Global Trial Accelerators™

Dave Dolan, Co-Founder & Executive Chairman at MultiFunctional Imaging

• Julio G. Martinez-Clark • Season 1

Share episode

Dave is the Co-Founder & Executive Chairman at MultiFunctional Imaging, a University of Utah startup company that provides software solutions for improving the efficiency and accessibility of multi-tracer imaging with PET, PET/CT, and PET/MRI scanners. Dolan’s career has been built on successes centering around the commercialization and customer adoption of innovative MedTech products/services. Spanning from Fortune 500 corporations through startups, businesses have benefitted from his track record of success in turning medical device innovation into record growth, high market share, and attractive market valuations. He is a trusted business leader who draws upon an analytical and data-driven approach with KOLs, advising boards of directors, investors, C-level executives, and other stakeholders in identifying and capitalizing on opportunities to advance each organization’s strategic vision.

Speaker 1:

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. I heard radio, Pandora, or these are welcome to the Metech Leaders podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America Today. Our guest is Dave Dolan, co-founder and chairman at Multi-Functional Imaging, a company that provides software solutions for improving the efficiency and accessibility of pet, pet CT and PET MRIs scanners. Dave has a track record of success in ge, bd and j and j among other companies. So, Dave, it's great to have you here today. Welcome to the show.

Speaker 2:

Oh, Julio, thank you so much. It was great to get this invitation.

Speaker 1:

Awesome, Dave. All right, so let's get started talking about your journey. How is it you got to where you are today? Uh, what's your journey to Latin America? How is it you got involved with the region?

Speaker 2:

Yeah. Uh, well, uh, I'm a med tech veteran. I, I started up my career at, uh, at GE Healthcare, like you, uh, brought up earlier. And, uh, I was very fortunate to be exposed to quite a few international roles and responsibilities. And, uh, Latin America was, uh, was one of those. Um, I've, uh, spent some time doing some business development work in, uh, in Mexico City, uh, Columbia, as well as, uh, Brazil. And so, uh, I, I can't, um, I can't say that, uh, I'm a, a, uh, long term veteran of doing business in Latin America, but have come to strongly respect the, uh, the marketplace.

Speaker 1:

Good, good, good. And, um, let's talk about trends in Latin America. Dave, what are you seeing in the news of what do you know from experience about the region in terms of changes or trends or happening, political, economic, social disease trends, whatever, anything you can tell us about it?

Speaker 2:

Yeah. Well, I, all of it's quite positive. Um, you know, I think, uh, when you're, uh, in terms of, uh, an early company, uh, which, you know, technically multi multifunctional is a common, um, commercialization or regulatory oftentimes would be to go through Europe and, uh, able to do your, your trials over there. But with, uh, mdr, that's becoming, um, untenable, you know, quite frankly, in a lot of arenas. And, uh, you know, I, I'm, I'm probably sharing nothing that the listeners to this, uh, show don't already know, in that there's a lot of first inhuman studies that are going on. I know in Intuitive is doing quite a bit of work in, uh, Chile right now. Uh, you know, and the regulatory environment is, uh, is much more favorable in Latin America. And you're seeing a, a, a, not a subtle shift from people trying to commercialize or at least do the early regulatory work in the EU or Eastern Europe, um, getting away from that and getting away from the US and doing a lot of this work in Latin America. And so it's something that is, uh, that is out there, and I don't think it's much of a surprise to anybody right now.

Speaker 1:

That's an interesting point. I wrote an article about that specific topic, Dave, uh, about a year and a half ago before the U M D R was going to take, um, effect. It was supposed to take, effect or become, uh, active or a law in May before the pandemic. Right. And it was pushed a year, but I interview about 30, uh, CEOs of medical device companies about this specific trend that you're referring to. And, and, and I, and I think you're right on, on, on, on, on point. I mean, it's, uh, it's certainly a, uh, um, uh, a trend that will benefit Latin America in one way or another with clinical research and commercialization, because the, the old strategy of EU first and then the United States is being reevaluated now, I think, uh, because, uh, of the, um, the stringent requirements, and you don't have notified bodies anymore. I mean, just a few have survived, for example, and it's getting tougher and tougher to do trials. So, so yeah, we've seen a trend, um, in, in terms of the number of, of companies interested in doing first in human work in Latin America. Uh, we're being busier than ever. And, uh, we've also seen a trend of companies looking at Latin America to start commercialization after the United States, of course, and, and some other markets in, in Europe. But, um, but they're now looking at Latin America more favorably,

Speaker 2:

So, yeah. Yeah. And it's changed so much. I mean, when I first started, you know, working in the med tech field 20 years ago, you know, a lot of people view Latin America as, geez, it's such a vibrant, you know, market, but boy, there's so many different regulatory fys, uh, within Latin America. It, it, it, it just didn't look attractive at the time. Um, and now the shift is going the other way where there's a lot of commonality in terms of regulatory pathways in, in Latin America, and like in our case, multifunctional imaging. We've got a five 10 K and a 5K is accepted in Latin America, in, in a lot, in a lot of Latin America, uh, territories. And so we're actually<laugh> the timing of our, of our discussion is, uh, is, is, uh, pretty compelling in that we're having a board meeting the end of this week where, hey, we need a America strategy. You know, we need this market because we think we could add a tremendous amount of value. And that's something that, you know, hey, five years ago, I don't think people like me would've said.

Speaker 1:

Hmm. That's, that's quite interesting. All right. So let's talk about, um, specific countries or, or your plans. Let's begin with your plans in Latin America. Do you have any specific countries in mind? Of course, you don't have to disclose confidential information, but, uh, any, any direction that you have in Latin America? Are you gonna pick specific countries first, uh, or are you gonna go for, for the big ones first and then the smaller ones? Or, you know, go for middle countries first and then the big ones? What do you have in mind terms of

Speaker 2:

Yeah, we're pretty unique in that we're, we're gonna, we're gonna approach this from how our technology can best serve, uh, the markets. Um, what we do in essence is we make pet scanners or pet CT scanners and pet MRI scanners run faster. And oftentimes it's, um, older systems that our software actually delivers the most value for, because we can make older systems operate much faster. And so rather than sort of like, um, oh, we're gonna focus on Columbia because we know physicians there, or we're gonna focus on Brazil, um, we're gonna be no, where actually is the installed base available that we can take our products to? And yeah, there might, there's still, I'm sure there's still some regulatory pathway differences between, uh, the different countries, but, uh, we're gonna approach it more in terms of work. Where can we provide the best value? And where could we commercialize as quickly as possible?

Speaker 1:

Yeah, yeah. Good approach. Yeah, I think that's, in your case, that's probably the best, uh, strategy and, um, going back to the issue of, um, fragmentation in Latin America. But that's because that's always been, uh, a problem. I don't know how much you know about the Pacific Alliance. You don't know, I don't know how much you know about the, the initiatives of all, well, the top countries, at least, uh, to homogenize the regulations to make them more similar in, in all these countries. And, and, uh, go, just for the listeners, um, as you correctly said, if you have CE mark or, uh, f d a approval, five[inaudible] approval in your case, uh, the pathway for approval is pre straightforward. Uh, and Columbia seems to have the fastest regulatory approval time in Latin America except for Chile. Mm-hmm.<affirmative>. Cause Chile doesn't have any. Right. So, uh, not many people know this. Uh, a lot of my clients get like shocked when I tell them this. Uh, Chi Chile is quite a unique country in the region. Um, but it's gonna change. And, and, and specifically because the reasons I just mentioned, which is the Pacific Alliance, Latin America's going through a transformation, um, where the countries are going, are becoming more mature, uh, countries are becoming O E C D members. Every year there's a new O E C D member which says a lot about countries being serious, about implementing best practices, best international policies and best practices on how to do business, how to do regulatory approvals, how to do social, uh, uh, uh, strategies, whatever, uh, healthcare, et cetera. So we definitely see a trend, uh, of, of having more uniform regulatory, uh, requirements and accepting reference countries, uh, Columbia, for example, and that's the case in Brazil and Mexico. They accept reference countries like the United States, Europe, uh, some of them accept Canada, some of them accept Australia, uh, Japan. So that makes things easier for foreign companies to do business in Latin America.

Speaker 2:

Yeah, no, it's tremendously exciting cuz uh, you know, boy, you know, you know, 10 years ago, um, you know, people like myself saw Latin America as, as, hey, it's a, it's a, it's a excellent place to manufacture your products at, whether it be Tiana or Nogales or in Costa Rica. And now the table has completely turned up. No, actually this is a marketplace for a company as like multifunctional imaging.

Speaker 1:

Yeah, yeah. And that's, and I think they've, that's how the countries in the Pacific Alliance want the block to be portrayed as, as a marketplace, if you see what they're doing for the Pacific Alliance, which is something historical, I think, because, uh, the medical sewer, do you know what that is, right? Mm-hmm.<affirmative>. Yep. Uh, in the south, uh, Argentina, Brazil, Uruguay, and Paraguay, they haven't really made any traction<laugh> in terms of, of, of creating a, a, a, an attractive business friendly marketplace. Whereas the Pacific Alliance, since they have O A C D member countries, Chile was the first one about 10 years ago. Uh, then Colombia, then Mexico, uh, in Costa Rica, just joined in May, I think. Uh, and, uh, their Peru will join very soon. And so Panama is also, uh, in, in, in the path to, to join the, uh, alliance, but for now is only officially is Mexico, Columbia, Peru, and Chile. And the marketplace that they're creating is about 260, 200 70 million people. So they really wanna compete

Speaker 2:

Just those handful of countries. That's a very big market.

Speaker 1:

It is. It is. It is. Exactly. So, and the idea is to have, and I was speaking with, uh, somebody, uh, from, from that organization, um, a couple years ago. I was interviewing her, uh, in, in the adas to have a single regulatory market where if you get approval in Mexico, you gonna get instant recognition in Columbia. And that's already happening.

Speaker 2:

Absolutely. It's incredibly attractive.

Speaker 1:

Its, yeah, it's, it's, there's another trade block that not many people talk about. I don't know why. It's probably because they are smaller countries, but it's called the Indian Pact. The Indian P the Indian Pact are of course, the Indian countries. Uh, Colombia used to be Venezuela, not anymore, for obvious reasons. So it's Colombia, Ecuador, Peru, and Bolivia, I believes. And they're, they're, they have made it so similar to Europe, Davis, they're probably behind like 10 years. But, uh, just, uh, a couple weeks ago, I, I've read the news where a Colombian citizen can easily move to Bolivia or Ecuador and live and work and study and, and, and get a job and everything. So it is just, uh, amazing what they're doing. So they're already integrating the regulatory environment for cosmetics, for some, for food. So they're starting with, you know, low risk products, but eventually they're gonna go up to drugs and medical devices. Mm-hmm.

Speaker 2:

<affirmative>. Yeah. No, it's an incredibly attractive market. And like you said, you know, just a handful of countries right now you said 270 million. Oh, by the way, that's about the size of the US market. That's pretty

Speaker 1:

Exactly.<laugh>. Yeah. Yeah. So imagine if, uh, we all get our act together in Latin America. Um, Colombian of course. And, and, uh, we as a, as a region, we are 30 something countries, over 600 million people double the size of the United States, but we have to get our act together. Come on. I mean, it is about time that we all join forces and move in the same direction. Not

Speaker 2:

Everybody. Well, well, I mean, in, in, in the defense of Latin America, there's been tremendous progress over the last five years.

Speaker 1:

Yeah, yeah. I agree with you. Yeah. Yeah. The countries are becoming more mature. Absolutely. Yeah. Middle class is, is growing and, and, and all that. Anyway, so going back to your experience, Dave, I'd like to dig a little, a little deeper into, into your life in Mexico or your experience in other countries. Uh, can we talk about that? I mean, what is it to be doing business in Mexico or elsewhere in, in the region? Mm-hmm.

Speaker 2:

<affirmative>. Yeah. No, my, my, my experience has been, uh, typically with, uh, either capital equipment or with, uh, disposable products, specifically. Most of my experience in Latin America came during my tenure at, uh, Beckon Dickinson. Cause, uh, we did have a manufacturing facility, um, just outside of, uh, of, uh, Rio. And so there was, there was some, um, there were some, um, strategy meetings and, and some, uh, and some, uh, interactions that I had, uh, you know, in that area. You know, again, it was, it was always just challenging meeting with the country leaders where there was just not a lot of commonality between the marketplaces. And I'm talking, you know, this is 10, 12 years ago, there just wasn't a lot of commonality when I've would talk to the country managers and I'd be saying, geez, we have the same product. You know, why is the product, you know, priced, um, this much per piece in Columbia versus Peru? And it was, it was always a challenge where it was just, you know, geez, it's, it's difficult to have the country managers and find synergies amongst themselves, even though our product was exactly the same in delivering the exact same clinical value no matter what country it was being, being, uh, sent to. And so, uh, that was always, again, you know, the big challenge, you know, for us as a, as a mass producer of, uh, of medical devices is, you know, geez, getting to the final mile, you know, you know, to the, the facilities was always a challenge. It was never a clinical challenge. It was really more of a, of a business development challenge to be able to effectively market products, uh, correctly over there.

Speaker 1:

Hmm, interesting. Did you ever have to deal with distributors or find distributors or manage distributors in the region?

Speaker 2:

Yeah, it was, it was, again, it was by country because, you know, in some countries, um, you know, distribution was really the only effective way to go. Um, you know, there were, you know, countries like Brazil where we had to have a direct Salesforce, you know, because the market there expected a representative to be there upon, uh, adopting a new product, doing the in servicing and what have you. So, you know, again, it highlights what you're talking about. It was highly variable and fragmented, um, in terms of, uh, which country you're working with in Latin America.

Speaker 1:

Yeah, yeah. In experience in Argentina, for example.

Speaker 2:

No, actually very limited. Very limited in, in Argentina.

Speaker 1:

And, and the reason I ask is because, uh, it's such a, such a difficult market, such a, uh, it's ups and downs, economic ups and downs. It's just impressive. I mean, the inflation, uh, it's just, uh, every time I have an interview like this, Argentina comes up, uh, because, uh, that's the, like, the prime example of challenges in Latin America, political changes, left, right center.

Speaker 2:

Yeah. Our, our Argentina was always just a really quick discussion whenever we spoke with our country leaders, because literally the average price sold looked like our scale because of the inflation issues that you, you're speaking of. And, uh, so it was, it was just, whoa, this is really difficult for us to get our hands on. And so, uh, yeah, we, it it wasn't a strategic imperative, at least Dickinson's part to, uh, focus on that country.

Speaker 1:

Yeah, yeah. Yeah. It's really a shame because it's such a developed country. Um, culturally speaking, uh, socially speaking, educationally speaking, there used to be a, a very powerful country in, in the twenties, in the thirties, absolutely. Forties. Absolutely right. Yeah. Yeah. So it's, it's really a shame. Uh, and, and Buenos Aires is one of my top places to visit in Latin America. It's a beautiful, beautiful city.

Speaker 2:

Yeah. Well, that's, uh, that's a bucket list place for me. Cause everybody I know that has been to bu rs, uh, does nothing but rape about it.

Speaker 1:

Yeah, yeah. Yeah. It's, it's a country full of Italians who speak Spanish<laugh>.

Speaker 2:

And I, I hear the best steaks in the world, is what I hear.

Speaker 1:

Yeah, exactly. Yeah. Bueno Air is a beautiful mix between Madrid and Paris, actually. Yeah. And a little bit of Rome<laugh>, so,

Speaker 2:

Yeah. And, and, uh, multifunctional imaging we're headquartered in, uh, in, uh, salt Lake City, Utah. And so, um, as you're probably aware there, there's a, uh, a church of latter day Saints, um, Mormon, uh, culture here. And, uh, so I have a lot of friends or associates that did mission work down there. Oh, yes. Graves about Argentina.

Speaker 1:

Beautiful. Yeah. I'm glad to hear that. Yeah. Yeah. Yeah. So you have to go,

Speaker 2:

The bucket is,

Speaker 1:

And what about Columbia and experiencing Columbia doing business in, in the country or

Speaker 2:

Anything? Yeah, actually, uh, Columbia was a pretty big and strategic, uh, um, um, country for Beck Dickinson when I was there, uh, because, uh, they, even back then, um, they adhere to Thek, um, back then. And, uh, you know, obviously it's a, it's a highly, you know, developed country with, uh, a very good healthcare system. And, uh, so yeah, in, in spite the, the fact that it's, it's not the, uh, and from a population standpoint, it's not the largest marketplace. It's a highly developed marketplace. And, uh, yeah. And, uh, you know, like I said, we're gonna be meeting as a board, uh, this coming Friday. And, uh, not only are we gonna walk out with the Latin America strategy, I wanna hear what our Columbia strategy's gonna be.

Speaker 1:

Beautiful. I'm really happy to hear that as a Columbian<laugh>. And, and, and, and just to add, uh, to that, uh, I'm not, uh, um, this is not a commercial for Columbia. It's a fact. Uh, just like Chile is so easy to get into, Dave. Uh, I'm sure you know, as I said initially, you don't really need a regulatory registration in Chile. All you need is an importer, and you're good to go. You're in business. Uh, there is a voluntary registration process that needs to happen. What doesn't need to happen that you could do, if you wanna prepare yourself for the future, probably in the next year or so, the Congress will pass a new law where they're gonna make mandatory the regulatory registration process. The other countries of the Pacific Alliance, Chile is just getting in the same train as the other countries so that they have, uh, uh, unified sale of laws. Anyway, my point with, uh, this is that, um, uh, just as friendly as Chile is, I will say the second country in Latin America in terms of friendliness and market, ease of market access is Columbia. Just to give you a hint, the Columbia, the regulatory agency in Columbia in Vima is the only agency in Latin America that allows foreign entities to be the owners of the title holders of the registration certificate or the market clearance certificate. No other country does that. They all mandate, they all force you to have a, either a local entity or contract the services of a, what is called a registration holder, and you have to pay hefty prices for that monthly prices for other annual prices. Or even worse, they make you, uh, have the distributor as your title holder, which is not always a good idea because the distributor today may not be the shooter tomorrow, you know, that, uh, you have to probably go through two or three the shooters first before you find the, the guy, the right guy. So, um, so yeah, that says a lot about how much this country is one business, how much they want, uh, to make it easier for companies to, to enter the market, to, um, have access to patients, have access to innovative technologies faster than other countries. Right. Um, I mean, we're

Speaker 2:

Panama also. Yeah. And also these countries, you know, they respect the intellectual property that, uh, technologies like multifunctional imagery bring to the table, you know? Yeah. We've made a strategic choice not to go into China, for instance. Uh, yeah. Cause we have to share some of our ip, you know, with, with their regulatory board. And, you know, quite frankly, we're, we're not quite comfortable with that. Cause we've written a lot of proprietary code<laugh>, and we prefer that to be a trade secret. And, uh, and Latin America, uh, is, is is very respectful of, uh, companies like ourselves, um, in terms of that aspect.

Speaker 1:

Yes. That's a, that's a great point, Dave. And the reason for that, one of the reasons for that is first the E C D, right? They, they require you to enact certain laws to protect intellectual property and other type of protections, et cetera. And second, free trade agreements, right? If you wanna have a free trade agreement with the us you, you have to comply with certain guidelines or mandates, or, or, or you agree to respect, uh, or to have a way for companies to, to, to have access to a core system in case of infringement or, or things of that nature. So,

Speaker 2:

Mm-hmm.<affirmative>. Yeah. Yeah. Again, it's, uh, we're gonna have a Latin America strategy<laugh> come this Monday.

Speaker 1:

<laugh>, I'm, I'm so happy to hear that, Dave. It's that it's great new for the region, it's great new for patients, it's great new for the healthcare systems of these countries. And, um, well, we're close to the end of the show. I usually keep it short to about 30 minutes. I think we covered so much in only 20 something minutes.<laugh>, is there any final words of wisdom do you wanna share with the audience? If you had the ceo, e o of a medical device company in front of you, what would you say to him or her, uh, if he or she were just starting to explore Latin America?

Speaker 2:

Oh, there's a fantastic opportunity in Latin America right now. My company recognizes that. And, and we're not the first, and we're not gonna be the last to, to recognize that. Um, I think that, uh, with any new market you go into, it's, it's important to identify and build tight relationships with partners that can help you. You get access to those markets, and that's where we're at right now. And it's folks like yourself, Julio, that we wanna, uh, partner with, uh, and able to, uh, take our technologies, uh, moving forward to Latin America. It's a fantastic opportunity. And, uh, you know, I think, uh, if, if you're thinking that it's gonna be a aeu strategy first, I think you need to rethink that right now. I think you need to, you know, cast your eyes upon Latin America, uh, especially for early stage companies like Multifunctional Engine.

Speaker 1:

Excellent. Dave, I'm, I'm so happy to hear those words coming from you. All right, Dave, thank you again for being the show. It's being a delightful conversation. I'm sure listeners got a lot, uh, from your insights and your wisdom and your experience, and I look forward to seeing you succeed in Latin America.

Speaker 2:

Oh, I look forward to, uh, speaking with you again. If there's way that we can of assistance to yourself, lu, please let us know.

Speaker 1:

All excellent. All right, Dave. Thank.