Why an Eye Imaging Device Needs More Than a Fast Exam

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0:00 In medtech, the difference between a good quarter and a great one isn't always the product. It's the friction standing in the way. Broken sales cycles, misaligned teams, deals that stall at the finish line. Every leader feels it, and the best ones know how to remove it. Welcome to Zero Friction, the podcast where we go inside the minds of MedTech's top commercial leaders to uncover the real barriers they face, the decisions they make, and the systems they build to keep the revenue moving. I'm your host Terry Coutsolioutsos. Let's remove some friction.

Well, welcome guys. I have an exciting day today on the Zero Friction podcast. I am blessed to be with Stan Miele. Stan and I actually go way back into the stent and anti-platelet wars and we'll make that part of our conversation. But why why Stan is here today. He heads up operations for ADOM Advanced Optical Technologies and they have a very unique imaging machine called the tear film Imager. and stands here to talk about his career, his leadership style, what he's done to actually get um the Tear Film Imager to market in its current place and where he sees it going in the future. So Stan, I appreciate you being here today. Why don't we start off with a little background on yourself and we'll lean into um the ADOM Advanced Optical Technologies.

Well, thank you Terry. It's a pleasure to to be with you this morning. And boy, we did have some fun conversations as it relates to the early interventional cardiology world, but very quickly looking at my background postmilitary, I've been in the medical device, biotech, pharmaceutical realm for approaching 40 years. started with big pharma. uh was a sales guide and eventually migrated to medical device and was fortunate enough to be with a a big company like Abbott Laboratories and I really cut my teeth there with 2200 products very focused on the hospital segment everything from an IV bag to infusion pumps but it really gave me some good insight into the landscape associated with certainly hospital sales but the the critical care environment and when you're converting big health systems like Duke Medical Center to infusion pumps. It's a it's a all hands on deck to try and execute something like that over a two to three month period. But with all that being said, I eventually migrated to the biotech world

And uh really loved that type of environment. The I use the term often building the plane as you're flying it. I like that nent startup mentality where everyone's wearing multiple hats. Perhaps you're an inch deep and a mile wide. But I really enjoyed that smaller, nimble type of biotech, small medtec type of environment. And through that had many great experiences again getting into the anti-platelet world with a UB3A inhibitor which was really great experience and and calling on some key academic medical centers and the like and eventually moved up in the food chain with Core Therapeutics. core was acquired by Millennium. I moved to the Boston area at that time and at that point was heading up the US sales operation for the interventional cardiology team. And after that, it's just been a real runin journey with nent startup biotech. From there went to Sucampo Pharmaceuticals. After 10 plus years there, I eventually at at one point was president of the US subsidiary. was with a company when they

3:31 Went through an IPO, involved in global licensing agreements, and that to me was sort of the pinnacle of pulling many different types of things together from all of my background because it was everything from frontline sales, but then also to building infrastructure and doing license agreements and getting everything going, but eventually pivoted over to the med device and have stayed in the biotech realm on multiple consulting realms, but have been with ADOM for several years now, initially as an advisor working with them in this pretty exciting technology and we'll certainly have time to get into that as well.

That's great. Well, it was a great career and and tell us where ADOM is today and where you see ADOM going in the future because I think that's a really exciting play. ADOM has an exciting technology. You mentioned it earlier, the tear film imager. And when we think of a standard visit to a general opthalmologist or an optometrist, over 60% of office visits typically surround the surface of the eye. And we we hear very frequently and we see a lot of television commercials for the retina area, whether it's dry or wet AMD. But the surface of the eye, ironically, has been an area that's somewhat neglected. And what what I mean by that is when we look at a lot of the therapeutic developments as well, it's a little bit of hit or miss when we think of things when it's ocular surface disease. For example, if a patient comes in, they say, and I happen to reside in the Arizona area where it's an exceedingly dry climate, dry eye disease

Is a very, very common disease state here. But the patients, they end up becoming what we refer to as frequent flyers. The clinician will say, "Look, try this over-the-counter drop. Try this, try that." Often ocular surface disease becomes a bit of a secondary type of diagnosis, but again, it becomes a bit of a nuisance. Then the workup on a patient is everything from a simple questionnaire to it can be more involved to invasive tests like the Shurmer's test or maybe testing for inflammation with an MMP9 test but it can end up starting at 5 minutes or it could end up being a 45minute workup and in the end the objective here is to see if there is a simple holistic type of method that can do a thorough assessment of the surface of the eye like they do for the back of the eye. And I think that the simple analogy is when you look at devices that are in just about every opthalmology or our optometry practice today. A device that's very common is

6:19 The OCT. It's been out 30 years. Very standard practice. It helps diagnose retina disease, glaucoma, etc. But if you say what's the singular device that a cornea specialist or an opthalmologist will use to assess the surface of the eye, there is no one simple device, right? And I think the beauty of the Tear Film Imager is twofold. Number one is it it's it's the only device that's able to look at all the layers of the surface of the eye. And I think that's that's a real critical success factor in that the surface of the eye has multiple lipid layers, but no one to this date has been able to look at a a key layer which is called the muccoacquous layer.

And if you're if you're unable to see all the layers of the eye, you can't determine the health of the surface of the eye. And so it's a bit fractioned and then use surrogate methods to try and triangulate to this. So in summary, you have a device now. It's a simple device that can do a 40- secondond assessment for each eye and give the clinician and the patient very significant both qualitative and quantitative information on the entire surface of the eye over a 40-second exam. And it will help the clinician clearly determine what is the state of the surface of the eye. So there's more predictive and precision medicine to say you have X and then give the appropriate treatment and then you can and then you can have the appropriate followup. So it's like if you get knee surgery, right? You have an MRI before you do the surgery and then you do the postsurgical imaging. Right now there's really no before and after. So the beauty of this

Again it falls into the realm of assisting the clinician and the patient from a precision medicine standpoint. But I think that's going to be the key to the future is is getting this device more mainstream as a very important tool in the toolkit of the clinical practice. So what are the implications of not having this type of precision medicine? And we talked about frequent flyer capabilities, but that's just people coming back when things don't work. But what what are the potential implications that that the tear film imaging technology is actually going to solve for? Well, the term precision medicine, I I I use that almost like AI, right?

Sometimes these terms get thrown around loosely. All right. But in the in the realm of the the medicine world, whether it's diagnostics or certainly therapeutics, the objective for all clinicians is to be more precise. If you can be very definitive on the initial diagnosis and know, for example, when it comes to dry eye disease, is it aquous deficient? Is it evaporative dryey or is it a combination of both? The the objective is to not do sort of try this, try that, but that but be more honed in specifically on the exact type of treatment that would be required. And again, that can immediately reduce the frequent flyer syndrome, right? But also, it's a better outcome for the patient. we would hope and and certainly they're going to be more pleased with their clinician if they know that they're able to not only have the right diagnosis but then also know when they show them after the the post imaging you can say look at the

9:46 Improvement on the health of the eye again I think the best way to equate this is to think of something like an invasive knee surgery right there's the before and after the patient may feel better but in the end you also want to be able to prove prove to them that there's actually been improvement on the health of the surface of the eye. That's great. So, you get the right diagnosis and I'm guessing off of that there are different options of treatment, right? So, there's a surgical treatment, there's probably a pharmacological treatment, there might be other types of wellness treatments, functional treatments, that type of thing. So, that really makes it interesting. Where do you stand today?

Like I I I know that you talked a little bit about where you do have some industrial buyers at this point, but it really hasn't hit the mainstream in terms of the marketplace in the optimal logic marketplace yet. Right. And I think that's what brought us actually together from a quote unquote friction perspective, right? And uh when we think of companies that have somewhat of a traditional launch cadence, there's usually one launch, right? One robust launch. And what the company did was from a regulatory perspective, and I think we both know there's two types of PAP. There's a new technology or there's what's called a 510K exempt registration where you parlay your regulatory filing with the FDA as where there's different types of predicates. And so due to speed to market, it was elected by the company to move forward with a 5K, which is perfectly fine. But what that allowed us to do is instead of doing what we called a robust launch, it was let's get the

Existing technology the Tear Film Imager in its current form into the marketplace. And so we we have it at key academic medical centers. We have it with industry the some of the top companies that you can imagine that are you know the allergans of the world for example very big players in the therapeutic as well as the wellness center but very big in the eye space and and then we also have a program where it's in high volume clinics right so between the three key pillars I look at that as a foundation we have 13 devices placed where we've been gaining tremendous insight on the device itself almost like a pilot launch and I you I'm I'm stating this more as it's like real world quantitative and qualitative market research. So they have this device and we're getting great feedback from all of these but at the same time it's um we're using it as a as an avenue to say let's work out the kinks before we go mainstream.

12:30 And one of those areas, for example, was related to automation. Right now in its existing form, the device is not 100% automated. Data from the readings is uploaded to the cloud. It goes to a reading center. It's fed back to the device. Well, look, if that takes longer than 5 minutes, that doesn't have great applicability into a mainstream very busy general opthalmology or optometry practice. They're they're moving patients through. So we're working on the AI automation piece as an example. We want to make the device footprint much smaller than its existing state.

And in a similar vein, we're building one device at a time. So our cost of goods are not exactly what one would say are highly efficient. So we have to scale to a commercial scale manufacturing, drive down our cost of goods. So, we're in the midst of a capital raise, but in the meantime, we're still making great product pro progress. We've already improved dramatically the automation piece, and we're basically down to 5 minutes due to the AI integration and having thousands of readings because you use that as a normative database, and then you're in a great position. So, to summarize, the device is is right now being, I would say, revamped and enhanced based on a lot of this great feedback we've received. And then with the capital raise, we intend to scale to get our get our cost of goods down dramatically, scale commercially, and then we will be in a position to hit the mainstream where we would hit all of the dryey disease centers of excellence, all of

The key cornea departments and every academic medical center. It's very targeted and specific to who is your your top tier of the market, right? And we we know those that do the most procedures. And then the another big segment of this market quite frankly is those that do uh cataract surgery right that there when we talk about precision medicine like the the optimum outcome of a cataract surgery is really derived by the health of the surface of the eye before the cataract is implanted. So if the surgeon knows the health of that surface of the eye is pristine, the probability of having a more optimal outcome is dramatically improved. And so we're we're talking with cornea specialists, the cataract surgeons, dryey disease centers of excellence, and we're building this ground swell. Not to mention we the fact that we have 15 publications. So the company is very based in strong evidence-based medicine where you have publication supporting this technology and I think that's uh also something that's been very

15:17 Important to me in my entire career whether it's medtech or biotech evidence-based medicine is is the key to everything. So the more peer-reviewed publications and data you have that can then become even that much more helpful when you do find yourself in the position to do the significant launch that everyone's expecting. That's awesome. So you've got, you know, an approved technology in place. You have 13 centers today that are utilizing the technology helping you to actually get it to your V2 or your 2.0, right? And then the next phase is getting it to the mainstream sort of upper tier of the marketplace where you can begin having that dramatic impact on a a larger array of patients, right? Whether they are surgical candidates or whether they're pharmaceutical candidates, right? So along those things, the other side for me that really, you know, coming from a device background and more of a surgical approach is that, you know, I think precision medicine is a great term and I

Don't think you're overusing it by any stretch of the imagination, by the way. I think that anytime that you're treating a patient for something, having that really nice narrow channel of what you're going to do, what it is today, creating the baseline and what it is tomorrow, whether or not that candidate's a great candidate for this surgery or not a great candidate for this surgery. All those things are really going to help better care, better patient experience, better economics for the whole healthcare marketplace, which we all know is economically broken. And so these are the technologies that really not only advance patient care, but it also allows us to be an economically viable health care provider as well. So I think these are all really good things. So which pivots me to the next point. So you're you're in the process of building a strategy around a next round looking to attract from that next round. Who do you think would be a equity partner, venture partner, family office partner, strategic partner?

What's next for you on that side? Well, it's a great question and I think it starts with when you're looking at your ask and if it's X million dollar that drives well do you want to talk to big institutional investors and we all know the standard healthc care big names in the med device realm. There certainly are several opthalmology driven institutional investors as well on the venture capital side as well as family offices as well. they tend to play it a very pivotal role depending and in fact one of the current inside lead investors is someone who's with great high net worth but this has been a bit personal because he personally has actually had access to the device right and uh I think you know those types of things make it fun at some level while raising capital is never fun and easy it is great to know that you are making a difference and when it comes to the strategics that's that's a bit broader but my vision from a strategic

18:13 Standpoint there's all the big household I've even mentioned the allergans and the alcons of the world but there's many many companies that fall in the realm where they have great technologies whether it's stem cell companies or companies that are looking at they do regenerative work on the surface of the eye and they're all excited about demonstrating the before and after effect of what's happening. Do they truly reset the surface of the eye? What a beautiful compliment type of cell that could be if you have a device that can truly help them in the diagnostic realm but then prove the great improvement after their particular technology. And and then in a similar vein, there's the the device companies that the the infrared sort of pulse technology that works on the Mayobbian glands for those with excessive dry eye where it's driven from the glands. They're they're talking to all of these dryey disease centers of excellence. Right? So there's a great again another great strategic fit that

We think of if we end up getting to the point where we want to collaborate with a strategic partner. There's certainly numerous and many on the treatment side that I think this could be a nice one-two punch. We want to get a a better cadence in terms of market penetration, but we are having ongoing discussions already with some of those strategics which I think will play out quite nicely especially as we start proving that their technologies are having a benefit then it becomes a win-win. So, we talk about before and we talk about after using the Tear Film Imager. What about during? Like what about during some of these procedures that you know you don't have to wait until you come back. Is it something that you could actually use during the procedure to make sure that you're directionally correct while you're doing it or no?

The answer to that is no. But when we use the but I will just simply redefine your during right. So if we say before there's the upfront component of saying all right we've done an initial assessment of your eye and you have A and C then we want you to start XYZ treatment and then we're going to have you come back in a month and then at that point we'll call that the during right because then we can start to see if there's impact actually happening whether it's a month or two months or whatever the time frame that in my mind is what would be considered the during And then after the the the treatment has been completed, then when the patient comes back, it can just be subsequent visits to see if they've reached somewhat of a steady state, if there's been any further changes or uh that they need subsequent follow-up type of treatment. Many of the therapeutics, as you can imagine, for any sort of eye

21:00 Surface disease are going to be chronic in nature. So, so with that in mind, the goal is to get them through that inflection point where they're having difficulty, but then we can then it can migrate to a little bit more of a steady state where we're just trying to make sure from a maintenance standpoint the therapeutic or the or the invasive treatment is doing what it's supposed to do. Well, that's awesome. So, um, so moving forward, it's getting the funding, getting to version two, which is going to be a smaller, more economical version of what you currently have today.

Correct. Correct. And I'm sure And I'm sure with AI every day changing the world, I mean, AI is moving so fast, what you have in AI today is probably not what you're going to have when you get it out there later as well, right? So, you'll have all sorts of opportunities of improvement. It's pretty exciting. When do you think if you were to have money today like when do you think that next version would be able to be ready to go? Well, we would anticipate if with the tech transfer and the manufacturing process as soon as that happens, it's anywhere from probably 8 to 12 months where we would actually have that revised version two. To your earlier point about AI, it's already having a dramatic impact on the software enhancements, right? from a programming standpoint, those those changes have occurred and again as mentioned the automation pieces is already well underway and we're probably about 95% there even as of today. But I think the

The blocking and tackling associated with just the fundamental building a device one at a time manually to then moving to more of a robotic fullcale manufacturing operation does take a little bit of time. And that's probably the the 8 to 12 month mark. And then with that also comes refinements of shrinking the size to a to to a certain degree the molding associated with just simple structure of the the device itself. But within 12 months we would absolutely envision from the moment of of funding that we we would be well on our way.

That's great. That's a pretty quick turn too. So pretty exciting. Well, Stan, as we close this thing up a little bit, I do have a surprise question for you. Um, okay. And it's a pretty and it's a good one, and it's more personal than anything else. So, you know, if you could go back and offer advice to 22-year-old Stan, what advice would you give Stan? 22-year-old Stan. Boy, and if I think about what I was doing at that time, boy, that was uh having a a nice military career. And I was thinking, do I want to move forward in my military career or do I want to get out of the military and start getting into this rat race of the medical device world or the medtech world, right? Right.

23:49 But in all seriousness, I think the the the biggest the biggest advice is is just more about staying focused and and not getting distracted, right? And I think one of the one of the things that and I've had we've all had several mentors over our respective careers. And one in particular just because sometimes I have a tendency and this is just to your point getting personal, right? But you know, I mentioned the fact that I loved biotech because it's an inch deep and a mile wide. When you're with a nent startup organization, and that can be true for medtec as well, but at the same time, when you're an inch deep and a mile wide, sometimes you don't get to the depth that you need to and you're not having that quote unquote focused execution because you're focused on so many different things, right? And so I think for me personally it's about sometimes you can't straddle that fence if you want you have to you can't you can't be

An expert at everything. So as much as I personally love the naent startup type of environment, there are cons that come with that because at some point expert expertise in specific areas drops off because you do need sometimes expertise in some of those specific areas. And I think whether it's whether it's relating specifically to ADOM or other experiences in my life, I think with companies that I've been with, it is important. I think there's a balance between that, right? That at some point you can't have it both ways. If you want focused execution, sometimes you need true expert expertise in all of those respective areas as opposed to the incheep mile wide mentality because you can only get so far. And uh the best example of that I think is just as I've been with companies sometimes when you're too nent and you're struggling for capital you do not do the appropriate hiring that you really know you should do. Okay. And at at some

Point you will reach a plateau. And I think it's important to to sometimes keep your eye on the ball for the bigger picture and not not lose focus. And as much as maybe you can get to a certain point with the inch deep, mile wide mentality, at some point that will only get you so far. And I hope that answers your question. It well it's not, you know, really is not my question. It was more of your question. You know, and I agree with you totally. and and and in the startup world, it does not afford you the ability to have all these experts sometimes because again, you're balancing getting to market and cash burn and all these different things and and experts typically they do cost money, right? And so that's where, you know, advisers and leaders like yourselves trying to lift these startup companies off the ground, you know, you need to have expertise in different channels, too, which is what sounds like

26:48 You have developed some of those skills. But again, just because you're good at 10 skills doesn't mean you should be doing all 10 either, right? Just because again, I I truly totally believe that whole that that lens of focus is such a great point that I wish I would have had when I was 22-year-old. And that way you can find your northstar, understand what's important, and then deliver on those things that are important. So, I really appreciate you kind of delivering that from a personal perspective. So again, Stan Miele from ADOM, they've got a great new technology with the tier film Imager. We'll be uh putting this out in various channels with with Apple, with Spotify, and with YouTube, Stan, and we look forward to uh next steps and hearing your success story down the road. Thank you so much.

Well, thank you, Terry. It's a, you know, I really appreciate the opportunity that you've given me and and ADOM to be able to share this exciting technology and I look forward to further discussions with you and keeping you informed about this success of the company as we move forward. Thank you, Stan. Thank you very much. That's a wrap on Zero Friction, the show built around one simple idea. Remove the barriers and the revenue will follow. If today's conversation was valuable, please subscribe and share it with somebody who needs to hear it. That's how we will grow this community. I'm Terry Coutsolioutsos, revenue architect powered by AI. Come find me at my website, my revrx.com, and let's talk about what friction is costing you and your organization. Until next time, keep removing the barriers and keep the revenue flowing.