Ask the Experts: Globalization Strategy and Partnership Readiness | LSI Asia '25

Kristi Nakayama  0:05  
So you know, today, we're going to be talking about how in the Medtech landscape, the path to commercialization is rarely linear, right? So rarely funding with one single partner. So we're hoping that this session helps you to think about your a goal, which may be an acquisition or strategic partnership, but how do you continue moving forward with your B plan and your C plan? And my speakers here will be able to offer some real insights into that, and also looking at your partnerships in maybe a different perspective, not just funding, not just commercialization partnership, but also from an IP perspective. So I'm happy to present her main Mousavi, President and CEO of CathWorks, and Alex Lynn from Mayo Clinic ventures. And yeah. So having a clear path for critical you know, long term sustainability is is really important. And Ramin, I think you've done a good job of that throughout your experience with your two rounds with cathwork. So take us through your journey a little bit from your first time around with CathWorks, your your first attempt at partnership, and then your second round,

Ramin Mousavi  1:21  
sure, as you mentioned, we are very lucky. We have a great team. They've done a great work, and they've been very resilient. So we've had two different experiences. We call it CathWorks, 1.0 and 2.0 you know, we've tried to the same thing twice. We failed really, really, really good the first time, which gave us a lot of learning. For the second time, the concept was, as you tried to construct it, how do you create something sustainable? I'm of the belief that if you have a technology that has a lot of promise. If you want it to become standard of care, it is really hard to do that in a startup setting, even if you were given all the money in the world, which you will never be given. But even if you were given that, when you count for time, you will be in a very difficult position to create a channel that can actually reach globally for something to truly become standard of care. We believe the technology that we have so we combine AI and computational science, fancy word for algorithm, to non invasively detect coronary artery disease, which is the number one cause of death. The mindset was, if we partner with the right strategics from the get go, eventually, you can tap into their channel, because this will be a better thing in their bag. And we were very lucky that we had multiple strategics. You know, as investors in our cap table makes your board meetings very interesting. You know, when you have all of them there. We tried to do this the first time around, and it failed. You have had some visibility to that, you know, years ago, and really was based on the fact that the technology wasn't ready, which is one of the things that founders and CEOs of startups have a hard time accepting. We did too, but eventually we had to acknowledge and learn that. And so this is the sustainable kind of growth. Thing is that, can you create something that can repeat itself over and over? We had to take that learning coming back from our partners at Medtronic, and go back to the drawing board and change the technology, you know, and make it what we were hearing back from the customers in the catworks 2.0 we took that back to the customers, and it turned out that they actually told us the truth, because we put that in front of them, and the same customers accepted that. We went back to the same construct that can we tap into the existing channel here, the CO promotion that we have in Medtronic, and actually worked out, you know, we've been able to see an amazing growth of the technology a fantastic adoption across the globe, something that most of startups don't get to do, and the fact that we are here in Asia is because we're growing that into a pack, which is something you don't get to do as a startup that often. So I'm a big believer of if you have a way to expand this out using established channels. Maybe he's a little aspiring, maybe more pragmatic than some like to, you know, see that way. It does work, but it's it comes with its own learning. And, you know, we've had the luxury of learning it a real way, right? A

Kristi Nakayama  4:37  
couple questions going back to 1.0 attempt, because I actually was when BD at the time. So I was seeing what was going on behind the scenes. Dave Allen in the last session, earlier today, Medtronic, BD as well. He made a good point of one of the most important things along that journey is, or maybe it was Kristi so but it was building. The relationship and the trust, because you also don't know what is going on on the strategic side behind the scenes of what they're looking for. It could be we're looking for a, you know, a long term partner to develop technology with which we'll get there we'll get to with Alex. It could also be that we're looking for near term revenue, like they want to acquire something that immediately can help their P and L, was Medtronic that first time very open with you about really, truly, it's the technology. Are there other things that were at play that didn't make it the right timing match?

Ramin Mousavi  5:32  
You know, I think on reflection, they were, I don't think at the time you saw it that way, you know, it felt like very vague. And was like, Why are you picking at this. And I think Medtronic, very clearly, all the strategics that invested in Catherine saw a potential for a disruptive technology that I think they believed needed to be proven. You know, now, when you're sitting inside the startup, it's really hard. You're skeptical and like, why you're not really believing in this thing that we believe in. I think they signal to us very clearly that what they wanted was, they wanted it to be in the startup construct, because we get to go a lot faster. I'm sure you will touch on that. That's the benefit of a startup. You can go a lot faster. You can fail a lot faster than you would do in a larger company. You've been on the other side. You know, the speed is something that goes away. I think they told us what we needed to hear. Now, we were probably not as good listening, you know, very quickly, but eventually, as we listen, there was one clear thing they were looking for. They wanted to see the adoption in a way that they could scale it. That's the feedback that we ultimately had to, you know, sit down and reflect and understand, and it's really hard, because when you raise a lot of money and you tell your investors that the product is going to be ready by such a milestone, when you miss that, you know, you have to go back to the drawing board and say, you know, just kidding. They're not ready. But I do recommend very strongly to my peers, when we talk that if you haven't taken the time to build a relationship early on with the strategics that you know, who are the targets for your technology, you should take the time from early times, and I do, having worked, you know, half of my career at the strategics, and being On the other side of it, they will give you good feedback on what they're looking for. And if they don't, you can ask questions. And, you know, in good faith, most of the strategics will tell you what is it that they really want. Are you and the management team ready to take that feedback? That's a different story, and I think that's what we had to get really good at. You know, listening to that feedback. We

Kristi Nakayama  7:43  
often see startups thinking, Oh, I'll get to the documentation that's required once. You know, we're ready to go for due diligence and opening our data room. But you never know when that timeline can shift quickly. So how were you preparing for that when after 1.0 and you came on, then a second time, back to CathWorks as CEO. And I believe you and Jason Weinman got that deal done within a matter of eight or nine months.

Ramin Mousavi  8:11  
Maybe he really got it done in, I think, 90 days. It took six more months for the lawyers to come to an agreement. You know, we had our deal, I think in nine, in 90 days. And, you know, it was a lot of trust trying to get, it's a series of agreements in us, one of the most complex, built to buy deals that goes out there. But, I mean, I want to force the issue to ask, how many people here have been involved in any, any sort of diligence. Just raise your hand if you've been, you know, involved in any sort of diligence. Well, this is, it's a the most, the most vivid way I can explain to you, it's like colonoscopy without anesthesia. You know, that's how it is, just is. So what you have to do is, you can't say, I'm gonna do my stuff, and then we gonna get to diligence, and then we're gonna be ready. You have to be mid flight and be ready. So what we learned, I mean, we are very, very lucky that we have a really good team that have worked with each other for a long time. When you're a startup, it's not like you can pull the entire team in when you do diligence, it's a very sensitive thing. And as you were previewed to the 1.0 when a diligence falls apart, it's a heartbreak that takes a psychological thing to recover from. You know, I remember it took me a couple of days after the first deal four apart to just figure out, what are we going to do? So we will learn now to treat it as if at any given time you're ready to do the diligence and understanding the difference between the two world, because you get hundreds of people at the strategic and the same four or five people in the startup. So how do you make the two work together?

Kristi Nakayama  9:45  
I don't know what is more stressful on FDA audit or going through diligence

Ramin Mousavi  9:51  
ideas. Diligence, because, you know what the FDA I mean, most FDA audits, you get in trouble because you're not following your own documentation. You know, FDA has some rule. Rules. Most companies decide to get you know creative and have their own rules that are more strict to FDA, which FDA is fine with that, but then when you come back, they want to make sure you meet your own and you don't, then you have a problem. I think the diligence is really hard, because you find some third year quality engineer who's scared of their life to accept some documents so they keep asking questions, you know? So you know, we we've learned that the best way to do it to put the most strict person on your team as a response correspondent. So in our case, is easy for our CFO, and he's like, he will say no to everything.

Kristi Nakayama  10:34  
Well, I want to come back. I have more questions on your overall global strategy and lessons learned in hindsight now, but I want to shift over to Alex. Mayo Ventures has a really interesting way that you approach partnerships. And you know, if you can share for the audience, what does that look like? Who are the ideal companies that Mayo would like to partner with? And then how do they approach Mayo

Alex Lin  11:00  
Yeah, thanks, Kristi, I think to your point, Mayo Clinic ventures, we engage with startups and innovative companies across the spectrum of healthcare. We look at anywhere from biopharmaceuticals to med devices to even digital health and AI, which is now a very strong area of interest at Mayo Clinic, but I know a lot of companies are also very interested in that space. You know, when we look at Partners, what we typically consider first is the innovation itself. We want to approach those technologies by with the lens of the 10 techno clinical impact. Because for us as a hospital system, what we want to do is to to see the pathway from where the technology is currently until what it looks like in the market. And I think that's like for startups. That's a critical journey. And we at Mayo Clinic, we have the clinical expertise, we have data assets, IP resources, as well as the key opinion leaders that can help those companies drive that journey. And I think what we look for, typically, is companies that are willing to to have us join in on that journey, because I think there's tremendous value that we can add to those companies and and we are really flexible too, because we view ourselves as strategic partner. We're not, you know, we're not a CRO we have the key thought leaders that can really help the company idea if they aren't quite at the stage where they have that roadmap figured out. So we view ourselves as a full partner. For all those companies are willing to engage with one of our the top hospital systems,

Kristi Nakayama  12:40  
and likewise, I imagine you want a partner on the other end who's very open to feedback, to to approaching it as a true partnership with you. Right?

Alex Lin  12:50  
Absolutely. I mean, you know, we work with a lot of different teams, and I think, you know, our scope is very broad, so we want to work with everyone that that wants to work with us. But I would say the projects and the the companies that tend to to take make the most value of these collaborative relationships are the ones that want to participate fully with our clinical teams. And I know there's a panel later on about getting on a plane, flying to your partner sites, and doing a lot of those sessions and ideation in person. And I think Mayo Clinic especially has that culture where you know companies, when they come to Mayo Clinic, you get the full experience. You sit in all these innovative meetings with the clinicians, and a lot of the ideas and concept just get developed organically. And I think that's the beauty of working with a group like us, is that we can enable that like if you if you really want that experience, and you have have a hypothesis of where you like to go, but you haven't quite figured that out, I think that's where we typically come into play and deliver the most value.

Kristi Nakayama  14:03  
And what we had discussed earlier was really on the IP side, right? So our is a company coming to you saying, you know, we're interested in investment and we're interested in your clinician feedback, or is it better to say we feel like we have an idea here? Can you help us really idea and change and make our IP stronger for what clinicians need. Or is it both? 

Alex Lin  14:27  
I think there's a little bit of both, but I think the latter is where I think we I think we deliver the most value, right as a so we're a hybrid tech transfer office and a venture arm as a major hospital system, and the way we view ourselves is that we have a dual purpose, a dual value prop, and that is, we have our assets which incorporate our really broad and robust IP portfolio, our clinical data, which sometimes can be quite valuable, especially with the. Uh, the emergence of AI. And additionally, we have some of the top clinical leaders, right? And these are thought leaders that you know are top of their fields. They sit on major societies. They inform a lot of the standard of care. And you know, for a company, it's really valuable to engage and think about the assets that we can bring. And on the flip side, we have a investment vehicle, which, for us, is used more as a strategic tool for us to help the company accelerate that journey and help us and the company bring that solution to the market faster. So I think there is a role for both, and we try to approach that question with which path makes the most sense. But with one caveat is that, from from the investment perspective, we look for that first defined collaborative relationship, because without that collaboration, it becomes very difficult for us to to to deploy capital. Because we are not a VC investor, right? We are a strategic partner for the companies. And if, if funding is basically used as a mechanism to help the companies really accelerate that journey.

Kristi Nakayama  16:08  
What I found really interesting too, is that you know you, I think of maybe you may have clinic ventures as early strategic partners, but I know you have a great case study of when a more mature in market company has come to to your team and have asked, like, how do we now iterate into our next gen and expand our portfolio? So can you share a little bit about

Alex Lin  16:33  
that? Yeah, that's that's a wonderful question. And I know you know Mayo Clinic ventures, we like to be early and engage with partners in the early stage. But really, if you look at the market, we work with companies across the spectrum, right? We even work with large strategics in terms of enhancing their their products and solutions. But the one example that you know, that I have in mind Kristi is there is a company called opti scan there. I'm sure there's maybe a few Australians the room. I know there's a lot of Australians at the conference, but they are a publicly traded company out of Australia, based in Melbourne, and what they have developed over over 20 years of of technology development is this really unique optical probe that can go into the body during surgery to look at tissues and margins and be able to do that classification. So they have a mature product. They are using this in clinic, and are obviously commercial, but they have an idea of engaging with Mayo Clinic to incorporate this into robotic surgery. Obviously, Mayo as a flagship institution, we do a lot of robotic surgeries. We have a lot of surgeons that really enjoy doing it. So there's a lot of innovation going on, and it really worked out really nicely, because it's innovative technology, but a new use case, and it allows Optus scan to really bring their solution to this market that is currently untapped and and the way to do this is, is really you just roll up your sleeves and you map out, what are the accessories you need, what are the data integrations? What are the key things that show up in the console when the the surgeons are doing the procedure, and also what the surge, what would be helpful for the surgeons, right? What do they see, and how they make those determinations? And we have, we brought on one of our key clinic, key clinical leaders, who is an expert in robotic, robotically assisted breast surgery, and and she was able to help the company figure out what they need, and and they just went ahead and build it. They actually rented a space in Rochester so they can actually that the founder can actually fly from Australia to Rochester and engage with our clinicians, and actually have a team on the ground to do a lot of that work. So it's just a really, really cool partnership that just showcase the power of what we can bring. And also a company willing to, even after 20 years of innovation, still wanting to improve and add value to their existing solutions, and trying to do that with a lens of looking at the trends in the market, which I think is just super, super critical. And last but not least, there's also a few kind of, I think, things that just happened that by chance, it really helped the collaboration become even more robust. So the clinical leader actually recently joined Mayo Clinic Florida, so now, essentially, they're engaging with two different health systems now, because you have Mayo Clinic, Rochester and Florida both engage with the collaboration, so it just allows the company to land and expand. I don't think that was by design, but when you work with mayo clinics, things like that tend to happen, because it is a fully integrated system where people move around and there's collaborations going across campuses. So I think. Another value add for startups and companies looking to innovate with Mayo Clinic is that there is that possibility, like with the big strategic where you could start small and then eventually grow the collaboration across geographies as well.

Kristi Nakayama  20:14  
So how does a company reach out to Mayo Clinic ventures to say, hey, here's a problem we think we are trying to solve for, or we're not even sure what the problem is we're trying to solve for. We just know we want to expand our portfolio. How do they, how do they start that conversation?

Alex Lin  20:31  
Yeah, I think, well, if you always reach out to you, I think that's, that's, that's most of the case. You know, our I think we tell companies that Our door is always open, where, you know, you can feel free to reach out to us by any of the channels. You can reach out to us on LinkedIn. You know, we have the inbox, but I think it's also events like this right where everyone is here on site, and there are these opportunities to connect, and we're always open to hearing about ideas, what you're working on, and also, what are your hypothesis? Because I really like hearing about people's ideas and kind of breaking it down to see if we can actually a, add value to to your project. But also B, is there a viable path to commercial value and commercial viability? Because we are hyper focused on that. I think for Mayo Clinic, we view that that that commercial value is a direct impact on patients. And because the patients are so important to the equation, we always, you know, vet the ideas with with that lens. So if you feel like you have something that you know has, can, can, has the potential delivering value, and you feel like you have some ideas, feel free to engage with us, and we are happy to always be your first call. And if there's interest in moving forward, we then just engage directly with our clinical staff and clinical teams and bring them to the conversation. Because I think we always help companies really upfront about their strategy, and then we can figure out the details later, as we build out the project, and then also the pathway to to that journey. Yeah,

Kristi Nakayama  22:11  
well, coming back to technology and how important it is to shift to really meet the needs of your patients and your clinicians, I think that was one of the key shifts that you made from 1.0 to 2.0 but in the meantime, you really had to continue forward as if there might not be a 2.0 scenario, right? So explain to us how, after you realized the partnership wasn't going to happen the first time, what then was your strategy and your plan going forward?

Ramin Mousavi  22:39  
You know, I think you try to focus on the things you can control, and an acknowledgement, you know, after you go to a round that doesn't work is that, well, we can't control that anymore. And actually, the likelihood that you can revive it is probably very low, because if somebody gave up on you once, it's a lot harder to bring them back to zero and then get them excited. So one of the things that we did is that, like what is in our control, let's focus on the things that we can do. And I am a true believer that great companies are bought. They're not sold. So we tried to build a truly successful, independent company. Luckily, at the time this is, you know, we talking about 2021, there was still some public market, you know. And then we went to the drought, you know. And then now we are back, you know, or we're being told that we are back. We We tried to focus on all the options we could control. And ultimately, what we acknowledge was that if you were to bring the technology to the market, we need to find a very sustainable business model. So we did a lot of work on the go to market strategy, which, if I can take a side note, and I have no conflict of interest in this, but you know, in what you guys do and other service providers, do you? We don't need to recreate everything, you know, in our recreating in the real is what sometimes gets the startups in, you know, into trouble. You know, there are a lot of people who their expertise is having exercise the things that failed, and you get to benefit from that. So we were very cognizant on who do we partner on the IP side? Who do we partner with the regulatory pathway? Who do we partner with when we are trying to do contracting so we don't have to reinvent and fail at everything on our own. That goes a long way to accelerate your go to market strategy. So going back to it, that was the focus. And in fact, the RE engagement of strategics was just basically something that you would do routinely. I think conferences like this, it is and building to build up on what you said. Think about it like an annuity, like when you come in. We have been at LSI, you know, every year we haven't raised money since 21 In, and we are every single one of them all the time. And we always get this morning, we got a question of, why here, you know, you're not raising money. I'm like, there's another one coming, you know? And you know, I want to know everybody that they need to know. So when that one comes, and it's actually very fascinating how willing people are to listen to you when you don't have an ask, you know, that's when you get to know each other. So then when you do have an ask, they actually trust you, and they want to interact with you. So I, I'm a big believer in, you know, show up, have the conversations, even if there's no immediate transactions. Don't think about it. Transaction.

Kristi Nakayama  25:34  
Yeah, when I used to sit on the Medtronic BD side of the table and seeing, you know, startups over and over again at different conferences. I think part of the building trust is you say you're going to get this amount of activity done in next six months, we'll see you at the next, you know, TCT, or next conference, and then you get to that conference and you haven't accomplished any of that. So what is your story? What happened? Why haven't you gotten to where you said you were going to go. And I think that is really key. And if time and time again, you're not hitting the milestones you've set for yourself, it's really important to have not a story. But you know, that's part of the trust building is as a leader. This is what I'm I'm set to accomplish with this current funding milestone, and I understand what it's going to take their both time and money, so that when we meet again, I can show you the progress it is.

Ramin Mousavi  26:26  
You know, we we're very lucky. Our CFO is probably one of the best people dealing with investors because of when we were in the public company side. And one of the things that he always reminds me, you know, he spent a lot of time interacting with the public side, the equity research people, and, you know, he always reminds me of the notes they take when you're having casual drinks. And it's not casual conversation, they will remember you the next time. And it's just a human nature to be over excited, you know, telling them you're gonna overcome the world, you know. And then what you say becomes so true, because you're like, Oh, you're gonna be in 500 accounts, you know. And then six months later, somebody suddenly progress, you know, we 12 accounts. And the polite people will not tell you, but in their minds like, well, next time you say something, I'm gonna adjust it down. And if you're close to the anybody in this world being strategic institutions or even analysts, they were like, what happened? So I think the two really good learnings in what you're saying, number one, going back to if you're surrounded by the people who actually check you in, is super helpful. Because, you know, we go through this exercise all the time. I you know, just by nature, I'm a glass half full guy. He's like, why not? We're gonna do something. Having people who died at your back. He's like, but what if we didn't? It's like, okay, you know, we kind of can open up the range, you know, rather than being narrowed. And number two, it's just like any other relationship that you're building. Like people remember what you tell them. It's okay to you know, we all miss things, you know. But knowing that you're telling a story and that, and that is actually what revived the relationship with Medtronic, because when we went back with a 2.0 we really didn't have much ground, you know, after what happened first time. So when Jason and I met, I was the most open book I've ever been. Like, well, here's what we fixed, and I think it's gonna work. But what we're gonna do is that, as we go to the customers, let's listen together, which is a big risk. I had my board members at a time like, oh, you know, what if he said, What if your customers hate it. I can hate it. We don't have a product, so I don't know how to make up for that. Might as well be transparent. But it was so much credibility in when we together, heard, oh, it's amazing you fixed it, because there was no setup. There was no so I had for, you know, your former colleagues, you know, when they wanted to reach out to customers, I would just give them the contact information. And the first thing your strategic does when they call your customer is, who did you talk to at the startup, and what did they tell you? And you know, clinicians being clinicians, allow, you know, Ramin called and said, focus on this and this, whereas when the answer was nothing, I actually I had collisions reaching out to me and like, what do you want me to say? I'm like, tell them whatever you believe. And you know, Dad builds credibility because they heard the worst they could hear is was much better than what I already told them, and that's how you recover and come back and build credibility. At the end of the day, it's all about the trust. I know, you know, I feel like at every LSI panel that we have this trust thing comes back over and over, but it is. It's you can make a deal that's hundreds of millions of dollars if there's not some level of a strong trust,

Kristi Nakayama  29:38  
I think being open to clinician feedback too, and then being flexible to change. And I'm sure Alex with Mayo Clinic ventures too, that's so important, if you if you're working with a company and they're really stuck, they're digging their heels in on what they think is best, but you're here providing the clinician perspective. You. Know, are there? Have there been cases like that where it's been easier or more difficult to partner with people who aren't as open to, you know, the workflow? You're, you're a physician, you're, you're in your your your staff is in the workflow and providing guidance.

Alex Lin  30:15  
That's a great question. I would I would say, I mean, typically we let the company drive the collaboration, because at the end of the day, they're the ones that are accountable for commercialization, positioning the technology in the market, and also being able to close the deals that that are important to the company and that will allow them to deliver the solutions to the market. I think typically, the companies are very receptive to to our clinicians. Because, you know, first of all, there are the world experts, and I think there is that level of respect. When companies do show up, they are generally receptive to to our clinicians and and they want to make use of, you know, their brain power as much as possible. And a second of all, I think that the way we structure about the lot of these relationship is it is a kind of a risk, reward sharing type of arrangement. So, you know, effectively, the companies are incentivized to to really engage and engage meaningfully and be like a like a sponge, where you absorb everything that, that that that gets kind of brought up in a conversation, because that that's how you're able to capture that value, right? The whole, the whole thing about engaging with Mayo Clinic Ventures is value creation, right? That that's, that's, I think that's the overarching goal. And if you can't be receptive to clinical feedback, I think that fundamentally, sort of de tracks from the from the goal. So, so I would say it's incredibly rare for that to happen. Most of the groups that we work with are very receptive and open.

Ramin Mousavi  31:46  
And I mean, I think you This is one of those founder dilemmas that come in. You know that it's not your baby, it's a company, you know, he's just, that's a very harsh thing to say, but you have to acknowledge that, and like you can treat it like it's your baby. You have to be comfortable knowing, and there might be time that there's nothing there. You know, if you believe in it strong enough, you should follow it true. But being able to tell that a story, and I think I am constantly remind the fact that telling that a story to the particular audience that you need to tell the story is very different than how you see it in your head. You know, sometimes you see these, like technical presentations that go into such a depth. It's like, that's fantastic. You lost all the investors in the first you know, three minutes or worse, you tell people about the total reversible market that they live in every day, so off and you're like, three times larger or smaller. It's like, there he goes. Your credibility in the first so again, I go back into relying on the people who do this for a living is actually helpful at times. You know, you don't need to be the expert of everything. Getting somebody who does that in a very credible way helps you because, you know, having experienced interactions with, you know, some of the key clinicians at Mayo, sometimes the feedback comes without much of a filter. But if you really want to improve, that's what you want.

Kristi Nakayama  33:05  
So I think what you did well. And the benefit of working with may have Ventures is we often get clients saying, Okay, our investors just care about that, 510, K clearance. So we just want to focus on regulatory we don't really care about market access yet. And working with physicians. Part of market access isn't just reimbursement, right? It's like, how are you going to get it through the value analysis committees? How are you going to get adoption? So I think that you're adding that very early on the adoption piece, the guidelines piece, you know, how are you going to make sure that once you do get clearance, it's actually going to be adopted? So I just want to say that's a an incredible way of thinking about the mayo venture partnerships, as well as how important and how much you stress that that physician feedback during your your process, it

Ramin Mousavi  33:55  
is, and I think you're so right, you know, I get it now because, you know, I think we've opened the door for all the NGO based, you know, physiology, technology. Every day I'm reminded that, you know, somebody has some probe and they're gonna have it with one view. And I welcome that, you know, I was like, where's your peer reviewed validation, right? Where's your randomized control trial? Where's your reimbursement? Yeah, welcome to the arena. You know, we'll meet you there. You know, when you get there, it is far more than just that 510 k, because the strategic or the investors that only cares about the 510 k, the minute you give them the 510 k, they're like, so what about reimbursement? Right? Immediately, like, and now you're two years behind, yeah, because you again, I go back to talk to somebody who does this for a living, because they will the part of the job is you telling them that, though we will get you the 510, K you should think about the next

Kristi Nakayama  34:41  
thing. And even going back to kind of globalization strategy we're focused on us first, and then we're going to go to EU after. But if you're not understanding the clinical requirements for Europe when you're building your US pivotal plan, there are just maybe some slight nuances you could have covered in your us. Pivotal. That's going to allow you to accelerate to market quicker with MDR and CE mark. So yep, these are all things that are super important. I'm realizing we're at five minutes. This is supposed to be a workshop. Really want to give anyone in the audience an opportunity to ask questions, especially on the lessons learned, what worked, what didn't work, especially women's experience. And then any questions on how to approach Mayor Mayo partnerships, don't be shy.

Audience Question  35:36  
I have a question. 

Kristi Nakayama  35:37  
Great. 

Audience Question  35:39  
uesNo, it's okay. I think I'm loud enough phobia. I just want to learn also like so when you're engaging strategics, sometimes we start the conversation, and then it takes some time to get back due to, you know, you're sorting out the legal NDAs, or whatever it takes time. Especially, I come from a government partnership sort of thing. While developing a product I've not spun out into a company. I have to take care of the legal aspect of it, and then I find it very difficult to go back now, because I should I make an excuse and tell Oh, sorry things got missed. Or should we just be upfront and say, I'm really sorry. This took time to get to you, but it took a lot longer than I initially anticipated. Or, you know, some some suggestions on what would you suggest? How do we continue to engage them while also appeasing our own organizations? Yeah,

Ramin Mousavi  36:27  
you know, I think they live that every day. So while you are self aware of that, oh, it's taking a lot longer than you want. Do you live it every day? And you know, one of the things about larger strategy is that they're not the fastest in the world either. Sometimes they have to. Sometimes they have things that takes forever, you know. So I wouldn't, I wouldn't be shy. I think go through the process, you have to take care of what you got to do, especially if you have any government ties, the legality becomes a priority. Just go back. Don't waste time. I think there's a value given to transparent people. And then the other thing that I say is, there is a value in persistent. There's difference between persistent and testing people actually strategic partners across, you know, the different companies that I know appreciate the person who reaches out proactively. You have a reason for. You know, every time you're somewhere, it's 30 minutes, you know, give an update. If you have no update, give your no update update. You know, if you're stuck where we are, you keep them. Because remember, every day, every day, they get calls from the moment they start the day til the end, with people trying to sell them the ideas. So as much as you may think they remember the last thing you told them, they may not, you know. So my suggestion is that don't be shy about it once you get through the thing. And then the other thing that it does is that it will establish a baseline that, hey, that's a kind of a timeline I'm talking about when I'm dealing with you. So if I never need to accelerate something, I have to account for whatever delay of legality or reviews and stuff that ueesyou have. 

Audience Question  37:59  
Yeah. Thank you so much. 

Kristi Nakayama  38:03  
Yes.

Audience Question 2  38:06  
For Alex, I'm curious, what are your guys screening criterias you guys use as you evaluate different medical technologies? And has that changed? Ramin kind of mentioned the funding environment has gone from, you know, really rough, to kind of improving. How has that changed over time? I mean,

Alex Lin  38:20  
I don't think it has changed very significantly, because I think the way we engage with with companies as as a partner, is we you look at the tech, the technology first, and understand what is the pathway for it to become a commercially viable solution. And if we can kind of see that journey and map that journey, typically, there is potential for us to engage and I think another thing that we look at very initially is also the unmet need. What are you trying to solve? And how are you solving it? What's different from the other solutions on the market? So basically, answering those fundamental questions will allow, if you can answer them, it'll allow us to really accelerate the timeline for us to find a minimal, a meaningful way to engage because if we can answer those questions, then we can think about what is next and where we can add value. Because that's ultimately the ball game for us is finding answer, being answer those few questions to drive to the commercial viability of the solution that you're you're interested in

Ramin Mousavi  39:21  
developing the common theme across very successful, successful, commercially viable technology, for anybody who's working on a new technology, is that unmet need, the benefit of a males or a Stanford body design, is that they do a very good gut check in up front? Is this an unmet need? Other way to know if it's an unmet need or not. It shouldn't take more than 30 seconds for you to describe what you're solving for and get a broad agreement if it takes five minutes for you to explain the clinical issues you're solving for, is not big enough for anybody have thought about it. So I think that's a big, big you know, are you on a right path or, you know, no, you need to fine tune it.

Alex Lin  40:00  
And I think many times, I think especially early stage companies, when they're engaging with VCs, they are focused on the market, sizing the opportunity and all that information. And I think for us, that's a little more granular, right? I think when we're looking at the solution initially, is in initial assessment is truly a high level understanding of the Met need and how your technology is solving those challenges, and if you can kind of have an idea of what that is, that's usually enough for us to continue the conversation, to start digging into the details and mapping out that pathway.

Ramin Mousavi  40:30  
So a million patients, 36 million patients is a lot, still, you know, just go for it. It doesn't matter where you are in the range.

Kristi Nakayama  40:37  
Well, thank you so much for that time. I have 1000 more questions for you, as I'm sure people in the audience do, so please seek out both Rami and Alex and myself if you'd like and we'll be here the rest of the day. 

Ramin Mousavi  40:48  
Thanks, for having, us. 

Kristi Nakayama  40:49  
Thank you so much.