Oct. 20, 2019
Guy Vinograd, CEO at bio-T
Guy Vinograd is CEO at bio-T, a seasoned high-tech executive and an expert software architect of cloud platforms for medical devices. As an industry leader he is a popular speaker and the organizer of the meet-up group: Smart IoMT Product Experts of Israel.
Guy has co-founded bio-T, the first and leading medical IoT cloud platform designed to enable medical device vendors to fully realize the potential of the data collected by their devices.
Guy is considered a leading expert of Amazon Web Services and a creator of best practices for efficient software development in the cloud.
WEBVTT
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Welcome to the LATAM Medtech Leaders Podcast.
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This is a weekly conversation with medtech leaders who have succeeded in Latin America.
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Today, our guest is Guy Vinograd, CEO and Co-founder of bio-T, the first and leading medical IOT cloud platform designed to enable medical device vendors to fully realize the potential of the data collected by their devices.
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Guy is seasoned high-tech executive and an expert software architect of cloud platforms for medical devices.
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Guy is an industry leader, a popular speaker and the organizer of the meetup group Smart IoMT Product Experts of Israel.
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Guy, welcome to the show.
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Hello!
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Thank you so much again for joining the call and for accepting my invitation to speak.
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I went to your website, your company's website, and I kind of got an idea of what you guys do.
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So I'm very intrigued with the technology that you have and how that fits into the whole EU MDR situation.
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So please tell me a little bit about it and let's see if we can tackle the question.
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About bio-T you mean?
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Yes, and your technology.
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I'm very intrigued how that works.
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Well, bio-T is technology that is aiming medical device vendors, more innovative companies that see division those buzzwords like IoMT: Internet of Medical Things or hospitality home, precision medicine, any kind of medical value that benefits from connectivity of a medical device cloud or mobile web applications, remote monitoring, remote diagnostics, stuff like that.
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What's happening?
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The major, they established a medical device, vendors know they need to move to be connected medical devices, but actually they don't have the expertise.
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They are mainly focused on the medical side and physics or chemistry or biology or electro-optics and stuff like that, that they need for the device.
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They are very far from understanding the IoT world, the cloud development, mobile development and how to regulate it with all the cybersecurity guidelines.
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So, IOT is great shortcut for them, our platform implements all this cloud and connectivity and mobile side of things, lots of fair features that they can use just out of the books and minimize the time they spend on creating their own specific solution.
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So of course there is customization and integration between the platform and the device, but the heavy lifting is already done for them.
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Fantastic! So interesting, and are you regulated?
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I mean, do you have to comply with regulations?
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Indirectly because bio-T is a software tool and a software component in a larger system that is, includes the device and the sum and the customization and integration code on top of bio-T.
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So the whole system, which is owned by the medical device vendor has to be regulated, but we provide the vendor with all the necessary documentation in order to pass the regulations, to pass though it's on the cloud side and on the mobile side and of course we also commit to them sign.
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Do you know what the BAA is?
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No.
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Do you know, HIPAA?
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Yes, of course.
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HIPAA accepts the fact that a medical device vendor is not solely responsible for the security and privacy if you walks with subcontractors and suppliers.
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So there is this chain of BAA: Business Associate Agreements.
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This supplier signs with the vendor and then a takes the liability and responsibility if something happens in his domain.
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So we provide is the ability for them and they can rely on us and uh, not be exposed if something happens in the privacy that is, you know, in our[inaudible].
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Hmm.
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Approximating.
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Interesting.
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All right, great.
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Thank you for that introduction of your technology.
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So the future implementation of the EU MDR has increased barriers to entry in the European union and apparently more[inaudible] companies are looking to other alternative markets.
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For example, the U S Asia Latin America to first initiate the commercial activities.
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So these are some of the questions that come to mind around the topic.
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Landlords regressivity of the EU, MDR or us med tech companies in your opinion, is still considering the EU as a first commercial market before they take the approval.
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Okay.
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First just to be on the same page, uh, by OT and myself is a Israeli company and again, mainly show the point of view of Israeli method companies.
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So first I'll share that the Israeli metal companies consider most of them, not all of them.
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Consider the U S market as the first one and the U S the second one.
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Um, not the other way around.
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I think as you imply that, uh, most companies do, you know, first one to market in the EU before they want to market in the U S
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that used to be the product line or the way to go, uh, years ago.
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Now things are shifting a little bit.
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Okay.
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What I say my mainly is a first to go to FDA and then go to you.
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But actually maybe it's 50, 50 coming to think about it.
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I know vendors, so first go to get the CE Mark and only then go to the FDA.
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Okay.
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So first I think that the, the U MDR did not change this, uh, that you market, uh, conomic power is still the second in the world for a second.
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So regardless of being a bit more rigorous, it is still the target because of the potential.
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But I would like to say another thing from our understanding of the EU MDR, we embrace it.
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We think, uh, it is actually easier in some ways because the predecessor of the MDR was the MDD, you know about this directive and the meaning of the UDA directives was that each country can supplement it and override it with its own regulation or the MD where the MDR is not a directive, it's a regulation.
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So once you comply to it, you are already good to go with all your, whereas before that with MDD, still companies had to go state by state, country by country and apply to its own notified bodies in order to gain the regulation.
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So from that respect, it's easier now that you became easier than it was before.
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Interesting insight, huh?
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Okay.
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And other point is that we really appreciate what the MDR is trying to do.
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From our perspective, it is a pioneer in the world.
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It is really drawing the future for efficacy and safety of medical devices.
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Yes.
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Pharma as well.
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For example, they have, they have a requirement for clinical evidence is called the DMC F it's an acronym for post-market clinical followup.
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Okay.
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What it means that the medical device companies cannot just settle with doing a clinical trial and then go to market.
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They have to continue monitoring the drugs, their devices when they are in the market, get the data from them and make sure that they are as effective as they thought they they were.
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And I think that making them do it is something that will make the devices much better and more effective and advanced medicine faster than it used to be.
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Yes.
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Good point.
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So to summarize, EMDR is the new line of excellence and I really hope that all the world will follow these guidelines.
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Interesting.
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Okay.
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Okay.
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Alright.
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So question number two guy is if yours or a company that is a client of yours is a medical device design, development and commercialization company, what's being their company experience or what's been the impact of the EMDR on them?
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Can you cite a specific use case?
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Well, I'm sure you know that uh, the UN DIA is not yet effective.
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It's only going to happen in a modern year in may 20, 20.
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Yes.
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So it's, everybody is talking about it, but it's too new to share any experience with it.
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But you can ask me that lane, uh, six months from now maybe my answer will be different.
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Okay.
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That's fine.
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Do enough companies, by the way, that already changed the product for the EU MDR?
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Yes.
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I've heard about, I be having interviews like this for about a month and a half and I hear cases about companies that are really a shift in their gears are hiring more people, getting new registration under the new MDR instead of the old one.
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There's been some, some little changes.
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What would you say is that our learning about it like we do?
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Perfect.
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Okay.
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What about question number three?
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How has the EMDR affected the company or a company that's a client or yours?
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[inaudible] strategy.
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I've heard of other case where a company has said, forget about Europe or we're going to change the way we're going to go to market like this or like that.
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From that perspective.
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As I said, uh, we see it as a new standard of excellence and the the company so wants to avoid it, I think they don't really have a future for us.
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Let's say that the MDR affected in a good way.
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As I explained earlier, we are dealing with the IoMT and this requirement of the post-market clinical followup goes, uh, IoMT is a great solution for that because the devices can just send data to the cloud and the vendor can immediately see what's happening with their device, how much they are diagnosing and stuff like that.
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And the quality as the maintenance where, uh, without IoMT.
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The only other way would be to ask patients to come for visits from time to time in order to learn if their device is helping them.
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So providing the patient an application and a connected device is really a good solution to comply with.
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EOM EMDR.
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So this is also something of commerce elevation change.
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It pushes more companies to create connected devices.
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Very interesting.
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I guess it's very good for your business.
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I mean for your business model, the EMDR is pushing your business model to be more successful.
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Actually it was a good letter.
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We walled everywhere, eh, not only in the U, in the U S as well.
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For example, they have a value based reimbursement strategy.
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Now in the U S you get paid the hospitals, the caregiver gets paid only when they really treated you, not for every visit you visit them.
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So this is also a great push for, you know, to give you devices, wearables that can monitor you and, and alerts when you are starting, you know, to deteriorate and not when you are exhausted.
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Totally.
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And must go to the hospital.
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Yeah.
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So yeah, there's a lot of push from all kinds of laws and regulations towards medical connectivity.
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I'd say.
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Very good.
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Okay.
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So number four guy, are mid tech companies considering now other alternative markets to the you where they can start generating revenue faster?
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If so, do you think that America is one of those markets?
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As I say, I don't think it changed anything.
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They are not running away from the EU because of that.
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Yeah.
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Okay.
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Number five, what are your thoughts on early stage clinical trials or selling medical devices in Latin America?
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I'll go first.
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Some of our customers do sell in Latin America.
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I'll connect it to the Pacific Alliance.
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I think this initiative is a great move towards increasing the appeal of selling to Latin America because really for a device vendor, it's a nightmare to go to each of the countries.
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Yes, I did the regulations of each of them.
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So having one like the MDR in the EU or having one that covers many countries is great.
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Important initiative.
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Yes.
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Fantastic.
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Have you had practical experience yourself with early stage clinical trials and certain medical devices in Latin America?
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No, only in the U and the U S Oh,
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okay.
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Okay.
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What's your general perception of the region guy?
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I mean, when I say Latin America, what comes to mind?
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Is that a positive feeling?
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A negative feeling?
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What do you think about the region as a market for medical technologies?
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I have to say that not positive.
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Hmm.
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Why is that?
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I think it's mainly the currency fluctuations, but that's only me.
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I don't know if
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sure.
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Yeah.
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Yeah, I mean that's, that's it.
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Yeah.
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You'll give me your perception and that's exactly what I want to hear your honest thoughts about the region.
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Anything else on that?
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When I said about the sentiment I'm feeling is about the South America, I don't feel the same about a Mexico, Colombia.
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Oh, I see you, you mentally the Southern corn con, uh, colon.
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I'm sorry.
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So you always,
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yeah, but I have to say that Chili's stands out as different, more like a European country.
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Yes.
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She lives a very forward looking country and if you allow me, I'll give you a little bit of background about the Pacific Alliance guys who kind of understand the context about it.
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The Pacific Alliance starting in 2011 and the whole idea was to take the, for most competitive economies of the region, I'm saying competitive, not largest competitive.
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I need economies that are very forward looking economies that are aligning themselves with policies of international standards.
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For example, four of these countries are members or members to be the case of Peru, of the OEC D which is the organization for economic development and cooperation.
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I was going to comment about the rule.
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I'm surprised it's there.
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Yes, but Peru is a very forward looking country actually is one of the top performing economies in Latin America.
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He has opened his doors and he's aligning himself with the wealthy countries of the OACD.
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Israel is part of it.
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The U S is the GDP, I don't recall, but he's growing at around, I was just reading about it a couple of days ago is growing around four, 5% a year, so it's really, really good.
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Whereas Columbia is growing about 3.54 or something like that.
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So Peru is, is one of the top performing economies based on their GDP growth.
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So the idea is to have these four countries become a trade block because the other trade blogs in the region like medical[inaudible], which is Brazil, Argentina, Uruguay, and I believe also per Y and Chile as well.
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That is not really working well.
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There's another trade blog called the Andean pact, which here are the England countries of course, Columbia, Venezuela, Peru, Bolivia, Ecuador.
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That didn't go well.
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I mean that hasn't really materialized.
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However, Pacific Alliance seems to be something that is gaining traction and it looks like it will become a reality.
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These are already working.
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They are already putting together all the pieces, and the regulatory piece is a big part of it.
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So that's why I think there's a lot of hope for this.
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By the way, the GDP per capita of Chilla is more than 15,000
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yeah, it's magic.
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Yeah.
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Chili's a very good country economically speaking.
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All right, go ahead.
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So thank you so much.
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Unless you have anything else to add or like to conclude the interview here, I'd like to thank you for your participation and your insights.
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I mean, very interesting.
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If there's anything I can do to help you in any way, shape or form Latin America, please let me know.
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Okay, great.
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All right.
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Bye.
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Bye.
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