Dr. Heung Bae Kim - Medical Device Innovation – What’s the Problem?

Well, we're especially thrilled today to have Dr. Kim, one of our own coming for a special grand round's event. Dr. Humbay came as a professor of surgery at Harvard Medical School and the Weissman Family Chair in surgical innovation at Boston Children's. He currently also serves in a role as a vice chair for clinical operations. He's the director of the pediatric transplant center and serves a major role as a co-director of the surgical innovation fellowship here at Boston Children's. He was born in Korea but raised in Philadelphia. He then attended Yale University as an undergraduate in the Albert Einstein College of Medicine prior to starting his journal surgical training at the University of Pennsylvania. He then completed pediatric surgery fellowship here as well as liver transplant fellowship at the late clinic in 2004 and then he assumed the role of surgical directorship of both liver and kidney transplant programs here. And under that, under his leadership, those programs have thrived and the pediatric transplant center here has grown into one of the busiest and the most comprehensive pediatric transplant centers in the country. And even outside of his role within our transplant center, he has done so much in the world of surgical innovation. Particularly if we look at examples like the step procedure, Tesla and magic, these are among many, many other facets that he has served our system quite innovative in an innovative fashion. On a personal note, the fellow has looked at Dr. Kim for some of our toughest and most challenging patients and cases. He guides us with his wisdom and he shows us a lot about massive exposures and ways to get on challenging scenarios in the operating room. So we are overall so grateful for him, not just in his role as a teacher and a mentor, but as a true innovator in that role. Thank you so much for coming to give our grand round of state, Dr. Kim. Morning, everyone. And thank you for that introduction. Nice to see you all and nice to be back up on the podium first time since COVID I've been up here. I'm going to share with you today a little bit of a story of how I got into device innovation. Wasn't what I planned when I was seeing in your shoes. But this department is very cutting edge. I've always been open to new ideas and I was allowed to forge into a different area, a mid-career and I'll get a little bit into that. I'm having a little mouse issue here. Hold on. Let's go down here on a second. I'll share for a second here. Thank you. I told you to stop the zoom. I think it does cut everybody out here. I think you're going to have to make me a. There we go. Okay. I'm getting an echo now. That better. Okay, that's better. Sorry, everyone. I'm hoping to get fired as a guy finally here. Dr. Shamberger miles to help now. So let's start. I actually have a disclosure for the first time in my life. I am a co-founder for a medical startup called Kirk Cutsurgical. I'm going to be talking a little bit about the story about how we developed this device and got to the point of launching a startup. The point is not really about the device itself, but it's just using this example to share some knowledge that we've gained over the years. And in full disclosure, when I started this years ago, I knew nothing about this area whatsoever. So what's the problem? This is actually the most common question asked when you've started off thinking about innovation. Generally, you're trying to solve a problem. And in 2016, I was trying to solve my own personal problem. I was running a community lab. I've been running one for about 15 years since I graduated from fellowship. And I've been working on a UNO STEM self-transplant in tolerance. And initially things went really well at the beginning of my attending career. I got funded and things were rolling and then life happened. And in 2016, I realized I hadn't had funding for about eight years. And things weren't going as I had fully planned. I also felt like I was losing a sort of my competitive advantage in the area because it had been so long. Since I had had funding and it was time for potentially a change. So this was, I guess I could call this my professional midlife crisis. So what do you do when you have a midlife crisis? You go talk to your friends and I decided I wasn't going to do the research anymore. And I had to think about what else was it that I was going to do. So I went to talk to Steve Fishman. I had talked over the years about the fact that young people tend to be, I guess, more innovative, right? Because you're not sort of bordered in your knowledge. You have an open, much more open mind. And we had talked about starting this what he called kindred garden fellowship. And I felt like, yeah, that's something I'd be interested in doing. And so we discussed how this might happen. I went to Dr. Shamberger who was the chief at the time and told him I dilemma. And he was fully supportive of this. And this is what I was getting out of the beginning. It's unusual to have a culture where you can just turn on dime and decide to do something different. And something highly risky actually. So he gave me his full blessing and support for this effort. So I started on my journey. It took some time to think through this process and how are we going to set this up. Ultimately, we developed what's called what we call the surgical innovation fellowship at Boston Children's. And the goal of this fellowship, you can see here was to create future surgical innovators within an interdisciplinary environment that combined clinical experiences with a unique hospital based innovation platform. I wanted to be the first student in this fellowship. Like I said, I actually knew nothing about this area. I was I was particularly interested in developing some devices and I had some ideas, but I knew nothing about this. We looked around to see what was out there. There was actually wasn't much the Stanford biodesign is probably the most well known program and still is. But we thought we'd leverage our competitive advantage here, which is really incredible work. So I started meeting with people and the first part, the first two people I met with outside the apartment actually were Sal Afstar who's an oral surgeon. And Michael doctor who's GI doc and both of them had already been in the innovation space. And in fact, both of them had started companies already in the digital world. And so we met for dinner one night. We talked through how we're going to do this. And we were excited about this prospect. And then we gathered a team. We teamed up with both the innovation. The individual health accelerate IDHA, which was led by Carlos small at the time. As well as the simulator program. Which is led by Peter Weinstock and Steve Wilson, the engineer. Most importantly had to find the first fellow for this project. And we went through our normal interviews that year. And I told many of the prospective residents like all of you about this topic. Most of them were really scared and sort of shied away from it. But Gabriel, Ramos Fondales. His life lit up. He was really excited about it. And I knew he was the right person for this. He was willing to take the risk. He knew it was a new venture. But he wanted he wanted to be another. So what's the problem? So we're full of energy now. We're excited. We got team. What do we do now? Right. Because actually I didn't know anything about this. And so we went to the textbook. Went to the biosign to text book. And you see a diagram like this. It looks pretty simple. But what you realize is. Basically your first second third fourth question is always what's the problem. And. And if you just keep asking that question over and over again. Hopefully you get to the end of the road. It also looks easy in this biosign textbook. So. I'm going to start with the example that led us to this. And the problem that we identified is. You can see in this diet in this video that there's there were five hands here. Right. Five instruments. One of them is a suction. And it's continuously going. That's the assistant and there's two surgeons operating. And you'll see right here that the surgeon is unhappy with the suction. Grab drops the four steps. Grab the suction. And then has to go back and and and grab the other instrument. And what what I realize personally this is a sort of pet peeve of my deal or. You're constantly going back and forth between those two instruments. The pottery and suction. And this surgeon in this video is actually using a suction that left hand and said. Actually holding a force up because it's just too inconvenient to keep switching instruments. In this example, the surgeon on is that's holding liver only has one hand available. And they're actually using both instruments in the same hand. And the constantly going back and forth between the suction and the colorey. And so I've identified this as a personal problem. I don't know if any of you experienced this in your operating rooms. But as I've talked to surgeons in various fields, it's a fairly ubiquitous problem in any surgeries. Where in open surgeries where people are using the caries. In fact, it's even a bigger problem in laparoscopic. But I'm getting to that. We've talked about making a similar laparoscopic device to solve that problem. Okay, so we got stage one down easy, simple need finding we found a need we want to tackle. At this point, it seems to me like, okay, you know, the diagram looks pretty linear. It's going little circles and make your way down the road should be pretty simple. And the things to remember about this about this whole area. And for now, I've talked about this. You really don't accomplish anything until you make something that gets to a patient. So in fact, you could work and we have worked now for seven years on this. And we basically in my mind haven't accomplished anything because we haven't done it across the finish line. And you really, so it's a long road for any of these things. And you just have to keep working at it. Now, what I, one of the things I've learned through this process is this is not a linear process like is shown in the textbook. It's more like this. And unless you're Elizabeth Holmes, you're not going to get anyone to buy into your ID on the left side of this diagram. Now, one question I want you to keep in mind as we go through this talk is when would you invest in this idea or any other idea? And invest. What you can invest. Well, you have time. So our fellows invest their time coming to children's and working with us. And if you're a financial investor, you can invest money. If you're an angel investor or venture capitalist, you can invest money. Or if you're a hospital, you can invest in creating a system where you can give out seed funding for projects. So think about that as you're going through this. So, you know, just we just identify an idea and just use this as an example. When would you invest in this idea? So to go back, we've identified the problem. It's a constant switching between clottering and suction. And we had the idea that we would combine the two instruments into one. So it sounds pretty simple. So the first thing we learned that you should do in these circumstances when you have an idea like this is you got to do a put pattern search. Because odds are someone else's thought of the idea. There's very few really new ideas in the world. And so when we went and looked for pottery and suction, you found hundreds thousands of things, right? And it's hard to sift through them all. Ultimately, we decide there was nothing actually really like what we were talking about despite those buzzwords being in some of these patents. Next thing, think about the market. So who is this benefit and who's actually going to use it and most importantly, and we don't think about this enough as physicians who's been actually by the thing who makes the purchasing decisions. And these are all things that you have to figure out as you're going along. But in our in our quick to early assessment. We were saying we're like, yeah, this is great. Everyone's been used this. It's going to be awesome. You know, it'll be used by thousands of surgeons around the country or on the world. It's going to be great. Very exciting. And we looked at the market players at the time. So who's actually in this space? Turns out everybody is in fact, all the big players have electrocordory pens pencils, whatever you want to call them. The interesting thing about 2016 was it was it was a time of transition. Everyone is going to smoke evacuation now. Everyone here is probably use a smoke evacuator. I've pulled a lot of surgeons. A lot of surgeons don't like smoke evacuators. I don't know if you're on the same boat as me, but they feel like they don't add anything. The things are bulky. They kind of structure views sometimes. And for me, the Buffalo filter machine is just beyond irritating. It's like a vacuum cleaner going on every time you push the button. But everyone was in the space. So you wonder, OK, is it possible for a new player to get into space? It is, but it's difficult. And so this is sort of good news and bad news because the fact that all of these huge med device companies have a form of this device means that they're making a profit off of it. And if they're making a profit, that means as you're developing your device, people are going to be interested in investing because it's a proven huge market as shown by all of these players. Now, the interesting thing is everyone was in smoke evacuation and almost known was in fluid evacuation, which is what we're talking about. The only one that had anything that was touted as evacuating fluid was Ramora by AMT. And he, as you know, is a YouTube company. They do plastics and they had a clip on attachment. You can see there that basically had a little plastic piece connected to a suction. And I tried this. I don't find it the most useful device. It's kind of bulky and difficult to use. But. So I felt like those those going to be room for improvement in this area. And it's a huge market. The other good thing and I'm going to get too much into this, but. The cost of a single. Covenian pen that we use in the OR these days is about $3. The cost of these smoke evacuators pens. Runs in now $60 90. And so one of the things that has changed over the years and it's actually it's in our favor as we're developing our device is that the baseline price for these have gone up over 10%. And so it gives you a lot more room to work when you're developing your device in terms of cost. Now, I know it's unusual. You don't hear much talk about money and traditional ground rounds, but money is important in this field. And you can't shy away from talking about it because it really drives all of this type of work. Alright, so how many of your old enough to know what my guy wearing is, but. We decided to my guy or something to prove that having suction and bobe next to each other was useful. So we have to took one of these Buffalo filters, which we had in the hospital. And we cut some plastic young car tips and shoved them into the end. And basically made two prongs device. But the thing didn't move so it was a rigid. Cardi on one side and suction on the other. And we use this in the or I use this. Through many cases actually gave it to many residents to try and fellows and see what they thought. And here's a video of one such example. So you can see caughtery there and then you turn the device and you have a suction on the other end. And it turns it out actually that having the suction and caughtery on the same device actually is kind of useful. The problem with this configuration is that you have two things. There's widely spaced apart again in each other's way. And so if you're in a tight spot doing delicate work, you're hitting the other. You're hitting the other device again, something. And it just wasn't the most delicate and ergonomic setup. But we felt like we proved and again, I gave this to many residents and generally people felt like it was useful. Now to keep in mind, I understand that's a biased situation. I'm not like one of the I don't think the residents they tell me that they felt crap, but. That's a different story. So we went to brainstorming sessions and Gabriel drew out our first prototype design for what we thought would be our future device. And we basically wanted to have a retractable suction tip that would retract with a push of a button. And we thought about all different ways of making it and powering it and moving actual device. And should you move the lottery tip or should you make the suction tip mobile. There were a lot of considerations. Alright, so that's an original question. You know, just think about like, are you willing to invest time and or money at the stage. Pretty early, just an idea, just a drawing on an app. So our problem at this stage, you know, what's the problem now? The problem is, well, how do we make this thing? Right. And I had never prototyped a device. I went to a simulator program. They had engineers at 3D printers. We did some brainstorming with them about design and considerations and tried some 3D printing with them. It didn't work out real well with that group. And at this point, the Gabriel and I got lucky because Gabriel was having lunch over at the IDHA one day and ran into a student. Alitian was an undergraduate Harvard at the time and an engineering student. And they were, they got to talking about the project. And he got really excited about it. He was working in the digital space, but was a mechanical engineer, a battle mechanical engineer. And really wants to do some hands-on work. So we started inviting to our meetings and loan behold. He had the experience and the knowledge to do computer design, CAD design and could come up with things like this. And he was a expert 3D printer and had access to 3D printer technology that was better than the simulator program at the time. And so we brought Alisson basically full time when he was finishing up his undergrad degree. And he has continued to work with us throughout this whole process and as a co-founder in the company. So we began to design a clarity that had the fluid substance that was deployable and retractable. And we went through many prototypes. The first thing we decided is that we would use the OR suction itself to power the device. And so we wanted to figure out if OR suction was strong enough to actually move something and here's our first prototype it was. Then we went on to multiple rounds of 3D printing. And we just kept iterating. We brought devices to lab meetings. So many fellows in the past that looked at these things. And we wanted to add a locking mechanism so that you actually dissect with the device. So we spent some time designing that. And then ultimately we got to a point where we had a prototype of the deployment mechanism. But at that point we didn't have a functional prototype in other words we couldn't test it in any real way. And so. At that stage it was clear to us that we need a higher level of engineering skill. And so with Dr. Shamberger support we actually went externally found a company that was into medical device prototyping. Smith wise they're local to here in Philadelphia. And we work with them with the goal of creating a functional prototype that could be tested in real models. And functional meaning it combined all the electrical components as well as the suction and deployment mechanisms. Working with them was eye opening. It was really impressive. They're a level of skill and detail. And they brought the project to a new level for us. They were able to create. What they call industrial design model, which is an ergonomic design that would be very functional for surgeons. And one of the things I. I noticed over my years looking at devices is I'm a very fickle surgeon and I think very many surgeons are fickle. They get handed the device. You get about five seconds to impress them. And if they if you don't impress them in that five seconds, it's over. And so we knew we had to make a device that was intuitive and you just handed to surgeon. They started pressing the buttons and then they would realize what it's for. No, no manual needed. And so we did a lot of testing again with the help of our lab. And so we actually the fellows were very instrumental in this because we had many people look at the various designs but on the left, but on the right, but on top, but in the middle. Where things should be and how things should be played out. And we came up with this industrial design where the trigger button is right behind the coag, but as a, as the most ergonomic design so that you don't actually have to move your hand to trigger the button. This resulted in a final report and you can see some of the pages in their design. It's it was very impressive. All the things they looked at, they looked at the actually power of our suction and those kinds of things. And did relatively high level calculations that we were unable to do on our own. This is the first functional device. We sacrificed a nice kind of state to test it. And you can see that deployment of the suction lots in place and then you go back to the car. You can see it's not really the ergonomic design that we talked about, but this was this was most of mostly to test the functionality. And when you had combination of the electrical part with the suction. So we actually presented this at absent got what we consider an infrared market assessment. Gabriel actually won the innovation award that year for the presentation on this device. And the only two questions that he got were how much the little costs and when can I get one. And we felt and we talked a lot of people at the meeting about this and we felt like this was a more sort of anonymous assessment. It's different asking your residents what they think versus going to a big national meeting and just having surgeons will get it. So we were pretty happy with this sort of intro mark assessment. Okay, so are you ready to invest now? I'm money. Maybe I don't know hard to tell. So the true people on the our journey was game bigger. So we had Smith wise on board. We had our team. Now what? So we haven't talked about in social property. So before you invest, you probably want to know that someone else is actually it's going to copy this thing and and and and beat you to market, right? So in parallel to all the work that was showing you, we were working with Cheeto. And for those who don't know Cheeto is our base there is a proper property office at Boston Children's. And I'm going to go on a little change in here just to explain a little bit of what I've learned about in social property. Because I actually knew nothing about it seven years ago. The in social property office has a really robust website now to have a lot of documents on there. So if you're interested in learning more about this, you know, in their website and the slides are actually from their website. So what is in social property? It's basically a set of laws that cover ideas, discoveries, other intangible properties. And mostly what we're talking about with mental devices are patents. But they also cover inventions, copying right trademarks and materials. Okay, so the big question. That I asked is okay, who owns them for in social property on this if there is anything to be had right beginning. Turns out Boston Children's owns in social property. Turns out all of you. Are subject to their policies. I didn't know this, but they have a very robust policy that if you invent anything in the hospital and you can look at the three bullet points. That basically tell you what qualifies as a social property that's owned by Boston Children's. If you basically invent anything here that's tangentially related to your work at Boston Children's Boston Children's has first right. To that to that in social property. So that's kind of good news and bad news. The good news is they will actually pay for all the work that's required to get that in social property filed. The bad news is they're in charge of it. And so I think it's I think if you if you team up with them early and work with them throughout the process, it ends up being a mutually beneficial process. There is a revenue sharing agreement that you've also all signed on to that you don't know about. And this is it. So I'm not going to read all numbers, but you can take a look. But this is the set division should you end up getting some revenue down down the road. As I mentioned, you haven't accomplished anything unless you get anything something to market and you've got to get some market. You're not going to immediately start generating huge amounts of revenue. So it could be years and years down the road. And some of you have been down this path and know this, but this this this is something I learned as I was going down this pathway. If you want to know more about patents after the US patents and trademark office website is now quite robust to much better than seven years ago. And so you can learn a lot about it there. Now what the what's he do recommend that to me and I think this is their general approach is to go through initially what's called the PCT pathway or patent cooperation treaty pathway. And this is I'm going to take a moment to explain this a little bit because I didn't get this at all when I started on this path. And I think it's useful to understand this at a high level. So the PCT system. It's a patent cooperation treaty and it's been signed by 155 contracting states. And what it allows you to do is to file a single patent internationally and as a placeholder before you have to file a national patents. So if you just look if you just look at the timeline at the bottom at the zero month from priority date. What you'll see is that that that zero months basically refers to the point at which you disclose things, but mostly at the point where you file a provisional patent. Now for those of you who file a provisional patents, there's a process for doing it. You have to obviously get a language right and then you file it. And what I didn't understand about provisional patents is actually no one reads them. They actually just get filed, they get numbered and that's it. They just leave it there. What it is. It's a it's a time mark for your priority for when you disclose that you discovered something. And it's and it only becomes useful later if you end up filing international or US patents real full patents. So we file a provisional patent on our idea time zero. From that time you actually have 12 months to either file a US patent or one of these PCT patents. The advantage of the PCT patent is if you file the PCT patent in 12 months, it gives you another 30 months of protection. Now when you file the PCT patent, that goes to the WIPO and they actually they actually review that patent. So that's like a national patent. And in fact, they review it and they give you an opinion on the validity of your patent. And the national patent offices around the world, then use that as their sort of launch point when they review your patent ultimately. The good thing about that is if you're developing a device, it gives you 30 months more time to develop the device while being protected. And before you have to file your US national patent. And then ultimately you do have to file national stage patents. This is a copy of our patent and you can see a few things. The first applicants is children's hospital. You can see the inventors listed. But the assigned the first actually owns the patent is actually children's hospital. And you can see the data, the filing of the PCT and there's other things that you can clean from the patent. But that's where the basics of patents and the Tito outforses the legal work to write and file a patent. But you have to work very closely with those lawyers and Tito to get done. So turns out, Google patents is actually a really good way of looking at patents, probably easier than the US patent office website. And it gives you a lot of the. And they agree on the right side there and you can see actually our patent, even though it was followed a while ago, still pending. I don't know if there was a slowdown in COVID for reviewing these things or not, but our patent is still pending at the US patent office. All right. How do I get out of this thing now? Because I've been on this road for a really long time. I fear getting tired. And how do you how do you exit something like this? Once you're access strategy? Well, so we had a functional prototype and we felt like, okay, this is something we can show people and see if they're ready to invest. You're two major options at that stage are getting licensing agreement or doing a startup. So how do you decide about that? So startup companies are important and the simple way of thinking about it. It's sort of a way of getting the project out of the academic and hospital environment into the business world, which gives you a lot more freedom to operate around developing the device. And by free and operate, I really mean raising money. It's hard to raise money in an academic environment. And so that's one approach you can take. As a children's employee, what I learned is you can't just go start a company on your own without talking anybody. There's actually a lot of rules and conflict of interest issues that you have to talk about before you do a startup. The interesting thing is once you have a startup, you don't end up negotiating with the company in your absence for that intellectual property and licensing. A lot of what you need to know about conflict of interest is actually based on the Harvard University of happy medicine policy on this topic. So if you're interested in that, you can look that up online. All right, so because of all those conflict issues and because we felt like it was going to be the easier, more rapid exit, get it out to a company we decided we were going to try for licensing agreement. So we, at that point, we started calling around to companies and putting in on disclosure agreements, presenting the device and trying to get someone to agree to licensing agreement. So we called Striker. I told them about the device. They said, yeah, come back to us when you have a company. Metronic, they really didn't want to talk to me even. Ethicon, no way too big. And by the way, all these people are in this business too, right? Part of the reason, part of their issue is that metronics told me that they didn't. They didn't want to talk to me because they might be, they might be working on something similar. So hard to say. Symmetry was interested. We showed it to them, but they declined. Went to AMT, the people that make them Ramora. They said this was, they were in only in plastics. They actually looked at the idea. They thought it was good, but they only do plastics, so they were not interested. And then once a bolder surgical, I figured, you know, Pete's connection, they actually didn't want to talk to me either. So things were looking pretty bad. Went to Buffalo filter. They're the original smokeback waiting company. They love the device. It was great. So we thought, okay, this is great. We're going to get a licensing agreement, Buffalo. And so Cheeto started working with them on licensing agreement, sent them a term sheet. And two weeks later, I see this on the internet. I'm a acquired Buffalo filter. So one of the big players bought Buffalo filter. Buffalo at the time was a relatively small company. So then we got notification from Buffalo that they had to stop all, all discussions of anything because they were about to be acquired. And they put things on hold. And they told us to call back in six months once everything was settled. So it was disappointing, but it was good to see that they were interested. So then Conmed became the owner of Buffalo filter and they continued the Buffalo filter name in line. And we had a second meeting with them. And Rob Crum and Kyle, who helped set up another demo, they came to my office. And we showed them the device. And at this point, we're showing Conmed the device. And again, they are actually very impressed. They liked it. And they want to start discussions about the licensing agreement. So Cheeto started that process. And this was in November of 2019. And then it took months. And as you know, something happens in 2020 that derailed pretty much this and all other similar projects, probably across the country. Because all these companies, when COVID hit, this is basically pulled back. And because of the uncertainty, you didn't go into any new licensing agreements. So they they withdrew from the discussions for this licensing agreement. Okay, so we're still in the road. What we do. So we've tested the wires a little bit. We've showed it to a couple of companies. There was some interest. No one really wanted to really invest. What do you all think you really want to invest? Any takers? Anybody come on, fellas, you want to invest? Yeah, good. So one of the one of the global learnings that I've achieved over the years is. What what are we doing this whole process? This whole process is really about something called g-risking from the very beginning. You're trying to assess what is the risk of me putting my time and money and energy into a project. And me being me or me being a company that wants to invest in licensing agreement. How much risk do I want to take when you're at the very beginning, the risk is very high. And when you have a market, when you have a product on the market and you're making revenue. And you're making profits, the risk is very low. And everyone has a different level of risk that they're willing to take. And you need to find the people that are willing to invest early time, money, energy into a project. And so we do risk it to a certain extent. We made a functional prototype. It was okay. It wasn't perfect. We only made five of them. And we didn't know how to manufacture it. So we need we need to at this point, we had to make the decision. We're going to get off the road and quit. Or we're going to keep pushing this thing and try to de-risk it even more. So we tried licensing agreement didn't work. So our only choice at this point was to do a startup. So how do you do a startup? This is the next question. The problem. How do you do a startup? I had no idea. So what does any self-respecting innovative entrepreneur person do when they want to figure out how to do something? You go YouTube. Right. Everything's on YouTube. And I suppose to Martha Murray, who started her company for ACL. And she said she learned everything about startups on YouTube. Turns out you can't. And so I did. I went on YouTube and I started watching videos and multiple channels. Why coordinator turns out to be one of the best ones to actually have what they call a startup stole. But there are other multiple websites where you can actually learn the nuts and bolts of startups. And it's very valuable. The other thing we did and this was just coincidental. Al Cian was now a medical student and he decided to become to go combined MBA. And so he was at Harvard MBA. Doing his work. And I had signed up for an executive course at the business school. And my my term there got deferred because of COVID. And so just by chance we ended up at the Harvard business school together. And what are the odds, right? Some 50 year old over over the Hills Virgin and the student at the business school. Same time. We took this as sort of a a science universe that we needed to start up. And so we made the commitment and we figured out how to do it. And we strategized about it. So how do you create a startup? We there are two there are two basic roads we could have taken one. Do it yourself. Just figure it out. Bootstrapped it. Second, get professional help. We decided on the second. We decided to get professional help. Through our connections through the business school, we found this company general inception. Their venture studio. They invest in very early. So we decided to start up a business with a company. And they, they have pointed this term industrial co-founder model. They basically come in as a co founder with you in company. And they offer a lot of expertise that we could have figured out. But it would have been difficult. And we wouldn't have been sure if we were doing it right. And you don't want to have regrets later that you didn't do something right. is resources, but they offer those resources in a fractional way. So when you're starting a company, you don't need a full-time CEO, but you do need an executive. You don't need a full-time back office people, but you do need a couple hours here and there. You do need R&D manufacturing services, and you need to help finding those. You need capital. At the end of the day, nothing works without money. And so they provide capital. They provide all these resources. And Tito basically worked with General Inception and us to make this happen. What's their help? We launched a clear cut, surgical. And they brought us again to another level. With the startup, we were able to raise money. We got a, again, another highly professional medical device company to take our device to the next level, which is the design for manufacturing. And that's where we are now, we're in the process of doing final design for manufacturing. What that means, which I didn't understand before, is when you make five of a device, which is what we had with Smithwise, it's there's one process. They basically just put it together by hand, right? But you can't do that when you're making thousands of devices. And even as we were designing our second prototypes, you know, thinking about manufacturing. We really need to ultimately scale this up to hopefully make millions of devices. And that's a whole other ball game. And in order to do that, you really need people who are expert this area. So that's what we're doing now. We're in the process of design for manufacturing prior to an FDA submission. So it's a problem solved at this point. So here's a little model that's showing the old way you grab a suction. OV. And with the new device, this is our latest functional prototype with all the ergonomics integrated. And it is a problem solved not yet because we really haven't gotten to market. We haven't gotten the device into certain hands to help patients. So we still have a way to go. We didn't do another market assessment when I also said the business school he pitched this our company in the new venture competition. High level competition at HBS, a lot of the students enter this and else did a great job and was the runner up. And most importantly, the crowd favorites. Of all the companies that pitched. All right, are we there yet? Actually, no, we're not there yet. The next hurdle is the FDA. I'll let you know if I give this talking kind of about what that's like. I don't know if you can give me some advice, but we do have to go through the FDA process. Fortunately, we think we're going to be able to go through it by the end of this year through the five 10 K process, which is a much more straightforward process than if you have a novel device that has no predi-kits predi-kits are basically prior similar that are approved. This is obviously a very simple device. It's a lottery and a section and those are both already on the market. I hope that will actually see the end of the road maybe by the end of 2024. All right, so back to the original textbook. One of the things that as I thought about this whole process. I think we talked about the de-risking issue and I think really what this whole thing comes down to is de-risking. The whole process from the beginning to the end. What do we de-risking? We're de-risking the biology, the technology, the market, financial part of things. How do we do that? Well, as surgeons and physicians, we do experiments actually and we de-rispile all the time. That's what we're good at. That's what we're used to. We don't necessarily think of it as de-risking, but when you think of it from business standpoint, that's what it is. What most of us aren't good at is the next step in development of the device, which is the prototyping part where you're trying to de-risks the technology and trying to prove. And again, this is a very simple example, but there are other technologies that are way more complex and you got proof that you can actually do it in many of those cases. Then you have to de-risks the market and part of that is figure out what is it that people are going to buy and what is it that people need. And that can be very difficult to do. And then finally, you know, the startup is a really good way of de-risking the financial part. People are very much more interested in investing in a startup than when you're within an academic environment where they feel like whatever the money you give, they give or time they give is going to be totally diluted. In a startup, there's a singular aim of the company and that's the advantage of the startup situation in this kind of environment. Now, I've talked to the hospital about all this, talked to Tito extensively, maybe had a few parking sessions with them about the fact that I had to learn everything on YouTube. And so what they've done actually, and this is the first time that's being announced publicly, is that they've developed, they have a plan to develop a PFU device incubator. This is after Irene Abrams was ahead of Tito discussed a lot of these issues with many other people around the hospital who are also similarly developing devices. And the hope for this is that people, okay, so you can still go on YouTube, but hopefully there will be more guidance in this whole process for people who are coming down the path for the first time. And hopefully there will be some early seed funding to help people with their devices as well. So that's all I have to say thanks for your time. I do want to thank everyone who's been on this journey with me also actually here. He's back in the back there. He's been with us the whole time and we'll continue on this path with us. All our fellows who've been involved Gabriel Ray most of all was in this at the beginning. He's actually working with Smithers on the Florida right now. Rob from and Kyle who actually were very instrumental in helping with a lot of those pitches. Unfortunately live and failed, but nonetheless they helped a lot and they learned a lot. I hope Brianna Slatnik came in as an innovation fellow. Unfortunately, she was the one that really got affected most by COVID and during that time we did the bird all of our attention to COVID projects. And then I need and Donna who are here. Current fellows. Thank you all. And broke for being just crazy enough to take the risks to join me in this process when he finished his fellowship. And then Dr. Fishman and Dr. Schamberger were really instrumental in this again. You're all lucky to be in this environment where you're allowed to innovate, a lot to do things that are a little bit risky, a little bit out of the box with full support of your two chiefs now. And so thank you for giving me the chance to go into this risky risky business. Thanks, I'll have to take any questions. Hey, Brent. I'm not sure in how much detail you can disclose, but you touched upon the importance of money and sort of the potential to generate profit and interest in the product for the future. But what have been your sources of funding to this point has all been title or view had grants or other sources. That's a great question. Their early work was all just within the Department of Surgery funded by by the spin off from my chair funds actually. So that was that contributed to the initial prototyping. And so that's what we meant. Into the startup, we were able to raise money not only from general section, because as I said, they come as a co founder and their contribution largely is capital on top of all the expertise that they provide and resources. And also, we've been able to raise money from several other sources. I don't want to get into details, but there are multiple other investors now in the company. Our next we feel we believe we have a runway to pass to getting to the first stages of getting to market with regard to the amount of funding we have currently. We obviously are going to have to raise more money. The thing about this and every other device or startup is that fundraising becomes a big part of the work of the executive. And it's a, I'm not going to say it's never ending, but it's a continuous effort. And it all gets back to the whole de-risking issue. Everyone's at a different level of their risk tolerance. The connections that have hard business goal have been tremendous here. A huge advantage when you're doing a startup to have those connections. But the current funding for clear cut, the initial seed funding came from general inception. And then multiple other investors that we've acquired over over the last year. Spirit. Thank you for a great talk. I know it felt like a really long slog and has been the interest you generated in the research. Fellow program demonstrates I think that there's growing interest in this in the younger generation of surgeons. And we've obviously done some work on that and looking at it and. We're seeing more and more applicants with interest in things like this. And I think that's a great question. I think that's a great question. There's also many questions. When I was interested in your revenue sharing. Because it seems like the hospital almost has two hands in the cookie charts. Because there are two lines for. One for the hospital itself and one potato. And I was curious what the. Reasons for that were what the what the sort of ramifications are in terms of the revenue sharing there. That's a great question. I actually asked the same question. And the answer I got was Tito is not the same as the hospital. So. Yeah, I don't know any more than you do. I don't know if Dr. Shambri knows the secret, but I won't make him tell it to us. But. Yeah, it's it's a mystery. I'm not sure. But. I've also never tried to. I haven't tried to negotiate a different revenue sharing agreement with them either. I don't know if anyone in the hospital ever has. But. It is surprising to find out that we've all signed on to that revenue sharing agreement. I know. We. It would be a fantastic talk. And thank you. I have a general question for you. If you were setting up innovation. I think you would have a patent system to start with. Would you have a patent system? Yes. Or do you think the way we do things in surgery where we just innovate and spread the knowledge is actually a better way to. You're talking about for procedures. No, it's not the thing. Yeah, procedures, but also even in this. I think it's a good thing to have a patent system. Once you develop it, it seems that if you find a company that is willing to make it, then. It's a done deal. Yeah, so I'm not sure in their sense question. So are you saying. We choose that there are a lot of intermediate. Staffs before you go to the start. Oh, yeah. Well. So you can jump into a startup and point. The question is, will you be able to attract investors in a startup with an acting drawing. Right. And like I said, unless you're those with homes, it's going to be very difficult. Right. I mean, what what venture capitalists would would jump on me coming to their office with a napkin grind. Of some crazy device that they don't understand. Right. I think the more you do your risk it. More likely people are to jump on board. And that's that's sort of what I've learned, right. At the beginning, no one was interested. And as you do risk it more and more, you prove. Point after point after point. And you solve problem after problem. Ultimately, you get enough momentum. And buy in that people want to want to help. And one again involved. And. Yeah, I think it's just human nature. Some people are more risk diverse than others. Right. You have to find the people that are more willing to think of us early on. And then you get to other people on board later. All right. Say it's a lot. Thanks. Thanks for coming everyone.