S2E33 Custom Medical Device Manufacturing, Durability, & the Future of Med Device Tech | Mark A. Farber, MD

Dr. Mark Farber has worked as a physician consultant helping medical device manufacturers develop their products for over 20 years. He is Chief surgeon within the Division of Vascular Surgery at the University of North Carolina (or UNC for short), Program Director of the Vascular Surgery Fellowship, and a Professor of Surgery at the UNC School of Medicine. Join our conversation in this episode to hear Dr. Farber’s suggestions for how medical device engineering & MFG teams can enhance their process for developing successful products. 

The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us.  

About Being An Engineer

The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.

The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

Transcript

Presenter: 0:00

The Being an Engineer Podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people, resources and opportunities. Enjoy the show.

Mark A. Farber, MD: 0:14

Be really nice if I had a device that I could get in you and make it fit a lot of people. Right now we have devices that fit about 25% of people off the shelf. It'd be nice if that was 80%, right? Because right now, I've got to wait sometimes two, three months to treat you because it takes that long to get a device manufactured in our hands.

Aaron Moncur: 0:49

Hello, and welcome to another episode of the Being an Engineer Podcast. Our guest today is Mark Farber, who is chief surgeon within the Division of Vascular Surgery at the University of North Carolina or UNC, for short. He's also the program director of the Vascular Surgery Fellowship, as well as a Professor of Surgery at the UNC School of Medicine. Mark, thank you so much for being with us today. Thank you, Aaron, for having me. Well, what made you decide to become an MD?

Mark A. Farber, MD: 1:22

Oh, wow, that's not a short answer. But when I was in engineering school at Cornell, I spent a summer at Shell Oil as a intern, doing a three month rotation. And I enjoyed solving problems. And that's really what the summer project was about. But what I realize is that at that time, there was not a lot of personal interaction with solving problems. So I have an uncle that's in the medical field. And I talked to him. And after some discussions with him, I realized that medicine is just problem solving. On a personal level, sometimes answers aren't zeros and ones, it's 01 and maybe, but it's the same algorithms and trying to solve the problem that you go through. And so really, I found that much more appealing.

Aaron Moncur: 2:18

That's a very interesting way to look at it. I often say to people, when they asked me what I do, I'm an engineer. But instead of saying an engineer, I tell people that engineers are professional problem solvers. So sounds like we have that in common. Now, this episode is going to be a little bit different, because typically, we interview engineers on the show, and you are not an engineer, although you love solving problems, as you've just shared. So in won't get into this more as as we go through this. But tell me a little bit. How have you been involved with the development of medical devices? In what capacity have you been involved?

Mark A. Farber, MD: 2:56

So just take you one step back, Aaron, while I don't practice traditional engineering, in other words, I'm not working for a company that's engineering something. As you said, I've been involved with medical device development now for 20 years. So as a chemical engineer, we deal with fluid dynamics and flow and things like that the vascular surgeon, that's exactly what I deal with, right? I have to reconstruct the arteries. So the blood flow through the artery is appropriate, because if the blood flow is not appropriate, and there's too much turbulence, and how I reconstruct the vessels, it leads to things like block just developing and that bypass or that conduit, clotting off and no longer providing blood flow. So I have a lot more interaction with engineering from that perspective, when we are developing new devices that are either opening up blockages are creating basically a realigning new blood vessels, if they're not designed the right way, and they don't provide the same characteristics, you may not have the same in organ function, because blood flow to that organ has a direct impact on how that organ functions and works. If I put a stent in your neck arm that goes to your brain, and the blood flow is not correct, you may not have the same function as if it was a normal artery, and part of my job is to correct problems with blood flow.

Aaron Moncur: 4:31

And how did you get involved with that in the beginning, I mean, you became an MD, you're practicing medicine, and at some point, what did someone approach you and say, Dr. Farber, we would like your help consulting on this new medical device we're developing.

Mark A. Farber, MD: 4:45

So to parse that so in medical training, you do four years of medical school and in that process, I determined that part of problem solving that I wanted to do had to do with surgical discipline. Okay, one of the reasons for that is that when you do a surgical discipline, if you come in and your side hurts, and you got to figure out, does the patient have appendicitis or something else, you take the base, the operating room, you take out the appendix, and an hour and a half later, you know whether you were right whether the patient had appendicitis. So you take all these factors, well, he had a fever, he had pain, he had this going on that going on. Yeah, I was writing my diagnosis. And then you know that the algorithm worked and you modify your algorithm to figure out how in your hands, you can solve that problem. So other aspects of medicine, you may not know for months or weeks later, if you have the right answer to the problem, and it's hard to trace it directly back to what the decisions you made for it. So that pushed me to the surgical discipline. Once I was in surgery, I gravitated to vascular surgery, probably because of my chemical fluid dynamic and understanding. Look, I'm, I'm a glorified plumber, in a sense, right? I mean, I have to figure out how to how to rework the plumbing, but I have to do it in a sense while the water is running, okay, I can't just shut off the water. Now, in one sense, we put clamps on shut off the water, but I don't stop the heart, except in certain certain instances where I need to do that. And so I have to fix it while everything else is is working, so to speak. In that process, I was at a time when new devices were just really ramping up to treat what's called an aneurysm, which is a weakening of your arteries. So if you have a pipe that either clogs up, or it rust and corrosion and rusting, corrodes, it leaks Well, that's what an aneurysm is, when you're already because of the cholesterol and high blood pressure and smoking deteriorates and weakens, then it busts. And when that happens, you tend to have some sniffing and bleeding. And generally you don't make it. So I got involved in the design of new devices to put a new lining in to strengthen the artery. And at that point, this was just the the really infancy of that. And it allowed us to help felt that and so I got involved on the early stages. And because we were a big center, they asked me then to consult because my engineering background. And in medicine, I think the following is true, I can ask an engineer to design me a device to do a, and he'll do that. Okay, and that's what we did. Or they'll say we needed to strengthen the wall of the artery. But we didn't tell them that after 10 years, we wanted to be flexible. We wanted to not wear through the artery. And we wanted to do this and that and the other thing. So over the years, it's caused some refinements, right. And as an engineer, I think some people would come and see me and say, 'Wow, it looks like you're struggling doing that we can make the delivery of that a lot easier by doing this.' So there always has to be a communication between the engineers, and the clinicians. And in sometimes having someone with an engineering background, like myself, that connection and that discussion happens a lot quicker.

Aaron Moncur: 8:04

What are some of the devices that you have the opportunity to use now that just didn't even exist 10 years ago, or, or the procedures the the the outcomes that you're able to facilitate now because of devices that 10 years ago just didn't even exist.

Mark A. Farber, MD: 8:20

So the first device in the US were approved in late 1999, October 1999. And those were simple tubes, and a simple tube that split to do an upside down why that split into two, two branches. Now, fast forward to 2012, when the first devices got approved, that had a lot more than just a single split, I now have vessels that have four branches, or, or four or five windows that I can add branches to and I can reconstruct several different divisions of your artery inside you through basically needle sticks in your groin. what that translates into is that if you're 75-80 years old, you get through the hospital stay in four or five days, your battery covered in a month or so if I would have to do that with traditional surgery mean make a big incision and replace those arteries with artificial arteries and so on place. You're in the hospital for two weeks, and it's nine months to a year recovery. That's a big difference if you're 75-80 years old. Okay.

Aaron Moncur: 9:32

That is a big difference. My father who thankfully is still with us, when he was oh, he must have been 50 or so. He he had open heart surgery for a double bypass, I believe it was and I remember he was in the hospital for at least a week and he was pretty weak when he came home and that was the case for some time these days. Bypass surgery I think is largely performed without the need to open up the patient, thanks to some of the new devices and technology that we have, is that right?

Mark A. Farber, MD: 10:07

Yeah, that's that's a different area coronary, I don't really do work in my area field doesn't involve the heart. But yes, the coronary stents that are there now. And the the refining of the technique has really improved that there still are a few cases that need to be done with traditional bypass and so forth, that the diseases too extensive or are a difficulty getting there, so forth, but by and large, a lot of them are done, purely mainly basis.

Aaron Moncur: 10:34

Yeah, amazing. Well, what have been some of the biggest challenges for you as a physician to help medical device companies bring their instruments to market?

Mark A. Farber, MD: 10:44

Wow, challenges? Um, that's a difficult thing. One of the things I would tell you is that, I think that the human body, from a mechanical standpoint is a much harsher environment than you could ever think of. Okay, you wouldn't think that if I put a piece of nitinol and fabric inside you that the body is going to wear that nitinol and cause that stent, the fracture, okay. I mean, it's a really, there's that much force, right, right. So so the repetitive nature and the amount of heartbeats and so forth, that the devices have to undergo is quite extensive, we test devices in the lab for 10 years durability, and they're supposed to not fracture, but we can't always design all the tests to mimic exactly what happens in vivo, in the in the body. And so we've had some devices fail, because we said, well, we didn't really think that device would ever be in this condition. And then we have a stent fracture. Now, majority of time those fractures are not a clinical problem, they don't result into clinical issues that we have to to deal with. But the FDA, and all this concern that, hey, there might be a situation where it is a problem, we just haven't run into it yet. Because it's not, as I said, it's not zeros and ones, it's not one plus one equals two. And if we do this, this is gonna be the outcome. And that's, I think, what we all try to work on and improve. Having been in this area for over two decades now. We also need to not learn from past mistakes. We know that some things happened early on how to design stuff and not design stuff, and make things better, we started with the nitinol and the metals, we have to polish the nitinol, because the unpolished nitinol leads to more fractures and things like that. So we learn some things from an engineering standpoint, and that's mainly the company's engineers. That's just not me. But they get it from my clinical data from this these devices being in patients and getting them back the information they need.

Aaron Moncur: 12:54

I see very interesting, I'm going to ask that same question. But in a different way. If you could just wave a magic wand around and give medical device engineering and manufacturing teams, one gift, one thing to help them develop more more useful and successful devices? What would that be?

Mark A. Farber, MD: 13:18

Well, I'm going to answer in an old different nonprofit you look for, I tell them to come watch the cases, and see what if you don't know what the problem is, it's a lot harder for you to solve it. If I just tell you what the problem is different than you seeing it as an engineering my opinion. That's why I try to tell the guys look, I can talk to you on the phone, you can go sit in your lab across the United States, wherever your company is, but you come to the operating room, you see me put a device in and you see the process and what all goes on, you see the patients that are in my clinic, you then get a better understanding of what problem is you're trying to solve. And I think that communication is what makes a good outcome in the long term. In all honesty, I mean, it's different than saying, 'Okay, well, we've got an oil well, and we're gonna put a pump in the oil well, and how much does oil viscosity weigh and so forth to get this job done, or so forth?' Yeah, that's just a simple calculation that you can do on paper is not such a difficult concept, I think understand is, is seeing what happens in a living environment, which is what we're dealing with.

Aaron Moncur: 14:34

So it's really helping the the engineering and the manufacturing teams understand the problem, the heart of the problem in a very intimate, thorough manner. Yes. We had a guest a while back, Robert Morley, who, when I asked him, 'What are some of the most important things for your engineering teams to keep in mind as as they're developing new products?' That was basically his answer as well. He said they need to understand the problem really, really well. And when they think they understand it well enough, they probably don't. So go back and understand it even some more. It's such a simple but very profound answer. Sounds like you're, you're suggesting the same thing here.

Mark A. Farber, MD: 15:13

Yeah, I've known Robert for a while. So yeah, so I know these guys for quite some time. So I mean, we work on stuff. And it may be that they move to a different company. That's the other thing is that we do have some long longitudinal relationships that go on that are very helpful.

Aaron Moncur: 15:30

How fun. What, what are some of the most interesting problems that you've been able to solve as a physician and consulting with medical device companies?

Mark A. Farber, MD: 15:44

Well, I'm, we're embarking on another area right now, Aaron, right now we've been able to improve the treatment that we do. And if you go back 20 years, there are patients that couldn't even undergo open surgery like your dad, right? They couldn't tolerate that type of a procedure. And we would tell them, Look, we have nothing to offer you. At least now we have we have devices that we offer patients, some are already FDA-approved, and some are in clinical investigational scenarios. But they the thing that that's hardest, is that we're trying to struggle with is their durability, we still have to look at 10 years down the road. So, if you're 80 years old, and I say, look, I got an advice in the last 10 years, you're fine with that you're like, I'm gonna get to me, my nine is our problem. But if you're your age, I say, Look, I'll give you some last 10 years. Now, we've been open surgery for 50, 60, 70 years, and I know it's their abilities, got 100,000 miles on it, and you're gonna get out to be much older. But it's gonna take you longer to get through the procedure long and recover. Which do you choose. And it gets to be a difficult decision for patients. Because most patients focus on the next one to five to eight years, they have a hard time thinking about 10 years from now, not just patience, but probably everybody has a hard time trying to figure out where they're gonna be in 10 years, and willing to take a chance on 10 years to get a better quality life early on, it's no doubt that the fast recovery returned to their baseline is quicker with the minimal invasive, but what we don't have an answer for yet is the durability and thin years. And one of the problems is is in our field. Device changes are happening so rapidly that by the time I get to five or eight years on a device, it's already changed. I'm not really working on the same device anymore. So it's hard to meet predict longevity, because I've now got another device in my hand that's got some improvements, and are the early devices that we saw failing and 10 years, no longer gonna apply to these devices that we're using, 10 years later. And so it's much harder to predict that it's not like we have one device that we've used for 20 years, and we can figure out what the issues are.

Aaron Moncur: 18:11

One of the questions I wanted to ask you was how has recent medical device technology shifted procedures from fully invasive to minimally invasive? And it sounds like at least one of the things that you're saying is that while that shift has occurred, outcomes, long term anyway, are still maybe better from a fully invasive procedure versus minimally. Is that is that accurate?

Mark A. Farber, MD: 18:35

So yes, and no. So, so yes. So if I'm looking at fixing rd below your kidneys, which is the local infrarenal, below the kidney area, we had data that says after 10 years, those early devices don't as well as open surgery, we have no data for the devices that extend above the kidneys, because they have been out there as long then. So I don't know if it's gonna translate because those procedures are more invasive, and even harder. So our difference between open surgery and invasive is a big difference to start with. So it may take maybe 15 or 20 years, but you have to realize the average patient I'm working on is probably in their late 60s, late 70s that decade of life. So I thought, 'Tanya, hey, I'm gonna get you 10 or 15 years,' you say, 'Well, I'm 75. I'm looking at 90 I'm okay with that.'

Aaron Moncur: 19:22

Yeah, that makes sense.

Mark A. Farber, MD: 19:24

The other problem we don't know, is what I do today. I didn't think I was gonna be doing 10 years ago, with how much we've advanced. So who knows another 10 years, I may have other things to fix the problems that we have now that make it last even longer. And so that's something that's a recurring issue, right? Because we're advancing so quickly in what we know.

Aaron Moncur: 19:46

Okay. Well, they say that mankind overestimates what he or she can do in the short term, but underestimates what they can do in the long term. It sounds like you're seeing some of that.

Mark A. Farber, MD: 19:56

Well, the thing I will tell you that I've learned, never bet against technology, technology and advancements are generally going to always went out. I mean, when people said, 'Oh, that stuff will never work.' Sure enough, I mean, 85% of what we do is all minimally invasive. Right?

Aaron Moncur: 20:11

Yeah.

Mark A. Farber, MD: 20:11

So in one sense, you say, well, it doesn't work at 20 years, that's okay. It's working really well, early on. So

Aaron Moncur: 20:21

Back when you first started helping engineering teams develop devices, what what were one or two of the things that you thought would be so easy for the engineering teams that you've learned over time are actually very, very difficult.

Mark A. Farber, MD: 20:38

The devices we put in roughly speaking, are six or seven millimeters in diameter, so about the size of a pin, okay, when we started, they were probably on the order of eight or nine. And the smaller they are, the easier it is to get it through your because we use the access through your groin arteries. And why we can just make this smaller, we can lower the profile the fabric, but what we're finding is that there's a certain limit to the durability, and make the fabric a little thinner, the Dacron, the polyester, and the fabric has a tendency to wear out and have problems with the stitches pull through or something like that. So if we change the way that nitinol is done and change that it may not have the same rate of force to keep it in place. So there is a limit to how miniaturize we can get things to make it easier to implant then people were hoping to have these down to four or five millimeters, but I'm not so sure we're going to get there.

Aaron Moncur: 21:41

Interesting. Interesting. Okay. Well, I'm going to take a very short break here and share with the listeners that teampipeline.us is where you can learn more about how we help medical device and other product engineering or manufacturing teams develop turnkey equipment, custom fixtures and automated machines to characterize inspect assemble, manufacturer and perform verification testing on your devices. We're speaking with Mark Farber, today, Mark, how, how do surgeons learn to use new devices? I mean, they're all always these new devices coming on market? Is it a pretty short learning curve? Or is there usually a pretty in depth process through which you and your colleagues go to learn how to use these devices?

Mark A. Farber, MD: 22:28

Aaron, there's two parts to the process. So at the university here, we have a training program. So that we have guys, it's been anywhere from two to five years with us learning advanced techniques in vascular surgery. And they're under my direction or my supervision. So we'll do cases together. So they'll learn how to use devices or do these techniques in that fashion. Now, since we're an advanced center, and there's about basically 10 centers that have access to some of the stuff that I have access to, they will leave here to go to a different center a different place, and they may not have access to what they had access here for five or 10 years later till that vise gets approved. But they understand the techniques, they understand how to get device like that implant. So one way they learned is coming here, and they may stay here and go to center seminars and then carry the technique on. If they've already been through training and didn't have access or get the train that we have here, then they can go to some training courses. Generally once devices get approved, okay, companies do provide that as part of the approval process, because every device awaits implant is not exactly the same. There are some similarities, but that the same, so they go through a training course, I may go someone else or I may go proctor them and help them from an observation standpoint, get the device implanted. And once they get the skills up, then they're on their own. And that's how it runs with the clinical trials that I supervise. So I'm the national investigator for one trial United States. And so they asked me, Hey, you need to take the new other investigators, people learning how to use this new device and teach them. And then if they need me to I will fly to that center. And while they're doing the case, give them pointers to how to do that. So that's the two processes by which it occurs.

Aaron Moncur: 24:22

I see. Okay, thank you for sharing that. I listened to a short video of you speaking about your work online. And one of the things I heard that I thought was really interesting is that you mentioned UNC is one of I think it was only eight sites in the world that has access to some of the cutting edge or custom manufactured medical device technology. Can you talk a little bit about that? I mean, why is access limited to these eight sites and what are some of the devices that you have access to that other hospitals just don't.

Mark A. Farber, MD: 24:56

So in the United States device approved occurs through the FDA. So if a company a says, 'Hey, we've designed this device to do to do this,' and they have to then collect data on patients take that data, take engineering data to say, hey, we've done the engineering testing, and this device is durable. And they submit that all through the FDA, they get a device approved, the FDA is working in the patient's best interest is why we don't have as many problems historically here as another countries, okay. Some companies are international companies, they developed devices for all over the world. And the one company that you're referring to that about 10 of us now work within us is that they have devices approved in Europe, they're approved in South America and Australia, but they're not approved in the US. So the company could say, Hey, we're gonna come to you, Mark Farber and everybody else and put together a few sites to do the trial, okay. But if they don't have all their things in a row to do that, and think they're going to get approval yet, because they need some added resources, then they won't do that, because that would be a waste of the money to start a trial. The other process that can happen in United States is that I was a physician in split and takes it back. Those companies are sponsors of the trial, they sponsor the trial and say, Hey, this is our device. we're sponsoring it. Okay, since a company sponsored investigational device trial, the flip side is is I go to the FDA. And I go to Company A and say, 'Hey, can you support me in implanting these devices? I want to test whether the device is going to impact someone's kidney function,' for instance. And then I go to the FDA and say, to the FDA, 'I am going to be the sponsor, and I'm also the physician implanting it. So this is a physician sponsored device and guest negation trial.' And that takes a lot of work, because normally, the company or the sponsor is at risk and responsible for reporting the FDA, collecting all the data and doing all this. In this case, now, not only do I have to take care of the patient, but I'm also responsible for submitting all the data and all the follow up to the FDA on a yearly basis. And so in our trial, now, we have probably close to 400 patients that I'm following. So that requires a lot of work on my part and puts me technically at risk. If I don't do the report, or I failed to do something, if they will shut me down, they won't go after the company. So I'm on for an investigator in this situation. And there's about 10 of us that said, Look, we're willing to take that responsibility, because I get to have a company that makes the device as I said, if I make a device, but it it seals your aneurysm off, but doesn't provide good blood flow to your kidneys. And you have kidney failure five years later, that's a problem, right? That's not a good device for us. So the FDA process says, look, we're going to look at one year data on devices. Well, there are things we need to study beyond one year. And so what I do is the company gives me that access, I go to the FDA, and I run the trial. And then I work with a company to make sure that I get the back the information that yes, your device is or isn't impacting kidney function. Or if I designed in this way it changes kidney function, we need to stay away from that in your design trials, and move that forward.

Aaron Moncur: 28:29

How does this collaborative process typically work between physician consultants such as yourself and the the OEM the medical device manufacturer? Do they typically come to you with an idea? And you provide feedback? Or do you go to them with an idea, and they decide if they want to make it or not?

Mark A. Farber, MD: 28:48

It happens both ways here. And so there are some times they say, 'Hey, I've got this idea in my head to do this to fix this problem that we see. I don't have the engineering tools to test it, and so forth and so on. And I can file for the patent at the US Patent Office to get a patent. But then I got to get someone to help me manufacture it and get it through the testing process.' That's one way. The other way is the company has engineers, and they come up with an idea that's an improvement or something on something, they come to me and get my input, say, Hey, we need to do this advanced trial, can you help us do that. So it happens both ways. And, and it gets harder and harder. As time goes on. The patent lab landscape gets a little bit harder to negotiate and get around what everybody has in their IP. And so you just have to be good at that stuff. If you're going to do those things. at a university here. I find it a little harder to do my own patents because university would want rights to that and so forth. So I tend to just consult with companies and I don't try to go after my own IP, because it gets to be hard to do that. But there are people other institutions, maybe in private practice that can do that easier?

Aaron Moncur: 30:05

Got it. Okay. And what kind of relationship have you seen worked very well, between engineering teams and and physicians? I mean, what does the dynamic or process need to be for successful outcomes? Or conversely, are there any specific situations where you've seen these relationships just not work well at all?

Mark A. Farber, MD: 30:27

But I think that people have to be honest, if you put a product in my hand and say, 'Look, guys, this doesn't do what we need to do, this is a problem.' The engineers have to believe in you and believe that they say,'Well, we don't believe what you're telling us' and go on to do it, there may be issues down the road. And so I think that's something that always has to be there, you have to be honest with people when something isn't work or isn't designed the right way. And you think it's going to be an issue, you have to tell them, because if they persist down that pathway, either device won't get approved, it'll be a waste of money for the company, or if it gets approved, and then it has problems later that you thought could have been there but didn't show up early on, it could be a problem for patients. So we have to always keep the patient in the forefront of what we're thinking about, and make sure that we do things safely.

Aaron Moncur: 31:17

What what advice or feedback can you share with engineering teams out there who are developing medical devices?

Mark A. Farber, MD: 31:27

I think is, as I mentioned before, when you're looking at medical devices, the environmental work in isn't such a defined set of factors that influence things, it's not as controlled of an experiment, as you think it is, you can put these devices in some modulation device that mimics heartbeats and oscillations. But if you don't do it with it sitting a little bit of a twisted configuration, and realize, for instance, the blood vessel is not a static tube, that when your heart beats, that tube expands and on coils and coils, in terms of its edges, you've got to factor all that in. And sometimes you just can't design a test to test for all that. You can test one component, or the other component, but you are a third component, but you can't test all three at the same time. And so, as we all learn engineering, you want to control for what you testing. So if you can control you can fair what the problem was, though, then for if you have an issue, you can go figure out why it happened because you control for all those variances say, well, let's increase the speed, let's increase the amplitude of the oscillations or whatever the test everything, the body doesn't quite work that way. So you have to realize that.

Aaron Moncur: 32:48

So when when you're testing a device, or engineering teams are working with they're testing a device, and you know that A, B and C, they all happen simultaneously in the body. And that's really the conditions in which we need to test this device. But for whatever reason, the engineering team comes back and they say, well, we can only test A or B, or C individually. There's no way we can test all three of them at the same time. What's the answer? What do you do then?

Mark A. Farber, MD: 33:14

Well, I mean, there's simulations. I mean, there's one thing do mechanical testing and devices. The other thing is to do finite element analysis and those types of things to try to supplement that. You try to say, 'Well, look, we can use a computer try to model this.' But like always, it's still not exactly the same. I mean, we see that in testing devices, we could have some failures that don't occur ever in the human body and vice versa. Revenue body and we never can prove by testing, right. So we don't have that all worked out perfectly. Because it's it's not like I said, it's not a well defined finite environment. There's a lot of variables, right. And even like anything, you have an experiment, and you only, you only can think of three of the five variables that are impacted, you might not come out with the answer you think because there's two variables that are impacting the outcomes that you don't have any idea of how they're influencing things.

Aaron Moncur: 34:12

Yeah, well, we do the best we can with the information we have. Right?

Mark A. Farber, MD: 34:16

Right.

Aaron Moncur: 34:17

Well, what do you see as the future of vascular medical device technology? I mean, 10 or 20 years from now, what do you think will we'll have then that we don't have or maybe we're not even imagining now?

Mark A. Farber, MD: 34:30

Well, I mean, it from a human anatomy standpoint, what really impacts us is where all the branch points are, and in connection points and we've marched all the way up to the heart, we can do the heart valve, we can do that ace in the order that's in the investigational phase and do the branches that go to the brain. But right now we have been able to hook the heart valve to the main artery that leaves it and so the next 10 years that will probably happen. Those two right In our separate procedures, we'll work on fixing those together. And then we're going to probably work on durability of devices. As a general rule a relatively stiff. So if you think of the heart as an engine, or a motor, and I've got a pump through a tube, normally that's elastic, then that resistance is relatively low. If I put a stiff piece of metal with fabric in there, the amount of energy that that motor has to generate the pump fluid through there is going to be a lot greater. Yeah, because it doesn't have that elasticity to dilate as the pressure goes up, right? So it's gonna require more. So we got to make sure as I said, just like say, well, maybe the kidney doesn't function, well, well, maybe we're gonna run into heart problems 20 years later, because the hearts got to work harder. For that 20 years, when I put a device in you now there are some things that argue against that, that when you get an aneurysm, you're RDR is different. So but we don't really know what those numbers are inside of human because I can't test that in you. When you're seven years old, I can't figure out how elastic your artery is, when you when you do an autopsy, I could take that out and test that tissue in pullet. But that's not the same as being alive specimen inside you, and what's happened to have your heartbeat. And so those are things that technology will help. As imaging has improved, we went from a two or five millimeter segment down to sub millimeter segments. Pretty soon we're gonna get into the biologic imaging, that I can start to do these tests that tell me how really functioning that iord is that kidney is on a biological level. When that starts to happen, I think we're gonna get some of this other data as we get into the microscopic analysis of things from another perspective.

Aaron Moncur: 36:49

Tell me more about that. What does that mean, exactly? Biological imaging?

Mark A. Farber, MD: 36:54

Well, right now, I can look at your artery. And some people think already is just a tube carrying blood. Well, it's got other things, it's got a lining on it, that stops the vessel from clotting off. And it secretes a hormone, endothelial. So if I construct tests that say, What if this patient's aren't is clotting? Maybe they'll know not producing that chemical enough in that one area? Maybe that lining is damaged there, right? I can't really test that right again, I go and take a piece of that lining. Well, I got to expose that artery, and then I changed the whole artery itself, by getting imaging that says, 'Hey, that's functioning,' I can look at your liver, I can test some gross liver function by doing a lab study in your blood. But can I tell you that one side livers not functioning as well as the others, that's creating as much bile? No, I got to look at the liver as a whole unit. Right? It's hard for me to get to one part versus the other. So I think we can do things that are going to help us think about that and figure those things out as time goes on. And that's, that's the pie in the sky Star Trek. Hey, you're gonna take that tricorder? I'm gonna wave it on and say, 'Oh he's got kidney problems.' Right?

Aaron Moncur: 38:08

Got it. Very cool. Well, I've just got one or two more questions for you. And then then we can call it a day here. What are one or two of the biggest challenges that you have within the context of using medical devices?

Mark A. Farber, MD: 38:25

Well, one of the earlier challenges was getting them in, right? There are nuances look, in general, the body habits of a woman is smaller than a man. And so the arteries that they have are smaller than men. So when devices are bigger, we had a hard time getting it into women, because I would damage you're already doing that. Okay, so we've helped that with profile getting a little smaller and things like that. And then you run into durability because of that issue. So those are things we deal with is that you're not the same as me on the inside. And so that's why all this custom manufacturer stuff has come out. In the future, maybe we'll be able to do in vitro, or in vivo modification device I put in you and I can modify it inside you to fit you, instead of me having to do a study, figure out your anatomy, tell someone to make me a device to fit this be really nice if I had a device that I could get in you and make it fit a lot of people. Right now we have devices that fit about 25% of people off the shelf. It'd be nice if that was 80%, right? Because right now, I've got to wait sometimes two, three months to treat you because it takes that long to get a device manufactured in our hands. A lot of these things are man made by hand still, we've got something right in your factory really sewing the fabric and the stent together. It's got to get tested an X-ray and then sterilize it's not a it's not a turnkey process where to turn the machine on and rolls in one end and out the other. And the production time is an hour right? It's it's sometimes 24 hours of someone actually manufacturing that human work.

Aaron Moncur: 40:04

That is so interesting, I think of some of the medical devices I'm familiar with, a laparoscopic instrument or a catheter. And these things are made by the hundreds of 1000s, if not millions. It sounds like the devices you are working with are more custom, you mentioned that it might be two or three months before you can get the device that was built specifically to treat a particular patient. Does that mean that a lot of the devices you are using are really built to order based on the the the patient's anatomy?

Mark A. Farber, MD: 40:36

Yeah, those 10 sites we've talked about earlier in the in the podcast, what do you do majority of those sites do custom manufacturer devices, I get the CT scan, I get the imaging, I say, 'Okay, I want this window here at 12 o'clock position, down five millimeters, and now at the down to one centimeter for that at the nine o'clock position, I want a six millimeter window to this artery.' And so I specifically get all those details. That's why that imaging, the CT scan, and I talked about him is going so important. It's a sub millimeter analysis, I can tell you where all your vessels are all the critical things I need within a millimeter, one another, and then they can manufacture it to those specifications.

Aaron Moncur: 41:19

How interesting.

Mark A. Farber, MD: 41:19

Now, 25% of patients fit a pattern, that we have a device that will fit them. Okay, but I would like that to be much more. Now the other option is say we're going to ramp up manufacturing, and I have all these devices manufactured in a day or so instead of three months to get it for my hands. But that's not realistic, either, right? Because then they're going to have a lot of resources there. And I don't think that's going to happen either. But we'll get to some of that as time goes on.

Aaron Moncur: 41:51

Yeah, I see the trade off that you're talking about, you can get mass devices very quickly, but that aren't really customized don't work as well for the patient. Or you can get something that's custom made for that patient will work very well. But it's going to take quite a while. Right. Well, Mark, Dr. Farber, this has been just delightful. I really appreciate you taking some time to speak with us today and share some of your insight and wisdom. How can people get a hold of you?

Mark A. Farber, MD: 42:18

So I'm listed at the University of North Carolina and get a hold of me there. I have an office number. My email is public email mark_farber@med.unc.edu. Happy to talk to you call the office. I'm happy to speak to anyone who wants to speak to me, engineering wise. Happy to see people that sees me. I have a LinkedIn account. I think you can post that up Aaron, on the podcast.

Aaron Moncur: 42:46

Absolutely.

Mark A. Farber, MD: 42:47

Happy to connect people through LinkedIn,either those methods are just fine.

Aaron Moncur: 42:51

And if people want to engage with you on a consulting basis, are you open to that?

Mark A. Farber, MD: 42:56

Yes, you can consider send me an email and then we just start the process. And we got to work through the non-disclosure stuff and things like that. But that's that's typical. That's what I do. I work with a lot of companies, not just one company because I think it really helps broaden your perspective on things.

Aaron Moncur: 43:12

Fantastic. All right. Well, Mark, thank you again, so much. I really appreciate your time today.

Mark A. Farber, MD: 43:17

All right. Thanks, Aaron, you take care.

Aaron Moncur: 43:22

I'm Aaron Moncur, founder of Pipeline Design & Engineering. If you liked what you heard today, please share the episode. To learn how your team can leverage our team's expertise developing turnkey equipment, custom fixtures and automated machines and with product design, visit us at teampipeline.us. Thanks for listening.