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Ready to revolutionize your clinical trials, visit www.Greenlight.Guru and discover how Greenlight Guru Clinical can take your Medtech innovations to the next level. Greenlight Guru Clinical, where Medtech dreams become reality. Today, with me is Shehara Yancey. We're going to be talking about why developing a clinical and regulatory strategy is critical for Medtech. It's interesting how I met Shehara was at the Life Science Intelligence, the LSI conference in California.
I was getting ready to leave and she was getting ready to leave and we just said, hey, let's just split an Uber. It turns out we were both headed back to Tennessee from California. We got to talk quite a bit on the Uber ride and I just learned so much from her and I just really am excited to have her on the podcast today. So Shehara, how are you doing today? I am doing well. I'm very excited to be here. Thank you for the Uber ride.
First of all, second of all, thank you for inviting me to the podcast. I'm very excited. Well, I'm excited to have you as well. This topic, developing a clinical strategy, we talk about regulatory a lot on the podcast and we've talked pretty extensively about quality. Clinical is something that we don't get into as much and it's something I'm trying to do more of. So before I get into that, though, I'd like to tell people a little bit about you and then maybe you can fill in the gaps.
Shehara Yancey is a seasoned global leader in clinical and health operations with over 20 years of expertise in medical devices, pharmaceutical science and hospital administration. She excels in developing strategies that enhance organizational growth, operational efficiency and business alignment. Previously, she has experienced at Metronix, myth and nephew and striker where she spearheaded strategic efforts across the US, Europe and Asian Pacific.
Her areas of expertise include orthopedics, spine surgery, abdominal transplantation and oncology. Shehara has led global clinical trials, managed PNLs and developed strategies for rapid commercialization and market expansion. Currently, she is the CEO of research life cycle solutions, where she delivers transformative clinical strategies for the biotech and medtech sectors, focusing on portfolio improvement, market strategies and actionable plans.
She has an extensive background, which is one of the reasons I'm excited to learn from her today. Did I miss anything or did I miss state anything? Feel free to correct me. You didn't miss anything. I hope I can live up to all of that. You just mentioned it this podcast. Let's talk a little bit about developing a clinical and regulatory strategy, specifically why it's important. I know this is a topic that you're passionate about. Why is it critical for early access?
Maybe one of the things that would be to set this up is market access is usually what we focus on when we're developing a medical device. We want to get to market, but we don't always focus on staying on the market, market adoption. I know that's one of your topics. However you want to tackle that, what are your thoughts on this topic today? Yeah, absolutely.
I am very passionate about that topic, and as you mentioned with my background, with those companies, you named the Metronik strikers and Smith and FU, we know those companies to be key players, really top players in the global Medtech industry and have been the opportunity to lead clinical and regulatory for those organizations with really large portfolios.
My key responsibility was about market access, new market introduction, developing evidence and doing those things that it takes to get the product to market. But beyond that, the next part of my key responsibilities were looking after the portfolio to keep the products on market that we have already established.
And really it came about when with the European medical device regulation, that's when we really started paying attention to what it takes to keep a device on the market, which is clinical evidence, it takes that to get to the market and keep it on the market.
So essentially, when I developed the company research lifecycle solutions, it was with the goal and the mission to help the young companies actually get to market and taking those same strategies and the large industry perspective and deliver that to smaller companies to help them be successful. As we know, 75% of your eat amongst small companies getting to market and because that is such a daunting rate, and actually it has increased, that was a statistic three years ago.
So that rate is higher now. So I wanted to tackle that problem. So that is really a problem that needs to be addressed. So when I work with early companies, I realized that the mission is usually, let's get to market, let's get market access, but the gap is we have to think beyond that. Once your product gets to market, I will just be blunt. So what your product is on market? There are a lot of products on market.
And most products, medical device products, when market, make it to market, be up by 10 kiln, which means me to substantially, substantially equivalent. So that's the kind of the gap that I tackle and really work with companies to overcome the strategies that I used with the future companies. So that's kind of my goal. Okay. So that's 75%. I'd love to dive into that just a little bit deeper.
So you said 75% of the medical device companies that are attempting to get to market are likely going to fail or do fail with that number, having grown since in the last three years. How much do you think of that is related to their clinical and regulatory strategy? Yeah. So most of it actually, but I'll take a step back. Sure. It's commonly, it's because of lack of funding, right? But you have to dig into why there's a lack of funding.
Okay. There's a lack of funding because as a young company, you grow up, well, I will say the first prop already is fundraising, right? You have to get the capital in order to do anything. But when they are raising capital, there's a lack of strategy in capital raising. So that makes venture capitalists or investors less interested in you if you don't understand the strategy.
If you can't articulate your strategy, if you can't understand the key milestones or when you will see a return on investment, you're decreasing your likely to get funding. So if you get funding for your first C and that's to kind of develop your product, we are not thinking beyond product development. So now that this spiffy new shiny product is developed, how are we going to get to market? So that's when clients call me and say, okay, I'm ready to go to market.
Let's get this thing submitted and probably do a clinical study. And I say, well, hey, going, hey, going, we have to have a strategy in place. So by the time we talk to FDA, they figure out, oh, my 510K is not what I thought. I may need to actually do an IE. I may need to do a PMA here to get to market. So now you have to go back into fundraise and to get more funds in order to fund. Now you're regulatory strategy and you're clinical strategy, right?
So but back time, you go back to try and raise funds. What if you're probably a year behind, you put yourself a year behind. Number two, investors are thinking you didn't know that at first. So why do I want to invest in you now? And also because you are behind, that's a longer return on me, get that investment. So the point is developing your clinical and regulatory strategy is very key upfront so that you can tackle those issues and kind of know where you're going before you get there, right?
Okay. So now that we've gotten the funding part out of the way, do you see how that kind of connects to your clinical and your regulatory strategy and how that kind of drives some of the failure rate? In addition to that, if you think about the right team, don't go at it alone. We have CEOs all the time. They are about the science. You may have a scientist that's starting the company that don't understand the business perspective.
You may have a business person that you're in, or you're entrepreneur here that don't understand the technical aspect. So the key is surround yourself with advisors. surround yourself with mentors, build a strong board with the proper expertise to help you have these conversations and articulate your strategy. That will increase your funding that will increase your sense of knowing from a clinical perspective and even from a regulatory perspective, what I need to actually be successful.
I really like what you said there too because the lack of funding, and I know the end of the year, the year 2023, early 24, the lack of funding was a big topic of discussion because everybody felt kind of the squeeze or the crunch, but there's always money for something that is going to be really impactful. That's going to impact safety. Actually, I just spoke with the surgeon.
I think it was a few weeks ago who said, yeah, if there's something that could impact recovery time, reduce the amount of time that we spend in each surgery and is actually a safety mechanism, then yeah, I'm interested in that. There's always, there's always interest and there's always money for things that you need. We'll never stop spending money on different things, but do we have the right things and are we positioning them appropriately?
You mentioned something about not necessarily having a very good strategy, if any strategy at all during that capital raising aspect until it's time to take it to FDA and then you realize, wait, I got to take a step back and have that clinical and regulatory strategy knocked down. I wonder if you can just give a quick comparison on the best companies who start out and what the difference looks like.
If a company starts out with a strong clinical and regulatory strategy, as they go look for that funding versus the company that waits to do the clinical and regulatory strategy a little bit after the fact. Just this week alone, I spoke with two of my clients who are founders. Both of them are physicians, actually, they're physician founders. They have really, really good products. I believe in their product, but they were defeated when I spoke.
That was because their investor pulled out at the last minute. They said, hmm, I may have just forget it, close my company, the investor pulled out. They were pretty bummed about it. I was bummed for them. However, I had a conversation with both of them. I said, did your investor give you a reason for pulling out at the last minute? They just said they had to give it some other thought and they just took a pause. Let me take a look at your pitch today.
Let's talk about some of the things that you talked about with the investor. What was glaring was the lack of strategy. They talked a lot about the technology. Why is it needed in the market? This is a great technology, but what was missing was how are you going to execute, not only get it to market, but how are you going to execute once it's on the market? How is this product going to be a dot into the market? One thing for sure, and investors are very smart. They're key on this.
Even though they don't know technology piece, they understand the market of what they're trying to invest in. You have to be able to articulate to your investor that once I get this product on market, this product is going to be adopted by X hospitals, X surgeons. We already thought through the reimbursement codes. We understand what the payers need. That's what I mean by execution. How do you prepare your device for such execution? It's through clinical evidence.
You have to have clinical, that's the cornerstone of it all. That's the cornerstone of getting to market. That's the cornerstone of staying on the market. If you think about it, let's take an example of orthopedic searching. I don't know. Hip replacement, hip device, hip system. Why would they choose to switch and use a different system if the current system works for their patient population? They're familiar with it. They're very versed in it. They completely understand it.
They even understand the long-term outcomes of the system. You come to the market with a new system that's also a MeToo system because you've gone to the market for 10K. There are a lot of systems out here. Why would that surgeon choose to use your system over the one they already have that's working perfectly? If you do not have that clinical evidence to support what's superior about your system. We already said it's the same, but what is superior?
If you don't have that evidence to communicate that, surgeons are not going to switch. What makes your product better? Okay. Now let me tie this in to investors. Investors understand that. They know the market. If they're investing in your particular product, that means they have an understanding for that market. If you can't convince an investor why this product is great, going to convince a surgeon will really understand the product why it's great.
It all ties back to this strategic component of being able to communicate that during your fundraising while you're talking to investors. If you don't get the funds, you can't move with your company. All of it ties in. If you don't have that strategy, I can't say that enough, it's that strategy, that clinical regulatory strategy, which equals your commercial strategy, essentially. That's an idea how you ask me to look at it and give you an example.
Two examples, just in a league of investors not making the product because they have a proper strategy. That's really powerful. That's fantastic. When you're talking about that, I'm thinking about the regulatory strategy. We'll get in a little bit more to the clinical and the market adoption. The 510K, a lot of companies that I speak with, they like that idea because they don't have to have a clinical investigation or there's a higher likelihood that they won't need a clinical investigation.
It sounds like you're suggesting that do that anyway. Does it make sense to pursue the 510K or is there an advantage to going all out and become a Class III medical device? Can we talk through a little bit of that just your observations there? Clinical study, these clinical investigations, clinical trials, is just not a dirty order. We feel that way. It's scary. I'm going to hear it and think, all you see is dollar signs, right?
I'm not suggesting by any means that you need to do a clinical study before going to market or what have you. Because 510K, that is a viable pet. It's a great pet. But you really have to think about the goals of your organization. The cautionary tale with 510K is really to make sure you are building the right strategy for your product. In the mindset doing a 510K, inventors normally look at it as quick, fast to market, but fast is not always the solution.
Sometimes you have to move a little slower for your intended outcome. So it's really about what intended outcome. Sometimes 510K is the proper pet. Sometimes a PMA is the best pet. So you really have to look at your portfolio, look at your goal, look at your budget, look at your resources to understand what you need to do. So what I am suggesting is regardless of what pet you take, you need evidence on your product.
Whether you get it before market access or after market access, I am a firm believer and advocate and I do suggest even if you get a 510K approval, once you get that 510K, you have to be ready to switch the mode and go into market adoption, which means evidence on your device. You used evidence on your predicate device to get to market, but you can't live under evidence. That's what I am suggesting when I say clinical trial, clinical study and evidence that's needed.
It's not a matter of do I need it, it's a matter of when I need it. So I encourage investors and entrepreneurs and CEOs to be smart about that understanding when you need it. I have this theory that medical device companies kind of have three legs. The legal, the regulatory leg, we look at that as almost, okay, that should cover all my testing. So everything the regulation requires.
So I'm a class two medical device, I'm moderate risk, I'm just going to go class two, the 510K requires that, you know, that's all I need. But there's more to it. Like you said, I'm just reiterating, but in my mind, you have the legal, you have the regulatory, but you also have the ethical, well, do you want to go a little bit above and beyond?
I mean, I would like to think that if I was going to put this device in my, my, my mom or my son, my daughter, there's probably a few more things that I'm going to do than just what the legal requirements are. But then that third leg is that profitability. We assume the ethical and legal cover just about everything. And if we do that, we'll be there.
But like you're saying to your point, you may want to do additional things that the regulations would suggest that are actually going to make you more profitable. They may cost a little bit more, but they'll make you more profitable as well. Let's talk a little bit about aligning your clinical plans then for that optimal clinical market or that optimal market adoption. What are some practices that you recommend that can get providers to use your device?
What are the strategies beyond that regulatory approval? Oh, yeah, absolutely. So, you know, digging into that market adoption is, you know, it is so key. And this is a phrase, I like to say, I mean, I started with this phrase kind of all the time when I speak with investors or entrepreneurs or such. The way access is a milestone that's not your goal. Market adoption is your goal. So make sure you understand it too. There's milestones and then there's ultimate goal.
So getting to market, simply a milestone. And remember earlier, I said, it's what you're a market. Everyone else is a market. So yeah, let's talk about it beyond FDA. Oh, well, and what it takes really to get your product, you know, adopted and, you know, used to buy surgeons and even picked up by your insurance companies, your payers, right? So some of my advice around that or strategies around that is to, you know, really think about your post market surveillance.
Once your product is on the market, collect, you know, studies, look at registries, patient registries, health record outcomes, that's for that short and long term surveillance because that type of data is looked at or used by your, your, your, um, payers, right? They want to know that beyond the safety and efficacy, that's what the FDA looks for. They're looking for, you know, health, economical data, right? They're looking at those patient reported outcomes, the cost effectiveness.
They're looking at the standard of care. How does your device compare to what's already standard here? So you want to look at kind of comparative data. So if you even run a study to say how does my device compare to the standard of care device, we call those head to head or compare to studies, just that, you know, maybe you want to take over what is called standard of care. So just kind of again, looking at what is your goal for your device?
How do you want your device to be perceived in the market? So once your device, you know, get the market, do you want to automatically start generating revenue? Or, you know, is your device even prepared for that? Or, you know, it just depends on what the market calls for. So you really have to be keen and aware of those things. And when I talk about developing your clinical and regulatory strategy for your market access and market adoption, that's really what I focus on.
Let's look at the market and see what the market calls for now because you could be bringing up product to market at the market. It's just not prepared for it at this moment, right?
So you may want to take your time and do a clinical study before going to market because now, you know, it may be a year later, the market is really calling for what you have, but you also may have that product where the market is calling for right now because the market, the product that's on mark, the product that is on market currently looking shabby. And you're saying, hey, I see an opportunity to slide in there and provide better care for patients.
So that's when you may want to say, I need to do a 510K and once I get this 510K, I'm immediately ready to do a comparative study to take over that, you know, and show superiority, right? And now I can show that this device has a better, I don't know, operational workflow, this device saves money. It saves time and ER patients are able to go home faster. So you start to show that economical and patient benefit immediately. So again, it's just about how built your strategy.
There's no one size fits all. And I'm very, very big one. One size does not fit all, but there is one thing that does fit and that is you need evidence on your device. What are the biggest drivers you think for adoption when it comes to, let's just to say, I think you use the example of an orthopedic surgeon with shoulder or a hip replacement.
If you can't show that to your investors, I'm just going to use that example again, if you can't show that evidence to and convince them to invest in you as an investor, how are you going to do that with the surgeon? So now let's take a surgeon. Let's suppose we're imagining or just reverse engineering that adoption process. What are some of the biggest drivers that you see? I mean, I talk to people every now and then, but those are more one off, in of one sample size.
You've talked to a lot of different companies. What are the, what are the, the different criteria that you're looking for when you're trying to figure out how we can really best attain this market adoption? Obviously, safety and efficacy. We can, we can check that off, right? If you obtain market clearance, we got the safety and efficacy part, right? So what I look for is I start with standard of care to be honest. I just start with that.
It's the standard of care product, which means that product already has a reimbursement called, that means the majority of surgeons or providers are probably used in this product. So I know we're not going to go below that standard. So I'm looking for equivalent or above. So really above. And when I say above, tell me if this product that's equivalent to the product that is standard of care, will you have additional indications, right?
Or will this product, does it have, would say, the potential to expand globally? Because if it expands globally, that lets me know that there's a different patient population that will be utilizing this product. So now we understand the product in a different light than just the US patient population, right? We, we under, that means it has a greater potential for growth, a greater potential, yes, and dollars and cents. But it makes a greater impact on patient benefit, right?
Because we're learning, we're able to learn the product a little bit more. We can go back and make a generation too because we, we look at the long term data from the current product, input that data into another generation. And now you have your generation two of that product. So you're looking at the potential for that product. And another thing I tell my entrepreneurs or CEOs, you know, don't get stuck in the strategic or in the exit strategy.
Don't get stuck there and think that this is all I have to do because I am planning an exit. Well, to be attractive for that exit, you have to show that commercial viability that I'm talking about.
So the same effort that you would put into your product and your evidence to make your company grow, if you were, you know, going IPO or what have you, is the same effort in clinical data and such that you would need to put into it if we're trying to get picked up or, you know, acquired by a bigger company. So I think what I'm saying overall, I just have to go back to it is that need for clinical evidence.
We can be creative and innovative in how we get the evidence, what type of endpoints we're looking for. But I definitely like to design studies with endpoints that are more impactful than the safety and efficacy because we remember we checked it. So let's go beyond and talk about the patient benefit. Let's go beyond and talk about the economical benefit.
You know, let's go beyond and talk about, you know, the hospital benefit, the workflow and how it expands to market and look at other regulations even into China and such. Let's look at how this product is going to be integrated worldwide. Now, I love that. So let's talk a little bit about study design then. If that's something that is obviously you keep going back to clinical evidence and I agree, that's really powerful.
If you have a company that is focused only on your regulatory and just trying to fulfill the regulatory requirements, that seems like that would be a little bit different than trying to build that clinical evidence for the final physician or maybe it's not. Maybe there's a lot more overlap than I'm imagining. How do you design your study strategy to encompass both of those?
From an efficiency standpoint, I do recommend comprehensive clinical studies with smart employees, but sometimes that's not always the need. You know, it doesn't always all for that. So we have to go back and look at what's your current budget. Again, what is the market calling for right now? Because if you are a new company, you may not have the funds to run a huge comprehensive study to collect endpoints to satisfy FDA as well as look at your endpoints to satisfy your market adoption.
Pines, what we're making retracted. Sometimes you're just trying to meet one step. If we're talking about what's the vision and for me, is it a more costly vision in the long run? It's to run a comprehensive study. You have your primary endpoints, your primary endpoints is going to be your safety and efficacy, your secondary endpoints. That's going to be your claims data. What do you plan to claim about this product?
You may not be able to collect all of those endpoints or design your study to call for all of that from assigned to extent point, especially if a study is not on the market just yet. You may just have to focus on safety and efficacy first, but you can also extend your study that same study beyond safety and efficacy. Once you get that data, extend that study to collect a long-term patient. That is something that you can really always collect in a study.
If you're doing it for safety and efficacy, let's extend the study to get the long-term impact. Follow that advice for whatever the perceived lifetime is and lifetime means. If you're doing it implanical, how long is it going to be? How long do you expect it to be a functioning in a patient? For orthopedics, lifetime is 10 years, but you're not collecting certain data. You're only saying, how does this device work in the patient based on the patient's perspective?
How long did it take for the pain to subside? That's a key point. When did you get up and start walking? It's just how is your quality of life to let those endpoints in your first study that can automatically feed into your claims data. That can automatically start feeding into that once you hit market access. I just call them smart endpoints or even critical factors. Find your studies such that no matter what the study comes out to be, you have those critical factors colored.
Considering you talked to a lot of early-stage companies, and you already mentioned a couple that maybe their pitch decks weren't quite robust enough, or maybe their strategy really is not just the pitch deck. If the strategy is not there, of course, it's not going to be in the pitch deck. But if the strategy is not robust enough, what do you feel like is really lacking? Surely they're thinking about it to a certain degree I would expect. Is there a certain area where everybody messes this up?
Is there anything like that that comes to mind? You have your template pitch deck right? You start with, let me tell my story of why I even ventured out to do this. My life story would happen. Now you've told that, and then you've told, why is this product important for the market? It's going to help patients do XYZ. Now you want to talk about who's on my team to help me get this done. They flashed it up really quickly. That's my team. How much is it going to cause?
Or how much money do I need to get this done? I'm trying to raise $10 million right now to make this happen. But when they talk about to make this happen, they don't go deep enough with what is the best. That's what they're interested in seeing. So when you say, I'm raising $10 million to do my clinical study. Go ahead and talk about what that clinical study means.
Go ahead and talk about in this particular clinical study that I'm raising this $10 million for, I'm raising this money to prove this, to prove that such that it can impact this and impact that. Once it impacts that, we expect the adoption rate to look like this within this amount of time. So you saw how I use, we expect this because of that and that leads to this and this leads to that. You will get an investor really interested to say, oh, they know what they're talking about.
But exactly if this is executed correctly, all they need is the money to fill in to make it happen, but they know what they're going to make happen. That's what they're investing in. They're investing in your strategy, your knowledge, your team, how you're going to get there and really the decks and knowing that it's going to happen and there's going to be a real benefit. But not only the benefit of this is how we're going to get it to market.
Go ahead and talk about, yes, I am going to do a $5, 10K. I need money to do my $5, 10K. But when I do my $5, 10K immediately, this product will be adopted because there's already a CPT code for it. But while there's a CPT code for, we plan to improve the standard of care because we're going to collect that. Do you understand how I'm just walking down the road within five minutes, right? You can track people within five to ten minutes. This is what they're looking for.
But when you get stuff on the technology, this is a great product because this product is there. Here's an experience as a surgeon. That's a blah, blah. Yeah. I mean, it's necessary. It's table stakes almost. I mean, it's like, just if I were to condensate even more, you're basically saying why we're doing this? Who's going to do it? But then what we're doing, it kind of makes sense that you'd want to know what exactly you're doing. I'm curious if there are any specific endpoints.
If you could just give me, I don't know, if we go one layer deeper with those endpoints, the endpoints for the regulatory safety and efficacy. But then you said maybe go beyond and there are certain endpoints that maybe you can't attain if you're just pursuing safety and efficacy. What are some of those other endpoints that are really going to lend themselves for market adoption, not just the market access endpoints. I'm almost kind of differentiating these endpoints.
Market access, endpoints, and market adoption endpoints. I'm guessing the economic makes sense, the standard of care makes sense. Are there any specific, maybe close to universal endpoints that you see as the market adoption endpoints? Yeah. So from a market adoption standpoint, when I think of endpoints, so let's say if we're talking about economics, right, we want to just say, hey, this is more economical product and it's a waste of it.
So the endpoints I will look at is because you use this product, this product has a switch on it that makes this run faster. You probably want to test how long did it take for the surge, right? So the standard of care may take maybe an hour surgery, but because our product is this and has this feature which makes it, I don't know, easier for the surgeon to blah, blah, blah, right? Now you have completed surgery in 30 minutes or 45 minutes versus an hour.
So you're looking at the operation of workflow. And because this product has this additional feature, the patient may recover faster because it provided improved blood flow, right? The patient loss less blood. So now we're measuring the blood loss in the ER. So things like that, little things like that, you can just kind of dig into. So if a patient has less blood, blood loss, they may be more likely to get out of the hospital faster, you know, faster recovery. So now it's cost effective.
We just say the patient money from a hospital standpoint, we just saved these insurance coming a little bit, a little bit of money, you know, the patient is happier. There's a better quality. So now you can offer this to more patients and, you know, more patients aren't going to come to this surgeon because now this surgeon looks great. So, you know, less infection rate because the patients are getting out of the hospital faster.
So these are some examples of some of those, if I get tactical with it, some of those end points that you can look at. So that's the short term game, right? But if you want to look at the long term game, you're looking at those quality of life, patient reported outcomes is super important to collect long term patient reported because that benefits the patient, right?
So that makes it more attractive to the patient and the patient see that, oh, this surgeon or this hospital, this clinic, they have better results than what I've seen over here. So I may want to even go to that surgeon. So that makes it more attractive to a surgeon to say, hmm, I want to use that manufacturer's product because the data has shown that this is, you know, more cost effective, it has a better patient benefit. So it makes my, it looks better and it makes me look better.
And I'm using the one that I look better, but I'm really talking about patient benefit. I know what you're talking about. Yeah, absolutely. I know how to assume people know that. It makes me think of the phrase, the heart of the problem is the seed of the solution. And the reason I say that is it's important to understand what problem you're actually solving. I'll just give you an example.
I don't know how specific I can get with this, but I remember hearing, I think we were judging the, the mass. It was one of those incubator challenges where people would pitch and they were giving the time savings that they believed would happen. And they say, okay, we're going to reduce this amount of time in the OR, which is going to be the OR costs X amount of dollars. And so that much reduction is going to reduce the amount by X amount of dollars over the year.
And it, which is a big amount of money. So that's going to matter. Well, later when the judges were all talking about that, they said, well, you know, that is something that happens in parallel with other things in the OR. So it's not really going to save any OR time. And so essentially what they were saying was this, whether they were right or wrong, is they didn't believe that they truly, that the person pitching really understood the full process of what happens in the OR.
So it makes me think in project management, you know, when you're building out your process flows or I don't know your Gantt charts, your timelines, there are some things that are that have float, you know, some things that well, we can do that whenever because this other thing is aligned to line situation.
And so I know talking with one orthopedic surgeon, he's, he changed his methodology or that's the, he changed the fixation device that he was using because it reduced the amount of setup time by like 30 minutes. They would, they would spend 30 minutes fixing, you know, stretching the arm or whatever it was. And that was, everybody was waiting on that one thing. And that's more valuable than someone waiting on something that while other things are happening.
It's just kind of a, just a mild point there, but it's made me think of that. No, I think that's a, I wouldn't even call them a mild point because when fixation, you talk about setting up a different, you know, fixations setup and workflow, think about, think about the impact that takes away distraction points from surgeons, right? And they can actually concentrate more on what they're doing than what's going on around them in the ER.
So the more you eliminate these descriptions, the stronger, right? You have the surgeons attention. If they enter the distractor or what have you, it's just a point of improvement. And that's how we raise the standard of care. That's how we optimize what we're doing. So I actually think that's a wonderful point. Well, I appreciate that.
Now, I want to ask another question, though, if we move away because some of the examples we've used, I am a mechanical engineer, so I focus, so I like the mechanical side of things. And I'm not talking about the real fixation and so forth, but what about novel technologies? What if you could touch on some of that?
Because I know one of the areas that's been hit pretty hard from a funding standpoint are the maybe more technologically advanced devices that have a software component or an AI component. Are there any specific pieces of advice that you have for that, that segment of the market? Yeah, or for novel technologies. And you're probably going to laugh at this evidence. I should have known. You know that already. No, when I say evidence, so it's really key, devising those endpoints.
But especially when you have a novel technology, putting together a surgery advisory panel or a group, a surgery at a surgeon advisory group, and you prep the market. And you know you're coming up with a novel product, do what you can to prep the market. Once, and when I say prep the market, I'll give you an example. I don't know that we utilize a limited market releases enough.
That's when there's a novel product, I really suggest that's my advice, a limited market release, because you're putting a few products out there. It's already clear, right? And you're able to collect real world evidence on your product being brand new. And because it was a limited launch, you have opportunity to go back and do some fine tuning, right? You know, do some things to get it back out there when you push out your global or your extended market release.
So I do recommend limited market release. And with that limited market release, publish, you know, go ahead and get a white paper out there. And you know, you're going to have a lot of money in the market, so they know what's coming, what the evidence suggests so far, you know, with the first 10 cases, the first 30 cases, this is what we're seeing. Don't be afraid to get the evidence out there.
But putting together that surgeon advisory panel, getting input, you know, just, I can't state it enough. Don't go edit alone, you know, just because you are the CEO of your organization, just because you have a few, you know, people, you know, made experts around you, don't limit the potential and really the impact of having that surgery, that surgeon advisory panel next to you to help give that input as you're developing and to be a part of your limited market release.
And to get that publication out there and to get you on podium, I just believe prep the market when it's not all. I love that. Sometimes you can be too early and one of the examples I like to use, I don't know if you've heard of general magic. It was the most important company to come out of Silicon Valley that no one's ever heard of.
But while nobody's ever heard of general magic, most of the people have heard of the people, they built a smartphone, essentially a touch, touchscreen in the early 90s. And they failed because they weren't, they didn't prep the market. And so they all split up. These geniuses one went on to go develop the iPod. The one went on to develop the Android and another one went on to develop. What is that? I'm forgetting, I'm losing my words, but it's just a classic example in the broader field.
We don't hear about it as much in the medical device field, but I think you go back to that statistic you gave 75% of companies that fail. Everybody wants to be show how innovative they are, but if we don't prep the market, then there's not a lot of benefit to being that innovative, too innovative. I know we're coming close to the end of our time. Any last piece of advice, where can people find you? Just any last piece of advice for the audience? Yeah, last piece of advice.
You probably can guess it. No, joking. Get that clinical evidence. But no, don't be afraid of clinical evidence. Don't be afraid of running a clinical study, but not only clinical study. I think I want to leave you with understanding the power of developing your strategy. Understand the power of that. I like to look at it as traveling. If I'm going to a new city, state, country, or what having that I've never been to before, I'm not going to drive their blind.
I'm not going to leave my GPS at home. If I know that there's a resource, there's a GPS, I can plug in where I am going. This is going to show me exactly how to get there. It's even going to mitigate traffic. It's going to let me know what's ahead, what bumps in the road, what I'm able to look out for. That's a simple concept, but it's the same with starting a medical device company. Use your GPS, navigate.
Use your resources to develop that strategy such that you can have that roadmap while you travel this journey. That roadmap will empower you, raise money. It will empower your team to execute more flawlessly. It will empower you to get through those regulatory and clinical hurdles, because that's where a lot of us get caught up.
We don't know how to navigate regulatory, and we certainly don't know how to navigate that clinical piece, because the only reason why we do a clinical study before getting approval is because it's required by FDA. We're not doing it because we just love to do it. Use your navigation, use your GPS. If you don't have a navigation system or GPS, you can call me. My name is Shea Harry-Anci, and I can be found at www.rLCsolutions.net.
It's my website, or you can easily find me on LinkedIn, but you're to talk and chat, because I am really trying to solve a problem. I'm trying to bring a solution to the market and get these much needed therapeutics to the market into our patients. Fantastic. I appreciate it. We'll put those links in the show notes so people can find you, find your website, and see what it is that you're doing. I can personally attest so many people think they're alone, but it is very hard to do.
It is very unlikely that this is the first time that this path has been traveled. When we went to LSI, we were surrounded by people who were all going through this different journey of bringing a medical device to market. You're not alone. Find that cohort, find the advisors that can help you get through that. Thank you, Shea Harry. I really appreciate you being on the show today.
Those of you who have been listening, I hope this has been a benefit to you all, and I look forward to seeing you all next time. I hope you all will be here for now. 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.
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