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Bringing Augmented Reality MedTech to Market

April 6, 2022

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, ​CEO and President of MediView, about bringing augmented reality (AR) medical technology to market.

MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen.

Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives.

 

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Some highlights of this episode include:

  • MediView solved the problem of how to place a 3-D representation of a patient’s specific anatomy underneath the skin to millimeter accuracy.

  • MediView’s solution enables opportunities for digital health care for minimally invasive procedural guidance and data analytics.

  • MediView’s imaging technology and data feed its platform through a pre-operative or intraoperative scan, such as a CT or MRI, taken of the patient.

  • The scan is communicated to a headset and an algorithm combines/lines up digital AR and physical coordinates to create a 3-D reconstruction that’s put directly into and onto the patient.

  • In the U.S., between physical therapy, loss of productivity, and time off, there’s $120-billion of economic impact due to ergonomic injury of medical imaging.

  • The first therapeutic area and clinical unmet need MediView is targeting is liver and kidney cancer. Only 1 or 2 patients receive a minimally invasive procedure, while the others have to go through chemotherapy or resection.

  • Mina describes the differences of virtual reality (VR) versus AR. VR puts you in a fully digital world, while AR superimposes digital content onto the physical world.

  • MediView’s work culture materializes into the company’s business strategy and model across four functions—trust, transparency, team, and track record.

Links:

Mina Fahim on LinkedIn

MediView

Medtronic

Mark Griswold

FDA - Medical Device Overview

Code of Federal Regulations (CFR)

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from mina fahim:

“We are hardware agnostic. So, we don’t depend, actually, on any one specific headset because of the unique algorithms that we built in.”

“We have an algorithm that combines the digital world in AR with the physical world.”

“The interventionists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon blindly to get that tumor ablated.”

“We give clinicians imaging modalities they trust and are comfortable with today to validate the new way we’re providing them to practice and exercise medicine.”

“If a company’s exit strategy is acquisition, having a robust QMS that someone can look at effectively, efficiently, and simply…that has a mental impact, an emotional impact, a burden impact."

 

Transcription

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts in companies.

Etienne Nichols: Hey everyone, welcome back to the Global Medical Device Podcast. This is Etienne Nichols, with me is Jon Speer the founder of Greenlight Guru, hosts of the podcast. And also with us today is Mina Fahim. Did I pronounce your last name correctly? I didn't ask about the last name. Okay.

Mina Fahim: You got it. Good job.

Etienne Nichols: All right. He has a lot of background in many different companies that you're probably familiar with, Medtronic, Abbott, Beckman Coulter, Excelen, and serves as the CEO and president of MediView. So we're going to talk maybe a little bit about your technology, and I know there's some other specific things we want to talk about related to startups and how to go about starting that medical device company and how to take care of things. But yeah, do you want to talk to us a little bit about your technology? I'd love to hear about it.

Mina Fahim: Yeah. I mean, Jon, Etienne, thank you so much for having me on. It's a pleasure and I appreciate the opportunity. So yeah, MediView, we're really giving clinicians x- ray vision, if you really boil it down to what we're doing. And what does that mean? How do you do it? It means that we take a patient specific CT or MRI and we're able to take it, peel it off of a 2D screen, and put it in the real world in full 3D depth. And we do that using augmented reality or mixed reality technology which is just the enabler. That technology's going to continue to evolve, and it'll look like my glasses someday and well, all of us are wearing glasses, but eventually that's what's going to get to. But today, what we do is we leverage the power of display technology in the AR world to be able to say," Okay, here's the liver, here's the spine, here's the heart." And we can do that at the millimeter scale. And the time I spent at Medtronic, I actually started the mixed reality and AI initiatives for the ablation solutions, cardiac ablation solutions division there. Wasn't trying to leave Medtronic. I never say I left Medtronic because I loved it. I just went to MediView because the inventors and co- founders had solved a problem, which is how do I place a 3D representation of a patient specific anatomy underneath the skin to millimeter accuracy. That is a very difficult problem to solve. And once you enable kind of that foundation, what you can do then for minimally invasive procedural guidance and then data analytics, it opens up the whole world to what data and digital in healthcare could do. But it all starts with that fundamental foundation around our competitive differentiator of, I can take anatomy put inside the patient and let the clinicians see where the is and where the surgical instrument is underneath the skin in real time.

Jon Speer: Yeah. It's so fascinating. I'm on your website now and just seeing some of the images and reading a lot about the technology. It's so fascinating. And I'm curious, obviously there had to be some sort of imaging files or data to help feed, if you will, the MediView platform, how does all that work? I mean, and I know I'm not asking for your secret sauce. Share what you can because it's just fascinating.

Mina Fahim: Yeah. I mean, so a couple of ways, either a preoperative or intraoperative scan, meaning a CT or an MRI or a cone beam CT, can be taken of the patient. We have a way of hand shaking between the imaging solution, and today we use the HoloLens platform, but we're obviously exploring things like Magic Leap, Light Space, et cetera. We're hardware agnostic, so we don't depend actually on any one specific headset, because of the unique algorithms that we've built in. But you take that pre operative or intraoperative scan, we communicate it to the headset, and then we have an algorithm that combines the digital world in AR with the physical world. So basically, you're lining up all these coordinate spaces. And you're saying," If this is this coordinate here, this is this coordinate here," we line them up. And by achieving that, that's how we actually display the 3D reconstruction of that patient specific image directly into and onto the patient. So kind of a unique way to track the patient, track the instrument, and correlate that. If A equals B and B equal C, then A equals C to say," Great, we've accomplished that, and this is how you can see the anatomy and the instrument inside the patient."

Jon Speer: Yeah, it's so cool. My early days in the med device industry, I worked for a company called Cook Medical. I worked as a product development engineer. And Cook, I guess back in the day, they made their mark back in the early sixties, I think, as being really a guidewire company, specifically building guidewires for radiologists. And you would see all these guidewires, and for the lay person out there, think of a guitar string, sort of kind of, it kind of looks like that. They would always talk about, some of my colleagues, older ones would and people that had been there for a long time, talk about how the radiologists was so skilled that they could just twist and turn this guidewire with a little j- tip on the end and be able to navigate all sorts of crazy tortuous anatomy. It seems like that skill isn't there today, or it's evolved. But it does seem like there are so many applications for your technology, whether it's trying to place a stent or an artery or in the brain or a coil or a guidewire, try to get it to a difficult location, and so on and so on and so on. So there's so many applications I can imagine for your technology.

Mina Fahim: Yeah, Jon. And think about the clinical unmet needs, which definitely are an input to how we come up with our user needs as a company, is that you kind of hit it spot on. I mean, most people don't know this and I didn't until I joined MediView actually, in the US alone, there's$ 120 billion of economic impact due to ergonomic injury of medical imaging.$ 120 billion, I thought it was a typo. So I reached out to the author of the white paper. They're like," Nope, that's correct. It's$ 120 billion between physical therapy, loss of productivity at work, having to take days off, et cetera." And one of the things that it's used to is clinicians are practicing like this. They're looking behind them, they're looking to each other, so that's one of the clinical unmet needs that is even beyond just the ability to drive an instrument to a target, is what about making the life of the practitioner easier? And there's a lot of peer reviewed literature that talks about how cognitive load and comfort actually does impact clinical outcomes because the practitioner is experiencing these challenges. So that's one area. And then exactly to your point, the first therapeutic area we're helping target is cancer patients. So today out of 10 patients that have liver or kidney cancer, all only about one to two of them will actually receive a minimally invasive procedure to try to kill the cancer using heat or cold through ablation. Whereas the other nine to 10 actually have to go through chemotherapy or actually have to take resection where it's very invasive. But the reason is exactly what you just said, Jon, is the interventionalists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon, blindly, to get that tumor and ablate it. And that's when people start talking about the MediView solution, one of my favorite quotes of all time is you've made this minimally invasive ablation so easy my 12 year old could do it every single time. And that's exciting because what that means is that over the course of time, more of the indicated patient population for ablation will actually find its way to the referral pathway because more clinicians are going to feel comfortable doing the procedure. It's going to be a better quality of life, a faster recovery time, and if done properly, the data shows it can be as effective as resection and or chemotherapy. Which if we can even take that from one to two patients to three to four patients, we've made an impact on patient end care.

Jon Speer: Yeah. I want to come back to the 12 year old element here in a moment. But, to me, it's like the grape and a watermelon, that's a great image think of. Because most imaging, I know there's been a lot of advances and more 3D imaging, but there's still usually 2D slices in different planes. That sort of, kind of get pieced together, and it's still a little clunky, if you're just going from the imaging. Especially, if I'm in procedure to your point, I've always got to turn my head to see this image on a screen that's probably 2D anyway.

Mina Fahim: Spot on.

Jon Speer: It's crazy, right?

Mina Fahim: I mean, they're fundamentally perform a 3D task in 2D, black and white.

Jon Speer: Yes.

Mina Fahim: I mean, that's realistically what they're doing, and they're looking away, right?

Jon Speer: Yeah.

Mina Fahim: So, I mean, I don't drive down the highway doing 70 looking behind me. There's lots of medicine practice that way. So I mean, not taking anything away from the practitioners, they're extremely skilled. They're very proficient, but we've heard from them," Yeah. We can do it. But why don't we do it easier, safer, more efficiently, and hopefully one day that translates into more effectively."

Jon Speer: Now to my comment about the 12 year old, and I'm hogging the conversation, Etienne. But the doctors of today, I mean they grew up probably more so than you and I... I don't know your age, Mina, I'm not going to ask. But I gathered, we were both a little bit older than Etienne. Yes, there were video games when we were kids. But the doctors of today, especially those who are going through medical school, they're more accustomed to video gaming type technology. And I'm not trying to diminish anything that you're dealing with MediView, but it's more like a game right? I hope that's an okay way to describe it, but I didn't mean to trivialize or minimalize what you're doing.

Mina Fahim: No, I don't take it like that. You're spot on, Jon. If you look at some of the most prominent medical schools across the country, Stanford, Case Western, Duke, these institutions are starting to adopt augmented reality to the point where some of them have started to replacing some cadaveric labs. You look at a university at Case Western and what Dr. Mark Griswold is doing there, you look at the simple metric of retention of cadaver and textbook versus holographic teaching, and it's night and day. And one of the things where, and I give Medtronic a lot of credit for this, where it's been observed, that if you can train in a way that represents what you're going to be actually using in the real world, intraoperatively, it actually has an impact on outcomes. They did this with the stealth station For spinal procedures. They said," Listen, we're going to teach in institutions with this." And the folks come out and that's what they're demanding they use. And well, do you got a stealth station? And if the answer is no, it's one of two things. Either get one, right, or I'm not coming to work there. And we're seeing that start in augmented reality, where you're spot on Jon, the students are being taught using this technology because of its intuitive nature. So when they go to actually practice, you're basically saying," I need the same way of intuitive visualization, appreciation and understanding of where is anatomy and where is my tool so I can most effectively perform my procedure." So creating that nice segue from training, from education to training, to planning, to execution, the more cohesive you can draw a common link between them, the greater off the patient's going to be off in the end.

Jon Speer: All right. Etienne, I thought of one more thing and then I-

Etienne Nichols: Go for it.

Jon Speer: I will let you in. I just, as you described that Mina, about the teaching aspect, I mean, I remember when I first heard about the robotic surgery. I mean, it's still crazy to think about, but I could see where MediView would play a part in improving the outcomes of robotic surgery as well. I don't know if that's part of your roadmap or where you are, but anyway, it just seems like that would be a great fit too.

Mina Fahim: Yeah. I mean, robotics and mixed reality have a natural synergy, and they have unique, sometimes overlapping and sometimes different, use cases. But absolutely, just understanding the robotic manipulation, even in a training environment, for someone to be able to learn about the robot without having actually to be at the robot. That's really early on. And then number two, is someday you've got Etienne is in Ohio, you're Indiana, I'm in Minnesota, not even to say from across the pond, across the world, eventually... It's already happened, right? People are doing robotic surgeries across the world. Where I'm in the US and someone is in Southeast Asia, and I'm actually performing surgery using a robot there. But the safety component of that, is can I see the environment that they're in? Can I understand the position of the robots simpler from where I am to perform that remote procedure. Again, you're spot on Jon, from a training and understanding of the robotic systems to actually using them intraoperatively, there's a natural synergy between robotics and augmented reality. And it's not even that's going to come in the future, it's already starting. So I think it's a very, very exciting time for digital health and in MedTech.

Etienne Nichols: I'll just throw out, so being the young guy in the room, and I'm not going to take a offense to that, I'm going to lean into that a little bit. So I've used virtual reality, and a VR headset, the first time I did that, I remember driving down the road, got in a wreck in this VR world, and it kind of gave me a migraine almost.

Jon Speer: Virtually driving down the road, you didn't-

Etienne Nichols: Virtually.

Jon Speer: Okay.

Etienne Nichols: But what's crazy, is that it impacted, I was curious if you have any... When you first encountered VR, what was your experience or thought or any stories there?

Mina Fahim: Yeah. So that's a really nice segue, Etienne. So my first time in VR, and I should be very specific, right? VR, virtual reality puts you in a fully digital world, whereas augmented superimposes digital content onto the physical world. But my first exposure to the technology was actually in the upstairs attic of one of my now coworkers. I'm afraid of heights. I'm not afraid to say it. I'm not shy to say it. I don't like roller coasters. I've grown to like them because my wife does so I go on them with her. But he put me on the side of a mountain and he gave me a little bit of a push and I was tumbling down the side and I had to take the headset off, I was like," This is nuts." Then he kind of put me in a gladiator game where I was fighting gladiators in VR and then shooting bow and arrows in VR, which was kind of more my speed. I wasn't falling off any mountains. And that was incredible, I'm like," I feel like in the Coliseum." And then on the drive back, I told my wife," I just saw the future of medicine." She's like," In a video game?" Because I told her I'm going over to check this thing out. I'm like," No, I guess, kind of yes, but also no." And that's really what started it all for me almost seven years ago in this space now. And from there, I learned about the difference between virtual reality and augmented reality, what you can and do to merge the digital and physical worlds to accomplish better care. If we really think about unlocking the full potential of imaging, like Jon was talking about, and the data analytics that are stuck on computers and flat 2D screens, and unlocking that full potential to make procedures safer and more efficient and driving towards improvements and efficacy down the road. So my palms we're definitely claming up a little bit and I was sweating on the side of that mountain, but we're hoping that we can... We hear this from even folks that come out of fellowship, and that first procedure that they're doing without an attending there and without oversight, maybe we can take a little bit of that claming of the palms and a little bit of the worry out of it with solutions like MediView's building.

Etienne Nichols: Well, I don't think there should be any shame in the fear of heights. You're just going to live longer that way so no shame there. So one thing I wanted to ask early on, I think you kind of answered it already, but I'm especially glad that you kind of illustrated the difference between augmented reality and virtual reality. But the augmented reality, when this something's overlaid maybe on a patient during a surgery, one of the questions that popped into my head was have you had a surgeon who's maybe experienced this, I don't know how far you've gotten the testing and so forth, where there they're hesitant to trust what's there? Of course, maybe if they're looking behind themselves, they've already have that sense of trust in technology to a certain degree, but what's their reaction?

Mina Fahim: Those are tremendous points, and I wish we had a long time, as they're really important, Etienne. But the short answer is yes. I mean, just to kind of give you all and the listeners an appreciation for where MediView's at, we've actually performed 17 inhuman procedures with this technology. I want to give a lot of credit to the co- inventors, Dr. Karl West and Dr. Jeff Yanof at the Lerner Research Institute at the Cleveland Clinic, that's where this technology was incubated. MediView's then taken it down the design and design controls path to build it into a medical device. And to be able to gain that real- world firsthand experience in patients, we're doing it under an IRB clinical assessment, so obviously you've got to use it in conjunction with the standard of care and you've got to use the standard of care for clinical decision making, but just the qualitative assessment of a solution like this has been tremendously valuable. And Dr. Charles Martin is one of the interventional radiologists who's used this technology, has been a great partner to us, which kind of leads to the trust component, right? Having the voice of customer in the end user clinician driving the value proposition and communication about it, humbly that speaks way louder than a startup trying to convince the world about value. Now, we have good marketing literature and our maturity in marketing and sales is growing, but nothing replaces clinician community championing this idea. And I really want to highlight and really commend groups like SentiAR and Medivis and Augmedics, or the other players in our space, because they're also creating this ground swell of support from the clinician community. Where MediView is really special, and that's why I joined the organization, is that we have an integration with live imaging that allows you to trust that 3D projection of the anatomy underneath the skin, it really is where we say it is. So when you're looking at a kidney and it's underneath the skin, and you're seeing this to Jon's point, all these 2D slices built up and a 3D model is generated, and you're saying," Hey, there's the kidney. I see it, it's right in front of me. What if that shifts from the day the image was taken or during the procedure?" We actually have this really unique way of using live imaging to kind of nudge the hologram to where it actually should be inside of a procedure. And building up that trust to validate with live imaging, that the 3D image is where it should be, that builds up a level of confidence and trust. And the way we summarize that is we give clinicians imaging modalities they trust and are comfortable with today to validate the new way we're providing them to practice and exercise medicines.

Jon Speer: I mean, that's huge, because that original image that patient might be in a completely different position, or they may not be inflated with air, or whatever they case may be, depending what the procedure might call. So definitely, procedure time, positioning, and all the other things that are going on, there's a good chance things have moved from that original image. That's awesome. That's really cool.

Mina Fahim: Yeah. And we're just starting down the road, right? I mean, this is a capability that we've developed today. It's going to continue getting better. We have an incredible team across all the functions, product development, R& D, regulatory, quality. And that's something that we made a big commitment to early on, Jon and Etienne, is that there comes with a new technology like this, almost a requirement for a internal team that's fully bought in to developing it from concept to commercial. And it's okay to outsource some of those things but not all of them and not the critical components of development and regulatory. You got to have a team so intertwined with one another across the functions that's all rowing in the same direction to accomplish the vision, of simplifying and democratizing and informing healthcare delivery with augmented reality, like we're trying to accomplish, that they make my job easy, realistically speaking. So we know it's a competitive differentiator. The way we talk about it is you've got to establish that fundamental base of trust with a new technology like this, by giving them things that they're comfortable with today, so that they can trust the tools of tomorrow and develop that nice learning curve along the way. So that's something we're very committed to.

Etienne Nichols: That's very cool. And we could keep talking about AR and the differences in your technology. I do want to pivot a little bit, because I want to take advantage of some of the knowledge you have in different companies and your serial entrepreneurship. So coming into this company of MediView, you did mention you're taking this technology, you're taking it to market as a medical device. What are some of the tips you can give to maybe a broader audience, our listeners, different kinds of medical devices, early on the things they can be doing to establish good practices and get their product to market as efficiently as possible?

Mina Fahim: Yeah. I'm going to start with the culture that we're really trying to build that MediView and how that then materializes into the operation and business strategy. So, at MediView, our culture isn't lip service. We embody it in four fundamental values, and they are specifically in this order: Trust, transparency, team, and track record. And if that foundation of trust isn't there, you might as well abandon the rest of the projects. Because the team has to trust, that across the functions everyone knows, that they have the entire project and eventually end user clinician and patient in mind and is rolling in the same direction. And building that culture front and not it being just a passive part of the company, but actually where compensation is tied to it, incentives are tied to it, and people are encouraged to call people out for it in a valuable way, in a constructive way. That's where it all starts. And when you think about it, that all comes down, in our world, to fundamentally three core things: Is there a clinical unmet need? Can I develop a solution to fit that need? And can I get this through the regulatory process to get it to the bedside? So when you think about that, and at Medtronic I had an opportunity to present and talk to Omar Ishrak couple of times, and we got up there to present on a new technology opportunity. I think we got three minutes into it, he said," Stop with the business talk. I think we would all agree that I'm a pretty good businessman." And we all sat there like," Yeah, we'd agree." So he said," Demonstrate this to me. Is there a clinical unmet need? And do you have a technology that feasibly can fill that need? And can you get it through the process to the bedside? If you can answer those questions, the business model will figure itself out because you're demonstrating value and the clinicians are going to want to adopt it to deliver better care." Now, whether that ends up being medical device as a service, a SaaS model, a capital model, an OPEX CapEx, we'll figure that part out for how it fits in the market. Because the market changes all the time, right? I mean this idea of operational expenses has become increasingly popular in institutions to help offset some of the capital expenses. So I'm going to leave that part aside just for a second, right. But let's talk about the clinical unmet need, development, and regulatory, start with that. Get passionate about it, understand that it has various stakeholders as the clinician, as the patient, as the family of that patient, and can you actually make a difference there. You got to start there, and then build a class A team. Don't compromise. And I know in today's world, it's easy to say that, hard to do it. Because we know that there's a lot of market challenges in talent, which I really commend you guys, the ability to grow like you did during COVID, that's not the pattern that we've seen over the past two years. But build an amazing team that can all get around this mission and vision and work towards filling that unmet need, and unleash them and let them go do what they do to their fullest potential. Eventually, you got to at end of the day submit a docket to the FDA or the EU and say," Can I use this and can I market it commercially?" And that's something that we have not ignored at MediView really early on, we had a good contract partner, external third party, that was kind of helping us along the way. But if I tie it back to what I just said, you need that regulatory component to be bought in day in and day out with the development team, to be passionate about what we're doing, bought into the technology, understand the technology, be able to defend that technology, and then carry it through all the way through the regulatory process. So we did that, we brought in an excellent head of our regulatory in clinical and quality affairs group, and he's really changed the dynamic and the speed at which we're able to move down this path. And one of the things I told him early on, is we're not taking shortcuts. At the end of the day, a quality management system, if we ever get to the point of strategic development, which we have some really exciting things in 2022 that folks will hear about in the coming months around strategic partnerships and positioning the company to scale. When they lift up the hood, yeah, they're already interested in MediView because of our technology and the solution, but you know the next place they're going to look? It's your QMS because what's one of the greatest areas of inefficiency when it comes to integration into a big company? It's the quality management system. And a lot of the warning letters that gets sent out, they're typically around a quality management system. So that's something that we've invested in early. I was going to say nothing against paper QMS, but that's not true because there a lot of things I have against it. Because think about the number of linkages and traceability that you've got to accomplish in building a surgical navigation system and augmented reality, to your point Etienne, that you can trust, right? If you're trying to do that manually and create those linkages, we're humans and God's blessed us with incredible capacity, but also we don't lose anything from getting the benefits of a computer helping us out. And that ability to create linkages all the way from user needs to design transfer, and across that entire process, as you define the user inputs, the design inputs, and flow that into a design process and create your outputs and verify and validate, something that's actively tracking that along the path, the efficiency gain is tremendous. When in a startup, if our focus can be on delivering the greatest value in the technology and clinical solution that we exist to provide and make our internal business processes a little bit more efficient and simpler, it creates a financial and time efficiency, that quite frankly, we can't negotiate on right now.

Etienne Nichols: I love that you brought that out because I work with a lot of different customer of Greenlight Guru, so we'll talk about the benefits of an EQMS and putting these things together early and having that traceability. I totally agree. Having your risk drive your design controls, for example, that's just a huge benefit to actually have that feedback loop instead of just a checkbox activity. I know Jon's talked about that extensively in the past. But that being said, that's in the weeds. I'm usually thinking I'm in the forest, I'm staring right at the bark of the tree, and I don't zoom out to look at, okay, how does impact the worth of a company? But it sounds like what you're saying, is if an investor or whoever else may be valuing the company is looking under the hood, that's one of the things that they may be considering. Is that accurate?

Mina Fahim: Yeah. And I'll put it very simply. If a company's exit strategy is acquisition, having a robust QMS that someone can look at effectively and efficiently and simply, which is very difficult to do. If you handed somebody a file drawer, which I have one here but you can't see it, and say," Here are the keys to the steel file drawer. Go ahead, unlock, and start looking at my QMS," versus" Here's my QMS, it's on the computer. Feel free to query however you want," just the empathy that you've connected with the due diligence person who's doing, that has a mental impact and an emotional impact, a burden impact to say," You know what? I can at least go look at what I'm looking for much more efficiently." So if that's the strategy there, and I won't call out any specific ones out of respect, but there have been due diligence activities where there was a clinical unmet need. There was a viable technical solution that was competitively differentiated. But then when they understood the burden that was going to come along in the integration side through were an acquisition, they said," Nope, this isn't going to work for us." And they went somewhere else. So that is the extreme as to the level of impact of having a proactive, well thought out, and obviously conforming QMS and simplified by on the EQMS side, has on potential business operations.

Jon Speer: And, Etienne, I would add to that. I mean, I'm reminded of a conversation I had quite a few years ago. Not that long after Greenlight got started with a serial entrepreneur, similar to Mina and his team, but also someone who'd worked at large net device companies. And he was involved in M& A activity for that large medical device company. And he could almost see him salivate when he would talk about when they were going to look at a company that had clinical need, good team, good product, but yet they didn't have their ducks in a row when it came to their quality system. Basically, to kind of paraphrase what he said, he would give them a valuation haircut. Company thought they were worth a certain amount or value, and because they didn't address the quality system needs, that was risk that the acquiring company was going to have to inherit and address. And because of that, they reduced the value, the price they were going to pay for that company. But it's also important, even if you're a company listening, and acquisition is always something I think you're mindful of, but even if you're not. Even if you're go to market, this is something that will be your Achilles heel at some point in time in your company, if you don't start it early. And even if you haven't started it yet, it's okay. You can pivot and get it back on track. Because I think that's something that a lot of people look at quality system as one of these things that is the must do. And I guess technically speaking, that is right, but I hate having to do something because I have to do it. I hate it. I want to see the value in it. And I realize we're not going to get into all the value propositions of a quality system, probably in this conversation, but reach out to me and reach out to Etienne and reach out to myself, we'd love to share with you the value propositions by having a quality system. It's just a better way to run a business.

Mina Fahim: I couldn't agree more. I mean, just that being able at the end of the day, to say I built the thing that I know my customer actually wants and is going to use. At the end of the day, if you think of it that way, that's where the value is. And yes, there are the CFR regulations. There's the legal side and compliance. But think about it this way, do I want it to be used in my grandma or my mom or my child? And if your answer to any of those is no, you're probably not doing something right to start with. But the QMS, it's not just to check the box. It's to make sure that I build something useful and valuable that someone wants to use, that I'd be comfortable if someone used it on me, that's at the end of the day, what it helps us achieve in MedTech.

Jon Speer: Well said.

Etienne Nichols: Yeah, that's great. I don't have anything else, because I just feel like that's a mic drop right there. That was really good. If anyone wants to learn more about Mina or the technology MediView's working on, you can go to mediview. com. We'll put a link in the show notes. But any last piece of advice, thoughts, before we close?

Mina Fahim: The only thing that I'll say, and Jon was just touching on it, is don't worry about where you are in the process. Even if you haven't been proactive, don't wait longer to do it because it becomes increasingly complex. Don't let that scare you and make quality part of the culture and infuse it. And it's not a restraint, it's not meant to be something to put controls around the company on to mitigate, to limit innovation or to throttle it. If anything, you actually learn more about what you're building and your customer base and the clinical environment where these needs exist. So look at it as a competitive differentiator, and it's going to separate you as an organization, like Jon said. Whether it's for internal business operations as you scale, whether you're looking to be integrated into a large organization, et cetera, it just becomes a competitive differentiator. At the end of the day, your customers are going to look back and say, the thing you gave me, if I compare it to the guy next door, it's robust, it's reliable. I won't talk about foreseeable misuse here. But even when I use it however I want to use it, it performs how I want it to. I'm never encouraging that, but that's what you want, at the end of the day. You put in the hands of a user, you want it to be robust and you want it to do something that's going to benefit patients. And that's what QMS integrated in design and business operations does for our organization. So thank you guys. It's been an absolute pleasure.

Jon Speer: Absolutely.

Mina Fahim: Appreciate the questions and the opportunity.

Etienne Nichols: Yeah. Thank you, Mina. We appreciate you telling us about your technology, and then also letting us look into the hood a little bit at MediView. That was really helpful. Appreciate it. Like I mentioned, if you are interested in learning more, check the show notes. You've been listening to the Global Medical Device Podcast and we'll let you get back to it. Thanks for listening.


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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...