The 3 T’s – Technique, Technology, and Teaching – with Steve Charles, MD

PODCAST EPISODE 288

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Legendary retinal surgeon and innovator Steve Charles, MD, has a long list of accomplishments. He’s performed more than 40,000 vitreoretinal surgeries, lectured in more than 50 countries, and operated in 25 of those countries. He’s also authored 150-plus medical articles and the go-to text, Vitreous Microsurgery, which is coming out in its sixth edition (with a complete rewrite of every chapter). Dr. Charles speaks five languages, has degrees in mechanical and electrical engineering, and was a fellow at the National Institutes of Health. He also has, at last count, 106 issued or pending patents.

Dr. Charles has been in practice for 46 years and has no plans for retirement. He continues to perform more than 700 vitrectomies during his 52-week work year. He hasn’t been on vacation in 25 years, spends his nights, weekends, and holidays studying engineering or stem cell biology, doesn’t have a house, a wife, or pets, but instead he has jobs and that’s the way he prefers it.

Click “play” and listen in on a fascinating discussion about:
• How Dr. Charles’ background in engineering became the foundation for solving problems by building better medical and surgical devices.
• How his relationship with industry began and why he chose to formalize an exclusive consulting agreement with Alcon over the past 30 years.
• The many techniques and technologies that he has developed that have been adopted by thousands of surgeons around the world.
• Where he thinks there’s room to improve in techniques and technology today.

Transcript:

Firas Rahhal: Welcome back, everyone to the OIS Retina podcast. Again, this is Firas Rahhal. I’m the host. I’m a member of the Retina Vitreous Associates Medical Group here in Los Angeles. I’m also a partner, and a founding member of ExSight Ventures, which is centered in New York and also here in Los Angeles. Today, I’m super delighted to have an amazing guest. He happens to be my friend, but he also happens to be a legend in our business of retina surgery. And in a lot of aspects of retina surgery, retina development, retina innovation. Everyone who has been around this business, even for a minute, in the last 40 years, knows who Steve Charles is. My guest is Dr. Steve Charles, I can’t give his fair bio, because we’d spend the next 90 minutes doing it. But I’m going to I’m going to do a quick list of a few things, just to give a background on some of the amazing accomplishments. And then I want to talk to him for the next 30 to 60 minutes about some of these great accomplishments and the future. Steve has performed himself over 40,000 vitreoretinal surgeries in his career. He’s lectured in over 50 countries. He’s operated in 25, which is amazing. Steve has authored a textbook that we all know about. It’s now in his fifth or maybe sixth edition Steve?

Steve Charles: Sixth edition is at the printer and released September eight.

Firas Rahhal: 5 languages. He’s published over 150 original articles and 47 book chapters at last count, although I’m sure that’s still growing as well. He has a background education that includes mechanical and electrical engineering. Of course, he has a medical degree residency in ophthalmology fellowship at the NIH in vitreoretinal surgery and other things. And I assumed you had a lot of patents, Steve, I didn’t know quite how many 106 issued or pending patents at last count. What a run! We can’t cover it all in one second, but maybe just start with a little bit of the medical training background that you did some NIH I know and maybe you can tell us about some of that in your residency experience.

Steve Charles: Sure. I went to med school in Miami and my dad was a professor at the University of Miami undergraduate, he was our professor and so he knew Dr. Norton, the founder of Bascom Palmer, and but I decided when I was an engineering school that I wanted to one continue engineering throughout my career and two I wanted to be a micro surgeon so that my first I didn’t have any money. I stayed in the VA in Coral Gables, part of the University of Miami med school and I was a blood draw at four o’clock in the morning. They had free room and board. So I hung out with the eye residents. I watched a little EMT watch little neurosurgery. It was a slam dunk. I want to be an ophthalmologist. We’re talking about two weeks into med school firm decision ophthalmology, already started hanging with the retina people started working at the Bascom-Palmer in the lab built an ERG machine from scratch, built the DOJ machine from scratch, built an ultrasound machine from scratch, built an infrared pupil autography machine from scratch. And so I’ve operated on monkeys and cats. In the middle of the night, as a med student when I was on call, I’d be in emergency room and then run over there and do monkey surgery two or three o’clock in the morning by myself. And I did that all through four years of med school internship. And during my three years of residency, and then Dr. Norton made an arrangement with NEI, they had like 400 applicants, they took two people, and I was fortunate to be one of them. And I built the vitrectomy program there. So there was an agreement that I would be trained in vitrectomy by Machemer as a resident so I could bring the vitrectomy program to NIH. So I did the first cases ordered the equipment, train the team, and then it started development work. So I’ve invented endo photocoagulation, fluid/air exchange and endo drainage cervical fluid, built the first real time grayscale v-scan, hand built the first endo photographic layer myself. And while I was at NIH, finally finished there went into practice. Memphis is a low-tech city except in spine and orthopedics. So it’s big metal cutting stuff, but there’s no electronics and photonics. So I traveled a lot, and I began flying jets and I communicate a lot to Orange County. And I built a company out there that Alcon bought that resulted in the Accurus and the Constellation. But before that, I have Carl Wang build at MidLabs, which is the MDS machine. And before that, I developed the Ocutome 8000, which was the first linear section machine with Coopervision. So the engineering has continued. It gets harder every year because it’s more complex, the easy stuff has been done. The Constellation had 14 processors and 750,000 lines of code. And the next generation machine I’m working on the Alcon will have more lines of code and more processors and more functionality. So it ups the game, or you have to study instead of microprocessors FPGAs and GPUs, and bus architectures and real time operating. systems and such things and motor control schemes. So I’m continuing to teach myself engineering. So every single holiday night weekend, I’m studying engineering, or Stem Cell Biology, because I’m doing a big project at the NIH without around replacement.

Firas Rahhal: It’s a lot that you’re doing now we know and I’m absolutely coming back to the here. and now, after I hear a little more about the background, you mentioned Alcon your association, decades long association with Alcon and you’re instrumental. In fact, creation of Accurus and Constellation are well known to anybody who does this surgery like myself. And by the way, the Constellation is phenomenal. When you started way back after finishing your training, and it sounds like you were already doing a lot of engineering and innovation during your training. Was it your goal? What was your first goal be a great clinician? Was the innovation part of it? Just a part of that equation? Was it your goal to innovate new things? Or did that just come about in the course of solving problems?

Steve Charles: It’s really a problem-solving thing. When you look at engineers, I mean, habits are just a business strategy isn’t about how many you got on your wall. It’s not something you stuff your resume or CV with. It’s a business protection. So my goal wasn’t to have X number of patents. My goal wasn’t to be famous. My goal was to solve problems that we experienced every day in the operating room. And people have said to me things that I find ridiculous, quite honestly, they’ll say, well, if you like engineering so much, why don’t you quit surgery? That’s like saying, let’s have an aeronautical engineer that’s never been in a plane. How great. Thank you, you know, the best aeronautical engineers are also pilots that fly heavy duty aircraft, you know, and I happen to fly jets. And I saw I know a bit about that as well. But high-volume surgery, plus developing the equipment or go hand in hand. Many of the techniques I developed were on the fly in the operating room, I was at the NIH, I did a penetrating keratoplasty took the button off, I knew there was a cataract, I could see that, I thought there was a vitreous sandwich, took the button off, take the lens out. And there was a detachment behind the vitreous hemorrhage. And I said, You know, I think I’ll put the vitreous cutter in the retinal brake and drain all the fluid out. I said, Whoa, random went flat. I saw the button on book an hour and a half. And I said, why we should always drain through the retinal brake. Why don’t we do a cut down to the square the way Machemer did? And so that’s how endo drainage came about. I wanted to build the eye were there. And I said, You know what, I think I’ll connect there to the infusion system and the vitreous cutter, why are we injecting with the separate needle the way Machemer did, and flattening the eye out and reinflating it with gas? Let’s do fluid. So a lot of things happen on the fly, or I’ll be in the operating room, and I’ll have an idea. And then I’ll make notes. I’d be with my laptop right outside the door of the OR. And I’m constantly working on PowerPoints for the engineering team and working on what they call memorandums of invention and patent revisions in between cases. Well, the teaching is a natural outgrowth of that my dad is a college professor, and he was a terrific speaker. And I used to be his projection. So I go to all his lectures and run the slides for him, and I learned a certain speaking style that seems to work for me. So I don’t speak about stuff. I looked up in textbooks and copy articles out. But statistics up, I speak about stuff that I personally am involved in all day, every day that I much of which I’ve actually developed.

Firas Rahhal: In makes for talks that are much better, honestly, I think when you have somebody on a podium, speaking, really off the cuff based on personal experience that, that doesn’t need rehearsing or even slides, it comes off much better, because it’s real knowledge, it’s real time rather than sort of just you know, regurgitated I agree totally.

Steve Charles: Yeah, I call the regurgitate or slide readers.

Firas Rahhal: Sort of, it’s totally true. I find the making of slides, kind of the worst part of preparing to do a podium talk. I actually like the talk itself, but preparing the slides seems like even regurgitation for yourself sitting at home. When you started doing all these things, and of course, there’s the Alcon Association, but you mentioned MVS, and so many other developments. A lot of this has to be done hand in hand with industry. You have a great reputation with industry, you’re in great demand for companies to get your assistance and help. How did that start? Did they seek you out? Was it happenstance? How did the relationship with industry begin?

Steve Charles: With regarding you know at the NIH, of course it’s there’s no industry involvement by definition. So the patents the first patents I got at the NIH were on a syringe drive and a chin switch and L and NEI own those and then the real time grayscale ultrasound there was a vendor in town that worked at the National Bureau of Standards that build an ultrasound for my design with me, and then I commissioned him to build a personal unit remian members then people started buying them, but with respective industry guide that I’ve lost contact with almost immediately said can I show you the Conor O’Malley detraction machine the Ocutome 800, and I was using the device rotor extractor my first year in practice, he brought by us that this is it, this is a homerun yet, this is a great idea. This is far better than Machemer’s devices approach, you know, provided three port vitrectomy instead of one port vitrectomy. And so I didn’t approach them, they approached me and so we bought one and I adapted fluid/air exchange into photocoagulation, scissors segmentation, retinotomy, subretinal surgery, all these techniques that about I adapted them to that, and I went to the Academy in Las Vegas, and their sales rep was really a fireball. And he said, Steve Charles, the foremost advocate of this machine, I didn’t get paid, I didn’t, I wasn’t the investor, I didn’t own anything. So all these people slide up outside some hotel room while I gave speeches on the Ocutome. So that was my first sort of KOL experience. And then I started working with Berkeley and pretty soon Coopervision bought them. And I started working with them. And again, in those days, I didn’t even get paid a payment and transportation. And, but that’s how linear section or proportional vacuum got in bed is the first patent that ended up on a machine. And that was the Ocutome 1000. And Conor O’Malley was a real sweetheart, we lost him, unfortunately, several years ago, and Conor was came and stood by me and gave me a hug in front of the machine. So instead of being threatened by he was he saw the future that way and was just very gracious about it. So then I’ve Coopervision didn’t want to do disposable cutters. So Carl Wang and I started MidLabs, it was incorporated in Tennessee, I raised the money, I wrote the business plan. I didn’t make any money on it. But I, that’s where the first disposable cutter with our last shape came about and much faster for weddings. And so that was MidLabs. And then I flew around the country trying to get companies to buy MidLabs for stores, which became B&L, and then others and then I got Alcon to buy. And finally, and I didn’t make any money in that transaction either. But I was supposed to get a finder’s fee. And it didn’t work out, right. And I said, well, I’ll start my own company. So I started InnoVision. I raised all the money for that. And we had 100 employees and built a machine to actually used in the operating room. And so that’s how, and that’s what led to the accuracy in the Constellation. So then in 1991, when Alcon bought the InnoVision Technology, then I got a formal consulting agreement. And but because they bought ACARS, I didn’t get a royalty on that. But then I had a bunch of intellectual property that resulted in the Constellation. So I did have a 10-year royalty run in the Constellation.

Firas Rahhal: I liked it use the term KOL, which is now a commonplace term in our specialty and others. And I always had some issue with it. But I’ve come to know what it means today. And I have an understanding of what it meant to me then I was a resident in 1991, some of the time periods you’re talking about, and I had the fortune of training under Stanley Chang and learning about some of those machines and I had a different impression of KOLs then, do you get the sense that sometimes today the KOL industry relationship can be the tail wagging the dog, sometimes it seems like people make themselves into a KOL. Whereas in a situation like your own, you’re doing the deeds and doing the work. And so you were sought after in order to be a consultant because you’d already done the work. It seems sometimes in reverse now is that am I exaggerating?

Steve Charles: I couldn’t agree with you more. There was a guy who actually served 42 months in the penitentiary. I won’t mention his name that was here in Memphis for Medicare fraud with faking Lucentis injections. And he was sought after at one time to be an advocate for PDT and later for Lucentis. And I called the company and I said, Look, KOL, K you’re supposed to have K – Knowledge, O your Opinion is supposed to matter and L you’re supposed to be a Leader. He’s none of the above. He’s a high-volume user with a big ego. And it turns out he was not only doing it properly, so the Medicare lock him up. But that doesn’t count. It’s not about being a high-volume use of the product. My situation is unique. As you will know, when you go to meetings, it’s commonplace for people that are really bright and effective people like David Boies, or your partner and David Brown that are the leaders in medical Retina, to consult for 25 or 30 companies. And that’s perfectly fine. It makes perfect sense in the pharmaceutical space. But with the equipment side, I wanted to be an insider. I want to be a real engineer, Alcon’s team where I’m talking about manufacturing processes, but and literally helping influenced choices of bus architectures and processors and motor control theory. You can’t do that in the normal KOL, where it’s a very formalized meaning, hey, Doctor, what do you think about this, and there’s five of your colleagues there. And they all have pine and how it works, I don’t want to be one of those guys. I call that a wine tasting. And so that’s why I only consult for Alcon. So since January of ’91, I’ve consulted for one company, I did consult for GRI Schober, Intel. And then of course, Alcon bought them. So that’s it, and all those years. So we do clinical trials, but I’m not a consultant for anybody else. Never. And that way, you’re an insider, and you can really help them with building product.

Firas Rahhal: I agree 100%. And I’ll add some color to that from my side. And I won’t waste any more time from myself on it, but as an investor, and I’m involved in a lot of these meetings, with startups deciding whether to make an investment with the VC firm or not. And so you hear from their KOLs, or they’re giving you the names of their KOL is most of guys that I actually know, and I’m friendly within what I have found is when you put all the KOL so to speak together on a panel, and they’re all at the same time, it becomes a bit of an echo chamber, no one ever disagrees with each other. So the consultation from the investor side, which in that when I’m wearing that hat, it becomes almost not useful, because it all said, Yeah, and they’re agreeing with each other. Where are you really want to hear who’s got a negative opinion on this product to help me decipher if this is worthwhile carrying to the finish line or not?

Steve Charles: Yeah, and I, you know, one of the things that I realized is that with companies is that if you’re going to get product out there, if you can possibly work with the market share leader, that’s how the product gets into most doctor’s hands and helps the most patients. So Alcon’s, the market share leader and has been throughout the duration of the 30 years of working with them. And now that means because they’re big, that the kind of the decision making is very complex. So there are numerous people on the commercial side and marketing and sales that have input, even people on the service side or that’s hard to fix, it’s hard to repair, the warranty costs will be too high. So it isn’t about talking to your sales rep who introduces you to one marketing guy. That’s how most dogs get involved with companies. With me, it’s talking to line engineers, 150 engineers on the next generation, big COVID machine 150 engineers, I know two thirds of them on a first name basis and talk to them on a regular basis. So it doesn’t get funneled through you know, one door. But that’s because I don’t consult for anybody else. And they know that they share an idea with me, it’s not going outside the company.

Firas Rahhal: Yeah, they’re definitely the 800-pound gorilla and for good reason. They’ve made unbelievably great products for a long time. We’re all using them every day and addicted to them. I’m going to ask you a question that may be hard to answer, maybe not like asking to choose, which is the best of your children. And in your case, there’s 20,000 examples but of all, because then that want to move on to what you’re currently doing. But of these myriad of previous accomplishments and developments and innovations and in the surgery itself in the patients. What do you think about most often when you’re taking a moment to feel gratified about what you’ve done? Is there a certain aspect of this run that gives you the greatest feeling of joy or what?

Steve Charles: Well, it’s interesting, it’s in two categories. And I’ve never thought about that specific question till this moment, but the techniques are different than the technology in this sense. techniques can work on many people’s machines. So endo drainage is so bad, and a fluid is not machine dependent. And a fork regulation isn’t such a segmentation system, the lamination ports of every building, Retinectomy, subretinal surgery, those are techniques that every vitreoretinal surgeon in the world uses, and those impact a lot of patients, and they’re independent of the machine. So as a surgeon, and a teacher, I’m glad that those things work out that everybody uses them. Nobody says, Oh, that’s a bad technique. We don’t use that everybody uses that list. Now with respect to technology, each generation has been far more complex, more lines of code, more components, more processes. And obviously the Constellation at the moment is the ultimate. But that said, next generation phaco machine is I haven’t I can’t talk about it because it’s pre launched. But it is an extraordinary machine. I’ve done pig eye surgery with not living pigs. And I’ll do that again this coming Friday as a matter of fact, and it’s so that will be the machine I’m the most proud of. But it’s you know, sitting on the top of the calculation and the accuracy and the MDS and before that, the Ocutome 8000.So it’s my fifth-generation machine.

Firas Rahhal: It’s gonna be super gratifying to hear people use the term air fluid exchange or fluid air exchange like I do 10 times a week as you imagine as a retinal surgeon and know that that was coined because of something you did first and shared with the rest of us. That’s amazing, man, really.

Steve Charles: So it’s sometimes when people ask me, what do you do I say the three T’s, technique, technology and teaching and they all have massive overlap. None of them are freestanding. They don’t compete with each other for time. They’re all part of the same story.

Firas Rahhal: Good. I want to talk about teaching with you in a moment, but first, give me a little we’re gonna get to the present. Tell me about your current practice. It sounds from previous conversations we’ve had you’re still full steam ahead in the clinic and in the OR what’s your practice like? You have partners are you solo flyer?

Steve Charles: We have, I have an MD partner, two MD partners. One was surgical and now does medical only and is a world class RFP expert. We manage over 190 beds, Nikki beds, we have the biggest RFP practice in the country or in the world. And Dr. Paul Runge does that. And he trained with me 30 years ago and then practice in Sarasota and then came back a little over two years ago, and it’s been a real blessing for the fellows. And for the RFP babies. It’s extraordinary. And then of course, he sees medical renovations in the office, although he’s surgery trained. And then Stephen Huddleston is an associate he trained with me where the through residency and fellowship and then been an associate and owns half the practice with me, we have two full time optometrists whose job is liaison with the optometric community. And the senior one is the most respected optometrist in the country in terms of retinal imaging. So he gives all he knows the Heidelberg and Aptose. And all this stuff inside now and has been involved a lot of clinical trials on equipment. And so we have a good team that way, I see 70 to 75 patients every Monday, and every Wednesday, the two patient days. And then once a month, I see about 55 at our satellite and Mississippi, and Oxford, and I did 682 vitrectomies in 2020, the COVID year, and I’ll probably do 750 this year. So that’s 16, 17, 18 a week, 15 a week, but I work 52 weeks a year, I’ve never been on vacation and 25 years. I don’t have a house, I don’t have a wife, a bird, a plant or fish. I got jobs.

Firas Rahhal: That is incredible, man. 700 plus vitrectomy is a year that that’s super high volume. And I know it’s right because you’ve been doing it a long time.

Steve Charles: 46 years.

Firas Rahhal: 46 years now since you finish.

Steve Charles: was a little bit in practice 46 years as of July 1st.

Firas Rahhal: Obviously, no sign of slowing down?

Steve Charles: No slowing down and no interest in retirement. I know. People say Don’t you want to smell the roses should not make you sneeze?

Firas Rahhal: The roses or the OR for you and maybe some surgical device? There’s nothing wrong with that.

Steve Charles: Around here. People always say, is this is your calling? And I say no, I must be on call forwarding. Nobody’s called me.

Firas Rahhal: Very good. With all the surgery and all the development. So what’s next for us? Like the next generation that will come post-Constellation. Of course, there’s always one in the works. I’m sure you’re involved in some of these projects, if not all of them. Where do we still need to improve a lot with technique and or technology in the OR what’s next.

Steve Charles: The next generation phaco bit will have a new approach to fluidics that which I am very proud of I did not invented but I endorse it and I played a role in it. They it has some other features that I think will be great. But actually I think the biggest impact is on visualization I bought out of my pocket, not the surgery center, not the hospital. The first ingenuity in the country, I don’t get a royalty. I didn’t invent it. But now I’ve invented a bunch of stuff that goes on ingenuity 2.0. And that will make visualization far better. It will help us deal with multi-focal iOLs, it’ll help us deal with glare, it’ll improve color quality, as well as resolution. And so I’m actively involved on the photonic side and making ingenuity 2.0 a lot better than ingenuity. But I do every case with ingenuity, except for a few that have to do at the Baptist Hospital like I do this morning. But so visualization is the next big thing. The other thing I’m involved in is on a big project at the NIH. I built a vitrectomy program there back in ‘73-‘75. They never had vitrectomy there before. And about five years ago, Juan Emmeraal whose was the top vitreoretinal surgeon in Peru. Well, he contacted me he joined the NEI probably 15 years ago. He wanted to do bench research and he does a ton of animal surgery. We’ve done over 500 pigs so we’re using venipuncture to extract cd 34 positive hematopoietic stem cells from the circulation, those are then transformed first to neural crest cells in tissue culture to authentic RPE cells on a biodegradable sky fold. I’m not a believer in perylene, or any permanent material scaffold, I think it’s going to cause inflammation, I believe in a biodegradable scaffold, it’s ultra-thin, low volume. So there’s a high density of the RPE cells that have to be oriented in a monolayer. And they’re inserted onto the macula through a tiny retinotomy, two by four-millimeter patch. And I’m doing my first patient Thursday of next week, after doing many, many big surges up there, the team has done 500 and I’ve done probably 30, then, and I helped them improve the technique and develop some of the instruments that have that are special for this insertion of this very flimsy monolayer of cells under the macula.

Firas Rahhal: So this is, I’m glad you brought it up, because I wanted to ask you about modern regenerative medicine in your interest and your role and thoughts about it in this specific project. You’re talking about an RPE sheet is this for geographic atrophy potential.?

Steve Charles: That’s the first round and we were approved to do I’m approved to do up to 12 patients by the FDA one at a time. But we’ve in the lab, we’ve also done with one scaffold of photoreceptors on the top and RPE underneath properly oriented. And those have been implanted in the pig model of GA and they work. So we can do what we call outer retinal replacement, both RPE with autologous cells. So there’s no rejection, not embryonic stem cells that require immune suppression, so no immune suppression. And with autologous cells, and that’s extremely exciting, literally, they do 25 different tests to guarantee the cells are safe and effective. So they’re not, for example, peripheral RPE doesn’t support the macula. Built has been published on that 30 years ago. And it has to be the RPE that belongs under the macco, ectopic macros lose vision in their 20s and 30s. So it’s not just any RPE, it’s not only authentic, it’s not only safe, but think about it, it’s new, its nascent. So when you have a disease that although it’s genetic DME, dry AMD, geographic atrophy, it takes time. And so now you’ve installed you know, baby RPE, which is exciting. And so I’m really fired up about that and with replacing the photoreceptors as well, we work with David Gamm at the University of Wisconsin and a company out there called Opsis, Fujifilm put 400 million into cellular dynamics in national those offices. So that’s where there’s technology sharing back and forth between NEI in this bunch of University Wisconsin in Madison and a spin off huge company there. Jamie Thompson is the Co-inventor of in Duisburg potential stem cells is there at universities not so very exciting projects. I’m not involved in gene therapy at all. But I study it and kind of know what’s going on. But I think the whole cell-based products, not cell suspensions, they do not work. You can’t inject cells under the retina, you make PVR. If you inject stem cells in the eye and make a teratoma or a scar, so you have to make sure the cells are proper in a proper orientation and a cellular construct outside the body and then implant it.

Firas Rahhal: I think that makes a lot of sense. I’m familiar with that program. And I been directly involved here in LA with Mark Hamayun’s RPT program, which is apparently a patch, you’ve read the papers we did 15 patients in the first cohort. And that’s just an RPE layer. It’s a brilliant concept. And I do think that this sandwiching and being able to do both layers simultaneously will be the best, maybe next frontier is the idea is that if the GA is already there, the geographic atrophy, and you put the RPE cells, well, maybe that’s too late, that the cones are maybe already gone. So maybe it’s gonna have to be the sandwich approach, as I call it, but both layers and that’s

Steve Charles: We got a quite a few pigs that way, but the protocol costs for us doing RPE first has to be autologous can’t be cryopreserved according to the FDA. So that’s what we’re doing.

Firas Rahhal: I agree with you also about the injection part I it still escapes me a little even though I’m involved in some of the trials of some of the injection protocols, injecting cells freely in a liquid form and expecting them to reorient and create a layer it seems. It seems. Look, I’m not a biological scientist in this regard, but it seems a long shot.

Steve Charles: Yep. They don’t engraft properly. A cocktail party runs through any eyes program. He’s absolutely brilliant. And we discussed the various options that are out there all the time. I email four or five times a week and he certainly would agree with you and that’s who taught me this he and David Gamm at University Wisconsin. So I’ve learned so much from them.

Firas Rahhal: You’re a surgeon, I mean, you’re gifted surgeon. So do you do feel then down in your heart of hearts that we could turn, GA and other kind of medical retina conditions into surgical diseases? You think these can be surgically corrected?

Steve Charles: I do. I think, you know, once cells are gone, no pharmaceutical agent is going to make them come back. And injected suspension themselves makes doesn’t make it doesn’t engraft and it can make PBR. So I think this Yeah, it’s invasive, sir, the real issue is, the larger the area that you’ve replaced, the larger the load. And that’s the challenge. Now, Mark Hamayun, of course, believes you can fold the perylene, I’m concerned about cell adherence, once you fold, so we’re not folding, we have a two by four-millimeter patch, with a very special canula that we’ve had that is protects the cells in the canula.

Firas Rahhal: So your insertion device for the subretinal space is a proprietary specific device for this procedure.

Steve Charles: Yes, and it has very low surface activity. So the cell stopped becoming here, too. It’s kind of like Teflon, and there’s patent applied for that it’s curved. The material science of it was my idea. The curve was their idea, because you want to inject tangential to the retina, you can’t take a monolayer of cells and come at a retinotomy this way, it just scrolls it up, like go into shape. So you have to come at it at an angle almost tangential to the retinal surface to get it to insert properly. And the tip of it the design of it’s very properly done in order to not scrape the pigment epithelium or the photoreceptors, and make sure there’s no leak as you ease this thing at the center of the space with Ilan Pro.

Firas Rahhal: You’ve identified exactly something I’ve spoken about with some of the guys who’ve developed this concept, that curvature is key and you’re trying to bang it against, you’re going through the retinotomy in the wrong direction. And you do need a very specific device with that curvature or bend to slide it in properly without damaging the already present RPE or choroid, or the device or the implant itself.

Steve Charles: You’re absolutely right. Absolutely.

Firas Rahhal: And so, are you just for techniques since a lot of our viewers are virtual retinal surgeons? I’ve done these and participated in these are you planning in the early cases to put oil not laser the retinotomy, laser the retinotomy? And if you put gas or both? What are you thinking on those early cases?

Steve Charles: Gas, no oil, no laser. The retinotomy, what I do is I press the edges together. Like for when I used to do some magnet or surgery for like a histo case where it’s on top of the pigment, if they’ve done a big map thing, you can’t do some ankle surgery. But if it’s on top of the pigment epithelium, even now I’ve had some like histo that was quite a downward they’ve asked then from five months ago is now 2100. I just make this little, and retinotomy and take it out. But what I do, I take the tissue and use it like a smooth instrument, a soft instrument. And I literally massage the edges. So I bring the retinotomy edge to edge back together. And that expresses some of the viscoelastic as well. So it’s together, then we do fluid air exchange immediately, and we aspirate at the back of it so that it sucks the implant up in there and gets rid of the viscoelastic we use to inject the scaffold, and that means it’ll be implanted, and the hole is slam shut. The oil doesn’t has a very low oxygen extraction ratio. I’ve done 60 macular patch graphs and remembered its operation. And I’ve convinced him and many others that are now doing that to use medium term PFO to leave PFO and for two weeks. Why? Because the PFO has three times the oxygen carrying capacity of hemoglobin, whereas silicone oil has a very low oxygen extraction ratio. So you’re causing ischemia when you use silicone oil, that’s why I hate it in diabetics. And, and so I’m a huge fan of medium term PFR I use it for all my inferior detachments and fear giant breaks as well.

Firas Rahhal: That’s an area I’d love to get into. At some point with us. Are we going to get a longer term PFO at some point you think?

Steve Charles: Well, I leave it in for two weeks, which is so long enough for chorioretinal adhesions to form with laser so I’ve done over 1000 cases with me in therapy if I’d done it 20 years and published in the peer reviewed literature, but still people beat me up in the podium oh my god buckles the standard of care how to do a buckle anymore I should have done 1000 but you know I got over it. This like I took the training wheels off my bike you know.

Firas Rahhal: You know we’re talking about so many cool operating techniques and tools. This is the interface that you live in engineering and surgery interfacing. Are you surprised or bothered historically that ophthalmologists on the whole not yourself? Obviously, and there are others, Mark Hamayun has a great engineering background, that there’s a paucity of people that live with that interface with proper training and both, that it’s two different camps trying to work together without the little one guy or the 10 guys who do both.

Steve Charles: Well, yes, I am concerned because where it goes wrong. In fact, I just this afternoon recorded a lecture for the Harvard fellows’ course, because I’m doing an Orbis. I’ve been working with Orbis for 30 years. And there’s a Orbis event at Oshkosh, that is at the same time as the Harvard fellow’s course. So just two hours ago are recorded using loom the lecture and then the lecture was similar to one I gave to the Alcon fellows meeting, which was a month ago. And the point I’ve made is, when doctors use terms like flow efficiency, there is no physics or engineering term of flow efficiency, their separate flow is CCS permitted, it’s a volume construct over time. Efficiency is if you’re drinking a milkshake, and you hear, it’s because you’re not in the milkshake. So if you’re sucking out VSS, it’s not efficient. So efficiency is 100% technique-driven not technology-driven yet marketing people and doctors on the podium ball with this probe is more flow efficient, what? They have no clue. And they say, Oh, this probe is fast cutting, no, high cutting rates are not higher velocity. Fast is the velocity term, it’s millimeters per second, you know, whereas cutting rates are cuts permitted. So frequency term, and just the people that don’t even get that straight and don’t understand things like duty cycle. But so if you’re up there teaching others how to use this equipment or interfacing with industry to try to say what the parameters should be in the console, and you don’t understand basic simple physics and simple math, that’s a problem. For example, how do you appeal IOM? Well, we’re the microscope scales your position up, right? So what do you how do you tell people do it simple, go really, really slow? They say, Oh, you I wouldn’t be efficient than telling you that this scale that up to things like that. So that you, I watched the fellows and I’m like, what’s the here’s their approach to dialogue like that. He said, Hey, slow down, slow down. Decision takes, you got to slow. So the first derivative of position is velocity, dv-dt, and dx-dt. And so in the first derivative, that’s acceleration, so things like that, it helps me be a better surgeon and teach better and develop equipment better, because I understand that stuff. But when I talk to the fellows, it’s like, Huh, you know, and sometimes it gets frustrating. So they just tolerate me they nod their head when I talk to them. Why does the Heidelberg and I don’t consult for Heidelberg? Why does it make great angiograms far better than any fundus camera ever did or ever will, because it’s confocal? So that means that 15 DBS, better signal to noise ratio can because the point source and the point detector or co line, that’s what that their conflict with so all scattered light is rejected. That’s a big deal, that you can’t fix that with more pixels on a fundus camera. It’s possible and 50 DBS that’s a big deal. And but it’s hard to get this point across to people that have no idea of simple physics and engineering.

Firas Rahhal: So we need more engineers going into clinical medicine.

Steve Charles: But you know what happens? They get that taste of dollars, and an engineering stuff stops immediately. One way to make sure your engineering knowledge goes to hell in a handbasket, get an MBA. Here in the chat, when you see doctors that get an MBA, the amount that ever contributed on the design side, it’s over. They can be engineering managers. And it’s good if they’re literate, but their contribution on the technical side, as soon as they become a businessman, it’s over the whole technical contributions over.

Firas Rahhal: That’s great advice. I think my son who’s a young engineer would agree with you, he’s 25. And he has a master’s degree in mechanical engineering and an undergrad also, and I asked him, you know, do you want an MBA? Is that something he’s like, No, I don’t I want to design, and I want to create, and he saw the dichotomy that you just described.

Steve Charles: And you know, in biomedical engineers, they’re not hired for design jobs either. Because it’s too smorgasbord that’s too broad, not deep enough. Mechanicals, and electricals that even in engineering, in engineering, physics, people are the people that get the design jobs. And the people that know mechatronics which mechanic for example, if you if your son called me today and said, What’s my next degree of B and I said electrical, because controls are what it’s all about. I mean, whether it’s a Tesla or an aero plane or a constellation, the interaction between the mechanical world in all the transduction motors and sensors. That’s where the action is. And so you got to understand control theory.

Firas Rahhal: I’m glad we’re on record. I’ll take that as an invite for me to have Michael call you so when I get a call from young Michael, sometimes students leave. Speaking of the young guys, I wanted to ask you about this anyway, it’s a good segue. We talked about stem cells, gene therapy peripherally, obviously, surgical innovation, obviously surgery, where should a young guy who’s a vitreoretinal surgeon who feels he wants to be involved in innovation? Or wants to be entrepreneur. Where should they be looking in the next 10 or 20 years? What do you think? Are these frontiers that somebody like what you’ve done wants to do again?

Steve Charles: Okay, well, guys will come to me and say, I’m going to start a company, I’ll say, what’s the product now say, huh? Just gonna explain to you a company’s need a product? And they’ll say. Okay, well, let me start a different way. What technology? Are you literally? What do you mean, I want to start a company? Well, in order to have a company has to have a product in this space, it has to be a technical product, whether it’s biotech, or its engineering, a laser physics or something, imaging, so Well, I’m going to hire guys for that. And I said, Why don’t you study it? Why don’t you hang with brilliant scientists in angiogenesis or in complement the alternative conflict pathway? Or try to understand tumor biology because we’ve made no progress with melanomas and ever Forever? Why don’t you study that? And in? They’re like, Oh, no, studying is something I did. There was a pain in the ass in order to get a residency and a fellowship and a job that I have to do that anymore. You know what, you’re not going to win? Why am I doing reasonably well, and to in complicated things now, because I study endlessly. I have a huge library. In my in my apartment or room that was supposed to be a dining room is the library. And there’s literally sections like a formal library, and mechanical engineering, electronics, laser physics, photonics, optical system design, you know, neural networks, etc, etc. And I’m constantly reading and studying, but it’s never reading, quote unquote, for pleasure. It’s all about I need to learn more about this. I buy a book every two weeks or so to teach me something, I read a book on fiber lasers over the weekend. really complex math, because I want to understand how photonic crystal fibers bandgap fibers work and how see Sam’s work and how chirped pulse amplification works. So I’m studying that stuff. But some of these guys don’t want to do that. They just want to be entrepreneurial. It’s like a guy, if people in the gym read a book 100 ways to satisfy your lover, if you’re leading this, it’s over. Did anything happen? aspirational innovation, you know, I want to be famous Well, okay, you know, jump off a building or something, because you’re not going to make it any other way. It’s in there, there’s not enough people willing to roll up their sleeves, do their homework and learn something, I don’t know, anything. I didn’t know anything about STEM bio cell biology, I will not make a contribution there. But I don’t want to be sticking implants underneath somebody’s retina if I don’t have a basic understanding of the biology behind it. I will never make a contribution there employer that other than helping develop the technique and doing the cases. But I want to be able to talk to these guys and learn from them. And it but if it’s all about the business model and creating buzz and, and the website and fancy names for stuff and all that and the color, what the product looks like, but not understanding the functionality. That’s the frustration to me. And but, you know, frankly, there are companies who are, you know, their core competency is buzz and they’ve made money. And, you know, it’s there certainly fame. I mean, do you think Floyd Mayweather has contributed to our culture, he’s the number one earning athlete in the world, these multiple I work, I support some domestic violence victims personally, and I’ve been involved, I was on the board of the National Domestic Violence Hotline on the board of the Shelby County domestic sexual domestic violence Council. And so here’s the guy that’s a, you know, multiple times DB person, perpetrator, who makes more money by the world. So clearly buzz flies. Yeah. And it does, and I hate it. You know, I mean, is Twitter really a value to our culture? I’m not sure. Is Facebook, other than connecting with friends and family, a big contribution of our culture compared to their value? It’s hard to say. So I’m not that kind of stuff frustrates me.

Firas Rahhal: I’m with you, I think you’re absolutely spot on. And actually what you said about it to start, you know, I’m going to start a company and you’re at Well, what’s the company going to do? That is the epitome of what I termed earlier. You know, the tail wagging the dog. We have a lot of that no question about it. And it does work sometimes. And it is frustrating, I’m sure to somebody like you who has rolled up his sleeves for so long.

Steve Charles: I consult for free for a guy that used to run both CT and then MR. For GE medical systems, and he’s an Orthodox Jew and he’s in love with Israel. So he asked him, Hey, can I go run even for $1 a year GE Israel, I want to live over there on embedded myself my culture did. So now he has a venture firm and they he shows me all this innovation coming out Israel as we review it. And I had a sort of a rude awakening, or I said, go back and look at my report card when I said no, don’t invest. How did I get it right and Or how often do I get it wrong? And he said, Well, he went in and they look back over the data. And there are a number of companies that I perceived of as buzz only that actually got second and third rounds of financing. And there’s to me no real product that’s going to help anybody. But I got it wrong in terms of the financial world. If I had to criticize myself, what I’ve done very poorly is raise capital. I have a startup right now that had the CEO of Blackstone was one of our investors. And he kind of pulled out and founder of AutoZone is a billionaire kind of pulled out, I put 5.4 million in his for neuron spine, my dad died of a brain tumor. And I built a robotics company for that and sold as a striker. And now I’m doing a visualization company for neuron spine. And it’s extraordinarily cool. We got 30 patents with Konami, Martin, and run the money. And so I’m not good at porting the financial world or understanding what makes it work. It’s hard.

Firas Rahhal: It’s not the buzz, no question. And, you know, raising money is hard. And a lot of time, it’s style over substance. Unfortunately, there’s no doubt about.

Steve Charles: Well said. Well said.

Firas Rahhal: I want to get to the teaching part, you know, I can’t, God knows how many fellows you’ve trained. You, I’m sure know the number. But before we get into the training of the docs, how much lecturing you doing these days? How much of the International surgery are still doing? Are you still writing a lot?

Steve Charles: I rewrote my entire book, 330 pages, all 30 chapters, many new 60 chapters. So a complete rewrite of the book. I put seven, don’t lectures, not surgery, but lectures on Eyetube. And I’ve got 20 the lectures of mini lectures on Alcon’s Experience Academy. But last year, because the COVID I didn’t travel internationally, but I gave more lectures than I’ve ever done before. Because of zoom, and another software, for example, I had I did, I think seven or eight lectures to India, typically 3000 surgeons, a couple of heads, 7000 people online. So I’ve done it for Orbis, I’ve done it for example, I spoke the New Orleans Academy and I gave six talks or five talks. While I was there, six talks that I pre-recorded in two live panel discussions were for the Philippines Academy of Ophthalmology, and the Philippine Vitreoretinal Society. So zoom is now that it’s been adopted. So worldwide and other you know, WebEx and Microsoft Teams and other software I’ve used, it’s allowed me to teach all the time. I mean, it’s incredible. So I love it. I love the lecture, that I never get the same lecture twice. I’m constantly revising, I spent three hours working on lectures today, because they’re rebuilding parts of stuff in our surgery center. So I lost that operating day on either three cases today, instead, eight or nine. So once a teacher,

Firas Rahhal: Vitreous microsurgery, you made me think of an anecdote that I want to share with you that in the years we’ve known each other I’ve never shared with you. So this will be the first time you’ve heard it. And I might get in trouble here in a minute. When I moved to California, I guess it’s well, it’s over 20 years ago, now. I packed up my books and stuff, and I came in, I discovered, and I probably recently met you around that time I was probably five, seven years in practice. And I discovered that I had your original vitreous microsurgery textbook, pretty small. I think it’s issue 1, 1970 something I’m guessing I don’t know. And sadly, I realized then and I still have it and I’m gonna ask you to sign it for me sometime in the near future. I never returned it to the UConn medical school library I probably owe about $400,000 in late fees. I checked it out as a med student in 1987. And I still haven’t been asked you to sign at one point.

Steve Charles: I will not pay the fees. That David Peyton and Daisy Stillwells book Atlas of Eye Surgery out of the VA library when I lived at the VA as a freshman medical student in the I read the residents of Bascom Palmer give me broken instruments and I take him to the machine shop and fix it and then practice all these procedures on Greyhound dogs that they were using for kidney transplants. So I did trabeculectomies and totally other peripheral iridectomy synplant extra caps, even lid procedures on these Greyhound dogs while I was helping them to kidney transplants, but I stopped that book and I still have it.

Firas Rahhal: That’s amazing. gonna definitely bring you to a meeting. I want you to see it because it does have the UConn med library imprint inside with the checkout date. And I’d love you to sign it. We’ll have a laugh over it next time we’re together. Let me ask you about vitreoretinal fellowship training. And I know you’ve trained zillion. And I know many of your former trainees, of course, around the country. What are we doing right? What are we doing wrong? What could we do better? And ultimately, I want you to weigh in on do we need this was talked about some years ago, the late great Paul Tornambe took some issues. And with this, do we need a vitreoretinal board? Is this something that we need? And I’d love to hear your thoughts?

Steve Charles: Do we need a vitreoretinal what, I didn’t understand that?

Firas Rahhal: A board. Like we’d have certification, like for Ophthalmologist?

Steve Charles: So let me first comment on, if you look at the business trend, the practices are huge. There’s lots of private equity play out there, as you know, and one of the reasons they’re huge is that for code for geographic spread, because of this absolute explosion of the need for intro vitro injections, and OCT interpretation. So the average fellow probably goes into practice where they go four or five places every week, spend time in their car driving to satellite offices, looking at OCTs and injecting and in and then that’s fine, that are helping patients. It’s an incredible miracle drug, the whole array of individual compounds we have it is extraordinary, safe, extraordinary safety profile. So it’s a wonderful and I’m not putting it down when I people said burnout, burnout, helping patients and getting paid, paid to inject really, you’re burning out doctor then you should have been a golf pro or something. And I don’t get that. And I don’t get the burnout thing when I hear it irritates me because they’re helping patients, the AMD patients and crap provision until anti-VEGF compounds, DME is much better treated this way than it is with laser. It’s a big deal. But here’s the problem. Now you’ve got this huge injection, you know, volume to be done. And so people will join a practice with 8,10,12, 15 partners, and the average guys doing three cases a week in the operating room. And Intel, people are willing to say I’m capable of doing the diabetic trash attachment or PBR, a macular patch gap, those are hard. Here’s our designated tough surgery guy. And then if you look at economics, we may have a warm, I mean, I do a lot of surgery, and I make more money in the office than I do in the OR. I make more money doing RCTs and injecting. So if you look at there’s roughly 125 fellowships and about 25 per medical, I might be a little off, but it’s roughly it, you wonder, should that balance shift to be more medical. And you wonder if having a surgeon, that’s the tough case, surgeon can evolve. Nobody can mandate that. But you know, egos and greed and all that are not easily managed is, as we all know. So that’s a problem. Now with our board, you know, the vast majority of vitreous surgeons that are probably the majority, I don’t know if the word bass is right, that are academic players that are actually in private practice. And so the fellow funding comes from the revenue they generate as a second year. But if you had an ACGME approved fellowship, then you can’t charge for their services, according to Medicare, fellows and residents are identical. And you don’t get paid for supervision, period. And you can’t that’s against the rules. So you got to participate in the patient’s care and be in the room and provide care yourself where you don’t get paid. And so there’s this thing where it sounds nice to have an ACGME approved fellowship, but where’s the money going to come from? The pay their salaries, and their expectations are much higher than when I trained. I mean, I made $90,000 a year at the NIH or something like that. And the fellow was making 80, or something, and I have plenty of vacation time, and you know, great health insurance, and maternity insurance and all that stuff and which is fine. I’m glad to have them rewarded. But it’s a bit upside down in the private equity thing is tossed another hope of you know, level of complexity on these practices. And when I look at the private equity thing, I’m not sophisticated enough to judge is there going to be a play on their stock, or it’s only the front-end money. But if MBAs are going to decide for us how the practices model and address some of these decisions we’re talking about, that’s a paradigm I’m not comfortable with in. So for example, can I get a check from a private equity firm right now? Yeah. Do I want one? No, I wanted, and I don’t have I’m not sitting on a lot of money because I put 5.4 in this startup, that might fail. And so it’s not that I don’t need money. My kids and all that, although two of my daughters are physicians and do quite well. And but I you know, our business is very complex right now. For example, What will happen to clinical trials revenue? What will happen to rebates and variable pricing and pharmaceuticals what will happen with biosimilars? It’s a very complex marketplace more than ever before.

Firas Rahhal: It is, and I like to point you were making and we’re starting to elaborate on with the, that’s the guy who does the complex surgery, I still teach our fellows and we teach fellows here. And we’re in a very academic private practice, just as you described, we do tons of trials, and we train fellows. I tell them look, in real life, when we retinas surgeons evaluate each other and talk to each other and consider who’s really great. Often it comes down to, you know, can the guy fix a retinal detachment? And what kind of successes is he getting? And I find that that’s sort of gone, because of the economics of it. It’s kind of been pushed to the side, even though we in the business, respect that aspect of it, maybe at the highest level, and there’s so much money in the injections and the OCT. In the industry drugs side. I think it’s taken away from some of the even admiration of the skill of what we do in the OR for the harder stuff. I think we should focus on that the problem is the economics of it and we have to find a way or maybe convince Medicare or the others that there’s real value in that because it’s diminishing.

Steve Charles: There’s no question about it, the Medicare consciously to save facility fees, not just surgeons fees constant changes the reward to the office, and they made a bad call-in terms of overall costs because now we get paid to inject into CDs, you know, and, but look at one other aspect real quick, like I know, we probably only have another minute or two but what’s really interesting and almost terrifying, is how hard biologics are example. neuro drugs, Alzheimer’s, Parkinson’s, MS, average trial, 8.5 years, average cost 2.3 billion average failure rate 90%. While the retina, the retina is brain tissue is neurologic, it’s threatening its brain. And if you look at for example, Adverum from a patient.
pan uveitis hypotony went to David Brown’s patients. He’s an investor and he said it’s the first drug that actually blinded a patient. Okay. And bright people trying to do the right thing to lots of money spent, it’s gonna go down the drain, most likely, we you know, jittery, it was a 1-800-Bad-Drug. You know, and so there are that Dobbins inflammation, withdrawn study. Some other clinical trials, of course, Bayeux view is had this post market analysis, Shawn, and now that many of the clinical trials for Bayer view are being are on hold. And so in short, it’s hard. And yet there’s biosimilars in biosimilars are not the same molecule. They’re similar and therefore, there’s the likelihood we’re going to see inflammation and serious side effects and biosimilars great, and yet they’re out there trying to, you know, be bottom feeders in terms of the costs side of the equation. It’s I’m concerned about biosimilars. And I’m concerned that dollars may escape if you have continued to have a high failure rate, with things like DARPA NinjaTrader, and all these turns out being failures. It’s a tough, tough game.

Firas Rahhal: Thank you, Steve. You’re right. We’re up against it on time. Thank you for the insights. Thank you for coming. your level of busyness, I know what it is, we’ve heard about it, and we know what it is. For the audience. Steve Charles, literally a living legend in the specialty my friend, a great guy I’ve enjoyed over the years. Talking joking around with you, you’re always pleasant it to meetings, really a joy to have you and by the way, a plug for us and an invite to you. We’re going to have the OIS Retina meeting. Just prior to ASRS in San Antonio. That’ll be October 7th. It’s always the Thursday before we’re going to have it, we hope people will come and want to be in person. OIS is a fabulous meeting Steve, you’ll get my invitation and be able to join us as a panelist.

Steve Charles: I look forward to it. I’ve attended many meetings in the past. It’s extraordinary operation. I’m delighted to be involved.

Firas Rahhal: Thank you. Thanks for coming on Steve. Really an honor.

Steve Charles: Thank you my friend. My pleasure. Be well.

Firas Rahhal: You too.