Consistent Engineering Process Leads to Excellent Results

Hello. Welcome to engineering experience by Paragon Innovations. I'm your host today, Tyler. Current alongside Mike Wilkinson, Mike. Good to talk to you today. Good to see you. Always good to to sit next to a a friend. Here, and today we have a fantastic guest. His name is doctor Philip Purdy. He's the co founder and CMO of Endophus Holdings. LLC, and also the former Vice Chair of Clinical Operations at the Department of Radiology at UT Southwestern Medical Center. Doctor Purdy, thank you so much for joining us. Happy to be here. So I could run down a a two or three paragraph bio of all the things that you've done in your career, which is extensive, and you've done a of amazing things. But why don't you just tell me a little bit more about your role and what you do at Endophus Holdings and a little bit more about some of the things that you've achieved there. The company was started based on some work that I did while I was on the faculty at UT Southwestern I'm was trained as an interventional neuroradiologist. It's a somebody who uses catheters to things in the brain the way that cardiologists use catheters to do things in the heart. And in the course of doing procedures on patients, felt that there was a a problem in the way that we monitor blood pressure during procedures because that technology hasn't changed since before. I was in medical school in the nineteen seventies, and and it's analog technology and basically just gives you a waveform. And the patient care monitor derives the pressures from that waveform. And I felt that technology for pressure monitoring had advanced to point where we should be able to do better than that in in medicine. And so, started down a road of trying to figure out how to do better measuring of blood pressure during procedures and decided on this fiber optic pressure sensor technology, the particular sensors that we use take individual discrete digital pressure measurements from five hundred to a thousand times a second down to one or two tenths of a millimeter mercury. So it's much more vast and the fact that it's digital and gives discrete individual measurements enables the possibility of doing statistical analysis and much more mathematical treatment of that data than you can do off of an analog waveform. That's really, really interesting. And incredibly fascinating that you saw an opportunity and said, you know what? We can do this better and you went out and did it. So you hold twenty four international patents including several for the Indifis pressure sensing access system. So tell me about your journey between doctor and innovator and a little bit more about that process And, you know, what occurred for you to come to the realization that these solutions were needed in this industry? Well, I was very lucky. Honestly, the late nineteen eighties when I was early in my time out of training and we were there was a technology that was developed for using catheters to treat cerebral aneurysms. And those are called coils. They're made of platinum and they are you put a catheter inside the aneurysm from placement in the leg. And you run it up into the brain and put it inside the aneurysm and introduce these platinum coils to fill that aneurysm and it was a treatment that supplanted neurosurgical operation removing part skull and and doing it direct open surgery. I developed or had some ideas about configurations for coils. And I was training somebody had started a program for training interventional neuroradiologists at UT Southwestern, and was training somebody and and talking to him about this idea and said, you know, I really need a patent attorney, but I don't even know how to find one. And he said, well my brother's a patent lawyer. As it turns out. And and so he put me in touch with his brother and the first five patents that I ever filed were patents related to cerebral aneurysms and cerebral aneurysms, and long story, but I I'll try to shorten it for you. I was I wound up speaking with a company after those patents were issued speaking with a company called Cordis, the about those aneurysm coils and they were gonna license my patents and then in the middle of that process, they got bought by Johnson and Johnson. And then so that took eighteen months out of the calendar to do all that and then Johnson Johnson wanted to continue on with those patent licenses. And so they license those patents. And then over another three or four years, the these things play out in decades. I mean, it it was it was the we were the fattens were filed in nineteen ninety two, and it was in the mid two thousands when Johnson Johnson actually started selling coils. And but that gave me a royalty stream through UT Southwestern that gave me some access to funds in an account at the university, and then that as it started growing, I thought, you know, I need to do something with this money because I could either this in my career traveling and on, you know, it was it was university money so I could I'd go into meetings and that kind of thing. Or I could try to do something and and I decided to try to figure out to do something and and so then that was another three years or so. Settling on what to do with several animal experiments and several investigations of different types of approaches and I had been doing a technique in the spinal cord to cool the spinal cord in the case of spinal cord injury and navigating the subarachnoid space, which is a space in this around the spine in the brain that contains cerebral spinal fluid. And needed to monitor pressure in the brain and spinal cord as I was infusing this fluid and decided to come up with this technique for monitoring the pressure around the spinal cord, and then I had a a moment in that process somewhere where, you know, we don't do blood pressure monitoring that. Well, and there's a much larger market in blood pressure. So that's what kind of launched me and that was around two thousand seven or so. Right. Then I started heard an engineer in Minneapolis. We hired a company in Minneapolis that made catheters and then we made trips to several places to identify the pressure sensor technology we wanted to use. And settled on a company in the United States that that we were working with and We got to the place where we were we knew the technology platform we were gonna use and then we had to figure out how to make it something that could be used in patients. And that was a that turned into a medical electronic device project. And I I had already hired an electrical engineer in Dallas to helped me with that aspect of it, and he had familiarity with paragon. And and so he got me and the people at it's called the Technology Transfer Office at UT Southwestern, in touch with Paragon and Mike, and that's how it started. So Mike, when you first heard about what doctor Purdy was doing, what were your first impression And what do you think? Oh, that was really cool. I mean, I love we love medical devices, and this is just another medical device that It sounded really cool. He had already done all the homework on how to what technology to use this in this optical fiber And so we were really excited to get to work with doctor Purdy and and and make a product they can go to market with. So doctor Purdy, when it came to choosing a technology partner. You kind of talked about how you you know, the the journey by which you came to meet Mike and and know Paragon, but what made them the right choice for you? Doing a start up and and this was sort of a start up that was being done inside the auspices of the university doing a startup is a very frustrating and difficult experience. And and I had we had problems related to the optical company that we were using that they're they didn't address some problems. And the low the proximity to Paragon was real attractive and also the I we went to several medical device companies around in and paragon seemed at least as robust as any of them and and more robust in the sense of being able to partner and work with them locally And so that was the most very attractive event turned out they were also real competent. So that was I mean, that was a real place. We fooled them good. Yeah. So from from your perspective, Mike, what makes an ideal partner? When it comes to partnering together with with a company like what doctor Purdy does, what makes an ideal partner when it comes to communication or working together? What how does that partnership really come together and well. Well, I think it works well when there is a lot of communication. That's the most important thing between partners. In this case, we've got an expert in the technology and the medicine side. That's not our expertise. We we're not doctors. We went to school far less. And And so they bring to the party exactly what the product needs to do, why it needs to do what it needs to do. And then basically, we're the we're the chefs in the kitchen that can take what needs to be done and then build that that device to perform that function. And so working with doctor Pretty was great because he he knows all that. He's been, you know, been in the business for a very long time as a doctor, and then for us to just make the device was more straightforward. So doctor Purdy, you know, what are the future plans for the end of this pressure sensing access system? So what what do you see happen in the future and maybe what excites you about that? Well, so to to do that, I have to really kind of talk a little bit about how things are done now. Mhmm. Blood pressure monitoring since at least the nineteen sixties. As as I said earlier, been an analog technology. And this technology predated the invention of the personal computer. It predated all of the the huge, you know, Silicon Valley experience that we've seen over the past several decades. And in the lab at UT Southwestern before I was ever in touch with paragon, I was experimenting with trying to figure out how to use these technologies and there was a whole catheter design piece of this that that was separate from the electronics. But for instance in lab experiments with flow device that I created. Giving pressure waveforms, I I saw that what looked like this on a waveform on a patient care monitor which was the standard for monitoring in medicine, looks like this when you start actually breaking it down to to the with the kind of fidelity that you can get off of these sensors and I I've the that that it it was a it's a kind of a silly thing, but it's a telling thing. I took two pieces of tubing one of them made of silicone and one of them made of latex. They had exactly the same wall thickness, they had exactly the same diameter on the inside of them, but since in each of those pieces of tubing and collected some data off of them and looked at the waveforms and you can't really tell them apart to look at them, but the company that I acquired the the it was really a scientific company. That I acquired the the the means to do that with head software and it allowed to do mathematical treatment of those that wave that numbers system and and I did a there's a process in math called fourier transformation that that I'm no mathematician, but I I was familiar with it because it's used in reconstructing images from CT scanners in medicine. And and so I I was able to do a four a transformation on those waveforms and when you look at the slopes that are created by that mathematical process, I could tell which I could tell silicone from latex. Wow. And so I'm looking at that and and thought, I could probably tell atherosclerosis from not atherosclerosis. And there's no telling what else I might be able to tell, like I said, I'm no mathematician. If it ever got in the hands of a mathematician, what they might be able to do with data of that kind of fidelity. And so The end game for me is that. To be able to do that with this technology, not their yet because there have been a lot of bumps. I mean, doing a medical device startup is a lot more frustrating than I ever thought it would be. But but that's what this is about is getting to the point where we can look at that kind of data and there are questions that are very difficult to answer with the analog device and very simple to answer if we had this sensor because what happens in in measuring pressures is that you have to have a fluid, direct continuous fluid channel from the place you want to measure out to the device that hangs on an IV pole and that is where the is that does that analog pressure monitoring. And if you are in a setting where you have a catheter in a position, you want to measure a pressure through that catheter, then you want to do some manipulation through that catheter, and then you want to measure another pressure through that catheter. You have to put in a guide wire, direct the catheter to where you want it to be, take the guide wire out, hook it up to the transducer, make your measurement off of that transducer, then do whatever you wanna do through that catheter which may involve moving it again. Right. And then rehook it up and do all that all over again, and it is very time consuming. And there are situations in like, when they wanna patient has renal failure and is has a shut in their arm that goes from an artery to a vein and that starts to block up. And they want to go in there and do a procedure to open it up, they have to measure the pressure and see the pressure on one side and on the other side of that shunt and they have to go do their manipulation with an angioplasty balloon or whatever, then they had to go back in and make more measurements on either side of the shunt. If you've got a catheter with sensor in it, you're just making those measurements continuously a thousand times a second as you're doing those procedures. And you can and so the time of the procedure is cut a lot. And risks of procedures are related to how long they take. And so you can conceivably cut the risk. Similarly, what has happened since our company started. I I left UT Southwestern in two thousand fourteen. There's private equity firm in downtown Dallas that agreed to acquire that technology and develop it, but I had to come with it. And so I left the university and went with this firm here, and what what then had to happen was we we'd spent a lot of time developing the tools to to do that. And during that transition time, medicine changed. My area of medicine changed used to be that the big area that interventional neuroradiology did was cerebral aneurysms. But in the meantime, they developed a way to treat stroke that involve putting a catheter up in the brain and putting a device into the blood clot that was in the brain and then pulling the blood clot and and opening it back up and it transforms stroke therapy. I mean, it's it is revolutionized stroke therapy. And it turns out that time is very important. And so if if you're going to do a procedure that's going to take forty five minutes, your outcome is going to be much worse than if you're doing a procedure that takes ten minutes. Mhmm. But it also turns out that monitoring patients blood pressure is important. When they're having a stroke, And with our device which is a sheath, it's a it's it's a device of catheter that's put in an artery and then all seizures done through that catheter. And my basic catheter technology was I developed means to embed our sensor into the plastic wall of that sheath so that you can monitor patients pressure continuously while you're doing other procedures through that sheath, whatever you want to do, but you know what their blood pressure is. And so the the prior technology used that transducer on an IV pole, you had to put a separate catheter into the artery and the wrist and hook it up to that transducer and just getting that catheter put into that wrist and putting it on IV hooking it up to the IV pole, takes anywhere from real fast would be five or ten minutes, not unusual as thirty minutes, could be forty five minutes or an hour. And so with our sheath, you have instantaneous blood pressure monitoring because you're going to put a sheath in where there's or sensor in it or not. And so this has turned out to be something that makes stroke therapy much more robust. Wow. That's incredible. Yeah. It's been real rewarding, but there are a lot of frustrations when you translate from being able to do something in the lab to getting hospitals to pay you for it. Right. Right. And those are some of what we've been going through. So when you talk about, you know, saving lives and and putting devices in patients and and that sort of thing it's it's obviously important that these devices are consistently engineered with the utmost decision and with the utmost care taken to ensure that every product is is functioning and is correct. So, you know, how do consistent engineering processes lead to excellent results when it comes to your products? It's very important that the engineering people you're working with know medical device technology and also know medical device regulatory requirements. I mean, we call our the the device that paragon helped us develop as we called our blood pressure monitor. It's the electronic box that hangs IVPO that get that reads out the pressure and also communicates to a patient care monitor. And so to shorten it, we call it the BPM. Our BPM has to meet the regulatory standards and that includes electronic insulation, what they call means of patient protection, that that if there's electrical shock to the patient that can't get or or to in the box, it can't get out to the patient or if there's electrical shock off of some other device connected to the patient, this our box can't be a conduit to transmit it to the patient. It has to be able to withstand temperature variations and and it has to be able to not there's a test where they put it on a a turnstile, like an old phonograph turnstile, and they have dripping water on it and they can't have water or get into the box during I mean, there's a whole long list of regulatory requirements with electronic medical device and you gotta be working with a company that knows that -- Sure. -- or if you don't design it into your box, you get to start over. And it was between our first box and our second box that we started and found Paragon, because the first box we didn't have that in, all and so it came out in a form that was really stripped down. Right. And because paragon was familiar with it and knew how to do it and could do it. Second box was much more robust, and we're working with them on the third box now, which will be even further more robust. So Mike, from your perspective, how do you ensure that everything that you do is of the utmost quality? What kind of quality checks do you do and and and that sort of thing? So they're required for the FDA There's ISO thirteen forty five, which is a design and manufacturing requirements. There's also the Credit Federal regulations twenty one CFR eight which is required. And to do all that, we basically have to get trained. So our guys are constantly going to training events, both online and in person to keep up to date. We also use an outside regulatory consultant mix of the rep to date on all the new requirements which are changing. And for medical device. And then just by doing it a lot with a lot of different customers, it keeps us up to date on everything we're doing so that all of our medical customers get that quality that they need and required. Absolutely. Absolutely. So doctor Purdy, you know, you you mentioned that you're working on third box now with with paragon, talk to me a little bit more about how you see endophis in the wider medical market. And, you know, what's the future of your business and how does paragon play a part? That? Well, this is all related to at the end of the day, my learning curve, that the, you know, what we did with our blood pressure monitor box was add a USB port on the second box and add a patient monitor interface on the second box. And then patient monitor interface then connects directly to a patient care monitor and the patient care monitor thinks it's looking at one of those wheatstone bridge transducers because patient care monitors have been designed and built around the Wheatstone Bridge Transducer. That's that's the analog thing that hangs on at my people. And so we have gotten to the place with that one now where we can talk to the patient care monitor, and that gives our data access to the patient medical record, the electronic medical record. And so that was a real plus. The USB port has the ability to collect that data. And to do mathematical analysis with it, statistical analysis. That's something we haven't done yet. But so that's on the horizon. And one of the regulatory issues that we have to solve with this version is getting away from is getting to be able to use it in the broader hospital environment. Right now, we're kind of restricted to the cath lab environment. And and some of that is related to regulations that are in a cath lab are different from regulations that are intensive care unit, and emergency room, etcetera, and we're trying to be more generally applicable across the patient care experience in a hospital because patients move from place to place inside a hospital, they come in the emergency room. They're hooked up to a patient care monitor, but that patient care monitor is bolted into the wall in the emergency room. So then they go over to the cath lab and they get hooked up to a different patient care monitor, which is bolted onto a stand in the in a cath lab. And then after the procedure, they go up the intensive care unit and there's yet another patient care monitor, not counting the one that they're hooked up to to be transported from the cath lab. To the patient to the ICU. And so, so there are a lot of changeover experiences that this goes this technology goes through as a patient is transported around in a hospital and each time you connect to a patient care monitor, you have to, what they call, zero, the monitor. In other words, monitor the patient care monitor has to observe what atmospheric pressure is. And then based on that atmospheric pressure, you know how high the systolic or the diastolic pressure is because it's that many millimeters of mercury above the atmospheric pressure. Yes. When Marsheath is put into a patient, it doesn't come out. So there's not currently a way to zero to re zero to a new patient care monitor etcetera. And so that's one of the things that we're gonna put in this so that, you know, it'll become a more generalizable hospital experience. For that device. That's fantastic. Well, this sounds like a fantastic partnership that helps people and is very beneficial be very rewarding for the two of you to work on. And so It is. I agree. Yeah. Absolutely. Well, it's been a pleasure getting a chance to learn a little bit more about that today, doctor Purdy. So thank you so much for joining us here on engineering experience.