (00:57):
Awesome, Rue . So let's talk about your journey
to Latin America. Ruben , howis it that you got involved
with the region?
Speaker 3 (01:05):
Absolutely. So, well, first of all , uh, I was
working in Mexico, so I amnaturally engaged with the
region and well, I have abackground in biomedical
engineering. So right after Ifinalized my students at
university, I joined and startcompany, you know, developing
medical devices and trying tobring , uh, innovations from
the university into the market.
(01:25):
This was a small company whichwas launched by a professor at
university. And essentially myrole was like , uh, only in
engineering aspects, you know,developing , uh, electric
circuits and some software kindof in a very, very geeky way of
the innovation, if you will.
And after some years, thecompany was , uh, acquired ,
(01:46):
uh, by another , uh,entrepreneur effort, and he
received some busy funding. Andin that moment, it was kind of
an inflection point because acompany sees to be a , you
know, like an only academicendeavor, and they start to be
like a more professionalcompany. So in that period, we
developed our processes withcertifications, and we actually
(02:07):
started to offer a , you know,the office services for other
customers also in , in Mexicoand also in, in the u s a . And
at the same time, the companywas incubating its own
technology. Most of regionalcame from the previous , uh,
company that I mentionedbefore. And , uh, after some
time we understood that even ifwe were having some good
(02:28):
traction in terms of gettingcustomers for developing very
specific portion of the devicesin Mexico, this was not really
creating value for ourinvestors. And that's when we
decided kind of only to focusinto the technologies that came
from the portfolio, fromoriginal portfolio of the
company. And for the reason,you know , it's been like
around maybe four or five yearsin which we , we have been
(02:49):
lesser focusing on developingour own IB portfolio, as you
mentioned , uh, during theintro, kind of our start
product or our main efforts are, you know , being targeted to
critical care and to cardiacsurgery. Essentially, the
problem that we are trying tosolve right now is helping
doctors , uh, particularly inthese settings, having a
(03:10):
objective information fordelivery treatment for the
patients. So, for instance,when a patient enters cardiac
surgery or a patient isadmitted into the I C U ,
doctors need to have a fairassessment of how likely is ,
uh, for the patient to developcomplications. And in that
regard, there are a number oftechnologies and a number of
biomarkers that offer someinformation, but none of them
(03:32):
are truly objective. And, youknow, there are some biases in
the methodologist . So ourdevice is essentially a gastro
tube, you know , is a tube thatgoes all the way down to the
stomach, from the nose or fromthe , from the mouth. And the
catheter measures certaingenetic properties that
correlate with , uh, thedevelopment of complications.
So we have recently completed aclinical trial in Mexico in a
(03:55):
very specific patientpopulation. Uh , you know,
patients receiving electivecardiac surgery. And the
results indicate that ourtechnology is capable, you
know, of , uh, differentiatingbetween the patients , uh, that
undergo without complicationsand the patients that develop,
you know, complications andeventually die. So the results
are pretty encouraging. Andwell now we are using this data
(04:17):
for, you know, getting ruralapproval for technology in ,
uh, western market , let's saythe us , the uk, and of course
Mexico. And we are also puttingour always in Australia. So
that's kind of the naturalrelationship that I have with
Latin America . And , and yeah,I mean, I am absolutely, I I
absolutely privileged to havethis opportunity of developing
(04:38):
this kind of technology hereand also kind of , you know,
serving perhaps, you know, as ,as inspiration hopefully for
other entrepreneurs , uh,willing to start this journey.
Speaker 2 (04:48):
Yes, yes. Well, congratulations. Um, seeing a
startup medical device companyfrom Latin America is, is, is a
surprise. And , uh, uh, is , is, uh, it's , uh, I'm , I'm
proud of it as Latin American ,uh, because , uh, it's not
common I , being in thisindustry for about 13 years
(05:09):
now. And , uh, I I've seen lessthan three companies, I will
say less than, I mean, it'sjust a handful of companies ,
uh, coming outta Latin Americawith , uh, and , and , and ,
and fewer of them with greatproducts like , like yours and
that , that are going in theright path. So , uh, I'm , I'm
very pleased to see your ucceyour success and, and, and to,
(05:31):
to see something good comingout of your, your efforts in,
in the region. So let's talkabout , um, trends , uh, Ruben
, uh, what trends , uh, do yousee happening in Latin America
that are relevant to ourdiscussion about clinical
research or commercializationor development of medical
technologies?
Speaker 3 (05:53):
Well, from the way they , the way I see it is
that, you know, Latin Americahas usually been a place where
companies come to sell theirdevices or manufacture the
devices, not necessarily a ,you know, a continent which
creates a new , uh, technologyfor the launches innovations.
Uh , I think that there aregood reasons for being
(06:13):
optimistic in that this regard, because from , let's say from
the last, I dunno , maybe sevento 10 years, there have been
some very timid , uh, efforts ,you know, for starting
developing technology. Oneexample, of course is Aandra
medical, but I have seen thatlately. Uh , well, first of all
, these kind of endeavors weremostly funded by, by , by the
(06:33):
government in terms of grants.
And usually the companies kindof were living for maybe about
, uh, six or seven years , uh,before finding financial
collapse. What I have beenseeing , uh, lately is that
this capital and private moneyis, you know, pouring into this
kind of endeavors. And I thinkthat , you know , success will
(06:54):
naturally attract more and moreinvestment into these kind of
projects. Uh , you know, I'mvery happy to see that, let's
say funds like SoftBank orCastech are starting, you know,
to, to bet and to put moneyinto a medical technology, not
necessarily, let's saysophisticated medical
technology in terms of , youknow, a monitoring device with
a , I dunno , an implantablecomponent or , or something
(07:16):
like that. But more into, let'ssay a digital technologies,
particularly those which are ,you know , uh, that , that you
can install in a cell phone ,whatever. And you have like an
app measuring biomarkers or arelike an measuring fitness and
things like that. And I thinkthat, you know , uh, success
will eventually create moreappetite within the investment
community to fund even riskierprojects . In the case of
(07:40):
Alandra. Well , this iscertainly kind of a riskier
product , if you will ,because, you know , uh, the ,
we are an invasive device, youknow, we're in contact with ,
with the patient, and, youknow, the kind of information
that our device producing canhave an impact, you know, in on
the outcome of criticalpatients. So from that
perspective, investment isreally not flowing. You know,
(08:00):
as much as I , I I would liketo, but I , and I , this is
something that actuallymotivates , uh, my team and I
that , uh, in the measure thatwe get success with this
technology. You know, otherinvestors will be willing to
put the money in there, butregardless of that, I really
think that , uh, you know, wehave seen more and more
startups, you know, operatingin the, let's say, wellness or
(08:22):
healthcare environment. Andyeah, I , I think that that is
something very nice. On theother hand , uh, well, I think
that a major advantage that wehave , at least in Mexico is
that we are network with the usand there is also creating a
very, very interesting trend,which is medical tourism. I
mean, this is completely, youknow , different from
evaluation part . What I thinkthat is also kind of a massive
(08:44):
business opportunities for ,uh, you know, healthcare
companies here in Mexico.
Because if you go to theborder, you will see fluxx of
American tourists , you know,get into a country for
receiving , let's say penilecare , or even what is called
the pharmaceutical tourism. Youknow, American citizens
crossing the border, weregetting know the same
medication, but I dunno , maybe10 times cheaper. So this trend
(09:04):
is, you know, increasinglybeing capitalized by
entrepreneurs and by, you know,companies in here. And actually
you've , you've go to , let'ssay private hospitals in Mexico
City, you'll see Americanslooking for, you know, cardiac
surgery or , or kind of, youknow, very procedures to be
performing here. Of course,there is, you know, some
skepticism about whether ,whether or not , uh, healthcare
(09:26):
here, you know, is reliable.
But the truth is that, youknow, increasingly more and
more people are coming toMexico to, you know, get
affordable healthcare and, youknow , uh, really our
physicians, you know, most ofthem have received training in
the US or in Israel or inEurope. So quality healthcare ,
uh, I believe that can be verysimilar to what you can get in
(09:48):
the us at least in privatehospitals, you know, but at ,
at that cost . So Ibelieve that, you know, I'm not
sure what would be the resultof these , uh, different
parameters. We're certainlyexcited . I mean, if you have
like on one hand, a privatemoney pouring into , uh,
entrepreneurial efforts formedical technology, and on the
other hand you have likeAmericans coming into the
(10:10):
country for getting treatment.
So I think it's kind of an ,you know, interesting fer solve
for, you know, for, for themarket . And I would say that
those are perhaps the twotrends that I see most
exciting, you know , uh, forLatin America. And of course,
you know, in terms of clinicaltrials , uh, well , uh, we have
kind of , you know, ourpopulation is suffering mostly
(10:31):
the same non-communicablediseases than, you know , uh,
western markets , if you will .
So we have diabetes, and wehave, you know, kind of the ,
the same grievances that you'llfind in the , uh, states or in
or rest of Europe. We have themin here. And of course, you
know, needless to say , uh, thecost effectiveness of run a
trial in Mexico, you know, isvery, very attractive. So
(10:51):
that'll be kind of thetraditional trend, if you will
. But I think that the two mostexciting trends are medical
tourism and, you know , uh,private money pouring into
local , uh, you know,entrepreneurs. Mm-hmm .
.
Speaker 2 (11:04):
Yes. Yes. That's , that's very interesting , uh,
especially about the privatemoney pouring into local
companies from VC funds . Um ,are you seeing other companies
like yours , uh, in Mexico ,uh, with innovative products,
receiving funds? I mean, haveyou being a witness to, to, to
(11:25):
, uh, success ? Uh , cases,
Speaker 3 (11:27):
Certainly, yes. Uh , I mean , uh, there's a company,
I do not remember the name inthis moment, shame of me , but
they are , you know, screeninga breast cancer. So essentially
what they're using is imagingtechnology, and they're able,
you know, to detect cancer or,or , or at least, you know,
tissue anomalies . You know, wedon't necessarily needing the
traditional mast. So that , ofcourse, you know, having an
(11:50):
infrared camera is very cheaperthan having, you know, like ,
um, extra equipment. And as faras say , no , this company has
already received funding fordeveloping their technology,
and if my memory serve me well,they are already applying for a
five , 10 K in the US for
Speaker 2 (12:06):
Wow , nice .
Speaker 3 (12:07):
And yeah , and mean , you know , and there's some
other efforts, I mean, notnecessarily in the diagnostic
space, but mostly in thewellness space. So, you know,
you have like companiesdeveloping wearables for, you
know, measuring a certainassignments from the body in a
way that you can maybecorrelate with them with other
, uh, data and, you know, todeliver , um, wellness advice
(12:29):
to, to the patients. So, soyeah, I mean , uh, I , I really
must mention that I have notseen another company developing
like biomarkers as we are , butI think there's a very
interesting case in Chile, andin this case, I do remember the
, the name I think's Levitamagnetics , I mean , uh, they ,
as far as I understand ,they're like Chilean
entrepreneurs, and they havereceived funding from the u ssa
(12:51):
. And what they're developingis , uh, I understand is , uh,
robot assisted surgery. And insome measure they're using
magnetic fields for control.
The robot . I'm not reallysure, but I can , can , I think
this kind of , uh, remarkableexample of, you know , people
from Chile developing this kindof technology. Another company
that I have , uh, very good inmind is miraculous . I think
(13:15):
they also come from Chile, andthey're currently based in San
Francisco, and they'redeveloping, you know, this
fantastic platform for, youknow, developing , uh,
laboratory analysis over , overthe , over blood samples. And
they offer this platform for,you know, customizing different
, uh, uh, laboratoryexperiments , uh, you know, in
(13:36):
a miniature platform. And Ithink that they have also
received, you know, funding notonly from Latin America, but
also from American investors.
So I think those two are very,very inspirational examples for
us, for Aandra in a way thatit's possible to develop this
kind of , uh, inno innovationsand getting funding not only
from friends and family, fromthe government, but also, you
know, from real , uh, vc VCcapital.
Speaker 2 (14:00):
Excellent. Yeah, just , um, um, text you here,
another company that I learnedabout , uh, Ipol from Mexico.
They opened an office inSilicon Valley and they got
funding from the United States.
So, so I'm very happy to seeall those examples of companies
, uh, succeeding in , in LatinAmerica with their innovations
(14:22):
, uh, because as you correctlysaid , uh, the region is not
famous for that , but ,uh, slowly we we're gonna get
there.. So Roy , yeah,go ahead.
Speaker 3 (14:33):
So , sorry. I was just saying, I mean, and I
think that , you know, all ofthe companies that some extent
we have, you know, evolved to ,let's say a busy stage . I
think that , you know , besidesthe motivation of , you know ,
of course having a successfulbusiness , also creating
success stories in LatinAmerica , I think that should
also be, you know, aninspiration for us all , you
know, because that willcertainly bring more , uh, more
(14:56):
interest in the region, notonly for manufacturing, for
clinical trials, but also kindof for , uh, an innovation
laboratory, so to speak.
Speaker 2 (15:03):
Yes, yes, exactly.
That's a great point because ,uh, um, the talent available in
the United States, in SiliconValley, in , in Minnesota, in
Massachusetts is, is worldclass talent that , um, but but
at the same time, it's veryexpensive , right? So
if you wanna develop something, uh, using those engineers,
(15:26):
biomed engineers, or softwareengineers , I mean, you have to
pay a he hefty price. Uh, and Ithink , uh, there's , uh,
comparable or, or close tocomparable , uh, talent in
Latin American countries likeMexico, Colombia , Chile,
Argentina, Brazil, thatcompanies can tap into to
develop , uh, uh, technologiesat a lower price and, and
(15:48):
combine that with the othertalent in the United States so
that they can save , uh, money,right? And that's course big
issue for startups , of course,
Speaker 3 (15:58):
And most , most interestingly, I mean, at least
in my experience when I've beento Minnesota or to this other
major innovation centers,typically the engineer teams ,
you know , combine , I meanlike, you know , uh, scientists
and engineers from all over theworld, right? So I , I was in
Minnesota having , okay, soyou're from Mexico as well, but
you're here in Minnesotaworking medical innovation .
So, so yeah, it's kind of , youknow , uh, I think that part of
(16:20):
the glory, you know, of the USin terms of innovation is that
capability of attracting talentfrom all over the world. Uh ,
and , and so yeah, hopefully wecan replicate that in our
countries as well.
Speaker 2 (16:31):
Exactly. Exactly.
Well, and people like you are making our region
famous for verticalinnovation. Congratulations
again. Um, alright , Ruen , solet's talk about what you're
doing in Latin America. What isit that , uh, you are involved
in right now, clinical research, uh, commercialization
(16:51):
development? How is LatinAmerica , uh, fitting into your
plans to develop yourtechnology ?
Speaker 3 (17:00):
So let's say from the Orlando perspective, I
mean, as I mentioned before,we're like 100% focused on, you
know, getting this technologyto market. Uh , we have already
concluded , uh, of course the,you know, the research and
development phase, you know ,uh, and recently the clinical
clinical validation. And rightnow we are , you know , putting
all of our efforts in getting,you know, the regulatory
(17:21):
process for, you know, startselling this technology , uh,
first let's say in westernmarkets over where Mexico
course included, but also the US A and in Europe we are facing
some challenges, you know, forthe European market because as
you know, recently they havethe medical gas regulation .
And it is not a matter that ourtechnical information is not,
(17:41):
you know , up to the levelrequired by the mdr , where's
more , you know , a saturationproblem , you know , notified
bodies in Europe completelymore incapable of coping with
the demand. So that's kind ofthe challenge that we have
right now. Uh , but you know,at the same time, we are
pursuing the approval forcoffee and also for , uh, for
the F D A and they use , youknow, for getting approval in
(18:02):
the USA is that our technology,you know, can feed into a five
10 K process . So, you know,we're optimistic about it and
we're also putting our eyes inAustralia because Australia
right now has very interesting,you know, incentives for , uh,
creating . And sothat's where we are right now.
I mean , uh, we are, you know ,uh, we have, you know, 90%
(18:23):
ready , uh, our technical thisyear together with that, you
know, we are creating thescientific publications of the
result from our experimentsbecause , you know, we, we need
to, to cover all of the aspectsof , of innovation, not only
the regulation , but also weneed to pay attention to, to ,
to a clinical , uh, uh, papersand also to the IP and all of
(18:44):
that. So we are, you know, alsomaking those , uh, aspects
stronger in, in the business.
And , and yeah, and , and let'ssee . On a more personal note,
you know, I have some sideproducts with the family, which
are also trying to capitalizein the strength that I
mentioned before. Uh , youknow, so we are also working,
you know, with dermatology and,you know, it's very curious
that everything that is relatedto beauty and to personal care
(19:07):
in Mexico is kind of on fireright now. So let's say
whatever from a laser , uh,hair removal or to cause me ,
you know, which are thesehighend dermatological pro
products that can , you know,improve , they have all the
skin . And , and that kind ofthing is also very interesting
trend. You know, kind of themiddle class is increasingly
having, you know , this kind of, so, so that's also a very
(19:30):
interesting trend that we're,you know , uh, focusing right
now, at least, you know, in ,in the closest sphere , which
is the family. But , but yeah,I mean , uh, again , uh, in
terms of aandra , uh, we hopeto get this approvals within
the next year. Of course, youknow, we have already have ,
uh, in terms of Euro Brexit,and then we have the pandemic,
you know, certain unexpected ,uh, things have came across,
(19:51):
but we are kind of 100% , uh,convinced that we can make it
and that we can get thisapprovals. And of course, you
know, once that you get an fFDA approval, capital, you
know, is far, you know,complicated , right
? So that's part of thestrategic reason that we are
pursuing also this kind ofapprovals in western markets.
Speaker 2 (20:11):
Very good. So Roen , let's focus , uh, for a minute
on your experience with yourclinical trial, with your early
feasibility , first in humanclinical trial in Mexico, and
your experience with Coveredpriest , because I'm , I'm sure
that's where our audience , um,uh, wants to, to focus the
(20:35):
conversation because that's oneof the reasons companies , uh,
medical device companies , uh,from the US go to Latin America
to, to test the , or tovalidate the safety and , and
efficacy of their innovations .
So what's the framework , um,for , uh, doing a clinical
(20:55):
trial in Mexico? Uh, what wasyour experience , uh, finding
investigators, finding sites?
What was your experience withCarris , et cetera ? Could you
elaborate on that?
Speaker 3 (21:07):
Absolutely. So let's say I , I , I'll start, you
know, with the , uh, researchcomponent of this. So in our
experience, you know, doctors,particularly young doctors, are
very keen on trying, you know,new , uh, new technologies and
trying new pharmaceuticals. Andthere are kind of many drivers
for that. One of them is that,you know, they want to create,
you know , a reputation for ,for their own. So that's kind
(21:29):
of a , a big driver for them toget involved with these kind of
projects. And on the otherhand, you know, kind of the
incentives that most of thedoctors that work, you know,
let's say in public centers isthat, you know, the more
publications that they have,the more likely is that they
can, you know , uh, grow , uh,within the , the hospital. And
well , that, you know, makesit, I wouldn't say easier, but
(21:50):
I would say it really helps,you know, to, to attract this
kind of talent into, intoprojects like , like this.
Something that , that I mustmention though is that, well ,
aand has only kind of operatedwith public hospitals,
particularly, you know, thehospital for cardiology and for
respiratory diseases, and alsofor nutrition is that, you
know, these hospitals aresubjected to state bureaucracy,
(22:13):
and there are also some unionswhich are operating there. So
that can bridge somefrustrations, you know, when
you are kind of plan planningand developing a trial. And
that is something that I willreally advise , uh, other
companies to keep in mind that,you know, state bureaucracy is
something that exists in thepublic centers and well , that,
that may influence theirdecision for getting perhaps
(22:33):
into a private hospital. But interms, you know, of the, I
would say , I would sayintellectual , uh, capital
within the hospitals isabsolutely fantastic. And, and
yeah, I mean , uh, in ourexperience, you know, the
patient population isavailable, at least for our,
our kind of device. I'm prettysure that, you know, any
(22:55):
company working with , youknow, with , uh, grievances in
, uh, from the western worldwill be able to find, you know,
a patient population for thestudy here in Mexico. And also,
you know , uh, regardless offocusing into private or public
healthcare , they willcertainly find a hospital for
that. And, eh , and yes , so interms of coffee, please , uh, I
(23:17):
think that if you have a verygood understanding and of , and
also very good counseling, youcan really get a grasp on the
processes and really get agrasp, you know, on what is
required for, you know, havinga decent human study here. And
yeah, my , my advice would bejust like, you know , get a , a
reliable consultant from Mexicoand , uh, you know, be really
(23:40):
diligent in terms ofunderstanding the local
relation . I mean , and if youtick all of the boxes , uh,
you'll will really not find anykind of , of problem. Uh , as ,
as a side note, some people,you know, is tempted to
recommend that they need tocreate, you know , certain
personal relationship with theofficials at Coffee Press . I
will really discourage thatkind of approach because, I
(24:00):
mean, you can do it , you know,by the book, you know, and you
can tick all of the boxes andyou'll really, you know, you'll
not be in need of any kind offriendship, you know, with so ,
uh, this , becausein many instances I've heard
that kind of advice, you know ,uh, that's advice and that's
advice that I have heard, youknow, in other instances. So I
would really discourage that.
(24:21):
And I would say that , uh, aslong as you are really diligent
in understanding regulation,all you need is kind of
intellectual capital , uh, uh,and that's it, that you'll be
on the other side.
Speaker 2 (24:32):
Okay. So in terms of timeline , uh, how long will it
take to get a trial approval ingeneral? I mean, based on your
experience and based on whatyou've heard about , uh, other
companies doing similar studiesin Mexico, what will be the
ethics committee approvaltimeline? What will be the
approval timeline?
And in general, how long willit take for a company to, to,
(24:55):
to from the day they , theysubmit , uh, to the ethics
committee and the day they getthe patient on the table?
Speaker 3 (25:02):
Okay, lemme put it this way , uh, for this last
trial that we executed, let'ssay from day one, from day one
in which we say, okay, helloguys, we want to run a hospital
to day one with patient, it was, uh, 15 months, you know, from
the , from the very first dayin which we, you know , uh,
were engaging with thephysicians and we were
(25:22):
developing the protocol. Uh ,they , we have the very first
patient. It was , uh, around 15months, give or take. And in
terms of cough quiz , somethingthat I would really recommend
then is to go to what is calledgoodness in English , is the ,
uh, well , I , I , I can getthe name for you, but it's kind
of , um, preliminaryapplication that you have for
(25:42):
your protocol before you filethe actual thing. So that, that
is very useful because KarisScan came back to you, you
know, with somerecommendations. I , with some
gaps in your, in yourpaperwork. And again, I mean,
as long as you understand whatthe law says about , uh,
clinical trials here, I mean,you can be , uh, I would say
pretty confident that , uh, youcan get your paperwork, you
(26:04):
know, approved , uh, within thetimeframes , uh, that are
advertised on , on Con'swebsite. So , uh, yeah, I mean
, that , that's kind of ourexperience. I cannot mention
kind of , uh, clear dates. Imean, to to say like, it was
three months and there fourmonths, but day one to the , to
our first patient, it wasaround 15 months. And again ,
(26:25):
uh, just for having some , uh,uh, parameters, this was a
trial on elective cardiacsurgeries, you know, very, very
little patients. And , uh, youknow, the , uh, the check marks
that we had to, to payattention to in terms of the
secular trial where you, youknow, kind of , uh, noticeable
and , uh, um, my assumptionwill be that , you know, trials
(26:49):
with less risky patientpopulations, you know, most
likely will require , you know, a shorter period of time for
, for getting the trialapproved and for getting the
first , the first patient . Andafter that trial , you know, we
had zero adverse events relatedto our technology. However, you
know , uh, if a patient diesduring your study, whether you
(27:10):
know it is related to yourtechnology or not, you still
need to report it to a ris .
And I can tell you that thereporting process was
absolutely flawless. I mean, wejust sent paperwork and we had
absolutely zero inconveniencein that, in that regard. And
also when we notified CoffeePriests that our study was
completed, I mean , it was justkind of a matter of creating
the paper once and sending itover, and it was absolutely
(27:31):
fine. So, so yeah, I mean,again, I, I cannot recommend it
enough to, to have a goodunderstanding and to have, you
know , good counseling and youshould be able to run a smooth
trial here.
Speaker 2 (27:43):
Very good. But you mentioned something that is
very intriguing. You mentionedsomething like , uh, a
pre-submission to Cover Priest. Are you talking about , uh,
uh, um, predic timing ?
Speaker 3 (27:55):
Exactly, yes. That , that , that was the , the thing
that I was trying to, to Okay .
Speaker 2 (27:58):
Predict timing .
Alright . Yes . Could you ,could you talk a little bit
more about that? Is thatsomething that is, because I
heard that before the pandemic,it was , uh, uh, a real thing
was the , the, the unidas , thepredict timing where everywhere
in Mexico, but after thepandemic that , uh, went away
and they're no longer active.
(28:19):
Um, could you clarify on that?
I mean, how does it work?
Speaker 3 (28:23):
You know what? I dunno . That's a very good
point. I mean, in our , yeah ,because I mean, yeah , we , we
submitted that credit , uh,before the pandemic , uh, and
yeah, on me, I'mnot really sure about how it's
working then right now, becauseyes, I mean, in our case , uh,
it was very smooth, but afterthe pandemic , uh, yeah, most
(28:45):
likely it has suffered somesort of disruption.
Speaker 2 (28:47):
Yeah, yeah, exactly.
And , and for the audience here, uh, a predict timing is , um,
is , is is something in theMexican system , uh, to , um,
approve , uh, new medicaldevice, well, new , uh,
clinical research studies,pharma or devices , um, that ,
(29:11):
uh, allows third party privateentities to review the Dosier
before the dossier is sent toCover Priest . So these private
entity is of course, certifiedby Cover Priest to review , uh,
these dossiers and, and, andcover priest trust the , the
opinion of these third partyentities. And , uh, after you
(29:35):
get the review and the opinionof the third party entity that
they'll call is the predicttiming , uh, then you can just
attach that letter to you tosee it , to cover Priest . And
you should get a very, veryfast , uh, approval at ,
because you already have apre-approval at the timing ,
uh, unit ,
Speaker 3 (29:55):
Right , as most likely there's some disruption
in there after the , thepandemic. And also, you know,
after maybe some restructuring, uh, uh, inside coffee ,
please . Uh , but yeah, I mean, uh, I , I really need, I I'm
taking that away, you know , ashomework after this call,
.
Speaker 2 (30:12):
Yes, yes. I think that that's a , that's a great
, uh, thing that Mexico hasalso for the registration of ,
uh, commercial devices. Theyhave these , uh,
right, authorized thirdparties, which is fantastic.
Uh, it's a great system. But ,uh, uh, the new government ,
uh, Lopez , I understand tookthat away or restructure that
(30:38):
because there was some, somecorruption involved in, in that
, uh, model . Soprobably similar
Speaker 3 (30:49):
Rabbit , but yeah , I mean that , that will take us
to very tight places. So
Speaker 2 (30:52):
Yes, I know, I know.
Let's avoid that. But , uh,avoid my, my opinion of Covered
Priest now, and from what Ihear from people, I just came
back from Mexico last week, isthat Covered Priest is really
Wiki really making an effort to, um, to fix the reputation of
inefficiencies that he had ,uh, is , um, making their
(31:16):
timelines way better and makingtheir processes more
predictable. And by the way, Ialso heard that Ka priest just
join I c h, the InternationalConsole of Harmonization , uh,
which is a big deal. Iunderstand he's the only agency
in Latin America that is partof I c h , uh, for clinical
(31:37):
research. So that sends thesignal that cover really,
really wants to be competitivein Latin America for the
approval of , uh, clinical ,clinical trials . So I'm very
happy to hear that .
Speaker 3 (31:51):
Absolutely , absolutely. And I , I must also
mention, I mean , uh, I thinkthat within the very few
positive things, if you will,after the pandemic, is that I
think it was a seriouspotential call for , uh, all of
Latin America in terms that wetried , at least in Mexico. You
know, there were various , uh,incentives to develop, you know
, uh, respiratory machines andstuff like that. And I think
(32:14):
that we'll just see it like ,like , like a brick wall in
terms that , uh, I mean, youcan't build , uh, respiratory
machines out of the blue. And Imean , I mean, of course there
were, you know, successful eefforts , uh, to , to some
measure. But in general, kindof the, the scientific
community, the engineercommunity , and the general
(32:36):
ecosystem , you , we , you know, hit hard in a way that we do
not have a robust e system forthis kind of emergencies. And I
think that , uh, will down theroad, you know, influence
politics , uh, and influence ,uh, you know, how , uh, and
other stakeholders, you know,operate in a way that we really
(32:58):
need to have, you know, a , arobust ecosystem in place for
this kind of emergencies. So,so again, I mean, I really
admire the people that, youknow, went through the process
of building this kind ofmachines, but I think that ,
uh, one of the results is thatwe are shocked by the fact
that, I mean, our capabilitiesfor responding to these things
is not what was necessarily twoor three also . So I think that
(33:22):
one of the positive things thatwe can say after all of this
pain is that , uh, this willshake , uh, the , the policy
around around technologydevelopment here.
Speaker 2 (33:31):
Yes, yes, you are correct on , on that. Uh, I was
stuck in Columbia during thepandemic, and I witnessed the
development of about at least10 different efforts to , uh,
create , uh, ventilators bylocal , uh, universities and,
and innovation groups, butnothing really materialized.
(33:52):
And, and the regulatory agencyreally, really hard had a hard
time , uh, coping with thedemand for , um, uh, reviews
and, and applications forapprovals. And you could see,
because those are publicdocuments Yeah , I was reading
all of them. You could see that, uh, the innovators didn't
really know what to do, and theregulatory agency didn't even
(34:14):
know what to do either. So itwas a lot of confusion. Yeah.
Speaker 3 (34:19):
And again , I mean , this is not , not not , you
know , a matter of blamingpeople or , or kind of , I mean
, it's a matter that as asociety, we have not the
conditions for , uh, you know ,being able to respond to this
kind of emergency . So I reallywant to be optimistic in the
way that this should shape ,uh, policy , uh, you know, down
the road for the next pandemic.
(34:39):
We , it's just a matter of time. So sadly, . Yeah ,
Speaker 2 (34:43):
Yeah . Now, now Columbia's regulatory agency ,
DEMA is a better agency becauseof the pandemic. I think the
digitalization of the agencywas , uh, fantastic. The, the,
the, the new people that theyhad to , uh, put in the
committees to evaluate thesetechnologies, it was fantastic
because they had to up theirgame , uh, for these new influx
(35:06):
of innovation that came duringthe pandemic. So it's a win-win
for everybody at the end, Ithink.
Speaker 3 (35:12):
Yeah , absolutely.
Speaker 2 (35:14):
Alright , Wayne , I think we're close to the end of
the show. And , uh, do you haveany final words of wisdom, any
final , uh, thoughts , uh, thatyou wanna share with the
audience before we close?
Speaker 3 (35:25):
Well , I mean, I , I just want to , to stress that,
I mean, we can do very nicethings in here , uh, and , uh,
you know , uh, as I mentionedbefore, the latest experience
with the pandemic and togetherwith , you know, with these
trends of busy monitoring intoLatin America and, you know,
the, the size of the market inLatin America, you know, I
think it's , uh, those areconditions, you know,
(35:47):
promissory of having, you know,an innovation cluster in here.
And , and again, I mean, weshould not try to copy models
from Silicon Valley, which is,you know, kind of this , uh,
weird thing that everybodytalks about. I mean, of course
Silicon Valley works because itdeveloped under very specific
conditions. We have differentconditions, different, you
know, society and whatever. Soinstead of trying to emulate
(36:08):
what has been done in there, Ithink we should really just ,
uh, study those success storiesand create our own ecosystem
for, for innovation. Because Imean, we have fantastic
universities, we have fantastic, uh, inter , inter to capital.
We all speak Spanish, and weare a gigantic , uh, continent.
So I think that there areconditions , uh, and I think
(36:28):
that, I mean, there are verygood reasons for being
optimistic and to attract, youknow, prosperity for our
societies.
Speaker 2 (36:36):
Well said. Thank you, Ruben . All right . So it
was great having you here,Ruben . Thank you so much for
sharing your knowledge and ,uh, I look forward to being in
touch with you. Thank
Speaker 3 (36:47):
You very much .
Thank you very much for, forhaving me. And well , thank you
.
Speaker 2 (36:52):
Bye bye-Bye.
podcast, a conversation withMedTech leaders who have
succeeded or plan to succeed inLatin America. Please subscribe
on your favorite podcastingplatform, apple Podcast,
Spotify, Google Podcast. AmazonMusic is teacher. Tune in
iHeart Radio, Pandora or Deezer.
Speaker 2 (00:20):
Welcome back to the Latin MedTech Leaders podcast,
a conversation with leaders whohave succeeded or plan to
succeed in Latin America.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, 45 , GooglePodcast, et cetera . Today our
guest is Rue Gaitan Ortiz, c eo. At Allandra Medical, Ang is
(00:43):
developing novel monitoringtechnologies to save the most
vulnerable patients from direcomplications in cardiac
surgery and critical care. So,Rue , welcome to the show.
Speaker 3 (00:54):
Thank you very much for having me.
Speaker 2 (00:57):
Awesome, Rue . So let's talk about your journey
to Latin America. Ruben , howis it that you got involved
with the region?
Speaker 3 (01:05):
Absolutely. So, well, first of all , uh, I was
working in Mexico, so I amnaturally engaged with the
region and well, I have abackground in biomedical
engineering. So right after Ifinalized my students at
university, I joined and startcompany, you know, developing
medical devices and trying tobring , uh, innovations from
the university into the market.
(01:25):
This was a small company whichwas launched by a professor at
university. And essentially myrole was like , uh, only in
engineering aspects, you know,developing , uh, electric
circuits and some software kindof in a very, very geeky way of
the innovation, if you will.
And after some years, thecompany was , uh, acquired ,
(01:46):
uh, by another , uh,entrepreneur effort, and he
received some busy funding. Andin that moment, it was kind of
an inflection point because acompany sees to be a , you
know, like an only academicendeavor, and they start to be
like a more professionalcompany. So in that period, we
developed our processes withcertifications, and we actually
(02:07):
started to offer a , you know,the office services for other
customers also in , in Mexicoand also in, in the u s a . And
at the same time, the companywas incubating its own
technology. Most of regionalcame from the previous , uh,
company that I mentionedbefore. And , uh, after some
time we understood that even ifwe were having some good
(02:28):
traction in terms of gettingcustomers for developing very
specific portion of the devicesin Mexico, this was not really
creating value for ourinvestors. And that's when we
decided kind of only to focusinto the technologies that came
from the portfolio, fromoriginal portfolio of the
company. And for the reason,you know , it's been like
around maybe four or five yearsin which we , we have been
(02:49):
lesser focusing on developingour own IB portfolio, as you
mentioned , uh, during theintro, kind of our start
product or our main efforts are, you know , being targeted to
critical care and to cardiacsurgery. Essentially, the
problem that we are trying tosolve right now is helping
doctors , uh, particularly inthese settings, having a
(03:10):
objective information fordelivery treatment for the
patients. So, for instance,when a patient enters cardiac
surgery or a patient isadmitted into the I C U ,
doctors need to have a fairassessment of how likely is ,
uh, for the patient to developcomplications. And in that
regard, there are a number oftechnologies and a number of
biomarkers that offer someinformation, but none of them
(03:32):
are truly objective. And, youknow, there are some biases in
the methodologist . So ourdevice is essentially a gastro
tube, you know , is a tube thatgoes all the way down to the
stomach, from the nose or fromthe , from the mouth. And the
catheter measures certaingenetic properties that
correlate with , uh, thedevelopment of complications.
So we have recently completed aclinical trial in Mexico in a
(03:55):
very specific patientpopulation. Uh , you know,
patients receiving electivecardiac surgery. And the
results indicate that ourtechnology is capable, you
know, of , uh, differentiatingbetween the patients , uh, that
undergo without complicationsand the patients that develop,
you know, complications andeventually die. So the results
are pretty encouraging. Andwell now we are using this data
(04:17):
for, you know, getting ruralapproval for technology in ,
uh, western market , let's saythe us , the uk, and of course
Mexico. And we are also puttingour always in Australia. So
that's kind of the naturalrelationship that I have with
Latin America . And , and yeah,I mean, I am absolutely, I I
absolutely privileged to havethis opportunity of developing
(04:38):
this kind of technology hereand also kind of , you know,
serving perhaps, you know, as ,as inspiration hopefully for
other entrepreneurs , uh,willing to start this journey.
Speaker 2 (04:48):
Yes, yes. Well, congratulations. Um, seeing a
startup medical device companyfrom Latin America is, is, is a
surprise. And , uh, uh, is , is, uh, it's , uh, I'm , I'm
proud of it as Latin American ,uh, because , uh, it's not
common I , being in thisindustry for about 13 years
(05:09):
now. And , uh, I I've seen lessthan three companies, I will
say less than, I mean, it'sjust a handful of companies ,
uh, coming outta Latin Americawith , uh, and , and , and ,
and fewer of them with greatproducts like , like yours and
that , that are going in theright path. So , uh, I'm , I'm
very pleased to see your ucceyour success and, and, and to,
(05:31):
to see something good comingout of your, your efforts in,
in the region. So let's talkabout , um, trends , uh, Ruben
, uh, what trends , uh, do yousee happening in Latin America
that are relevant to ourdiscussion about clinical
research or commercializationor development of medical
technologies?
Speaker 3 (05:53):
Well, from the way they , the way I see it is
that, you know, Latin Americahas usually been a place where
companies come to sell theirdevices or manufacture the
devices, not necessarily a ,you know, a continent which
creates a new , uh, technologyfor the launches innovations.
Uh , I think that there aregood reasons for being
(06:13):
optimistic in that this regard, because from , let's say from
the last, I dunno , maybe sevento 10 years, there have been
some very timid , uh, efforts ,you know, for starting
developing technology. Oneexample, of course is Aandra
medical, but I have seen thatlately. Uh , well, first of all
, these kind of endeavors weremostly funded by, by , by the
(06:33):
government in terms of grants.
And usually the companies kindof were living for maybe about
, uh, six or seven years , uh,before finding financial
collapse. What I have beenseeing , uh, lately is that
this capital and private moneyis, you know, pouring into this
kind of endeavors. And I thinkthat , you know , success will
(06:54):
naturally attract more and moreinvestment into these kind of
projects. Uh , you know, I'mvery happy to see that, let's
say funds like SoftBank orCastech are starting, you know,
to, to bet and to put moneyinto a medical technology, not
necessarily, let's saysophisticated medical
technology in terms of , youknow, a monitoring device with
a , I dunno , an implantablecomponent or , or something
(07:16):
like that. But more into, let'ssay a digital technologies,
particularly those which are ,you know , uh, that , that you
can install in a cell phone ,whatever. And you have like an
app measuring biomarkers or arelike an measuring fitness and
things like that. And I thinkthat, you know , uh, success
will eventually create moreappetite within the investment
community to fund even riskierprojects . In the case of
(07:40):
Alandra. Well , this iscertainly kind of a riskier
product , if you will ,because, you know , uh, the ,
we are an invasive device, youknow, we're in contact with ,
with the patient, and, youknow, the kind of information
that our device producing canhave an impact, you know, in on
the outcome of criticalpatients. So from that
perspective, investment isreally not flowing. You know,
(08:00):
as much as I , I I would liketo, but I , and I , this is
something that actuallymotivates , uh, my team and I
that , uh, in the measure thatwe get success with this
technology. You know, otherinvestors will be willing to
put the money in there, butregardless of that, I really
think that , uh, you know, wehave seen more and more
startups, you know, operatingin the, let's say, wellness or
(08:22):
healthcare environment. Andyeah, I , I think that that is
something very nice. On theother hand , uh, well, I think
that a major advantage that wehave , at least in Mexico is
that we are network with the usand there is also creating a
very, very interesting trend,which is medical tourism. I
mean, this is completely, youknow , different from
evaluation part . What I thinkthat is also kind of a massive
(08:44):
business opportunities for ,uh, you know, healthcare
companies here in Mexico.
Because if you go to theborder, you will see fluxx of
American tourists , you know,get into a country for
receiving , let's say penilecare , or even what is called
the pharmaceutical tourism. Youknow, American citizens
crossing the border, weregetting know the same
medication, but I dunno , maybe10 times cheaper. So this trend
(09:04):
is, you know, increasinglybeing capitalized by
entrepreneurs and by, you know,companies in here. And actually
you've , you've go to , let'ssay private hospitals in Mexico
City, you'll see Americanslooking for, you know, cardiac
surgery or , or kind of, youknow, very procedures to be
performing here. Of course,there is, you know, some
skepticism about whether ,whether or not , uh, healthcare
(09:26):
here, you know, is reliable.
But the truth is that, youknow, increasingly more and
more people are coming toMexico to, you know, get
affordable healthcare and, youknow , uh, really our
physicians, you know, most ofthem have received training in
the US or in Israel or inEurope. So quality healthcare ,
uh, I believe that can be verysimilar to what you can get in
(09:48):
the us at least in privatehospitals, you know, but at ,
at that
sure what would be the resultof these , uh, different
parameters. We're certainlyexcited . I mean, if you have
like on one hand, a privatemoney pouring into , uh,
entrepreneurial efforts formedical technology, and on the
other hand you have likeAmericans coming into the
(10:10):
country for getting treatment.
So I think it's kind of an ,you know, interesting fer solve
for, you know, for, for themarket . And I would say that
those are perhaps the twotrends that I see most
exciting, you know , uh, forLatin America. And of course,
you know, in terms of clinicaltrials , uh, well , uh, we have
kind of , you know, ourpopulation is suffering mostly
(10:31):
the same non-communicablediseases than, you know , uh,
western markets , if you will .
So we have diabetes, and wehave, you know, kind of the ,
the same grievances that you'llfind in the , uh, states or in
or rest of Europe. We have themin here. And of course, you
know, needless to say , uh, thecost effectiveness of run a
trial in Mexico, you know, isvery, very attractive. So
(10:51):
that'll be kind of thetraditional trend, if you will
. But I think that the two mostexciting trends are medical
tourism and, you know , uh,private money pouring into
local , uh, you know,entrepreneurs. Mm-hmm .
Speaker 2 (11:04):
Yes. Yes. That's , that's very interesting , uh,
especially about the privatemoney pouring into local
companies from VC funds . Um ,are you seeing other companies
like yours , uh, in Mexico ,uh, with innovative products,
receiving funds? I mean, haveyou being a witness to, to, to
(11:25):
, uh, success ? Uh , cases,
Speaker 3 (11:27):
Certainly, yes. Uh , I mean , uh, there's a company,
I do not remember the name inthis moment, shame of me , but
they are , you know, screeninga breast cancer. So essentially
what they're using is imagingtechnology, and they're able,
you know, to detect cancer or,or , or at least, you know,
tissue anomalies . You know, wedon't necessarily needing the
traditional mast. So that , ofcourse, you know, having an
(11:50):
infrared camera is very cheaperthan having, you know, like ,
um, extra equipment. And as faras say , no , this company has
already received funding fordeveloping their technology,
and if my memory serve me well,they are already applying for a
five , 10 K in the US for
Speaker 2 (12:06):
Wow , nice .
Speaker 3 (12:07):
And yeah , and mean , you know , and there's some
other efforts, I mean, notnecessarily in the diagnostic
space, but mostly in thewellness space. So, you know,
you have like companiesdeveloping wearables for, you
know, measuring a certainassignments from the body in a
way that you can maybecorrelate with them with other
, uh, data and, you know, todeliver , um, wellness advice
(12:29):
to, to the patients. So, soyeah, I mean , uh, I , I really
must mention that I have notseen another company developing
like biomarkers as we are , butI think there's a very
interesting case in Chile, andin this case, I do remember the
, the name I think's Levitamagnetics , I mean , uh, they ,
as far as I understand ,they're like Chilean
entrepreneurs, and they havereceived funding from the u ssa
(12:51):
. And what they're developingis , uh, I understand is , uh,
robot assisted surgery. And insome measure they're using
magnetic fields for control.
The robot . I'm not reallysure, but I can , can , I think
this kind of , uh, remarkableexample of, you know , people
from Chile developing this kindof technology. Another company
that I have , uh, very good inmind is miraculous . I think
(13:15):
they also come from Chile, andthey're currently based in San
Francisco, and they'redeveloping, you know, this
fantastic platform for, youknow, developing , uh,
laboratory analysis over , overthe , over blood samples. And
they offer this platform for,you know, customizing different
, uh, uh, laboratoryexperiments , uh, you know, in
(13:36):
a miniature platform. And Ithink that they have also
received, you know, funding notonly from Latin America, but
also from American investors.
So I think those two are very,very inspirational examples for
us, for Aandra in a way thatit's possible to develop this
kind of , uh, inno innovationsand getting funding not only
from friends and family, fromthe government, but also, you
know, from real , uh, vc VCcapital.
Speaker 2 (14:00):
Excellent. Yeah, just , um, um, text you here,
another company that I learnedabout , uh, Ipol from Mexico.
They opened an office inSilicon Valley and they got
funding from the United States.
So, so I'm very happy to seeall those examples of companies
, uh, succeeding in , in LatinAmerica with their innovations
(14:22):
, uh, because as you correctlysaid , uh, the region is not
famous for that
there.
Speaker 3 (14:33):
So , sorry. I was just saying, I mean, and I
think that , you know, all ofthe companies that some extent
we have, you know, evolved to ,let's say a busy stage . I
think that , you know , besidesthe motivation of , you know ,
of course having a successfulbusiness , also creating
success stories in LatinAmerica , I think that should
also be, you know, aninspiration for us all , you
know, because that willcertainly bring more , uh, more
(14:56):
interest in the region, notonly for manufacturing, for
clinical trials, but also kindof for , uh, an innovation
laboratory, so to speak.
Speaker 2 (15:03):
Yes, yes, exactly.
That's a great point because ,uh, um, the talent available in
the United States, in SiliconValley, in , in Minnesota, in
Massachusetts is, is worldclass talent that , um, but but
at the same time, it's veryexpensive
if you wanna develop something, uh, using those engineers,
(15:26):
biomed engineers, or softwareengineers , I mean, you have to
pay a he hefty price. Uh, and Ithink , uh, there's , uh,
comparable or, or close tocomparable , uh, talent in
Latin American countries likeMexico, Colombia , Chile,
Argentina, Brazil, thatcompanies can tap into to
develop , uh, uh, technologiesat a lower price and, and
(15:48):
combine that with the othertalent in the United States so
that they can save , uh, money,right? And that's course big
issue for startups , of course,
Speaker 3 (15:58):
And most , most interestingly, I mean, at least
in my experience when I've beento Minnesota or to this other
major innovation centers,typically the engineer teams ,
you know , combine , I meanlike, you know , uh, scientists
and engineers from all over theworld, right? So I , I was in
Minnesota having , okay, soyou're from Mexico as well, but
you're here in Minnesotaworking medical innovation .
So, so yeah, it's kind of , youknow , uh, I think that part of
(16:20):
the glory, you know, of the USin terms of innovation is that
capability of attracting talentfrom all over the world. Uh ,
and , and so yeah, hopefully wecan replicate that in our
countries as well.
Speaker 2 (16:31):
Exactly. Exactly.
Well, and people like you are
famous
again. Um, alright , Ruen , solet's talk about what you're
doing in Latin America. What isit that , uh, you are involved
in right now, clinical research, uh, commercialization
(16:51):
development? How is LatinAmerica , uh, fitting into your
plans to develop yourtechnology ?
Speaker 3 (17:00):
So let's say from the Orlando perspective, I
mean, as I mentioned before,we're like 100% focused on, you
know, getting this technologyto market. Uh , we have already
concluded , uh, of course the,you know, the research and
development phase, you know ,uh, and recently the clinical
clinical validation. And rightnow we are , you know , putting
all of our efforts in getting,you know, the regulatory
(17:21):
process for, you know, startselling this technology , uh,
first let's say in westernmarkets over where Mexico
course included, but also the US A and in Europe we are facing
some challenges, you know, forthe European market because as
you know, recently they havethe medical gas regulation .
And it is not a matter that ourtechnical information is not,
(17:41):
you know , up to the levelrequired by the mdr , where's
more , you know , a saturationproblem , you know , notified
bodies in Europe completelymore incapable of coping with
the demand. So that's kind ofthe challenge that we have
right now. Uh , but you know,at the same time, we are
pursuing the approval forcoffee and also for , uh, for
the F D A and they use , youknow, for getting approval in
(18:02):
the USA is that our technology,you know, can feed into a five
10 K process . So, you know,we're optimistic about it and
we're also putting our eyes inAustralia because Australia
right now has very interesting,you know, incentives for , uh,
creating
I mean , uh, we are, you know ,uh, we have, you know, 90%
(18:23):
ready , uh, our technical thisyear together with that, you
know, we are creating thescientific publications of the
result from our experimentsbecause , you know, we, we need
to, to cover all of the aspectsof , of innovation, not only
the regulation , but also weneed to pay attention to, to ,
to a clinical , uh, uh, papersand also to the IP and all of
(18:44):
that. So we are, you know, alsomaking those , uh, aspects
stronger in, in the business.
And , and yeah, and , and let'ssee . On a more personal note,
you know, I have some sideproducts with the family, which
are also trying to capitalizein the strength that I
mentioned before. Uh , youknow, so we are also working,
you know, with dermatology and,you know, it's very curious
that everything that is relatedto beauty and to personal care
(19:07):
in Mexico is kind of on fireright now. So let's say
whatever from a laser , uh,hair removal or to cause me ,
you know, which are thesehighend dermatological pro
products that can , you know,improve , they have all the
skin . And , and that kind ofthing is also very interesting
trend. You know, kind of themiddle class is increasingly
having, you know , this kind of, so, so that's also a very
(19:30):
interesting trend that we're,you know , uh, focusing right
now, at least, you know, in ,in the closest sphere , which
is the family. But , but yeah,I mean , uh, again , uh, in
terms of aandra , uh, we hopeto get this approvals within
the next year. Of course, youknow, we have already have ,
uh, in terms of Euro Brexit,and then we have the pandemic,
you know, certain unexpected ,uh, things have came across,
(19:51):
but we are kind of 100% , uh,convinced that we can make it
and that we can get thisapprovals. And of course, you
know, once that you get an fFDA approval, capital, you
know, is far, you know,complicated
? So that's part of thestrategic reason that we are
pursuing also this kind ofapprovals in western markets.
Speaker 2 (20:11):
Very good. So Roen , let's focus , uh, for a minute
on your experience with yourclinical trial, with your early
feasibility , first in humanclinical trial in Mexico, and
your experience with Coveredpriest , because I'm , I'm sure
that's where our audience , um,uh, wants to, to focus the
(20:35):
conversation because that's oneof the reasons companies , uh,
medical device companies , uh,from the US go to Latin America
to, to test the , or tovalidate the safety and , and
efficacy of their innovations .
So what's the framework , um,for , uh, doing a clinical
(20:55):
trial in Mexico? Uh, what wasyour experience , uh, finding
investigators, finding sites?
What was your experience withCarris , et cetera ? Could you
elaborate on that?
Speaker 3 (21:07):
Absolutely. So let's say I , I , I'll start, you
know, with the , uh, researchcomponent of this. So in our
experience, you know, doctors,particularly young doctors, are
very keen on trying, you know,new , uh, new technologies and
trying new pharmaceuticals. Andthere are kind of many drivers
for that. One of them is that,you know, they want to create,
you know , a reputation for ,for their own. So that's kind
(21:29):
of a , a big driver for them toget involved with these kind of
projects. And on the otherhand, you know, kind of the
incentives that most of thedoctors that work, you know,
let's say in public centers isthat, you know, the more
publications that they have,the more likely is that they
can, you know , uh, grow , uh,within the , the hospital. And
well , that, you know, makesit, I wouldn't say easier, but
(21:50):
I would say it really helps,you know, to, to attract this
kind of talent into, intoprojects like , like this.
Something that , that I mustmention though is that, well ,
aand has only kind of operatedwith public hospitals,
particularly, you know, thehospital for cardiology and for
respiratory diseases, and alsofor nutrition is that, you
know, these hospitals aresubjected to state bureaucracy,
(22:13):
and there are also some unionswhich are operating there. So
that can bridge somefrustrations, you know, when
you are kind of plan planningand developing a trial. And
that is something that I willreally advise , uh, other
companies to keep in mind that,you know, state bureaucracy is
something that exists in thepublic centers and well , that,
that may influence theirdecision for getting perhaps
(22:33):
into a private hospital. But interms, you know, of the, I
would say , I would sayintellectual , uh, capital
within the hospitals isabsolutely fantastic. And, and
yeah, I mean , uh, in ourexperience, you know, the
patient population isavailable, at least for our,
our kind of device. I'm prettysure that, you know, any
(22:55):
company working with , youknow, with , uh, grievances in
, uh, from the western worldwill be able to find, you know,
a patient population for thestudy here in Mexico. And also,
you know , uh, regardless offocusing into private or public
healthcare , they willcertainly find a hospital for
that. And, eh , and yes , so interms of coffee, please , uh, I
(23:17):
think that if you have a verygood understanding and of , and
also very good counseling, youcan really get a grasp on the
processes and really get agrasp, you know, on what is
required for, you know, havinga decent human study here. And
yeah, my , my advice would bejust like, you know , get a , a
reliable consultant from Mexicoand , uh, you know, be really
(23:40):
diligent in terms ofunderstanding the local
relation . I mean , and if youtick all of the boxes , uh,
you'll will really not find anykind of , of problem. Uh , as ,
as a side note, some people,you know, is tempted to
recommend that they need tocreate, you know , certain
personal relationship with theofficials at Coffee Press . I
will really discourage thatkind of approach because, I
(24:00):
mean, you can do it , you know,by the book, you know, and you
can tick all of the boxes andyou'll really, you know, you'll
not be in need of any kind offriendship, you know, with so ,
uh,
that kind of advice, you know ,uh, that's advice and that's
advice that I have heard, youknow, in other instances. So I
would really discourage that.
(24:21):
And I would say that , uh, aslong as you are really diligent
in understanding regulation,all you need is kind of
intellectual capital , uh, uh,and that's it, that you'll be
on the other side.
Speaker 2 (24:32):
Okay. So in terms of timeline , uh, how long will it
take to get a trial approval ingeneral? I mean, based on your
experience and based on whatyou've heard about , uh, other
companies doing similar studiesin Mexico, what will be the
ethics committee approvaltimeline? What will be the
And in general, how long willit take for a company to, to,
(24:55):
to from the day they , theysubmit , uh, to the ethics
committee and the day they getthe patient on the table?
Speaker 3 (25:02):
Okay, lemme put it this way , uh, for this last
trial that we executed, let'ssay from day one, from day one
in which we say, okay, helloguys, we want to run a hospital
to day one with patient, it was, uh, 15 months, you know, from
the , from the very first dayin which we, you know , uh,
were engaging with thephysicians and we were
(25:22):
developing the protocol. Uh ,they , we have the very first
patient. It was , uh, around 15months, give or take. And in
terms of cough quiz , somethingthat I would really recommend
then is to go to what is calledgoodness in English , is the ,
uh, well , I , I , I can getthe name for you, but it's kind
of , um, preliminaryapplication that you have for
(25:42):
your protocol before you filethe actual thing. So that, that
is very useful because KarisScan came back to you, you
know, with somerecommendations. I , with some
gaps in your, in yourpaperwork. And again, I mean,
as long as you understand whatthe law says about , uh,
clinical trials here, I mean,you can be , uh, I would say
pretty confident that , uh, youcan get your paperwork, you
(26:04):
know, approved , uh, within thetimeframes , uh, that are
advertised on , on Con'swebsite. So , uh, yeah, I mean
, that , that's kind of ourexperience. I cannot mention
kind of , uh, clear dates. Imean, to to say like, it was
three months and there fourmonths, but day one to the , to
our first patient, it wasaround 15 months. And again ,
(26:25):
uh, just for having some , uh,uh, parameters, this was a
trial on elective cardiacsurgeries, you know, very, very
little patients. And , uh, youknow, the , uh, the check marks
that we had to, to payattention to in terms of the
secular trial where you, youknow, kind of , uh, noticeable
and , uh, um, my assumptionwill be that , you know, trials
(26:49):
with less risky patientpopulations, you know, most
likely will require , you know, a shorter period of time for
, for getting the trialapproved and for getting the
first , the first patient . Andafter that trial , you know, we
had zero adverse events relatedto our technology. However, you
know , uh, if a patient diesduring your study, whether you
(27:10):
know it is related to yourtechnology or not, you still
need to report it to a ris .
And I can tell you that thereporting process was
absolutely flawless. I mean, wejust sent paperwork and we had
absolutely zero inconveniencein that, in that regard. And
also when we notified CoffeePriests that our study was
completed, I mean , it was justkind of a matter of creating
the paper once and sending itover, and it was absolutely
(27:31):
fine. So, so yeah, I mean,again, I, I cannot recommend it
enough to, to have a goodunderstanding and to have, you
know , good counseling and youshould be able to run a smooth
trial here.
Speaker 2 (27:43):
Very good. But you mentioned something that is
very intriguing. You mentionedsomething like , uh, a
pre-submission to Cover Priest. Are you talking about , uh,
uh, um, predic timing ?
Speaker 3 (27:55):
Exactly, yes. That , that , that was the , the thing
that I was trying to, to Okay .
Speaker 2 (27:58):
Predict timing .
Alright . Yes . Could you ,could you talk a little bit
more about that? Is thatsomething that is, because I
heard that before the pandemic,it was , uh, uh, a real thing
was the , the, the unidas , thepredict timing where everywhere
in Mexico, but after thepandemic that , uh, went away
and they're no longer active.
(28:19):
Um, could you clarify on that?
I mean, how does it work?
Speaker 3 (28:23):
You know what? I dunno . That's a very good
point. I mean, in our , yeah ,because I mean, yeah , we , we
submitted that credit , uh,before the pandemic , uh, and
yeah,
working then right now, becauseyes, I mean, in our case , uh,
it was very smooth, but afterthe pandemic , uh, yeah, most
(28:45):
likely it has suffered somesort of disruption.
Speaker 2 (28:47):
Yeah, yeah, exactly.
And , and for the audience here, uh, a predict timing is , um,
is , is is something in theMexican system , uh, to , um,
approve , uh, new medicaldevice, well, new , uh,
clinical research studies,pharma or devices , um, that ,
(29:11):
uh, allows third party privateentities to review the Dosier
before the dossier is sent toCover Priest . So these private
entity is of course, certifiedby Cover Priest to review , uh,
these dossiers and, and, andcover priest trust the , the
opinion of these third partyentities. And , uh, after you
(29:35):
get the review and the opinionof the third party entity that
they'll call is the predicttiming , uh, then you can just
attach that letter to you tosee it , to cover Priest . And
you should get a very, veryfast , uh, approval at ,
because you already have apre-approval at the timing ,
uh, unit ,
Speaker 3 (29:55):
Right , as most likely there's some disruption
in there after the , thepandemic. And also, you know,
after maybe some restructuring, uh, uh, inside coffee ,
please . Uh , but yeah, I mean, uh, I , I really need, I I'm
taking that away, you know , ashomework after this call,
Speaker 2 (30:12):
Yes, yes. I think that that's a , that's a great
, uh, thing that Mexico hasalso for the registration of ,
uh, commercial devices. Theyhave these , uh,
right, authorized thirdparties, which is fantastic.
Uh, it's a great system. But ,uh, uh, the new government ,
uh, Lopez , I understand tookthat away or restructure that
(30:38):
because there was some, somecorruption involved in, in that
, uh,
Speaker 3 (30:49):
Rabbit , but yeah , I mean that , that will take us
to very tight places. So
Speaker 2 (30:52):
Yes, I know, I know.
Let's avoid that. But , uh,avoid my, my opinion of Covered
Priest now, and from what Ihear from people, I just came
back from Mexico last week, isthat Covered Priest is really
Wiki really making an effort to, um, to fix the reputation of
inefficiencies that he had ,uh, is , um, making their
(31:16):
timelines way better and makingtheir processes more
predictable. And by the way, Ialso heard that Ka priest just
join I c h, the InternationalConsole of Harmonization , uh,
which is a big deal. Iunderstand he's the only agency
in Latin America that is partof I c h , uh, for clinical
(31:37):
research. So that sends thesignal that cover really,
really wants to be competitivein Latin America for the
approval of , uh, clinical ,clinical trials . So I'm very
happy to hear that .
Speaker 3 (31:51):
Absolutely , absolutely. And I , I must also
mention, I mean , uh, I thinkthat within the very few
positive things, if you will,after the pandemic, is that I
think it was a seriouspotential call for , uh, all of
Latin America in terms that wetried , at least in Mexico. You
know, there were various , uh,incentives to develop, you know
, uh, respiratory machines andstuff like that. And I think
(32:14):
that we'll just see it like ,like , like a brick wall in
terms that , uh, I mean, youcan't build , uh, respiratory
machines out of the blue. And Imean , I mean, of course there
were, you know, successful eefforts , uh, to , to some
measure. But in general, kindof the, the scientific
community, the engineercommunity , and the general
(32:36):
ecosystem , you , we , you know, hit hard in a way that we do
not have a robust e system forthis kind of emergencies. And I
think that , uh, will down theroad, you know, influence
politics , uh, and influence ,uh, you know, how , uh, and
other stakeholders, you know,operate in a way that we really
(32:58):
need to have, you know, a , arobust ecosystem in place for
this kind of emergencies. So,so again, I mean, I really
admire the people that, youknow, went through the process
of building this kind ofmachines, but I think that ,
uh, one of the results is thatwe are shocked by the fact
that, I mean, our capabilitiesfor responding to these things
is not what was necessarily twoor three also . So I think that
(33:22):
one of the positive things thatwe can say after all of this
pain is that , uh, this willshake , uh, the , the policy
around around technologydevelopment here.
Speaker 2 (33:31):
Yes, yes, you are correct on , on that. Uh, I was
stuck in Columbia during thepandemic, and I witnessed the
development of about at least10 different efforts to , uh,
create , uh, ventilators bylocal , uh, universities and,
and innovation groups, butnothing really materialized.
(33:52):
And, and the regulatory agencyreally, really hard had a hard
time , uh, coping with thedemand for , um, uh, reviews
and, and applications forapprovals. And you could see,
because those are publicdocuments Yeah , I was reading
all of them. You could see that, uh, the innovators didn't
really know what to do, and theregulatory agency didn't even
(34:14):
know what to do either. So itwas a lot of confusion. Yeah.
Speaker 3 (34:19):
And again , I mean , this is not , not not , you
know , a matter of blamingpeople or , or kind of , I mean
, it's a matter that as asociety, we have not the
conditions for , uh, you know ,being able to respond to this
kind of emergency . So I reallywant to be optimistic in the
way that this should shape ,uh, policy , uh, you know, down
the road for the next pandemic.
(34:39):
We , it's just a matter of time. So sadly,
Speaker 2 (34:43):
Yeah . Now, now Columbia's regulatory agency ,
DEMA is a better agency becauseof the pandemic. I think the
digitalization of the agencywas , uh, fantastic. The, the,
the, the new people that theyhad to , uh, put in the
committees to evaluate thesetechnologies, it was fantastic
because they had to up theirgame , uh, for these new influx
(35:06):
of innovation that came duringthe pandemic. So it's a win-win
for everybody at the end, Ithink.
Speaker 3 (35:12):
Yeah , absolutely.
Speaker 2 (35:14):
Alright , Wayne , I think we're close to the end of
the show. And , uh, do you haveany final words of wisdom, any
final , uh, thoughts , uh, thatyou wanna share with the
audience before we close?
Speaker 3 (35:25):
Well , I mean, I , I just want to , to stress that,
I mean, we can do very nicethings in here , uh, and , uh,
you know , uh, as I mentionedbefore, the latest experience
with the pandemic and togetherwith , you know, with these
trends of busy monitoring intoLatin America and, you know,
the, the size of the market inLatin America, you know, I
think it's , uh, those areconditions, you know,
(35:47):
promissory of having, you know,an innovation cluster in here.
And , and again, I mean, weshould not try to copy models
from Silicon Valley, which is,you know, kind of this , uh,
weird thing that everybodytalks about. I mean, of course
Silicon Valley works because itdeveloped under very specific
conditions. We have differentconditions, different, you
know, society and whatever. Soinstead of trying to emulate
(36:08):
what has been done in there, Ithink we should really just ,
uh, study those success storiesand create our own ecosystem
for, for innovation. Because Imean, we have fantastic
universities, we have fantastic, uh, inter , inter to capital.
We all speak Spanish, and weare a gigantic , uh, continent.
So I think that there areconditions , uh, and I think
(36:28):
that, I mean, there are verygood reasons for being
optimistic and to attract, youknow, prosperity for our
societies.
Speaker 2 (36:36):
Well said. Thank you, Ruben . All right . So it
was great having you here,Ruben . Thank you so much for
sharing your knowledge and ,uh, I look forward to being in
touch with you. Thank
Speaker 3 (36:47):
You very much .
Thank you very much for, forhaving me. And well , thank you
Speaker 2 (36:52):
Bye bye-Bye.
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