George Lewis 0:05
Hi, folks. I'm George Lewis, I worked for Arena PTC company, and I lead growth for the organization. So I'll do the moderation here. I was asked to introduce my team here of panelists, and so I'll go ahead and jump right into it here. Not in order of the background. I'll go in order on my page here. Kevin Chu. Kevin is principal of the healthcare team at f prime capital. Prior to f prime capital. Kevin was an associate consultant with IMS consulting group in New York, where he advised biopharma, biopharmaceutical clients on development and commercial strategy across multiple therapeutic areas. Kevin is currently based in the San Francisco office and works across the healthcare sub sectors including therapeutics, med tech, healthcare IT and services and also works closely with eight roads ventures China healthcare team to manage F Prime's existing and new investment efforts in China. So why is he here f prime collaborates very closely with a venturi consortium in China in his experience, consulting with consulting companies and establishing cross border partnerships between the US and China. Kevin is at the center of much of this work. Next David Webster David joins the executive team with decades of executive experience in medical device imaging and healthcare technology information. He's a passionate leader with a demonstrated track record of leading cross functional teams from early clinical development to m&a through global commercialization in 60 different markets and geographies. He comes on board at a pivotal time in the company's journey, bringing wealth of knowledge and expertise necessary to take body visions business to the next level. David holds an MS in Business Administration and Management from Troy University and a BA in psychology from the Citadel. So why, why is David here today, David has extensive experience in standing up global global markets for emerging med tech companies. Having done it with a previous venture neurological Corporation, which sold in over 60 countries. He plans to have body vision stood up in 60 countries by the end of 2024 Ryan McGuinness Ryan has spent 35 years in biotechnology medical device and r&d, engineering services industries. He's worked with many companies that have applied innovative technologies to a range of markets including cell and gene therapies, bioinstrumentation medical devices and in vitro diagnostics. At Triple Ring Technologies, Ryan leads a team of world class scientists and engineers who work at the junction of complex biology and cutting edge technology. As an active participant in the Silicon Valley innovation ecosystem. Ryan also spends time connecting early stage companies to the infrastructure know how in funding needed to successfully bring new products to market. Ryan was trained in Genetics and Molecular Biology at the University of California Davis. He is CO inventor of six US patents and has published multiple scientific scientific communications and presents frequently at the international science and technology conferences. So why is Ryan here Ryan and his team support a client's with a product development and market market entry globally and have strong partnerships in Japan and other parts of Asia which are extremely relevant to this panel. And then finally, Matthias Bellmann Matthias is Director global focus team cardiovascular at TUV SUD. Excuse me. Prior to joining TUV SUD spent over 12 years at bio Tronic in roles of increasing responsibility or in business development, strategic marketing, product marketing, product management, communication and more. He earned his Bachelor of Arts and Master of Arts in European management from teknis.
It's German, its German.
Hunch Lu, while do so why is Matthias here today to have yesterday provides testing and inspection services worldwide with over 1000 locations. They have a deep European experience expertise and also a broader global focus via their global market access GMA services, determining applicable applicable international regulations and managing product compliance to those regulations. So welcome, gentlemen, if we can give them a round of applause. We'll kick things off here. Excellent. All right. So first question for the panel here is around market prioritization and preparation. So guys for emerging med tech companies aiming to expand internationally? What criteria should they consider when identifying potential market markets assessing market readiness, and strategizing to minimize risks while successfully entering new region? It's Mathias Alt, you take the lead on this one? Sure.
Matthias Bellmann 5:03
So first of all, to suit is a notified body for MDR in the Europe in Europe. So this is also why I'm taking maybe a little bit more for European perspective on this question. We've heard a lot about MDR is bad. It's prohibiting innovation. Now, the companies won't come to the European market anymore. And I think maybe this is not the complete truth anymore. I think we will not see the same level of first line and Europe product development. But I think it's not a question either, if it's FTA, or MDR, I think it's a FTA and MDR. And if you do the planning already with the for your FTA strategy with the MDR in mind, I think there are a lot of synergies that then bring your product not just from the to the US market successfully. And I think we will not change that anymore. The FDA first strategy is here to stay. But I think you can have a successful strategy by minimizing your risk when keeping already the European market in the back of your head. I mean, Europe, in the end accounts for 25% of the global medtech market. We're talking about almost 450 million people in Europe with I think very nicely build up a healthcare system that is ready to take on innovation when it's approved. And when we talking time to market, I'm representing basically under the suit umbrella, we have now two notified bodies that we can do. And there are even, let's say fasttrack options that, like if you're ready, we are ready. And I think we can also work getting C approval on your product quite fast.
Gentleman little thoughts. Yeah. So regulatory is incredibly important, of course, for accessing markets. But another kind of higher level thing is, is understanding who your partners are, and what types of partners that you will need in the geographies that you're going into. And so, very often, if we're leaving home and going into new geographies, we need what we call jungle guides, folks who are on the ground and understand not just who the patients are, or what the specific problems of a given population might be, but who to access for regulatory help or for financing, or for supply chain and these types of things. And so no matter where you are or where you're going, these development programs are this this innovation work needs teams, it needs partners, it's complicated. And we need friends to do this. It's it's an important part to figure out who you're going to be working with anywhere you go.
George Lewis 7:52
Yeah, makes a lot of sense. Kevin, any thoughts? David?
Kevin Chu 7:56
No, I mean, I completely agree. I think I think for us, it's maybe a slightly more straightforward answer to your direct question, which is just you have to follow where the money is, right. And depending on what the product is, depending on what indication it's serving, you know, certain markets will offer a very favorable economic value proposition they should go after. Whereas others, they may not make as much sense. But I think, to Ryan's point, understanding the complexities of navigating that market, what resources you need to tap into, or invest in, in order to get access to that market, I think are all part of the equation as well.
George Lewis 8:34
The thoughts that Ryan had in the jungle guide, I mean, oftentimes entering a new market for anybody like ourselves included, I mean, you really needed to get those local regulations. I
David Webster 8:43
don't think you can do that by finding a good distributor in each country. So having commercialized a bunch of times, now, what I do is, first of all, you're gonna get a response from the doctors as you go out, and you go to trade shows, and you're gonna see where the interest lies, the clinical interest, then what Kevin said is you take a look and say, does the product make financial sense, because if it's too expensive, it's not going to move, then you look at what the total available market is in that country. So you take a country like India with a huge market, right? And in a reasonable regulatory process, and you can, you can jump off in those countries very easily. And then, of course, when you find your distribution partner, most of them have their own regulatory team. And they'll guide you through the process who holds the regulatory, that's a negotiation. But a lot of those teams have a clinical team, they have a sales team, they have a service team, and they'll guide you through and they'll launch the product for you. And you just have to make sure that they can hope they can cover down on the product in the country. And it's not a terribly complex formula. And you sort of feel your way through it as you go. But the distributors as Ryan said, the distributors will be your guide. They'll let you know if you're priced right. They'll let you know if you don't have any distribution interests. Well, there's your answer. They don't think they can make money. But distribution is the key good distribution.
George Lewis 10:07
All right, thanks, folks. Next question is around regulatory complexities. So what significant challenges and opportunities has the EU MDR pose for the life sciences industry? Since its inception? And how have companies navigated these changes to ensure compliance and continued innovation?
David Webster 10:28
Nightmare, right, we
Matthias Bellmann 10:29
are in the hallway. But yeah, I
George Lewis 10:32
think you I think you had a valid point. Of course, if you look at it from the since the 2017. Inception. Yes, I think the perception was that it's a big mess. And it was a gigantic change, I think for every metric company in the world. We're still working through it. The MDR extension, however, has cooled down the pressure on the US as notified bodies. And yes, we are quite aware of our image also in that regard. We're working through it. We're working with manufacturers. I think the biggest recommendation from our side we can make is come talk to us, come talk to us early. Come talk to us about what you are have the MDR now gives us the opportunity also to talk to you we call it structured dialogue. There is actually even if you're talking about submission in 2026, even now would be a good point in time to reach out to get first contact gets most of these uncertainties out of the way. And I think then there can be a collaboration between notified bodies and manufacturers.
Matthias Bellmann 11:38
Yeah, in the US defense, and FDA is still not making things super easy. And I don't know how many of you have seen the recent guidance on cybersecurity. But essentially any medical device with a USB port is going to be subject to the new guidance around cybersecurity, and that's an onerous guidance and expensive to meet. So it's, these are challenges that no matter where you go, you're gonna find I
David Webster 12:07
can say this, I've led two companies through it now. neurologica, we were one of the first people to get EU MDR in the US. And most recently at body vision. We got it about six weeks ago, it was it was a nightmare scenario, I'm going to tell you, they're backed up. They can't do the inspections, they've had to extend it, we all knew that there was going to be an extension because we were all talking to each other. And everyone's like, this ain't happening right? Then the the UK broke away from it. And I don't know what they're up to over there. They've got their own thing going on. But it was a whole, you know, I'm just being I'm very, very pragmatic about it right. From our side, it took a lot of manpower, it took a lot of time to do it. It was very disjointed. My hope is it gets better, and it flows a little bit better. But I don't think they're through the woods yet. I think it's going to take another year before it sort of levels out. See mark, dream? Why did we change it? I don't know why he was perfect. If we could get to market super fast, we could start selling products over there and get things going. And then sort of bring it to the US. And now it's I think it's the opposite. They're both equally complex. So why not go for the FDA first, and then and then pick up the EU MDR? And then we'll figure out what the Brits are doing at some point.
George Lewis 13:23
Kevin, is there a VC view on this one?
Kevin Chu 13:25
No, I think I think I echo at least through the transitive property echo through my portfolio companies what the gentleman to my left and right have have already shared it does seem like it's there's a lot of turbulence right caused by MDR. And people are still figuring it out. Obviously, the Extension helps to mitigate the blow a little bit, but I think it just heightens the need for a lot of information as you're thinking about whether or not you want to prioritize that path versus going straight into FDA. And again, you know, I think in certain indications for certain products, the the headache and the investment in resources and expert consultants to navigate you through the process is warranted because the upside is there. Right. And we saw that in one of our recent companies that was in EP right upon getting their MDR saw significant sales right over the over the first 1224 months. So I think it really depends. You
George Lewis 14:31
know, it's interesting, I mean, I'd be curious if the the other gentleman up here have a view on its mean is that the type of device determines which market you may choose to enter first, does that have a an impact on it?
Kevin Chu 14:40
I would say maybe less so type of device and more. So the specific indication and kind of the market dynamics around that interesting.
David Webster 14:49
I'll tell you what, I was in imaging before now I'm in AI. There's a lot of confusion in AI like we're we're going into China now and China hasn't made up his mind, the FDA made up its mind there was a backlog and then suddenly, boom, they made a decision and everything sort of flooded through. So in the cybersecurity pieces is becoming significant. I mean, that's, you got to anything that connects, you got to bake something in. And there's a lot of documentation that goes with that. And then when you're dealing with individual hospitals, and it's super complex, so it's it's, there's still things that are being defined as we speak.
George Lewis 15:31
Yeah, I mean, regular regulation is complicated by virtue of the fact that's always changing. We deal with that all the time. In the software side of things, too. It's always updating and you have to keep up with it. So Alright, so moving on. Next question around partnerships, while seeking global expansion. What proven strategies can US based firms employ to foster strong and mutually beneficial collaborations with international partners? David, ahead, you tagged to take this one?
David Webster 15:57
Okay. This is an interesting one, right? Because you're gonna go out there, and you're gonna deal with dealers. Okay, and dealers are all over the map. So the first thing you have to do is figure out a good vetting process, right? What's their reputation? How well are they known in the market? What are their financials, right? Because they'll tell you and promise you the whole world. And then you have to have a good distribution document. Right? Once you vet them out, and you talk to References, talk to other companies, talk to some customers, then you have to have a great contract to cover it. And you just you have to visit them, you really do. They'll show you pictures and all the rest of it. But meet with them, go visit them, see their operation, talk to their off key opinion leaders and everything. And just make sure they have what it takes. And frankly speaking, some of the products are too heavy lift for the dealers, there to sales isn't the issue, it's the service and the clinical lift, right? Do they have the wherewithal to really support the product, Europe is becoming a problem child, because because of the Union, I'm not bashing Europe today, I'm just these are facts, I'm spitting facts. Because they've United now you'll have a dealer who feels like they can cover all of Europe. But Europe is very different from state to state to state. So despite the being united, and despite us wanting to look at Europe, like it's the United States, where you can get one dealer to cover a region or a bunch of states, you really need to find country distributors. And that's a pain, because you want to sort of give it to one person and let them run with it. But the reality of it is I've tried that, and it just doesn't work. So you really need, you know, you can have like a company that covers benna locks and a company that, you know, there's there's sort of congregations over there, but you probably need three or four good distributors to cover that country and provide the what they need. Yeah,
Kevin Chu 17:55
maybe just to completely agree with everything David said, maybe to echo or emphasize two points. So one, we've seen so many times when a company has gotten really excited about the first inbound, distributor, right? And then all of a sudden, they're they're mentally married to that, that distributor, and they don't do the diligence, and they don't go out and kind of scan the field and see see what other options are out there. I completely agree with David, take the time to really serve a ask peers that you trust, who have gone through the process who understand those markets, you know, what are some of the other people that should be talking to, and really take the time to do that work. I completely agree with that.
David Webster 18:35
Keep an eye on your price too. Because they'll tell you, they'll play games, they'll jack it up to lower it and then you lose control of it. So keep an eye keep an eye on what they're selling it for.
Matthias Bellmann 18:46
And another very pragmatic thing to think about, is when you're going into fragmented markets, look at your product, look how it's going to address problems in those specific markets and then prioritize which markets you do first, second, third, fourth, don't try and go after too many all at once. Establish something in a region and then grow from there.
George Lewis 19:12
Matthias, I saw your head nodding there, you have a reaction.
Other than we are the problem chat. I think what you mentioned is valid also with the importing into the EU. Also the MDR there plays a little bit of a role that they need to be the authorized representatives for you. So keep an eye out for the proper documentation that they are prepared on their end to receive your product and are you know part of the whole value chain of documentation that you bring?
Excellent. So on to a risk mitigation. What are your thoughts on reimbursement as a commercial risk for early stage innovators? Ryan, any thoughts on that? But,
Matthias Bellmann 20:00
yeah, for early stage innovation and for early stage companies, what we've seen over the last few years is that when you think of business risks, that the primary risk has always been funding, the financial risk, when are you going to get where you're going to get your next round? And then it was regulatory risk very often. And then some form of reimbursement now reimbursement has leapfrogged the regulatory risk, especially here in the United States. And so it's one of these elements in a business plan and business modeling that has been brought much further up the chain, in terms of when you consider it, and when you think about it, when you strategize for it. So it's, it's become a very, very important part of a company's existence.
David Webster 20:50
I'd say cost, the two systems are basically at odds, there's the United States, which is how much revenue can we drive out of it? How much revenue can we get for the technology? And then when you leave the United States and go elsewhere, they're like, how do we lower the costs. So we love to charge for capital, we love to charge for consumables per case, that's a great model in the United States. But that model doesn't work in a lot of countries. So you might find out that you have this great thing that's sort of working here with the GPOs. And the it ends, and everything's going well, and you go to another country, and they're like, we can't afford the cost of the capital, we can't afford the upkeep of the equipment. And we certainly can't afford the case by case consumable, it's just not big enough, which is why in a lot of cases, surgical robots aren't playing in other countries, because the capital cost is too much, the cost of ownership is too much. And then the cost of the consumables are too much. And then if you try and go through distributor, it's such an electoral, mechanically complex product, they can't provide the support. So it doesn't make sense. Like in the US, you see, a lot of the robot companies they park a rep in the AOR, with the robot for every case, won't work in Europe won't work in many of the countries, there's not enough meat on the bones for it. So I think you really got to look at that. What's the cost of your product? What's the cost of acquisition ownership, and a fee and Nick, and per case, it just might not work?
George Lewis 22:16
You know, you're talking to the hallway before you hopped in here, and it's just in the US, it seems like there's a lot more comfort, maybe not comfort, but it's more acceptable to ask for everything and try to compete with the hospital down the road, where in the European market, maybe less. So. I mean, certainly we've talked to companies at Arena that Do you know, proton beam therapy and things along those lines, and all of a sudden, you need to build a bunker around the device, because it's shooting on protons. So any other thoughts on the subject? Guys?
David Webster 22:47
Yeah, I think you're exactly right. I think even the build out costs of a lot of the stuff just doesn't work. So it's, it's a whole different. It's, it's a whole different world, having traveled to all these countries and went into the hospitals, talk to the administration, it's like two separate worlds. I used to say it's like the Wizard of Oz, right? The United States, the rest of the world is like Dorothy, and then when she pops the doors open and walks into Oz, and it goes to color. It's like, boom, that's how Stark the differences can be not in all countries, but in many of them especially. It depends where you go. I mean, they're just, they're not, they don't have the resources to put into medical care like we do here. And I know, there's a lot of discussion about who's got better, better medical care, but we got a lot going on over here. We got a lot of good stuff. So it's different. real difference.
George Lewis 23:39
Excellent. So another question on on Asian markets. You know, we've talked a lot about the state of regulations in the US in Europe. Do you have some insight and the challenges of entering the Asian markets? have any thoughts on that one?
Kevin Chu 23:52
Yeah, I might expand it beyond just challenges, because I think, you know, the conventional wisdom, especially when you're dealing with maybe markets like China, for the first time is that it's really tough way of doing business, very different. You know, maybe they don't respect IP, etc. Like they're all these mantras that that I think it perpetuated through the industry. But I think from our perspective, where we sit, especially because we actually deploy a good amount of our portfolio across Asia, China being one of the biggest markets for us, I think we've seen in situations where you have two companies, one in the West, one in China that have mutually aligned incentives, we've seen that be very successful in a way that benefits both parties, right? For the US company, maybe it's on top of just gaining access to the China market, which, you know, no Western company should ever try to do alone. Even the strategics for that matter, right? Even the guys with a lot of resources just because so different. So in addition to getting market access, we've seen companies gain access to cheaper manufacturing, right, or a partner that can help them with a gen two that optimizes for cogs in a way, in a timeframe that they would never have been able to achieve by themselves. And so I think for us, we actually think of it less as necessarily challenges and more just kind of how do you navigate your way to, to a successful arrangement. And I think, at the root of it, it kind of comes back to something that Ryan said early on, which is, you've got to find people that you trust. And there's, there's no shortcut for doing that, except to really spend the time go to the local market. You know, talk to people who are kind of in those spaces, and then slowly wiggle your way to someone who you can genuinely trust, you feel like after critical analysis of what they're what it is that they're after that there's clear alignment and incentives. And then, obviously, to something that David said, making sure that you have a very good contract, and that you spend on good legal to ensure that I think when you pull all those things together, what we've seen is a lot of really successful relationships. And so we we try to foster that in or we try to advocate for exploring those types of partnerships, and all of our companies when we make investments,
George Lewis 26:25
makes a lot of sense. Ryan, anything from your experience? I mean, I know we talked about that earlier, is triple ring played a role there?
Matthias Bellmann 26:33
Yeah, it's interesting for us, for the work that we've done in Asia, it's much more focused on Japan now. And it is it's very unfortunate, because China was, is a fantastic market. But as you say, it's cool down for many of us to be bringing products and technologies into. And it's not because of regulatory, and it's not because of market size, or need. It's purely, I guess, you could say political almost right, or geopolitical. And so that's very, very unfortunate. But there's opportunity there if you have the right partners, and if you set it up correctly. And then but you look all around the rest of Asia, they are filling gaps, and are good markets, not nearly as big, but still worthwhile places to be, you know, investigating and seeing if you can bring a product into. So it's, it's a constant evolution.
David Webster 27:34
I talked three markets, right? There's a bunch of them. There's Singapore, there's Indonesia, there's Malaysia, well, let's talk three, China, Japan, and Korea. They're all protected markets mean they protect their market, right? So know that when you go in, you absolutely need a local company that somehow connected right? thing in China, it's a long regulatory process, it costs money, you want to hold your ownership of that there, even if you do it through a company, you want to hold the regulatory, because if you don't like them, you can get rid of them. And you can find another company. One of the issues with China, too, is that if you manufacture they're a percentage of the machine, and there's a little slide and rule there, you get priority when it comes to government contracts. So you have to find a partner, it depends what you sell, who can do some manufacture, do assembly there, at least, which gets you preference, if there's a competitive bid. Japan also has a really long process. And if you're in the radiation business, they're very radiation sensitive for a lot of reasons. And they have a lot of rules. And they're also an imaging country. They have imaging companies, they have scope companies, they protect those markets, very strong. In Korea, the same thing goes, if they have local stuff, they'll slow it down, it'll, it'll just be I mean, it's doable. I've been in all three, I work in all three, they're great markets, but you got to find that local partner. And with respect to China, everybody's worried about China, stealing your ideas, I haven't really seen that they're smart enough to know now that they got to keep that under control. And if you have a good partner over there, first of all, you can file your patents over there. Second of all, if you have a good partner over there, they'll protect you. Right, because they're usually a distribution partner, they're not going to try and steal the manufacturing. So though, sort of keep an eye on things and keep things going. But those seem to be the three more challenging countries. The rest, you can sort of slide in pretty easily. They have high populations, you can use them but it's it's it's tough. Yeah.
Matthias Bellmann 29:33
But speaking of Japan, they are lowering barriers and there are companies that are very actively trying to reduce the friction for introduction of products into Japan and also coming back out of Japan. So most of the large medical corporates in Japan have us cvcs And US operations that are doing just this building relations. chips understanding product and how they fit in the Japanese market and vice versa. And it's it's succeeding and will only get better over time.
George Lewis 30:12
Alright, so guys parting thoughts on the subject of international expansion, cross border partnerships for med tech companies? Mateus. Any thoughts there?
Sure. So I think we've covered a lot of different aspects here in the round. I think what we all can agree on is that communication, early communication, good planning, like let's say, from my perspective, building, also, especially your regulatory strategy, combined with a lot of testing, I think there's like, things that you can prepare that you need probably in multiple regulatory areas of the world for from biochem to packaging, the, you know, the rules are similar in that regard. And I think you can build already a strategy upfront, talk about it, get input, get a CRO, on board, maybe even quicker, that helps also with a translation into local regulatory schemes. And, and then I think the FDA first strategy is probably here to stay. And then let's see where it takes you from there.
Matthias Bellmann 31:22
Yeah, I guess, back to partnerships, I think, stick to the mission. And one of the wonderful things about medical device and healthcare broadly is it's a mission driven industry. And we're, by and large, as an industry, we're here to help one another and collaborate and do it quite well. And so leverage that and keep your eye on the fact that you're here to help patients, and you will find willing partners in any country who wants to help you do that. And those are the ones you want to keep.
Kevin Chu 31:53
Yeah, I think maybe just parting thoughts. So, again, I come back to the idea that international market expansion or international strategy is really a case by case depending on what you're doing, what product what indication, and what those local market dynamics are, in the various geographies that you're considering. I think the prioritization has to look different, there isn't a blanket strategy, in order to inform that, I think, taking the time finding the right sources of information, not to throw shade on any of the market research firms, but I've seen so many kind of market reports where the data is just off completely right, I think the best source of information, talk to the distributors on the ground, talk to the people who are actually working in those local markets, and then get real, real real world data, right. Use that to inform you know, your calculations around what is what is the return that I actually get from trying to get in this market? And then based off of that prioritizing markets, and then lastly, is find the right partner and make sure you do the full diligence. Don't skimp on it. Because in the long run, I think it'll it'll pay dividends.
George Lewis 33:11
Excellent, David, any parting thoughts? Or I think it's if their product is good, it's worth it. It's worth it.
David Webster 33:16
It's it's, it's, it's a having run around the world for a bunch of years. And I'll tell you, sort of the block and tackle of it is this. Go to the when you're in a specific market, if you think the product makes sense to go internationally, the prices right now that just go to the international meetings in your area of expertise, and set up a 10 by 10. Booth. And they'll come to you like flies, right? The distributors and everybody and they'll learn about it. And they'll talk to you and you can get a sense, you know, meetings like medica, Arab health China Med, you can go for short money, it's a lot of travel, but you can go and you can get a sense on the ground. And by the way, if you go to some of the world congresses, too, you'll get a bigger collection. And a bunch of them come to the US shows too. And it starts with listening to the doctors do they think it'll work? And then you'll start finding the people but I'll tell you at neurologica it saved our company because we started the company you know for against the wishes of my board, I decided to go international in Oh 809 The market collapsed in the US. But here's the beauty the international market, they operate under a tender, and once a tender is on the move, it can't be stopped. So the year that the US just pulled the plug on everything, all the tenders came in. So then that by the time the tenders slowed down the US market grew again. So it's sort of like playing a roulette table where you put something on black and red and even in odd and no matter where the ball lands, you end up winning. And that's that's helpful for a small company in generating revenue. So if you can make it work If it works, it works. It works. But there is a formula. And that formula consists of a lot of the things everybody at the panel said, All things to consider.
George Lewis 35:12
That was a fantastic panel today, guys. Thank you for your time. Let's give them a round of applause. It was a great session today.
As a Strategic SaaS Executive in the Product Lifecycle Management and Quality Management Systems space, I possess a wide perspective in these industries. My 20+ years of experience in PLM/QMS ranges from CAD-centric solutions with traditional deployment methods to Cloud-based SaaS and PaaS technologies. In fact, I've spent the past 15+ years working in the Cloud industry, long before SaaS technologies were so widely accepted as business solutions. Past experience includes providing visionary presentations and recommendations to small startup organizations, through large Fortune 500 companies. Currently I work in the areas of strategic corporate vision, corporate development, and work to provide business alignment with customers, technology partners, and private equity organizations.
As a Strategic SaaS Executive in the Product Lifecycle Management and Quality Management Systems space, I possess a wide perspective in these industries. My 20+ years of experience in PLM/QMS ranges from CAD-centric solutions with traditional deployment methods to Cloud-based SaaS and PaaS technologies. In fact, I've spent the past 15+ years working in the Cloud industry, long before SaaS technologies were so widely accepted as business solutions. Past experience includes providing visionary presentations and recommendations to small startup organizations, through large Fortune 500 companies. Currently I work in the areas of strategic corporate vision, corporate development, and work to provide business alignment with customers, technology partners, and private equity organizations.
Accomplished life science and medical device executive and business leader with extensive experience in driving commercial success through innovation. Proven record of adding value to technology, device, and therapeutic R&D efforts by building strong teams, and leveraging deep scientific, technical and communication skills.
Accomplished life science and medical device executive and business leader with extensive experience in driving commercial success through innovation. Proven record of adding value to technology, device, and therapeutic R&D efforts by building strong teams, and leveraging deep scientific, technical and communication skills.
Senior Executive, Business Builder & Natural Leader who provides the breadth of experience and shared vision needed to position early-/late-stage medical product and technology startups for new phases of market creation, P&L performance, and valuation as well as acquisition and maximum investor ROI.
Senior Executive, Business Builder & Natural Leader who provides the breadth of experience and shared vision needed to position early-/late-stage medical product and technology startups for new phases of market creation, P&L performance, and valuation as well as acquisition and maximum investor ROI.
George Lewis 0:05
Hi, folks. I'm George Lewis, I worked for Arena PTC company, and I lead growth for the organization. So I'll do the moderation here. I was asked to introduce my team here of panelists, and so I'll go ahead and jump right into it here. Not in order of the background. I'll go in order on my page here. Kevin Chu. Kevin is principal of the healthcare team at f prime capital. Prior to f prime capital. Kevin was an associate consultant with IMS consulting group in New York, where he advised biopharma, biopharmaceutical clients on development and commercial strategy across multiple therapeutic areas. Kevin is currently based in the San Francisco office and works across the healthcare sub sectors including therapeutics, med tech, healthcare IT and services and also works closely with eight roads ventures China healthcare team to manage F Prime's existing and new investment efforts in China. So why is he here f prime collaborates very closely with a venturi consortium in China in his experience, consulting with consulting companies and establishing cross border partnerships between the US and China. Kevin is at the center of much of this work. Next David Webster David joins the executive team with decades of executive experience in medical device imaging and healthcare technology information. He's a passionate leader with a demonstrated track record of leading cross functional teams from early clinical development to m&a through global commercialization in 60 different markets and geographies. He comes on board at a pivotal time in the company's journey, bringing wealth of knowledge and expertise necessary to take body visions business to the next level. David holds an MS in Business Administration and Management from Troy University and a BA in psychology from the Citadel. So why, why is David here today, David has extensive experience in standing up global global markets for emerging med tech companies. Having done it with a previous venture neurological Corporation, which sold in over 60 countries. He plans to have body vision stood up in 60 countries by the end of 2024 Ryan McGuinness Ryan has spent 35 years in biotechnology medical device and r&d, engineering services industries. He's worked with many companies that have applied innovative technologies to a range of markets including cell and gene therapies, bioinstrumentation medical devices and in vitro diagnostics. At Triple Ring Technologies, Ryan leads a team of world class scientists and engineers who work at the junction of complex biology and cutting edge technology. As an active participant in the Silicon Valley innovation ecosystem. Ryan also spends time connecting early stage companies to the infrastructure know how in funding needed to successfully bring new products to market. Ryan was trained in Genetics and Molecular Biology at the University of California Davis. He is CO inventor of six US patents and has published multiple scientific scientific communications and presents frequently at the international science and technology conferences. So why is Ryan here Ryan and his team support a client's with a product development and market market entry globally and have strong partnerships in Japan and other parts of Asia which are extremely relevant to this panel. And then finally, Matthias Bellmann Matthias is Director global focus team cardiovascular at TUV SUD. Excuse me. Prior to joining TUV SUD spent over 12 years at bio Tronic in roles of increasing responsibility or in business development, strategic marketing, product marketing, product management, communication and more. He earned his Bachelor of Arts and Master of Arts in European management from teknis.
It's German, its German.
Hunch Lu, while do so why is Matthias here today to have yesterday provides testing and inspection services worldwide with over 1000 locations. They have a deep European experience expertise and also a broader global focus via their global market access GMA services, determining applicable applicable international regulations and managing product compliance to those regulations. So welcome, gentlemen, if we can give them a round of applause. We'll kick things off here. Excellent. All right. So first question for the panel here is around market prioritization and preparation. So guys for emerging med tech companies aiming to expand internationally? What criteria should they consider when identifying potential market markets assessing market readiness, and strategizing to minimize risks while successfully entering new region? It's Mathias Alt, you take the lead on this one? Sure.
Matthias Bellmann 5:03
So first of all, to suit is a notified body for MDR in the Europe in Europe. So this is also why I'm taking maybe a little bit more for European perspective on this question. We've heard a lot about MDR is bad. It's prohibiting innovation. Now, the companies won't come to the European market anymore. And I think maybe this is not the complete truth anymore. I think we will not see the same level of first line and Europe product development. But I think it's not a question either, if it's FTA, or MDR, I think it's a FTA and MDR. And if you do the planning already with the for your FTA strategy with the MDR in mind, I think there are a lot of synergies that then bring your product not just from the to the US market successfully. And I think we will not change that anymore. The FDA first strategy is here to stay. But I think you can have a successful strategy by minimizing your risk when keeping already the European market in the back of your head. I mean, Europe, in the end accounts for 25% of the global medtech market. We're talking about almost 450 million people in Europe with I think very nicely build up a healthcare system that is ready to take on innovation when it's approved. And when we talking time to market, I'm representing basically under the suit umbrella, we have now two notified bodies that we can do. And there are even, let's say fasttrack options that, like if you're ready, we are ready. And I think we can also work getting C approval on your product quite fast.
Gentleman little thoughts. Yeah. So regulatory is incredibly important, of course, for accessing markets. But another kind of higher level thing is, is understanding who your partners are, and what types of partners that you will need in the geographies that you're going into. And so, very often, if we're leaving home and going into new geographies, we need what we call jungle guides, folks who are on the ground and understand not just who the patients are, or what the specific problems of a given population might be, but who to access for regulatory help or for financing, or for supply chain and these types of things. And so no matter where you are or where you're going, these development programs are this this innovation work needs teams, it needs partners, it's complicated. And we need friends to do this. It's it's an important part to figure out who you're going to be working with anywhere you go.
George Lewis 7:52
Yeah, makes a lot of sense. Kevin, any thoughts? David?
Kevin Chu 7:56
No, I mean, I completely agree. I think I think for us, it's maybe a slightly more straightforward answer to your direct question, which is just you have to follow where the money is, right. And depending on what the product is, depending on what indication it's serving, you know, certain markets will offer a very favorable economic value proposition they should go after. Whereas others, they may not make as much sense. But I think, to Ryan's point, understanding the complexities of navigating that market, what resources you need to tap into, or invest in, in order to get access to that market, I think are all part of the equation as well.
George Lewis 8:34
The thoughts that Ryan had in the jungle guide, I mean, oftentimes entering a new market for anybody like ourselves included, I mean, you really needed to get those local regulations. I
David Webster 8:43
don't think you can do that by finding a good distributor in each country. So having commercialized a bunch of times, now, what I do is, first of all, you're gonna get a response from the doctors as you go out, and you go to trade shows, and you're gonna see where the interest lies, the clinical interest, then what Kevin said is you take a look and say, does the product make financial sense, because if it's too expensive, it's not going to move, then you look at what the total available market is in that country. So you take a country like India with a huge market, right? And in a reasonable regulatory process, and you can, you can jump off in those countries very easily. And then, of course, when you find your distribution partner, most of them have their own regulatory team. And they'll guide you through the process who holds the regulatory, that's a negotiation. But a lot of those teams have a clinical team, they have a sales team, they have a service team, and they'll guide you through and they'll launch the product for you. And you just have to make sure that they can hope they can cover down on the product in the country. And it's not a terribly complex formula. And you sort of feel your way through it as you go. But the distributors as Ryan said, the distributors will be your guide. They'll let you know if you're priced right. They'll let you know if you don't have any distribution interests. Well, there's your answer. They don't think they can make money. But distribution is the key good distribution.
George Lewis 10:07
All right, thanks, folks. Next question is around regulatory complexities. So what significant challenges and opportunities has the EU MDR pose for the life sciences industry? Since its inception? And how have companies navigated these changes to ensure compliance and continued innovation?
David Webster 10:28
Nightmare, right, we
Matthias Bellmann 10:29
are in the hallway. But yeah, I
George Lewis 10:32
think you I think you had a valid point. Of course, if you look at it from the since the 2017. Inception. Yes, I think the perception was that it's a big mess. And it was a gigantic change, I think for every metric company in the world. We're still working through it. The MDR extension, however, has cooled down the pressure on the US as notified bodies. And yes, we are quite aware of our image also in that regard. We're working through it. We're working with manufacturers. I think the biggest recommendation from our side we can make is come talk to us, come talk to us early. Come talk to us about what you are have the MDR now gives us the opportunity also to talk to you we call it structured dialogue. There is actually even if you're talking about submission in 2026, even now would be a good point in time to reach out to get first contact gets most of these uncertainties out of the way. And I think then there can be a collaboration between notified bodies and manufacturers.
Matthias Bellmann 11:38
Yeah, in the US defense, and FDA is still not making things super easy. And I don't know how many of you have seen the recent guidance on cybersecurity. But essentially any medical device with a USB port is going to be subject to the new guidance around cybersecurity, and that's an onerous guidance and expensive to meet. So it's, these are challenges that no matter where you go, you're gonna find I
David Webster 12:07
can say this, I've led two companies through it now. neurologica, we were one of the first people to get EU MDR in the US. And most recently at body vision. We got it about six weeks ago, it was it was a nightmare scenario, I'm going to tell you, they're backed up. They can't do the inspections, they've had to extend it, we all knew that there was going to be an extension because we were all talking to each other. And everyone's like, this ain't happening right? Then the the UK broke away from it. And I don't know what they're up to over there. They've got their own thing going on. But it was a whole, you know, I'm just being I'm very, very pragmatic about it right. From our side, it took a lot of manpower, it took a lot of time to do it. It was very disjointed. My hope is it gets better, and it flows a little bit better. But I don't think they're through the woods yet. I think it's going to take another year before it sort of levels out. See mark, dream? Why did we change it? I don't know why he was perfect. If we could get to market super fast, we could start selling products over there and get things going. And then sort of bring it to the US. And now it's I think it's the opposite. They're both equally complex. So why not go for the FDA first, and then and then pick up the EU MDR? And then we'll figure out what the Brits are doing at some point.
George Lewis 13:23
Kevin, is there a VC view on this one?
Kevin Chu 13:25
No, I think I think I echo at least through the transitive property echo through my portfolio companies what the gentleman to my left and right have have already shared it does seem like it's there's a lot of turbulence right caused by MDR. And people are still figuring it out. Obviously, the Extension helps to mitigate the blow a little bit, but I think it just heightens the need for a lot of information as you're thinking about whether or not you want to prioritize that path versus going straight into FDA. And again, you know, I think in certain indications for certain products, the the headache and the investment in resources and expert consultants to navigate you through the process is warranted because the upside is there. Right. And we saw that in one of our recent companies that was in EP right upon getting their MDR saw significant sales right over the over the first 1224 months. So I think it really depends. You
George Lewis 14:31
know, it's interesting, I mean, I'd be curious if the the other gentleman up here have a view on its mean is that the type of device determines which market you may choose to enter first, does that have a an impact on it?
Kevin Chu 14:40
I would say maybe less so type of device and more. So the specific indication and kind of the market dynamics around that interesting.
David Webster 14:49
I'll tell you what, I was in imaging before now I'm in AI. There's a lot of confusion in AI like we're we're going into China now and China hasn't made up his mind, the FDA made up its mind there was a backlog and then suddenly, boom, they made a decision and everything sort of flooded through. So in the cybersecurity pieces is becoming significant. I mean, that's, you got to anything that connects, you got to bake something in. And there's a lot of documentation that goes with that. And then when you're dealing with individual hospitals, and it's super complex, so it's it's, there's still things that are being defined as we speak.
George Lewis 15:31
Yeah, I mean, regular regulation is complicated by virtue of the fact that's always changing. We deal with that all the time. In the software side of things, too. It's always updating and you have to keep up with it. So Alright, so moving on. Next question around partnerships, while seeking global expansion. What proven strategies can US based firms employ to foster strong and mutually beneficial collaborations with international partners? David, ahead, you tagged to take this one?
David Webster 15:57
Okay. This is an interesting one, right? Because you're gonna go out there, and you're gonna deal with dealers. Okay, and dealers are all over the map. So the first thing you have to do is figure out a good vetting process, right? What's their reputation? How well are they known in the market? What are their financials, right? Because they'll tell you and promise you the whole world. And then you have to have a good distribution document. Right? Once you vet them out, and you talk to References, talk to other companies, talk to some customers, then you have to have a great contract to cover it. And you just you have to visit them, you really do. They'll show you pictures and all the rest of it. But meet with them, go visit them, see their operation, talk to their off key opinion leaders and everything. And just make sure they have what it takes. And frankly speaking, some of the products are too heavy lift for the dealers, there to sales isn't the issue, it's the service and the clinical lift, right? Do they have the wherewithal to really support the product, Europe is becoming a problem child, because because of the Union, I'm not bashing Europe today, I'm just these are facts, I'm spitting facts. Because they've United now you'll have a dealer who feels like they can cover all of Europe. But Europe is very different from state to state to state. So despite the being united, and despite us wanting to look at Europe, like it's the United States, where you can get one dealer to cover a region or a bunch of states, you really need to find country distributors. And that's a pain, because you want to sort of give it to one person and let them run with it. But the reality of it is I've tried that, and it just doesn't work. So you really need, you know, you can have like a company that covers benna locks and a company that, you know, there's there's sort of congregations over there, but you probably need three or four good distributors to cover that country and provide the what they need. Yeah,
Kevin Chu 17:55
maybe just to completely agree with everything David said, maybe to echo or emphasize two points. So one, we've seen so many times when a company has gotten really excited about the first inbound, distributor, right? And then all of a sudden, they're they're mentally married to that, that distributor, and they don't do the diligence, and they don't go out and kind of scan the field and see see what other options are out there. I completely agree with David, take the time to really serve a ask peers that you trust, who have gone through the process who understand those markets, you know, what are some of the other people that should be talking to, and really take the time to do that work. I completely agree with that.
David Webster 18:35
Keep an eye on your price too. Because they'll tell you, they'll play games, they'll jack it up to lower it and then you lose control of it. So keep an eye keep an eye on what they're selling it for.
Matthias Bellmann 18:46
And another very pragmatic thing to think about, is when you're going into fragmented markets, look at your product, look how it's going to address problems in those specific markets and then prioritize which markets you do first, second, third, fourth, don't try and go after too many all at once. Establish something in a region and then grow from there.
George Lewis 19:12
Matthias, I saw your head nodding there, you have a reaction.
Other than we are the problem chat. I think what you mentioned is valid also with the importing into the EU. Also the MDR there plays a little bit of a role that they need to be the authorized representatives for you. So keep an eye out for the proper documentation that they are prepared on their end to receive your product and are you know part of the whole value chain of documentation that you bring?
Excellent. So on to a risk mitigation. What are your thoughts on reimbursement as a commercial risk for early stage innovators? Ryan, any thoughts on that? But,
Matthias Bellmann 20:00
yeah, for early stage innovation and for early stage companies, what we've seen over the last few years is that when you think of business risks, that the primary risk has always been funding, the financial risk, when are you going to get where you're going to get your next round? And then it was regulatory risk very often. And then some form of reimbursement now reimbursement has leapfrogged the regulatory risk, especially here in the United States. And so it's one of these elements in a business plan and business modeling that has been brought much further up the chain, in terms of when you consider it, and when you think about it, when you strategize for it. So it's, it's become a very, very important part of a company's existence.
David Webster 20:50
I'd say cost, the two systems are basically at odds, there's the United States, which is how much revenue can we drive out of it? How much revenue can we get for the technology? And then when you leave the United States and go elsewhere, they're like, how do we lower the costs. So we love to charge for capital, we love to charge for consumables per case, that's a great model in the United States. But that model doesn't work in a lot of countries. So you might find out that you have this great thing that's sort of working here with the GPOs. And the it ends, and everything's going well, and you go to another country, and they're like, we can't afford the cost of the capital, we can't afford the upkeep of the equipment. And we certainly can't afford the case by case consumable, it's just not big enough, which is why in a lot of cases, surgical robots aren't playing in other countries, because the capital cost is too much, the cost of ownership is too much. And then the cost of the consumables are too much. And then if you try and go through distributor, it's such an electoral, mechanically complex product, they can't provide the support. So it doesn't make sense. Like in the US, you see, a lot of the robot companies they park a rep in the AOR, with the robot for every case, won't work in Europe won't work in many of the countries, there's not enough meat on the bones for it. So I think you really got to look at that. What's the cost of your product? What's the cost of acquisition ownership, and a fee and Nick, and per case, it just might not work?
George Lewis 22:16
You know, you're talking to the hallway before you hopped in here, and it's just in the US, it seems like there's a lot more comfort, maybe not comfort, but it's more acceptable to ask for everything and try to compete with the hospital down the road, where in the European market, maybe less. So. I mean, certainly we've talked to companies at Arena that Do you know, proton beam therapy and things along those lines, and all of a sudden, you need to build a bunker around the device, because it's shooting on protons. So any other thoughts on the subject? Guys?
David Webster 22:47
Yeah, I think you're exactly right. I think even the build out costs of a lot of the stuff just doesn't work. So it's, it's a whole different. It's, it's a whole different world, having traveled to all these countries and went into the hospitals, talk to the administration, it's like two separate worlds. I used to say it's like the Wizard of Oz, right? The United States, the rest of the world is like Dorothy, and then when she pops the doors open and walks into Oz, and it goes to color. It's like, boom, that's how Stark the differences can be not in all countries, but in many of them especially. It depends where you go. I mean, they're just, they're not, they don't have the resources to put into medical care like we do here. And I know, there's a lot of discussion about who's got better, better medical care, but we got a lot going on over here. We got a lot of good stuff. So it's different. real difference.
George Lewis 23:39
Excellent. So another question on on Asian markets. You know, we've talked a lot about the state of regulations in the US in Europe. Do you have some insight and the challenges of entering the Asian markets? have any thoughts on that one?
Kevin Chu 23:52
Yeah, I might expand it beyond just challenges, because I think, you know, the conventional wisdom, especially when you're dealing with maybe markets like China, for the first time is that it's really tough way of doing business, very different. You know, maybe they don't respect IP, etc. Like they're all these mantras that that I think it perpetuated through the industry. But I think from our perspective, where we sit, especially because we actually deploy a good amount of our portfolio across Asia, China being one of the biggest markets for us, I think we've seen in situations where you have two companies, one in the West, one in China that have mutually aligned incentives, we've seen that be very successful in a way that benefits both parties, right? For the US company, maybe it's on top of just gaining access to the China market, which, you know, no Western company should ever try to do alone. Even the strategics for that matter, right? Even the guys with a lot of resources just because so different. So in addition to getting market access, we've seen companies gain access to cheaper manufacturing, right, or a partner that can help them with a gen two that optimizes for cogs in a way, in a timeframe that they would never have been able to achieve by themselves. And so I think for us, we actually think of it less as necessarily challenges and more just kind of how do you navigate your way to, to a successful arrangement. And I think, at the root of it, it kind of comes back to something that Ryan said early on, which is, you've got to find people that you trust. And there's, there's no shortcut for doing that, except to really spend the time go to the local market. You know, talk to people who are kind of in those spaces, and then slowly wiggle your way to someone who you can genuinely trust, you feel like after critical analysis of what they're what it is that they're after that there's clear alignment and incentives. And then, obviously, to something that David said, making sure that you have a very good contract, and that you spend on good legal to ensure that I think when you pull all those things together, what we've seen is a lot of really successful relationships. And so we we try to foster that in or we try to advocate for exploring those types of partnerships, and all of our companies when we make investments,
George Lewis 26:25
makes a lot of sense. Ryan, anything from your experience? I mean, I know we talked about that earlier, is triple ring played a role there?
Matthias Bellmann 26:33
Yeah, it's interesting for us, for the work that we've done in Asia, it's much more focused on Japan now. And it is it's very unfortunate, because China was, is a fantastic market. But as you say, it's cool down for many of us to be bringing products and technologies into. And it's not because of regulatory, and it's not because of market size, or need. It's purely, I guess, you could say political almost right, or geopolitical. And so that's very, very unfortunate. But there's opportunity there if you have the right partners, and if you set it up correctly. And then but you look all around the rest of Asia, they are filling gaps, and are good markets, not nearly as big, but still worthwhile places to be, you know, investigating and seeing if you can bring a product into. So it's, it's a constant evolution.
David Webster 27:34
I talked three markets, right? There's a bunch of them. There's Singapore, there's Indonesia, there's Malaysia, well, let's talk three, China, Japan, and Korea. They're all protected markets mean they protect their market, right? So know that when you go in, you absolutely need a local company that somehow connected right? thing in China, it's a long regulatory process, it costs money, you want to hold your ownership of that there, even if you do it through a company, you want to hold the regulatory, because if you don't like them, you can get rid of them. And you can find another company. One of the issues with China, too, is that if you manufacture they're a percentage of the machine, and there's a little slide and rule there, you get priority when it comes to government contracts. So you have to find a partner, it depends what you sell, who can do some manufacture, do assembly there, at least, which gets you preference, if there's a competitive bid. Japan also has a really long process. And if you're in the radiation business, they're very radiation sensitive for a lot of reasons. And they have a lot of rules. And they're also an imaging country. They have imaging companies, they have scope companies, they protect those markets, very strong. In Korea, the same thing goes, if they have local stuff, they'll slow it down, it'll, it'll just be I mean, it's doable. I've been in all three, I work in all three, they're great markets, but you got to find that local partner. And with respect to China, everybody's worried about China, stealing your ideas, I haven't really seen that they're smart enough to know now that they got to keep that under control. And if you have a good partner over there, first of all, you can file your patents over there. Second of all, if you have a good partner over there, they'll protect you. Right, because they're usually a distribution partner, they're not going to try and steal the manufacturing. So though, sort of keep an eye on things and keep things going. But those seem to be the three more challenging countries. The rest, you can sort of slide in pretty easily. They have high populations, you can use them but it's it's it's tough. Yeah.
Matthias Bellmann 29:33
But speaking of Japan, they are lowering barriers and there are companies that are very actively trying to reduce the friction for introduction of products into Japan and also coming back out of Japan. So most of the large medical corporates in Japan have us cvcs And US operations that are doing just this building relations. chips understanding product and how they fit in the Japanese market and vice versa. And it's it's succeeding and will only get better over time.
George Lewis 30:12
Alright, so guys parting thoughts on the subject of international expansion, cross border partnerships for med tech companies? Mateus. Any thoughts there?
Sure. So I think we've covered a lot of different aspects here in the round. I think what we all can agree on is that communication, early communication, good planning, like let's say, from my perspective, building, also, especially your regulatory strategy, combined with a lot of testing, I think there's like, things that you can prepare that you need probably in multiple regulatory areas of the world for from biochem to packaging, the, you know, the rules are similar in that regard. And I think you can build already a strategy upfront, talk about it, get input, get a CRO, on board, maybe even quicker, that helps also with a translation into local regulatory schemes. And, and then I think the FDA first strategy is probably here to stay. And then let's see where it takes you from there.
Matthias Bellmann 31:22
Yeah, I guess, back to partnerships, I think, stick to the mission. And one of the wonderful things about medical device and healthcare broadly is it's a mission driven industry. And we're, by and large, as an industry, we're here to help one another and collaborate and do it quite well. And so leverage that and keep your eye on the fact that you're here to help patients, and you will find willing partners in any country who wants to help you do that. And those are the ones you want to keep.
Kevin Chu 31:53
Yeah, I think maybe just parting thoughts. So, again, I come back to the idea that international market expansion or international strategy is really a case by case depending on what you're doing, what product what indication, and what those local market dynamics are, in the various geographies that you're considering. I think the prioritization has to look different, there isn't a blanket strategy, in order to inform that, I think, taking the time finding the right sources of information, not to throw shade on any of the market research firms, but I've seen so many kind of market reports where the data is just off completely right, I think the best source of information, talk to the distributors on the ground, talk to the people who are actually working in those local markets, and then get real, real real world data, right. Use that to inform you know, your calculations around what is what is the return that I actually get from trying to get in this market? And then based off of that prioritizing markets, and then lastly, is find the right partner and make sure you do the full diligence. Don't skimp on it. Because in the long run, I think it'll it'll pay dividends.
George Lewis 33:11
Excellent, David, any parting thoughts? Or I think it's if their product is good, it's worth it. It's worth it.
David Webster 33:16
It's it's, it's, it's a having run around the world for a bunch of years. And I'll tell you, sort of the block and tackle of it is this. Go to the when you're in a specific market, if you think the product makes sense to go internationally, the prices right now that just go to the international meetings in your area of expertise, and set up a 10 by 10. Booth. And they'll come to you like flies, right? The distributors and everybody and they'll learn about it. And they'll talk to you and you can get a sense, you know, meetings like medica, Arab health China Med, you can go for short money, it's a lot of travel, but you can go and you can get a sense on the ground. And by the way, if you go to some of the world congresses, too, you'll get a bigger collection. And a bunch of them come to the US shows too. And it starts with listening to the doctors do they think it'll work? And then you'll start finding the people but I'll tell you at neurologica it saved our company because we started the company you know for against the wishes of my board, I decided to go international in Oh 809 The market collapsed in the US. But here's the beauty the international market, they operate under a tender, and once a tender is on the move, it can't be stopped. So the year that the US just pulled the plug on everything, all the tenders came in. So then that by the time the tenders slowed down the US market grew again. So it's sort of like playing a roulette table where you put something on black and red and even in odd and no matter where the ball lands, you end up winning. And that's that's helpful for a small company in generating revenue. So if you can make it work If it works, it works. It works. But there is a formula. And that formula consists of a lot of the things everybody at the panel said, All things to consider.
George Lewis 35:12
That was a fantastic panel today, guys. Thank you for your time. Let's give them a round of applause. It was a great session today.
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