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Accelerating Cardiac Care Innovation: How Can Major Device Companies Collaborate with the Startup Ecosystem? | LSI USA ‘24

Listen to this discussion panel of 5 as they open up a discourse about the startup ecosystem, specifically in cardiovascular health, as well as the vitality of partnerships and how they can provide patients with efficient care.
Speakers
Ken Nelson
Ken Nelson
MedTech Advantage Fund
Lisa Suennen
Lisa Suennen
American Heart Association Ventures
Chris Eso
Chris Eso
Medtronic
David Hochman
David Hochman
Orchestra BioMed
Nathan Harrington
Nathan Harrington
Philips Ventures

Ken Nelson  0:00  
I'd love to first thank Scott and Henry for putting this the event together. But also this panel just to have this group of four people on stage and the opportunity to meet with them over the next few days is really incredible that they do this. Really excited to this panel will be talking about a lot of different aspects of the startup ecosystem on the cardiac front. And maybe we'll start with some some brief intros, starting with David. Sure.

David Hochman  0:30  
I'm David    Hochman. I'm the Chairman and CEO of Orchestra BioMed. Our whole businesses of round forming partnerships, long term partnerships that can help accelerate innovations to patients, by aligning us with strategics. We have a partnership with Medtronic, for example. And it's really about bringing, forming a way where strategics can get involved with products during development while we're doing the work and we're protecting their p&l. And we know that at the end of the day, if we deliver a provable product with strong data, we have a partner that's much better position than we are to commercialize that technology and in allowing us in that partnership to truly integrate our our thinking our strengths, and work collaboratively. And it's gone pretty well in terms of what we're doing with Ben Tronic. And, and true mode and other partnerships.

Lisa Suennen  1:21  
Hi, I'm Chrissy, so I'm the better looking and younger Chris from leading corporate development. Now, so I'm actually new in this role took over for Chris Cleary just about three weeks ago. But I lead cardiovascular business development and m&a for the last, I guess, 13 years with Medtronic now. So all on the cardiovascular side. Hi,

everybody. I'm Lisa Suennen. I lead the American Heart Association ventures, which is a multi platform, venture capital firm that does invest in med tech, as well as digital, as well as in social drivers of health. And among other things. We're working on the platform.

Nate Harrington  2:05  
Hi, I'm Nate Harrington. I'm with Philips Ventures. And I've been with Philips for about 13 years and prior to that was nine years of Boston Scientific and both operating BD roles and over to the side of venture and very much enjoy working with my portfolio company so hopes, hope some of the pearls come out of it from this group.

Ken Nelson  2:30  
Hey, I'm Ken Nelson, started first half of my med tech career with guidance on the cardiac or the management side, and then Boston Scientific post acquisition. And then the back half of my career, building the commercial teams for what are become three of the four biggest players in cardiac digital health and remote patient monitoring. The first was Ira them. The second was biotelemetry, which got acquired by Philips. And the last one was Bharti diagnostics, which was acquired by Hill rom slash Baxter. More recently started a venture fund with Paul Graham med tech advantage fund, med tech advantage fund will be investing exclusively in med tech innovator companies, alumni companies that go through the program. We'll talk about all of that as we go through the discussion today. And then I'm on the boards of a handful of cardiac startups, including cardiac care who's here if anyone's interested in that company came over from from Israel, happy tech, who's also here from Amsterdam, smart cardiac or Switzerland heart beam out of San Jose, and a Carex out of Sweden. So yeah, excited to have this discussion. And maybe we'll start off with someone who's been a pioneer in collaborating with within this ecosystem and love to for Lisa to maybe tell the story. I didn't know this until recently. But Lisa started carnation capital and carnation capital is a combination of of HA Phillips UPMC. And I think our CT ventures now but we'd love for you to maybe talk about how that happened. And she's now blazing the trail to where some of the other cardiac institutions are. We'll be following in her footsteps and starting to invest in companies but we'd love love to hear the story.

Nate Harrington  4:30  
So the story is that I was on a board with Nancy Brown, who's the CEO of the American Heart Association, longtime CEO. If you know, my guess is most people don't realize the level of activity that goes on at the Heart Association has $1.2 billion dollars a year of income that's split between philanthropy grants and $400 million of revenue from commercial enterprises have they operate so it's a pretty big organization, broader than cardiovascular stroke? Brain Health, a lot of other things related. So Nancy and I met each other aboard. I had just left my venture fund while during that time that I was at silos group for many years and said, Why don't you guys do adventure? You find all the science and research but you don't get the financial benefit of all the things that come from it later. She said, That's a good point. Why don't we look at that? Why don't I hire you to be a consultant and help us think through that. And I use that, that was my first consulting project after my my gig at silos. And I helped them start creation. And we decided that the best way to do that was to be in partnership with others that had interest, shared interest in the space. So we approached Phillips, and UPMC first, and went in together on doing this. So we created a standalone entity called carnation capital, it's actually managed by a Philly on Capitol. I don't know if Jake's here from that organization or not. But he was earlier that rip is run by Ned sheets. Some of you may know him longtime venture guy. And each party chipped in money and jointly owns it. And it went, you know, and started investing. And now it's in fun, too. And UPMC is no longer in the mix on fun too. But RCT ventures joined up. So I ended up back at Heart Association after speaking to Nancy sort of randomly last year, and she said, you know, this creation thing worked out really well. We started a social venture fund as well, while you were elsewhere. And now we want to do more. And would you want to come back? And let's see that through. So there I am. Great. So you know,

Ken Nelson  6:33  
when you think about the the the continuum of a startup and you think about incubators, so So there's regional incubators, there's national incubators, it's the companies get a little bit more developed. There are, again, regional, academic, national, and global accelerators, they vary very differently. And we can talk about them in a minute. And maybe I'll talk about the Texas environment just to give an example of that. But then, as you as you continue to go along, a lot of these companies will do multiple accelerators, I did several and highly recommend a few of them, including MedTech Innovator, which is the biggest, globally. But we'd love to know how, where Orchestra BioMed kind of fits into that ecosystem, and how the the collaboration between you all and Medtronic came about maybe Chris can talk about it as well.

David Hochman  7:27  
Sure, well, actually, you know, we grew out of our own accelerator, I ran an accelerator called ATI, and we had a venture fund associated with it. And, you know, the ideation was really physician driven, you know, identify unmet needs, create or identify solutions. The challenge we found, and I think being at this meeting, and they haven't just led a session with fascinating array of companies is not necessarily a shortage of good ideas. It's the gap between those ideas when they begin to show real proof and promise, and how they're actually going to be brought to market and the kind of significant capital, the change in skill sets and expertise that needs to happen. Because for medical device, medical technology therapies, generally, we're asking these innovators to become commercialized. And so our business was born out of kind of frustration, maybe desperation of having created some powerful good ideas. The one we're partnered with Medtronic is we call it backbeat, we've now gotten referring to it as atrioventricular, interval modulation therapy or ABIM. It's a powerful treatment for reducing blood pressure, huge problem targeting high need patients has delivered through a pacemaker. So we had gotten it through the stages of showing great clinical data. But now we were confronted with if we had to go down the normal path, do we need to build a new pacemaker business? You know, we're going to try and compete with Medtronic or Boston Scientific. And we always felt that, you know, well, why are they buying us based on our early clinical results? And eventually, there was some discussions with Christmas, you know, there's a couple of Chris's in the rooms and their chats here. We realized the issue that was preventing Medtronic from acting was constraints that they and their peer group have on r&d spent, hey, we want to do that. But you know, we have to live within, you know, the 8% span that we have in r&d, that's a 7% average spin for the industry. And so we were inspired by what happens in biopharma where there's prolific partnerships and without partnerships, and the most famous is bio and tech and Pfizer now, but there's so many partnerships that help bring drugs to the market and said, Hey, how do we rethink our business so that we can be a long term participant in the value creation and also execute and financially enable that program with all of the expertise Medtronic and bring to the table. So we figure that out, it took us a while. But it's working really well. Now we are pooling our knowledge or expertise. We're running a pivotal trial on Medtronic commercial device with our technology. We're paying for it. But motronic is a stakeholder in that. And ultimately Medtronic has the rights to commercialize and we couldn't think of a better partner for a pacemaker based therapy. So we're able to think big, and work hand in hand without necessarily triggering r&d challenges, which maybe Chris can talk about how that worked for you guys. Well,

Lisa Suennen  10:32  
yeah. And what it did is it solved our problem, right, our problem was the constraint, right. And so collaborating and working together, we actually are connecting the dots across the ecosystem, so that we can do what we do good at what we do really well at which is bringing it therapy to market and establishing it to standard of care and bring it to the mass patients that we possibly can. What we obviously would love to do is bring more technology into our p&l and into the into our organic or inorganic investment. But we have constraints that we have to live within. And so these types of partnerships and collaborations are what actually enable us to bring more technology to the market than what we would typically do. Another example right is back in us working with a with an incubator, back in 2015, after we bought 12, for mitral replacement, we looked at the landscape across for for mitral repair, didn't see any kind of technology that we felt really comfortable in actually going in and either investing or acquiring at that stage. So we said, well, we have IP, what can we do with it, we actually partnered with the foundry formed a company's gave license to our IP. And that is the creation of halfmoon that we are a major investor in and they've now you know, treated close to 20 patients in their early feasibility. And so it's those types of creative thought processes. And, quite frankly, the constraints that actually stem and develop innovation from a partnership collab collaboration standpoint,

Ken Nelson  12:16  
great, thanks for sharing that. So when you think about how things have evolved, especially over maybe the last 10 years, and you see a lot more support of the device, companies have incubators, accelerators, programs like this, that have really gotten very strong, you see the attendance from investors, I mean, all four of you are here, which is great. And you're giving access to yourselves to all these startups, which is also a really nice thing that you're doing to kind of give back to the ecosystem. What do you see? Or what are some of the other things that that you support? So for the startups, I talk to anyone who's in the room that I've talked to about this, I always recommend trying to get into med tech innovator. It's, you know, from a networking standpoint, it's the biggest and I think, the highest quality accelerator, and then when you're going to raise money, I said, You've got to gotta be a part of LSI. And they'll tell you that I'm pretty consistent with that. There's a couple other things I recommend, but we'd love to hear other things that you would recommend the companies do other incubators, accelerators, or other things that can help these companies set themselves up better for success. Maybe you start with with Nate. Sure,

Nathan Harrington  13:31  
and I'll focus probably a little bit more on the basic blocking and tackling. I think one thing that you can do is introduce yourself to strategics early. Even if you're perhaps not looking for money from a strategic at a given point, I think the important thing is to realize is that it's important to have a conversation. And if you think about the spectrum of business development, which may ultimately end in an exit, you want to think about the beginning or how to work backwards towards it. And I think you want to take advantages of of engaging with strategics, perhaps looking for money, perhaps looking for more of a partnership. One thing that I think has been helpful for Philips not so much in that part of the business where where I work, but if you think about installed base imaging, and things of that nature, there's a lot of data being generated. And I think one of the great things is saying that startups who are able to think about how to use that data, of course, the buzzword AI comes to mind. But I think that's a good example of where partnerships can make sense. And then I think being open to having a strategic as an investor and on your board. It's a great chance to get insight from the inside of How a strategic is thinking about it what you need to do to set yourself up for success. If you have particular problems, and you want a sounding board, whether it's in regulatory clinical r&d. I know most of my colleagues at places like Medtronic, definitely Boston are very open to working with startups and trying to give them the best best advice possible. Ultimately, we want to see all these types of companies flourish and succeed. And frankly, get to the point where any of us might find them attractive to bring on inside. And it's a way of helping us de risk some things because if you're on the inside, and you have to deal with a quality system of a Philips or Medtronic, it can be a little bit daunting. So it's, it's nice to be able to work outside that system. Perhaps not the most exciting answer, but I think some of that helps. Well,

Ken Nelson  16:02  
I'd love to hear from the rest of the group, what your insights are there, how you're collaborating with the different parts of the startup ecosystem. And maybe we can start with Lisa and I don't know if you want to talk about the the heart and brain accelerator or however you want to talk about and we're,

Nate Harrington  16:18  
you know, we got a cut, we do a couple different things. And it's, it's still evolving. But we've made a partnership with MTI to focus on supporting young cardiology and related companies to come through, you know, our whole mission is to advance the field of treating patients. And so for us, anything that translates science, and research into real medicine and real delivery of care is a good thing. So what our we can foster that as a plus. So that's one of the things we do. And we also have an accelerator focused on health equity. In our mix, we have a program that allows young companies to license and utilize our care guidelines and integrate those into their products that my colleague, Patrick Waite runs, we have programs and projects that we like we like to collaborate, and we get approached to do all sorts of wild and crazy stuff. And so to the extent that companies are interested in working with us, we're always interested in hearing about it. But I would say that the thing I do most, you know, myself, not necessarily as part of the heartbeat Association has help young companies really understand. And this is, I think, a particularly big problem in med tech, how they, the folks who are innovators are often they're not often very savvy about the healthcare system itself. They don't learn about how Medicaid works, they don't want to know how Medicare works, how payers work, what they care about. They just live in sort of more of their technology world. And some of that technology is amazing, but never has the ability to really come to market because they don't fully understand the payment dynamics, the alignment of financial incentives, and all the things that go around that. Let's just forget about all the FDA and regulatory issues. That's a whole different bucket. And this is not what I'm not talking about reimbursement codes, I'm talking about the reality of how money flows through the through our medical system that ultimately pays you for your products. And so I spent a lot of time educating and training on that stuff. Helping other organizations do that. And I think it's so important and thinking about Lean Startup methodologies and go talk to your customers. I don't know how many companies I see, you know, that's I say, how many customers have you talked to and they go? Done? Or, well, we have a guy, you know, that type of thing. And it's like, yeah, we all have a guy who need to talk to, you know, lots of customers about what they will buy and why. And so I think, you know, getting involved and understanding the whole lean startup approach and not raising money to really need to really have clarity on what you're trying to do to the extent you possibly can get it is really important. But understanding the healthcare system and figuring out how to learn about it, if you don't know is critical.

Lisa Suennen  18:59  
Yeah, I mean, so if I think about, you know, where we collaborate and partner, right. It's across the whole ecosystem within there's, there's no rhyme or reason, and no specific area that we target that we focus on. It's all about making sure that we're bringing the value we bring, and capitalizing on the value that our partner brings. And to me that, you know, that's a it's a very pharma perspective, because they've done this really well for a lot very long period of time. But I mean, if you look at a 10 years ago, structured deals weren't that common. Right, there wasn't strategics making tranche investments with a call option on the back end. Now. They're all over the place, right? And so it's trying to solve a problem with a solution that maybe can work for everybody to create a a win win win situation. What I love to always be buying things, you know, early and, you know, be able to take it exactly the way I would want it. Sure, yes. But that's not how life works, right? I think if everybody asked themselves, what is a typical standard, you know, venture backed funding model, there is not there, every situation is different. Every market is different, every competitor or strategic environment is all different. And it's adapting and being nimble, but also being open to that, right. I mean, to me, that's the feedback that I always give is like, don't go in with a bias. Let's talk through it and see if we can get to a solution that might work for you and might work for me, if it doesn't work for one of us, that's fine, we at least talk through it, and we've removed that off the table, and then we can go to different structures or opportunities to talk through. So

David Hochman  21:03  
I'm gonna go back to Lisa's gonna come. And I think the most important thing is to understand the economics around your product. You know, what we've done that badly, it's been painful, and where we, you know, thought it through and where we had, you know, alignment, it becomes clear, it's the most important piece, and it's not always the answer you want, you know, the best innovation, the most exciting innovation may have a very difficult path to, you know, either get paid or reimbursed, or actually to incentivize the physician to use it. So I think that's critically important. And building on the comments I made earlier, if you want to build a company to get bought, you need to understand what the buyer is looking for. And in those conversations, I think going back to Nate's comments, I think he needs to talk to the strategics of interest early, often. And remember, you're in that meeting to learn as much as and maybe even more importantly, than you are to pitch and make sure you come out of the meeting with more information than maybe you deposit it. Because that's the only way you're going to be able to align eventually to that acquisition or that you know, structure do I think that that points really well made, the amount of structure we're seeing in med tech, and the amount we're going to need to see to make deals happen, is just going to continue to proliferate?

Lisa Suennen  22:27  
Well, and every interaction that you have with a strategic right is to your point at deposit of investment, right? It's building the relationship with that strategic with that, hopefully champion within the strategic so that they become your champion inside and can actually do the work for you. Right, that's what you ultimately want. And so building that relationship, fostering that, and building it on trust is the most important piece of this whole equation.

Ken Nelson  22:58  
So when you think about the collaborations that are happening, and happening right now, and you think about how things have evolved, what do you all think is working? Well, what's not working so well? And what can we be doing better as a collective group to accelerate innovation even further?

David Hochman  23:18  
There's so little, you know, to speak about to be honest, but there's so much opportunity. So we're seeing examples, but, you know, the kind of collaborations we have in med tech are dwarfed by, you know, decades of if you think about biopharma, they are partnerships on top of partnerships, they are so advanced in taking slices of revenue streams, or potential revenue streams and turning that into a financial instrument. So I think there's a huge opportunity. And we're seeing it not just at this level of developing new technology, but I think we're seeing collaborations happen with health systems, and major device companies with imaging companies with device companies and health systems. So I think we're in a transformational moment. And it's going to continue to build but it's still very early days, I would say,

Nate Harrington  24:08  
I think the collaborations with between the little companies and the big companies not to random, everybody's parade, they're really tough. They don't work so well, a lot of the time. You know, the big companies expect things to be done a certain way the little companies can't afford to do them that way. And sometimes the better thing to do is to wait to get a little further along. You know, I've seen so many collaborations with health systems in particular, where the pilot never lands, you know, they fly or fly off into nowhere. And it's because they have other things to worry about, you know, they're worried about whatever is going on at that health system or whatever is going on at that big med tech company that quarter that needs to be attended to, while the little company is desperately trying to get us first real paying client. And so I think sometimes the best answer is to wait on the collaboration and Try to get smaller partners customers are not the go after the biggest, you know, 100 pound gorillas on your day one, because you probably can't work with them very well yet. They don't know how to work with you culturally, and you don't know how to work with them culturally, it could kill you in the process. So I don't know, I worry about that sometimes how early some of these deals get struck.

Ken Nelson  25:24  
So the other thing you're starting to see is you're starting to see the big end industry societies like American Heart Association, like ACC like heart rhythm society, doing more, they're doing pitch competitions, you hrs now has HR x, which is the digital health summit. They're getting better about pitches. But what I'm trying to get them to do now is to collaborate like like Aj is doing with med tech, but not if there's nowhere to catch it right. And so it's getting the right people at these events at hrs and Ha, and getting investors interested in a reason to go. So you're starting to see that evolve, though. But I'd love to hear from the group. What do you think is the best way to do that? And what, what kind of structure would you want to see it say in an hrs or ha pitch event that would make you want to go and actually spend time listening to the pitches

David Hochman  26:23  
to give credit, where you at and depend on Israel, the meeting that I would point to that I think did the best job of this is ici. And ici was doing a shark tank type competition before CRF Did Shark tanks and everyone's doing Shark Tank. So years ago, they created a meeting where there's great clinical content. But it really also integrated that with early ideas and startups. And it's part of the Israeli culture. And it drew all of us from the US and all over the world to that meeting. So that one, we could spend time with each other, but also, you know, be surrounded by innovation. I think that models grown into all these other meetings. And the meetings become so much more interesting, where it's not just about the new big trial data, but it's about the new ideas, and there's platforms for those ideas. And the discussion is not just about physicians perspective, but big companies, perspectives, small companies perspective, so a lot of credit to the Israelis again on that for

Lisa Suennen  27:20  
and if you recall early on, right, there was a workshop, the first day of ici, I don't know if people remember that 1215 years ago, but basically, they would put a bunch of different medical device, you know, tools and other catheters and other things on the table. And they would pair strategics, with startup with, you know, entrepreneurs with government, and say, You guys have the day to come up with a new medical device, just using the stuff on the table. Right. And so they created that environment where there was collaboration, then it went into the Shark Tank as as the follow on. And so they have innovated how they think about innovation. And, you know, I thought, you know, at the at the panel earlier today, there were 7200 startups in Israel, right? Nobody thinks about how many are they actually there, everybody thinks about, well, the US Minnesota, you know, Boston, the bay area here, right? But Israel is probably one of the largest in terms of that innovation, and that collaboration across the various stakeholders. So

Ken Nelson  28:33  
I'd love to hear a little bit more about the Shark Tank idea. One of the things I heard that UT Southwestern is doing with I think it's the Blackstone Launchpad is they're calling it dolphin tank, because Shark Tank, you know, they start to we run out of time

losing power, but it's a more friendly environment. So instead of attacking the founder, like you should do this, and you should do that. And that was a terrible pitch. It's a little bit friendlier. It's, it's, you know, you can tell them positive and negative feedback. But we tried that at HR x this year, and we had a panel of couple investors, you're

Nate Harrington  29:18  
able to find a nice VCs to do that.

Ken Nelson  29:23  
The physicians were not nice, but the VCs were actually pretty nice. But I think we should do more of that. And I think having a group of people like after a pitch, we should have a set like an assessment, real time feedback, and maybe have somebody from the FDA, somebody from CMS, an investor to a strategic or to to give them good feedback, because a lot of times what you'll see is they'll design a study protocol that might get them FDA clearance but will never get them payer coverage. And they could have solved that problem and save millions of dollars in If they sat and got that feedback, and yeah,

Nate Harrington  30:01  
the best amount I was ever part of like this was one where the prize was you got time with payers and providers to ask them questions. And so we had signed up a bunch of provider organizations, the right people, the purchasing people, we had signed up a bunch of payer people, the right people who make decisions about what to cover. And instead of giving prize money, or whatever we gave time, and the commitment to counsel and mentor them for a period of time, and it was really effective in helping those companies, I think that type of mentoring model is really good, more than just sort of a one day competition, you know, and everybody goes home with a trophy or whatever. But the longer term mentoring matching, I think, is, is a highly effective approach that helps companies for real. And

Ken Nelson  30:49  
I think if you get payers and you get CMS, and you get FDA, they're some of the best feedback we got from this last HR x was, I can't believe you had an FDA lounge, and then you talk to the people from the FDA, and they loved it, it's so cool to see all this emerging innovation. But before we did that, a lot of the startups were afraid to even talk to the FDA, they there is a perception that if they talk to the FDA too early, it's going to delay their process. Or they may say something wrong, maybe that's true in some cases. But for the most part, the FDA is going to give you great advice, and it's free. And it's not going to cost you $1,000 an hour from a consultant and it's the right advice in many cases. But I think we should do more of that it'd be great to get the FDA and CMS here, and have some sessions with them. But we'd love to hear any other ideas that you all think we should do at conferences like this, or

Lisa Suennen  31:47  
well, I'll give you another example. Andrew cleeland at Fogarty Institute or innovation, brought, you know, the deputy FDA director and had a two week session with them under, you know, educating them on innovation. And so invited, you know, VCs and strategics. And so I spent about two and a half, three hours explaining how we view innovation, and the collaboration that is needed and required. So it's not only just to the startup community, right, it is to how the whole ecosystem works together and, and educating everybody along the whole chain.

Ken Nelson  32:31  
And so some of the things are starting to see come to fruition, they now the FDA now has this TAP program, the total product lifecycle Advisory Program, which is in a way a concierge service, if you can get breakthrough status, and then get into the program. It's an amazing program to get into and just looking in the crowd. I know Philip just got in without cry. So congratulations on that. And then happy tech and some, some of the others accuride They've are accurate cardio, they've they're trying to get breakthrough status to get into the program, any of the the startups in the room that have not heard about the program, I highly recommend that you look at it and try to get into that program. It's amazing. But we need more of that. And I think that's, uh, that will, if it works, and it seems to be working well, they'll expand it. But I would love to hear maybe Nate's perspective on as you see things evolving. You know, are there certain things that Philips is wanting to get involved with? Or how are you collaborating with the industry? I know you have creation capital, but are there other things that you're able to share that you guys are doing?

Nathan Harrington  33:45  
I mean, one of one of the things that we do, and which is more of the clinical partnership. So I think a lot of med tech companies do this, too, is reaching out with their customers, and creating collaborations and clinical studies. To expand and bring out more knowledge there. And then I think that's the opportunity to bring it back to startups. I think the most important thing is just to have healthy candid conversations, and understand where each side is coming from and what problems you're trying to solve. I often say well, it's it's, it's great to be creative. One person's creativity is another person's complexity. So trying to keep things simple. And I think one way to do that is to demystify, where various stakeholders are coming from. And once you find sort of the common ground, whether it's working with the payers working with regulatory understanding where our strategic might be coming from, and also an investor, I think that's where you try to get the win win. And I think having those candid conversations Jim says, is very helpful.

Nate Harrington  35:03  
Can I just that's the only thing I think that's really helpful from, you know, either VCs or large strategic groups is, you know, we often say to young companies, you should do this, you know, you should have an FDA strategy or reimbursement strategy like this, bla bla bla bla, and then they leave, and they're like, Shit, I don't know how to do that. So we should have an, you know, as much as possible, a list of vendors that are. And I don't mean the ones that cost a million dollars for a project, small people, great consultants, who really know how to work with these companies and help them and we should give them that list. You know, we should say you need a regulatory strategy that looks like this, here's a person who can help you, you know, when to keep a curated list that you can offer to people, when you tell them you're good advice that you can't personally help them with. Because I think, then it's practical. So

Ken Nelson  35:51  
to your point, as a startup that went through med tech innovator, one of the biggest benefits I got from that was the network of consultants on the reimbursement side. And just in general, to ask those questions that we just didn't know what to do or how to do it, you got a network of people going through the program you could talk to, I know, we've only got two minutes left, I'd love to hear any, any closing comments people out, and then maybe open it up for a question or two, probably break on this

David Hochman  36:20  
topic of where we need to it's sort of enable more efficiency and collaboration, clinical evidence generation, it's hard, it's expensive, and it's not getting easier, it's getting more expensive and more difficult. Hospitals are being forced to focus on efficiency. And, you know, running trials is is a is a, you know, a bottleneck issue. And so if you think about what we all want, we want products that are impactful, we want evidence that shows that impact that drives the economics and drives the utilization drives regulatory approvals ultimately drives the business. And we should all be concerned about, you know, how do we make that more efficient for all of us, whether it's trials have been tronics, running, or Philips running or a small company. So it's definitely something we haven't talked about. But I think it's definitely key to our business and trying to be good at it and figure out how to work within a system that is constrained to somebody we should certainly put more energy into.

Lisa Suennen  37:17  
I think one area that we haven't talked about that I see going forward, that's going to have a lot of kind of collaboration and partnership is data and AI, and imaging for that matter, right? All of the guided procedure technology. If you think about what the world looks like, in 1015 20 years from now, from a medical device, it's going to be all connected, it's going to be all data generating, it's going to be how do you use that data and to get better outcomes longer term? And, you know, that's not what the historical medtech world has been. Right? And so we have to partner and collaborate on that front that people had had been living this for 20 3040 years, and understand all the trials and tribulations of what needs to happen. And then how do you actually apply it to medical devices?

Ken Nelson  38:16  
And I think right along with that, we've got to another reason we need CMS in the room and commercial payers is they're not, they're not reimbursing it appropriately today. And you look at the RPM codes or remote physiologic parameter codes as an example. It should not be one reimbursement rate for everything, you know, it should be different if you're managing heart failure versus sleep apnea versus other chronic conditions. And so I think you're right, you will see a massive shift, you see all this data in influx into the clinics, and I'm sure you have the same discussions I do. These clinics are overwhelmed, they can't handle more data. So us as a collective group, we've got to figure out a better way to get actionable data and only actionable data to the right physician on the patient's care team. You can't send all the data from a defibrillator to the EP because they don't want all this additional data. A perfect example of this is when they put a temperature sensor in the biome Hunter Biotronik, we thought in the middle of COVID, it would be really useful but nobody wanted the data or the the piece of great data, send it to the primary care physician, but we didn't have a mechanism to do it. So you're right, we've got to solve the data problem. But there's got to be quick reimbursement around it or people just won't spend time

Nate Harrington  39:36  
nobody's gonna reimburse it if it doesn't prove it does something material. And that's the real issue. And I think, you know, the giant med tech companies have had pretty mixed success in the digital front. And it's really not a field that lends itself to traditional sales models, business models or anything else. You know, it's traditional about medtech. And so one of the things that we can do to help all the innovation, all the innovative companies working on this, is make sure that the Big Men tech companies hire people that understand these things and really help them build those businesses differently. Because it's not a traditional business model and it can't be.

Ken Nelson  40:08  
So it looks like we're out of time. But I'd love maybe we do that panel next year or in Portugal. We'll do we'll tackle the the AI data issue what we could be doing, but appreciate this was awesome. Thanks for doing this. Ken. Thanks. Thank you.

 

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