I'm going to turn it over first to Evan, who's going to talk a bit about his journey. And again, feel free to chime in, ask questions along the way, and we'll prompt along the way. I want to introduce before he starts our moderators, Brian Boe, who's the director of the Cat Lab at Joe DiMaggio, and John Breyholt, who is the division chief over at Penn State. So welcome, and Evan, I'll turn it over to you. Thanks a bunch, Arash. As I was telling the guys before I let everybody in, ironically, I am at a startup company today that hopefully we'll all get familiar with in the future, but one of the things these guys are not are computer engineers. They are pretty smart stint engineers. So I've asked to use one of their computers, and this is what they've given me. So you know, you can draw your own conclusions about whether you want to use this new innovative product or not. So instead of looking at me upside down, which means to me, you've got to leave it on, man. You've got to. Really? Well, I don't know if you can tell upside down, but anyway, instead of making y'all do that, Arash, you didn't ask us for a slide, so you can just look at my blank screen. So in my couple of minutes, Arash thought it might be helpful for you to tell you my journey. I'm not sure how applicable it is, because my journey with industry started when probably a lot of you weren't out of college yet in 1995. So things are very, very different, and they're different in a good way. That's the good news. But I did learn a couple of things along the way, so I'll try and be as preachy as possible towards the end and leave you with a couple of things that working with all these kinds of folks has taught me. So my deal went like this. My first real job was down in Miami. I was pretty young, in my early 30s, and there was really only one company that was doing anything with pediatric device trials at that time. Their name was NMTI. They don't exist anymore, and they had taken GymWalk's Boston Children's Clamshell and turned it into the CardioSeal, which was kind of Gen 2, because of all the problems with Gen 1. And they were looking to do a clinical trial, and they had, at the time, all the icons. So that would be GymWalk, Bill Hellenbrand, Chuck Mullins, and John Cheatham, all legends in our field. And to their credit, they were looking to get some of the young guys involved. So just to give you an idea of how long ago this was, the young guys were me, Phil Moore, and Jack Rump, a couple of young guys. We're all like in wheelchairs now. But I had just gotten to Miami literally a month ago and was just dying to get our program on the map. I had no street cred. I hadn't done anything. My only claim to fame was I trained with Lee Benson, who was already super regarded in the field, and actually was also on that trial. So you do what you have to to get on these things. I flew these two guys down to South Beach in the middle of February, picked them up at the airport myself, brought them to the Hoppinus Bar on Ocean Drive, got them wildly drunk, gave them cigars, and got a spot on the trial. That's all actually 100% true. And I will tell you, I can't emphasize the importance of getting on that trial to the program we were trying to build in Miami. We became immediately legit, if you will, because we were one of only six or seven programs in the country to be able to offer this novel, albeit terrible, technology. And that really made a big difference. I think equally importantly is as we were going through that trial, I got approached by W.L. Gore. And my point in telling you this whole story is how these things build on each other. W.L. Gore had an idea. They wanted to expand into the transcatheter space. They had been a surgical company. They got to me through my surgeon and said, hey, we hear you're on this ASD trial. Would you be interested in this? And they showed me a table napkin drawing of what became the helix. And we got involved in those guys. And I had to make the difficult conversation with CardioSeal to say, hey, I think there may be something different on the horizon I'd really participate in. It turns out that became a bit of a theme during my career and my relationship with industry. And I think it's important because as much as I like those guys from CardioSeal, and they gave us this huge break, I didn't work for them. I worked for the field like we all do. I worked for the patients. And given an opportunity to come up with the next perhaps useful tool, I took it. And I think that's something I learned along the way. And we were a tiny site, right? So this Boston Children's, Texas Children's, CHOP, all these wonderful sites with these brilliant operators. And here we are at Little Miami Children's Hospital doing just a couple of cases. And one of the things we determined from the beginning was I was going to put a lot of effort into getting really smart research assistants because they save you. They do all the grunt work. And I was going to beat Boston Children's single-handedly in terms of enrollment because when these companies get involved with you, you need to overperform. And we didn't do that. We, of course, couldn't get more patients in Boston Children's, but we weren't that far off. And my point is, if you're going to get a break with one of these companies, you do not want to blow it. You want to push everybody and yourself as hard as you can to be the top performer in that study. It is competitive. Make no mistake. Now I'm on the other end of this sometimes, and I'm looking at sites. And we look at, you know, we don't care kind of what your name is. We care who performed best in the last trial. And I don't think it matters. I don't think size matters in this particular case. You just need to distinguish yourself as somebody who takes this seriously. It's high on your priority list. This is not the last thing you do on your day. This is something that you really value because, remember, most of these are for-profit companies. And they are betting on you to get their product across the finish line. And there is no better way to form industry relationships than to show them that you are serious and you are a top performer. We then went on and got lucky enough, I think, based a lot on that experience, to get asked by Medtronic to be one of the original three Helix, I'm sorry, Melody sites. Very advantageous, right? Transcatheter valve was, you know, the next great thing. But again, when their competition, Edwards, came knocking at our door after doing Melody and getting involved in Harmony, both of which we think are great products, quite honestly, we didn't think Edwards were doing a very good job with the products they had. And got offered an opportunity and kind of had the same conversation with Medtronic that I had with Edwards, which is, love you guys, but, you know, it's not about our relationship. It's about trying to get more products out there on our congenital shelves and went on to sort of lead the Altera trial, which I think was a really interesting experience. And again, I think the concept here always has to be the more stuff we can get on our shelves for our patients, the better. That also led to some consultantships with some of the Chinese companies. And basically any opportunity that's offered me, I have rarely turned it down if I think it's a legitimate company with legitimate business in mind. Learned a lot by working with Abbott, with the Piccolo device, interesting experience. And all of that sort of culminated in where I am today. I'm at this little company, Renata, who some of you might or might not have heard of, but they've put together a pretty interesting baby stent that may or may not turn out to be something wonderful. But honestly, this company would have never formed itself if they didn't come in. These were a couple of engineers from Edwards that came in contact with a bunch of us, a bunch of congenital people. Dan Levy, Amy Armstrong, Shabana Shahnawaz, a bunch of people came through Edwards, primarily looking at Altera, but talking to these engineers. And these guys just caught the pediatric bug. And the more of that that happens, the more of these bright, young entrepreneurial engineers get interested in our subspecialty, the better. Because they look at the world a completely different place than we do. So I'm going to end there. I'm going to say sort of four things I want to reemphasize. One, if you're interested in doing this kind of work, I think the singularly most important thing is to stay impartial. The only loyalty we have is to our patients, perhaps a little bit to our institutions. But we are not working for these companies. We're working for the patients. Prioritize these relationships. Work for it. Outperform. Be the biggest enroller. It doesn't matter how big your site is. And I think with that, there's so much opportunity now with so many companies looking to invest in congenital. I think it's really wide open and there's just a ton of opportunity out there. I'll close it right there. That was great. That point you just made was exactly my question and something I'd like to hear your comments on. How do you bridge that or walk that fine line between, you know, promoting the advancement of technologies that these companies are working on and not feeling as though you are working for them? You're essentially giving them a lot of your intelligence and expertise. And there are ways to do that and ways not to do that. But how have you found that to be? Have you found a way to balance that to your loyalty to academic medicine and hospital and most importantly, the patients? Yeah, I mean, it's really worthy of it. It's a great question point. And it's worthy of, I think, discussion among a lot of experts on this panel. It's harder than it sounds. I mean, you know, let's be honest, right? These big multi-billion dollar companies in some cases, right? Medtronic, Edwards, Abbott, these are billion dollar global companies. And, you know, they're flying you around and they're buying you meals and, you know, they make you feel good. And, you know, you're an expert and we all, you know, that feels good after all the time we put in med school residency fellowship. I think it's hard to keep that. And we form relationships, personal relationships, you know, and people go on vacation with folks from these companies. And I actually don't think there's anything wrong with any of that. I think where I get a little miffed and I get a little soapboxy and is, you know, I don't think we have the obligation or right to be up on a podium. And we're all guilty of this, myself included, of touting one device versus another. That's just not our role. That's up to their marketers. That's up to what the data says. And it's interesting, if you've been in the field long enough, you'll see people who were 100% in this one type of device camp right until they had some fracture business relationship with the business. Now they hate that device and now they're in the other devices camp. And I just, it just shouldn't work that way. The companies, everyone that I've mentioned that I've worked with, and they've been some really good ones, they all understand that if you tell them, you know, I need to be imparted, they get it. I think we kind of just fall into our own desire for what we're working on to be successful. And I think it's something we really have to monitor ourselves with and our colleagues. I think it's fair game to call people out on it, say, hey, man, you know, let's just call them as we see them. But it is, I think it's hard to do. One thing I didn't mention is COI, conflict of interest. I work at a very legally conscious institution. And I will say, you know, being 100% transparent with anything you do with any of these companies with your organization is really important. Guys can get in big trouble. It's not worth it. And, you know, most institutions will understand the need for these relationships, but you really have to reveal everything. I think that's critical. I don't know the response on that. Yep. Yeah, I mean, I would pile, I would, unfortunately, I agree with Evan, with everything that he's saying. It hurts me to say so. A couple things about working with industry. And, you know, how do I keep it in the separation of my own mind? I work on things that I believe are actually the right things to be working on. So that's number one. I overdisclose everything. So to my institution and to my patients, up to and including putting it into consent forms, like these are the companies that I do business with and why I do business with them. Depending on even the patients, I'll tell them why I think there's technical advantages of one versus the other. And so I overdisclose because I think that that's a good way to sort of insulate yourself from all that. And, you know, there are boundaries and Evan knows them and there is a line that you walk with industry and they need to know you'll walk away if you feel like their technology is not, you know, doing what you think it should. And, you know, I think if you're honest and direct with these companies, if you do get involved with them, that actually leads to staying power because they know that what you're telling them is what you believe, not you're just not being shined on for, you know, for a meal or something like that. The other thing I would say that I would echo with Evan is if you want to work with industry on trials and things like that, it takes a tremendous amount of energy, like the trials that I've been involved with through the years. I mean, depending on how deeply you're involved with them, it can be a full-time job on top of your full-time job on top of everything else. And it's serious. And especially in congenital heart disease, because at the end of the day, and Evan knows this and Henry knows this very well, there has to be a return on investment for anything that you're working on to be sustainable in the commercial market. And if you have a company that's willing to invest in a market that is small relative to other markets, like congenital heart disease is, we have to support them. Because if you don't, we will not have technology. We just won't have it. I mean, we're living through it right now. People are just deciding not to make XYZ catheter or because the market isn't big enough. It's not worth it. So we have to work with them and, you know, we have to also keep them honest. And I think that's the way you do it. You just have your boundaries, you work for companies you like, with technologies you believe in, and you over disclose to everyone, your institution and your patients. I think that's the best way to do it. And the industry, I'll say one more thing, the industry folks that I work with regularly at Gore and Medtronic and Abbott, they will tell you if you get them aside that, you know, Evan and I and others can be sort of brutally honest and direct with them. And sometimes they don't like what they hear. So I think that that's, you know, that's a big part of sort of having a sustainable relationship. We have to do this with industry. Otherwise, we will not have the technologies that we need for our patients. Henry? Yeah, I agree with what you've said, Matt and Evan as well. I think it's a symbiosis, right? It's not industry. Sometimes academic institutions have almost a way of seeing the industry relationships as being like this negative or evil sort of influence, you know, academic institutions don't make medical devices, academic institutions, you know, train people, we run hospitals, we administer care. But, you know, the technology that we rely on comes from industry. And so if we want the technology to be available to our patients, we need to help that technology develop in the correct way. So that means we have to provide input into these companies and provide some of our time and effort to developing these devices. So I totally agree. I think if we disclose appropriately what we're doing, I think what we're doing is the right thing by working with industry in a transparent fashion to bring devices that serve our patients' needs.

medical industry

developing medical devices

clinical trial

collaboration

transparency