May 24, 2019

Lloyd Diamond, CEO, Pixium Vision S.A.

Show Notes
Transcript

Lloyd is the CEO of Pixium Vision S.A., —a company with the mission to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Prior to that, he was the President & CEO of Precise Light Surgical —a company that developed a disruptive surgical resection platform that has tissue differentiating capabilities.

Lloyd has 25 years of disruptive technology commercialization experience in the life science industry. Prior to Precise Light Surgical, he served as the CEO of BONESUPPORT AB, a European orthobiologic company, where he drove rapid market penetration in Europe and the US for their disruptive orthopedic scaffold. He has commercialized many other disruptive technology platforms at Kyphon and Laserscope where he served as the VP of Marketing for the Greenlight Laser system.

Throughout his career, Lloyd has been Instrumental in bringing life science technologies in the major markets in Latin America, including Mexico and Brazil, and established commercial infrastructures in the region.

Lloyd received a dual degree in Biochemsitry and Marketing from Florida Atlantic University and an MBA from the Thunderbird School of Global Management at ASU.

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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 we have Lloyd Diamond, President and Chief Executive Officer of Precise Light Surgical.

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So, Lloyd, thank you for joining this episode of the LATAM Medtech Leaders Podcast.

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Welcome to the show!

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Hi Julio and listeners, thank you for inviting me.

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I'm honored to be a guest on the show today and hope I can add some of my own experience in the Latin American region that your listeners will find helpful.

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Thank you so much, and it's really a privilege to have you here.

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So, listeners I'm going to describe Lloyd's experience and we're going to get the interview started in a few minutes.

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So, Lloyd is the CEO of Precise Light Surgical—a company that developed a disruptive surgical resection platform that has tissue differentiating capabilities.

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Lloyd has 25 years of disruptive technology commercialization experience in the life science industry.

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Prior to Precise Light Surgical, he served as the CEO of BONESUPPORT AB, a European orthobiologic company, where he drove rapid market penetration in Europe and the US for their disruptive orthopedic scaffold.

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He has commercialized many other disruptive technology platforms at Kyphon and Laserscope where he served as the VP of Marketing for the Greenlight Laser system.

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Throughout his career, Lloyd has been Instrumental in bringing life science technologies in major market in Latin America, including Mexico and Brazil, and established commercial infrastructures in the region.

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Lloyd received a dual degree in Biochemsitry and Marketing from Florida Atlantic University and an MBA from the Thunderbird School of Global Management at ASU.

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So, Lloyd is really an honor to have you here and let's start with the first interview question that I usually ask my guests, which is about how you got involved with Latin America, please, described to listeners your journey to the region.

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Sure.

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So I'd say my journey started primarily when I was managing as a Director, a business unit of a subsidiary of Zimmer, the large orthopedic company.

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I was responsible at that time for their new sports medicine arthroscopy business and when we were looking at potential markets for expansion, we had already a very strong footprint in the US and Europe and we were looking outward towards Latin America, Asia, Middle East.

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The Latin American market was an interesting one to us for several reasons, this was back when NAFTA was actually coming together and there was more and more manufacturing and medical manufacturing moving to the Maquiladora area in Mexico.

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So we had some initial familiarity with the region from a manufacturing supply perspective, which actually gave us some access and insight into the potential for commercialization, so the first market we really targeted was Mexico and later I think we'll have a discussion around sort of my thoughts around commercial strategy for entering to the market and Mexico really became a beachhead, a commercial beachhead for our company at the time.

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So it was really through that experience that I first gained access and awareness of the market.

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Excellent.

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So what's your overall perception of Latin America as a market to commercialize medical technologies?

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I think that's a broad question.

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I mean, you know, Latin America, I guess in a way we say things similar about Europe.

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I mean I don't know if Europe is a real market or Latin America is a real market, I think there are markets within Latin America that the region, and I say that because different countries I believe are in different stages of maturity when it comes to commercialization.

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So when I think of more mature medical markets for commercial reasons in Latin America, you know, I tend to think of Mexico and Brazil as sort of two of those leading more mature markets and then when I think of developing markets, I think of those perhaps in the Central American region, let's say Costa Rica for instance, who have put in place and interesting infrastructure for funding, for device development in particular.

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So Latin America, you know, I don't like to refer to as one overall sort of strategic approach.

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I think we need to look at Latin America, country by country.

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All right, so what specific countries in Latin America have you been involved with?

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So I've been involved in Mexico, Brazil.

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I've done market development work in Central America, so Costa Rica, Panama, and then some development work as well in Colombia and Venezuela.

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I have less experience in Chile and Argentina, but more in those other markets.

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Excellent.

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All right, good coverage, by the way, those are kind of the main countries in the region.

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When you were actively involved in the region, did you have a very well thought out strategy or proactive strategy where you created the market access plan for each country before you entered the country?

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Or do you have an opportunistic or reactive approach where you waited for distributor to contact you in a trade show or via email or something?

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That's really an excellent question and I think the dynamics of the market have changed a bit, but back in the early days, you know, 20 years ago or so, I called those the early days, we were deliberate about Mexico, I would say was, you know, the market where we spent most of our time looking at the right channel model, Is it distribution or direct?

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The regulatory approval process and environment, you know, the operational needs for the market and how local did we need to make sort of the support infrastructure for marketing and sales versus how much could we manage from the US.

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So Mexico I'd say has in many of the situations where I've been involved, we've always had deliberate strategies around Mexico, I think Brazil, the deliberate strategies came later, I'd say in the early days, like some of the other countries I mentioned, it was more opportunistic.

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So typically what we would see happen is we would begin to develop a foothold in Mexico and then we would be at trade shows either there or in the US, primarily in the US, and you would begin to get interest from physicians and/or distributors from the other markets in Latin America.

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They begin to inquire about the technology and do you have any presence in Latin America?

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And of course we would say in Mexico, so it's sort of, I'd say opportunistically developed from there.

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I think today, however, more recently that's changed because I think the markets are becoming more sophisticated and they require more of a deliberate approach.

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So I'd say for sure in Mexico and Brazil primarily driven by the regulatory environment, you have to have a very deliberate and targeted strategy, but again, in places like Venezuela, Colombia, Costa Rica, I mentioned those markets also are now becoming more demanding around the market entry.

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So I think we'll see in the future that companies need to have a much more deliberate approach.

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Very good, Lloyd, makes total sense.

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So when you were involved with managing distributors, how was your strategy with them?

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I mean, there are basically two ways to, generally speaking, two ways to manage distributors or a business in a country, a handoff management strategy where you just sell products to the distributor and you just let the distributor create a market and generate demand, etc., and all you care about is distributors orders or a hybrid strategy where you have a local agent, or an office that supports the work of your local distributor.

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You help the distributor generate demand, you help the distributor open doors, you visit clients with the distributor, you co-create or partner with distributor, with the local marketing campaigns and you have a local agent that represents your company's interest because not always the interest of the distributor is your company interest.

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So that's why a lot of companies choose to have a local agent who can support the work of distributors.

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So how was your approach in Latin America?

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I think the approach is a continuum, I would say, and that continuum is really dependent on how your technology is adopted in the market and how mature it is, so what I say by continuum is this is the typical sort of channel strategy in Latin America.

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So first, in many cases you begin through a distribution partner and you allow that distributor to function pretty much on their own locally, you might have a US Regional Sales Vice President or President that has Latin America as part of their responsibility and so they will work and the US team will work to support that distributor in country, but there's very little direct presence; that's one thing I'd say.

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The second thing I would say is that usually those distributors will identify key opinion leaders that they will then send to the US, in a way as I'd say a marketing or partners strengthening relationship, these are the key opinion leader where they send them to the US and that key opinion leader will get training, will get access to other key opinion leaders and then go back in country and begin to promote the technology.

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So that's sort of the first step, b,ut then I think as the market penetration increases, then what usually happens is you put a local country manager, you know, that's usually their title, in place, in the market and then they will work alongside the distributor and they may build a small infrastructure of marketing support, maybe some field clinical support, but then as the business matures, and especially the multinationals, I think the large medical device companies, they will actually have fairly substantial footprints in the larger markets in Latin America where they actually will have a regional President and they'll have their sales and marketing infrastructure in direct sales, regulatory support, etc.

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So I really think it depends on the maturity of the technology in the market, the amount of market penetration you have in the infrastructure of the company.

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Makes Sense, Lloyd, thanks for that.

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So let's speak about your experiences and recommended best practices in a few areas.

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So let's begin with obtaining regulatory approvals or market clearance in each country.

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What've been your experience with the regulatory agencies or the process of obtaining market clearance in the major markets in Latin America?

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So like most market, and again, I liken it to Europe and the US, I think in most cases the regulatory requirements and market access requirements are getting more stringent.

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I can tell you if we look at Brazil again, I keep referring to Brazil, 15 or 20 years ago getting approval in Brazil was very straightforward, it would take a few months.

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If you had 510K or CE mark, they would accept the dossier and off you'd go.

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I think that now the Brazilian authorities will come and audit your facility or manufacturing facility and so they're becoming more, I'd say onerous, the process becoming more onerous and in many cases they'll look for now clinical trials support documentation, not necessarily local, helps if it's local, doesn't have to be, but it went from a very relaxed environment to a more stringent environment.

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That being said, I do think there are opportunities If you look at perhaps Central American region, you begin to see sort of these regulatory zones of countries that are coming together where they're harmonizing practices and so you could, where before you might have to do a separate approval in Colombia, Venezuela, or maybe Panama, Costa Rica.

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Even though it was a straightforward process and simple perhaps to get approval, you still had to do separate applications.

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Now there's harmonization underway where perhaps one application may give you access to three or four countries.

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So on the one hand, larger, more mature markets are becoming, I'd say, more restrictive and that's leaving an opportunity for other markets to give a more favorable regulatory environment.

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Very good.

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I guess you are speaking lightly about the Pacific Alliance, right?

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Correct.

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Yeah.

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Okay.

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Very good.

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That's one of the most important initiative in the regulatory world in Latin America, I mean, it's going to make a difference for medical device companies when they look at Latin America because it's gonna make the region more attractive and easier to access.

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All right, so moving along, Lloyd, what about distributors or channel partners, how do you search and select distributors in Latin America?

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What's your experience and opinion on this?

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So, as a rule of thumb, I always ask the customer, and physicians are usually, especially in Latin America, the physicians tend to have very close relationships with the better distributors, more sophisticated distributors, in some cases, they even have some type of business relationship with them.

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So I think you go to the key opinion leaders, again, the major centers in the markets and you ask them who is providing the best service and that's one way.

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I think the other way is you take a look at the different types of product portfolios that the distributors have in Latin America and again, they will come to you if you have an interesting product, they're always looking for new products in the Latin American region and access to new products and so they will come to you and then the conversation is typically around what type of infrastructure do you have and what other types of technologies are you selling.

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I think that's another important aspect and then third is, especially if you're dealing in capital equipment, understanding the service infrastructure and again, you go back to the customer base in the hospitals and ask how was the service infrastructure of the potential distributor.

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So I think by assessing sort of those three criteria, you can easily or quickly come up with a good understanding of how that distributor might perform.

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Unlike the US, perhaps in Europe, the good distributors in Latin America are not necessarily very plentiful, in the US and Europe you have a lot of distributors and some are good, some are bad, and they have different reputations I think in Latin America you can sort of hone in on that relatively, simply at least that's been my experience.

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Okay, excellent.

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So what about end-user demand generation?

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In other words, there are products that are more suitable to be sold in the trade or retail space versus the institutional space or it can be sold in both spaces and some companies get involved with marketing strategies related to demand generation from the end-user.

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So have you ever been involved on a demand generation plan with your distributor or directly from the company that you were working for?

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Yes, and I think there are two ways that we have handled that.

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Again, my experience has been with disruptive technologies, right?

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So we were basically creating a market where one did not exist or we were introducing a technology for an application where there wasn't one previously.

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So that is a little bit different field than, let's say, a common use generic drug or a device that's been on the market for a long period time and so typically the way that we do things is: first, to the clinician directly.

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So whether we have the distributor or not, we've developed the relationship with opinion leaders directly in the market and then through those key opinion leaders and through clinical marketing so presentations at local professional trade shows, publications in local clinical journals and setting up a training environments where key opinion leaders can train other physicians in the market locally is sort of the place you start and then what happens is if there is a consumer aspect to the technology, so I think about, let's say green light for enlarged prostate, right?

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Which is a technology I was involved in, as you mentioned earlier, there was a direct to consumer component or direct to patient component, which was very strong because you're dealing with urinary symptoms and this is a very common problem in men.

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So we would sort of look at that marketing strategy as two-tiered: one you train the physicians, so you get a physician-based and then two you develop a referral marketing campaign where you now can get patients to go directly to physicians that have been trained and ask for that technology, so in instances like that, it's sort of a two-pronged approach.

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Now the distributor role, if you're going through a distributor channel, the distributor role in that is really to support the efforts toward the physician and training and managing that.

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It's also managing perhaps the referral process locally to make sure patients are being referred to the physicians that offer the procedure or the technology, and it's also to participate financially and let's say co-marketing of the technology.

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So that's typically the way I see it.

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Very good.

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So what about pricing?

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Some people say that Latin America is a very price sensitive region.

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So what are your thoughts on this?

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I think for the most part that's true.

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Again, I say that it really depends on, I think it depends on the country in question.

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Again, you know, we look at Mexico and Brazil of course they're not going to have the same price as Japan, which is a high price market for instance, but I think that there is becoming more and more of an appreciation in those markets for value, the concept of value, the concept of introducing technologies that have good clinical outcomes and can reduce healthcare costs and certainly not to the extent that we might see in Europe perhaps, but I think it's heading that way.

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Overall, I would say it is a price-sensitive market.

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In fact, in some of the companies that I've been involved in, we went through great lengths to ensure that there wasn't sort of this gray market, cross border purchasing of equipment and disposables by coding the disposables for certain markets to really prevent the transfer of lower price goods into a higher price good market and Latin America has been involved in that in the past.

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So there is definitely a price sensitivity, but I think in certain markets there're becoming more and more an appreciation for value.

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Very good.

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All right, so what about reimbursement?

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Have you ever been involved in strategies or tactics or lobbying efforts at insurance companies or government officials to get the product reimbursed by the national healthcare system?

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So I haven't been directly in Latin America.

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Of course, I have a lot of experience in doing that in the US and Europe primarily, and I think part of the reason for that is, again, in the disruptive technology space, there is no reimbursement in place because you are bringing forward a technology that didn't exist before.

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So what you see happens is in every market in Latin America, and again, I speak about sort of what I call again major markets, you know, Mexico, Brazil, perhaps Argentina, there is a certain segment of the market, the patient population physician group that will pay for new technology and so usually what will happen is you spend the first year in what I call the early adopter phase, maybe a little bit longer, where reimbursement doesn't become an issue, of course, as you want to go out to the broader market, it does.

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So that of course then becomes a negotiation with the national health system, but I've been involved in the very early phase of early adopter phase where reimbursement really isn't an issue because there are people that will pay to have that type of technology and in fact, I'd say one other thing, it's not uncommon that you have physicians, especially from Latin America that will come to trade shows in the US that will try and actually or do purchase equipment to bring back with them, especially new types of technology.

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Interesting.

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So what about the importation process, duties, shipping, etc, things of that nature.

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Where are your thoughts in experiences on this?

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So typically this is where I think identifying the right distribution partner becomes important, and again, depending on the market, right?

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Because if you looked at the formerly NAFTA, I guess, train into Mexico is fairly straightforward.

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Now, of course it's a different agreement but still fairly straight forward, but if you look at other countries like Brazil, that becomes a real potential issue, right?

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Because you need to make sure that your importation is in place and that you've done everything you need to make sure the product is landed appropriately.

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So I think that's where sort of identifying your distribution partner, that has the relationships in place, that has been successful in the process and actually has a good reputation amongst the government authorities that are responsible, customs, etc., for importation is very helpful.

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So my experience has been that they will usually manage that for you, the only thing that you do as a company is making sure you're providing them with the proper documentation in a timely fashion.

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Now that being said, I have been involved in situations where it doesn't go as smoothly and products are held up in customs, but usually, that is easy to rectify because it's usually some type of paperwork issue.

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So the distribution partner I guess in summary really becomes key in facilitating that process.

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Yes, makes sense.

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All right, so what about the FCPA?

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Have you ever been involved with things related to corruption or bribery in the region or have you seen it from others?

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So, what's your experience here?

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I have not been involved in corruption in Latin America.

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Unfortunately, when I was running another business out of Europe, I had been involved in a couple of instances in the Middle East and Eastern Europe, but not in Latin America.

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Now I'm not saying that it doesn't happen, but again, in most countries in Latin America, we go through distribution.

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So it's important to maintain an arm's length and what I mean by an arm's length is you really have an intermediary party to the organizations that are purchasing the technology, so the distribution partner will usually play a very crucial role in ensuring that you as a manufacturer are not subject to anti-corruption practices.

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Yes, makes sense.

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Okay.

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Are there any other areas that we haven't mentioned that you think are important for listeners to hear about?

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Yeah, I do think that we've discussed this before in the past as well, and that is, looking at the Latin American region as a region to begin to conduct clinical trials and product development, and I think as the European environment is becoming more strict with respect to sort of, now you have the medical device regulations that have been implemented, Europe may become less and less attractive.

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And so Latin America, I think as a region, especially close to the US where it's easier to conduct clinical trials and things of that nature.

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And so I see that region playing more of a role.

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Now the question really becomes, is that enough or does there also need to be a substantial market opportunity?

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Because part of the appeal of Europe was that you would do your trials there and then once you've got approval you had a substantial market opportunity.

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And, I think there are certain markets in Latin America that are going to fit that same criteria.

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So I would say considering, you know, the Latin American region as a trial point and new technology development is something that should be looked at.

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Very good.

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Okay.

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So before we close, Lloyd, have you identified, major trends in Latin America that you think are relevant to our discussion today?

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There is probably one I'd like to bring up and that in a way is related to the previous comment, but not exactly and I mean the previous comment about clinical trials.

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So I would say, and I'll take Costa Rica as an example, I would say that governments now in Latin America are really trying to attract research and development investment in the region.

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So if you look at Costa Rica, I know that the government has even funded early-stage incubators to be able to develop sort of the next device technologies, and I'm speaking specifically from device and so, I wouldn't only consider the Latin American region now moving forward for clinical trials, but also as an area to do some development and research development of new technologies and this concept of incubators which has existed in the US, Europe, Israel.

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When I think about, incubators and device I believe are now coming to Latin America, and that's one sort of trend.

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I would say secondarily if you look at the sector, let's just say Healthcare IT, which is a burgeoning sector now.

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Software development and within those incubators, looking at talent, especially in the area of software development I think is a trend as well and that we're starting to see in the Latin American region.

00:26:58.530 --> 00:27:05.009
So research and development to be done there, and I think it's in the early days, but I think that will only continue to grow.

00:27:06.180 --> 00:27:06.809
Beautiful.

00:27:07.049 --> 00:27:08.359
I like that trend.

00:27:08.369 --> 00:27:12.450
I mean it looks like Costa Rica is really looking forward.

00:27:13.500 --> 00:27:20.779
I haven't actually heard about any other country that is doing something similar to that, I'm going to research that.

00:27:23.069 --> 00:27:28.289
Lloyd, any final thoughts for our listeners before we close?

00:27:28.319 --> 00:27:36.690
I mean like, what do you think is the summary of your experience and your position or your perception of Latin America?

00:27:38.009 --> 00:27:54.480
First I think that the Latin America that we see today from the perspective of a medical device market is very different than Latin America we saw 10 or 15 years ago, and again, I don't think Latin America, we can look at it as one country.

00:27:54.480 --> 00:28:00.720
I mean it's a region, but it's got many different countries and I think we, depending on the country, there're different levels of maturity.

00:28:01.099 --> 00:28:08.400
So I think you really have to take sort of a unique approach depending on the maturity of the market that you are considering.

00:28:08.880 --> 00:28:35.279
I think third, however, is that there is now as we start to see, and you mentioned it before with the Pacific alliance, some other countries are seeing opportunities in the region to sort of surpass what I would say would have been considered the more mature countries like Mexico and Brazil by developing creative ways to facilitate the regulatory approval process and also the investment in research and development as I mentioned.

00:28:35.280 --> 00:28:39.900
So I think the market today is different than the market was even, 10 years ago.

00:28:40.470 --> 00:28:55.049
So what I would say to the listeners is don't only think about Europe and the US when you're thinking about, regulatory, clinical and or development strategies, but give the Latin American region serious consideration.

00:28:56.069 --> 00:28:56.579
Excellent.

00:28:57.180 --> 00:28:58.289
Thank you so much.

00:28:58.290 --> 00:29:11.549
I mean is being a fantastic interview and I'm certain listeners will get a lot out of it and, I truly look forward to having the episode uploaded and thank you.

00:29:11.730 --> 00:29:13.799
It's been a fun chat with you.

00:29:14.470 --> 00:29:20.589
Thank you Julio and I do appreciate the opportunity and anytime you want to have a chat about it, happy to join.

00:29:20.869 --> 00:29:21.589
Excellent Lloyd.

00:29:21.799 --> 00:29:22.220
Bye Bye.

00:29:22.221 --> 00:29:22.750
Take care.

00:29:23.089 --> 00:29:23.329
Bye.

00:29:23.330 --> 00:29:23.509
Bye.

Lloyd Diamond, CEO, Pixium Vision S.A.

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