An Innovative Approach for Advanced Physician Training and Patient-Specific Rehearsal
Episode

Ziad Rouag, President and CEO at BIOMODEX

An Innovative Approach for Advanced Physician Training and Patient-Specific Rehearsal

In this episode, we are excited to feature a thought leader in life sciences and health care – Ziad Rouag. Ziad is the President and CEO of Biomodex, a digital health company offering enhanced 3D printing.

In this podcast, he talks about the various applications of enhanced 3D printing in the medical device sector. He also shares how his company’s product can improve difficult and complicated surgeries, increase the comfort level of physicians, and reduce variability.

Ziad shares his thoughts on leveraging novel technology to continually improve health care, doing things a little differently, and the possibility of 3D printing to revolutionize medicine. You can hear the excitement and enthusiasm in Ziad‘s voice as he shares about Biomodix. If you’re a med device company looking to leverage tools like this to grow your business, this is a podcast you should listen to!

 

An Innovative Approach for Advanced Physician Training and Patient-Specific Rehearsal

About Ziad Rouag

Ziad is an Operational Executive and entrepreneur in the medical device industry, advising leading incubators and startups with over 20 years of experience. Before joining Biomodix as President and CEO, Ziad served as the head of Toxicology Pharmacokinetics, a regulatory clinical data management, and statistics at JUUL Labs, a venture-funded startup that developed the breakthrough nicotine delivery system. Altria actually acquired them. Previously Ziad served as the vice president, preclinical, regulatory and clinical affairs for Piku Bypass Fogarty Institute for Innovation of Incubation, a venture-funded startup that developed a breakthrough endovascular arterial-venous bypass system, really just spearheading a highly successful clinical trial and e launch and setting the ground for a US Eyedea Zayat for their served as the vice president. Preclinical, Regulatory Quality and Clinical Affairs for Altura Medical, Lumberton Medical Acquisition, a venture-funded startup that developed a modular Pendergraft for treating complex abdominal aortic aneurysms. He is an extraordinary innovator and just a thought leader in the life sciences industry But health care overall.

An Innovative Approach for Advanced Physician Training and Patient-Specific Rehearsal with Ziad Rouag, President and CEO at BIOMODEX transcript powered by Sonix—easily convert your audio to text with Sonix.

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Saul Marquez:
Welcome back to the Outcomes Rocket, Saul Marquez here, and today I have the privilege of hosting Ziad Rouag. He is an Operational Executive and entrepreneur in the medical device industry, advising leading incubators and startups with over 20 years of experience. Prior to joining Biomodex as President and CEO, Ziad served as the head of Toxicology Pharmacokinetics, a regulatory clinical data management and statistics at JUUL Labs, a venture funded startup that developed the breakthrough nicotine delivery system. Altria actually acquired them. Previously Ziad served as the vice president, preclinical, regulatory and clinical affairs for Piku Bypass Fogarty Institute for Innovation of Incubation, a venture funded startup that developed a breakthrough endovascular arterial venous bypass system, really just spearheading a highly successful clinical trial and e launch and setting the ground for a US Eyedea Zayat for their served as the vice president. Preclinical, Regulatory Quality and Clinical Affairs for Altura Medical, Lumberton Medical Acquisition, a venture funded startup that developed a modular Pendergraft for treating complex abdominal aortic aneurysms. He is an extraordinary innovator and just a thought leader in the life sciences industry But health care overall. And so today we’re going to be diving into his work at Biomodex, where he is the President and CEO to talk about the solutions that they’re providing to our industry in this time of drastic need. So, ZIad, such a pleasure to have you here on the podcast today.

Ziad Rouag:
Great. Well, thank you for having me. Looking forward to our discussion.

Saul Marquez:
Yeah, likewise. And so before we dive into Biomodex and the fascinating work you guys are up to there, I would love to really understand more about your inspiration for your work in health care.

Ziad Rouag:
Yeah. So I think it goes back to to childhood. I remember specifically when I decided to work in health care, so I have to go back a few decades. We’re talking early 80s. And as you recall, that’s when the AIDS epidemic hit. And nobody in ’81 ’82 had any real idea what was this thing, what was this virus. It was a very, very complicated period. People were very afraid. I was coming into my early teens was 11 or 12 and those days. But I’m a bit of a science geek and ended up reading on the isolation of the virus at the Pastel Institute in France. Pacific Institute. And France was actually one of the early countries to actually identify the virus and then eventually sequenced the virus. And I thought that was so amazing because the world was in such crisis and that lab and a few others in the US did a tremendous job. So I’m 11 or 12 years old and at school were asked to write an essay. What we wanted to do as we grew up, what would be our ideal job. And for me it was very simple. It’s to work and lead, developing novel technologies and medical solutions, working for the Pastel Institute. So I’ve never worked for the Pastel Institute. But that was effectively the key motivating factor in my personal life to say, OK, I really want to work in health care and find solutions to the human problem. And that’s kind of what drove it. So my entire education and then beyond that, my career has been moving in that particular direction, looking at novel technologies, chasing novel technologies, trying to find solutions to very complex healthcare problems, primarily the medical device industry, but not always. So that’s kind of how I got into or at least how I got to where I am today.

Saul Marquez:
And I think that’s so interesting. And obviously, your track record shows that you’re you’re certainly not looking for for anything easy to do.

Ziad Rouag:
No, no, but, you know, it’s interesting because really people are saying, why did you go work on this company or that company? And they’re very different technologies. And my answer is always yes. But there’s a common denominator. It’s the novelty, the complexity of the problem and the novelty of the technology. And so I spent my career looking specifically for novel technologies that can address complex problems, because that’s what basically motivates me, stimulates me. Not always very easy, not always a success. You know, you’re always taking risks with novel technologies, but always exhilarating, definitely never boring. I’ve never looked back.

Saul Marquez:
That’s great. Maybe maybe sideways a couple of times, but not bad.

Ziad Rouag:
Yes, sideways way, a couple of setbacks.

Saul Marquez:
I love it now. And, you know, it’s fascinating, right. And you tend to find entrepreneurs like yourself that have this track record of success. There’s a method to the madness. And so I’m very curious and I’m sure the listeners are two about Biomodex and the work you guys are doing, why you chose to join them and and sort of what the plan is there because. So can you talk to us a little bit about how the business is adding value to the health care ecosystem?

Ziad Rouag:
Yeah, so Biomodex with a fairly unique company. So just to give you a little background, I suppose it was an accidental meeting. Effectively, I was brought on to consult. So I had met the French team. I was down in San Diego at the TCT and I got this call from the French and they’re like, hey, we have this technology and we want to talk to you and can you come and consult for us? And so I said, OK, I’ve never heard of you guys. So I went down and I sat down with the two founders, actually. And this is technology now. I have a pretty strong clinical background. And one of the issues I’ve I dealt with in my career is how do you develop a new technology and how do you get people trained to it so that we avoid the medical errors, particularly early stage and then, of course, getting the adoption done. So, you know, we focus so much in our industry, in the medical device industry on developing the product, but we spend far less time in terms of training or rehearsing and so on. So I’ve always knew there was a need for some kind of a really nice, nifty, simple solution that can solve that particular problem. It’s just I never came across it and frankly, we never had too much time in the startups where I worked or any startups in general to go ahead and develop such a system. So when I met with these guys and they were quite humble and they showed me what they had, I was really I mean, I was blown away and I looked at what you got to this and and frankly, that I don’t think they had any sense of how ahead of the game they were and within the industry. So I came in initially to consult and then eventually, from a strategic perspective, I was asked to come in and take over the organization to a transition phase, things started taking off. So really complete serendipitous process. But sometimes things just happen and happen naturally and things go well.

Ziad Rouag:
So really, to tell you about Biomodex, what are we? Well, first and foremost, we’re a digital health company. What we do is offer a practical solution to physicians, primary surgeons and cardiologists to actually rehearse their specific cases. And our solution involves 3D printing, which is really the fundamental base that we always say we go way beyond 3D printing, because today, if you are a physician, you know, I have kids and kids. Now, you can buy a 3D printer just about anywhere, Walmart, and you can do all kinds of things with it. So today, basically, you can print an anatomy anything aneurysm using a variety of 3D printers. But what can you do with it fundamentally, you know, from a medical perspective? You can look at it, you can show it to your patients and say, look, this is my aneurysm, this is your aneurysm. Here’s what we’re going to do, the procedure, so you can use it as a teaching tool. But to be able to utilize it, to prepare you for the procedure, you need a lot more than 3D printing. And this is where Biomodex comes in. So we’re digital health company and we offer what we call enhanced 3D printing or 5D printing, because rather than just do baseline 3D printing, we print multiple materials. We print the actual anatomy, which anybody can do from a digital file. But we have a biomechanical model from an algorithm that gets added on top of that that gives you tissue properties. We also have a technology called Echotech that gives you imaging properties echoginicity, photogenicity and so on. And the entire system is packaged in a station with fluid and full dynamics.

Ziad Rouag:
So effectively what the physician can do is taking this tiny station, order from us the cartridge for a specific patient through a Web based portal. So simple upload of the CT and we do the rest. We send them the actual cartridge to save the aneurysm. It pops it in the box. And he actually performs the entire procedure on the system, which is identical to the procedures he will perform with his patient a day or so before the procedure with within his cath lab, within all the imaging, with all the tactile feedback that he would get when he’s actually using the technology, his main technology on the patient. So we view ourselves more as a simulator, just like in flight simulation, for example, where a pilot system is similar to the crew in the cockpit. They have all kinds of screens, a lot of input. They practice the flight, they can pick the runway, they can pick the weather conditions, the flight path and so on. And we think fundamentally we can do for the health care industry, which simulation has done for the airline industry, which is a significant reduction in accidents, near accidents and so on, and as simply a training and rehearsal tool for the pilots and for the physicians that are doing complex procedures that are fairly complicated and difficult and associated with a certain number of medical errors.

Saul Marquez:
Well, I think that’s great. And so the thought that that I have here is you’re you’re printing this 5D model in a station where you have the imaging properties, a platform that also includes a fluid dynamics and feedback, total simulation, are you are you doing this for every unique patient? So is it a form of precision medicine or is it kind of more general?

Ziad Rouag:
So we do both. When we first started, we started with the medtech companies and they wanted to use this for their training programs. So they’re launching a new product, The Tronic. We want to order X numbers of cartridges for these specific anatomy’s to train our new catheter system, embolic protection device or whatever, right.. And so that’s how it started. And then we got really developing relationship with them. These companies, the physicians, and then the physicians are coming back and saying, hey, we really we have these complex cases of the complex anatomy. This is very different. You know, if we could rehearse these cases and do the actual trials, because there’s no difference for us from a technical perspective, whether we do a standard cartridge for the patient that we can put 50 times or do it every time for each individual patient. So we’re starting to see the shift. We started the training initially of standardize cartridges from the companies. Are people ordering these things? And then now we’re moving more and more what we call PSR that we are patient specific rehearsal cartridges where the company, the physician, the client in general wants to rehearse a specific patient case and they will send us the Dicle files and then we will send them to the cartridge and they place it in the station.

Ziad Rouag:
They’re going to change their catalog with their team. So imagine the cath lab, typically cath lab you got Floro, you may have Echo. So you have the choreographer, you have the two physicians at the table. So the entire procedure is literally done in that specific cath lab with all the imaging, the full medical team, and that’s how they can actually rehearse the complete procedure. And as you know, physicians need haptic feedback. I mean, it’s not digital simulation. They have to feel when they’re moving around with the product of the characters. And so our entire system is about haptic feedback, biomechanical properties, plus imaging properties. So it’s all in one solution, which I think is very unique. There’s I don’t believe and we’ve looked very hard for anyone that does what we do today, this impression, and we make it very easy to purchase the order. We’re all pretty much web based. So we think we have a really nifty solution and practical solutions. Physicians don’t have time. They want to do this stuff, learn from it, go through their cases and we we try to accommodate.

Saul Marquez:
I love it. It sounds so practical. What would you say? I mean, I guess in a lot of ways what you do is so different. How has adoption taken?

Ziad Rouag:
So so we’ve been around for a few years. Obviously the first years were early stage development. So from an adoption perspective, you know, we tripled our sales number last year. We’re going to triple probably again this year. So we focus in multiple franchises. So we have a neurovascular franchise, we have a triple-A franchise, we have a structural franchise, and we’re developing multitudes of products systematically for those procedures that are very complex, difficult to do, like mitral valve, tatis and so on. And so we’re highly focused. And what’s happened is initially we started working with a handful of medical device companies and then we started working with physicians. Now we are having discussions with imaging companies. So our volumes are increasing the batteries. Last year we opened the Quincy, Massachusetts office from Paris. We’re adding more machines and then we’re gradually growing. So so we’re pretty happy with a controlled company. We want to do things well. We want to collect our data. At the end of the day, it’s all about the data and the results and the true impact of technology. So we are going well, we could grow perhaps faster if we choose a different path. But right now, technology is still in its infancy. We’re developing significant new platforms from an R&D perspective and things are growing very nicely. So we’re very happy with our direction, our physicians, with our B2B clients to try the medtech, the imaging company.

Saul Marquez:
And so I think that’s awesome. Congratulations on the progress thus far. And it really sounds like you guys are partnering across the aisles with with the imaging folks, the providers, the the med device companies, and maybe developing that set of data that you’ll need to really start making a play with the with the payers.

Ziad Rouag:
That’s correct. I mean, the long term goal is effectively to make this technology so ubiquitous, so standard, working with the societies, working with the payers, that in order to avoid medical errors and you probably know this, medical errors are one of the leading causes of mortality in the US is to make this technology as standard as doing a city or an X-ray or doing a digital simulation. So imagine that ten years from now, every neurovascular aneurysm cost will come down and technology will keep getting better and so on, and access will increase. But every single aneurysm procedure would be rehearsed by the by the interventionist, right before we can actually go and do the relocation that can become a standard of care in the industry in conjunction with insurance companies, in the liability perspective, hospital costs and reduction of morbidity and mortality. And so. So this is what with your technology becoming if you remember CTD I started my career early on and I worked in the early triple-A devices and in those days we had x rays came much later today. It’s impossible to think of doing a triple eight procedure and endovascular procedure without a CT. 15 years ago it wasn’t so common. So there is a natural evolution to the adoption of a technology and we think this technology can be come down the line a standard of care.

Saul Marquez:
Wow, that’s cool. And that’s where the vision comes in, right? I mean, that’s that’s the visionary part of this.

Ziad Rouag:
Yeah, that’s correct. And for me personally, having been involved in probably two dozen trials designing, running these complex trials, you made some errors. You learn from your errors. But the learning curve, when you introduce a new technology, every time you introduce a new technology, there’s a certain learning curve which physicians in those trials, if I had this type of technology those days, we would have shortened that learning curve. We would have probably learned a lot more patient, much quicker. We’ve learned a lot more about our technology. It’s due to limitations. Yeah, so so. So for me, it’s a really amazing tool. So just to give you a couple of examples with the Medtechs, we support a number of networks in their clinical trials from a case specific rehearsal perspective as well as training. But we also work where there are case now where they’re purchasing our technology, tailoring certain anatomy’s for their future developments, looking to avoid future animal studies, being able to do rapid iteration by using a variety of indications and anatomies. So we work across the board, within the strategics, between R&D, between clinical, training and preclinical and so on. And of course, we work directly with physicians KIC well, the major centers and now we also work closely with robotic companies because these new robotic systems coming out, physicians need to learn how to use them and we are an ideal system to actually rehearsal and or train on. So. So that’s also another viewpoint.

Saul Marquez:
Yeah. I mean and you know, I’ve been in med device for a while and, you know, the specimen’s using cadavers is one thing. But if you’re able to do this without having to use cadavers, I mean, it’s just so much cleaner, it’s more realistic. Right. a lot of times the cadavers, you freeze and you lose some of those haptic feedback you’re talking about.

Ziad Rouag:
So I can tell you, earlier in my career, I was running cadaver labs and we had 20 legs to do peripheral procedures sitting there, let’s say at a hospital. It’s not pretty. It’s very expensive. It’s not realistic. And so you can really see many, many companies now and many hospital groups want to move away from cadavers. And also they want to move from animal studies because the animal studies are not always very accurate. The models are not the same if you’re able to deliver an anatomy that represents the exact replica of the patient plus the mechanical properties, and they’re able to do the procedure on that particular model, you can improve the validation of your product to market much quicker and with a lot more valid data than running it in the pig or or a dog or any kind of animal. So we think there’s a huge market there as well. And we’re being approached to see how we can address that.

Saul Marquez:
I think it’s awesome. And so, you know, the outcomes are apparent Right. we reduce variability, increase comfort level of the physician, improve outcomes. You you talked about some of the setbacks, but anyone in particular that you want to chat about and share what a key learning was.

Ziad Rouag:
So within Biomodex, I would say not so much. We were actually learning our business model. And so we’ve tried over time different things. And we realizing we have multiple call points with multiple customers from a B2B group and a B to C group. So we really tailor a technology to a variety of consumers. We also have a platform. So we look at our technology as a platform which allows us to target specific indications. So in that area, what we’ve done is we early on, we were a little bit more scattered as a company, but then we said, let’s focus. Where is the biggest lead, which are the complex procedures? where the physicians have a big learning curve? And we said, OK, for the time being, for the next three years, let’s focus on delivering products that address those complex procedures that the physicians really need to improve skills, to grow skills and so on. So I think one of the learnings for us was focus as a company on what’s really critical, on those procedures that count and what the physicians need. So we have built a pretty extensive program of interactions, which positions both of us, so we have a certain advantage. I mean, I live in California. I’m here in Boston. I spent a lot of time in France. So most of my career has been done in the US, but also partially in Europe, because we are in Boston and in Paris, we have access to really two different pools of physicians, the Europeans and the Americans. And sometimes the techniques are different, the approaches are different, and we validate our products using both. So.

Saul Marquez:
That’s great.

Ziad Rouag:
And we have an excellent network on both. On both. And there’s a lot of customization and our teams go back and forth, but we’re learning quite a bit. Working with European physicians as well as U.S. physicians. So we’re trying to target both market and depending on the countries, the practices area little different, but we’re able to handle those. So so we’re just like with our product, we are tailoring effectively our relationship based on the culture and the environment and so on to depending on where we in Europe or in the US.

Saul Marquez:
A lot of fine tuning and learning from across the pond are so. Yeah. And so, you know, I think about the approach and then the actual product. So is this something that has to be FDA approved now,

Ziad Rouag:
For now? No, not yet. OK, and so there’s a couple of things from your perspective. We use it for training and rehearsal. We today make no claims to its predictability that we are working with a number of key opinion leaders to come up with data and publish a number of papers and then beyond those initial papers so we can test the limits of our technology to understand what we can and can’t do with it. I think it’s very important from a clinical guide that’s critical. Then we will engage with the agency on a complex, more complex studies to lead and eventually to potential reimbursement of the technology between the states. So right now, we’re very cautious what we claim. We obviously want to be on the good side of the agency. We are collecting data so we know that our product can do quite a few things, can predict a few things. And then we’re really learning about our technology where we’re very methodical in our approach. And then eventually, as we have a number of peer reviewed publications on the books, then we will take that information and engage with the agency and start a coordinated process with the agency. How do we make this technology mainstream? How do we prove it’s true clinical value, the technical perspective, and how do we get into coding reimbursement and so on?

Saul Marquez:
Love it now. This is really great, Zyad. And what are you I mean, there’s so many things you guys are working on about all the things that you’re working on, which one makes you the most excited.

Ziad Rouag:
So I’m a bit of a geek. So the products are amazing. The products are amazing. So and what excites me is I mean, this is really a tremendous opportunity and I enjoy very much what I do. Like France is not a country that you would think of technically from a medical device perspective, but there is something called the French player, and this is very real. So our products are designed with a certain aesthetic and its simplicity. So we like to think of products like Apple. So our technology is very unique. When you see the physical product, it doesn’t really look like a medical device or medical product. There’s a certain aesthetic about it. There’s a certain simplicity and elegance about it. And so that is very much the French side of the technology. And so we spend a lot of time, which really excites me. We spend a lot of time with physicians working out the kinks, the small, tiny details about the product, the technology, how to best use it, something that may be very small to one eye, may be big for another. So that’s what really exciting is developing these products, using core platform technologies. So we have three basic core technologies, and those technologies can allow us to effectively develop dozens of products in different medical specialties. So we view ourselves as potentially becoming the leader in this field, basically for technology. So to me, that’s quite exciting.

Saul Marquez:
I think it’s great. And I like I like your reference to the French flair. There’s a there’s an aesthetic there for sure. You know, my wife and I were in France last last March and were just like, wow and everything. So, like, just the style and everything. Right. You just leave Inspire. She got like a bunch of ideas. And this is more like fashion stuff. But even with the consumer products. Right. I mean, you see it.

Ziad Rouag:
Yeah, exactly. So so a lot of our secrets is so we have two designers in the company. They’re not engineers or designers. They’re both sort of top French design schools and so very artsy in their in their thinking, in their mind, their artistic skills are incredible. And that gives us where, you know, historically in medical devices, everything is done by engineers. We start actually with these guys going out and spending time with physicians, our artists from the company. And they’re the ones who actually kind of do the conceptualisation and and they’re really artistic. Their designed skills, their abilitu to drawa and paint and do textiles. So that’s the world that come from that kind of French sort of art work. And this is where we start. Then we talk about, OK, this is the conceptualisation and then what are the critical requirements and the engineering perspective? So we reverse it a little bit. This is the first time I’ve done this to make an experiment. But so far, I think we we’ve hit on something a little different, a little new. And I think we’re getting great results because people look at the products and I see it’s very easy to use and there’s an elegance about it. It’s like having we look we think of ourselves as the apple of the rehearsal digital health industry, and we want to keep that image. In fact, I would say I don’t know if you’ve seen the virtual tour of our offices.

Ziad Rouag:
Everything we don’t know is that it can be done about it now. So everything is done with design. And so we start with the designers, not the engineers, as a company, which is a little different than most companies do.

Saul Marquez:
Yeah, I love it. And so I imagine this link is available and we’ll probably be able to share it in the show. Notes the tour.

Ziad Rouag:
Sure.

Saul Marquez:
OK, ok, cool. So I’m curious, I’m sure listeners, your I want to see this tour so you’ll have the chance to do that when we shared in the show none’s Ziad. So cool. I think it’s great. And then the foundation obviously, you know, scientific and research based, which is a lot of where you have focused, I think it’s really neat to see that stylistic element be incorporated into this great promise here. And so I appreciate all the insights you’ve shared with all of us. Why don’t you leave us with the closing thought, Zyad, and the best place for the listeners could reach out to you or the folks on your team to learn more.

Ziad Rouag:
Sure. So. So our sense and our vision is that we believe digital technologies and 3D printing really have the potential to revolutionize medicine moving into tailored medicine. So we think that’s the future. We also think bionics is the forefront of this process. It’s a revolution that’s about to happen. So we’re really excited about that. And the easiest way to reach us right now now is via linked in account or our Web page through our contact page.

Saul Marquez:
I love it, Zayyad. This has been great. And folks take them up on, check out what they’re doing, reducing variability, improving outcomes. If you’re a med device company looking to leverage tools like this to to grow your business, certainly an opportunity as well. So, Ziad, appreciate you so much and definitely looking forward to keeping up with your progress.

Ziad Rouag:
Well, thank you very much for having me.

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Things You’ll Learn

  • Some of the possible applications of enhanced 3D printing in healthcare
  • The value of focusing the business to create the best outcomes.
  • The importance of tailoring business practices depending on which country or culture you are catering to.

Resources

https://www.biomodex.com/

https://www.bizjournals.com/boston/inno/stories/office-envies/2020/08/10/officeenvy-biomodex-makes-its-home-in-quincys-life.html

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