Laura Minarsch, R.T. RCIS, CVT, is a senior clinical affairs strategist and President of MMC Medical International Services. She consults for several novel innovative device companies in the MedTech space and has facilitated numerous acquisitions over her career spanning more than 25 years. Her track record is based on successful and strategically planned “First in Human” submissions and clinical studies in Europe, Canada, South America, New Zealand, and Australia. She has been instrumental in defining key scientific relationships with opinion leaders and strategic partners. Additionally, she has achieved several record critical project timelines resulting in optimized operations and realized corporate objectives.

Laura began her career as a Registered Cardiovascular Invasive Specialist, and Interventional Cardiovascular Specialist implementing several first interventional device programs in Europe. Laura has served as a Principal Clinical Affairs Advisor of several medical device companies acquired by Covidien, Boston Scientific, Medtronic and Johnson & Johnson Interventional Systems. 

Episode Transcript

Julio Martínez-Clark: Welcome to the LATAM Medtech Leaders podcast. This is a weekly conversation with MedTech leaders who have succeeded in Latin America. Today our guest is Laura Minarsch. Laura is a senior clinical affairs strategist and President of MMC Medical International Services. She consults for several novel innovative medical device companies and has facilitated numerous acquisitions over her 25-year career. Her track record is based on successful and strategically planned “First in Human” submissions and clinical studies in Europe, Canada, South America, New Zealand, and Australia. Laura began her career as a Registered Cardiovascular Invasive Specialist, and Interventional Cardiovascular Specialist implementing several first interventional device programs in Europe. Laura has served as a Principal Clinical Affairs Advisor of several medical device companies acquired by Covidien, Boston Scientific, Medtronic, and Johnson & Johnson. Laura, welcome to the show.

Laura Minarsch: Good morning!

Julio Martínez-Clark: How do you doing?

Laura Minarsch: Good!

Julio Martínez-Clark: Thank you for joining the call. Also, thank you for accepting my invitation to speak today. I truly look forward to this conversation today.

Laura Minarsch: Okay, well, let's see. What can I help with?

Julio Martínez-Clark: Well, Laura, two things here. I have two items for the agenda. First is the conversation about the EU MDR, you seem to have a very fascinating experiencing in clinical research and regulatory affairs. I sent you some of the questions that I have on the topic.

Laura Minarsch: I got it. In light of the rigor of the European MDR, are US medtech companies still considering Europe? To answer the first question, yes, absolutely. But what's happening right now is that a lot of small medtech companies are approaching sort of a parallel path where by depending on how far along they are, they might be looking at the FDA. the agency is now trying to entice a lot of small technology companies to spend more time in the United States and less time outside the United States. So the early ugliness platform is very enticing. So some companies are approaching a parallel path in that thereafter they do their first-in-human essay and feel comfortable with where they're at with that, which is definitely likely not to be in the US and likely to be in a non-tier one country. Then once they've achieved that hurdle, then they moved into a parallel path that could involve in early feasibility plan and a European plan at the same time. It's sort of a parallel path. Before the new regulations are implemented in June of 2020, some companies are actually expediting there application with notified bodies to get involved with the CE Mark strategy on the earlier side. There's a couple of notified bodies that are very excited to provide the early modules, even if clinicals haven't been executed yet. So that's a lengthy answer to the first question.

Julio Martínez-Clark: Very accurate and very comprehensive. Very good. Thank you for that. Alright, second question.

Laura Minarsch: Yeah. If yours is a medical device design, development, and commercialization company, what’s been your company experience with EU MDR? My company provides a strategy for a very early phase. I'm primarily focused on First-in-Human. So the work that I do is provide a clinical strategy for the very first time something's used. So my work with the European MDR. I'm only realizing this phase once we've gotten into, there's a couple of companies that I consult for where we're conducting registries in Europe, we're conducting clinical and where I'm writing a protocol that's designed to support a CE Mark submission. So at that point then the EU MDR becomes really much more important for me. But that's a smaller percentage of the companies that I consult where I would say probably 20%, the other 80% is a very early chase. I think there's, a lot of value to conduct classes on the European MDR. I think that a lot of regulatory consultants, quality consultants and clinical consultants, like myself, would be very interested to take classes to understand better so that they can consult better for their clients.

How has the European MDR affected your company's commercialization strategy? I'm not really involved in the commercialization strategy, so I've probably can't speak to that.

Julio Martínez-Clark: Okay. What about the clinical strategy?

Laura Minarsch: The clinical strategy? Again, I think what we're doing now is we're trying to advise companies to maybe get in with an application to a notified body on the earlier side. I can't really speak to commercialization other than in that 20% of clients that I work with that have CE Mark already. I've been heavily involved with supporting the registries, supporting the postmark clinical follow up and supporting their efforts with regards to vigilance and connecting with a European authorized representatives and how the cost for a European authorized representative is increasing because the responsibilities for reporting are much greater.

Julio Martínez-Clark: Out of curiosity, how much is it now? Well, how much it was before?

Laura Minarsch: Well, you could secure an agreement with the company to be your European authorized representative for a couple of thousand dollars a year, and now because the responsibilities for reporting are so much freighter and the EA have much more to be responsible for. They're charging more relative to that. So a couple of thousand dollars a month. It's a whole new business. For example, there are CROs in Europe that provide the service. There is a clinical consulting, a company based in Germany that provides the service, they pop up everywhere companies that provide a European authorized representative service, but it comes with lots of responsibilities. So they're charging more and that's a whole new business platform.

Let's see: Are MedTech companies considering other alternative markets to the European Union? They can start generating revenue faster. So is Latin America one of those markets? No, I don't see MedTech companies considering alternative markets to the European Union for revenue purposes. The Latin American market with the companies that I work with at the very early phase, we do a lot of work in Latin America, pre-commercialization. So not so much from a commercial perspective. I think if I understood a little bit more about the post-market phase and what Latin America could offer, I could maybe advise clients better. But I don't see any of the companies that I work with looking at Latin America as an alternative to Europe.

Julio Martínez-Clark: Okay.

Laura Minarsch: What are your general thoughts on early-stage clinical trials or selling medical devices in Latin America? I think we liked very much going to Colombia, we liked very much going to Brazil, which I think is equivalent to Germany far as how it is viewed upon for submissions both in the US and in Europe. I think data collected in Brazil is a very high quality, so lots of my companies like to conduct trials in Brazil. Obviously I do a lot of work in Paraguay because it's an approval sort of a private hospital setting. So companies want to get experience at a very early phase can go there and stay sort of under the radar before they go to Europe. So we do work in the Dominican Republic, we do work in Panama on a limited basis, we do work in Paraguay, Colombia, Brazil, Chile. That's about it.

Julio Martínez-Clark: Okay.

Laura Minarsch: Have you heard about the Pacific Alliance in Latin America? I've heard about it. I don't know that much about it. I would be very interested to learn a little bit more about it. It was a company that I work with, a CRO in Brazil called CRC or HCor, Hcor actually acquired CRC. So they do a lot of this submission. They helped me with my submission platform. There's a group out of Yale that I worked with.

Julio Martínez-Clark: Oh, that's Cardiovid. I worked with them before.

Laura Minarsch: Yes, exactly. Then, I have a client that wants to approach something a little bizarre. I've had clients that wanted to go to Panama and when you go to Panama, there aren't real ethics committees and then if there's not an ethics committee in a company want to go to a certain facility. I've actually written a charter and hired an ethics committee and put an ethics committee together to support the submissions. Yeah, okay. So let's go back to the drawing board and so they bought the shoes first and then we have to get the hat and the dress and everything else.

Julio Martínez-Clark: Yeah. A couple of months ago with a site in Colombia, with a clinic in Columbia. They didn't have an ethics committee, but the sponsor, which actually Hancock Jaffe a company out of Orange County, very close to where you are.

Laura Minarsch: Well, I went over there because Mark Glickman.

Julio Martínez-Clark: Yeah, he's a good friend. He just came back from Colombia, this is like his third or fourth trip and that we're conducting a trial at a site with Doctor Ulloa. Ulloa is a Vascular Surgeon who trained in the US and they called me because they wanted to conduct the trial at Doctor Ulloa's clinic, but the clinic didn't have an ethics committee, so I did everything to make that committee approval. Of course, we have to sit there at this committee and then we went to INVIMA, which is the regulatory agency. So it's already running.

Laura Minarsch: Yeah. So Mark and I were on a DSMB call yesterday for about an hour and a half with another company that's in the vascular access space and he sits on that. He's on the DSMB board. So he was telling us about just coming back, but came over to Hancock Jaffe because I worked with Warren Hancock many years ago. I've been in the industry for a long time and Warren was a wonderful guy and I knew MR. Jaffe as well, so I went over there and I was consulting with them before they, you know, I forget the guy who was the CEO, but they were asking me questions about getting approvals down there. So I really didn't get too involved with that because again, for me to do things down there, I have to partner with somebody. I told you who I partner with for Brazil and Panama, we sort of did our own thing.

Julio Martínez-Clark: Well, you already have a new partner in Colombia now.

Laura Minarsch: Yeah, I actually did a submission in Colombia on my own for a company that had a device for atrial fibrillation and we were submitting, I'm looking it up right now.

Julio Martínez-Clark: Mitralign? MitraSpan?

Laura Minarsch: No, it was an AF device. It was for a PAMA, which was acquired by Boston Scientific, but we were working with William Uribe, with university CES. Jorge Gomez was the president of the ethic committee down there, and I got approval actually, and I got to the point of going to INVIMA and then Boston scientific acquired PAMA and then we never went any farther, but I did the whole submission on my own.

Julio Martínez-Clark: Impressive! And you speak Spanish, I imagine?

Laura Minarsch: No, I speak Italian, which I got everything translated. But we were there because we were working with Vivek Reddy, out of Mount Sinai and Vivek wanted to work with William Uribe. He wanted to go to Colombia. That of going to a Paraguay or some other place that he was less than failure with.

Julio Martínez-Clark: Interesting. I don't know if you know something about our story, but we started because of my brother’s work through the University of Miami. He's an interventional cardiologist, Pedro. He started traveling to Paraguay with Dr. Adrian Ebner and that's probably who you're referring to. So we know him well. Pedro is been there a few times, he worked with him. He trained at the University of Miami if I remember correctly, and that's the affiliation that he had with the university and that's how Pedro, my brother, he was a professor in the university and he ended up doing trials with him and then he also ended up in Colombia.

Laura Minarsch: He must know me then.

Julio Martínez-Clark: Yes. Your name sounds very familiar. I mean, I'm sure my brother knows you.

Laura Minarsch: He has to because I'm doing things in Paraguay. I'm leaving Sunday, I'm down there. I've been going down there, taking companies down there for 12 years.

Julio Martínez-Clark: Wow, fantastic. Is it a CRO in Paraguay? It's anybody who's helping you with all these or not?

Laura Minarsch: I'm the CRO.

Julio Martínez-Clark: Interesting. What about the importation of the device? Don't you need like a local third party or something?

Laura Minarsch: No, we do it with Adrian and he walks us through.

Julio Martínez-Clark: That's what I eard. Costumes and everything. Yeah, that's what I heard.

Laura Minarsch: In fact, we just did the entire clinical trials for millipede medical in Paraguay and they were just acquired in January by Boston Scientific.

Julio Martínez-Clark: Impressive. I mean, congratulations!

Laura Minarsch: So that's why I'm more involved and much more expertise in the early phase of efforts for clients more so than later on.

Julio Martínez-Clark: Sure. Okay. I'd like to clarify, something is been kind of intriguing me for a while. Paraguay, am I correct in saying that Paraguay is a very good place for early-stage trials, cardiovascular devices, but anything other than that is difficult because you don't have an equivalent Adrian Ebner, no other therapeutic areas. Is that correct or not?

Laura Minarsch: So there's a couple of different answers to that. With a PAMA that I was talking about a little bit earlier, that's an electrophysiology device and they don't really do electrophysiology down there. They don't have the economy to support all of the equipment that you need. We did our first four patients for a PAMA down in Paraguay, just approve our catheter feasibility and we brought all of the equipment down there. We actually shipped it all, and there's been a couple of companies that actually have shipped down robotic equipment. They were doing robotic and laser for example. So you can do whatever you want to do in that lab because he runs that lab, but to realize that it's just basically a cath lab, but because Adrian is a Cardiac Surgeon and an Interventional Cardiologist. That's why it's primarily cardiology. It's his expertise or he partners with someone who's in the endovascular or the vascular peripheral space. If you partner with somebody like that and they're willing to come to his facility, then he can do whatever a client needs. So the only reason why it's been primarily cardiology is because this is a project that Adrian put together. You go there and companies love it because they can make his facility their own, they can bring their own operators. So if you've got one investigator and he's doing all the animal preclinical work here in the United States, you can't take someone like that to Brazil to Dante Pazzanese, have him and do cases, you can't do that.

Julio Martínez-Clark:: Yeah. We've done the same thing in Colombia for Mitralign and MitraSpan.

Laura Minarsch: Yeah. So when you go to the Czech Republic or Poland or any of the European locations, you also struggle with being able to have your physician from the US scrubbing and participating.

Julio Martínez-Clark: Yeah. Awesome. Laura. I mean, so if there's anything I can do to help in Colombia with one of your clients, I mean, we can partner up with that. I mean there'll be a very interesting collaboration.

Laura Minarsch: Yeah, absolutely. I mean if you have anything that you can send me that sort of a detailed, like for what I did for a PAMA where I did it on my own, I would have used you, cause it wasn't that, it was for a lack of fun that we were making those efforts to Colombia was just because I didn't have anybody else. Basically he and I, but in the future, I would rather work with someone like yourself.

Julio Martínez-Clark: Yeah, I have a whole team. We've done this for 10 years already.

Laura Minarsch: Thanks, Julio.

Julio Martínez-Clark: Thank you so much. I have been really a pleasure getting to know you over the phone and I look forward to meeting you in person someday. Hopefully.

Laura Minarsch: Yeah, I do too as well and I'm sure Pedro knows who I am or seeing my name float around. So we're actually getting on a plane on Sunday to go to Paraguay.

Julio Martínez-Clark: Awesome. Okay. Much success with your trip to Paraguay and I look forward to getting back in touch. Alright, bye, have a great weekend.

Laura Minarsch: You too.