EPISODE 85

Less Mechanics, More Thinking - David Fischel, CEO of Stereotaxis

12-09-2020

“The whole point of robotic medical devices is to reduce the role of the surgeon as a "mechanic' and enhance their role as a strategist, thinker and designer of the therapy which is best for each patient,” says David Fischel who first became aware of the medtech company Stereotaxis as an investor. Fast forward a few years, and he is now the CEO, and very passionate about the possibilities of robotic devices and digitized operating rooms. For instance, a surgeon with vast experience in a certain procedure could be in one location guiding multiple other surgeons in underserved areas with less experience, thereby extending access to the highest quality of care. “Once you digitize OR information and put the physician behind a computer, you allow for a whole range of additional capabilities that can enhance surgery and improve care,” he adds. In this fascinating look at the future of medicine, Fischel and host Shiv Gaglani explore his company’s technology -- which uses magnetic fields to permit finer control of the tips of surgical catheters -- and the uses it could have beyond its current application in treating cardiac arrythmias. Fishel also explains how a small company gets the word out while being dwarfed by giant global medtech companies, and why it makes sense for medical students and early career professionals to think like investors.

Subscribe

Download

Transcript

SHIV GAGLANI: Hi, I'm Shiv Gaglani, and today on Raise the Line, I'm happy to be joined by David Fischel, who's the CEO and Chairman of the Board for Stereotaxis, which provides robotic technologies for treating cardiac arrhythmias, among other interventional procedures. Before Stereotaxis, David had a long career as an investor and research analyst for healthcare and life science companies. So David, thanks so much for being with us today.

 

DAVID FISCHEL: Thank you very much for having me.

 

SHIV GAGLANI: So how does an investor go from obviously investing and looking at the healthcare industry, to then being CEO of a highly advanced robotics company?


DAVID FISCHEL: So, I worked for many years prior to coming to Stereotaxis as an investor in medical device companies, and as an investor, we were always passive fundamental investors in companies. So we would research the universe of medical device companies out there, try to find hidden gems, companies that had the potential to very positively impact medicine but were undiscovered by others.

And as part of that searching, we came across Stereotaxis. And they had developed a highly futuristic technology that actually worked in the real world, and they had very good clinical data, but for business reasons had lost its way and was almost going out of business. And we were intrigued by the technology and by the clinical data enough that we decided to step out of our comfort zone to become actually active investors. So we invested in the company, gave it capital to pay off its debt, gave it capital to invest in innovation, and took board seats. And then very shortly after that investment, I stepped in also to operate the company. That's the transition from wearing purely the investor hat to wearing both the investor and the operator hat.

 

SHIV GAGLANI: That's fantastic. So, can you tell us a bit more about what Stereotaxis does? What made you so bullish on the technology? And I know I heard earlier that there's about a 100 different places where you've already installed the device.


DAVID FISCHEL: Yes. So at its core, Stereotaxis has a robotic system that allows you to navigate interventional devices, interventional catheters with greater precision and with greater safety. If you think about the broad field of endovascular surgery, interventional medicine, where a device is navigated through the blood stream in order to diagnose or treat disease, in all of those procedures, you're handling flexible tools that have to navigate twists and turns in a body. And the control of those tools happens at the handle, at the access site, usually near the femoral access site in the leg, sometimes in the radial access in arms. And yet the actual therapy is being delivered two, three, four feet away from the access site.

 

And the mechanism of translating control from the handle of catheter to the tip is not perfect at all. It relies on rigidity of the plastic shaft. It relies on pull wires. There's all sorts of translation errors that happen from the handle, to the tip. So what Stereotaxis did is that they had this creative idea of using magnetic fields almost as kind of invisible fingers with which you can take direct control of a catheter from the tip. And so our robots are actually computer controlled magnets or mechanical arms. Those magnets are the robots on both sides of the patient's shoulder in the operating room. And then from a computer control station, a physician can control the magnetic field to take control of a catheter and move it directly from the tip. And when you do that, you have a level of precision and stability and reach that is otherwise impossible.

You also don't need to develop the catheters that are rigid. You can have catheters that are very soft, very gentle, which is obviously nice as a patient because it’s safer. And so that's really at its core. That's it, that's our technology. That's how we look to improve medicine. Stereotaxis has about a 100 of these systems out there in the world. Collectively, the physicians that have used it treated about 150,000 patients. And so there was substantial real-world validation that the technology works in a robust fashion, and there was also very attractive clinical data.

So as an investor, when you invest in medicine, you always want to ask yourself, if God forbid someone in my family, someone I know had this disease, would I want them to be treated with this drug or device. And all of us at the investment firm, DAFNA Capital, as we were looking at Stereotaxis, we said, if God forbid someone in our family had to have a cardiac ablation procedure done to treat arrhythmia, it was clear we would want them treated robotically. At its core, that's an important part of the due diligence.


SHIV GAGLANI: That's a fantastic way of looking at it. I'm curious, so there's so many applications for this type of technology. I know you've done a lot in arrhythmia and heart valves. What are some of the core things that make you most proud of, of how Stereotaxis has been applied? Any stories you can share as well as generally the range of procedures that the technology has enabled?

 

DAVID FISCHEL: Yeah, so we're actually still a relatively small company. And so we're focused really on one clinical application which is treating arrhythmias, cardiac ablation. I think that the technology has the capability to also positively impact other diseases. But for that, we would have to develop alternative interventional devices with magnets on them that could be navigated by the robot. And wherever you see clinical care being beyond what it should be, or difficulties with the reach, or precision, or safety, that's really where we would shine. And so there's a range of both endovascular and endoluminal applications that I think would be exciting. 

 

I've been asked sometimes in the past, and I've mentioned things like stroke. It's being an area which is particularly fascinating, given that most stroke patients really have no interventional therapy provided to them. Over just the last decade, you've seen more and more use of interventions to pull out clots for ischemic stroke and still most patients aren't great candidates for that therapy given the difficulty of accessing the clot, the difficulty of navigating anatomy. So I think that would be an area that would be very applicable.

In cardiac ablation, I'd say the most exciting thing and the most intrinsically rewarding thing, is not just being able to treat a broader range of patients in a way that I think improves the likelihood of success of the procedure and the safety of a procedure, but being able to treat a whole range of patients that otherwise wouldn't be good candidates at all for cardiac ablation therapy. And so we have several physicians around the world that use it to treat very complex congenital patients, children who were born with heart defects. They had to have all sorts of surgeries as children. Most of them then as they grow up having arrhythmia because of the surgeries that they were placed under as a child, and because of their different anatomy, manual catheters can't actually treat them. And so they're left with either subpar drug therapies, or with our system.  There are several physicians that have been able to do magical treatments that otherwise wouldn't be possible. So I think the ability to push the boundaries of medicine beyond what is otherwise possible, that is intrinsically rewarding.


SHIV GAGLANI: I can imagine. So that word magical resonates with me. I don't know if you're familiar with Arthur Clarke, the science fiction writer but he had a series of three laws, one of which was, "Any sufficiently advanced technology is indistinguishable from magic." So, that kind of resonates. When I was in medical school, I did some shadowing with a neurosurgeon and then also in the simulation center. And I remember one of the coolest experiences was trying to suture with a da Vinci robotic device and it takes a lot of training to get to that point. How do you approach something so innovative and futuristic?  How do you approach both educating your providers as well as educating the patients who would have to obviously go through informed consent to use this advanced technology?


DAVID FISCHEL: So in terms of educating physicians, you're right.  The core of our business lives off of physicians adopting the technology and using it. And so training is a big part of our business. Inherently navigating robotically is actually easier than navigating by hand, because if you're holding onto a catheter it's not at all intuitive that you want the catheter to turn right, and you should do this type of motion with your fingers and wrists and arms, but physicians learn it because they do hundreds of procedures during residency, during fellowship. They learn that type of muscle memory, and so you have to almost learn something that's easier, but you have to unlearn some of what you've learned before when you shift to robotics.

We've done various things to try to help the learning process. So we have a team that helps in the initial procedures and does training with physicians. We have actually built a simulator which allow physicians to work from their home computer, and navigate with a mouse and learn how to navigate a catheter in a phantom. We also started a fellowship program for electrophysiology fellows. We started a robotic EP fellows program which allows them to actually have a parallel path learning about robotic navigation. And so we've tried these various ways.

What you have is that typically, the younger the physician, the quicker they can get on it, and they can learn it very, very quickly. Because again, intuitively it's an easier form of navigation than manual navigation. We have quite a lot of actually older physicians who use us, I think to some extent, because it allows them to extend their career also. But you do sometimes have physicians who have done 30, 40 years of catheter navigation by hand. You put them behind our robot, and as much as it should be easy to navigate, and they should be able to just move their hand in slight motions to navigate the catheter, their shoulders and their arms will do dances because their body has that muscle memory that has been built over decades.

 

SHIV GAGLANI: Yeah, I can imagine. That's pretty fascinating. I didn't know about the fellowship program. That's pretty interesting. How about for a patient who's considering a cardiac ablation using the traditional method or Stereotaxis technology?

 

DAVID FISCHEL: That's actually a great question to give back to you because as the CEO of Osmosis, to some extent, one of your big efforts is to democratize knowledge, right? To make knowledge accessible much more broadly. And I think we've lived in this historical world where it's obviously been gradually transitioning. But years ago, to some extent, whatever the physician prescribed that was it. There wasn't a real way for a patient to do their own due diligence to learn what was out there beyond what the physician prescribed them. We've shifted much more to where patients are smart also, at least a subset of patients are smart consumers, and they want to understand, and they want to do their own diligence and they want to explore.

And so as part of that, we have been trying to improve our website, trying to improve our social media presence. We have videos on YouTube that describe how a robotic procedure exists. And I'm very much of the philosophy that open access to information is ultimately the best policy. There's a little bit over 400 publications, scientific publications, on our technology. We put them all online in a searchable database, and we included all the clinical data online, again with the goal of having open access to information.

And again, it's very difficult. We're a small company. The field is dominated by companies that are two orders of magnitude larger than us. Just their electrophysiology divisions, let alone the overall company which is three, four orders of magnitude larger than us. And so we have a small megaphone, so you can do it in your own way by providing open access to information, by celebrating the hospitals and the physicians that use our technology, and giving them the tools to be able to vocalize their technological and clinical differentiation in the community. And so those have been some of the tools that we use.


SHIV GAGLANI: I couldn't agree more with the democratization and consumerization of healthcare. As long as we get informed consumers, I think then they'll make the right decisions that are guided by clinicians, regardless. One of our recent guests is Dr. Aseem Desai, who is an --maybe you know of him -- electrophysiologist. He wrote the book, Restart Your Heart: The Playbook for Thriving with AFib. And so he's definitely someone I would like to send your episode to directly to and then-


DAVID FISCHEL: By the way, he's based in Southern California, and he actually has used our technology at Mission Hospital in Orange County for probably nearly a decade. And so he knows our technology very well. He's been a great supporter for many years in advancing the technology and advancing the clinical understanding.

 

SHIV GAGLANI :
That's awesome. I actually didn't know that connection. So that's great. I'll definitely make a note of that. And then another person we're going to have in a couple of weeks is a friend of mine, an Orthopedic Surgeon named Dr. Justin Barad, who started Osso VR, which is a virtual reality training company. So, a potentially interesting connection for you because like any in-person training, whether it's the fellowship you're talking about, one way to get more and more clinicians to be trained up is to give them the virtual reality access or those SIM centers-type experiences. So have you guys explored virtual reality training for your devices?

 

DAVID FISCHEL: We have less virtual reality training because our procedure is being performed on a screen with a mouse and keyboard. So to some extent you could do it on any laptop, any computer. And that's why we bought simulators instead. One thing that's interesting, if you think about the benefits of robotics with, let's say the da Vinci system in laparoscopic surgery, or if you look at the orthopedic surgical robots, or if you look at our robot, typically what we've talked about to date are the mechanistic benefits, precision, stability, safety.

I think there's a whole class of benefits beyond those mechanistic benefits that are only at the earliest stages of being tapped. Once you digitize operating room information and you put the physician behind a computer, you allow for a whole range of additional capabilities and tools that can enhance surgery. I call it the digital surgery revolution where you can provide data during a procedure. You can provide different image integrations that might not otherwise have been possible. You can provide things like remote support. You take the operating room from being a very isolated place in space to being a digital theater. And so that's something where VR, perhaps in the future, perhaps as VR also improves over time, and the tools that are disposable improve over time it might become also much more interesting,

 

SHIV GAGLANI: That's really fascinating. I think a lot about unmanned aerial vehicles and how for years people had to train to become pilots. And then now they're basically playing a video game, being able to fly these very complex pieces of machinery in the air, maybe from a totally different country or continent where they're seated. I'm curious, is that sort of the vision you all see as well, where maybe a very skilled surgeon could be sitting in Arizona and then doing surgery in an operating theater in Africa with maybe some other surgeons in there who they're helping teach along the way?

 

DAVID FISCHEL: One of the most interesting things that has taken place over the last six months given the pandemic, has been this broader acceptance of the concept of remote working, remote learning, telemedicine. And Stereotaxis has always had a capability to -- or at least for many years now, five, ten years -- to remotely support physicians during their procedures. So we have a team that actually sits remote, and can see everything that the physician sees on the computer screen -- the x-ray, the ECGs, the maps, ultrasound images -- can see that collective set of screens in the operating room, and can then provide remote technical and clinical support for procedure. We obviously saw the acceptance of that type of support go up significantly during the March, April may timeframe. And we also rolled it out much more broadly across our entire clinical support team.

And when we think about telemedicine, I think robotics serves as almost a necessary foundation for the future of telemedicine. We think about telemedicine actually along the spectrum. We're in the most practical happening today, every day several procedures are being supported using our telemedicine capability. But the most impactful thing in the future is tele-robotic support -- industry supporting procedures remotely -- and that doesn't have to be necessarily at the expense of in-person support, but it allows you to also have different layers of support. There's a limit to how much any individual's industry rep can know about the range of technical and clinical complexities that might be seen in any individual case. Now you can have layers of support where there's an issue or if there's a clinical question, you can have multiple layers of that higher level support available.

So that's the first. The second is tele-robotic collaboration which is very similar to telemedicine support, but it's peer to peer collaboration, enabling physicians to work together and to share best practices, to learn from each other in a procedure. And we've actually seen more of that also take place with certain hospitals, and sometimes between hospitals using the same network that we use for support, but using it to collaborate. And then the third step is what you were talking about, which is actual remote procedures. A physician in one location treating patients who are in another location. We've had several of these cases. Actually in July, we hosted a tele-robotic symposium, and a physician in Portugal and a physician in Italy, each one were treating a local patient and at the same time helping the other treat a patient at their respective location.That showed that you could navigate catheters remotely without any particularly complicated IT set up. Using our connectivity technology, you could allow that type of procedure to take place. 

 

Over time, we have heard from many physicians that practically, there is a difference in the level of care that is provided when you have physicians who have a lot of experience in a procedure, versus physicians who rarely treat a specific type of arrhythmia, in our case. And so being able to allow patients, irrespective of the location, to get the same level of care would be of great benefit overall. It's again democratizing access to care. And so that's something where I think over time, we will see more of it.  It's less a technological question, it's more of a societal question. Does society accept that? What questions does that raise in terms of liability, in terms of consent, in terms of reimbursement? I think those are things for society, and for governments, and insurers, and service providers. They'll have to think much more about that in the coming years.

 

SHIV GAGLANI: That's a fascinating breakdown. I hadn't heard it laid out in that spectrum, but we've had a lot of telemedicine guests over the past few months on Raise the Line. And the reason we called it a Raise the Line is because it's all about increasing health capacity which is clearly the vision you're laying out. You don't need the most specialized surgeon in every rural hospital, but if you had a core of them who were capable of working with people in those rural settings and providing them care, that would increase health care capacity. So that's a fascinating and interesting vision. Do you ever see it going to the point of someone who isn't necessarily even surgically trained, again, like in the pilot example, there are people who are controlling the UAVs, unmanned aerial vehicles who've never flown planes before. Do you ever see that happening? That's probably a societal question, but I’m curious.

 

DAVID FISCHEL: Well, so I think they have to step back and ask, what's the role of a physician, and maybe this gets us back. It can be applicable to the telemedicine question, but it's even applicable for the core robotics -- forgetting about the telemedicine question -- is what's the role of a physician? Let's talk about surgeons or procedural physicians. They have two big skills: they have a cognitive skill, which is somehow being able to determine what should they do to treat the patient. In the case of an electrophysiologist during the cardiac ablation procedure, they have to look at ECG. They have to look at a map. They have to understand the patient's kind of arrhythmia, and they have to try to determine what is the best way to treat that patient.

And then you have a mechanical skill, which is, given what you know about the patient and how you want to treat them, can you get the tools at your disposal to actually execute as you wish? The whole role of robotics is to reduce as much as possible the need on the mechanical side, and allow you to focus as much of your energy and time and effort on the cognitive side. And I think when you do that, you enhance the physician, you make them not a plumber. You make them a thinker, right? A strategizer or a designer of the therapy which is better for the patient. Because as a patient, I want my physician to put all their attention to thinking about me, not to them thinking about how it's hurting their back now that they've been standing up for six hours today, and that they're having to hold their body in a very specific position. So I think that's really one of the big goals of medicine.

Again, could you see a future where if robotics was ubiquitous, where a physician wouldn't have to learn at all, had to do manual navigation of a catheter, and they could just learn the cognitive aspect, and they could just be sitting remotely and that's the way things happen. Yeah, we're probably still decades away from that type of reality, but you have now many radiologists who almost their entire profession they're seated at a computer at home or an in-office, and they're just reading scans. And to some extent, is it possible that things evolve that way? Yeah, that's possible.


SHIV GAGLANI: It’s a fascinating vision to think about. And another quote I like is that "The future's already here, it's just unevenly distributed." And so clearly some of the stuff that you guys are doing out in St. Louis is the future. It just hasn't reached as many people as I think it's capable of. So, I know we're coming up on time, but the last two questions I had for you are, the first is, our audience is current and future healthcare professionals at Osmosis. What advice would you give to somebody considering a career as a healthcare professional, especially given all that’s happened this year with COVID and moving forward?

 

DAVID FISCHEL: That's a very, very broad question. Medicine is intrinsically interesting. It's an intrinsically rewarding profession so it requires a lot of effort, a lot of time, a lot of dedication to go into, but it's an intrinsically rewarding one. I think both because it's fascinating, biology is fascinating, and because it's rewarding to treat disease. I think coming from the industry side, what I'd say is that technologies only get improved due to the learning and the interaction between scientists and developers and good physicians. And so it's great if you have the interest in it, it's great to be involved, to try to see how -- almost put on like an investor hat -- how do you think your field of medicine is going to evolve over the next 10, 15 years, right? Try to find the innovators that are working on those types of technologies, and then try to hand hold them down that path. Real progress only happens when the two work together in a good fashion.

 

SHIV GAGLANI: Yeah, that's a really good point and interesting analogy of having people who are pursuing careers in health care to think of themselves as investors, where they invest in becoming a radiologist, for example, given all that's happening with AI and whatnot. So my last question is, is there anything else that I didn't ask you about that you'd like our audience to know about you, about the work that you're doing at Stereotaxis or anything else?


DAVID FISCHEL: It's very hard to answer broad questions. So, no. I’m delighted I got to join you today and it's nice to be able to connect with the next generation of leaders in healthcare. Again, collectively, we're all little soldiers in a very a big battle, to push forward. And sometimes you get something like statins and it moves many a little bit forward, and sometimes you get a really good targeted therapy for a specific type of cancer. But there's still a big battle out there and all of us are a part of that war to improve human health.


SHIV GAGLANI : I love that analogy. That's really interesting. And hopefully we can all not just Raise the Line, but push the line forward as you're saying. So with that, David, thanks so much for not only taking the time to be with us today, but for your leadership on the robotic surgery front.  I’m very excited to follow Stereotaxis’ progress, and to see what other conditions will benefit from the work that you and your team are doing.

 

DAVID FISCHEL: Thank you.


SHIV GAGLANI: I'm Shiv Gaglani, thank you to our audience for checking out today's show, and remember to do your part to flatten the curve and Raise the Line. We're all in this together.