PISODE 23: ROBERT BILKOVSKI, CEO AT MEDAPPRAISE INC

Episode’s transcript

Julio Martinez-Clark: 0:05

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 Robert Bilkovski. Robert serves as the CEO for medAppraise Inc., a health technology startup focused on transforming the health and wellness of employees in large industrial corporations through the use of a state-of-the-art musculoskeletal health evaluation solution. In addition, Robert currently serves as president of RNB Ventures Consulting Inc, which is a medical device/technology consultancy firm, within aim to provide medical/clinical affairs consulting expertise to medical device and IVD manufacturers on medical risk determinations and pre-submission expertise for new IVD assays. Prior to that, Robert served in medical leadership roles at Becton Dickinson in the Corporate Clinical Development organization; at Abbott Laboratories Molecular Diagnostics division, GE Healthcare– Lifecare Solutions and Hospira. During this industry venture, Robert was responsible for the design and execution of over 20 clinical trials for US and ex-US registration purposes, product safety review/remediation activities including interactions with notified bodies and clinical quality oversight for FDA and BiMo inspection readiness and post-inspection corrective action planning. Robert, welcome to the show!

Robert Bilkovski: 1:43

Happy to connect with likeminded people.

Julio Martinez-Clark: 1:45

Thank you. I went through your LinkedIn profile and I'm very pleased to be speaking with you today. If you don't mind, I'll give you a little bit of context here about who I am and what I do and then we'll probably speak deeper about the topic that I told you about. Then I'm doing research on, I'm originally from Columbia. As I said, I moved to the States around 1995 my brother Pedro also moved out of the country. He got involved Robert in the development of certain cardiovascular technologies and then he became a professional, the university of Miami. While he was at UAM, he started working with an investigator in Colombia power. Why Y under development? Sure. Or cardiovascular ecologist from us startups and that's how when I started working together in 2010 we created our company and in essence we are a construct research organization that has evolved to cover different needs in the industry. Firstly, Westwood clinic research and we still do clinical research, pushing human specifically. I guess we are the only teacher all in the U S that helps us medical device startups to do person human trials overseas in Columbia to be more specific. And so we have also expanded our services to cover needs related to commercialization though medical technologies in lodging America. We help these companies enter the market. We do market research, we do regulatory approvals or market clearance at the regulatory agencies, Mexico, Brazil, Colombia, anywhere we need to. We also do market access plans for these companies so that they can get on board so they can get paid and they can create demand for the products in every single country. So that's what led me to start writing about the topic of medical device commercialization and also clinical research in the region. Because I realize, Robert, that there's very little information on this. I mean if you read about the medical device industry, you find that other stuff, you'll find a lot of stuff for Asia, but you don't find much in Latin America.

Robert Bilkovski: 3:50

I totally agree. I mean just the go offline tangent for a sec just to, uh, provide some commentary to what you just described. First conclusion I drew is, wow, you're creating a pretty unique niche, a service offering because the, uh, the Latin market for medical device is for all intents and purposes, grossly underserved. Most of the medical device companies typically don't focus on LATAM within their first two waves of commercialization. Yeah. It's interesting how you've decided to find a, or carve out a niche.

Julio Martinez-Clark: 4:22

Yeah. Because I guess the reason why they don't look at Latin America is probably because there isn't much guidance or as much literature about it and they are in a position where, so that makes unknown territory, especially with our precedent out saying bad things. But there is potential in the 600 million people territory with over 30 countries. And of course he has a challenges. It's in chicken seas. Every country has its own regulatory approval and ways of doing business, but they don't tackle these markets first. She said they usually go to Europe or other countries in Asia early more familiar places because they already in the car for a song so that what I'm trying to do is bring awareness that there's potential here is yes you need the right guidance to do things right in this agent.

Robert Bilkovski: 5:13

Totally agree. I mean your Glidepath for entry of a product and I'll use the product more broadly. You have a relatively well-defined Glidepath in the United States. Europe has been somewhat well laid out. It's certainly, it always changes like it recently has changed with MDR and CFTA has clearly gone through an evolution in the past five to 10 years where they're trying to further clarify the entry into the market. The biggest challenge that the sponsor companies have is they want to have certainty and clarity and if you don't have certainty and clarity then the market appeal goes down and I think that's why Latin has been largely put as a second tier market.

Julio Martinez-Clark: 5:56

True. Good point. Good point. And also I would add that the choice of distributors in the region usually is limited to you going to a conference or an industry event and meeting somebody sitting next to you having a coffee or a couple of beers and then that person you should astute or in Columbia, Ecuador or whatever. So my way of choosing the partner for the next couple of years and that relationship usually starts very nicely. And with this women's, because you chose the distributor professional ways of choosing doing market research and just in the right partner usually didn't do your due diligence correctly. And then you ended up with somebody who is poorly is under finance, doesn't have the coverage that he claimed that he has the country, et cetera, or the connections. And then you have to break the agreement and try to transfer the registrations with[inaudible] that he probably got under his name, then tried to transfer it to another distributor. I mean it becomes a mess. An issue in the regional leasing in Columbia. I mean at least what I've seen in my experience. So anyway, so the reason to talk to you is to do other industry leaders and then you sell people, but your background in med tech, it's just because I was actually writing the story behind my article. It started because I wrote an article about general Latin American market. I think you probably saw it something in my LinkedIn profile but I spoke about the generalities about different countries and the trends or the demand that is specific conscious. I talk about along the hybrid feel Mexico, etc. And I kind of formulated this anchor strategy where a company should probably start with meteor countries to set up the bigger ones. Everybody wants to get interpreted CEO in Mexico but is probably not a good idea to start with those countries because it's more time consuming, more expensive and more corrupt, difficult. Usually Columbia, Peru, I probably did better choices or smarter companies to start selling the products. And then I wrote another article about Mexico. Would you send yourself a very chicken market? I mean it has five different health systems and you have to know how to formulate that market strategy for each system and it's full of corruption, et cetera, but there's potential[inaudible] as Italia or BCD, et cetera, so cardiovascular disease, all that stuff. And then I was about to write,

Robert Bilkovski: 8:22

just reaffirming what you're stating. You know, the medical trends and challenges that are facing in the Western societies such as the United States or Western Europe are not endemic to those areas. People have cardiovascular disease, they have diabetes, they have strokes, they have need for improvement in Parkinson's disease, et cetera, all around the world. I think the biggest challenge is the level of sophistication of the regulatory personnel within these respective emerging markets. I would say like in Latin America, being able to hold their hands, so to speak. It's a landmine. You need to be able to go and find the right partner that can walk you through that regulatory process. And the biggest challenge from a sponsor standpoint, I can share what my experiences, when I was chief medical officer for one of the divisions at the GE healthcare uncertainty, we have a finished product, the product is suitable for market but the market is not ready because we aren't going through the appropriate channels and then all of a sudden our launch plan is now delayed a year and that's devastating.

Julio Martinez-Clark: 9:29

Yeah, that's an interesting point. You're bringing it up. We just finished actually a project for Omron healthcare. It just comes to mind because you were mentioning this and managing Robert, I mean these companies, you know they either have the blood pressure monitoring market or the sector and it's a$10 billion company. They have prisons all over Latin America, but something particular was happening in Columbia even though they have distributors are being registered or have market claims for their products in the country and there being the contract for 10 years, but their sales were negligible. I mean, we're a joke compared to sales in Argentina and the team around markets of the same size or similar size, and they came to us well and we put together a nice project where we started researching, we spoke with all the stakeholders possible to really understand what was going on in the market, why we're not selling, and we've put together all these data, we analyze it and we came to some conclusions. We find out what the problem, why they were not selling in Columbia and we said some strategies and a market access plan for them to give them certainty. They do this, they're going to get these results. And that's not usually the way these companies entered the market. They enter. Yes. Trusting the shooters. I'm hoping that the shooter would pray the man and that creates so much uncertainty because you don't know what they're going to do.

Robert Bilkovski: 10:49

Yeah. You know, interestingly, China is very similar in that design has historically leaned on distributors for a lot of the emerging products, the GE, the Siemens of this world, they can go and get their own sales force, but more often than not, these companies don't want to go and invest in these sales force within each of these concerns. So they lean on distributors and you're totally right. The distributor will be totally excited to get your product into their toolbox per moral. They're having the same conversation with the next shiny tool that is also going to be perfect for their sales mix and then they only focus on the easiest one to sell.

: 11:30

Exactly. Basis went to sale. Yes, it does. Absolutely right. Going back to the issue of how these article came about, it got into a conversation with somebody in Europe, a medical device company, and he's like, Julio, how have you leaping an article about the difficulties that we're having here in Europe in compliant with these new regulations, the U N D R a and what markets should be addressed first now that you'll be so complex and so expensive, et cetera. So is that got me thinking about this topic and I didn't know much about UMB. Isaac was my focus. That's America, Europe, the answer and that is speaking for some people and it looks like there's apparently a big issue now. That's why I reached out to you and some other folks in my network.

Robert Bilkovski: 12:17

Totally agree. You don't, I'm not doing a lot of work with companies directly, but indirectly through my network. They're the ones that are, we're prepared, still are nervous, but those that were not prepared and now look at the regulations, they're in a panic. I mean they're mortified because their products may come off market. Your hypothesis is 100% valid. You know the other interesting thing, it's an intriguing question. A lot of medical device companies and med tech companies like the[inaudible] saw Europe as a easier entry because of the simplicity compared to FDA regs or PMDA or CFTA to get CE Mark, but now there's multiple layers of complexity to be able to support clinical evidence that is raising a question whether or not Europe is going to be your entry for your product. I can share at GE, we typically would have our products intended for a global market, but the first thing that would occur would be CE Mark. There would always be CE Mark. Now the question goes from my take is, is CE Mark first?

: 13:24

And I don't think it is anymore. Interesting. Yeah, that's been my experience. I've been dealing with us medical device startups for can use, Oh sorry. You said and first thing, human page or the person, human child States that they have to go through and they usually get the data from the sites in Columbia for the mission because that's their first market and then they become attractive to a larger like muscles and Quebec, Medtronic cetera. But now they're questioning that. Excellent. Excellent. Robert. So I like to kind of get to know you a little better. I mean, where are you up to these days? I kind of saw your profile that you were constructing something. Is it a private constructing something? Okay. On the what

Robert Bilkovski: 14:08

I am working with a startup, uh, so I serve as the CEO of a pre-revenue commercial stage medical technology company. It's a little unique. It's not a pure clinical play. We have a software solution that also has a biometric component that evaluates the musculoskeletal health of an individual and the software. When you take the inputs, the output is a risk score. It's a risk score to identify risk for musculoskeletal injury across four body regions, neck, lower back, upper extremities and lower extremities. And we have been targeting the employer market. There is a fair amount of injuries. We believe that our solution can help to screen out individuals before they even get hired that may not be suitable for the job. And then we believe in our solution can also then track musculoskeletal health over time to see what does the impact of the job day in day out do on the musculoskeletal health of an individual, not over weeks, but over years to see whether or not there is undue wear and tear on the workforce. It's fascinating technology, but to start up and you know, our greatest challenge is novel. Absolutely funding is a huge issue, but also getting customers. There's market prep, but we're trying to prep the market for something like this. So while I'm doing that, I set up a consultancy practice, RNB, ventures, consulting. So my background for the past 10 years, I had leadership roles in varying medical companies, whether it's pharmaceuticals, a drug device, a medical device, and in vitro diagnostics. So I use my experience and my medical knowhow to help companies, various stages, whether they're small startups or large fortune 50 companies, tackle any of their various medical clinical challenges. I do a fair amount of market development work at present, but most recently I helped the companies successfully navigate through the FDA pre-submission process, get their packages together, put together their clinical plans and defend that in front of the FDA. Those are the two hats I wear. I'm looking forward to expanding my a consultancy practice. I can always grow from where I am.

: 16:27

Yeah. I'm barely interested in your background. I may have something for you. Actually. Let's give the relationship part so that if there was anything I can do for you, for any of your companies, let me know or guidance or something I can provide to the American market. You really have my contact info. Yeah. Wonderful. Wonderful. Thank you Robert again, and actually the objective of the call was really to confirm my hypothesis and did it, I mean unless you have specific examples of companies that yes, forgot about Europe for now and they were focusing on America. Yeah, I'm open to hearing those examples and you was more interested in the interactivity. So if you thought, nah, I didn't want to go deeper.

Robert Bilkovski: 17:08

Let me take a couple of minutes and just give you a couple of my thoughts. At a high level, you know in the medical device world, the class three devices, you know the implantable, the invasive, the stuff that is more germane to what you have done with your brother Pedro. Typically class three devices, the regulatory and the clinical evidence plans had been well codified for years. They emulate the pharmaceutical model. So the level of uncertainty in terms of evidence plans and regulatory submissions from my taking, even with MDR coming on board, not much will change because neem already had to do that. What becomes much more precarious for the devices are the devices are class two or even class one. If you look at a class one device, which for all intents and purposes it could be a laryngoscope blade, so alert sculpt blade is used to help intubate a patient. It's disposable or maybe it's single use or the like. If it is sterilized, which it has to be, then it is now requiring all additional levels of scrutiny, even clinical evidence that these device companies are petrified above. That's where I see a fair amount of consternation in the medical community. The other one you look at the in vitro diagnostics I worked at at Abbott labs in their molecular diagnostics division. I was functioning as their chief medical officer, so we had a fair amount of molecular diagnostic products within you say hepatitis C, hepatitis B, HIV screening tests or viral load assays and then a fair amount of assays in the companion diagnostic space. Any diagnostic space typically works hand in glove with a pharmaceutical partner, so there's going to be that, that rigor that goes with a pharmaceutical product that I don't think will cause much eggs, but the viral load, the hepatitis C viral load, those classifications and the scrutiny that is going to be applied to them has changed. Those have to go through a notified body at this point. Even in my want to do a clinical study, I will have to go through a notified body, get a ethics approval before I conduct this. For me, that never happened before. So your development timeline has changed. It has now been extended because you now have to include the layers of notified body interactions at the beginning and at the end of the study. It's very similar to what's happening into the United States. So there's a fair amount of change that is going on and certain companies may be ready for this. Others, you know, I can just share. We were waiting to see what the regulations are, but there wasn't anything that was proactively being done. My experience just knowing of what the avid, I'm not sharing anything proprietary. My take is the organization was not ready. As MDR came out, there was going to be a whole bunch of, Oh my God, what am I going to do to fix this?

: 20:04

Interesting. Okay, fantastic. Thank you so much. I have no words to thank you for your time, Robert, and I look forward to keeping the conversation going.

Robert Bilkovski: 20:13

Yeah, absolutely. You know, I have a decent understanding of the regulatory strategy. I have a great understanding of the clinical strategy of, I serve as a advisors on these companies, so unfortunately the sad reality is in the device and diagnostics world, there's a lot of people that think that they understand the healthcare landscape and they're, no offense to you, you're an engineer, but I worked with a lot of engineers at GE. They think that they understand medicine, but they don't. To me. My biggest takeaway is that to be successful as a medical device or medical technology company, you to have a good solution, but the solution has to be able to fit not only from a product standpoint or from a patient and clinical ecosystem standpoint. Absolutely. Julio is, do you want to call me? Feel free to ping me anytime. Thank you, Robert. I appreciate that offer. I probably be in touch. I bet you. Well, I'm looking forward to networking with you further. All right. Thank you, Robert. Bye. Bye. You too. Bye. Bye.