Hello. Welcome to the Healthy Enterprise Podcast. If you're back for another listen, thank you for joining me. We're gonna be joined by Vince Clement. He's a CEO of Lineus Medical, a company transforming the vascular access space with innovative solutions like SafeBreak, a device designed to reduce IV complications.
Heath Fletcher:So Vance has led national sales efforts, launched new technologies, and now steers the direction of a fast growing med tech startup. He joins us to share insights and lessons he's learned along the way. So please welcome Vance Clement. Hi, Vance. How are you today?
Heath Fletcher:Thank you for joining me on this episode. I appreciate you.
Vance Clement:Hi, Heath. I'm doing great. It's a pleasure to be with you today.
Heath Fletcher:Excellent. Well, why don't you start by, doing a bit of an introduction of yourself to the, to the listeners and, tell us more about Lineus Medical.
Vance Clement:Yeah, thank you. So I'm Vance Clement. I'm the CEO of Lineus Medical. We're a startup that is ten years in business now. My background is an industrial engineering degree from the University of Arkansas.
Vance Clement:I went on to get an MBA, and I entered into the medical device field working for various orthopedic manufacturers. So I spent a little over twenty years in orthopedics, mainly hip and knee replacements. So a lot of time in the operating room, that sort of thing. And I got to the point in my career where I wanted to be working for myself and calling the shots and owning a piece of what I was doing. So I got into startups.
Vance Clement:And eventually that's led me to Lineus Medical. And that's in the what in the medical space they refer to it as the vascular access space. All that really means is that everything that has to do with IV care in patients. So but people the fancy name is vascular access. So I've been in vascular access now for ten years.
Heath Fletcher:Well, then that's not a small industry. It's it's big.
Vance Clement:No. I think the thing that's most interesting about it is, for example, knee replacements are maybe a million a year in The United States. Hip replacements, there's about half a million or more. But with IVs, there are 235,000,000 IVs annually in The United States alone. So the the volume of the procedures and how many little devices are sold for patients with IVs is is really incredible.
Heath Fletcher:That's a crazy number. 235,000,000. Wow. Annually. Annually.
Heath Fletcher:Wow. Okay. And so how what is what is Lineus providing in this space then?
Vance Clement:Yeah. So I met a nurse ten years ago that had an idea about there's a lot of IV failure. The clinical literature shows us that IVs on average fail forty six percent of the time before their intended use is complete. So and I think anybody that's been in the hospital knows that they feel like they're a bit of a pin cushion and getting stuck all the time. But I met a nurse that was pursuing a solution to this idea, and the idea was that there would be a breakaway in the IV line.
Vance Clement:So rather than a tug on the patient's line potentially causing it to come out or causing the IV to fail an hour later or something like that, the idea was when a damaging force comes on the IV line, let's let go of that force. Let's separate on purpose rather than the current technology is more tape, more adhesive, try and hang on to it.
Heath Fletcher:Oh, my god
Vance Clement:We're think like a lot of great inventions, our idea is the opposite of what's being done today, and that is to let go of a damaging force when it comes on the IV line. And I'll I'll do a quick demo for those that are able to see on the screen will see it, but I'll do my best to describe it as well. So our device is called SafeBreak, and nurses used to just take the tubing directly from the IV pump and attach it directly to the patient's IV. And we've just created a new breakaway that's in between the IV tubing from the pump and the patient's connector.
Vance Clement:And it's designed to be able to handle activities of daily living. The patient can talk on the phone, go for a walk, use their cell phone, whatever they need to do, and nothing happens but medicine passes through the device. But when the force on the IV line becomes a little more serious, a little more damaging, the device will separate on purpose to protect the patient's IV. So the IV remains intact in the patient's arm. And when the device, separates valves on both side of the device close, one side closes to prevent blood loss from the patient.
Vance Clement:The other side closes and keeps the IV pump from continuing to pump medication all over the floor or in the bed. So we're eliminating all of those non value added activities of cleaning up a spill, changing the patient sheets in the bed, going to get additional medication, you know, all of those things that really don't add any value in the process. All the nurse has to do is go get a new safe break that's sterile. They can unscrew the separated components, throw them in the trash, put in a new sterile safe break, and restart the patient's infusion with their existing IV still in their arm.
Heath Fletcher:Wow. Amazing. And I mean, this, I mean, this probably happens a lot. I mean, who best to come up with this idea than someone who's on the front line doing replacing these day in and day out?
Vance Clement:Yes. It's a nurse based product invented by a nurse and when most nurses see it, ninety nine percent of them get it immediately and are excited about it. And then the usually the first thing they say is why didn't I think of this first?
Heath Fletcher:They probably wished for it maybe. Yeah. Like, I wish someone would come up with something better with than than this. So were you you were one of the first people to hear this idea from her then.
Vance Clement:Yes. You know, a lot of people say these days that ideas it's difficult for them to have a single inventor that, you know, creates something and runs with it. Most patents these days have lots of names on the patent. I think that is a part of it. But, yes, it's interesting.
Vance Clement:This nurse knew about the problem and there was a businessman in Little Rock, Arkansas who had twice driven away from the gas pump with the gas pump handle still in the tank of his car. Yeah. And I don't know about this happens supposedly 10% of the time. I've not done it personally. But if you drive away, there's a breakaway on the gas pump so that they you don't tear up the gas stations gas pump, of course.
Vance Clement:Right. And then they don't want the parking lot to fill up with gasoline as you drive away. Right. So they have a breakaway that does the same thing our device does. And so this nurse was talking about the problem with this businessman who had done this twice.
Vance Clement:And he said, well, why don't they make a breakaway at the you know, like they have at the gas station for IV lines? And then I met them after that point. And with my engineering background, I helped solve the technical problems with actually getting valves and things in place that actually would would work in this particular situation.
Heath Fletcher:And what was your background and history that will put you in a position that you were able to kinda go, oh, I can see how we'll do this.
Vance Clement:Yeah. Well, I started off in manufacturing, but I moved over into marketing and sales and a lot of I've done a lot of product development. I can't I can't tell you accurately how many numbers of products I've or line extensions of products I've gotten through the FDA and brought to market. So, you know, sometimes it's just you add a new size to something, you get that through the FDA and add it to your product before they'll but other times, I've done much larger product launches where it's a straight up first time new thing, a whole family of products
Heath Fletcher:Right.
Vance Clement:Released. I've even done my last startup before this one was a surgical robotics company called Mako that was really, really successful. It had a exit for $1,600,000,000 and was sold to Stryker. So Wow. That was a piece of million dollar capital equipment sold to hospitals.
Vance Clement:And then we had the surgical implants, the knee replacements, hip replacements that were put in by the robot. And then you had all the surgical instrumentation that was required as well. So that's a very complex product, obviously, a a robot, the surgical instruments, and the implants altogether. So that was my background. I brought I brought the gray hair to the founder group to bring some medical device experience to the to the Lineaus Medical team.
Heath Fletcher:That's great. Well, they they called the right guy. It's it's interesting because you have, like, you've got a interesting career having started in engineering plus you went in in into marketing as well. So you kinda have two different sides of the coin going on in there. Actually, I had a a business partner that had an engineering degree who was also working in marketing.
Heath Fletcher:So I learned how to speak engineering, actually.
Vance Clement:Yeah. Well, I he he and I may be the rare extroverted engineer,
Heath Fletcher:you know, that
Vance Clement:likes to speak with people and work with people regularly.
Heath Fletcher:Yeah. And a lot of your background was working directly with sales, building sales teams and that. So you had to bring you already had some of the skill sets for doing that, but you had originally started in products and then went into working with with people building sales teams. Right?
Vance Clement:Right. Right. I had I had the idea when I went off to school that I needed to you know, engineers make things.
Heath Fletcher:Right.
Vance Clement:And I needed to I needed to make something. And I knew I liked people a lot, and that's why I selected industrial engineering. It's the kind of people engineering, assembly lines, efficiency systems, things of that nature. I wasn't designing gears and or pumping Jell O through a a pipe that's one mile long or something like that. Right?
Vance Clement:So right. So I went into industrial engineering and I just realized probably by the time I was a junior in college that it really wasn't cut out for me. I had that conversation a lot of people had with I had the conversation with my father. You know, I think I might like to teach math instead of doing this. My father said, nope.
Vance Clement:Not gonna happen, which was which was a good call on his part. So I I suck it up. I finished my degree. I got an engineering degree, and we I worked on the shop floor. We made hip replacements and surgical instruments, and that was a great start.
Vance Clement:And that never leaves you. I use that knowledge. Obviously, we make our product through a third party manufacturer, and I get to put on my engineering hat every now and then, and it all comes it all comes back to me. But my love is really marketing, and I I realized when I got into marketing, you know, doing a product launch is like building something. All the materials you have to have together, sales training, organizing or organizing meetings, all those kinds of things.
Vance Clement:And and then as you become an executive, you can obviously build entire sales forces or in my Mhmm. In in my situation now, build companies. So so it I'm still building things. It's just not a a physical product like it used to be.
Heath Fletcher:Right. And and building with and building things with people is obviously a little bit more challenging than just working with inanimate objects. So what were some of the challenges you faced during that time frame? And how did you kind of get get to it?
Vance Clement:A big question. And, you know, I've never met a manager that didn't say the human part of the management was the most difficult part.
Heath Fletcher:Or the most enjoyable.
Vance Clement:Right. I mean, there were three founders to our company, and I was 48. The other two were 24. I'm the only one remaining with the company at this time. I like to say it's a lot like a rock and roll band, you know, you have a couple of hits or whatever and
Heath Fletcher:Right.
Vance Clement:Try and keep the band to look together as long as you can.
Heath Fletcher:And Yeah.
Vance Clement:We had a good group of guys that all contributed in different ways. But obviously, I'm I was 48. I'm 57 now. But I had there's a big difference between when you're 24, you're still moving around, you're getting married, all those different kinds of things. Or if you're single, there's relationships and stuff that come into play.
Vance Clement:And so a lot of those factors happen over a seven to ten year period that cause people to need to move away or
Heath Fletcher:For sure.
Vance Clement:Have a different challenge. Right? So so, you know, those were all different turning points in the in the company along the way. But we managed to get through them, you know, amicably and keep keep on going.
Heath Fletcher:Mhmm. What what did you what did you what was what did you lean into when you're working with sales building sales teams? Because I think a lot of time, you building sales teams can be a bit challenging and and finding. How did you guide them or direct them in the way in the direction you wanted them to go?
Vance Clement:You know? And and I I won't say that this is perfected by any means. But in in orthopedics, it's very common to have a lot of distributors. So there's people that carry, you know, five to 10 different companies in their bag and they sell their products. But usually, the big orthopedic companies, if they're with an independent distributor, they're the main thing sold in that distributor's bag.
Vance Clement:90% of their sales could come from that big orthopedic company, and the remaining 10% comes from a smattering of other things. And that was my background. And I had watched my a couple of my companies do different things. They had tried some territories. The distributors weren't working out, so they went direct.
Vance Clement:And we ran that way for provided, you know, sales reps with cars and four zero one k's and did all that. And in the end, we found out that they were both about equally as profitable. Oh. And so the company's philosophy became do what's right for that territory. If we can find a good distributor that we wanna move forward with, then we do that.
Vance Clement:If we can't find that, we go direct and try to build our own team and so forth. And so when I came into this space, I assumed that there were vascular access distributors, people that had innovative products in the IV space. And and there were. And we engaged with them and hired about six of them across The United States. So we ended up with a a sales force of of roughly fifty, fifty five salespeople.
Vance Clement:And, of course, they're not all selling for you immediately. They've just met you. You do some sales training with them. You hope that you get two or three out of each distributor that will embrace the product, move forward, have some success. The other guys in the those distributorship see them making money, see their success.
Heath Fletcher:Right.
Vance Clement:How did you start asking the question? How did you do that? Where should I go? And you try to grow from there. It doesn't take all 55 people being successful.
Vance Clement:You only need five or six reps out of the gate, you know, to get you going. And so when you first start, you get that buy in from everybody. But if it proves difficult or it takes it's a long selling cycle Yeah. People start to fade off or fall away, you know, and so on and so forth. So we have cut back on our distributorships.
Vance Clement:And now we have two direct salespeople that are running east and west as parts of The United States. And if you if you do the math on that, if you have independent distributors, it doesn't cost you anything until they sell something and then you pay them the commission.
Heath Fletcher:Right.
Vance Clement:So they're free, and that gives you national coverage and it's helpful, but you got you're one of their 10 things in their bag and you got it.
Heath Fletcher:Other things. Yeah.
Vance Clement:There's other problems there. Time. Right?
Heath Fletcher:Right.
Vance Clement:Fighting fighting for their time. That's a prerogative. They're gonna sell whatever is the easiest. Yeah. It makes them the most money.
Vance Clement:So you you try to be that that product. But if you go direct, you've got a 100% of your sales reps' time. They're only selling one thing.
Heath Fletcher:Right.
Vance Clement:So you've got all that commitment and all that stuff's in the bag. Now you've got the financial side of it. Medical device reps are not inexpensive. They're expensive sales representatives. You can't hire a $60,000 recent college graduate and plop them into a five or six state territory and expect them to sell things to hospitals.
Vance Clement:It just doesn't go that well. So you need to hire people with experience, some maturity and experience with hospitals and other medical devices, etcetera. And to get that, you're looking you hire somebody in California, it's $200 $200,000 plus. You might be able to find people in the middle of The United States for a 150, etcetera. But if you add benefits and everything into that, if you wanna go direct with four sales reps across the entire United States for two years, that's gonna cost you a couple of million dollars.
Heath Fletcher:Yeah.
Vance Clement:Right? So there's a big price difference, $2,000,000 versus nothing and 55 people and fighting for time.
Heath Fletcher:Yeah.
Vance Clement:So so we chose the distributor route and and it hasn't worked out for us. Ultimately, we have some that have done okay Mhmm. But others that didn't, and we're going direct. And I would say the lessons learned, and maybe that's the most important thing for the audiences, is that our sales cycle is long. Our product is roughly $5 per per use.
Vance Clement:That same sales rep, it may it can take us nine months to a year to get an account because we're gonna get, hopefully, every IV in the entire hospital. We're gonna train every nurse in the entire hospital on our product. That's very different than something in the operating room or an intensive care unit. Yeah. And and some of our distributor reps, they sell incubators for the for infants.
Vance Clement:And those sell for $40,000, $50,000. So they can work for a year and maybe sell two or three of those to a hospital and get the commission on that immediately.
Heath Fletcher:Right.
Vance Clement:Whereas they can work on our product for a year. And now it's being implemented at the hospital at $5 every time it's used.
Heath Fletcher:Right. And so
Vance Clement:the payback's gonna be over a much longer time period and so on and so forth. So that's one of the things that we found out just didn't really make the distributor model the right one for us. Whereas a direct rep, one product, they got they're committed to it. Yeah. Work at it.
Vance Clement:And you just it's just a matter of how many irons do you have in the fire so that you are always producing something.
Heath Fletcher:What creates the drag on on the the on that sales process? Is it just because that, you know, they have they've got so much in stock and then, you know, they're not gonna implement. They're not gonna they're not gonna get rid of that. They're gonna use that and how you gotta get in the stock line. Like, how did what is the what creates the delay?
Vance Clement:Great question, Heath. So the we are the very first breakaway device for any kind of medical line. We are a new class of medical devices called the FDA calls it a force activated separation device. That's a fancy word for breakaway device. But they realized when we submitted our device that, hey, every medical line that is in a patient, whether it's a drain, a urinary catheter Yeah.
Vance Clement:Whatever it is, they all get pulled out or can have problems, get tugged on. And so maybe people are gonna create breakaways for all of these. I hope that we get to create more breakaways for other medical lines. So they created this new class of product. So we're not replacing anything Right.
Vance Clement:At the hospital. We're brand new. So that has its own issues, right, to bring a completely new technology to the space. It's a a blessing and a curse. Yeah.
Vance Clement:At the same time, we get to educate, but then there's nobody else out there that's also working at there's no we're not Uber and there's not a Lyft, you know, out there that's helping us get the message out. So so small startup company, five or six people, brand new technology, 6,000 hospitals, and over 2,000,000 nurses across The United States. How do you how do you get that message out? So that's that's a part of the challenge. But then I would say, beyond that, I would say the biggest challenge is that, this is something that goes across the entire hospital.
Vance Clement:We got cleared in the middle of the pandemic in, 2021. And our first couple years were really, really rough because if you remember back nurses, they're still overworked. They're still stressed. But it was the worst it could possibly be.
Heath Fletcher:Yeah.
Vance Clement:At that time, people were retiring. People were quitting. Suicide rates for nurses were way, way up and everything. So, hey, we've got a new product that's nurse based for your hospital that
Heath Fletcher:We might need to learn something new.
Vance Clement:Yeah. Train who wants to do that right now? Right. So so timing was not good. So we just had to kind of persevere for that time.
Vance Clement:And also hospitals were not profitable at that time. Over 50% of hospitals were not profitable. So kind of just had to wait our way through that till things got more normal and so forth. But I will say the biggest thing I've experienced from doing orthopedics where you're talking to a surgeon and the surgeon is choosing an implant for their patients and, you know, a good well, I should I shouldn't say a good a high volume joint replacement surgeon will do a 100 knees and 300 hips or vice versa. And so these are very, very profitable cases for a hospital.
Vance Clement:And they say that every dollar spent on orthopedics in the hospital generates I can't remember if it's 10 or $15 elsewhere in the hospital. Right. So hospitals love orthopedic surgeons in all of their cases. So if I come to a doctor and convince him that my product's better than what he's using today, or he's convinced by that, he's got a lot of power in that hospital. And that surgeon can say, I would like to switch from this to that.
Vance Clement:Here's the pricing. Can you negotiate with that with the company? And people will kind of hammer through that. And if the hospital doesn't want to do that, the doctor has the ability to say, you know, I'm gonna take my business from hospital a to hospital b here in town. And the other hospital is happy to take those four hundred joint replacement cases each
Heath Fletcher:year, etcetera.
Vance Clement:So that's why hospitals buy robots for surgeons and things of that nature because of that power and the customers coming in and the revenue that's generated by it. So let's talk about nurses. Yeah. Overworked, overwhelmed. There's a shortage.
Vance Clement:And the frank thing is is that they don't have a lot of power within the hospital. So I can show this to a floor nurse. They instantly see how it separates. It saves them twenty minutes on an IV restart. They see how it saves them from sticking the patient, how they don't hospital doesn't have to buy additional medication and supplies.
Vance Clement:It's really a win win win across the board. But but they're them to drive that through the hospital.
Heath Fletcher:Yeah.
Vance Clement:It's just a totally different situation. So we get into a lot more committees, infection control committees, value analysis committees. And every single time, so far, as we get more adoptions and so forth, we have to do a product evaluation. And luckily, an IV is usually in a patient the longest is seven days. So it's not like our product evaluations take six months.
Heath Fletcher:We can
Vance Clement:get if they'll give us 30 beds in the hospital, we can go through a 100 of our devices in just four weeks.
Heath Fletcher:Right. So That maybe oh, wow.
Vance Clement:Yeah. Yeah. But like I said, the volumes are crazy, crazy high on So so if we get 30 beds, we can go through a 100 safe breaks. They'll see 10 of them separate. Usually, there's some pretty dramatic cases.
Vance Clement:Somebody had a chemotherapy line and they get up to go to the bathroom and they trip and the SafeBrake separates and saves their line. That nurse is a believer for forever. I need this product, you know, so on and so forth. And that's usually enough for us to move on. They expand you know, they either expand the valuation or go through the whole hospital after that.
Vance Clement:But it's just it's a long haul.
Heath Fletcher:No kidding. You know, you didn't actually I don't think you would have thought that they would have to go through so many more sort of evaluative processes to make sure that, oh, it checks all the boxes and, of course Right. I mean, even though you've done it all, they have to do it Yeah.
Vance Clement:That's right. And I'll I'll tell you this this is something I learned in this whole process too. So animals get IVs too. Obviously, you take your dog or a horse to the veterinarian and they need a knee scoped or hip replacement or a surgery, whatever it may be. And they're gonna be in their kennel, or a horse is gonna be in a stall, and they're less likely to follow directions than a human patient, obviously, about their IV.
Heath Fletcher:So Yeah.
Vance Clement:So SafeBreak should work for them too. So we did a randomized controlled trial on humans and SafeBreak reduced IV complications by forty four percent. A massive number.
Heath Fletcher:That's a big number. Yeah.
Vance Clement:Big number. I always tell a nurse, you know, if I could solve forty four percent of your problems, would you talk to me for a minute? And they're of course. And that's what our device does. Well, in our and we did a dog study with Colorado State.
Vance Clement:And guess what? The device works even better in dogs. There's a sixty five percent reduction
Heath Fletcher:Oh, wow.
Vance Clement:In complications. So so we published both of these in peer reviewed journals. One for veterinarians. We do the dog study and we published one for the humans in a in a in a human journal. The people in the human journal read it and say, that's interesting.
Vance Clement:I'm gonna talk to my hospital about it. Well, a year later, maybe they're adopting it. It's getting used everywhere.
Heath Fletcher:Right.
Vance Clement:A veterinarian reads his journal. He calls our +1 800 number and he orders a box and they start
Heath Fletcher:weekend. Yeah. Exactly. Yeah. Interesting.
Heath Fletcher:So that's it kind of opens a whole new a whole other market for you.
Vance Clement:Yeah. Yeah. There are a lot of markets. There's the veterinary market. There's the emergency services, you know, ambulance market.
Vance Clement:Mhmm. Everybody's getting an IV that gets in the back of an ambulance. And then you can imagine they go from possibly the ground to a gurney to the gurney gets put in the back of the ambulance, gets out of the ambulance into the ER Yeah. Off the gurney onto a bed. There's a lot of opportunities for pulls on the line.
Vance Clement:Yeah. They're not positive for that patient's IV. A lot of pullouts, a lot of dislodges during that. So that's that's a whole market. And then there's dialysis centers and nursing homes and home health care.
Vance Clement:It can be used in any of those places and on any of those.
Heath Fletcher:Yeah. Home health care would be perfect. Yeah. Senior centers and and everything else as well. Nursing homes.
Heath Fletcher:Yeah.
Vance Clement:You know, we're a startup and our price is a little high coming out of the gates. We've been lowering the price as time goes by. I always say, you know, if it costs $2, everybody would put it on every single IV line. Everybody deserves one. Yeah.
Vance Clement:You know, right now, we're at that $5 mark, and we started at $6.90, but we've been lowering lowering the price over time with volume as we're able to able to do that. So trying to grab those early innovators, early adopters that really believe and see the value. It makes financial sense even at $5.90. Yeah. But but, obviously, as we reduce the price, more people can get it and it'll be used more broadly.
Vance Clement:Mhmm.
Heath Fletcher:And is it what does geographic limit you? Like, I mean, obviously, all of The US, but beyond The US, can you go pretty much anywhere with this?
Vance Clement:Yeah. So another interesting thing about IVs, they're all attached. The connections, the screwing connections on each end are called allure connector, and that's a standard throughout the entire world.
Heath Fletcher:Oh, really?
Vance Clement:Oh, sell one product number, one SKU across the entire world. I always say from Australia to Zambia, the exact same device works across the entire world. And the only geographic limitations are regulatory clearances, which are expensive from country to country. We're approved in Korea, Canada, Jamaica, and Panama currently.
Heath Fletcher:Wow. That's great. So there's a lot of opportunity, really.
Vance Clement:Yeah. The global number, I said 235,000,000 for The US. It's 2,000,000,000 IVs annually globally. Wow.
Heath Fletcher:That's outstanding. That's unbelievable. 2,000,000,000.
Vance Clement:Yes. Wow. A big market.
Heath Fletcher:That is huge. So you when did you guys go to market, actually?
Vance Clement:When did you actually pass? We were first cleared in May 2021.
Heath Fletcher:Oh, okay. That's good. Alright. And how what's what's next? Like, what's what's your next phase of of of business development now?
Vance Clement:Yeah. Well, we're moving to this direct sales model. Like I said, still trying to figure out the sales channel. That's been the, by far, the biggest issue. You know, when you're starting a medical device company, the very first thing is, do you have something that works?
Vance Clement:So working prototype that actually works, you get past that hurdle, then it's FDA clearance.
Heath Fletcher:Yeah.
Vance Clement:And then once you have FDA clearance, I I think it's so different than any other business. You've never put it on a patient, probably. It's never been tried. So you spent all this money with we spent, six years and $6,000,000 to get to that point. And now you get to start placing it on people and and see how it actually goes.
Vance Clement:Does it really work well, you know, all this time, money investment. And, of course, drugs are at a whole level above medical devices. So so we were the average for time and money spent to get us to market. And then everything after that, after COVID has been trying to execute on the sales side in different ways. I I think your question was, you know, like, well, well, what's next?
Vance Clement:I think in our space, we're trying to we are the thought leaders we've done. We're the only company that's done any clinical research on patients with with this type of device. There are two competitors now, one out of Sweden and one out of here out of The United States. Mhmm. So we do have a couple of competitors, so that's good.
Vance Clement:That's good. I hope hope that they help us expand Mhmm. The market, all of us together. We can all win. It's such a big market like Yeah.
Heath Fletcher:It's huge.
Vance Clement:Yeah. There's true. Discussed. But, you know, you're we brought to market our in in entrepreneur parlance, they call it the minimum viable product.
Heath Fletcher:Mhmm.
Vance Clement:So you bring that to market. You've find out, well, it'd be better if it was like this or, you know, if it was pink or whatever that that might be. So we have submitted patent applications that are looking good for our second generation device, and this is all public information since the patent is is being reviewed. It's been disclosed. So so I think the interesting thing is is the the future of the devices.
Vance Clement:There's connectivity always as a as a possibility. Right now, when our device separates and the valve shuts off the flow of fluid from the pump, the pump is still trying to pump fluid. And when it realizes it's hitting our valve and it can't get past it, it makes it alarm. Yeah. So we get we get the IV pump beep beep beeping that lets the nurse know to come in the room to check things out.
Vance Clement:But the FDA, we're only indicated for IVs that are using pumps. We're not indicated for a gravity line, a bag hanging from a a pole. It it could be used by a nurse for that application. It would be off label usage of device, and the device works the exact same way.
Heath Fletcher:Right.
Vance Clement:Still separates at the same amount of force. It still shuts off the flow of fluid. There's just no alarm on a IV bag. So that's why the FDA, didn't feel comfortable saying it could be used on a gravity line. So It's weird
Heath Fletcher:because it would be like it seems weird that that would be the case because if someone does have a rip out, there's no alarm. There's no alarm. Anyway
Vance Clement:We we we tried that argument with the FDA. It did not it did not go well.
Heath Fletcher:That's weird. Okay.
Vance Clement:Yeah. The the FDA is a little bit like the IRS, you know. Your your discussions with them are are touch and go. Yeah. Can't argue too much because they're gonna do your tax return the next year.
Heath Fletcher:That's right. Yes. Yes.
Vance Clement:So it's it's yeah. It's interesting. So our our the future is going to be when the device separates, that there's a light that blinks and there's sound a sound that's made from the device, and that could help us expand into the nursing home, home health care market even deeper with with with on label usage, you know, for what the advice actually indicated for that type.
Heath Fletcher:So Maybe maybe it's gonna become smart, and it'll actually send a message to someone's phone, like a
Vance Clement:Absolute absolutely. There are no all possibilities. Everybody wants this everybody wants this to cost 2¢, but they also wanted to send a text message to somebody somebody's phone too. So that's all the interesting thing chasing it. But we have
Heath Fletcher:Yeah.
Vance Clement:We have proven out that we can separate the device and have a light blink for two hours, you know, and at the end of two hours
Heath Fletcher:That's effective.
Vance Clement:Yeah. Yeah. Yeah. Yeah. So that so so that there's some other kind of a of notice being given to patient or caregiver beyond just the separation occurrence.
Heath Fletcher:Right. Right. So this is I mean, this is very niche as far as marketing goes. So how do you is it really your your what marketing efforts are you able to do? Like, I know you do some thought leadership and some articles.
Heath Fletcher:And what other ways do you kind of try and reach reach people? Do you do you are you using traditional marketing or digital marketing in this process?
Vance Clement:Well, it with with medical devices, I think there's a three step. It doesn't matter what it is, whether you got a surgical robot or something like our device that has no electricity, no software. I think that you gotta have some kind of bench testing or straightforward advantage that just people seeing it like our device separating. People could see that and they get it.
Heath Fletcher:Yeah.
Vance Clement:And that's there's a certain number of people that are like, I gotta try that after they after they see it. Just some kind of bench testing gets you there. And then there's some kind of short term. The next phase is getting some kind of short term data, something in six or nine months, you know, that gets you there. And then there's long term data that it really works.
Vance Clement:It really saves you money in a, let's say, like, a randomized controlled trial. Our device actually was required by the Food and Drug Administration to to have a randomized controlled trial before it was approved. So Oh, really? We went to market. We actually had data, level one scientific data that showed our device, you know, reduced IV complications by forty four percent.
Vance Clement:That's pretty tremendous. So it was more about getting the news out. I will tell you that we started with we started with a digital campaign. I only spent $50,000, zero. Nothing for it.
Vance Clement:Nothing to show for that $50,000. Wish I could have that back. Yeah. Right? We also got the booth and the exhibit display and everything, and we started attending intensive care unit nursing meetings and medical surgical unit nursing meetings and so on and so forth.
Vance Clement:And these meetings are national organizations, and there could be 3,000 people, 5,000 people at those meetings. And I tell you, the nurses, like I said, they see our device and they just love it. It's kind of, they have the moment. You see the light bulb going above their head. So we collect leads like mad.
Vance Clement:We can we can walk out of a two day meeting and have 200 leads from all over The United States. So then we go at it and working on it, and we did that for roughly three years with limited success. And what we really learned from all of that ongoing experience, trying different things, trying different messages, trying different demonstration methodologies, all different kinds of things, was that we really learned that in the long run, going bottom up through a nurse that works on a unit in a hospital, it's just not the right way to get you there. They just don't have the power, like we mentioned before,
Heath Fletcher:to move anything. Right.
Vance Clement:So we now do things that are more manager focused, chief nursing officer focused. We get a lot fewer leads. It's a much more powerful lead when we get it. So we work hospitals now completely differently than we did a year ago. We're trying to work top down only, and it is paying off dividends.
Vance Clement:The evaluations are bigger in hospitals. They're more broad. And the results of the valuation are accepted more broadly by everybody because a leader has made all of this happen rather than a nurse on 6 in Yeah. You know, on 6 North that, saw this at a convention and liked it, brought it in. So so that's really been the biggest lesson overall.
Vance Clement:And it basically puts us back to we're talking about how doctors are very powerful. We're getting into the powerful nursing base that can can make a difference in the accounts.
Heath Fletcher:Yeah. That makes that makes sense actually when you explain it that way. Yeah. That that that would be the decision maker at that level in that state in the management team. Right?
Vance Clement:Yeah. Ultimately, the foreigner sees it, loves it, gets the benefit of it, advocates for it, but it's after it's gone gone through a lot of consideration on the top down.
Heath Fletcher:Well, it's probably for them to know that well, there's not gonna be any pushback once we implement this. It's like That's right. If we as soon as we bring this, it's gonna be welcomed with open arms.
Vance Clement:Yeah. And the floor nurse can kill projects as well, obviously. If if there's 30 beds and there's 60 nurses involved, then they can kill that product if they don't like it.
Heath Fletcher:So Isn't that interesting? Wow. Amazing. Amazing. I mean, yeah, it's when you showed it, for those of us that could watch you demonstrate the breakaway of that device, is it's like, wow, that seems like it would be like, how hard is that to sell?
Heath Fletcher:But I mean, when you have some sort when you have a system like the health care system that requires so much, you know, proof of proof of of of operation and and and and so many sort of check boxes that need to be hit along the way. I mean, it really makes things complicated for for new devices and and to enter the market, isn't it?
Vance Clement:That's right. In the in this modern day purchasing at hospitals, I've been doing it for thirty years. So purchasing at hospitals in the past used to be, let's negotiate, get the best price, doctor so and so wants it. Let's get it in and let's get on with life and let's have a good partnership with this new vendor, you know, that the doctor likes.
Heath Fletcher:Yeah.
Vance Clement:And now that's gone to from purchasing being somebody that that facilitated things, negotiated pricing, moved on to purchasing is the most powerful department in hospitals today. And many hospitals are not profitable, so that makes purchasing obviously incredibly important. And I think one thing that I've seen happen just recently on some sales calls I was on that really brought this point home was I can talk to nurses that are in leadership positions and say, what do you think about doing an evaluation? Well, I would like to do one. I'm not gonna I'm not sure we're gonna be able to get one, but I would like to do one.
Vance Clement:And then two hours later, I'm in an appointment with a purchasing person at a different hospital. And I said, what do you think about doing an evaluation? And the person guy said to me, I really like this product. We're going to get an evaluation for you. So no clinical background, but a purchasing guy felt confident enough to say, yeah, we'll do an evaluation for you.
Vance Clement:But somebody that maybe has been in a clinical background for twenty years that sees the value of the product can't guarantee you that you're gonna get to an evaluation. That's how powerful the purchasing departments are today.
Heath Fletcher:Because it's potentially you can save them money.
Vance Clement:Yes. Right? Yeah. Ultimately. Yeah.
Vance Clement:Ultimately. Yes.
Heath Fletcher:That's what the idea is. But to make her job better or make nurses job better isn't necessarily a priority. But Yeah. And I also thought I also thought, you know,
Vance Clement:hospitals are gonna be really concerned about how many needle sticks the patients get. I think I think a lot of people a little kid can be going to the hospital with cancer and they're going in for chemotherapy treatment. And they know they're going to throw up and you know, have it's going to be rough while they're in there and everything. But you know, the thing that they worry about the most going to the hospital, everything is getting their IV line started and how many times they're going to get stuck. Know, that's going to deliver the medication that causes the healing and all the difficult time in the hospital, but they're really worried about the needle stick.
Vance Clement:And when you stick a little kid, you stick their whole family. Mom and dad, sometimes they're having a whole bum during the week.
Heath Fletcher:Feel it. Yeah. 100%. Yeah.
Vance Clement:So I went into all this thinking, well, the hospital's really gonna care about the needle sticks and the time savings for the nurse because in our in our randomized controlled trial, we recorded the time to replace our device versus starting a new line in a patient that lost their IV line. And, it's a dramatic difference. It was five minutes to replace a safe break, and it's normal for a nurse to take twenty five to thirty minutes to go get all the supplies to replace new IV line. So we're not talking about saving a nurse one or two minutes. We're talking about saving them fifteen, twenty, twenty five minutes of time.
Vance Clement:It's Yeah. Quite significant. And I thought all of that will rule the day you know, win the day.
Heath Fletcher:Yeah.
Vance Clement:That has not been the case.
Heath Fletcher:Wow.
Vance Clement:Hospital does not really care how many times the patient gets stuck. It doesn't show up in a patient satisfaction score. No. Yeah. And they're not firing any nurses because we saved a whole bunch of time.
Vance Clement:There's no head count saved. They need to hire more nurses. Right? So Right. So anyway, that that was really
Heath Fletcher:That's an
Vance Clement:eye been surprising to me.
Heath Fletcher:Yeah. Interesting. Very interesting. So what do you as far as building the company, you know, like, you've got a lot of leadership background, a lot of history working with people. What kind of leadership skills do you bring that you think are have been most valuable for you in in your role now?
Vance Clement:You know, I I think that, you don't realize kind of, some of your strengths or what you've been doing and why it's been good for you or helpful to your company. I remember I I left an orthopedic company after being there ten years, and I had some of those orthopedic surgeons come to me as I was leaving. And they said to me, I always knew if there was something new coming out, I had lots of them ask me, you know, you you would would you use it if you were me and so on and so forth? And I always had the test. Well, if it's my mom on the Operating Room table, what would what would I do for my mom?
Vance Clement:Right. Oh, yeah. Kind of the litmus test. But I had a lot of those guys tell me as I departed from one company to do something else, you know, that I could always trust you. And so I think, you know, just the honesty and integrity, those are the the biggest things that you bring working from that place first because those are the those are the two things that if you lose them somewhere along the way, they if they can be obtained back, it takes years.
Heath Fletcher:Yeah.
Vance Clement:It's not something that it's earned over a extended period of time to earn trust and earn your integrity back. So I guess lecture at the University of Arkansas. It's just up the street here from our offices each semester. And that's the one thing I tell all the students is never ever give the either of those two things away because they're so hard to get back. And once you lose them, it's almost impossible.
Heath Fletcher:Yeah. And they're it's those are the same things that if you have them and you you you demonstrate that that it's almost that you can actually do that with other people so that you can trust other people. Because when you're building companies and building teams, you have to be able to to trust other people as well. Right? So if you Right.
Heath Fletcher:If you exceed that, those strengths and those values, then you're you are also wanting those from other people because that's an important part of building a company is being able to trust others to do jobs that you can't do or used to do and and can't do anymore the same same away. Right?
Vance Clement:Right. Right. And I think I think the other thing just from an entrepreneurial spirit and standpoint is that people say all kinds of things all the time about it, you know, like but I I believe the two most important qualities are that is is the perseverance and optimism. Now if you have a bad idea and you persevere, well, that's just stupid, right? You're trying to make a bad idea good just never works.
Vance Clement:So so perseverance all by itself is not anything good. But with a good product and perseverance, you know, that that that that's great. But then you have to be an optimist almost to be an entrepreneur. You wouldn't start on the journey in the first place if you didn't see a pathway to success and so on and so forth. But, you know, we've had to do we've done seven fundraising rounds over time, and some of those were done on bad news.
Vance Clement:So going out and raising money when the FDA has told you you're not gonna get approved this way, you're gonna have to do a randomized controlled trial. And we didn't have the money to be able to pay for a randomized controlled trial. So you have to go out and raise that money and and get that done. That just requires optimism and perseverance and and putting together a plan that you think can be successful and trying to go execute it. There's no replacement for for those two things.
Heath Fletcher:And how do you keep your tools sharpened? You know, your leadership tools. Do you do you work with mentors or do like, how do you kinda keep those those those values and skills and and
Vance Clement:Yeah. I've got a a good board of directors that are you know, obviously, I always say every board meeting's a job interview. I walk out of it. I still have my job today. So they're always sharpening you.
Vance Clement:But the the biggest thing I've done is I belong to a CEO forum of usually, it's waxing and waning. People are going out of business. People are being bought, so on and so forth. But try to maintain 10 people and have diversity between ethnicities and sex and all of that to get lots of different experiences. But the CEO job is a a lonely job in that you can't talk to everybody about everything all the time.
Vance Clement:Total transparency to everybody would make a lot of people run out of the building with their hair on fire, you know.
Heath Fletcher:Yeah. No. So
Vance Clement:you you're always weighing that and having people to bounce that off of is great. And it doesn't matter if they're in your space or not. They're in your seat, you know, on a day to day work.
Heath Fletcher:They know it. They know your pain.
Vance Clement:Situation. Right? And I've been lucky enough. I've had two other startup medical device CEOs in my forum, and so that's always good. And and when you're banging your head against the wall, trying to raise money or whatever, and you talk to another medical device startup CEO in your town.
Vance Clement:Yes. I'm banging my head up against the wall too. And it it it somehow that makes you feel better. You gotta go back out and keep banging your head up against
Heath Fletcher:You don't feel so alone.
Vance Clement:Right? You're just not alone because that that's what makes it lonely because you're the one responsible for the fundraising. Nobody else is gonna do it.
Heath Fletcher:Yeah. You're carrying the you're carrying the load. Yeah. Absolutely. Well, Vance, this has been, so great and informative, and I learned a lot.
Heath Fletcher:I'm sure listeners did too. It's a great story you have, and I great product. I mean, I'm I'm a fan even though I don't even use it. I may use it one day. Who knows?
Vance Clement:Time you're in the hospital, ask for
Heath Fletcher:a second or year. Sure hope so. Right. Anyway, it's been a pleasure to have you on this episode. And how do how do if people wanna get in touch with you or learn more about the product, where where do they need to go?
Vance Clement:Yeah. Great. I would I my I'll give everybody my email. It's vance@lineusmed.com, and I'll spell Lineus med for you. It's lineus,med as in medical,.com.
Vance Clement:And they should follow us on our LinkedIn page. We release a video every week. As I told you earlier, social media hadn't done that much for us, but one thing we opted to do was we moved to comedy to start having some light messages and and trying to get more followers and the news out about our product. And so I make a fool of myself regularly each week. And I and what's interesting is I told my board that I was going to do that.
Vance Clement:And if I ever embarrass them or whatever to call me and let me know and tell me to stop, But otherwise, to give me two or three months of making a fool of myself to see, you know, what it rendered and our followers doubled. No kidding. We're we're attracting followers has doubled. So, yeah, we do a video every week and it's it's funny. Everything from fake arms that are flying across the room to to to whatever.
Vance Clement:But it it captures people's attention and interest and we still get our message. Yeah. You know, across. So that's that's always always the goal. So LinkedIn, there's a Lineaus Medical page and you can email me.
Vance Clement:I've got my email address.
Heath Fletcher:And the website?
Vance Clement:Website is lineausmed.com.
Heath Fletcher:Excellent. And we'll put those in the show notes below so people can look forward to them Thank you. As well. And laughter is the best medicine. So it's great that you're using comedy to reach reach that audience.
Heath Fletcher:I I can't wait to go watch those. Yeah. Awesome. Thank you again, Vance. All the best.
Heath Fletcher:We'll we'll talk again soon, I hope.
Vance Clement:Okay. Thanks for having me on the show.
Heath Fletcher:Great conversation with Vance Clement today of Lineus Medical. He shared the story behind the safe break. He even did a demo, first demo we ever had on the podcast. A simple but powerful device is helping prevent IV complications that seems to happen way more often than most people realize. He also was able to open up about what keeps him going as a leader, like staying positive, building trust, and and learning from the people around him.
Heath Fletcher:So whether you're in health care or building your own company or just love hearing about ideas, how ideas become reality, Vance's journey is full of insight and inspiration. So hope you enjoyed today's episode. Please subscribe and leave a comment if you like, and feel free to share this podcast with others you think might enjoy it as well. So thank you for listening. I will see you next time, and stay healthy.
Heath Fletcher:And we'll talk again.