Russ: Hi, I’m Russ Capper and this is HXTV, the show that features Houston’s innovators and entrepreneurs. Coming to you today from the Center for Device Innovation at the Texas Medical Center, here in Houston. And I’m very pleased to have as my guest, Dr. Billy Cohn, noted Cardiovascular Surgeon, Vice President for Johnson & Johnson Medical Devices Companies, and the Executive Director of the Center for Device Innovation at the Texas Medical Center. Billy, welcome to the show.

Billy: Russ, thanks. Thanks for coming.

Russ: You bet. So, I want to talk about your history of innovation. I want to talk about what might be over 100 patents now into several companies that are out there doing business. One that recently exited, is that right?

Billy: Yes, wonderful event.

Russ: And I also want to talk about your continuous-flow artificial implantable heart, but first let’s talk about the CDI.

Billy: Ok. That’s great because that’s a topic I love talking about. This amazing place is the Center for Device Innovation, and it’s a brand-new initiative by Johnson & Johnson, conceived of by Bruce Rosengard and I, Bruce is with Johnson & Johnson as well. The idea was to make a front-end makerspace with a lot of brilliant, energetic engineers, all the equipment it takes to make anything you can conceive of, and do it in the shadow of the largest medical center in the world, the Texas Medical Center, which is less than a mile away, leveraging all the resources of Johnson & Johnson, the largest health tech company in the world.

By taking a bunch of people that understand medical devices and understand the unmet needs, give them access to the hundred and six thousand employees that show up at the Texas Medical Center every day, give them access to the operating rooms, large animal facilities, the prototyping resources to make anything you would ever need to make, and the marketing and regulatory and reimbursement resources in Johnson & Johnson, maybe we can accelerate medical device innovation, take more shots on goals, do it faster and cheaper and come up with important stuff to help us all live longer, better lives.

Russ: Can’t argue with that at all. I’ve had the chance already to walk around and check this place out. It kind of looks like you had something to do with at least some of the design and structure and what all is included.

Billy: Absolutely. We started from basic principles. We asked for a space and the Texas Medical Center leadership, Bill McKeon, and his group gave us this place because they were excited about it. We sat down with Gensler Architects, we had a small group of people from Johnson & Johnson Medical Devices and Johnson & Johnson Innovation, carved it up and decided what we wanted where, moved things around. I kept pushing for a bigger shop, other people were pushing for more office space. We finally came to agreement, designed the place and started building it. We were involved from the very first idea of what this place would be, what the capabilities would be, planned it, worked with the architects. The shipping container, all this stuff were ideas that came out of this little room with the five or six of us spit balling ideas.

Russ: It’s just beautiful. What are the names, there are these blue names on some of the pipes and structures up here?

Billy: All of these names are people that have been inspirational to me. Historical figures that some are sort of abstract. Some of these names are all about failing epically and getting up and dusting yourself off and continuing on. They are probably that you don’t know. For example, Lieutenant Thomas Selfridge, he’s the first person to die in an airplane accident. The Wright Brothers were trying to demonstrate their airplane to the military and they killed one of the Lieutenants. Have you ever been on an airplane?

Russ: Yes.

[04:11]

Billy: They somehow got over that, you know? And so, each one of them is a trigger for a story, for storytelling, and each story has an important point that I’m trying to make. There are so many opportunities in the innovation journey when things aren’t going right, or when things do go right, and there’s a name that’s a trigger to a very impactful story that’s got a powerful message, and that’s what those are about. One specific name, right here, Michel Mirowski, I told you the genesis of this place came out of my interactions with Bruce Rosengard, on an airplane actually, we were on our way to Israel. Bruce has been with Johnson & Johnson a couple years longer than I, and while we were on the plane we came up with this idea. We started building it, we planned it, construction started coming together.

Roll forward several months. It’s weeks before the grand opening and I’m walking him around showing him how the place has taken form. He looks at all the names on the roof just like you did, on all the pipes, and said, “Oh, you should have put my father-in-law’s name up here.” I said, “Remind me of who your father-in-law is.” He goes, “Michel Mirowski, the guy who came up with the implantable defibrillator.” The implantable defibrillator is a box this big that goes under your skin. It’s got a battery big enough in it that if you have a cardiac arrest, it charges up and shocks your heart. Like the paddles, ‘Clear!’, but it’s inside your body. When he conceived of this, people stood in line to slap him in the face and say, “That’s idiotic, you can’t put a battery that big inside a patient. That’s like a bomb.” Well, he persisted, despite people trying to ridicule him and making fun of him. It’s now saved more lives than any other technology and it’s a $16 billion a year industry. I said, “Oh my God.” So, that weekend I read the manual on how to use the hydraulic lift, I went and bought the right color of paint, I made a stencil, I got a hard hat, and I snuck in here at night and painted that up there myself. True story.

Russ: What a story.  And there’s also, I guess it’s called Billy’s Wall back here, some of the early devices. I guess it’s all of your devices?

Billy: A lot of that stuff are my early prototypes that came out of my garage at home and shows how they evolved from something kluged together out of stuff from Home Depot or the hobby store, fifty bucks all in, to products that are in every hospital in the medical center now, because I’ve had a couple successes. Some of the things on that wall were in the final analysis, incredible waste of my time and other people’s money, and I show those as well because it’s a journey. In fact, the company that you said that just exited, I have a very first version of it that I made in one evening, $20 all in. It was the first pebble in the avalanche.

Russ: Tell us about that company. What was the company’s name?

Billy: The company was called TVA Medical. TVA. It was for hooking arteries to veins in the arm, so patients could undergo hemodialysis. I hired a CEO, wrote a business plan, and raised money. Now, eight and a half years later, it’s been acquired by Bard, Becton Dickinson, and so it’s going to be in every hospital on the planet. It works really well, we’ve done 500 patients with it.

Russ: That’s fantastic. How many patents do you actually own today?

Billy: It all depends how granular you are. If you actually say, well we filed this and this and this, and you go, well all seven of those are sort of on the same thing. And I go, well, but there are unique claims on all of those. I just a patent search and I’ve got 177 different filings.

Russ: How many of them are actually parts of operating businesses today?

Billy: Just two—no, I’m just kidding. Most of them. Operating business, well some of them, as I mentioned, have been monumental wastes of my time and other people’s money. There are big suites of—like, Viacor was the first percutaneous mitral company, one of the first. That was John Liddicoat, Mark Gillinov, and I, and we must have filed 18-20 patents on that. Those are all fallow. I’ve had a lot of patents that never came to fruition but I’ve always tried on them, but there are five companies that are still going that leverage IP that I file.

Russ: But that’s all part of the game. I mean, you talk about it here, celebrating failures, too. I mean, if you’re not willing to fail you’re never going to get to the success side.

Billy: What baseball player struck out the most? Babe Ruth. You talk to a fisherman and say, “How many times have you cast and not caught a fish?” and the answer is, “Almost always.” If we have five projects in here right now, and we do, we have five projects that we’re really working hard on. If one of those succeeds, the whole thing has been worth it. If two of them succeed, then CDI will be on the Mount Rushmore of medical device innovation.

Russ: We’ve got to talk about the continuous-flow totally implantable artificial heart that you’ve been working on for quite some time with Dr. Bud Frazier. You and he sort of came together in the beginning. What’s the status today? But for those that have never heard the story, give us a little overview up front?

Billy: It’s not a eureka or a creative idea that having an artificial heart would be a great idea, ok? Five hundred thousand Americans die every year of heart failure, and there are four or five million Americans walking around with it, probably twenty million worldwide. It’s a big, big problem. It’s our number one healthcare problem societally and economically. The really vexing thing about it is these patients undergo a progressive, slow decline. You can see it happening, its like a slow-motion car wreck, and we have very little to help them. There are a lot of new therapies that change the slope of that line, but a lot of these patients, there’s no therapy that can save them. An artificial heart, if we can take out the diseased organ and put a pump in, that would be a marvelous, marvelous thing. The heart is just a pump, why can’t we do it? Well, perhaps it’s because of how we’ve been going about it.

All the artificial hearts that have ever been designed and created, mimic the way the way the natural heart works. They would fill, they would eject, they would fill, they would eject. Well, that means there’s a machination, there’s moving parts, there’s flexible membranes, there’s inlet valves and outlet valves. And that’s fine, that’s a great way to pump blood. Those artificial hearts work great, but there are two problems. The mechanics to do that are going to be kind of large, and so, you either have a really big device with brilliant motors and bellows and things in it, and that’s been done a couple times. But none of those have succeeded. Why? Because they’re so big, because the mechanism that is required to actuate it takes up so much room and generates so much heat and it uses so much power.

There’s another challenge, and that is cyclic endurance. All those flexible parts have to flex with every heartbeat. If your heart is beating 100 times a minute, that’s 144,000 heartbeats in one day. That’s 52 million heartbeats in a year. No manmade device can tolerate that, they wear out.  Now, why don’t we just transplant all four or five hundred thousand patients that are going to die of heart failure? Limited donor organs. In fact, the busiest year we ever had we transplanted 3,000 patients. Most years it’s about 2,200 or 2,300. That’s all the hearts we have because you have to die in a very particular way for us still to be able to use your heart. Lynne Warner Stevenson, the famous cardiologist from the Brigham says, “Counting on heart transplantation to cure heart failure is like counting on the lottery to cure poverty. It just affects too few people.”

We need a permanent, implantable, totally implantable artificial heart that’s going to make it so you can take someone with heart failure electively during the day; you say, you’re a small, medium or large; take it off, you sew it in, they go on and live another decade or two with this device; the holy grail. So then, there was this huge shift around the late 1980’s, or early 1990’s, to looking at pumps that spun instead of filled and emptied, filled and emptied.

Russ: Like a turbine.

Billy: A turbine, exactly. And Bud Frazier was the first to test it on animals, the first to put it in a patient, and now the avalanche that started from that first success has generated tons of little turbines that go outside the heart. So, the weak heart is struggling, the turbine is taking blood from the weak heart and injecting it into circulation. And now, there are 40,000 patients that have been implanted with that. Dick Cheney had one of those, and there are patients that are out ten, eleven, twelve years walking around with these pumps. They don’t wear out. There’s only one moving part, there’s nothing flexible, no valves. The spinning piece is supported by a magnetic field. Bud Frazier, 14-15 years ago, got the idea that we were going to replace the heart with pumps like that.

Russ: Not just put them on the outside.

Billy: Not just put them on the outside. Why? Because when we just put them on the outside, there’s still complications. Patients still have bad outcomes and death, and it’s because we’re leaving the diseased heart in the chest. Getting that whole diseased organ out and replacing it might be a good idea. We did a number of studies where we would take two of those turbines, cut the whole heart out in the cow, replace it with two turbines; one, taking the venous blood from the arms and legs, and head and guts and pumping it to the lungs; another one, taking the bright red blood returning from the lungs and pumping it to the body.

These cows would get up and exercise on a treadmill, they would eat, they would respond to caretakers, they looked like completely normal cows, but they had no pulse and no heartbeat. Several of these animals were able to go 90 days and put on 70 pounds of weight. We thought, this is really exciting, so exciting that we seized the opportunity. We had a gravely ill patient that had no other options, he had been on temporary support, meaning a pump at bedside hooked by blood filled hoses. He had a condition that we couldn’t transplant him, we couldn’t put a SynCardia in. We put our twin turbine device in and he had been in a cardiac coma, he woke up and did well for about five weeks. He was in multi-organ failure; his liver was failing, he was on dialysis, and those things continued to progress. We found this condition involved his lungs as well. Anyway, we couldn’t save him, but it was the first continuous-flow artificial heart using a human, and there was a lot of publicity from that.

As a result of that, we got on the radar of a gentleman named Daniel Timms, a scientist in Australia, who had an idea for a continuous-flow artificial heart with only one moving part, that addressed some of the shortcomings that we had identified with our twin turbines. Twin turbines wouldn’t have mechanical wear, they would be small and powerful, but there were some other issues with balancing and the right side dealing with clot coming from the legs and things, and those were all beautifully dealt with with his concept. He’d never actually made a full, implantable one, but he came to Houston, we were able to get funding from Mattress Mack at Gallery Furniture, we made the first one and put it in the animal. The animal stood up a couple of hours later, looked around, and it’s been all just an incredibly exciting journey from that point on, with cow after cow doing better than the last, exercising on treadmills. The device has gotten smaller and smaller. Again, one moving part, we’ve never had a pump fail, and now we’re at design freeze. We just met with the FDA a month or two ago and getting closer to GLP studies. GLP is Good Lab Practices, where everything is proctored and documented so that we’re doing everything the same way every time. If we do those studies and take them to the FDA, and perhaps we are getting closer and closer to the day where we can implant one of those in a human, and it might be in the next couple of years.

Russ: How exciting is that. How is it powered?

Billy: So, there’s still a wire that comes out to a computer that you carry, but that’s getting smaller and smaller. We’ve got that all charted about how that’s going to progress over the next couple of years. Ultimately, we’ll use inductive coupling, which is the way you charge your iPhone, or your toothbrush, using oscillated magnetic field. The device would sit here, there’d be a computer a little bit bigger than your iPhone that sat inside you, and a coil that sat underneath your skin. And you’d wear a vest with a coil and a battery pack.

Russ: Wow, so there would not even be a puncture through the skin.

Billy: Someday. Someday that will be the case.

Russ: So, this obviously could be huge. I mean, even it seems like if you have other things wrong other than your heart, if you put in an actual working, artificial heart, it helps the whole body.

Billy: More than you’re saying. Exactly right. Patients with progressive heart failure, with congestive heart failure, they develop kidney failure, they develop a lot of problems all from high venous pressures of those organs and poor profusion. This device can out pump a human heart. It’ll do 25—your cardiac output right now is probably 6 liters per minute. That means your heart is pumping about a gallon and a half of blood through your body every minute. This thing will do four times that. And it can make a pulse if we wanted.  And so, just like your heart has to increase its heart rate when you exercise, this thing will spin faster, and the rotor moves to the left when you exercise.

Russ: So exciting. Keep that up, for sure. It’s real exciting.

Billy: One of us will probably need it. I think it’s you.

Russ: Well, I’m ready. Let’s go. Before I let you go, this show, HXTV, is all about really focusing on what’s happening in Houston. What does Houston mean to you and what has it meant to your success?

Billy: Well, I think Houston is the land of opportunity, really. It really is. It’s, what do you do? What have you done? It’s not, who are you and what’s your family? There was a lot of that in Boston. Boston is a very innovative place, but I think the Houston spirit, the way you’re talking about building the Astrodome, or the Johnson Space Center—

Russ: Or the ship channel.

Billy: Or the ship channel. Yeah, being one of the largest deep-water ports in the United States. Oh, by the way, we’re 45 minutes from the ocean. You know, there’s a spirit, a can-do spirit, there’s incredible philanthropy here, the largest medical center in the world. I’ve always been very proud to be from Houston. I moved here when I was one and a half. My dad came down here to do radio for the then Houston Sports Network, which was the Oilers and the baseball team which was named after a handgun, the Colt 45s, exactly right. He was part of the initiative to build the Astrodome and open that, and reported to Judge Roy Hofheinz, a very dynamic and interesting character. And so, we lived here, I grew up here.

I did all of my medical training here. I was with Michael DeBakey, the big, famous heart surgeon. I did four years of medical school, five years of general surgery, and two years of cardiac surgery, all in his program. I feel like I’m a real Houstonian. To see Houston go through this metamorphosis now where it’s now becoming a med-tech hub with this, JLABS, and TMCx, and Station, and biotechs, and Fannin Innovation; all these things sprouted out that didn’t exist when I was a little boy or even when I first came back to Houston. I think Houston is ascending to its rightful place as the third coast of innovation. There’s a lot of smart, energetic people that are fanning those flames. It’s been exciting to be a part of the process.

Russ: Fantastic. You are still practicing surgery, too, right? You go and perform—

Billy: I’m not practicing anymore, I’ve got it down. Yeah, I’m still doing some surgeries. I’m still a tenure professor of surgery at Baylor College of Medicine and operating at the Texas Heart Institute.

Russ: Billy, thank you so much for spending time with us.

Billy: Thanks, Russ. It was fun.

Russ: You bet. And that wraps up my discussion with Dr. Billy Cohn. And this is HXTV.