Feb. 16, 2023

Ruben Gaitan Ortiz, CEO at Alandra Medical

Ruben Gaitan Ortiz, CEO at Alandra Medical
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Season 1

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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Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform, apple Podcast, Spotify, Google Podcast. Amazon Music is teacher. Tune in iHeart Radio, Pandora or Deezer .

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Welcome back to the Latin MedTech Leaders podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, 45 , Google Podcast, et cetera . Today our guest is Rue Gaitan Ortiz, c e o. At Allandra Medical, Ang is developing novel monitoring technologies to save the most vulnerable patients from dire complications in cardiac surgery and critical care. So, Rue , welcome to the show.

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Thank you very much for having me.

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Awesome, Rue . So let's talk about your journey to Latin America. Ruben , how is it that you got involved with the region?

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Absolutely. So, well, first of all , uh, I was working in Mexico, so I am naturally engaged with the region and well, I have a background in biomedical engineering. So right after I finalized my students at university, I joined and start company, you know, developing medical devices and trying to bring , uh, innovations from the university into the market. This was a small company which was launched by a professor at university. And essentially my role was like , uh, only in engineering aspects, you know, developing , uh, electric circuits and some software kind of in a very, very geeky way of the innovation, if you will. And after some years, the company was , uh, acquired , uh, by another , uh, entrepreneur effort, and he received some busy funding. And in that moment, it was kind of an inflection point because a company sees to be a , you know, like an only academic endeavor, and they start to be like a more professional company. So in that period, we developed our processes with certifications, and we actually started to offer a , you know, the office services for other customers also in , in Mexico and also in, in the u s a . And at the same time, the company was incubating its own technology. Most of regional came from the previous , uh, company that I mentioned before. And , uh, after some time we understood that even if we were having some good traction in terms of getting customers for developing very specific portion of the devices in Mexico, this was not really creating value for our investors. And that's when we decided kind of only to focus into the technologies that came from the portfolio, from original portfolio of the company. And for the reason, you know , it's been like around maybe four or five years in which we , we have been lesser focusing on developing our own IB portfolio, as you mentioned , uh, during the intro, kind of our start product or our main efforts are , you know , being targeted to critical care and to cardiac surgery. Essentially, the problem that we are trying to solve right now is helping doctors , uh, particularly in these settings, having a objective information for delivery treatment for the patients. So, for instance, when a patient enters cardiac surgery or a patient is admitted into the I C U , doctors need to have a fair assessment of how likely is , uh, for the patient to develop complications. And in that regard, there are a number of technologies and a number of biomarkers that offer some information, but none of them are truly objective. And, you know, there are some biases in the methodologist . So our device is essentially a gastro tube, you know , is a tube that goes all the way down to the stomach, from the nose or from the , from the mouth. And the catheter measures certain genetic properties that correlate with , uh, the development of complications. So we have recently completed a clinical trial in Mexico in a very specific patient population. Uh , you know, patients receiving elective cardiac surgery. And the results indicate that our technology is capable, you know, of , uh, differentiating between the patients , uh, that undergo without complications and the patients that develop, you know, complications and eventually die. So the results are pretty encouraging. And well now we are using this data for, you know, getting rural approval for technology in , uh, western market , let's say the us , the uk, and of course Mexico. And we are also putting our always in Australia. So that's kind of the natural relationship that I have with Latin America . And , and yeah, I mean, I am absolutely, I I absolutely privileged to have this opportunity of developing this kind of technology here and also kind of , you know, serving perhaps, you know, as , as inspiration hopefully for other entrepreneurs , uh, willing to start this journey.

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Yes, yes. Well, congratulations. Um, seeing a startup medical device company from 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 this industry for about 13 years now. And , uh, I I've seen less than three companies, I will say less than, I mean, it's just a handful of companies , uh, coming outta Latin America with , uh, and , and , and , and fewer of them with great products like , like yours and that , that are going in the right path. So , uh, I'm , I'm very pleased to see your ucce your success and, and, and to, to see something good coming out of your, your efforts in, in the region. So let's talk about , um, trends , uh, Ruben , uh, what trends , uh, do you see happening in Latin America that are relevant to our discussion about clinical research or commercialization or development of medical technologies?

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Well, from the way they , the way I see it is that, you know, Latin America has usually been a place where companies come to sell their devices or manufacture the devices, not necessarily a , you know, a continent which creates a new , uh, technology for the launches innovations. Uh , I think that there are good reasons for being optimistic in that this regard , because from , let's say from the last, I dunno , maybe seven to 10 years, there have been some very timid , uh, efforts , you know, for starting developing technology. One example, of course is Aandra medical, but I have seen that lately. Uh , well, first of all , these kind of endeavors were mostly funded by, by , by the government in terms of grants. And usually the companies kind of were living for maybe about , uh, six or seven years , uh, before finding financial collapse. What I have been seeing , uh, lately is that this capital and private money is, you know, pouring into this kind of endeavors. And I think that , you know , success will naturally attract more and more investment into these kind of projects. Uh , you know, I'm very happy to see that, let's say funds like SoftBank or Castech are starting, you know, to, to bet and to put money into a medical technology, not necessarily, let's say sophisticated medical technology in terms of , you know, a monitoring device with a , I dunno , an implantable component or , or something like that. But more into, let's say 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 are like an measuring fitness and things like that. And I think that, you know , uh, success will eventually create more appetite within the investment community to fund even riskier projects . In the case of Alandra. Well , this is certainly kind of a riskier product , if you will , because, you know , uh, the , we are an invasive device, you know, we're in contact with , with the patient, and, you know, the kind of information that our device producing can have an impact, you know, in on the outcome of critical patients. So from that perspective, investment is really not flowing. You know, as much as I , I I would like to, but I , and I , this is something that actually motivates , uh, my team and I that , uh, in the measure that we get success with this technology. You know, other investors will be willing to put the money in there, but regardless of that, I really think that , uh, you know, we have seen more and more startups, you know, operating in the, let's say, wellness or healthcare environment. And yeah, I , I think that that is something very nice. On the other hand , uh, well, I think that a major advantage that we have , at least in Mexico is that we are network with the us and there is also creating a very, very interesting trend, which is medical tourism. I mean, this is completely, you know , different from evaluation part . What I think that is also kind of a massive business opportunities for , uh, you know, healthcare companies here in Mexico. Because if you go to the border, you will see fluxx of American tourists , you know, get into a country for receiving , let's say penile care , or even what is called the pharmaceutical tourism. You know, American citizens crossing the border, were getting know the same medication, but I dunno , maybe 10 times cheaper. So this trend is, you know, increasingly being capitalized by entrepreneurs and by, you know, companies in here. And actually you've , you've go to , let's say private hospitals in Mexico City, you'll see Americans looking for, you know, cardiac surgery or , or kind of, you know, very procedures to be performing here. Of course, there is, you know, some skepticism about whether , whether or not , uh, healthcare here, you know, is reliable. But the truth is that, you know, increasingly more and more people are coming to Mexico to, you know, get affordable healthcare and, you know , uh, really our physicians, you know, most of them have received training in the US or in Israel or in Europe. So quality healthcare , uh, I believe that can be very similar to what you can get in the us at least in private hospitals, you know, but at , at that cost . So I believe that, you know, I'm not sure what would be the result of these , uh, different parameters. We're certainly excited . I mean, if you have like on one hand, a private money pouring into , uh, entrepreneurial efforts for medical technology, and on the other hand you have like Americans coming into the country for getting treatment. So I think it's kind of an , you know, interesting fer solve for, you know, for, for the market . And I would say that those are perhaps the two trends that I see most exciting, you know , uh, for Latin America. And of course, you know, in terms of clinical trials , uh, well , uh, we have kind of , you know, our population is suffering mostly the same non-communicable diseases than, you know , uh, western markets , if you will . So we have diabetes, and we have, you know, kind of the , the same grievances that you'll find in the , uh, states or in or rest of Europe. We have them in here. And of course, you know, needless to say , uh, the cost effectiveness of run a trial in Mexico, you know, is very, very attractive. So that'll be kind of the traditional trend, if you will . But I think that the two most exciting trends are medical tourism and, you know , uh, private money pouring into local , uh, you know, entrepreneurs. Mm-hmm . .

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Yes. Yes. That's , that's very interesting , uh, especially about the private money 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, have you being a witness to, to, to , uh, success ? Uh , cases,

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Certainly, yes. Uh , I mean , uh, there's a company, I do not remember the name in this moment, shame of me , but they are , you know, screening a breast cancer. So essentially what they're using is imaging technology, and they're able, you know, to detect cancer or, or , or at least, you know, tissue anomalies . You know, we don't necessarily needing the traditional mast. So that , of course, you know, having an infrared camera is very cheaper than having, you know, like , um, extra equipment. And as far as say , no , this company has already received funding for developing their technology, and if my memory serve me well, they are already applying for a five , 10 K in the US for

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Wow , nice .

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And yeah , and mean , you know , and there's some other efforts, I mean, not necessarily in the diagnostic space, but mostly in the wellness space. So, you know, you have like companies developing wearables for, you know, measuring a certain assignments from the body in a way that you can maybe correlate with them with other , uh, data and, you know, to deliver , um, wellness advice to, to the patients. So, so yeah, I mean , uh, I , I really must mention that I have not seen another company developing like biomarkers as we are , but I think there's a very interesting case in Chile, and in this case, I do remember the , the name I think's Levita magnetics , I mean , uh, they , as far as I understand , they're like Chilean entrepreneurs, and they have received funding from the u ssa . And what they're developing is , uh, I understand is , uh, robot assisted surgery. And in some measure they're using magnetic fields for control. The robot . I'm not really sure, but I can , can , I think this kind of , uh, remarkable example of, you know , people from Chile developing this kind of technology. Another company that I have , uh, very good in mind is miraculous . I think they also come from Chile, and they're currently based in San Francisco, and they're developing, you know, this fantastic platform for, you know, developing , uh, laboratory analysis over , over the , over blood samples. And they offer this platform for, you know, customizing different , uh, uh, laboratory experiments , uh, you know, in a miniature platform. And I think that they have also received, you know, funding not only 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 that it's possible to develop this kind of , uh, inno innovations and getting funding not only from friends and family, from the government, but also, you know, from real , uh, vc VC capital.

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Excellent. Yeah, just , um, um, text you here, another company that I learned about , uh, Ipol from Mexico. They opened an office in Silicon Valley and they got funding from the United States. So, so I'm very happy to see all those examples of companies , uh, succeeding in , in Latin America with their innovations , uh, because as you correctly said , uh, the region is not famous for that , but , uh, slowly we we're gonna get there. . So Roy , yeah, go ahead.

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So , sorry. I was just saying, I mean, and I think that , you know, all of the companies that some extent we have, you know, evolved to , let's say a busy stage . I think that , you know , besides the motivation of , you know , of course having a successful business , also creating success stories in Latin America , I think that should also be, you know, an inspiration for us all , you know, because that will certainly bring more , uh, more interest in the region, not only for manufacturing, for clinical trials, but also kind of for , uh, an innovation laboratory, so to speak.

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Yes, yes, exactly. That's a great point because , uh, um, the talent available in the United States, in Silicon Valley, in , in Minnesota, in Massachusetts is, is world class talent that , um, but but at the same time, it's very expensive , right? So if you wanna develop something , uh, using those engineers, biomed engineers, or software engineers , I mean, you have to pay a he hefty price. Uh, and I think , uh, there's , uh, comparable or, or close to comparable , uh, talent in Latin American countries like Mexico, Colombia , Chile, Argentina, Brazil, that companies can tap into to develop , uh, uh, technologies at a lower price and, and combine that with the other talent in the United States so that they can save , uh, money, right? And that's course big issue for startups , of course ,

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And most , most interestingly, I mean, at least in my experience when I've been to Minnesota or to this other major innovation centers, typically the engineer teams , you know , combine , I mean like, you know , uh, scientists and engineers from all over the world, right? So I , I was in Minnesota having , okay, so you're from Mexico as well, but you're here in Minnesota working medical innovation . So, so yeah, it's kind of , you know , uh, I think that part of the glory, you know, of the US in terms of innovation is that capability of attracting talent from all over the world. Uh , and , and so yeah, hopefully we can replicate that in our countries as well.

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Exactly. Exactly. Well, and people like you are making our region famous for vertical innovation. Congratulations again. Um, alright , Ruen , so let's talk about what you're doing in Latin America. What is it that , uh, you are involved in right now, clinical research , uh, commercialization development? How is Latin America , uh, fitting into your plans to develop your technology ?

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So let's say from the Orlando perspective, I mean, as I mentioned before, we're like 100% focused on, you know, getting this technology to 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 right now we are , you know , putting all of our efforts in getting, you know, the regulatory process for, you know, start selling this technology , uh, first let's say in western markets over where Mexico course included, but also the U S A and in Europe we are facing some challenges, you know, for the European market because as you know, recently they have the medical gas regulation . And it is not a matter that our technical information is not, you know , up to the level required by the mdr , where's more , you know , a saturation problem , you know , notified bodies in Europe completely more incapable of coping with the demand. So that's kind of the challenge that we have right now. Uh , but you know, at the same time, we are pursuing the approval for coffee and also for , uh, for the F D A and they use , you know, for getting approval in 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 in Australia because Australia right now has very interesting, you know, incentives for , uh, creating . And so that's where we are right now. I mean , uh, we are, you know , uh, we have, you know, 90% ready , uh, our technical this year together with that, you know, we are creating the scientific publications of the result from our experiments because , you know, we, we need to, to cover all of the aspects of , of innovation, not only the regulation , but also we need to pay attention to, to , to a clinical , uh, uh, papers and also to the IP and all of that. So we are, you know, also making those , uh, aspects stronger in, in the business. And , and yeah, and , and let's see . On a more personal note, you know, I have some side products with the family, which are also trying to capitalize in the strength that I mentioned before. Uh , you know, so we are also working, you know, with dermatology and, you know, it's very curious that everything that is related to beauty and to personal care in Mexico is kind of on fire right now. So let's say whatever from a laser , uh, hair removal or to cause me , you know, which are these highend dermatological pro products that can , you know, improve , they have all the skin . And , and that kind of thing is also very interesting trend. You know, kind of the middle class is increasingly having, you know , this kind of , so, so that's also a very 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 hope to get this approvals within the next year. Of course, you know, 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, but we are kind of 100% , uh, convinced that we can make it and that we can get this approvals. And of course, you know, once that you get an f FDA approval, capital, you know, is far, you know, complicated , right ? So that's part of the strategic reason that we are pursuing also this kind of approvals in western markets.

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Very good. So Roen , let's focus , uh, for a minute on your experience with your clinical trial, with your early feasibility , first in human clinical trial in Mexico, and your experience with Covered priest , because I'm , I'm sure that's where our audience , um, uh, wants to, to focus the conversation because that's one of the reasons companies , uh, medical device companies , uh, from the US go to Latin America to, to test the , or to validate the safety and , and efficacy of their innovations . So what's the framework , um, for , uh, doing a clinical trial in Mexico? Uh, what was your experience , uh, finding investigators, finding sites? What was your experience with Carris , et cetera ? Could you elaborate on that?

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Absolutely. So let's say I , I , I'll start, you know, with the , uh, research component 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. And there 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 of a , a big driver for them to get involved with these kind of projects. And on the other hand, you know, kind of the incentives that most of the doctors that work, you know, let's say in public centers is that, 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, makes it, I wouldn't say easier, but I would say it really helps, you know, to, to attract this kind of talent into, into projects like , like this. Something that , that I must mention though is that, well , aand has only kind of operated with public hospitals, particularly, you know, the hospital for cardiology and for respiratory diseases, and also for nutrition is that, you know, these hospitals are subjected to state bureaucracy, and there are also some unions which are operating there. So that can bridge some frustrations, you know, when you are kind of plan planning and developing a trial. And that is something that I will really advise , uh, other companies to keep in mind that, you know, state bureaucracy is something that exists in the public centers and well , that, that may influence their decision for getting perhaps into a private hospital. But in terms, you know, of the, I would say , I would say intellectual , uh, capital within the hospitals is absolutely fantastic. And, and yeah, I mean , uh, in our experience, you know, the patient population is available, at least for our, our kind of device. I'm pretty sure that, you know, any company working with , you know, with , uh, grievances in , uh, from the western world will be able to find, you know, a patient population for the study here in Mexico. And also, you know , uh, regardless of focusing into private or public healthcare , they will certainly find a hospital for that. And, eh , and yes , so in terms of coffee, please , uh, I think that if you have a very good understanding and of , and also very good counseling, you can really get a grasp on the processes and really get a grasp, you know, on what is required for, you know, having a decent human study here. And yeah, my , my advice would be just like, you know , get a , a reliable consultant from Mexico and , uh, you know, be really diligent in terms of understanding the local relation . I mean , and if you tick all of the boxes , uh, you'll will really not find any kind of , of problem. Uh , as , as a side note, some people, you know, is tempted to recommend that they need to create, you know , certain personal relationship with the officials at Coffee Press . I will really discourage that kind of approach because, I mean, you can do it , you know, by the book, you know, and you can tick all of the boxes and you'll really, you know, you'll not be in need of any kind of friendship, you know, with so , uh, this , because in many instances I've heard that kind of advice, you know , uh, that's advice and that's advice that I have heard, you know, in other instances. So I would really discourage that. And I would say that , uh, as long 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.

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Okay. So in terms of timeline , uh, how long will it take to get a trial approval in general? I mean, based on your experience and based on what you've heard about , uh, other companies doing similar studies in Mexico, what will be the ethics committee approval timeline? What will be the approval timeline? And in general, how long will it take for a company to, to, to from the day they , they submit , uh, to the ethics committee and the day they get the patient on the table?

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Okay, lemme put it this way , uh, for this last trial that we executed, let's say from day one, from day one in which we say, okay, hello guys, we want to run a hospital to day one with patient, it was , uh, 15 months, you know, from the , from the very first day in which we, you know , uh, were engaging with the physicians and we were developing the protocol. Uh , they , we have the very first patient. It was , uh, around 15 months, give or take. And in terms of cough quiz , something that I would really recommend then is to go to what is called goodness in English , is the , uh, well , I , I , I can get the name for you, but it's kind of , um, preliminary application that you have for your protocol before you file the actual thing. So that, that is very useful because Karis Scan came back to you, you know, with some recommendations. I , with some gaps in your, in your paperwork. And again, I mean, as long as you understand what the law says about , uh, clinical trials here, I mean, you can be , uh, I would say pretty confident that , uh, you can get your paperwork, you know, approved , uh, within the timeframes , uh, that are advertised on , on Con's website. So , uh, yeah, I mean , that , that's kind of our experience. I cannot mention kind of , uh, clear dates. I mean, to to say like, it was three months and there four months, but day one to the , to our first patient, it was around 15 months. And again , uh, just for having some , uh, uh, parameters, this was a trial on elective cardiac surgeries, you know, very, very little patients. And , uh, you know, the , uh, the check marks that we had to, to pay attention to in terms of the secular trial where you, you know, kind of , uh, noticeable and , uh, um, my assumption will be that , you know, trials with less risky patient populations, you know, most likely will require , you know , a shorter period of time for , for getting the trial approved and for getting the first , the first patient . And after that trial , you know, we had zero adverse events related to our technology. However, you know , uh, if a patient dies during your study, whether you know it is related to your technology or not, you still need to report it to a ris . And I can tell you that the reporting process was absolutely flawless. I mean, we just sent paperwork and we had absolutely zero inconvenience in that, in that regard. And also when we notified Coffee Priests that our study was completed, I mean , it was just kind of a matter of creating the paper once and sending it over, and it was absolutely fine. So, so yeah, I mean, again, I, I cannot recommend it enough to, to have a good understanding and to have, you know , good counseling and you should be able to run a smooth trial here.

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Very good. But you mentioned something that is very intriguing. You mentioned something like , uh, a pre-submission to Cover Priest . Are you talking about , uh, uh, um, predic timing ?

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Exactly, yes. That , that , that was the , the thing that I was trying to, to Okay .

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Predict timing . Alright . Yes . Could you , could you talk a little bit more about that? Is that something that is, because I heard that before the pandemic, it was , uh, uh, a real thing was the , the, the unidas , the predict timing where everywhere in Mexico, but after the pandemic that , uh, went away and they're no longer active. Um, could you clarify on that? I mean, how does it work?

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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'm not really sure about how it's working then right now, because yes, I mean, in our case , uh, it was very smooth, but after the pandemic , uh, yeah, most likely it has suffered some sort of disruption.

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Yeah, yeah, exactly. And , and for the audience here , uh, a predict timing is , um, is , is is something in the Mexican system , uh, to , um, approve , uh, new medical device, well, new , uh, clinical research studies, pharma or devices , um, that , uh, allows third party private entities to review the Dosier before the dossier is sent to Cover Priest . So these private entity is of course, certified by Cover Priest to review , uh, these dossiers and, and, and cover priest trust the , the opinion of these third party entities. And , uh, after you get the review and the opinion of the third party entity that they'll call is the predict timing , uh, then you can just attach that letter to you to see it , to cover Priest . And you should get a very, very fast , uh, approval at , because you already have a pre-approval at the timing , uh, unit ,

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Right , as most likely there's some disruption in there after the , the pandemic. 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 , as homework after this call, .

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Yes, yes. I think that that's a , that's a great , uh, thing that Mexico has also for the registration of , uh, commercial devices. They have these , uh, right, authorized third parties, which is fantastic. Uh, it's a great system. But , uh, uh, the new government , uh, Lopez , I understand took that away or restructure that because there was some, some corruption involved in, in that , uh, model . So probably similar

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Rabbit , but yeah , I mean that , that will take us to very tight places. So

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Yes, I know, I know. Let's avoid that. But , uh, avoid my, my opinion of Covered Priest now, and from what I hear from people, I just came back from Mexico last week, is that 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 timelines way better and making their processes more predictable. And by the way, I also heard that Ka priest just join I c h, the International Console of Harmonization , uh, which is a big deal. I understand he's the only agency in Latin America that is part of I c h , uh, for clinical research. So that sends the signal that cover really, really wants to be competitive in Latin America for the approval of , uh, clinical , clinical trials . So I'm very happy to hear that .

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Absolutely , absolutely. And I , I must also mention, I mean , uh, I think that within the very few positive things, if you will, after the pandemic, is that I think it was a serious potential call for , uh, all of Latin America in terms that we tried , at least in Mexico. You know, there were various , uh, incentives to develop, you know , uh, respiratory machines and stuff like that. And I think that we'll just see it like , like , like a brick wall in terms that , uh, I mean, you can't build , uh, respiratory machines out of the blue. And I mean , I mean, of course there were, you know, successful e efforts , uh, to , to some measure. But in general, kind of the, the scientific community, the engineer community , and the general ecosystem , you , we , you know , hit hard in a way that we do not have a robust e system for this kind of emergencies. And I think that , uh, will down the road, you know, influence politics , uh, and influence , uh, you know, how , uh, and other stakeholders, you know, operate in a way that we really need to have, you know, a , a robust ecosystem in place for this kind of emergencies. So, so again, I mean, I really admire the people that, you know, went through the process of building this kind of machines, but I think that , uh, one of the results is that we are shocked by the fact that, I mean, our capabilities for responding to these things is not what was necessarily two or three also . So I think that one of the positive things that we can say after all of this pain is that , uh, this will shake , uh, the , the policy around around technology development here.

00:33:31.740 --> 00:34:18.800
Yes, yes, you are correct on , on that. Uh, I was stuck in Columbia during the pandemic, and I witnessed the development of about at least 10 different efforts to , uh, create , uh, ventilators by local , uh, universities and, and innovation groups, but nothing really materialized. And, and the regulatory agency really, really hard had a hard time , uh, coping with the demand for , um, uh, reviews and, and applications for approvals. And you could see, because those are public documents Yeah , I was reading all of them. You could see that , uh, the innovators didn't really know what to do, and the regulatory agency didn't even know what to do either. So it was a lot of confusion. Yeah.

00:34:19.079 --> 00:34:42.440
And again , I mean , this is not , not not , you know , a matter of blaming people or , or kind of , I mean , it's a matter that as a society, we have not the conditions for , uh, you know , being able to respond to this kind of emergency . So I really want to be optimistic in the way that this should shape , uh, policy , uh, you know, down the road for the next pandemic. We , it's just a matter of time . So sadly, . Yeah ,

00:34:43.159 --> 00:35:11.320
Yeah . Now, now Columbia's regulatory agency , DEMA is a better agency because of the pandemic. I think the digitalization of the agency was , uh, fantastic. The, the, the, the new people that they had to , uh, put in the committees to evaluate these technologies, it was fantastic because they had to up their game , uh, for these new influx of innovation that came during the pandemic. So it's a win-win for everybody at the end, I think.

00:35:12.039 --> 00:35:12.920
Yeah , absolutely.

00:35:14.320 --> 00:35:23.719
Alright , Wayne , I think we're close to the end of the show. And , uh, do you have any final words of wisdom, any final , uh, thoughts , uh, that you wanna share with the audience before we close?

00:35:25.000 --> 00:36:35.079
Well , I mean, I , I just want to , to stress that, I mean, we can do very nice things in here , uh, and , uh, you know , uh, as I mentioned before, the latest experience with the pandemic and together with , you know, with these trends of busy monitoring into Latin America and, you know, the, the size of the market in Latin America, you know, I think it's , uh, those are conditions, you know, promissory of having, you know, an innovation cluster in here. And , and again, I mean, we should not try to copy models from Silicon Valley, which is, you know, kind of this , uh, weird thing that everybody talks about. I mean, of course Silicon Valley works because it developed under very specific conditions. We have different conditions, different, you know, society and whatever. So instead of trying to emulate what has been done in there, I think we should really just , uh, study those success stories and create our own ecosystem for, for innovation. Because I mean, we have fantastic universities, we have fantastic , uh, inter , inter to capital. We all speak Spanish, and we are a gigantic , uh, continent. So I think that there are conditions , uh, and I think that, I mean, there are very good reasons for being optimistic and to attract, you know, prosperity for our societies.

00:36:36.090 --> 00:36:47.659
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

00:36:47.699 --> 00:36:51.659
You very much . Thank you very much for, for having me. And well , thank you .

00:36:52.440 --> 00:36:53.699
Bye bye-Bye.