Going back to the beginning of your journeys, with your great ideas, who is your first friend? Who is your first person that you kind of confided in? You know, my point is, is that I don't think you guys are making these things in your garage. So you're going to definitely need to kind of start working with some engineers. But then, do you need to contact a lawyer first and to make sure that you're protecting that idea and making sure that you're able to navigate that? Is there someone else that I don't know that you should really start to, you know, talk with, you know, when you're really taking those first couple of steps? Yeah, so the first thing that you have to do is you have to know, you have to understand the environment in which you're working, and you got to understand who owns you, right? Because if you signed a contract with a health system or with an academic center, or probably even with like non-academic hospitals, probably somewhere in the small print of your contract, it sort of lays out that if you invent something, we own X percent and you own X percent and we'll share this in some way. There are hospitals that do not have that, where your ideas are yours and you don't have to share it with them. But I think that they're the exception rather than the rule. So that's the first thing you have to do to think about. What is it that you actually own if you're signed on with Joe DiMaggio down there? Because you might only own 30 percent of your idea from the jump, and that's okay. I mean, that's what you signed up for. The second thing to consider is what is it that you're trying to invent? In Henry's case, this is a very complicated class three device that's going to require human data and all of this stuff. So that's a much more complicated engineering feat. But if you have simpler ideas, that conversation can be simpler. The engineering and the prototyping can be simpler, and you can find people. It's really easy, and we're going to run out of time here shortly, but there are companies that actually what they do is help build early prototypes. Depending on your institution, there may be some internal grants that you can get, like a $50,000 cardiac center grant or $100,000 that you can spend on prototypes. Building out your ideas to see if it works on the benchtop, right? So there's ways that you can do that. But the first step is to understand what are your obligations to the institution that's paying your check every month. I mean, you have to do your research. I would throw into there, Matt, in your very early friend group is a patent search. Patent attorneys are a dime a dozen, if you will, and you'd be amazed how many things are already spoken for and have never seen the light of day out there, and that could just make things pretty confusing, and it's just a good thing to be aware of early on. Yeah, but I'll tell you what, though. Patent search sounds simple, but it actually isn't, and this is where the tech transfer office at your institution can actually be very useful. I could complain for eight hours about my experience with tech transfer offices at universities and my experience, but the one thing that they will help you do early on is they will support sort of, if they like your idea, if you can sell them on your idea that it's worth pursuing, they will then provide patent advice and a counsel to sort of do that initial patent search, which, to Evan's point, is not easy. It's not easy to figure out if your idea is actually an original idea, and it turns out even there are issued patents out there that should not be issued, and this is why patent lawyers make so much money because, like, a patent is just an invitation to a lawsuit. That's Thomas Edison's famous saying, right? And there is some truth that there's no such thing as new ideas. So a patent search is not a simple thing to do. You can do a cursory one, and if that passed muster, then you can start to get your words, you do an invention disclosure first, and then you can do a cursory patent search, and then you can start drafting a provisional patent. And in my case, all of that early stuff, when I knew nothing about, I knew nothing about any of this stuff, the tech transfer office was very helpful. Yes, so to my point, use the tech transfer, use whatever you have, but that is an early part. If you're looking for who are your early friends, you don't want to just sort of go off running without having anybody sort of looking at that for you, I guess is what I would say. And don't disclose anything publicly, don't give a talk on it, until you've filed a provisional patent. And it's important, it's too complicated to get into right now, but a patent doesn't allow you to do anything. A patent does not allow you to do anything. A patent prohibits others from doing what you have patented. It doesn't allow you to go make a medical device or sell a medical device. That's a whole other topic called the freedom to operate and to operate search. That's like you can write tens of thousands of dollars to have attorneys do a freedom to operate search to determine whether you can get into the market with this idea that you have. That's a whole other thing separate from a patent. So it gets very, very complicated. But definitely talk to your tech transfer office. Don't try to, they are your friends. Don't get into an adversarial relationship with them. If you can avoid it, work with them as closely as you can. Yeah, all that is absolutely true. And then, you know, not to be too jaded about all this, but in my experience and what I've witnessed, and you can look at the headlines, the medical legal device lawsuit headlines, the little guy can really lose in this equation because the big guys have an army of lawyers. And and theft of ideas from small companies and small people who have good ideas from big companies is almost a matter of practice. Like this is this is it's a dirty little. Secret that I feel like I've stumbled onto, and like, for example, this is public. Edwards basically stole MitraClip from Abbott, right? Abbott paid a billion dollars to buy the MitraClip company. Edwards came forward their clip technology called Pascal. It's an obvious copy. Anybody who looks at you throw a three. So show it to a three year old. They'll tell you they're the same thing. Edwards runs it through their trial. They get FDA approval the day before they start selling this commercial. Abbott sues Edwards. Edwards puts up a symbolic defense and then says, OK, we'll pay you four hundred million dollars and then now they can both compete commercially. So this is what like everybody like this is what the big guns do. The core valve and the Edwards, you know, when Edwards sued Medtronic about core valve, basically Medtronic had to pay Edwards a billion dollars to be worth to do business in the space. And they agreed not to sue each other for 10 years because this is so so when you're so, you know, and again, I don't want to be too jaded about this, but I have had experiences where where big companies said, oh, yeah, that's a great idea. Good luck. And then you see you start to see things happening. You're like, wait a minute. You know, that doesn't seem it doesn't seem fair. So, yeah. Anyhow, but upfront, if you have an idea, the first thing to do is understand what your obligations are. And you can go to the institution, almost every institution has a tech transfer office or center for innovation or something, and you can go and you can talk to them to help you write an invention disclosure, they'll help you with a provisional patent, they'll help you do early patent searches to kind of figure out where you're at. But it all starts with knowing what you have. I'm still stuck on you saying I don't want to be too jaded about this. Guys, that's great. Guru, did you have a question? Well, it's well, thank you. This has been fascinating. And being here in Minneapolis, yeah, you know, the birthplace of so many stuff. I always wondered how some of you chose to go directly to industry. And some of you started with the university, like Dr. Justino said, started with grants, started with the prototype. Not that I have anything big here, but I in my little experience, you know, we start with the Office of Technology Commercialization. They take six months or a year to just do your patent search. And then you start with an undergrad student or a grad student, and then everything takes years and years. So university, in my mind, is just delaying everything. It seems to me that going directly to the industry may make things happen faster. But to your question, Brian, at least here at the U, 100 percent of anything I do is university's property. So we have to work with the university because ultimately they are the one who's going to, even if you go to industry, it has to be the university legal who has to come in. So how do you determine when to go directly to university? When any advice on. On navigating those, well, you know, so I, Henry, you want to start or I can I can start or. You know, Matt, you didn't get a chance to to do a deeper dive onto your device experience. So this might be a good way for you to answer, Guru. And sure, a normal you. Sure. OK, so I think what was I supposed to be talking about? Successfully taken device to market. OK, successfully. Can we put successfully in quotes? I mean, somebody who actually did that. Yeah. So so so, you know, Henry, you know, as you were talking, I was reliving like multiple bouts of historic pain that I've repressed and tried to forget about. Because when you're trying to get your guru, what you're talking about is you have this idea. Right. And you actually outlined it beautifully because when if you're working in academic center institution or hospital system in particular, there's there are many, many challenges. It's not just having an idea. It's having a good idea. And then it's and then you have to get that idea through your own internal process. And that process can be depending on is is a it's a full time job in and of itself. You have to talk to your tech transfer officer. You have to draft an invention disclosure. You have to do all these things that all these steps you have to walk through. And again, in my experience, they don't the you're dealing with people who don't have the same mania that you do about your idea. They don't see how the genius that you are, guru, and they don't have the urgency about it. So they move very slowly and it's making you crazy. But you can't you cannot go around them. You have to go through them. So you need to engage with them. And that's like and I mean, daily, how's it going? What do you think of this? I change this pair. So you really have to kind of prod that along. Right. So that's so so that's step number one, just building that relationship, getting them engaged. You have to sell your idea to them because they there are you know, there are probably 20 doctors within their system per week to come in and think they have a great idea. And they they are whether you like it or not. They own your idea and they're the gatekeepers. So you need to get them on your side. So so you have to put some time into your description and why you think it's good and why it would be good for the institution that you're in. So and then you have to work through this laborious process to actually get it going. And then if you're lucky enough to get funding, you know, depending on what it is. Now, Henry's thing is much more complicated. Building a heart valve and all the things incumbent in that is very, very complicated. I've done that, too. I have a mitral valve company that is struggling in the same way that that that Henry Henry is still working through. But the side project was the retrieval catheter that I called Ono. And like and that came out of, you know, just an idea that I had actually to facilitate mitral valve retrievals when I missed in the lab because that would cost me ten thousand dollars. I'd go in for mitral valve procedure with the pig and I would sneeze. And then the day was it was ten thousand dollars. So I had to get out. So I built this thing preliminarily that helped me get these big things out. And I was like, oh, this could be a good tool for the lab. And oh, this could be good for our field because I mean, maybe it's just me, but I make a lot of mistakes. So I like having things that bail me out. So that's so then I started working like on the on that as a as as an idea and as a concept and went through maybe 30 different versions of what Ono was through a product through. The guy who's now my CEO, but at first I met him, he was working at a nightclub company in Germany and then he moved to the States and needed a job, he was making mitral valve frames for me. And I said, hey, I want you to make this retreat. What do you think about this? So we started making what now became Ono, different prototypes. And at the end of animal experiments would launch ASD devices, pull them out. And so I was doing things in parallel. So all of that. So all of that sort of the internal stuff. And then what happened was a multi-year long slog trying to get somebody to fund us or fund me to actually get this into a point where I could get FDA approval. And I probably went to 40 or 50 different every pitch meeting you could have up and down on these coasts and was turned down at every single one of them turned it maybe because I was lousy at it. But usually it was this is a great idea, but there's no market for this. So then I had to go and figure out how to do a market validation for these people to tell them that the 50 people on this call are assassins. They all hurt people every day. So I went around badmouthing all of you trying to get people to believe that we were dangerous so that they would give me money so that I could keep this thing going. But nobody was buying it. So we did what Henry did. We at the same time, we were filing SBIRs and STTRs, which are really nice mechanism. But you need to build out a business infrastructure to even get in a reasonable STTR application. You need to actually form a company. And so now you have and I'm not having begun talking about the patent filing process. But once you have a patent and then when you form a company, suddenly your tech transfer office is no longer exactly on your side. You are now you now your ideas. You need to negotiate a license agreement for your ideas into your company, for your company to be able to make the device that you invent. And then so then you have so then to do that, you need to have money to pay attorneys to negotiate for you and for your CEO with the hospital and the university that benefits from your technology. But they're no longer your friends. They're negotiating for and you don't even realize that that transition happened. Right. So anyhow, I could go on forever, Evan, and I know you're enjoying this. So you have to go through all this stuff. And that's just to get, you know, out into the out into the world. And then then for for me, with Onocore, with Ono, it was how do we get FDA approval? So the first step was we we submitted there's there are various ways to get FDA approval. The probably the simplest and most straightforward way is the 510k pathway. And Ono is not a class three device in the United States. It's not considered a class three device. So what we what you needed was a predicate device that you could build a GLP animal study around based on a predicate device that the FDA would accept as a predicate device. And then I were they shot down the application at first. But then that prompted a conversation with them and multiple meetings with them about a experimental GLP animal study that if we did, they would and we did successfully, they would consider they would consider application in a different light. So so we got we got money to do all this stuff, pay lawyers to negotiate with Penn to license our intellectual property into the patent and then worked with our regulatory specialists to work with the FDA to develop a GLP pathway. And we did all that. And we got FDA approval in the spring of last year. So so all of that. So then it becomes, well, what do you do now? How do you launch something commercially? Because now I had an FDA approved device and, you know, really, I didn't really have a plan beyond that. It's like, what do you do now? Well, then the question became, well, what what are you going to charge people for this? How are you going to sell it? And there was no we have no business. It's me. OK, so how can you sell it? So I'm like, well, I won't sell it. What I'll do is I'll give it away at first just to just to prove to the companies out there that people will be interested in this. And the demand has been tremendous. And I started to just try to give them away. Turns out you can't just give them away. You you have to go through the value committees at all the different hospitals. And a lot of them will not accept something for free. But I can't charge them because I have no there's no accounting infrastructure or anything like that at this point. So then my struggle was finding hospitals that will accept those for free during a, quote unquote, limited launch. And that's where we're at now. So that fortunately has been, I would say, relatively successful. That has led to now just over 20 cases that it's been helpful for people. And that's generated enough interest that we're moving into a formal distribution relationship very soon, which will then give me the infrastructure I need for distribution and sales and all the stuff that has to go along with being a grown up company. So also, you know, that was 10 minutes on taking you through really a 10 year odyssey. But but and that's with a simple device. I mean, this is a is a very simple device. It's a catheter basket on it that gives you mechanical advantage when you want to pull something out. It's not a very complicated. But the process of getting it to where it's been has been anything but simple. It's been fun, but it's been anything but simple. I really want to jump in a rush. Can I jump in? Yeah, absolutely. Because like most, we have three minutes left. Like most times Matt speaks, I think the other 29 people on this call are now 100 percent convinced they never want to do this. And I got to tell you, there is an alternative way, there's different ways to do this. And I'm sitting here at this company today that we just it's an alternative way. And it goes back to what Henry said. And that is sure there's a lot of drudgery, but a lot of that can be done by other people, by surrounding yourself with and I don't mean engineers. I mean, you know, people who specialize in corporate governance, in raising money. I've probably gone to 50 pitch meetings. Also, the good news is you can do them all by Zoom these days and raise a ton of money because the people who are doing it have done it before. And I feel like all the drudgery Matt's talking about is all 100 percent real. But the difference between my experience with this company and his experience with Ono is I kind of participated in it when needed and watched a lot of it and watched the guys go through all this pain. But that is their job. Whereas my job is being a doctor who really wants to see this technology. And it's just that they're not analogous. But I will say there are probably as many different ways to do this as there are imagination. And I think one really key thing is early on, if you feel like you really have something you want to pursue, you don't have to do all this yourself and you got to give away some stuff. It becomes less yours and more of the company's. But the company will do a lot of what you frankly don't have time or in many or in my case, at least the expertise to do. Yeah, I agree. I'm going to just jump in and say that I agree, in particular, the last thing you said, you know, I've been an active participant in all areas of this, but I am not an expert expert in regulatory affairs. I'm not an expert in supply chain or sterilization procedures or warehousing. So once you have an idea and you get it off the ground, you know, we we we have we we pay people in all these different buckets to do all these different things. And it does cost money. And you you need at the end of the day, that's the bottom line. If you have money, because what Evan is saying is we have money, you can pay for people to do all this stuff. The trick is getting money and the trick to getting money. The SBIR, STTR pathway is amazing because it's non-dilutive, which which is great money. But most venture capital folks that I've encountered are they want to know what the market definition define the market. What's the return on investment going to be here? And so so if you have an unproven market or your market is small, you're always at a competitive disadvantage. So there are ways around it. There's philanthropy that can help. There's institutional grants that can help. And and again, the STTR SBIR pathway is very good. Thanks so much, guys. So I think this sort of the theme that you guys are ending on here goes back to a word that Henry said earlier, the word symbiosis or finding a symbiotic relationship with the right people at the right times in each step of the way when you have these ideas. And I think the the both the similarities and the contrast in earlier experiences was really valuable to hear because that informs some of the processes that everyone on this call may or may not go through at some point when they have that light bulb and in the lab when they're in the middle of a case or in an animal lab when they're in an experiment. So this was really great. I know I found this really helpful. I really appreciate you guys sharing your experiences and hopefully we can keep this forum going as a series. Thank you to all who are on this call. And I hope you guys have a great night. Thank you so much. Keep it going, guys. Thank you. Good job, Arash. See you guys.

medical device

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