#405: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1

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Etienne Nichols: Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today I would like to talk about prescription versus over the counter medical devices and we're going to compare the two.

With us to talk about, this is Dr. Mike Drewes from Vascular Sciences, a familiar voice on the podcast. Glad to have you with us today, Mike. How are you doing?

Mike Drues: I'm well, thank you Eddie.

Etienne Nichols: So we talked a little bit about this topic and there's the more I looked at it, the more I realized there's a lot more here than I than than I originally supposed.

And so what we've decided to do is make this a two part episode. So those of you listening, feel free to tune in to the the following where we're going to get into a little bit more detail about the specifics behind the two.

But just to start out with over the counter versus prescription medical devices, Mike, what is an over the counter or sometimes what we call an OTC device and how do these devices compare to prescription devices?

Mike Drues: Yeah, great question Eddie. And as always, thank you for having the opportunity to talk about this important topic with you and your audience. And I agree with you 100%. There's a heck of a lot more meat on this bone, so to speak, than might originally meet the eye.

So first of all, an over the counter or OTC medical device, sometimes these are referred to also as consumer medical devices. I personally do not like to use that phrase because that gets confusing with wellness devices, which you and I have talked about before, an OTC device is a regulated medical device.

n perspective, OTC devices in: 2023

So that's a heck of a lot of money in this particular area. The biggest markets of OTC devices include things like oral care devices, feminine care devices, first aid devices, adult incontinence, and even sexual health devices.

These are all examples of otc. But one of the fundamental differences between an OTC versus a prescriptive device, Ed Ian, is that an OTC device is sold directly to the patient.

Directly to the patient. Similar to an OTC drug. You know, aspirin, for example, you don't need a prescription. You just walk into a Walgreens or CVS or whatever it is and you buy a bottle of aspirin right off the shelf.

You don't need permission from a doctor or a healthcare provider or anything like that. Whereas a prescriptive device, just like a drug, is a controlled device. In other words, it does require a prescription.

The logic is to limit the use of that prescriptive device for whatever reasons. Perhaps the device has not been on the market for a long time, so it doesn't have a lot of history.

It doesn't have a long term understanding of safety and effectiveness. Maybe there's a higher risk for that kind of a device. And then the other thing that is important to remember any and about OTC devices is that the intended use environment may be different.

The intended use environment may be different. So in other words, although there are exceptions, I would say that most prescriptive devices are intended to be used by a healthcare professional in a clinical setting.

Of course, there are lots of exceptions to that. But as a general rule, whereas OTC devices are intended to be used essentially anywhere in any use environment. It could be in a hospital, in a doctor's office, it could be in your home, it could be in the park down the street.

So the intended use environment is usually broader. And then the other thing that's different is that it's the patient that is using the device. They're in control and the healthcare provider is essentially taken completely out of the loop.

So, for example, some of the requirements that are in this new guidance, that's one of the motivations for why we're talking about this product. This topic today is first of all, the labeling.

We assume that the patient can use the device all by themselves without a healthcare provider. That means that the patient, we assume, reads the label and understands the label. We'll talk about this a little bit more when we get to usability testing.

Back to the intended use environment. As I said, the device could be Used outside the home, for example, in somebody's office, school, hospital, ambulatory, surgical center, nursing home, outpatient facility, ambulance, outdoors,

even in outer space. Actually, there was a story in the news just a couple of weeks, a couple of days ago, and this is off topic, about 3D printing of medical devices in outer space is being done by a company now on the space station.

And finally, and this will be the last thing, and then I'm sure you've got things to add here. If we do a label expansion, in other words, if we have a device on the market now as a prescriptive device, and then we essentially want to take the hcp, the healthcare professional,

out of the loop and make it over the counter, that's a label expansion that usually will require additional testing, usually in these additional intended use environments. But here's my tip on that, Eddie.

Because there are so many potential intended use environments, especially for an OTC device, you can't possibly test it in every environment.

So what I would suggest, and I say this to my customers all the time,

don't focus on the actual environment. In other words, I don't care if it's a hospital, a doctor's office, if it's somebody's house, if it's an ambulance, or even if it's an outer space,

focus on the parameters of that environment that might influence how your device is used. For example, the temperature. Does the device have to be used within a certain temperature range or humidity or lighting?

Again,

it's a little hard to be specific when the medical device universe is so broad, but if we define sort of a technological envelope, if you will, such that as long as you're within a certain temperature range or humidity range or certain ambient lighting conditions or whatever it is, it doesn't matter physically where you are,

you can still use the device properly.

That's just a real quick overview of sort of OTC devices. I'm looking forward to digging into this in more detail, but I'm sure you have questions or comments or examples you'd like to share at this point.

Etienne Nichols: Yeah, well, one of the things that I think about when I am comparing the two in my head, particularly when you said if you want a label expansion, you want to go from prescription to over the counter, I agree completely.

Why would you look at every physical space, the thing in my mind, and maybe you can expand on this or limit me, I would want to know what it is that the healthcare professional is actually providing in this case.

Is it training? What is it that they're actually doing that is benefiting the patient, because I can think of a few different medical devices that the patient themselves use after the initial consultation with the doctor, but the doctor simply prescribes it, and then they go on their merry way.

I don't know if you have any thoughts on that.

Mike Drues: Yeah, actually I do. Any. It's interesting you use that particular example, because I have several IVD devices that have been used in Covid or for other things where essentially you spit in a tube.

That's literally what you do. You spit in the tube and then you send it off to a lab. Well, these devices started out as prescriptive devices in some cases. And when we went back to the fda, we said, we want to make this otc.

And one of the arguments that we made is, with all due respect, why does somebody with an MD after their name have to be involved in something as benign as fitting saliva into a tube?

So, you know so.

Etienne Nichols: Well, sir.

Well, I want to ask a less benign example and maybe see what your regulatory brain goes with this because. Okay, so I think of like the cpap, because we've covered that quite a bit with the Philips and so on pretty extensively.

What about that instance? What are your thoughts there?

Mike Drues: The CPAP is a great example. Let me give you even a slightly better one. And that is a cgm, a continuous glucose monitor.

Etienne Nichols: Sure.

Mike Drues: As you may know, Eddie, and FDA has now approved the first OTC CGM machines. I think this just this within the last six months or so.

So those are both examples of the classic label expansion where you start out with a device that's prescriptive, and then you change the label to make it otc. Just like in the drug world, this happens all the time.

You start out as a prescriptive drug, and then with additional history and a better understanding of safety and benefits and risk and so on, we can sometimes lower the dose and offer the same thing, otc.

So the regulatory logic is exactly the same. I hope there was an answer to your question in there somewhere.

Etienne Nichols: Yeah, I think. Well, the problem was there may not have been a question in my questions.

So if there wasn't, the fault is mine. But let's go ahead a little bit further down the line. So you mentioned a few examples, and we came up with a couple.

Are there any other that come to mind for you?

Mike Drues: Several. So, first of all, some, although Certainly not all, OTC devices are Class 1 exempt. Class 1 exempt. And remember, Eddie, and for the benefit of our audience, exempt in context means that the device itself is exempt from a formal review by the FDA in the form of a 510k or de novo or PMA or HDE or whatever it is.

It's still a regulated medical device. It still has to have design controls, you still have to be FDA registered, you still have to have quality management system and all that kind of stuff.

It's not a wellness device. So Class 1 exempt devices that are OTC would include things like band aids, would include things like mechanical wheelchairs and crutches and you know, all the things that you can basically walk into a CVS and buy without any kind of a prescription.

Moving up the medical device pyramid to the Class 2 non exempt level. And remember, non exempt in this context means,

pardon me, the FDA is required to review the device in the form of a 510 or de novo or TMA or something like that. But examples of those things would be things like menstrual tampons, condoms.

Believe it or not, in many cases a condom is a Class 2 non exempt device. Powered wheelchairs. And by the way, you may have noticed that mechanical wheelchairs are class one exempt, whereas class power wheelchairs are class two non exempt.

And some of our audience might be wondering why. Well, I actually give that answer, that explanation in the classification webinar that I did for Greenlight. So I would encourage our audience to listen to that if you haven't already.

And finally, last and not least, Eddie, and believe it or not, there are a few, admittedly very, very small number, but a few Class 3 high risk PMA devices that are even OTC.

Of course that's very much the exception rather than the rule. But as I've said before,

average regulatory professionals know the rules. The best ones know the exceptions. Just one last point and then I would welcome you to chime in further, Edin. And that is not all home use devices are intended to be used over the counter.

In other words, there are a number of devices that do require a prescription, but still their intended use environment is the home. And I see a lot of people making the assumption, well, if it's home use, it must be safe, it must be low risk, it must be over the counter.

Not necessarily so. Examples of devices in that category would include things like over the counter hearing aids. Now hearing aids are another one of these fuzzy areas, edien, where certain hearing aids are OTC and certain hearing aids require a prescription.

Just this past year, I believe FDA issue a de novo for the first hearing aid because it had some differences compared to other things. And as I mentioned a moment ago, we have Now I believe two continuous glucose monitors, CGMs, that are now over the counter as well.

Etienne Nichols: Yeah. Okay, that's interesting. And it does feel like the rise of digital health has sort of blurred the lines. What was once prescription is becoming mainstream and, and like you said, has a background of safety and efficacy and effectiveness.

It makes sense that you could make that label expansion.

Well, what types of devices would you say are candidates for that over the counter status, which, you know, including that switch from prescription to over the counter.

Mike Drues: So there's a couple of scenarios that we have to talk about separately. Scenario number one, which is, I think is the more common scenario, is a device that comes on the market originally as a prescription, and then for whatever reasons later, the manufacturer goes back to the FDA, as we talked about before,

and does a label expansion to add otc. But then there's another scenario where the device was never prescriptive to begin with and it went onto the market for the first time as otc.

Like for example, a band aid. Right. So unless you're doing some really funky, really crazy stuff with a band aid, which is possible, most band AIDS are Class 1 examination OTC.

End of discussion. All right, but the other thing that I want to emphasize, Edian, is, and this is perhaps, you know,

maybe I shouldn't say this, but one of the things that frustrates me sometimes about some folks in the medical device world is they focus nearly entirely on medical devices and they don't look at the broader universe.

And then this topic of prescriptive versus over the counter, I think there's a heck of a lot that we can learn and apply from the drug world. There are a lot of parallels, not 100%, but certainly more similarities, maybe substantially equivalent between prescriptive versus over the counter devices and prescriptive versus over the counter drugs.

But obviously this is a device audience, so let's focus on devices. So there are some general characteristics that OTC devices share in common. First is, as we talked about before, they can be used, or they're intended to be used outside of a healthcare setting, that is outside of a hospital or clinic or doctor's office or something like that.

They can be adequately labeled so that the patient, not the healthcare provider, but the lay user, can self diagnose their condition. In other words, okay, so you're considering buying a cgm, for example.

What is your reason for buying a cgf, right? Or, you know, that type of thing? Because if you have a prescriptive device or drug,

presumably the doctor has made some sort of diagnosis or treatment and he or she says you need to use this device or drug. But again, for OTC devices, the doctor, the HCP is completely out of the loop.

The lay user also has to be able to self select the particular device that's best for them. So if you go into,

again, I don't want to give a commercial endorsement here, but a CVS or a Walgreens or something like that, looking to buy an OTC blood pressure monitor, you might have a half a dozen different models from different manufacturers and if you go online, God only knows, you know, you're probably going to find dozens and dozens.

Etienne Nichols: Right?

Mike Drues: Well, if you go to the doctor, the doctor says you need to take this drug or you should use this drug device. But for an OTC device there is no input from the healthcare provider.

And finally, once they do start using the device, is the lay user who remember, has not gone to medical school, presumably, are they capable of self treating and self managing their disease or their condition or their injury with that OTC device?

Because once again, we have completely removed the HCP from the loop.

So the patient, again,

not the hcp, but the lay user, but the patient needs to be able to understand how to use the device correctly based on the labeling, including the instructions, without any input from the healthcare provider.

And please. And I see this even with prescriptive devices, but nobody should make the assumption that, that first of all, the person has even read the instructions for use and B, even if they have read them, they understand them and they're following them.

I mean, I think that's just naive.

Etienne Nichols: Yeah. And finally the,

and I'll just say one thing and it's actually, I used to be very frustrated by that because we went through the same human factor studies and so on, but I've actually sort of grown to think, well, this is a problem that has stemmed from something really good and that is most of our devices are very intuitive and so there's just an expectation or standard.

Now you can take the pessimistic view, which is fine, but there's, there's two sides to this. But go on. I didn't mean to interrupt.

Mike Drues: No, no, no, please. On the contrary, I love your, your interruptions and I would not use the word pessimistic in that context. What I would say is realistic.

Etienne Nichols: Realistic. Yeah.

Mike Drues: The simple reality is even surgeons, you know, I've seen it happen many times where they, or maybe not the surgeon, but the assistant, they'll take the printed IFU out of the box and they throw it right into the trash.

Etienne Nichols: Oh yeah.

Mike Drues: So that's a topic of a different discussion.

Two other characteristics that most OTC devices share in common is they usually have a low potential for reasonably foreseeable misuse. And I took that quote directly out of the guidance.

A low potential for reasonably foreseeable misuse. I know this is something that we've talked about many times before, Edian, but with all due respect, I have no idea what the hell that means.

And I'm being a bit facetious, but I'm also being very, very serious because that can be interpreted in a zillion different ways. And it's up to the company because remember, guidance is written for a very, very broad audience.

If you have an OTC band aid, for example, what is reasonably foreseeable misuse is going to be probably quite different than an OTC CGM or as you mentioned, an OTC CPAP machine.

So we have to take that guidance and we have to apply it or interpret it based on our particular device, what it does, how it works, and so on and so on.

And then the very last characteristic, and then, please, by all means, Eddie, and chime in with questions or comments.

Is the safety margin, the safety factor, what an engineer would call the benefits of having the device available via over the counter status versus the potential risk or harm of not having them available, of requiring a prescriptive device.

There are some cases where it's not very likely that a patient is going to go to the doctor with this particular condition and ask for this particular device or something like that.

So what's, you know, is it better to have the device available OTC so that the patient doesn't necessarily feel obligated, that they have to go to their doctor first? Or is the risk sufficiently high that we say, no, no, no, no, no, you really have to do this under doctor supervision?

Again, I can't give you an answer that applies to the entire medical device universe across the board. But just like anything in the guidance, we have to take that phrase of reasonable, what was it?

Reasonably.

Yeah, low potential for reasonably foreseeable misuse, whatever the heck that means, and apply it to our particular device, our particular technology.

Etienne Nichols: Yeah, yeah, because that is an interesting statement because across companies different people will see different potential. So anyway, this is subjectivity there.

Mike Drues: Absolutely. And I'm sure many of the senior management. I'm just being realistic. Oh yeah, OTC is easier. So, you know, we have an artificial heart. Let's put that on the market over the counter.

Obviously that's an extreme example, but anyway.

Etienne Nichols: Well, and so one of the things that I think about when you're talking about the additional aspects of to make sure that there's a lower margin of error or what am I trying to say?

To make sure that the patient can easily use it without the healthcare professional being in the loop. One of the things that I think about is does that mean we have to go to the lowest common denominator?

Not to judge people across a different spectrum of intellect and so on, but different people have different passions and interests, whether they're a healthcare or they have that kind of background.

And I'll use your example with the blood glucose, the continuous blood glucose monitor. I don't know if you're familiar with the company levels. I'm not that familiar with them, but I just briefly ran across them at one point where they were doing subscription to do continuous blood glucose monitoring.

I thought, well, how can you do that? Well, you, they were giving the Dexcom and the way you bought it, it was through. You basically got into a large clinical study.

I thought it was an interesting run around and maybe have more details on that. I thought that was interesting. But that was to a, a group or an audience that was very passionate about their fitness and making sure their glucose levels and trying to get into these different states.

So I curious what your thoughts are there and do you have to lower your level of safety to lowest common denominator or is there any kind of middle ground?

Mike Drues: Yeah, great question, Eddie. And first of all, I am familiar with that product that you just mentioned a moment ago. However, for our audience, let me offer sort of a broader perspective and I love the way you use that phrase, the lowest common denominator, because that's exactly what we have to do.

And in this politically correct everybody shows up, gets a trophy kind of an environment, it's not always so easy to do that anymore. What I mean is, and we'll talk about this more in part two when we get into a little more discussion on usability, especially usability testing for OTC devices.

It is quite different if you have a device prescriptive or over the counter, doesn't matter where the intended user is. The healthcare professional, doctor, nurse,

Pennsylvania, whoever it is.

When it comes to usability testing, the only usability testing you will likely be expected to do is with those healthcare professionals. Doctor, nurse, you know, what have you. When you have a device that's now labeled for OTC where the intended user includes the patient.

Now you. I can't. There are some exceptions, but I think it's, you know, and more often than not usability using the actual patient or caregiver is going to be, is going to be expected.

Now, one other thing that I'll mention, Edien, and that is Statistics 101 says that your sample has to be representative of the patient. Unless you're labeling your device to only be used by people who have a PhD after their name or something like that, your device has to be tested in a range of users that will represent the educational spread of the people here in the United States.

I'm trying as best as I can to be politically correct, and I'm not trying to imply that anybody is smarter than anybody else, but the simple reality is not everybody is equally the same.

Etienne Nichols: Well, and I heard a phrase that I really liked and that was common sense isn't common anymore. Not because of problem, but because nobody has a common background. And I think that's a really good way to look at it.

And maybe what you look for is a comprehensive cross section of the population.

Mike Drues: But. Yeah, yeah,

yeah, I like that. And one other thing, and again, we'll get into this more in part two, because I think it's something that a lot of companies don't appreciate or certainly don't appreciate in advance, is one of the things that pretty much FDA wants to see in most, if not all,

usability studies when it comes to the demographics of the patient, is their educational level. Did they graduate high school, did they graduate college, did they go to graduate school?

And so on and so on. So the short answer to your question,

and this is true not just for this particular topic, but this is true for benchtop testing, for clinical trials, for everything. Your sample has to be reflective of the population.

So if your population is a diverse population,

then your sample has to be diverse. On the other hand, if you want to label your product to be used only in males between 35 and 36 who have blonde hair and blue eyes, you could certainly do that.

I think it would be difficult to get your marketing image to do that, but it would certainly make your testing much easier.

Etienne Nichols: Oh, yeah.

To go the other direction, to go upstream of this, back maybe back in time to where it's a prescription device. You mentioned the intended user. And tell me if we're getting out of scope here.

I totally. You reel me back in.

That prescription device, if its intended user is truly a patient, but it's prescribed by the doctor, how much is required as far as usability testing in that regard?

Mike Drues: Good question. And in the past, and I would say, you know, more than just a few years ago, it was very, very common for submissions of all types to go through without specifying or specifying clearly things like the intended user, the intended use environment, and so on, you would obviously have to specify the high level labeling,

the intended use and the indications for use. And sometimes intended user and intended use environment would be embedded in one of those, but oftentimes it wasn't. Now, more and more FDA is looking for the intended user and the intended use environment, among other things, to be included in the labeling.

We could have a debate, and I've debated actually with some of my FDA friends whether we would consider the intended user environment and the intended user to be part of the high level labeling, like the indications for use in the intended use.

But bottom line, whether you put it in the high level labeling or you put it in the lower level labeling, like the instructions for use, more and more it's going to, it's expected to be in there.

I personally think that's a good thing. So that there's not any question as to who should use the device and who should not, or where the device should use and where it should not be used.

But it's also a very good thing for the manufacturer to know because it will tell them in black and white terms what you have to test for and what you don't have to test for.

Etienne Nichols: Yeah, yeah. And it seems like if that's the case, if that's how you are set up, maybe that greases the skids a little bit later if you do decide to go down the road of over the counter.

I don't know.

Mike Drues: Absolutely. Yeah, absolutely. And by the way, and we'll talk about this a little more in the, in the Part 2 section, but if you have a device the conventional way, where you put it on the market first as a, as a prescriptive device, and then in the future you might want to consider flipping it or adding otc.

You might want to include that as a PCCP in your original submission to the fda. A predetermined change control plan to tell FDA what you plan on doing in order to change the status or add to the status of, you know, of otc.

It's a very new idea, Erin. To be honest, I don't know of anybody that has actually done that yet because, as you know, the PCCP is also still relatively new.

However, I have two devices where our tentative strategy right now is to do exactly that. So one of the things that I pride myself on is not to be one of the followers that are, you know, the 50th person or the hundredth company to do something, but one of the first and in some cases even the very first.

Etienne Nichols: Yeah, very cool. Well, that's exciting. Look forward to hearing more about that. And I do appreciate how you push us all to be leaders rather than just simply followers. So what other questions do you think are worth asking in this before we I mean, we're about to get into the nitty gritty and I know that's something people will be interested.

Stay tuned for the next episode if you're interested in that. But any other things that you think we should cover in this first, first round?

Mike Drues: Well, if you want to wrap it now and cover the rest in part two, I'm certainly happy to do that.

Just to kind of wrap up part one and maybe to give you give our audience sort of a prequel as to what we're going to discuss in Part two. So let me do the prequel first.

Some of the things that I hope we can discuss is getting into the mechanics, getting into the minutia, if you will, in greater detail about how exactly we switch from prescriptive to over the counter.

For example, would a new 510k be required? Or in some cases would a de novo be required? Is it possible to use real world evidence as part of this label expansion?

Or for that matter, as part of the original OTC clearance or approval to begin with? What's the process if you're bringing a novel OTC device onto the market? Not a me too.

What if you, for example, are doing a de novo as a otc? Under what circumstances would you switch from prescription to OTC and need a a 510k or a de novo or possibly even a PMA?

Most importantly to my engineer friends, what considerations do we need to take into account during the design of the device? Because obviously you can appreciate that if the device is designed only for a physician to use, the design might be a little different or in some cases significantly different than the if it's going to be used by a lay user or a patient,

and then some additional kind of miscellane topics like for example, the usability testing, how that's different, the labeling requirements, cleaning disinfection,

universal device identifiers, udi. So there's a number of other subtopics that I want to discuss in this broad topic of prescriptive vs OTC. But for right now, Eddie and I think the most important thing for our audience to remember is whether you when you have an OTC device, whether it's an OTC device that used to Be prescriptive or it's just a flat out OTC device and it never was prescriptive.

At the end of the day, what that means is you're taking the physician or the healthcare provider completely out of the loop in every sense of the word. Even something as benign as going into the store and looking at the overwhelming number of choices that you have to buy,

you know, picking out which one to buy, there is no guidance from the healthcare professional on any of that stuff.

Etienne Nichols: I want to ask you a question about that then, because right now the picture I feel like we've sort of painted is in a prescription device has the oversight of the healthcare provider.

And in my mind I just inherently think, okay, that must mean it's a little bit safer. And then we want to put it in the hands of a user. The manufacturer needs to really make it safe.

And so if you go the other direction, why could you not start out with the over the counter? And I'm just gonna, I'm just gonna tell you why I feel this way.

The, the CPAP situation with the Philips, I still wonder, would it have been safer had it not been under the purview of a healthcare provider? And the reason it was with the healthcare provider was simply so the healthcare provider could prescribe it.

Obviously they need to be able to do that. For when you have this issue, you don't typically just prescribe a, go get a, a band or a wellness device. So you need a prescription device for the healthcare providers to prescribe something.

But could it have been safer? And just one example, and I don't mean to just keep bringing that one up, but that's the example at the top of my head.

I don't know. What are your thoughts?

Mike Drues: Yeah, great question. And first of all, a couple of things. I would be a little bit careful about making the assumption that a prescriptive device is somehow safer than an OTC device.

There may be cases where that's true, there may be cases where that's not true. And as a subject matter expert for fda, and several different areas, one of them being risk and safety is just sort of the flip side of risk.

I would be very cautious about making that assumption. With regard to the particular example that you're pointing at the cpap, let's, you know, be, let's be a little bit open here since the case has now been settled, you know, the case against Phillips, which largely involved CPAPs, among other things like ventilators and so on,

which by the way, it was the single biggest class action lawsuit in the history of the medical device industry.

I can now announce I may have mentioned this before I was an expert witness in that particular case. Of course, there were many expert witnesses.

But if you're. Depending on what problem with the CPAP you're talking about, if you're talking about the foam degradation breakdown program problem that essentially led to particulates getting into the patient and in some cases causing problems, possibly even cancer, I can't see how.

Whether it was prescriptive or over the counter, you know, that would have been prevented because it's not, you know, at the end of the day, as long as the patient plugs themselves into the machine, whether it's prescriptive or over the counter, what the hell difference does it make?

Now, if you're talking about maybe some other aspect in terms of usability or something like that.

Etienne Nichols: Possibly so, but I guess my counter argument is, well, how does the FDA look at that? Like, okay, it's prescriptive. The doctors are overseeing all of this. Is there sort of.

Well, you know, a little bit of hand waving happens with that device? But I agree the actual safety of the device makes no difference. It was the design itself.

Mike Drues: But yeah, let's put it this way, and I'm being extremely kind here, but there were some truly boneheaded mistakes that were done by this particular company and.

Boneheaded, quite frankly, as putting it politely. But to be fair, it's not just that particular company. I see other companies making similar boneheaded mistakes.

Etienne Nichols: And I know I'm dragging us off the different directions, but I guess I appreciate you indulging me there, just thinking about those, but. But all of the different.

It's interesting to me that you primarily start out with an RX device, and maybe that's the question I should have led with. Can you go straight to over the counter?

Mike Drues: You can go in any order that you want. The most common way. And again, this is certainly not the only first prescriptive, then otc, I would say the second most common way would be just directly OTC without any prescription.

And then the third option, which is, I think what you just mentioned, put the device on the market OTC first, and then maybe change your claims a little bit and put a prescriptive label on there.

That last option, Edienne, is very similar to what I do with a lot of wellness devices. And again, a wellness device is something that doesn't require anything from the fda.

So we'll put a device on the market under the wellness exemption first, because quite frankly, it's easy. And as long as you're careful with your claims and so on, you won't have any problems.

And then once the company gets a little more money and you get a little more data and so on, you go back to the FDA with your wellness device and say, now maybe we want to strengthen the claims and now it becomes, say, a Class 2 non exempt device that would require a 510 or possibly even a de novo.

So the regulatory logic that I'm using in all of these scenarios is exactly the same. And this is exactly why throughout our many conversations and I keep coming back to if you understand the regulatory logic, it is largely product agnostic.

Etienne Nichols: Yeah,

I get some of the things that I'm interested in. Maybe we can get this into the future. In the. In the next topic are the benefits from a financial perspective, because I could see the reimbursement maybe being a better advantage, but maybe not always from a prescriptive.

I don't know if you have the thoughts on that, but maybe we can cover that in the next round.

Mike Drues: Yeah, we can touch on reimbursement next time. Sure, absolutely.

Etienne Nichols: All right, well. Well, I've dragged us on long enough. I really appreciate your patience with me today, Mike, and look forward to the next episode. Those of you who've been listening, you've been listening to the Global Medical Device Podcast.

I hope you'll tune in for the next episode where we talk a little bit about more of the minutiae, the details of actually accomplishing this. Thanks so much.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform form.

If you've got thoughts or questions, we'd love to hear from you, email us at Podcast at Greenlight Guru. Stay connected for more insights into the future of medtech innovation. And if you're ready to take your product development to the next level, Visit us at www.greenlight guru.

Until next time, keep innovating and improving the quality of life.