In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur.

They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her journey of pioneering nasal health products during the COVID-19 pandemic, emphasizing the importance of flexibility and addressing real clinical needs. The conversation explores the broader implications for the future of healthcare, prevention, and patient empowerment.

Key Timestamps:

• [02:15] – Introduction to Dr. Gail Lebovic and her background.
• [06:45] – Discussing the shift from traditional payer models to direct-to-consumer strategies.
• [12:30] – Challenges faced during the COVID-19 pandemic and pivoting strategies.
• [20:00] – The importance of flexibility in MedTech innovation.
• [30:10] – The significance of nasal health and hygiene.
• [40:25] – Going to market on Amazon and its impact on the business.
• [50:50] – Future trends in MedTech and women's healthcare.
• [01:05:15] – Advice for aspiring MedTech entrepreneurs.

Quotes:

• "People are smart, our patients are smart, and all of our patients are consumers." – Dr. Gail Lebovic
• "Healthcare is really not healthcare; it's really sick care." – Dr. Gail Lebovic

Takeaways:

Key Insights:

1. The shift from traditional reimbursement models to direct-to-consumer strategies can enhance patient care and accessibility.
2. Prevention and self-care are becoming increasingly important in the healthcare landscape.
3. Innovation in MedTech requires flexibility, robust research, and addressing real clinical needs.

Practical Tips:

1. Stay open to changing strategies based on market demands and environmental factors.
2. Ensure your product stands out by maintaining high clinical standards, even in consumer markets.
3. Utilize platforms like Amazon to reach a broader audience while maintaining rigorous quality controls.

Future Questions:

1. What new preventive health products will emerge in the next five years?
2. How will the healthcare system adapt to increasing patient empowerment and self-care trends?

References:

1. Greenlight Guru – For all-in-one QMS software designed specifically for the medical device industry. Visit Greenlight Guru.
2. Silicon Valley Innovations – Founded by Dr. Gail Lebovic, introducing anatomically directed drug delivery. Learn More.
3. Dr. Gail Lebovic on LinkedIn – Connect with Dr. Lebovic for more insights into MedTech innovations. Connect on LinkedIn.
4. Nasoclenz on Amazon - Check out how Silicon Valley Innovations is marketing their products direct-to-consumer on Amazon. Learn more.

MedTech 101:

Direct-to-Consumer (DTC) Strategy:

A direct-to-consumer (DTC) strategy involves marketing and selling products directly to consumers, bypassing traditional healthcare providers or payers. This approach can increase accessibility, reduce costs, and empower patients to take control of their health.

Nasal Hygiene:

Nasal hygiene refers to the practice of cleaning and maintaining the nasal passages to prevent infection and improve overall respiratory health. Similar to brushing teeth, regular nasal cleansing can help remove pollutants, allergens, and pathogens.

Discussion Question:

What are your expectations for future healthcare changes due to advancements in MedTech? Email us at podcast@greenlight.guru

Feedback:

We'd love to hear your thoughts on this episode! Please leave us a review on iTunes and email us your feedback and suggestions for future topics at podcast@greenlight.guru

Sponsors:

This episode is sponsored by Greenlight Guru, the industry's leading eQMS software designed to ensure compliance, accelerate innovation, and simplify the entire product lifecycle for medical device companies. Visit Greenlight Guru to learn more and get a special offer for podcast listeners.

Etienne Nichols: 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 and companies. Hey guys, real quick, I'd like to tell you about Greenlight Guru's all in one QMS software. It's designed specifically for the medical device industry and greenlight guru ensures compliance, accelerates innovation and simplifies the entire product life cycle. So sega byte of spreadsheets and manual processes and embrace efficiency, reduce risk and bring your devices to market faster with confidence, join the leaders in med tech who trust Greenlight guru, elevate your quality, boost your productivity and make a difference in patient lives. Greenlight Guru where innovation meets compliance to check it out, go to www dot Greenlight dot Guru today I want to talk about going direct to consumer versus the traditional route for, for the payer for your medical devices. It's a, it's an interesting, it's an interesting take and I've met someone who, who maybe proposes that this is a future route and so we're going to talk about that. And so with me today to talk about this subject is Doctor Gail Lebovic. I should have asked before I got started, how do you say your last name?

Gail Lebovic: Perfection. Well, you're french so it kind of fits.

Gail Lebovic: Thank you for having me. It was. It's just such a pleasure to be able to do this. I'm doing great and excited about getting this under our belt.

Etienne Nichols: Yeah. So we met at LSI. Life sciences intelligence. Life science intelligence, if I have that correctly. I'll have to check that. After the recording, and we had a great conversation, and I learned that you are not pursuing traditional pay methods or reimbursement strategy. So I wonder if you could maybe you could describe a little bit of what that is that. That you recommend or are pursuing currently, and then we can talk about your background and how you reach this conclusion.

Gail Lebovic: Sure. Well, you know, it's. It wasn't planned, let's put it that way. And not much in my life has been planned. So I. I kind of go about life in a very open fashion and try to follow those opportunities that I think are going to be fruitful for patients, obviously, for improving lives or improving the way we deliver healthcare. And I've been doing that for about 30 years. In addition to being a surgeon, I'm no longer operating at the moment, but I've done medical device development for a long time. And almost all the companies that I had started, we went the traditional route, which is venture funding for, obviously, development, and then ultimately launching the product into hospitals and or clinics, sometimes breast imaging centers, and having to go through the process of getting products approved, like by a Vac committee, the typical pathway, and then having to have reimbursement by a payer. And it was just part of the deal. You know, that's just. That's just how it goes. And you have to think those things through before you even start a company, let alone design a product, because the product has to be innovative, obviously to be protectable and proprietary. But yet, from a reimbursement standpoint, they want to know. It's just like something else. So that was always kind of a patch 22 situation. Right? It's like, hmm. So I was very used to that model.

Etienne Nichols: Go ahead, you have a question. The venture funding model.

Gail Lebovic: Venture funding, and then ultimately also how to sell a product in the medical environment, the medical community, which always entailed some type of reimbursement. Somebody's got to pay for the device.

Etienne Nichols: Right?

Gail Lebovic: The original plan was to work with EnTs and allergists on patients who were scoping and then to go to the hospitals, because we know if you decontaminate the nasal passage before surgery, you can decrease postoperative infection by 60%. So that's honestly what got us on this path. Starting with a nasal cleanser, we're like, this is something, if we extrapolate, obviously people would lead healthier lives if we were cleaning our noses. Right. So we kind of took that theory, extrapolated that out there, and said, well, we should be cleaning our noses just like we brush our teeth to promote nasal hygiene and nasal health.

Etienne Nichols: Yeah. So when you started getting these requests from consumers then, and it altered your strategy, I'm curious, how do you come up with the strategy for reimbursement? Or what did that look like prior to, because when you're building that company you mentioned, you really need to have that strategy in place prior to even having the product or the company. A lot of investors that ive spoken with at different times, they strongly recommend against going the consumer route because they say, oh, its difficult then to switch gears and go back into the clinical route. What do you say to that? And how do you counter that argument, Trey?

Gail Lebovic: Yeah, I think its a great point. So because we are starting a new category of product. We have products that actually fit really well in the consumer space, and then we have other products that fit really well that haven't been developed yet. We're still developing those in the clinical space. And so what we did was we flipped our strategy and everything, our rollout, we flipped it on its head and we said, let's start with the consumer. Whereas we were going to do the opposite. We were going to start in the clinical setting and move to consumer. We've done the opposite of. And I think it's a really important lesson to learn in running a medical device company. You have to be flexible. You have to work within the environment and what the world is throwing in your lap. And it's been great. I think it was a blessing case.

Etienne Nichols: You're one of the few entrepreneurs that I met at LSI who you said, yeah, running a medical device company is great. Why do you think that is? I mean, it seems like you have a different approach.

Gail Lebovic: I think we do. And some of it is just experience in the school of hard knocks over 30 years and watching a lot of other people who develop great technology but who don't succeed for one reason or another. And you learn over time that you have to be flexible. I think flexibility is key. Key. It's so important.

Etienne Nichols: Well, I want to ask about that flexibility because I think it is impressive that you recognize the consumer need. You were able to pivot, and that sounds like that's been a successful strategy up to this point. Sounds like you're still, I mean, obviously still a proponent of it. What would you say? How do you know that you've reached the tipping point when it's time to change that strategy versus the leader who says, shiny object over here, maybe I'll make buck doing this versus that and being pulled in different directions. Any thoughts or advice regarding that?

Gail Lebovic: So you kind of have to flush it all the way through. You have to look at all the aspects of each part of that. Like, for example, even the manufacturing, the quality systems. Everything that we've done foundationally was to create a medical device in the medical community. And the standards are actually lower on the consumer side. But that has put us in a unique position in that we're bringing a clinically relevant, clinically validated and really robust product to the consumer market. So we stand out. For example, when we talk to retailers, they're like, oh, you're FDA registered, HSA approved. All of those things were because we were on a different path. Right. We didnt just make a widget in a foreign country. And bring it over.

Etienne Nichols: Right. So one of the other things thats interesting to me is youve steered multiple companies to successful acquisitions. Does this strategy affect that youve been able to steer companies towards that successful acquisition? What is the difference between what youve done and what some of the others who maybe have failed? And does this reimbursement strategy? How do you think that this will affect the future if that is a target of yours?

Gail Lebovic: I think it's a great question, and I've been asked this question quite a lot, because you do one after the other after the other, and you sell them all, and it's like there's got to be a recipe. And so I sat back and I thought, what do we do that is different? And I will say there's a recipe. And we start with building a very strong foundation. First things first, you have to identify a real need, right. It has to be a clinical need. It's got to be something that people need. You don't want to design a really cool product and then go searching for where it's going to be used, how it's going to be used. It just doesn't work that way. So we find a clinical need, and then we do a lot of research in the background on that. Intellectual property is critical. Being able to design something that's proprietary and unique, the regulatory strategy. And those two things can kill a company in 15 minutes. You know, if you don't flush out the details on intellectual property and regulatory, forget it, you know, then obviously build the quality system. Think about manufacturing for us. We do a lot of things in the design, and the engineering is pivotal, and we work together clinically. I work directly with the engineers on the design. So it's like, oh, should it be this soft, or should it be a little harder, or should it be, you know, whatever? The design is really important, and manufacturing is part of design. You got to think about, how are we going to make a billion of these? So we do all of that really early before we fund the company, reflush it all out as much as you can. You can't do it, do everything. And then we go to work when we think we have something like that, and we create something and we go out and we do, we go slow. We basically do test markets, and we test our theories constantly, not only clinically, but sales as well. Test the marketing messages and just keep pushing ourselves to the limit.

Etienne Nichols: Case, I love that you said you talk about a clinical need first. People have probably heard me say this before. I don't even know who I'm quoting when I say this, but the heart of the problem is the seat of the solution. And don't just get married to your idea. You want to be solving a real problem. I think that's really impressive when it comes to this reimbursement strategy. I suppose that could be tied into your regulatory strategy as well. I mean, that's a subdivide component of the regulatory strategy. What are your suppositions about how. Actually, maybe I should ask this question first. Is this the first time you've gone direct to consumer in a medical device company?

Gail Lebovic: Yeah, it is. And the interesting thing is, so it's now been, we've been out in the field for a year testing the product in various, various ways. Like I said, I think it's the biggest blessing that could have happened to us because I think we're on the leading edge of a tsunami. Right. If you step back, and I think one of the things that entrepreneurs have as a gift, for lack of a better term, is the ability to observe things really carefully and observe patterns which allow you to kind of predict what's going to happen in the future. It's really, that's, I think, a lot of it. And I can tell you that just watching over the last ten to 15 years, the way healthcare has changed that, along with the Internet and making information available to people, people are smart, okay? Our patients are smart, and all of our patients are consumers. And all consumers are patients at one point or another. So this leading edge of the tsunami is people taking care of themselves, self care. They can't get in to see a doctor. We have a huge physician shortage. Our medical system is completely overloaded. And so people are taking to the street. Right. And they want to live healthier, they're eating healthier. Everybody's interested in self care, and they're willing to pay for things that are going to improve their health and their life. So that eliminates one big problem, the reimbursement problem. But on the other hand, you have to make your product affordable. So it's got to be comfortable, it's got to be cost effective. It's got to be effective clinically, and you've got to be solving a real problem. But we know how to do those things.

Etienne Nichols: Trey, youre speaking my language here, because for a while, Ive thought something, maybe not to the point where I extrapolated it out to going direct to consumer, but Ive thought a lot about the amount of technology thats out there, wearable data, and now AI being able to crunch that data, give it into a presentable information format, and the desire for people to own their own health, that is huge. I think youre right. Could convince me that this is the edge of the tsunami.

Gail Lebovic: The more I'm in it, the more I see it. It's like I said, I think it was just one of those things. We were forced to do it because of what was happening. And now it's just like, wow, everything has lined up in our favor. And I know that the med tech venture community is still very reticent and they have this kind of aversion, which I think is a mistake. And you heard it here first. Five years from now, things are going to be really different because they're going to have to shift. And it's actually about risk, right? I mean, the key to a successful medical device company is eliminating risk. So like we talked about before, intellectual property, big risk to create something unique and proprietary so that, you know, you want to make sure you lock that down. Regulatory risk, right. We're doing a class one medical device. It's registered with the FDA, minimal risk. It's not a PMA. It's not, you know, going to go sideways somewhere along the line. And, you know, basically you use the same formula to decrease risk, optimize sales and the margins. The same principles in business. Right. Except our markets are gigantic. Yeah, they're gigantic.

Etienne Nichols: Yeah. When you're talking about everyone.

Gail Lebovic: Yeah, we're talking about everybody has a nose, right. 155 million people search on Amazon a year in the United States for nasal relief products. 155 million. I mean, I've been in breast cancer for 30 years, right, the breast cancer world, and we have about 250,000 cases a year.

Etienne Nichols: You've got me thinking a little bit about this. So a lot of this is prevention many times. And that's an assumption I'm making, so feel free to correct me. A lot of times, medical device companies, when they look at that clinical need, they're trying to mitigate a problem thats existing or heal diagnosed, et cetera, whereas your market is much wider open because of the prevention. And maybe that's, maybe that's something that we were sort of striking the heart at earlier when we were talking about going this direct to consumer with people wanting to own their own health. Prevention is going to be a much larger market than maybe it's been in the past. Would you agree or thoughts there?

Gail Lebovic: Yeah, I totally agree. I think some of this was instilled in me when I was working at the Cooper Clinic in Dallas because I ran a preventive women's healthcare clinic and programmed. And in breast cancer. Look, I was a breast cancer surgeon for years, and I love doing surgery and reconstruction, and I loved it. But I always wanted to get to a point where, how can we prevent this? Right? Because we're coming in late on the deal when we have to do breast cancer surgery, it would be really nice to prevent it. And we know there are ways to do that now, right? Healthy eating, exercise, limit your alcohol intake. I mean, we know there are patterns to how we can help prevent bad things from happening to our health. I want to encourage everybody to think about oral health because I think that has changed our lifestyles in the last hundred years dramatically.

Etienne Nichols: What do you mean? Explain.

Gail Lebovic: Yeah, yeah, let's go back. There was a day when there was no toothbrush. It wasn't that long ago. Okay. And what happened in those days? Well, people lost their teeth. They had wooden teeth. They couldn't have. I mean, and not only that, your oral cavity is another gateway to the inside of your body. Look, the inside is meeting the outside of our body. The mouth actually has enzymes to protect itself, but still not enough, right? You're gonna lose your teeth. If you don't take care of your teeth, you're gonna get cavities. You're gonna. We know this. It causes cardiac disease. If you have a tooth abscess, you can infect your heart valves. So these anatomic areas of our body that are exposed to the outside world need help because we're bombarded with things all day long. If we talk about the nose, which I've become really intrigued by, it filters the majority of the air that we breathe. It's directly connected to our lungs. Right. And the nose has mucus to help it. But these days, the nose is overwhelmed. We've got air pollution, we've got exhaust from cars. That is like these volatile organic compounds. We've got wildfires, we've got all sorts of things that get into our nose, gets filtered, causes allergies, causes chronic sinusitis. You know, there's junk. And you have to ask yourself this question. Why are we not cleaning our noses?

Etienne Nichols: This, this makes me think of other areas. I mean, we could hone in on these specific. The mouth. Like you said, there's already an oral. I want to delve into that for just a minute, but I'm going to take this somewhere else. So. So work with me here for. For just a moment. I'm reading a book currently about the health. Let's see, what's the book called? The price we pay for healthcare. It's a doctor at Johns Hopkins hospital, and he's evaluating how things are paid out through insurance and so on. And there's different aspects of healthcare that's completely different. For example, dentists, they get paid a little bit differently. There's me a little bit on the fringe here understanding this, and I wonder if that prevention has changed how it pays and almost evaluated this subset of healthcare. You look at all of healthcare, a lot of people are clamoring for reconstruction on that, on health, healthcare payout, healthcare prevention and so forth. And so you're talking about this, this nose. I wonder if there's something that could potentially disrupt the entire healthcare. I mean, it sounds like there could potentially be something like that. And I'm gonna. I'm gonna throw one other random thing out here, and please bear with me with this TED talk. When I travel, I've been told that when your nose dries out, that's when you're most vulnerable for, uh, for getting, you know, other diseases that come in. So I try to make sure I take care of that because im on the plane a lot. I have a family friend whos very. They now have interstitial lung disease, and theyre going through that right now. And I never made this connection, this potential connection until you were talking about this, how she actually has Sjogren's disease, which reduces her ability to produce moisture in a lot of areas. And I wonder if that has something to do with it. You see that nose? That gateway to the lungs? Maybe thats an aside. And I dont mean to get into this too technical area that I have. No, yeah, but go ahead.

Gail Lebovic: No, no, no. It's. You're absolutely right. It's Pandora's box right here in the middle of our face. We've completely ignored it for a long time. And I want to back up to something that you said to begin with. You know, healthcare is really not health care. It's really sick care. Right. We go into the hospital, the majority of healthcare dollars are spent kind of trying to fix a problem that is already far down the track. And if we back up, if we back up to where we get more into the preventive mindset and live healthier lives, we will save massive healthcare dollars. Massive.

Etienne Nichols: Absolutely. Yeah.

Gail Lebovic: And I think that's what has me so excited about what we're doing, because it's so novel, it's so different, and it's never easy, I'll be honest. It's never easy to be out there on that, you know, you're, like, out there on the gangplank. It's a lonely place to be in the beginning, but I've been there before, and I'm comfortable there. So I feel very confident from the work that we've done to date that we are onto a massive explosion in this field. Some people have known this for a long time. There's. There's ancient writings and teachings about nasal irrigation with different types of oils and even saline rinses. But the nose is actually anatomically very sophisticated. We don't know very much about it, to be honest. But, you know, the front part of your nose is real soft and squishy, and it has hair. It's kind of mysterious in there. The cilia, they work overtime. They're capturing. It's like a filter. They capture junk. That junk includes particles in the air. Like I mentioned before, toxins, germs, so bacteria and viruses, and then they make their way up into the higher parts of your nose, which are the turbinates, which is a mucosal surface. So it's very delicate tissue, and it has to be treated that way. And we've got the smell and all that stuff going on here. The nose is directly connected to the brain. Right. It's like, smell. I mean, think about the memories that smell invokes. Good, bad, ugly, all of the above. So I think we really are opening pandora's box. It's our responsibility. We created. Our first device is just a nasal cleanser, but it's specifically designed for the nose. So I think you've seen it. It's. It's looks like a toothbrush. This is the little applicator. Yep. Right. And you put some gel on here. Small amount of gel goes a long way because that gel is designed to moisturize and cleanse. And you're right, if the nose gets dry and the humidity on a plane is less than 1%.

Etienne Nichols: Yeah.

Gail Lebovic: So the nose is going to get Dryden, it gets crusty inside. Right. And then people pick their nose, their hands are dirty. They're introducing bacteria right into the scene of the crying, and then the bacteria or the viruses can get in those cracks. So we want to keep the nose clean and moist and let it do its job. You know, we have some early studies that show even allergy sufferers 84% reduction in symptoms just by cleaning their nose twice a day.

Etienne Nichols: Wow.

Gail Lebovic: Massive. Yeah, massive. And those same patients had a 71% reduction in coughing because allergy patients get this chronic sinus stuff. Then they get post nasal drip, which goes into the lungs makes them cough, they get asthma, things like that. So just by cleaning the nose, you're improving that sort of homeostatic balance.

Etienne Nichols: I'm going to abandon my script for just a minute because I usually do this anyway at some point. But I'm curious about. So, yeah, I've always wondered, maybe this is a dumb question, but when I smell something, is that particles coming into my nose or. Because that seems crazy. It really is a particle of that thing.

Gail Lebovic: It is. I know. So. But that tells you everything, doesn't it? It's volatilized, right? Sometimes these are nanoparticles. They're really tiny. They're really tiny.

Etienne Nichols: Right.

Gail Lebovic: But it has to be volatilized into the air and then it's a particle.

Etienne Nichols: Okay.

Gail Lebovic: Indeed.

Etienne Nichols: There's another book that I read many, many moons ago called the dog nose. I think it's called the dog nose with a k. But they talk about ideas, just things like certain cane, because I used to train a german shepherd. I was working up with her for Schutzen. But this dog could smell things that nobody else would. They could find dead bodies from the civil war or in a lake. It could do things like that. And I've just always been blown away by that. Maybe that's a different. Maybe that's a different topic. I don't know.

Gail Lebovic: But no, I love dogs, so I will talk all day long about dogs. And their sense of smell is beyond incredible. And I'd love to study more about that because at Stanford, there was a pulmonologist who actually did research on dogs being able to detect very early small cell lung cancer by smelling the breath.

Etienne Nichols: Yeah.

Gail Lebovic: So there's something. There's something mysterious but also very real about our sense of smell. And as you know, Covid impacted the sense of smell because it attacked the cilia, and the cilia could break off and actually would be found in the lungs. So it's a very delicate, very, I think, precise part of our body that we've been ignoring for a long time.

Etienne Nichols: Yeah. Well, I'm excited to see the change. And it sounds like, like you said, it's. It's not always comfortable to be out there on the gang plank, which you could potentially be, but you're not a, you're not a hero until you've truly succeeded. So, you know, we always look at it hindsight. But I want to go back to your decision to market on Amazon because you mentioned something earlier. You said, what was that? 155 million hits potentially on Amazon for nasal products versus what you were experiencing with breast cancer. So Amazon of all places. How is that, how is that a decision? What did that conversation look like in the beginning? I'm curious.

Gail Lebovic: Well, I'll tell you, three years ago, if you had asked like, oh yeah, you're going to put your product on Amazon, I'd be like, you're like crazy. But it's really interesting. So we, we did, as I mentioned, we started on the sort of the traditional pathway. We hired a medical sales rep to head up things and go into the ENt's office and this and that. And as we look at it, just again during COVID it was not going to work. It was obvious it was not going to work. So we developed our own website first so that we would have a platform to fulfill orders. And we were doing that, but we very quickly learned from customers. They were like, can you put it on Amazon? Because I already have an account on Amazon and I get free shipping. And when you're working with consumers, you got to listen to the consumer. So we started doing that and it's a huge undertaking to get on Amazon and it's, it's a behemoth. So it's great as a customer. It's much more challenging as a supplier. And we wound up hiring a team to just focus on Amazon. And they came in last June and we kind of, we're still refining and building that platform. But since July of last year we've grown 213% on Amazon. Just organic growth. We have not turned our marketing machine on yet, which is going to be the fun part. Yeah, but you got to make sure fulfillment and everything, you know, again, from the ground up, manufacturing quality, you have to make sure everything is in place before you turn on the gas.

Etienne Nichols: Yeah. And you know, I wrote the, I wrote maybe five or six, I don't know how many bullet points I wrote down when you were talking about developing a medical device company because you said there's a recipe. I think that's interesting. A lot of people probably hear it goes one, one error out the other. But you mentioned identifying a real need. We talked about that a little bit. Intellectual property research and regulatory strategy. I think most people have an idea of what that means to a certain degree anyway, at least ip. But the regulatory strategy, I mean, it's kind of what this whole conversation has been about. But you mentioned the quality system, building that out. That seems like an afterthought to a lot of people. How does that look like to you? Well, not, not an afterthought. Well, okay, let me back up, let me rephrase for a class one medical device company, that seems like a check the box activity. But how do, how do you approach. Yeah, go ahead.

Gail Lebovic: Yeah. So, again, we go back to the whiteboard, where we think everything all the way through. Right. And we ultimately are looking at having a drug delivery system, a platform. So we want to start with a robust quality management system, because we want to be able to track everything. If there's a complaint. The whole reason to do this is because if there is a complaint, we want to be able to track it all the way back through the manufacturing process and everything. So everything has a lot number. Everything has an expiration date. Everything is trackable, traceable. And that's really important because you also need to know your customer satisfaction, be it consumer or in the clinical space. You want to stand behind your product. And, for example, we know that over the course of one year, approximately 20,000 people have used our product, and that includes giving it out at meetings and people who've bought the product. And our complaint rate. We track all comments that come in to the company, and the majority, the vast majority, are overwhelmingly positive, which was cool, because that's how you know you have a winning product. And our complaint rate is 0.09%.

Etienne Nichols: Wow.

Gail Lebovic: Yeah. So, again, you want to know this before you raise capital to commercialize product and get out there.

Etienne Nichols: Okay. So I try to categorize this conversation a little bit, because when we talk about that quality system and you talked about needing to know your complaint rates, being able to track it all the way through, there's two components of this conversation. I feel like maybe three. A medical device company has three obligations. I mean, number one, they have that regulatory legal requirements. You have to meet the FDA requirements, whatever those may be. But you also have some ethical requirements, which I think using it yourself and all these other things, you want to build a good product. But then there's that third one. Money is the air companies breathe. They have to be profitable. Which would you bucket this in as far as, is it required to track it all the way through? That's why you want to have that robust quality system. Or is this, uh, what the best companies do? Yeah. What. What would you say to that?

Gail Lebovic: This is just our experience, and we want to be the best of the best. I mean, we don't want to just be any other company.

Etienne Nichols: Yeah.

Gail Lebovic: It's just not. Just not what we do. You know, if we're going to do it, it's like, go big or go home.

Etienne Nichols: Right.

Gail Lebovic: You know? Yeah. And I'm a surgeon at heart, I don't want that risk. Right. We want to dot the I's, cross the t's, double check, check again. And our team has been working together for many years, for decades, and we all bring that culture to the table. So, yeah. Is it overdone for a consumer product? Absolutely. But let me tell you, when I buy other products and I look at their labeling versus what we've done, we're creating a clinically relevant, clinically validated consumer product that can be used in the clinical environment.

Etienne Nichols: So to me, that might even be the answer to those naysayers who would say, okay, you're going to go that route now. You're going to have a trouble, going to have a problem going back the other direction with clinical if you want, but maybe you've already paid that way, so there's not going to be any issues. But the other side is that that venture capital funding, should you ever need that, you have that presentation of how good you are. Would you agree, or can you expound on that?

Gail Lebovic: Oh, yeah. Yeah. I think it does help with credibility and the understanding that, yes, we're doing something different, but different is what you want. Right. We're trying to innovate here. A great example is our device is now being used in a small clinical study before nasopharyngoscopy. Before scoping. Okay, that's a mouthful. Yes.

Etienne Nichols: Nasopharyngoscopy.

Gail Lebovic: Yeah. So that's when the ents, like, they put the scope in. Yeah. So what we've done is we've created a proprietary gel for use before the scope that actually will open up the passage, numb it, and clean it at the same time. So again, we took the clinical needs that they needed, we formulated the gel, they've tested it, and it was accepted for presentation at the upcoming meeting in September, the AAO meeting. So we're riding the wave, the tsunami, but it's going from the patient consumer space, and it's basically covering the whole patient care continuum right into the clinical.

Etienne Nichols: I love that. Because if you focus on the prevention, well, what are you preventing? You could potentially help with the mitigation of that diagnosis, evaluation, et cetera.

Gail Lebovic: Yeah. Yeah.

Etienne Nichols: Very cool. There's one other question I wanted to ask about that. How do you feel as a recognized leader, maybe in med tech? What would you say are some of the other trends you're excited about? I mean, you talk about the NAso and this direct to consumer, those are kind of two separate, that's a sub niche within this direct to consumer potential tsunami. What are any other trends you've noticed or really feel like are potential incoming?

Gail Lebovic: I do. One of them is, again, close to my bucket of experience in women's healthcare. We do have an entire part of our company that's still in R and D, which is in feminine healthcare. And again, it's the same platform technology. It's just different. It's designed for intravaginal use, and it's yet another orifice in the body that we've identified that's been ignored, largely ignored. Women for years have been told, oh, the vaginal area is a self cleaning oven. No, no. It can probably use some help. And again, we know clinically that pelvic inflammatory disease, which is a very serious health problem in this country, is increasing. It is about $12 billion nugget to the healthcare system in the United States. So a lot of healthcare issues from intravaginal, multiple sexual partners, and all sorts of reasons, it's just a fabulous place for bacteria and viruses to grow. So we are looking at that as well and doing something very revolutionary. Again, it's going to have the same, similar platform, same rollout. Consumer to clinical. Yeah, different.

Etienne Nichols: Yeah. What advice would you have to someone who is pursuing this strategy, the consumer to clinical? Or maybe, maybe not necessarily advice would be good, but maybe challenges or pitfalls that you think. Man, I just didn't expect that to be so hard.

Gail Lebovic: Well, I'm not sure it was a strategy. You know, I think for us it really worked well. You know, I think, don't be afraid of the consumer markets. I mean, I'm not one who is ruled by fear. So, in fact, I kind of try to embrace some of those things that I shy away from. I'm like, okay, let's dig in and let's learn about it and conquer it, as opposed to the other way around. So again, I think flexibility, it's not going to work for every product. It's going to really depend on what they identify as that clinical need. And for us, we have two huge markets with massive clinical need where I think we can make a huge difference given our devices that we've created as well as our physician formulated medications.

Etienne Nichols: I'm sure there are others who are listening to this who would love to make a mark in healthcare or entrepreneurship or whatever, and would like to follow in your footsteps to it, as much as that is even possible in some of these different areas. But what advice would you offer to someone who, who wants to make that? Maybe you've already talked about this a little bit in your discussion about being the best whenever you're building that quality system and those other things and following those. But what advice would you have?

Gail Lebovic: You know, for me, it really started when I was really young because I was a gymnast and failure was not an option, you know?

Etienne Nichols: You were a gymnast.

Gail Lebovic: I was. I was. And, you know, my two favorite things were the balancing and the uneven parallel bars. So if you, like, don't do your best, you're going to fall off and it doesn't feel good. So you really daily challenging yourself, being open. Don't be hard on yourself, necessarily. But, hey, if that didn't work, let's try to do it this way and let's be really flexible. Get a great team around you. I think it's really important. The thing I do the best is understand my shortcomings and, like, what? I don't know. And I try to get really smart people around me to fill those gaps. Right. And I think working as a team is essential. You got to check the ego at the door and look, everybody's the same and how do you feel? Is that just.

Etienne Nichols: Sorry, I didn't mean to cut you off.

Gail Lebovic: No, no. Go on.

Etienne Nichols: Is it innate that you recognize your shortcomings? Do you feel like. Or is there some way you've honed that to be able to see your blind spots? Because not everybody's always recognizes that.

Gail Lebovic: I think for me, you know, it was interesting because I. I never thought about this, but I was a woman in a very male dominated field in surgery when I. When I started in surgery. Yeah, but I never thought of myself as a, you know, woman, man. I mean, it just wasn't important. Getting the job done was really important. But I did a lot of listening. I didn't do a lot of talking. I did a lot of listening, and I learned a lot. And what I didn't know, I forced myself to learn as best as I could. Except for physics, which I hate. That's where the engineers come in.

Etienne Nichols: That's right.

Gail Lebovic: And we just work in a very fluid environment. You know, everybody knows there are no dumb questions. Or, you know, I heard you say that before, and I meant to tell you, there are no dumb questions. There just aren't. Everybody feels like they can contribute, and if they have an idea, we just talk about it and, you know, it's a very open environment. I think that's important.

Etienne Nichols: Yeah, that's really good. I'm trying to. There was one other question. I wanted to have it. It's going back to quite a bit earlier. So those of you listening sorry for circling back so far, but you mentioned when you pulled in your Amazon crew in June, I believe it was, you said it's a behemoth. How would you say it differs from a medical device, a medical device product in general versus consumer product? I mean, I wonder if the medical device industry isn't already sort of ripe for disruption as far as how we distribute our products. And I wonder if you could speak to that briefly.

Gail Lebovic: I love that question. I, I think it is ripe for disruption, and I think that's kind of what we're doing. Again, I didn't set out to, like, disrupt the whole thing and turn it on its head, but guess what? We did. And there are companies that have cropped up. Some of them worked in the early days of Amazon, and they are doing this with medical devices. Again, it depends on the level, but hospitals and large buying groups, gpos and things like that are going down this route because at the end of the day, it's a very cost effective way to sell product.

Etienne Nichols: Trey, I can't wait to see more. And I appreciate your product. I appreciate the samples that I was given and being able to use those.

Gail Lebovic: We'll send you some more.

Etienne Nichols: All right.

Gail Lebovic: You can get it on Amazon.

Etienne Nichols: Well, that's right. Yeah, just send me a link. Yeah, I've got the buy it now button. So, yeah, we'll send you some. Any other thoughts or piece of advice or last parting words of wisdom that you'd like our audience to hear, whether about this topic or you're just as a surgeon, you know, it's, it's always interesting to hear things from, from the side of the user of some of our more complicated devices. But any, any last pieces of wisdom or advice?

Gail Lebovic: Yeah, I mean, we, our last product was an implantable device, so it was really challenging from a regulatory standpoint, manufacturing everything was really challenging. Very high bar. And I just would encourage people to push themselves. Nowadays, people are like, yeah, whatever. No, I mean, it's within you. You just have to tap into that resource and find something you're really passionate about that you love doing. It doesn't feel like work. Yeah, there are good days and there are really rough days, but who said it was going to be?

Etienne Nichols: Yeah, well, it may not be an implantable, but a drug delivery combination product is still, you know, has its complexities.

Gail Lebovic: Yeah, it does. But we've started with co packaging, so you'll notice that the platform is designed to be that way so that we can co package over the counter monographs and drugs. And then if we wanted to. We have designs wherever it could be a combo, but we may not go that route. We don't know.

Etienne Nichols: All right, well, the future is bright. I'm excited to see where this tsunami, I love that word, too, is going. Gail, thank you so much for your time. I really appreciate it. We'll put links in the show notes to some of the things we talked about so people can find both your product but also your company and see the different things that you're doing and the things that you've done, and maybe they can get some inspiration there.

Gail Lebovic: We'll talk to you all next time.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.