
Global Trial Accelerators™
Hosted by bioaccess® CEO, Julio G. Martinez-Clark, the Global Trial Accelerators™ podcast delivers actionable insights for Medtech and Biopharma innovators battling lengthy timelines and costly delays. Each episode features candid conversations with clinical trial pioneers, regulatory strategists, and startup founders who’ve slashed 6–12 months off approvals by leveraging emerging regions like Latin America, Eastern Europe, and Australia.
What You’ll Learn:
- Speed Secrets: How to secure ethics approval in 4–6 weeks (vs. 6+ months in US/EU) using harmonized pathways like MINSA (Panama), ALIMS (Serbia), and Australia’s CTN.
- Cost-to-Speed Hacks: Operational strategies to reduce trial budgets by 30% while maintaining FDA/EMA compliance.
- Global Patient Access: Leverage treatment-naive populations in cardiology, rare diseases, and advanced therapies across 50+ pre-vetted sites.
Why Listen?
- Actionable Playbooks: Reverse-engineer success stories from startups that enrolled cohorts 50% faster and secured Series B funding 12–18 months early.
- Regulatory Intel: Stay ahead of shifting LATAM, Balkans, and APAC guidelines with on-the-ground experts.
- Future-Proof Insights: Explore decentralized trials, AI-driven recruitment, and post-trial commercialization in $1B+ markets.
“bioaccess®’s Serbia site activated in 8 weeks-9 months faster than our EU delay.
This podcast is why we partnered with them.”
– Digital Health Startup CEO
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Brought to you by bioaccess® – Turning “anywhere” into accelerated FDA/EMA submissions since 2010.
Global Trial Accelerators™
Yoku Sashida, CEO & Co Founder at Kenko Solutions
Yoku Sashida is the CEO & Co-Founder at Kenko Solutions, a company dedicated to managing and developing biomedical projects based on technology. He is responsible for opening economic relationships, capturing technology-based projects, forming work teams to carry out technological development, and administrative and financial accounting. The first product of its own is ecglove, the wearable able to determine the state of the heart in less than 60 seconds.
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 tuning iHeartRadio, Pandora, or these are welcome to the MedTech Leaders podcast, a conversations with leaders who have succeeded or plan to succeed in Latin America. Today our guest is Yoku Sahi, c e o at Soci Kenco in Mexico, Kenco helps medical device innovators develop their products in the, for the Mexican market in[inaudible]. Uh, I'm sorry, <laugh>. Yoku, it is great to have you here today. Welcome to the show.
Speaker 2:Thank you. Thank you for the invitation, Julio. I'm very excited about this conversation and talk more about Mexico and Latin America.
Speaker 1:Beautiful. I'm glad to hear that. All right, so Yoku, let's get started with your story, with your journey. How is it that you got to where you are today?
Speaker 2:Yes, it's kind of complicated because I start as a, a student of biomedical engineer here in Guadalajara, Mexico. And we start, uh, to develop a product who, uh, is a electrocardiogram that we just touch in the superior part of the chest of the patient. We could know the, uh, electrical, uh, activity of their heart like an, uh, electrocardiogram. So as I entrepreneurs, we start to, uh, develop our product and also find, um, investment to develop the technology and we reach the one difficult step to, to, to reach, uh, or to obtain the certification or the medical certifications. And then we start to, to develop a company who can create a great, uh, path to accelerate this process in, in Mexico. And at the end, we create this infrastructure to take our product like the easy glove, the one who start everything to obtain the medical cert, uh, qualifications here in Mexico. And nowadays, well, our product now say, saves lives in the, in the medical, in the Mexican market. And, and we notice that the main business or the, the special, the difference of solution can or kenco solutions is that we accelerate this process here in Mexico of different technologies because we already take that, um, hard part path to, to take these technologies into the market. Yeah.
Speaker 1:Hmm. Beautiful. Beautiful. I'm, I'm glad that you were doing this type of work. Uh, was there anything you wanted to, to say? I'm sorry, I think I interrupted you.
Speaker 2:Uh, no, uh, actually, yes. Well, I, this is the, the quick version of, of my story, but, uh, to pass from an entrepreneur to have this company of medical or regulation affairs, uh, it's been kind of hard. But actually here we have, uh, great opportunities in Mexico because we were a fortunate, or we were, um, lucky to get the, the infrastructure of the, of the state here in, in Mexico of Jalisco, which is investing in new medical devices, uh, opportunities. Actually, there is a lot of programs of the government to support these initiatives. And we were on that path and in the right spot in the right time. Yes. Excellent. So, so it's kind of of lucky. I, I think
Speaker 1:I'm, I'm so happy to see local governments in Mexico supporting the work of entrepreneurs like yourself. And, and medical innovation specifically is, is an industry that impacts so many stakeholders. I mean, patients, uh, scientists and inventors, uh, uh, generates high income, uh, or high profile jobs, uh, for an area, et cetera. So it's, uh, it's a fascinating thing to know that, uh, Mexico is in the path of supporting medical innovation.
Speaker 2:Yes. And I think that it's kind of, uh, sometimes it lose power to, uh, the, the initiatives of different governance because Mexico, Mexico is actually a really big, uh, country and with a lot of states that not all of them have this infrastructure of technology, but, uh, we have the, the lucky to be in Guadalajara, which is a state that's, or, uh, Jalisco, which is a state that supports a lot of technological industries, uh, big enterprise such as, uh, arrow Electronics, uh, Samina. There is a, a lot of, of really huge, uh, companies that work here in the area. And they promote this innovation of, of medical device technologies. Uh, actually they create a, a cluster of your medical engineers. And this, um, synergy of work with also one of our biggest clients is the eum, which is one of the, uh, biggest university is the, is the biggest university here in, in, in Mexico. And, and while they start to create these new programs of, takes aude and medical device development. So they start to, to create a, a hub of, of innovation here in the area to support that. No. So they need us, they needed us to, to be part of the bio change of the medical, yes. Yeah.
Speaker 1:Nice. Uh,[inaudible]. Alright, so let's start, let's, let's speak, I'm sorry, about, um, trends in the Mexican market that you see happening today that are kind of beneficial to your work. Um, any political economic, uh, social trends that you see happening?
Speaker 2:Yes, of course. Actually, uh, there is a high trend in the, in the Mexico environment of, of medical devices, uh, because we have not reached the total, um, I, it transformation, these, these things for the medical, uh, industry are kind of new here in, in Mexico. Uh, all the health tech data, these new solutions actually, the, the medicals or the doctors are looking for these new, the new, these new ways to do things because they also see, uh, like the innovation in other, uh, countries and they want to apply it, but they don't reach the technologies and some kinds, um, the, that makes that without any support of interests of companies to achieve the, uh, medical, uh, devices market here in Mexico, that makes a lot of, of transactions, uh, informally. I, um, and, and that makes a lot of intermediate in a lot of intermediates, uh, industries or, or companies that start to increase the price to, uh, level that is not comparable to the price in, in other states or the original term,
Speaker 1:The Irish middlemen. Middlemen in
Speaker 2:The chain. Yeah. In the supply chain. Yeah. That makes a lot of middle mains, that rich market. But actually the companies in, in the, in other countries didn't realize that they are, um, start to moving new technology to, to, to the country. And, and there is a high trend to, to this digital transformation and also this telemedicine. It's, it's also a thing that they're looking a lot.
Speaker 1:Yeah. Telemedicine is a big, big trend. I know that. All right. So let's talk about your work, your specific work. Uh, let's talk about the challenges you faced while developing products in Mexico, obtaining regulatory approvals at Coffee Breeze. Uh, can you elaborate a little bit on that?
Speaker 2:Yes, of course. We, we started since, uh, the five, five years ago. So, uh, in order to construct, uh, our, our development, uh, lines to, to manufacture and certificate of or industry or company, we face a lot of of issues. The, the first one was to, to know the right path, because they, the government says that we can find everything online, but the two is that we just have like one paper, and that's all. And we have to develop all, all the, the, the significant significantly values of, of this, of these certifications. And we start to create this plan to, to produce or create, construct, uh, ucco that can have these, uh, these electrical, mechanical constructive, uh, devices or develop devices here in, in the, in the assembly line. And well, we start as, as an entrepreneur, but we go to, to the, to the, to the city of Mexico to reach, uh, more capital. Since then, we start to construct the, the line to develop the quality system and also start the certification with pri. PRIs is kind of the F d A here in Mexico, and they give some, some rules to, to follow. And at the end, sometimes the, well, the, the paperwork gets, uh, out of, uh, time because have a lot of delays. They are, they, they were told me that they are kind of, uh, 17, 17, uh, people who are flying all the Mexican country to develop or to certificate industries. So, uh, 70 people for a whole country is kind of, uh, a small teamwork, and that makes sometimes the process to be kind of slow. But nowadays, they are now improving new technology to be quicker in their in or faster in the, in the, in their paperwork. And well, it's kind of, uh, great thing to us here in, in, in Guadalajara. And sometimes it's kind of frustrating to, to don't obtain the, the information as quick as you might be changing or, or as the market needs here in, in, in as an entrepreneur, as a company. But they are starting to change now. And we, we also obtain the, the, the certificate of good practice in manufacture in one year. And after that, we now can, uh, take some developments into our assembly lines in just few months. And then those companies or those technologies, like in three or four month, four months, they already have their better production and also with the coffee pre certificate. So we start to make a faster, um, organization of the documents or the, the things that we have to present to CORIs. And we could have, well, new times of development, medical technology, uh, because we plan or or company to be able to do that. We also have different kinds of, of regulations such as, uh, type one, type two, type three depending of, of the medical device that we are going to, to manufacture or also help to import here to Mexico. And we create a strategy to develop that, um, certification because we know what are the, the, the difficulties in the, in the medical, in the we coffee breeze actually. Um, we, uh, reduce that pain of, of the new enterprise to enter here in the, in the market. Um, in order to do that, well, we use our, our company as, um, a manufacturer. So we, uh, import different materials to make the final assembly and also the label project. And with that label project, the assembly, we make also the translation about of, of the, of the manuals, because everything has to be in, in Spanish. And the regulation also says that all your, all all your assembly process have to be in the same language with your, uh, specifications. And we work on that to make to the, uh, company that want to bring the technology here to Mexico will, uh, more faster, um, development or, or go to market time, actually.
Speaker 1:Interesting. That sounds like a lot of work, huh? To develop something in Mexico,<laugh>.
Speaker 2:Yeah, it's, it's kind of of hard and, and it's not a, a linear path. I mean, we, we now try to make this, uh, like, uh, linear regression about our work and to provide that to our, our clients and, and, and companies that want to work with solution kenco. Um, but to obtain that linear regression<laugh> of, of our work, well, it's been like, uh, just random points in, in of, of a lot of work that sometimes we have to, well, to, to learn about how things didn't work and and now improve improvement, improve it.
Speaker 1:Yeah. Yeah. So let's talk about your portfolio. Right now you have the glove, right? Is that your intellectual property or is somebody else's intellectual property?
Speaker 2:Uh, yes. We have three develop t three technological technological developments, and we have actually three different patterns of intellectual property, and yeah. But we also work with other, other entrepreneurs or industries to develop their technology that we don't have the the
Speaker 1:Intellectual property. Yeah. Ip. Yeah. Okay. So
Speaker 2:IP
Speaker 1:In regards to, let's talk about commercialization. Uh, in regards to the three IP assets that you have today, are you commercializing any of them? I mean, are you commercializing the glove right now?
Speaker 2:Uh, yes. Actually we have the glove, uh, in the final process, but we launch, uh, light version of the, of the love who that we already commercialized in here in Mexico. We have a lot of, of e-commerce, uh, with the, with the medical industry. But we also have a great alliance with the leaders of the, of the medical, uh, commercialization here in, in Mexico. They have, I don't know, the 60% of market shares here in, in the, in the area, um, because they're, well, they are so big and they have now this, uh, market, uh, access. So sometimes they ask for, they ask us for, uh, a development to, to have more market share, and sometimes there are some connectors that they need, uh, to, to create an interface with within two products, also some iot to, to reach their, their commercialization products. And, and they also are always looking for new technologies to, to, to start to, to incorporate in their portfolios.
Speaker 1:Okay. Okay. So the glove, I, if I understand correctly, you're trying to commercialize the glove through distributors or third parties, right?
Speaker 2:Yes, yes. The and that's because as, as an entrepreneur in our story, they're big, um, parties of, of here in Mexico where the distributors, right. Uh, we don't have actually a really good, um, uh, industry here in Mexico to ha that have their or their own brands. So the big part of the, of the pie is, is distributed to the distribute distributor distributors
Speaker 1:Towards
Speaker 2:Distributors. Yes. So, um, they have kind of power of distribution and they support us in the start. Uh,
Speaker 1:Interesting. Okay. So how are sales going for the glove? I mean, who is the buyer of the glove?
Speaker 2:Well, actually there is, uh, we, we want this, this, uh, uh, this phrase that we want to make, uh, electrocardiogram, uh, reliable products, such an pulse oximeter. So we are providing these gloves or this, uh, portable, uh, electrocardiograms to medical, uh, medical professionals. They buy their own product. There is no, the, the product is not as a, there is not a device for the big consumers, such as the hospital or the institution. They, the, the medical, the doctors want to equip their, their selves with more, uh, devices, so they start to buying to improve their services. So
Speaker 1:It's, it is retail sales direct to consumer. And the consumer is the physician, the cardiologist, yes. Or uh, uh, internal medicine doctor. So any doctor that who wants to, to do an a k G on a patient during the consultation. Yes. So they put the glove in the patient's, uh, sheds. Right. And it will measure the, uh, signals. Interesting.
Speaker 2:Yes. And, and for, for other countries, sounds like we were pitching our idea in London, uh, a few years ago, and the investors told us something like, well, why do you need to buy a glove if we have, uh, electrocardiogram or a, or a different devices here in the corner? And of course, well, yes, they have, uh, cardio protect buildings all over the place, and they don't have the deficiencies of our medical devices, uh, uh, structure here in Mexico healthcare industry. And that's one of the biggest opportunities that we saw from Latin America, actually, because we, we start to make promotion not only in Mexico, uh, Colombia, uh, Argentina, they're also like the same structure, or they have the same pains of, of the, of the healthcare systems. Um, that makes a big opportunity to, to other technologies, to, to, to, to take that market share. Actually, we made it because here in Mexico it's kind of of incredible, but to take an c g to a patient, it's a pain for the physician. And actually they, in order to rely on that, that pain, they buy their, their own stuffs to make, uh, faster services. And that is the value of, of the EC glove here in, in the Latin America. Yeah.
Speaker 1:I see. I see. Huh. All right. So let's talk about the other two products that you have developing in, in development. Uh, could you please describe them? I mean, what problem do they solve?
Speaker 2:Yeah, yeah, of course. Actually, one is a really, uh, social product that we, that, that we have because we wanted, and it's our mark in the, in the, in the world as, as we say, is, it's, uh, the name is re Rero, C p r. It's, uh, c p R practice. It's a name in, in English in Mexico. It's, it's, uh, Risa. And it's a really reliable, um, device that helps students of different communities, um, to make the CPR r and learn that CPR r and actually, we have these initiatives of learning c p r in women. Actually, we are the first, um, uh, tool for learning CPR r for women. And we have this, uh, new, uh, uh, anatomical, um, uh, figure in the, in the product that makes to, that wants to avoid this, uh, issue of doing some CPR in,
Speaker 1:In, oh, I think, I think it's called a simulator, right?
Speaker 2:Yeah. It's,
Speaker 1:It's, yeah. It's like a man key simulator Yes.
Speaker 2:For students, man, key simulator.
Speaker 1:Okay. Interesting. Yes. All right. All right. And what about the third one and Yeah.
Speaker 2:Yes. And the third one is one trackable, uh, medical devices. Because here in in Mexico industry, we, well, we, they, the hospitals or some entities don't buy the, don't buy the, the, the, the big, uh, the big devices, right? They just, uh, borrow
Speaker 1:List, list them.
Speaker 2:Yes, yes. Yeah. They list, list the, the devices. And with, with that, we make some trackable, uh, devices to know how time is, uh, turning on how times it change the, the, the different, uh, consum abilities. And we now can track how much is using the device their, their, yeah. Yes. The, the industry.
Speaker 1:Interesting. This is fascinating. Yeah.
Speaker 2:Okay. And, and with that, uh, well, the distributions or distributor, uh, distributor distributors.
Speaker 1:Yeah. Distributors.
Speaker 2:Distributors. Distributors, yeah. The distributors can now optimize their Salesforce and, and know more, uh, about the users information about the devices. Yes. Yes. Actually, we adapt these, uh, devices for different, uh,
Speaker 1:Okay. So we're talking about biomedical equipment, big equipment like x-ray machines and things of that nature. CT scans Yes. Or whatever it is that is, uh, ventilators. Ventilators, yeah. Capital equipment in a hospital and or hospitals usually, uh, lease these from distributors, right? That's what you're saying? Yes. And they pay a monthly fee or something, and the children needs to know what usage the, the client or the hospital is, is, uh, having on the, on the equipment.
Speaker 2:Yes. And with that information will, they can optimize a lot of sugar
Speaker 1:Resources. Yeah. Yeah. Yeah. Yeah. That's that's great. How did that idea come about
Speaker 2:<laugh>? Well, as, as I was saying, uh, in, during the podcast, we have a great alliance with distribution with distributors, and they, they ask for us, they ask us for this development,
Speaker 1:They told you about the problem, and they suggested a solution. Okay. You guys started working on the solution. Okay, but you guys own the ip, the intellectual property. It's your intellectual. Oh, that's fascinating. That's, that's great. Uh, uh,<inaudible>,
Speaker 2:It's kind of fascinating.<laugh>. Yeah,
Speaker 1:Yeah, yeah, yeah.
Speaker 2:Our main, or our main, uh, idea and also our biggest, uh, uh, product that we work
Speaker 1:On. Okay. Okay. So aside from these three products that are you own, you said also that you also, that, that you help, uh, third parties, inventors, et cetera, develop your own products. Are you working on something exciting in that front?
Speaker 2:Yes, actually. Well, we are now developing, uh, four different, uh, intellectual properties for, from the esm, which is, uh, one of the biggest university. I cannot talk, uh, very, uh, explicit about these, uh, inventions, but they start to develop, um, new ways to, to be faster in their procedures of different, uh, industries here in Mexico to, uh, create a more safety place to, to do procedures and more faster. Yes, they, they're kind of doing that, uh, uh, development, and we are helping in a different devices.
Speaker 1:Nice. Very nice. All right, Yoko, we're close to the end of the show. So the last question I have for you is, what would you say to the c e o of a medical device company in the United States or Europe that is just exploring the Mexican market? What would be your, your best advice to him or her?
Speaker 2:Uh, I think that don't try to do it, uh, on your own and also find these clusters, these clusters in different, um, uh, states such as Calisco have a lot of, of knowledge about how to introduce products more faster in the Mexico market. And it's, it's, uh, it's a great advice because sometimes we hear it like, okay, now this new brand is coming, and they start to develop, uh, the, a whole new, uh, infrastructure or of, of commercialization here in Mexico. And it's like, well, sometimes it could be more faster and they could avoid different problems actually with the authorities, uh, knowing someone who has already passed those steps. So I think that there's, that's my main advice. And, and, and sometimes think it's like enuring into the Mexican market and Latin American market. I think for me, it's kind of think out of the box. And, and that happens for me as, uh, as a C E O here in Mexico. When I go to, to London, to Europe, uh, the US I say like, well, here is everything more faster. Here's everything more. Um, it's more direct, uh, to the point with, uh, they don't lose time. And sometimes in Mexico, it's kind of hard or frustrating these things about, uh, the efficiency of, of getting things done. But once, uh, you know, people that already have this hard part path to, to avoid these issues, well, you start to work like, uh, like in, like in, in your country. And, and yes, it's absolutely, I think to think outside of the box, it's here. Uh, there are more possibilities and, and we also have this, uh, flexibility about some things and the price to, to pace not always as big as it could be in, in this countries such
Speaker 1:In other countries. Yeah, in foreign countries, in other countries. Yes. Yeah. Yeah. All right. Excellent. Excellent. Yoku, thank you so much for being the show. Today is being a great conversation and uh, I look forward to being in touch,<laugh>.
Speaker 2:Yeah, sure. Julio. Uh, we'll be in touch very soon, and thank you for the invitation. All right. I hope this information could be, uh, great for some other c e o.
Speaker 1:Yeah, absolutely. That's the whole idea here. The spirit of the podcast is to show the challenges that Latin America presents and, and also how to overcome those challenges and to show that Latin America is a place of opportunity. Of course, sometimes it's difficult, but the reward is right there. I mean, it's a big market for medical technology companies from, from the United States and Europe to enter specifically Mexican market. It's a very well developed market. It is a top with Brazil, it's a top economy in Latin America. So it's certainly an attractive market and we need to have more people like you who are experts in the local market to guide other companies in their journey into, into Mexico, because patients need access to new technology. That's the bottom line.
Speaker 2:Yes, of course. And they are looking for it. Yeah. And they, they have the, the needs.
Speaker 1:Exactly. The needs is there. The needs is there. Yes. Alright, Yoku. Bye<laugh>.
Speaker 2:Perfect, Julio. Thank you. Bye.