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“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they sound so similar, but because their meanings are closely related.
However, they are not synonymous. There are big differences between intended use and indications for use statements. And understanding both terms and how they affect various aspects of medical device design, development, regulatory pathways, and reimbursement is essential for medical device manufacturers.
So, let’s break down the difference between your medical device’s intended use and indications for use.
In a nutshell, the definitions for intended use and indications are as follows:
Intended use is what you claim on your label that the device does. It’s the purpose of your device.
Indications for use are the circumstances or conditions under which the device will be used. These are the reasons you would use the device.
So, intended use is about the device itself. What does it do? How does it work? And remember, this isn’t about what it’s designed to do or what it could do. It’s about what you say it does on the labeling.
On the other hand, indications for use are about the patient. It answers questions like:
What illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat?
What are the circumstances under which someone would use the device?
What is the target population, the anatomical sites where it will be used, and the duration it will be used for?
In other words, your intended use is what the device is used for, and indications for use include where, when, and how it will be used.
The risk classification for your device is a function of its intended use. That’s why a pacemaker falls into Class III and a tongue depressor falls into Class I.
But your indications for use can also change the regulatory pathway for your device. For instance, let’s say you bring a scalpel to market with a general indication for cutting tissue. That’s going to be a Class I device. But if you bring the exact same scalpel to market with an indication for retinal surgery, it’s going to be Class III. That’s a pretty big difference, and the nature of the device has not changed at all.
Now, you probably don’t want to bring a scalpel to market as a Class III device because it increases your regulatory burden tremendously, as well as impacts things like design controls and other design and development activities.
So, what some companies will do is bring a device to market with general indications and a lower risk classification, and begin researching additional ways in which the device can be used safely. To be clear, it is not legal for a manufacturer to promote “off-label use,” but it is legal for a physician to use a device in additional ways in which they deem safe and effective.
However, reimbursement is another factor you need to consider as early as possible in development. A Class I scalpel may be easy to get to market, but it may be very difficult to get the Centers for Medicare and Medicaid Services (CMS) to reimburse you for it.
So, there’s more strategy and thought that goes into intended use and indications for use than many people may initially assume.
My advice to you is that little words matter. What you say—and what you don’t say—may make a big difference in the FDA’s eyes. You could easily write five or six indications for use statements for the same device before you find the one that works best for your company from regulatory, reimbursement, and risk perspectives.
The way you word intended use and indications for use statements matters. But what are some of the ways those different choices can play out?
One big difference is between bringing a novel product to market versus a “me-too” product. A me-too product is one in which you simply copy the 510(k) of your predicate device because that’s the easiest path to market. Novelty involves a new indication for use, something that isn’t on that predicate device’s 510(k) submission.
On Episode 16 of the Global Medical Device Podcast, guest Mike Drues, President of Vascular Sciences, used a baseball analogy to clarify the difference between the two strategies. According to Drues, you can think of the novel indication as swinging for a home run. There’s a lot of reward in it, but it’s more difficult and increases your risk of striking out.
On the other hand, you might conceivably get a me-too product to market with the goal of adding additional indications later—label expansion as a strategy. In this case, you’re playing small ball, trying to get a runner on first. Then, as you add new features and expand your indications for use, you move the runner around the bases until you drive in a run.
Different strategies that can both have great results. Neither of them is wrong, but you should try to base your strategy on your team, your funding, and your appetite for risk.
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Check out this podcast episode with Greenlight Guru founder Jon Speer and Mike Drues, president of Vascular Sciences.
On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them.
Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations.
Your intended use and indications of use statements are integral to getting your medical device to market.
These statements help insure your device meets regulation when used properly.
If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements:
First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible.
Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important.
“They think they understand what intended use means, but they really don’t…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues
Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible.
Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device.
Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage
“The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues
Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes.
Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road.
Tune in now to hear how these tips can be applied to you, your team, and your medical device.
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: What you say your product does, how you describe where your product is to be used are very important details with respect to your medical device. Yes, ladies and gentlemen, that's right, I'm talking about the intended use and indications for use statement of your medical device. Today, on this episode of The Global Medical Device Podcast, I have a chance to catch up with Mike Drues from Vascular Sciences. And Mike and I talk about the intended use and indications for use, and how important this is to getting your product to market. Imagine using a strategy when it comes to your indications for use and intended uses that can allow you to get to market faster when you want to do that. So be sure to listen in to this episode of The Global Medical Device Podcast.
Jon Speer: Hello, and welcome to The Global Medical Device Podcast, this is your host and founder, and VP of Quality and Regulatory at greenlight.guru, Jon Speer. Today, we have a familiar guest and somebody that you enjoy listening to on this podcast, and that person is Mike Drues. Mike is the president of Vascular Sciences, Mike does consulting for medical device companies. You know what, he also consults for regulatory bodies, FDA, Health Canada. I just had a chance to catch up briefly with Mike and he is traveling all over, well, at least, I'm guessing the globe, working with medical device companies, working with regulatory bodies, trying to set everyone straight [chuckle] on the topic of medical device regulations. Mike, welcome back to The Global Medical Device Podcast.
Mike Drues: Thank you so much Jon, it's always a pleasure to be back and to talk with you and your audience today.
Jon Speer: Well, Mike, are you ready to talk about something that confuses me at times?
Mike Drues: I definitely am, Jon, let's go for it.
Jon Speer: Alright, and here's the topic, intended use. The reason that confuses me is, well, intended use, indications for use, that's my confusion point, what's the difference? Why are they the same? And I'm guessing, you can set me straight today.
Mike Drues: [chuckle] Well, I'll certainly try Jon, let's focus on intended use first. So this is, as you know, one of the most commonly used buzz phrases in all of regulatory, and I think that there are a lot of people that, they think they understand what intended use means but they really don't. A lot of people, for example, think that intended use means what your medical device is designed to be used for, and that's not in fact, what intended use means. A lot of people think that intended use means what your medical device could be used for. And once again, that's not what intended use means, intended use is all about what we say, our label claims. In the regulatory world, it's what I call the high level labeling. So it's all about what we say, and I've got a lot of examples we can use, but intended use is, first and foremost about what we say our device is to do. Does that make sense? Does that help clear up that side of the equation?
Jon Speer: It helps a little bit. Yes, absolutely, and I'm sure as we chat here for the next few minutes, you will go through some examples and be able to make that even more clear to not only myself, but to our listening audience.
Mike Drues: Absolutely. And on the second half of your question, on the indications for use side, that's a little more as the name would imply the reasons or the situations where we would use that particular device. And by the way, these terms are not unique to medical devices, we use the same phrases for drugs and biologics and combination products as well. There is... Some people and sometimes even myself included, we will use intended use and indications for use synonymously. There is some overlap, but they're not the same.
Jon Speer: Right.
Mike Drues: The most important thing for the audience to remember, is that intended use is all about what we say our device is to be used for, and indications for use, is under what circumstances, under what conditions we would use that particular product.
Jon Speer: Right, right. So the key thing, I think from a product classification standpoint, is really gets into that indications for use, what we claim the product does. 'Cause that's the basis for regulatory product classification.
Mike Drues: Yeah, and that's a good point Jon, let's tie in the classification idea to the labeling. And I'll give you a very simple medical device example. In fact, this example is right off of FDA's website. A scalpel, if we were bringing a scalpel on to the market, one of the first questions we would have to ask is, what class is it? And the classification of a medical device is directly a function of what we say about it, its intended use. So for example, if we bring up scalpel onto the market for a general indication, for cutting tissue for example, that scalpel is Class I, on the other hand, the exact same scalpel, if we say that that scalpel is to be used for the eye, for example, in ophthalmological surgery, in retinal surgery for example, that same scalpel becomes Class III. Now, you don't have to have a PhD in regulatory affairs or an RAC after your name to appreciate that gee, there's a pretty big difference between Class I and Class III, simply because of what you say, the scalpel itself is exactly the same, molecule for molecule. The only thing that's different is what you say.
Mike Drues: So, the real question becomes, if a company is bringing a scalpel onto the market, even if it's for surgery in the eye, why would they label it for the eye? Because it's gonna make their regulatory burden much higher. So the challenge is, and this gets into [chuckle] advertising and so on, and so on. The challenge is, how do we bring this scalpel onto the market for a general indication of cutting tissue as a Class I, and at the same time, encourage either subtly or not so subtly, encourage surgeons to use it in other applications like for example, in the eye, where it would be Class III. Now, another thing for the audience to keep in mind is what we're talking about thus far, is purely from a regulatory perspective. There are other things that we need to consider as well, for example, reimbursement.
Mike Drues: Oftentimes, what we wanna say from a regulatory perspective is diametrically opposed to what we wanna say from a reimbursement perspective. So we might be able to get a scalpel onto the market through the FDA as a Class I for a general surgical indication, but I guarantee, when it comes to the Centers for Medicare & Medicaid services, CMS, who establishes the reimbursement codes, they're not going to reimburse for that scalpel, unless it's specifically labeled for the eye. So this is the dance, this is the discussion that we all have to have within our companies, is to where we play within that space. Jon, do you have any further comments along those lines?
Jon Speer: But I just know from firsthand experience in dealing with 510(k)s, one of the sections of a 510(k) is your indications for use statement, and FDA has a wonderful form that you fill out, and in firsthand experience, FDA is very, very... They want you to be very much to the point about what your indications for use are that you're stating about your product. And what I found even recently as well, is they almost want it to be word for word verbatim with the predicate device, which I find pretty interesting too. So that's been a little bit of my experience about how important that indications for use are. Sometimes, little words do matter, [chuckle] and they can change the whole process altogether. Like, your example is a good one. There's a big, big difference between being Class I versus being Class III. I'm sure everyone listening knows that. If you don't, Class I, requires no submission to the FDA, Class III is a PMA and often requires a long clinical study, and can be very, very expensive to bring up class III device to market. But the interesting comment, Mike, they offered is that reimbursement piece, because I think that's a topic sometimes, that we don't think about as medical device product developers, we think about, we have this cool idea we wanna indicate it for a specific use, we wanna bring it to market, we wanna understand that regulatory pathway, but we do forget about that reimbursement pathway.
Mike Drues: It can be a costly mistake Jon, I can tell you that there is a growing trend in the industry to not just consider regulatory early in the development process, but also now to consider reimbursement early in the process as well. And perhaps, this is a topic of a whole different discussion, maybe we could talk about this in a different podcast, but I feel very strongly and I do a lot of presentations at some of the MD&M conferences on regulation and reimbursement, and how do you integrate the two together? You have to have a good regulatory strategy, you have to have a good reimbursement strategy, and you have to have those things in place, or at least begin to think about them at the very beginning of your product development cycle. Any later than that, I don't wanna say it's too late, but the earlier the better.
Jon Speer: Sure.
Mike Drues: Coming back to what you said a moment ago, Jon, more on the regulatory and the labeling side, when you said little words matter, you're exactly right, I agree with you 110%. Regrettably, I spend an awful lot of my time, wordsmithing [chuckle] My background is engineering, whether I'm designing a physical widget, like a medical device, or I'm designing a clinical trial, or I'm designing a label, like an indication for use statement or a regulatory submission, to me, design is design, they are absolutely no different. And so, for example, I was just in California recently, working with a small medical device company, who's developing a medical device. We designed five or six different indication for use statements, all describing exactly the [chuckle] same medical device. And then, I did a regulatory burden assessment and a regulatory risk assessment on each one. Basically, what I did was I said, "Okay, if you wanna say this about your device, this is what you're gonna have to do, if you wanna say that about your device, that's what you're gonna have to do." And then we had a discussion with the company, with the senior management team, not just from the regulatory perspective, but from the product liability perspective, from the reimbursement perspective, and we got to decide as a company, where in that gray area we wanted to play.
Mike Drues: Because, at least in my experience, Jon and you can chime in as well, where one company might decide to play in that space, may be very different than what another company might decide in very similar circumstances. So there is no right or wrong, it has to do with a number of different factors. And one last thing that I'll pick up on, that you mentioned in terms of the 510(k), you're right, there is a trend at FDA to want more and more specific statements, like for example, in your labeling, in your indication for use, however, there is no regulatory requirement for that, you can, and I often do push back at FDA if they want me to be more specific than I really want to. But you have to know when to pick your battles, some things are worth fighting over and other things are not. But the other thing that you mentioned is, they want copy and paste from the previous 510(k). I'll be brutally honest, that is the easiest way in order to bring a medical device onto the market through the 510(k), that is, where you just literally copy and paste from the previous 510(k). The problem with doing that is, you're by definition now creating a me-too product. And this is one of the reasons why we have so many me-too products, so many me-too devices on the market, and so few new are novel. And maybe that's the topic of a different conversation [chuckle] as well, why do we have hundreds and hundreds and hundreds of me-too products and so few new are novel ones.
Jon Speer: Yeah. Yeah, you hit on a couple of things that, like you said, we could dive very, very deep, but the thing... Yeah, let's revisit at another conversation, the me-too versus novelty, because I think that will be interesting to dive into that, because there is that balancing act for sure, but the part that you said a moment ago, that I think is intriguing to me, is the example of the California company where you crafted a handful of different indications for use statement. And the reason I wanna pick on that just a bit, is what I understood from your example is each of those indications for use statement that you crafted, each of those sounded like they could have had a significant impact on design controls and design and development activities, and probably more specifically, in the area of things like verification and validation.
Mike Drues: That's absolutely correct Jon, as a quality and a design control guy, you now that all of that is gonna be a direct result, if you will, of your regulatory strategy. So, not only will the physical design of your device affect your quality and your design control requirements, what you say about your device, in other words, the labeling, the indication for use as we've been talking about, is gonna affect that as well. It may even affect it to the point that in some cases, some of the very low risk medical devices are actually exempted from design control requirements. So, it may be that if you really tone down or as I sometimes say, dumb down your indication for use statement, you might not have to even worry about design controls. Now, this is a topic that you and I have talked about in the past, I personally have a problem with that. I personally have a problem with companies who want to just simply avoid design controls because as we've talked about before, there's nothing in the design controls that I don't consider to be prudent engineering, but nonetheless, you are exactly right, what you say about your product, I.e the intended use, can definitely influence your quality strategy and your design control requirements, your verification and your validation, all of that stuff.
Jon Speer: Right. And so without going super deep today on the topic, let's imagine that I'm a company that has an indication for use in mind for my, what I believe to be somewhat novel technology, but imagine that I develop a regulatory strategy that is about going to market first with an indication for use that is very much a me-too, that can then allow me to establish a baseline if you will, with FDA and regulatory bodies that can get my product to market and at least hopefully, start generating some revenue even if it is in a me-too capacity, while in parallel to that, I'm developing additional features and benefits, and more expanded indications for use, and then I'll do a follow on submission then after that, do you have any thoughts about that strategy or approach?
Mike Drues: It's a terrific strategy, I've used that many, many, many times over the years. What you're describing Jon, to use a baseball metaphor, is the difference between swinging for a single versus swinging for a home run. I would much prefer if I had my choice to swing for a home run, maybe even a grand slam. [chuckle] The problem is, when you swing for a home run, you have a higher likelihood of striking out. So putting all of the claims, all of the bells and whistles in your medical device from generation one, although it's tempting from an engineering perspective to do that, you have a higher likelihood of striking out, that is, of not getting your device successfully on the market through the FDA and everything else.
Jon Speer: Right.
Mike Drues: So in this risk-averse industry that we've revolved into, many companies don't wanna do that, instead, they'll come out with, again, I use this phrase with all due respect, a dumbed down device, both in terms of design as well as in terms of labeling, that is they'll swing for a single. They'll get a man on first, they'll get the device onto the market, and then in the regulatory vernacular, we do what's called a label expansion, we add additional claims, we add additional features to our device, one or two at a time, that would be like the second batter coming up and swinging for a base hit. The person moves from first to second and so on, and so on. Both strategies are very effective, both are equally good, but it really depends on the nature of the company, the amount of funding that they have, the risk tolerance that they have, all of those different things. So do you wanna swing for a single or do you wanna swing for a home run?
Jon Speer: Mike, I love the baseball analogy. I'm a former high school baseball coach, and it's about, obviously, knowing who's on your team as well. If you have a bunch of power hitters and you have... You can go to the plate with a little bit more reckless abandon perhaps, but I've always been... Let's string a few hits together, let's get some guys on base because, you know what, a home run with nobody on base is not as impressive as a home run with everybody on base. So, let's make a combination of those two things together. But Mike, parting words, parting thoughts on the topic of intended use and indications for use and why that matters, share your parting thoughts with our audience today.
Mike Drues: I think, given that the majority of your audience Jon comes from a engineering and related background, I think the single most important thing that people should remember, is apply the same concepts and philosophies that we learn as engineers to product design, apply that same kind of thinking, if you will, to label design, to crafting indication for use statements or for that matter, designing an entire regulatory submission. There are many people that write regulatory submissions, be they 510(k)s or De Novos or PMAs, and so on, there are very, very few of them that designed them. And again, this is a topic of a different discussion, but there's a big difference between writing a submission and designing a submission. So as an engineer, we have a big advantage quite frankly, coming to this field as opposed to some other folks, is that we have or at least we should have an appreciation of that design philosophy, and what I'm suggesting to your audience is to apply that to more than just the physical nature of your product.
Jon Speer: Right. Alright, thanks Mike. My thoughts are this, understand that intended use and your indications for use do have an impact on your design control, product development, risk management, everything you're gonna do about bringing that product to market, it really does start with what you claim your product is going to do and it's going to infect your product classification and all of the things that you're gonna do thereafter. So, be smart about that. If you have questions about that, of course, you can get a hold on Mike Drues, you can find Mike very easily on... Well, just search for his name, last name, D-R-U-E-S. Mike writes for a lot of industry publications, has podcasts and [chuckle] as much as he's been traveling, he might be at a location near you any day now. [chuckle]
Jon Speer: So look Mike up, you can find him on LinkedIn, you can learn more about Vascular Sciences and what he does, but again, he does a lot of consulting for med device companies of all shapes and sizes. He works with FDA, he works with Health Canada. You're gonna wanna talk to Mike about your indications for use and intended use challenges that you might have. This is Jon Speer, and as I mentioned earlier, I am the founder and VP of Quality and Regulatory at greenlight.guru. Greenlight.guru has an awesome software solution to help you manage and maintain your quality management system and any other documents and records. We also have a feature set that's optimized around capturing, managing and maintaining your design control activities, and we've integrated that with an ISO 14971 risk management feature set. You're gonna wanna check that out, go to greenlight.guru and request the demo to learn more. This has been Jon Speer and my guest, Mike Drues, on The Global Medical Device Podcast.
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Jon is the founder and VP of QA/RA at Greenlight Guru (the leading cloud-based platform purpose-built for MedTech companies) and a medical device guru with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru...