EPISODE 63: MARIE O’MALLEY, SENIOR DIRECTOR OF SUPPLIER OUTREACH AT MEDTRONIC

Episode’s transcript

Julio Martinez: 0:00

Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher Tune in iHeart Radio, Pandora or Deezer . Today our guest is Mary Ly . Mary has close to 30 years of medical device experience. She is president and founder of LY advisors, vice President of commercial Operations at Centerpiece, and a member of the board of directors at Mass Medic , where she served as a chair over the last two years. Prior to this, Mary had senior director level supply management and supply chain positions at Medtronic. She specializes in global supply management and strategic sourcing strategies, commercial operations , uh, planning, m and a, due diligence and integrations, supplier diversity and sustainable supply chain strategies and execution. Mary was recognized in the 2018 and 2019 top 100 lists of women executive leaders in the MedTech industry, and she was , uh, recently recognized as a top 15 women in power impacting diversity for her work, supporting supplier diversity and inclusion. So, Mary, it is a pleasure to have you here today. Welcome to the show. Thank

Marie O’Malley: 1:30

You very much.

Julio Martinez: 1:33

Awesome . Mary. Uh, the thing that I like the most about you is that you are the first woman that I have on my show, <laugh> , and this is great <laugh>. It is fantastic. Um, exactly. That's, that's the idea. So, Mary, let's , um, get started with talking about your journey to Latin America. How is it that you got involved in the region on a personal professional level?

Marie O’Malley: 2:01

Yeah, I guess , um, on a professional level, I've had global responsibility for a number of years at Medtronic and , um, you know, definitely looking at a global supply base, but have found a number of suppliers that are in the Tijuana Costa Rica regions. Um, and it's just a growing area for medical device manufacturing specifically, which is what I had responsibility for on a personal level, I've traveled , um, quite a bit in Latin America. I've been to Costa Rica and a number of different countries. Um , my daughter's been there. She speaks Spanish fluently , um, to a number of different areas. Um, so it's an area that I enjoy visiting both on a personal and a professional level.

Julio Martinez: 2:46

Very good. And you also live in the Boston area, and I'm sure there's a huge Hispanic community there, right?

Marie O’Malley: 2:52

That's true, yes.

Julio Martinez: 2:54

Beautiful. All right . So Mary, what do you see as, as trends happening in Latin America that are relevant to our discussion today?

Marie O’Malley: 3:03

Um, I guess the , the , what I see is it continues to be a really rich environment for the medical device industry specifically. There's, you know, high quality operations there that , um, continues to grow in different, you know, regions. You know, Tijuana is a good example where , um, there's just , um, good representation across a large, large OEMs who have a nice presence in Tijuana, but also a tremendous supply base there as well. And that's true. You know, there's other clusters, you know, Costa Rica's another med device cluster, I would say. But I'd also , um, comment that, you know, there's more advancement of, you know, clinical trials development work within that region and the advancement of patient care , um, in the whole Latin America

Julio Martinez: 3:56

Area . Yes, that's, that's very true. And I also see , uh, countries maturing in Latin America, trying to attract more foreign direct investment. And certainly Mexico is doing a great job , uh, because of the free trade agreement , uh, Columbia is, is looking at , uh, bringing , uh, what's called now Nearshoring, right? Because of the geographical position of the country and issues that we had , uh, with China , uh, you know, the Trump administration with China and everything. A lot of companies were reevaluating their China strategy, manufacturing strategy, and they were looking at Latin America as a, as a near sharing , uh, place, which is perfect. It's just that the region was plagued with , uh, I'm sorry, plagued with , uh, political instability, economic instability , uh, uncertainty, legal uncertainty. But countries are maturing a lot , uh, Mary , I think , uh, so I think the discussion we're having today is, is, is timely , um, because , uh, you see countries like , uh, Costa Rica now joining the OECD , which just happened , uh, less than a month ago, which is a big event for Latin America. Nobody's really talking about this, but it's a sign of how mature Costa Rica , uh, is now, is is is a global player in, in , in, in, in the , in the global economy, of course. And , uh, you have Mexico, part of the UECD , uh, the first country was Chile, Columbia , uh, Brazil is looking to, to become part of the OECD . So I see a , a , a maturing region. So let's talk about , um, the operation that , uh, you , um, know in Tijuana and what's really happening in Tijuana. Why is it that all these companies from the US are doing manufacturing there, and why Tijuana out of all places?

Marie O’Malley: 5:54

Uh , I think Tijuana is just a good location because of its proximity , uh, to the us and it's easy to get in and out of Tijuana. I've probably personally been there. I can't even account the number of times, 50 times, maybe more. Um, but it's a pretty easy thing for us customers to go, you know, there. And it's also a very nice place to stay if you wanna stay there and do business. But, you know, there's just a very strong cluster , um, specifically in the med device space , um, that has the talented workforce, the , you know, educated, you know, team members that, you know, are needed in medical device manufacturing and a lot of high technology there that , um, you know, the focus on quality and execution is, is really high and strong in that area. You know, they have a good base of business and I think, you know, the surrounding government and , um, communities have been very supportive of that. You know, they have a skilled, trained workforce , um, that understands the requirements of working in the medical device industry.

Julio Martinez: 7:03

Hmm . And , uh, who has built these plans ? Uh, US companies, Mexican companies? What's the investment behind this ? Who is investing all this money in Tijuana?

Marie O’Malley: 7:15

I think it's global companies. It's, you know, a lot of the large OEMs in the med device field, and there's some regional , um, Mexican companies that , that are there as well. But I think very global. It , it's not just limited to us . There's European companies that are, you know, have a presence there, and they're taking advantage of the strong labor forces there and, you know, some better economics that they can be found in that region. Um, and then just ease of doing business with them in the close proximity to the United States and the borders.

Julio Martinez: 7:50

Yeah, makes sense. And , uh, the management is, I guess what I'm trying to get at is, is there is kind of a , a progression or an evolution of these places in Latin America. They first are doing McKayla type of work , uh, then they become a little more sophisticated. They do medical devices, for example, which is a very , um, um, complex , uh, manufacturing operation. I will assume. I've never been to a , a plant, but I imagine that's, that's, that's , you know, the clean rooms and all that involves a lot of , um, high tech . So the, the management is mostly , uh, European American and Mexicans are , at least for now, it's just the, the, the, the regular workers, or am I wrong with this assumption as I mean, of today?

Marie O’Malley: 8:43

Um, I wouldn't say that. I think a lot of the plants down there have , um, Mexican citizens that are, the plant managers are part of that executive team. I think there's some really strong leadership that's, you know, available in that region.

Julio Martinez: 8:58

Very good. Okay. Okay. That's what I wanted to hear, but I didn't know that was exactly the case. Excellent, excellent. So yeah, I know of a company in Costa Rica. We can talk about Costa Rica in a second, but , uh, I know of , uh, we had a client , uh, is a company of Costa Rica called Establishment Labs. And , uh, they, they were part of that cluster of, they, their , their , the story goes back to the Maquila work or the manufacturing plans for European medical device companies, US medical device companies that you were saying. And now the, the management is, is , um, or the management , uh, saw the opportunity to build their own company , uh, not act as subcontractors. And now they're developing and innovating in breast implants, and they are one of the top breast implant , uh, companies in the world. They trade in the stock exchange somewhere in New York. And , uh, they , uh, have clinical trials going on in this , in the United States, in Japan. So it's a great example of , of that evolution that I was referring to, where companies become, they , they learn from the experience of working for European or us , um, operators, and then they start on their own. And, and they, they, they leverage on those experiences and that global exposure that they get, and then knowledge that they acquire , I guess a transfer of knowledge is just immense.

Marie O’Malley: 10:29

Yeah. And I , I think that's great. 'cause it just helps them in terms of, you know, their , um, you know, ability and, and the , and the whole economics of the whole region, you know, if you continue to elevate the , you know, workforce and give them those opportunities, you know , and I do think there's tremendous learning, you know, medical device is a great industry to be in, you know, there's continued market expansion and , um, you know, it's definitely a strong industry to be in.

Julio Martinez: 11:00

Yes, agree. Agree. And , um, the medical device innovation that you see in Latin America, Mary is predominantly , uh, low risk devices, you know, syringes and, and tubes, things of that nature. So I'm , I'm always happy to see something that is more complex than that, something of higher risk. For example, I , I've , I've been in this industry 14 years, I've never seen A-P-M-A-P-M-A type device in Latin America except for one case in Brazil that I just learned about a month ago, <laugh> . So , uh, hopefully the region will , uh, mature and, and , uh, uh, that transfer of knowledge will be very impactful and, and will , um, make , um, uh, local innovation , uh, foster , right, yeah . And , and grow . Yeah . But I would

Marie O’Malley: 11:56

Comment that I don't think it's just commodities that are being manufactured in Latin America. I think there's some pretty complex devices that are being manufactured there, five 10 K and PMA devices and, you know, pharmaceutical devices, you know, so there's, you know, much more complexity I think, than maybe people really, you know , know of. Um, you know, I , I don't think there's a lot of limitations in what's being considered.

Julio Martinez: 12:21

Very well said. Yes. Thank you for the clarification. What I really meant is local innovation from locals in Columbia and Brazil, right? If you see the, the manufacturing , um, environment in Colombia , for example, all you see is local companies just innovating on, on syringes, <laugh> , which is, there's really no innovation. So that's what they make locally, that's what is , uh, really meant. Um, but Brazil, for example , uh, has a very, very strong local , um, medical device ecosystem , uh, not to the level of PMA or five 10 K devices, of course not. But , uh, they export to many countries in the Middle East, for example . I learned about it recently. And, and, and that , that's , that's, that's good. I mean, eventually they will graduate and start , uh, developing more complex devices, PMA type , uh, of , uh, technologies. So anyway, so let's talk about the work that you do. Uh , Mary, I'm , I'm, I'm very intrigued by your involvement with centerpiece, with your , uh, involvement with , um, um, mass Medic . So can we talk about that or , and your consulting company, how you help companies succeeding or how you could help companies succeed in Latin America?

Marie O’Malley: 13:39

Yeah. Um, you know, I recently left Medtronic after close to 30 years there, so I had a great career with a great company, but decided to do something different. So I started my own consulting company and , uh, pretty quickly took the role , um, with Centerpiece, who has their operations in , um, outside of San Diego in the United States. But they're doing , uh, quite a bit of work in Tijuana. They have a brand new facility doing contract manufacturing with a lot of great capabilities, and they've opened up a ETO sterilization site as well, so they can be full service in that region. So, you know, I'm pretty excited to be part of that team and , um, seeing that , um, you know, business really be able to service , um, you know, a number of different customers, both large OEMs and some regional ones. Um, so that's been really exciting for me. Um, I've continued to stay involved in mass medics , which is the trade association in Massachusetts. Um, I've served as the chair for the last two years , um, and the last year for the Pandemic has been really interesting , um, because we've been mostly , you know , an advocacy organization and networking organization, but we really shifted to a digital virtual platform and , um, been very involved in the women in Med tech , um, series and supporting and promoting women in med tech and , uh, just think it's a great organization with just so many resources and , um, proud to continue to service and work with them .

Julio Martinez: 15:13

Very good. Very good. Now that you've touched on that topic of women in , in med Tech , I've seen a recent , uh, interest in diversity in med tech , and there's even a, a newly created Latinos in clinical research. There's a newly created Latinos in Bio, something like that, I think, out of Massachusetts, out of Boston. And , um, yeah , it's, it's great to see that because I don't, I don't often , uh, find Latinos or women involved in med Tech .

Marie O’Malley: 15:49

Yeah, I mean, I think it's great. I mean, I think these types of, you know, organizations or networking groups are, are really coming up to really help support, you know, some of the, you know, historically underrepresented either women or, you know, diverse , um, people that are in the , that wanna expand their careers into medical device. So I , I think it's been a really great support system. We had a mathematic Women in Network , um, event last night, just networking and just really getting to know people and learn from each other and, you know, figure out where we can help each other.

Julio Martinez: 16:28

Excellent. Very good. Very good. Yeah, I'm trying to keep on top of , uh, the activity of Latinos in bio and also that other Latinos in clinical research organization and , and , uh, yeah, the , the idea is to network and kind of support each other in , in , in , in , in our , uh, personal goals. But , um, the other advantage that I see here specifically for Latinos is that , um, somehow the region, by having Latinos in med tech , the region gets a more , um, active role. Uh, in other words, the region is present on people's minds because , uh, I think , uh, America , that Latin America has been a little , um, undervalued by, by the med tech community , uh, for politic research, certainly is, is a place that , uh, has been receiving trials, but not to the volume that , uh, I love to see. I think there's so much potential for that, and we're just starting to see that. And I don't know what your take is, and I'd like to hear your thoughts on, on the UMDR and how that could potentially benefit Latin America . Um, what do you think?

Marie O’Malley: 17:45

Yeah, I mean, I think that , um, companies are always gonna be looking, looking at what's the most favorable place to do clinical trials and, and do that RD work. I mean, the EUMD and R just, you know, added some additional re restrictions or, or rigor to the whole process, which I think is good. I mean, it's , it has to be a tightly controlled and regulated industry, and I think that is true in Latin America as well. But I think, you know, companies are gonna look for regions that it is , you know, easier or conducive to doing those, you know, clinical trials or doing , doing r and d. And I think, you know, Latin America's probably well positioned to just to continue to raise their visibility. Um, they've demonstrated their capabilities in terms of being able to be that manufacturing center and having those clusters. And, you know, I think as healthcare advances in those regions too, it's just gonna open up more opportunities.

Julio Martinez: 18:42

Yes, yes. Yeah. As you said , uh, as healthcare advances, I think , uh, that , um, the healthcare systems of all these countries in Latin America are maturing , uh, a lot rapidly, rapidly, incredibly incredible pace. For example, the healthcare system in Columbia was recently ranked as one of the top performing healthcare systems in the world. It is probably the one, or the one of the top three top performing healthcare systems in Latin America. So that helps the , uh, clinical trial , uh, industry that helps medical device companies that are looking to , uh, looking for a place or destination for the early feasibility , uh, research , uh, cost effectively and ethically, and also helps companies to access the market when they already have an FDA or c mark approved product. Because , uh, as the healthcare system matures, access to the system is, is is easier or faster or , um, and , and reimbursement is, is, is , uh, something that is easier to obtain. Um, I don't know if you knew, but , um, healthcare is a constitutional right. It's a human right in , um, I mean, a lot of countries in Latin America, so that guarantee is reimbursement. So, and that's kind of our fairly recent , uh, thing in the region. Um, and, and that helps companies , uh, sell their products because they can have reimbursement, which is really key .

Marie O’Malley: 20:16

Yeah, and I think that's true. As , you know, companies look at expanding their, you know, market and their growth. A lot of it is coming from some of those emerging markets that have historically been underserved. So Latin America is , you know , definitely a key region that, you know, a lot of companies are, are looking at as a growth opportunity.

Julio Martinez: 20:33

Yeah, yeah. Yeah. And going back to Europe, I, I see a , a little shift happening. Uh , we do , uh, clinical with , uh, uh, trials, clinical research, that's our, our area of focus. And , uh, we help us companies do trials in, in Latin America with special focus in Colombia . And in the past , uh, six months, Mary, I've seen an influx of requests for, I mean, more than ever, I've never been busier , uh, to do trials in Latin America, in Columbia . Uh, just recently last week, I get a request from a company that was doing a trial in Australia, and they are not happy with all the factors involved with the trial in Australia, time zone , geographical location, you know, the distance to fly there , um, the jet lag, the covid , uh, the pandemic situation, the lockdowns, the inability to travel, all that stuff, which Latin America doesn't have, and is closer and is cheaper and faster <laugh> and, and , uh, easier to recruit patients .

Marie O’Malley: 21:44

Yeah. And I think as more as companies look at that opportunity and, and have that positive experience, it's just gonna strengthen that, you know, compelling business case as well to continue to expand and look at opportunities in Latin America.

Julio Martinez: 21:57

Yes, yes. Absolutely. And I also see Mary a trend , um, happening from the political , uh, standpoint. A lot of these countries are trying to move away from commodities and, and, and , uh, diversify their economies and bring foreign direct investment that is not somebody in the US or Europe that wants to set up a plant and employ a thousand people. No. They want companies to, yeah, setting up a plant is great. That gives , uh, uh, that employees , uh, a lot of people that brings money to the economy, but they're looking more at transfer of knowledge, which is really key when you bring , uh, new knowledge , uh, you, you, you raise the level, you, you elevate the community and, and, and then that , uh, local economy will become more competitive in the world and eventually will start exporting its own knowledge.

Marie O’Malley: 22:58

Yeah, I think that's right.

Julio Martinez: 23:00

Yeah. Yeah. That's what countries like, like , uh, Chile are doing, Columbia is doing or trying to do , uh, because , uh, commodity prices are down and, and they're looking for , uh, alternatives. So , um, yeah, I think

Marie O’Malley: 23:14

It's really developing those key capabilities that are beyond just , uh, basic commodities and really, you know, elevating the workforce and, and the types of jobs and roles that people are gonna have that , you know, elevates the economy as well. So yes , that all goes together.

Julio Martinez: 23:31

Yeah. Yeah. And the OECD, what's happening with OECD and not many people are talking about this, Mary , I certainly don't see it in the news at all, is that , uh, as I alluded to , uh, the first country was Chile about 10 years ago, then Mexico, then Colombia about five years ago. And now we have , uh, Peru on the ascension path, and these four countries are part of the Pacific Alliance. And then you have Costa Rica that just joined , um, less than a month ago . Uh , Panama is looking to join also the OECD and the Pacific Alliance. So these best practices of attracting foreign direct investment are being implemented and , and at least these countries that I just mentioned. And, and it will create a , a , a , a different set of , uh, of advantages or benefits for foreign companies to do business in, in, in, in these countries. For example, the common regulatory environment that is really kind , kind of the holy grail for medical technology companies to have in Latin America. As you know, right now we have over 30 something countries. Every country has its own regulations, right? Its own FDA <laugh> . So it's a mess to deal with all these , uh, uh, submissions and everything. So it'll be fantastic, eventually will happen. It is starting to happen with cosmetics, starting to happen with low risk devices and eventually will include everything, drugs, high risk devices and everything where if you submit in Mexico, the, the, the approval will be recognized in Columbia or in Peru or in Chile.

Marie O’Malley: 25:19

Yeah. And certainly any opportunity to reduce that complexity and streamline the process is gonna be beneficial for everybody.

Julio Martinez: 25:26

Absolutely. Absolutely. So Mary, we're close to the end of the show. What will be your muscles of wisdom? What would you say to the CEO of , uh, medical device companies that is just looking to, to expand or to do business or to do manufacturing , uh, in Latin America? What would be your final words?

Marie O’Malley: 25:47

Um, I think that there's such a good , um, infrastructure of really good companies in there that you can leverage a lot of the, you know, capabilities that are there, the strong supply base, you know, whether to start your own company there or to leverage some of the existing providers that are down there. There are some of the, there are the top, you know, medical device companies and medical device suppliers that are already established there. So I think it's a good opportunity to leverage, you know, some of the existing infrastructure and companies that are set up a presence there and have had tremendous success in that region.

Julio Martinez: 26:22

Very good. Very good. Now that you mentioned that , um, establishing a presence in Latin America, I think is very advantage , a advantageous , advantageous, I'm sorry, right now , um, because of the OECD countries are increasing their, their, their investment on in science, technology and innovation. So there are tons of grants, government grants, free money available to companies , uh, when they wanna do a trial or they wanna manufacture something or research something in Latin America. In the case of Columbia , for example, millions of dollars, I think last, my last count was like 200, $300 million available for companies to do , uh, research. So yeah,

Marie O’Malley: 27:07

And I think those types of incentives and support definitely help make a compelling business case for companies.

Julio Martinez: 27:13

Exactly. So now you have a , a very good value proposition for your clients <laugh> to tell them about the benefits of Latin America. Alright , Mary, thank you so much for being here in our show. I appreciate , uh, your insights and I look forward to being in touch and I'm sure that listeners got , uh, a lot out of your , uh, experience and knowledge of the region.

Marie O’Malley: 27:37

Well, thank you. It was nice talking to you today.

Julio Martinez: 27:40

Bye. Take care.

Marie O’Malley: 27:41

Bye.