Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective?

Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives.

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Some highlights of this episode include:

• Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials.
• Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence.
• Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it.
• The mechanism of going down the path of using real-world evidence in regulatory matters.
• How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial.
• Thoughts on the future of credible real-world evidence.
• Examples of how real-world evidence can be used.

Links:

FDA Final Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Aug 31, 2017)

FDA Webinar: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Oct 10, 2017)

FDA Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (CDRH, July, 2016)

Article: FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions (RAPS Focus, Aug 30, 2017)

Article: FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions (RAPS, Dec 8 2016)

Article: Real-World Evidence — What Is It and What Can It Tell Us? (NEJM, Dec 8, 2016)

Memorable quotes by Mike Drues:

“Real world evidence is how the products or devices are actually used in the real world, either by the physicians and surgeons or by individual patients.”

“Although the RCT is the gold standard, it is inherently biased.”

“Real-world evidence is data of a sufficient quality that it can be treated as evidence.”

Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: Real-world evidence. What does this mean to you in the medical device industry? What does it mean from a regulatory perspective? Well, on this episode of the Global Medical Device Podcast, my guest, Mike Drues, President of Vascular Sciences, and I, have a discussion about real-world evidence and the things that you can do to consider this and include this as part of your quest to having products that are gonna improve and save lives. So, enjoy this episode of the Global Medical Device Podcast.

Jon Speer: Hello, and welcome to the Global Medical Device Podcast, this is your host, the Founder and VP of Quality and Regulatory at greenlight.guru, Jon Speer. And today, we're gonna dive into a relevant and timely topic, something that's come up in recent years with FDA and frankly, other parts of the world as well, but we're gonna talk about this concept of real-world evidence and what does that mean as it relates to bringing medical devices to market and those sorts of things. He's been a familiar voice on the Global Medical Device Podcast before, and I know he has a lot to share on this topic of real-world evidence. Joining me is Mike Drues, President of Vascular Sciences. Mike, happy day to you.

Mike Drues: Thank you, Jon. Happy day to you as well. Always a pleasure to speak with you and your audience.

Jon Speer: Yeah, so this topic of real-world evidence, it's kinda surfaced... Well, I mean, a little bit more relevant in recent weeks or months. But it's been something that's been percolating for a bit from an FDA perspective. What does all this mean? And why should we care? Why does it matter?

Mike Drues: So that's a great place to start, Jon. The concept of real-world evidence certainly is not new, in fact it goes back many decades, but the reason why it's come up more recently is because last year, FDA put out a draft guidance on real-world evidence and actually just this past month, that draft guidance was finalized and now there is a final guidance coming specifically from CDRH, from the device side of FDA, on what real-world evidence is and how and when it can be used. So simply put, real-world evidence to me is how are our products, how are our medical devices actually used in the real world, either by the physicians or surgeons, or in some cases, individual patients for home use devices, that kind of thing. As opposed to what has been referred to in the past as the gold standard, which is the randomized clinical trial. Real-world evidence is, in my opinion, much more realistic than in a randomized clinical trial or RCT.

Mike Drues: Let's be honest, although the RCT is considered the gold standard, it is inherently biased. I've said this in the industry and I've said this at the FDA many, many times, because clinical trials, the way medical devices are used in clinical trials, is just simply not reflective of how they're actually used in the real world.

Jon Speer: Right.

Mike Drues: It's kind of the engineering equivalent. I know we have a lot of engineers in our audience, Jon. It's kind of the engineering equivalent. When I was an undergrad, we always made the assumption that frictional losses were negligible, and so therefore, we did not have to take into account friction. On the other hand, real-world evidence or what happens in the real world, how physicians or surgeons or even individual patients, how they actually use our device, that would be the engineering equivalent as we do in graduate school of no longer assuming that friction is negligible in taking those frictional losses into effect. So, in the end, which is more important? Well, I'll leave that somewhat as a rhetorical question for the audience, but it seems to me, Jon, and I suspect I know you well enough, I'm guessing you might agree that the way our medical devices are used in the real world is much more important than the way that our medical devices are used in the theoretical world of randomized clinical trial.

Jon Speer: Yeah, it's interesting though. Like you said, the current gold standard for some devices and some technologies, especially if you're a higher classification product, and that the clinical trial is a necessary component, and for many types of products to even get to a point where you're ready for any type of regulatory approval or clear answer submission. I feel a little bit stuck in some respects. It feels like FDA is saying two different things, they're saying, "Do this randomized clinical trial and we're gonna use that as a basis for evaluating your product, your technology from a regulatory standpoint." But then now they're coming out with this thing called real-world evidence, which it's not direct conflict, but it's certainly from a drastically different perspective of things, and it seems like that can create a lot of conflicts for companies.

Mike Drues: Well, it certainly can, Jon, and just to be clear, 'cause I wanna make sure that your audience understands when I make a statement that the randomized clinical trial is inherently biased, that it's not reflective of how we actually practice medicine in the real world. Let me just take a quick moment and explain what I mean by that. In a clinical trial, we have a lot of control, in terms of who uses our device, that the inclusion and exclusion criteria of the patients that use our device, how that device is used, we make sure that for example, physicians are trained, physicians are following a protocol and so on, and so on. But in the "real world" that is in the world of the practice of medicine, which is you very well know, Jon, the FDA does not regulate medical devices.

Jon Speer: Right.

Mike Drues: And to be fair, drugs as well are used however the physician wants to use them. And so, again, although historically, the randomized clinical trial has been referred to as the gold standard, a lot of people think of the gold standard because it's good. I don't think so at all. I think that, as I said, the way that our devices are used in the real world is much more important.

Jon Speer: Yeah, I totally agree. I think especially with... There's been a lot of emphasis, and you and I have talked a little bit about this in the past, there's been a lot of emphasis as well on topics like human factors and usability, and of course, that risk management topic that obviously is pretty important to medical technologies and products as well, and so, those are all in that spirit of real-world evidence. And I remember being at an event with you not that long ago, where I think we were both in a session on the topic of human factors, and there was some lively discussion on that topic, and I remember that you did bring up that idea of real-world evidence that that being more important. And so, it feels like from my perspective, being in this space for a while and picking your brain from time to time, it feels like we're in a shift, that although the gold standard may be that randomized clinical trial at present day that it seems like FDA is starting to change that, that they are sending a new message that says, "Hey, folks, you may wanna start moving in this new direction." That's a bit of speculation. I don't know if you have any thoughts about that.

Mike Drues: Well, actually it's pretty good speculation, Jon. There has been a gradual change in the direction the wind is blowing, so to speak. Historically, FDA and to be fair, not CDRH but CDER and Zebra and the other major centers at FDA, they have not been keen on accepting real-world evidence in lieu of randomized clinical trial data, and we can talk more about that in a moment. But with the advent of this guidance, and with similar guidances coming out from CDER, that is starting to change and bringing a tiny bit of politics involved, the new FDA Commissioner, Scott Gottlieb, shares a similar view that I and a few other people have about real-world evidence, and that is I don't wanna certainly put words in Dr. Gottlieb's mouth, but I think he would probably agree with this statement. As long as the real-world evidence is credible, as long as it is of good quality then quite frankly, why should we have to reinvent the wheel? Why should we have to go out and do a expensive, time-consuming clinical trial to collect data that we already have? So you're right, things are changing. But still to this day in 2017, even as we have this discussion today, I have several examples of devices at FDA, where it's still very, very difficult to get them to swallow that pill, so to speak.

Jon Speer: Yeah. And then it feels a little throwback this topic for me because I can... And I share a story every so often with folks about my first experience with the device that I was developing and being present for the first time it was used clinically. It wasn't in a clinical trial, and certainly that's something that you might be able to do these days because of the classification of the product and things like that. Yeah, we didn't have an IDE, we didn't have IRB, we didn't have any of those things. Was it significant risk knots?

Mike Drues: We're dating ourselves, Jon.

Jon Speer: We certainly are. Was it significant risk? Not significant risk? Alright, we're not gonna get into that, but I remember that it was a catheter-type product. I remember it very well, and I was there, bright and early in the morning one day, and sitting down just a few minutes before the procedure with the anesthesiologist, and the first time I had met the anesthesiologist, frankly, the first time he'd ever seen this device that I developed, granted it was pretty similar to other catheter technology so it wasn't new in that respect. And I remember being excited and then he's saying, "Right, go ahead and scrub up." Or, "Go put scrubs on and meet me in the OR." And then I did that and then I suddenly had this realization as I'm 12 inches away from the patient watching the anesthesiologist use this product for the first time it had ever been used and having this freak out moment, I felt like sweat was just pouring down my armpits, and I just felt a little flushed and a little clammy, and I remember at that moment very, very, very well. But at the same time, it was so invaluable because the procedure went just fine, no issues, anything like that. But I learned so much from actually being part of that actual real-world evidence of that particular device.

Mike Drues: Well, that's a great story, Jon. Thank you for sharing that with me and also with our audience. That actually would be a good example of what I would consider to be real-world data, whether it's real-world evidence or not, I'm not sure. And here's what I mean by that. In the guidance, it does distinguish between real-world data and real-world evidence. I won't bother to insult your audience's intelligence by reading the definitions, they are in the guidance. But simply put, real-world evidence is held to a... Here's basically the way I like to think about it. It's data of a sufficient quality that it can be treated as in fact, evidence.

Jon Speer: Okay.

Mike Drues: So, in other words, to use a medical device pun; real-world evidence is substantially equivalent to that higher level of standard, if you will. Or let me just try to put it one other way a little bit more simply; there's a lot of data out there, but how much of that data is actually evidence at that higher quality? This is exactly what I meant a moment ago. I do believe I'm not trying to put words in anybody else's mouth, but I do believe Dr. Gottlieb's position on this, and I agree with him 100%, is it comes down to the quality of the data.

Jon Speer: Yeah.

Mike Drues: So to get FDA to swallow that proverbial pill, whether we call it real-world data or real-world evidence, quite frankly, I could care less.

Jon Speer: Sure.

Mike Drues: Shakespeare said, "A rose by any other name still smells as sweet." The question is, is it of sufficient quality to be held to that evidenciary standard, if you will, that we might call it in a legal sense?

Jon Speer: Alright, that's interesting. I'm just thinking... 'Cause I'm a system guy, I like to think about how the mechanisms, the approach and that sort of thing. And so, if I start to think about, wow, how valuable this real-world data which could help me with this real-world evidence, I'm gonna learn so much more frankly about my product, it's gonna help me with those other things that I mentioned earlier, usability, human factors. I'm just gonna learn so much more about that product.

Mike Drues: That's right. And to put it even more succinctly and more bluntly, I have companies all the time that share with me real-world data, and I say to them, "Well, quite frankly, this is crap, and we can't possibly present this to the FDA." So, this is why historically, by the way, real-world evidence and being able to use it as part of a submission, as we'll get to in a moment, has been so controversial, because there is a lot of it out there that is, I hate to be blunt, but it is pretty crappy, garbage in, garbage out, that kind of thing.

Jon Speer: Well, and like I said, I'm thinking about this mechanism, and I'm thinking about being that product development engineer, and as many things as I can simulate and try to do from a bench test or an animal study, or something like that, those are all valuable learning opportunities to improve my product, but man, nothing is like... I'd go back to that story I shared. Nothing was like actually being there the first time that that product was used. You just learn so much. Well, frankly, it's a lot about your product, but it's also a lot about not just your product, but all the other stuff that's going on during that type of procedure, and all the other products that could interface and the environment and the user. And man, is just... Engineers and product developers out there, if you have an opportunity to go through that type of experience, it is so, so invaluable. And I realize that sometimes there are a little bit of, there might be some constraints or obstacles to do that, so I guess, curious for me, if we wanted to go down this path of gathering real-world data and hopefully, not being crap in helping us devise or establish real-world evidence about our technology, what's the mechanism? Am I still gonna go down an IDE path for a significant risk type of device?

Mike Drues: Well, let's talk about that for a moment, but before we do I just wanna clarify, 'cause I wanna make sure that none of our audience misunderstands some of the examples that you just shared, because some of it is actually not real-world evidence. So bench top data, for example, is not real-world evidence, animal data is not real-world evidence. If you have proof of concept, using some sort of a prototype in a human being or whatever, the device is not officially on the market yet, that's not real-world evidence either.

Jon Speer: Good points.

Mike Drues: By definition, real-world evidence is evidence or data of the device, how it's used when it is already on the market, when it already has a 510(k), or a PMA, or a De Novo, or something like that here in the United States. It just means that it's not part of a clinical trial, that's all.

Jon Speer: Okay. Good points.

Mike Drues: Oh, and by the way, I don't want our audience to assume that the only time we do clinical trials is before the product is cleared...

Jon Speer: That's true.

Mike Drues: On the contrary, we do lots of clinical trials for a variety of different reasons, after the product is already on the market as well.

Jon Speer: Good point. Thanks for that clarification, that's a really good point.

Mike Drues: You're welcome. So now let's move on to the question that you asked in terms of how do we use this? Well, my favorite way and the most obvious way, and probably the most common way that real-world evidence is and will be used in the future in terms of a label expansion. In other words, we have a device already on the market, it might be a PMA, it might be a 510(k), whatever, it's on the market for indication X. We wanna go back to the FDA with another submission and add another indication, call it indication Y. That and the regulatory vernacular is called a label expansion, and we've talked about that in some of our previous discussions.

Mike Drues: The question is, what kind of data or evidence do we need to support it? Oftentimes, we would need to do an additional clinical trial in order to gather that evidence to add that claim to the label. But here's the thing, if physicians are already using our device off label to do indication Y, as long as that data is of sufficient quality, so that we can consider it to be evidence, why should we have to reinvent the wheel? Why should we have to go and do a whole another randomized clinical trial to essentially collect data that we already have? So, we could use real-world evidence in lieu of a clinical trial, or at the very least, we can use real-world evidence to be able to justify doing a much smaller clinical trial, than we otherwise might normally have to do in order to do the label expansion.

Mike Drues: So that's the first and the most obvious. There are a couple of other examples that we can use real-world evidence for in the Class III PMA world, and in some Class II devices,'cause as you know, Jon, there are a small but growing number of Class II 510(k) devices that are also requiring clinical data. We can use real-world evidence to meet our postmarket approval study obligations or in the drug world what we call postmarket surveillance, as a part of a PMA and is a part of some 510(k) s. There is a requirement to do what's called a postapproval study, this is essentially a clinical trial after the device is already approved or cleared. So in some cases, we can use real-world evidence in lieu of, or at the very least, to shore up our postapproval study. And finally, the last example, and those two examples by the way are discussed in the guidance a little bit, but some of us have been doing this long before that time...

Jon Speer: Yeah.

Mike Drues: The last and the most interesting example that I think, and it's not even remotely touched on in any guidance at least thus far. Somebody asked me, "Can we use real-world evidence, not as part of a label expansion, but to actually get our clearance or approval for the first time for a new device here on the market in the US?" Most regulatory professionals, Jon, would say, "Absolutely not, you cannot do that." But as I've said in our conversations before, average regulatory professionals know the rules, the best ones know the exceptions.

Jon Speer: Right.

Mike Drues: Here's an interesting scenario that I could see playing out. What if we have real-world evidence that was collected on a device outside the US? So this is off label use of a device outside of the US. This is real-world data, no question about it, but if that data is of sufficient quality that we can present it as evidence, I think it would be a very interesting idea to present this to FDA, either in lieu of, or at the very least, in addition to, the data that we're already planning on collecting in our clinical trial for that particular new device. Call me a regulatory geek, Jon, and some people do but I think here in Boston, we would call that a wicked cool idea.

Jon Speer: You know, and here in the Midwest, I've been trying to get people to use the word wicked as well, but no place says it better than the Boston area, but I think it's a wicked cool idea as well. And as you were sharing that, that fun, that concept I was thinking, "Man," I mean, because and I had often put on that product developer hat, because one of the things that I always... I shared my story but as time evolved, now that story, doing that sort of thing today would be challenging frankly from a... And maybe rightfully so, we won't get into the nuances of that. But yeah, if I could get a private... And let's just play out your scenario or your idea a bit, maybe I can get to market in part of the world a little bit quicker for whatever reason because of the regulatory environment or whatever the case may be. And so, now I can launch this device in Europe or Canada, wherever in the world that it makes sense. And now I gather this real-world evidence on the use of my product in that part of the world and now I can use that to support my FDA submission for that product or my...

Mike Drues: Well, I think it's an intriguing idea, and to put it in a slightly different way...

Jon Speer: It's extremely intriguing.

Mike Drues: To put it in slightly different way, and this would be, obviously, the topic of a whole different discussion. But simply put, the idea of having to jump through different sets of regulatory hoops, just as a function of where you happen to be standing on the Earth at the time, or in this particular case, having to do clinical trials over again, just because you happen to be standing on a different part of the Earth at the time. I mean, with all due respect, that is becoming antiquated thinking, and I think one of the potential future benefits of real-world evidence is to bring new devices onto the market here, based on what's been done in other places in the world.

Jon Speer: Right.

Mike Drues: Now, again, I just have to reiterate my caveat. I do acknowledge the reason why that this has been controversial in the past, and this is a legitimate concern, that real-world evidence has to be credible, it has to be of sufficient quality. It can't be crap.

Jon Speer: Yeah, I can't be crap, yeah.

Mike Drues: So how about some examples of real-world evidence, Jon? Do you think your audience would be interested in that?

Jon Speer: I think that will be fantastic, like I said, this conversation has got gears turning in my head and I'm sure it's got listeners doing the same sort of things. But yeah, some examples may really just help seal the deal a little bit more as far as really grasping this concept and how it can benefit us as companies bring...

Mike Drues: So that's a great place to go next. The first example I'll share is the one that actually FDA shares in the guidance. And by the way, one of the criticisms by some people in the industry of the guidance is that FDA has not provided enough examples as to how specifically real-world evidence can be incorporated. And to be honest with you, I don't think that's a legitimate criticism and here's why, because I don't need, with all due respect, the FDA to tell me how to solve my problem. When we're growing up in school, in elementary school or high school, the teacher says, "Here's the problem, here's how you solve it, step one, step two, step three." Okay, that might work for 7-year-olds or for 12-year-olds, but it shouldn't have to be for us. That's our job.

Jon Speer: Right.

Mike Drues: But the one example that the FDA does share from the guidance is one of the minimally invasive heart valves that was recently brought to the market. Where the company, in this particular case, Medtronic, brought it on to the market and then used real-world evidence to do a label expansion later. And in the interest of full disclosure, Medtronic has been a customer of mine for a very long time.

Jon Speer: Sure.

Mike Drues: Although I was not involved with this particular device, but that's one example right out of the guidance, and if your audience is interested, they can see the guidance or they can contact me for more info. I'll share with you one example from my world, and this is actually a great illustration of what we talked about a moment ago, in terms of how easy or difficult it is to get FDA to swallow this real-world evidence pill. So, coincidentally, I went to the FDA with a pre-sub, for a company one month after the draft guidance before real-world evidence came out, so this was approximately a year ago. The brief history of the device, the device was already on the market, it was brought to the market about six years ago under a 510(k), a couple years later, they did a label expansion, they did not change the device at all, they instead just added another indication that was done with a subsequent 510(k). A couple of years after that, they went back to the FDA with yet another label expansion. Again, the device itself was exactly the same, no change in engineering whatsoever, but they added a third indication. In this particular case, there was a pretty big difference, so they did not go back to the FDA with a 510(k), they did it as a De Novo.

Mike Drues: We had a ton of real-world evidence to support that particular new indication, because surgeons have been using this particular device off label this way for a long time. FDA was insistent that the company do a randomized clinical trial, remember the gold standard, in order to support this new indication. I anticipated this. One of my philosophies that I've developed over the years in dealing with this, playing this game is, you can't anticipate every problem or question, but you're gonna anticipate many of them, I anticipated this. I brought a hard copy of the draft guidance, just literally a month after it came out, and I held that up, and I said, "Look, we are doing exactly what this new guy is telling that we're able to do." Okay, so I will do whatever I can, legal of course, to win this game. So that's a more current example, which even though that guidance now is final, it's still a difficult pill for some folks in FDA to swallow.

Jon Speer: Sure. Like you said, the gold standard has been the gold standard for quite sometime. So any type of shift or transition from that is, it's gonna take a bit of time and...

Mike Drues: That's right.

Jon Speer: Yeah.

Mike Drues: But again, Jon, I just wanna be absolutely crystal clear with you and with your audience here, I'm not advocating taking shortcuts, I'm not advocating not doing testing whether it's bench top, animal, or even clinical testing. When I think as a professional biomedical engineer, that it's justified either from an engineering or a biology perspective. On the contrary, I will often say to companies, "Gee, maybe you should do a little more testing," or even though it might not be required because it's the right thing to do. But on the other hand, I don't wanna do more testing than I have to.

Jon Speer: For sure.

Mike Drues: And if I already have data, and especially if it's better, more realistic data, real-world evidence, as opposed to some theoretical randomized clinical trial, why the heck should I have to spend the extra time and money collecting it? It makes absolutely no sense.

Jon Speer: It does not. And it's just not practical. And we've talked about and you've shared and I'll paraphrase things that you've said in the past, Mike. If we're just doing things because we're trying to check a box or fulfill a regulatory requirement, then we're missing the point, and I think that's a really key point for people to understand. And by the way, Mike referenced a guidance document during today's conversation, and there's a couple of items, guidance items from FDA that we'll make available with the post that accompanies the podcast as well as a few articles on this topic, as well. So, I guess, Mike, any parting shot on the topic of real-world evidence before we wrap up today's podcast?

Mike Drues: Well, just one last thing to add in terms of references, another thing we can provide to your audience, Jon, for those that are interested. In about a month, FDA is doing a webinar on the new real-world evidence guidance and we can post a link to that, the other website as well.

Jon Speer: Sure. And so that...

Mike Drues: I'll be brutally honest...

Jon Speer: That's gonna be like October 2017 time frame?

Mike Drues: Yes, I don't remember the date off the top of my head, but it's in...

Jon Speer: Alright, we'll find it.

Mike Drues: Oh, October 10th actually.

Jon Speer: Alright.

Mike Drues: We can post a link to that. It's sort of part of my team now.

Jon Speer: Right. For sure. For sure.

Mike Drues: But I'll be honest with you, most webinars that FDA puts on, this is not a criticism, it's just an observation. They're really not very useful, at least not to me, with all due respect, because they're really doing nothing more than reading to you what's already in the guidance. And they're not gonna tell you how to use it. They're totally not gonna tell you strategy, but to be frank, that's not their job.

Jon Speer: Not their job, that's right.

Mike Drues: That's our job.

Jon Speer: Right.

Mike Drues: So, using my poker game metaphor, as I've used many times, FDA would basically read you the rules of poker, but they're not gonna tell you how to win the game.

Jon Speer: Right, right.

Mike Drues: What you and I are talking about here, is a little bit about the rules, but more importantly, strategically, how do we win the game?

Jon Speer: Right. And folks, this is a really interesting topic and of course, if you would like to learn a little bit more about that and Mike's talked about competitive regulatory strategy in the past and that sort of thing, but obviously Mike is a guy that thinks about this topic of regulatory in a much more, I'll say, unconventional way, and I mean that as a compliment, because I think you're right. If we continue to do things the same way over and over again, I think there was a great scientist that once said that that might fit in the definition of insanity.

Mike Drues: I think that might have been Albert Einstein.

Jon Speer: I think that might have been Albert Einstein. So, folks...

Mike Drues: Well, that's very kind of you to say, Jon, and I'm certainly not gonna be so bold as to compare myself to Einstein, but I think what you just said is a very polite way of telling me that I'm wackadoodle.

Mike Drues: As as we wrap this up, the most important thing I can leave with your audience in terms of real-world evidence is that people should definitely follow the continuing discussion of this and be receptive, at least to consider the idea of using this in some of your regulatory submissions especially your label expansion.

Jon Speer: For sure.

Mike Drues: That's the most obvious one as I talked about, but first and foremost, remember, what it comes down to is actually very, very simple: The credibility or the quality of your evidence.

Jon Speer: For sure.

Mike Drues: If you are a medical professional, I would like to think that you can make that judgement yourself. And if that data meets your criteria of evidence, then you should have no problem selling it to the FDA. Or I shouldn't say no problem, but eventually you should be able to get FDA to swallow that pill.

Jon Speer: Yeah, for sure. Mike, I appreciate your insights and I like that final words, so to speak, and I wanna really highlight that word quality that Mike mentioned. I think sometimes in the medical device space, we really get stuck in this concept of compliance and sometimes when we get stuck in that concept of compliance, we're trying to check boxes and make sure we get the right forms and then right this and then right that, and so on, and we've really missed the point. And folks, that's why at greenlight.guru exists, frankly, is to really shift your way of thinking. We're trying to give you real-world evidence of how to really shift your thinking to instead of just checking boxes and blindly doing things that you don't always understand why, we've shifted it, we put the emphasis back where it needs to be and that emphasis is back on quality, and that includes making sure that you've got what you need to do, certainly to be compliant, but we wanna make sure that you're assessing your risk and your design control activities and your canvass and your complaints, all of these things that are so important to the overall success of your products.

Jon Speer: Remember, you're in this business to improve the quality of life, and we are too at greenlight.guru. So if you'd like to learn a little bit more about greenlight.guru and how we're helping companies all over the world improve the quality of life, you should reach out to us, go to www.greenlight.guru and learn more and request information. And thanks again to Mike Drues, President of Vascular Sciences. This has been Jon Speer, your host, the founder and VP of Quality and Regulatory at greenlight.guru. And you have been listening to the Global Medical Device Podcast.

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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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