Clinical Evidence: The Key to Market Adoption

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies.

Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.

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Key timestamps

• 00:00 - 03:00 Introduction and Sponsor Message
• 03:01 - 05:20 Introduction to Shaherah Yancy and her background
• 05:21 - 10:30 Importance of Clinical and Regulatory Strategies
• 10:31 - 17:15 Challenges of Securing Funding and Developing Strategy
• 17:16 - 25:45 Differences Between Market Access and Market Adoption
• 25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption
• 33:51 - 39:40 Importance of Evidence and Study Design
• 39:41 - 48:00 Examples and Case Studies from Early Stage Companies
• 48:01 - 55:15 Endpoints for Market Adoption
• 55:16 - 01:02:30 Strategies for Novel Technologies
• 01:02:31 - 01:07:45 Final Advice and Contact Information

Top takeaways from this episode

1. Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.
2. Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.
3. Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.

Practical tips for MedTech professionals

1. Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.
2. Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.
3. Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.

MedTech 101

• Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.

   

• 510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.

   

• PMA (Pre-Market Approval): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Related links

• Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC Solutions
• Greenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru Clinical
• Etienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedIn

Memorable quotes from this episode

• "Market access is a milestone. Market adoption is the goal." - Shaherah Yancy
• "Understanding the problem you’re solving is crucial for your strategy." - Shaherah Yancy
• "Don’t be afraid of clinical evidence; it’s your key to success." - Shaherah Yancy

Audience feedback

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Transcript

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Shaherah Yancy: Reality today with me is Shahara Yancy. We're going to be talking about why developing a clinical and regulatory strategy is critical for med tech. And it's interesting how I met Shahara 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.

So, 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, Sahara, how are you doing today?

Etienne Nichols: 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.

Shaherah Yancy: 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, we 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.

Shahara Yancy is a seasoned global leader in clinical and health operations with over 20 years of expertise in medical devices, pharmaceutical science, and hospital.

She excels in developing strategies that enhance organizational growth, operational efficiency and business alignment. Previously, she had experience at Medtronic, Smith and nephew and Stryker where she spearheaded strategic efforts across the US, Europe and Asian Pacific.

Her areas of expertise include orthopedics, spine surgery, abdominal transplantation and oncology. She has led global clinical trials, managed P and LS, and developed strategies for rapid commercialization and market expansion.

Currently, she is the CEO of Research Lifecycle Solutions where she delivers transformative clinical strategies for the biotech and MedTech sectors, focusing on portfolio improvement, market strategies and actionable plans. She has a extensive background and which is one of the reasons I'm excited to learn from her today.

So, did I miss anything, or did I miss state? Anything? Feel free to correct me.

Etienne Nichols: Oh, you didn't miss anything. I hope I can live up to all of that you just mentioned at this point.

Shaherah Yancy: 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?

And 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, and I know that's one of your topics. So however you want to tackle that, what are your thoughts on this topic today?

Etienne Nichols: Yeah, absolutely correct. I am very passionate about that topic. And as you mentioned, with my background with those companies, you name the Medtronic, strikers and Smith and Nephew. We know those companies to be key players, really top players in the global MedTech industry and having the opportunity to lead clinical and regulatory for those organizations with really large portfolios, my key responsibility was about market access, new market introduction. So, 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 was 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.

If we know there 75% failure rate 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, you know, the.

Their 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, how would you just be blunt?

So, what your product is on market? There are a lot of products on market, and most products, medical device products on market, make it to market via 510k, which means me too. Substantially. Substantially equivalent. So that's kind of the gap that I tackle and really work with companies to overcome via the strategies that I used with your company.

So that's kind of my goal, Jeff.

Shaherah Yancy: Okay, so that 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?

Etienne Nichols: Yeah. So, most of it, actually. But I'll take a step back.

Shaherah Yancy: Sure.

Etienne Nichols: It's commonly it's because a 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. As a young company, you grow.

Well, I would say the first priority is fundraising. Right. You have to get the capital in order to do anything. But when they are raising capital, there is 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 likelihood to get funding.

So, if you get funding for your first seed, and that's to, you know, 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, you know, probably do a clinical study. And I say, well, hang on, hang on. We have to have a strategy in place. So, by the time we talk to FDA, they figure out.

Oh, my 510 is not what I thought. I may need to actually do an i.e. I may need to do a PMA here to get to market. So now you have to go back into fundraising to get more funds in order to fund now your regulatory strategy and your clinical strategy.

Right. So. But by the time you go back to try and raise funds, what if you're. You're probably a year behind. You've 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 getting 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?

And in addition to that,

if you think about the right team, you know, don't go at it alone. You know, we have, we have CEO's, you know, 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 businessperson that's your inventor or your entrepreneur here that don't understand the technical aspect.

So, the key is, you know, 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.

Shaherah Yancy: Jeff, I really like what you said there, too, because the lack of funding, and I know the end of 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. And actually, I just spoke with a surgeon, I think it was a few weeks ago, who said, yeah, if there's something that could impact recovery time reduced, reduce the amount of time that we spend in each surgery and is actually a safety mechanism, then, yeah, I'm interested in that. And so, 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.

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 FTA.

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.

Etienne Nichols: So just this week alone, I spoke with two of my clients who are founders.

Both of them are physicians, actually, they're physician founders, and they have really, really good products. You know, I believe in their product, but they were defeated when I spoke to them, and that was because their investor pulled out at the last minute.

They said, hmm, you know, I may have to just, you know, forget it. Close my company. The investor pulled out. So, yeah, they, they were pretty bummed about it, and I was bummed for them.

However, I had a conversation with both of them, and I said, well, did your investor give you a reason for pulling out at the last minute? They just said, you know, they have to give it some other thought.

And, you know, they just took a pause. So, I said, take a look at your, let me take a look at your pitch deck. 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 on not only getting it to market, but how are you going to execute once it's on the market?

How is this product going to be adopted into the market?

One thing for sure, and investors are very, they're smart. They're keen on this, even if they don't know technology, the technology piece, they understand the market of what they're trying to invest in. So, 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 ex-hospitals, ex-surgeons. We already thought through the reimbursement codes. We understand what the payers need. So that's what I mean by execution. Right. But 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, let's take an example of an orthopedic surgeon. Oh, no. 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 said system. So, you come to the market with a new system that's also a me-too system because you've gone to the market.

510K. 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?

Right.

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 into 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. So, if you can't convince an investor why this product is great point to convince a surgeon who really understands the product why it's great.

So, it all ties back to this strategic component of being able to communicate that during your fundraising, while you're talking to investors. Because if you don't get the funds, you can't move with your company.

Right. So, all of it ties in. And if you don't have that strategy, I can't say it enough. It's that strategy, that clinical regulatory strategy, which equals your commercial strategy, essentially.

So that's kind of an idea how or, you know, you asked me to look at it and give you an example. Two examples just in a week of investors not making them because they have a proper strategy.

Shaherah Yancy: No, that's really powerful. That's fantastic. So, when you're talking about that, I'm thinking about the regulatory strategy. So, we'll get in a little bit more to the clinical and the market adoption.

But a lot of companies that I speak with, they, they like that idea because they don't have to have a clinical investigation or they don't. There's a, there's a higher likelihood that they won't need a clinical investigation.

But 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, just going all, all out and become, you know, a class three medical device or just.

Can we talk through a little bit of that? Just. Just your.

Etienne Nichols: Your observations there, clinical studies, clinical investigations. Clinical trials is just not a dirty word.

We feel that way. You know, it's scary when you hear it. You think all you see is dollar signs, right? But, you know, I'm not suggesting by any means that you need to do a clinical study before going to market or what have you, because 510, that is a viable path.

It's a great path, but you really have to think about the goals of your organization. So the cautionary tale with 510 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. You know, sometimes you have to move a little slower for your intended. So, it's really about what intended outcome. Sometimes 510 is the proper path. Sometimes a PMA is the best path.

So, you really have to look at your portfolio, look at your goal, even your budget, look at your resources to understand what you need to do. So, what I am suggesting is, regardless of what path you take, you need evidence on your product, whether you get it before market access or after market access.

I am a firm believer, an advocate, and I do suggest even if you get a 510 approval, once you get that 510, you have to be ready to switch to 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 on that evidence. That's what I'm 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 CEO's to be smart about that understanding when you need it.

Shaherah Yancy: 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 if I do 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, da da da. 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. 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. And 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?

Etienne Nichols: 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 start with this phrase kind of all the time when I speak with investors or entrepreneurs or such.

Market access is a milestone. That's not your goal. Market adoption is your goal. So, make sure you understand the two. There’re milestones and then there's ultimate goal. So, getting to market simply a milestone.

And remember earlier I said, so what? You're on market, everyone else is on market. So yeah, let's talk about, you know, beyond FDA approval and what it takes really to get your product know, adopted and, you know, used by 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 payers, right? They want to know that beyond the safety and efficacy, that's what the FDA looks for.

They're looking for health economic data, right? They're looking at that patient reported outcomes, the cost effectiveness. They're looking at the standard of care. How does your device compare to what's already standard of care?

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 comparative 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, hit 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 a product to market that the market is just not prepared for at, 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 mark, the product that's on Mar, the product that is on market currently maybe 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 510. And once I get this 510, 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. In 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 is no one size fits all and I'm very, very big on one size does not fit all.

But there is one thing that does fit and that is you need evidence on your device.

Shaherah Yancy: 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 use that example again. If you can’t show that evidence and convince them to invest in you as an investor, how are you going to do that with a surgeon?

Let’s take a surgeon. Let’s suppose were imagining or just reverse engineering that adoption process. What are some of the biggest drivers that you see? I talk to people every now and then, but those are more one-off n of one sample size. Youve talked to a lot of different companies.

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.

Etienne Nichols: Efficacy, 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 code. That means the majority of surgeons or providers are probably using this product. So, I know we are 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 indication, right.

Or will this product, does it have, let's 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.

That means it has a greater potential for growth. A greater potential, yes, in 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 two because we, you, 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 CEO's, you know, don't get stuck in the, 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, it's the same effort in clinical data and such that you would need to put into it if you were 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've, remember, we've checked it. So, let's go beyond and talk about the patient benefit.

Let's go beyond and talk about the economic 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.

Shaherah Yancy: 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, that I'm imagining. How do you design your study strategy to encompass both of those from an efficiency standpoint?

Etienne Nichols: I do recommend comprehensive clinical studies with smart endpoints, but sometimes that's not always the need. You know, it doesn't always offer 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 piece.

What will make you more attractive? Sometimes you're just, you know, trying to meet one step, but if we're talking about what's efficient, and for me is even more cost efficient in the long run, it's to run a comprehensive study.

You have your primary endpoints. Your primary endpoints are going to be your safety and efficacy, right? Your secondary endpoints, that's going to be your claims data. What do you plan to claim about this, you know, product?

You may not be able to collect all of those endpoints of or design your study to call for all of that from a scientific standpoint, especially if a study is not on the, I'm sorry, if a product is not on the market just yet.

So, 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 follow up.

That is something that you can really always collect in a study, even if you're doing it for safety and efficacy. Look at, let's extend the study to get the long-term impact.

Follow that device for whatever the perceived lifetime is, and lifetime means. If you're doing it implantable, how long is it going to be, how long do you expect it to be functioning in a patient?

So, for orthopedics, lifetime is ten years. But you're not collecting certain data, you're only saying what, how does this device work in the patient? Based on the patient's perspective, how long did it take for the pain to sub solve? Right. That's a key part.

Shaherah Yancy: Okay. Yeah.

Etienne Nichols: When did you get up and start walking? So, it's just, you know, how was your quality of life? Collect those endpoints in your first study that can automatically feed into your claims data.

Right. That can automatically start feeding into that once you hit market access. So, I just call them smart endpoints or even critical factors. Design your studies such that no matter what the study comes out to be, you have those critical factors covered.

Shaherah Yancy: 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.

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?

Because surely, they're thinking about it to a certain degree, I would expect. But is there a certain area where they just, everybody messes this up? Is there anything like that that comes to mind?

Etienne Nichols: So, you have your kind of your template, pitch net, right? You start with, you know, this is, this is why, let me tell my story of why I even, you know, ventured out to do this, you know, my life story.

What happened? Okay, so now you've told that, and then you 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.

And they flash that up really quickly. That's my team. How much is it going to cost or. Yeah, 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 happened, they don't go deep enough with what is the this?

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 am 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. They have an exact plan. 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 in 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, you know, yes, I am going to do a 510.

I need money to do my 510k. But with, when I do my 510 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 that road within five minutes? Right? Yeah, you can, you can attract people within five to ten minutes. This is what they're looking for. But when you get stuck on the technology, this is a great product because this product is this, this product is that or years’ experience as a surgeon, that's a blah, blah.

Shaherah Yancy: Yeah.

Etienne Nichols: I mean, it's necessary.

Shaherah Yancy: It's table stakes almost. I mean, it's, it's like just if I were to condense it 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, if we go one layer deeper with those endpoints, the endpoints for the regulatory, safe, 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, but I'm almost kind of differentiating these endpoints as market access endpoints and market adoption endpoints. I'm guessing that the economic makes sense. The standard of care makes sense.

But are there any specific may not maybe close to universal endpoints that you see as the market adoption endpoints.

Etienne Nichols: 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, you know, more and more more economical product and it's cost effective.

So, the endpoints I will look at is because you use this product, this product has a, a switch on it that makes, you know, this run faster. You probably want to test how long did it take for the surgery, 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 operational workflow. So. And because this product has this additional feature, you know, the patient may recover faster because it provided it improved blood flow.

Right. The patient lost 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 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 save the patient money.

From a hospital standpoint, we just save the insurance company 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 are going to come to this surgeon because now this surgeon looks great.

So, less infection rate because the patients are getting out of the hospital faster. So, these are some examples. Some of those, if I get tactical with it, some of those endpoints that you can look at.

So that's the short-term game, right? But if you want to look at the long-term gain, you're looking at that quality of life, patient reported outcomes. It's super important to collect long term patient reported because that benefits the patient, right.

That makes it more attractive to the patient. And the patients 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 money at this look better, and it makes me look, look better. And I'm using the word look better, but I'm really talking about patient benefit.

Shaherah Yancy: I know what you're talking about. Yeah, absolutely. And I would assume people know.

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 had pitched 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. And 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, he changed his methodology or 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. So, it's just kind of a, just a mild point there, but it's made me think of that.

Etienne Nichols: No, I think that's a, I wouldn't even call it a mild point because when fixation, you talked about setting up a different, you know, fixation set up 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 distractions, the stronger. Right. You have the surgeon's attention if they are distracted 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.

Shaherah Yancy: 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. I like the mechanical side of things.

I worked in cranial 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 segment of the market?

Etienne Nichols: 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 group surgery, a surgeon advisory group, and you prep the market. When 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, 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. 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.

Go ahead and get a white paper out there, prep the market so they know what's coming, what the evidence suggests so far, you know, with the first ten 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, maybe 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 to market when.

Shaherah Yancy: It’s novel, I love that sometimes you could 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 nineties, 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, another one went on to develop the Android, another one went on to develop.

What is that the.

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, 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?

Etienne Nichols: Yeah, last piece of advice. You probably can guess it. No joking.

Shaherah Yancy: Get that? Clinical evidence.

Etienne Nichols: 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, right? If I'm going to a new city, state, country or what have you, that I've never been to before.

I'm not going to drive there 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 need 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 to raise money. It will empower your team to execute more flawlessly, and 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.

So, use your navigation. Use your GPS. If you don't have a navigation system or GPS, you can call me. My name is Shaherah Yancey, and I can be found at www.rlcsolutions.net that's my website. Or you can easily find me on LinkedIn. But here 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 and to our patients.

Shaherah Yancy: Fantastic. I appreciate it. And 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, it is very unlikely that this is the first time that this path has been traveled. So, when we went to LSI, you know, we were surrounded by people who were all going through this different journey of bringing a medical device to market.

And so, you're not alone. Find the. Find that cohort, find the advisors that can help you get through that. So, thank you, Shaherah. Really appreciate you being on the show today.

Those of you been listening, I hope this has been a benefit to you all, and I look forward to seeing you all next time. But for now, take care.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never.

Shaherah Yancy: Done that before, but if you're listening.

Etienne Nichols: On the phone, look at the iTunes app. Scroll down to the bottom where it says, leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us, and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message. Because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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