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Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the president of Vascular Sciences, and he’s a guru on all things regarding compliance and medical device development. General wellness device development is relevant right now because they’re so popular and widely used in today’s health-conscious population. It’s important to understand what a general wellness device is, when it becomes a regulated medical device, and how the two are different when it comes to FDA regulation.

 

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Some of the highlights of the show include:

  • The FDA’s definition of a general wellness device, as well as Mike’s simpler definition.
  • What makes a wellness product low-risk, and what “low-risk” really means when it comes to both causing harm and the potential for providing incorrect information.
  • How to know if you’ve crossed a line with your wellness device and actually need to classify your product as a regulated medical device. Mike also gives examples to paint the difference more clearly.
  • How marketing a wellness device as a 510k can be beneficial for label expansion purposes, as well as how marketing it first as a wellness device can improve the 510k process -- with a caveat as to how to handle the submission.
  • The importance of prudent engineering with wellness devices; the lack of regulation is not an excuse to cut corners or take shortcuts. 

Links: 

Mike Drues on LinkedIn

Vascular Sciences

greenlight.guru

Guidance: General Wellness: Policy for Low-Risk Devices

Webinar: Final Guidance on "General Wellness: Policy for Low-Risk Devices"

The Many Connotations Of Risk In Medtech Development

Using the Bucket Method for Medical Device Risk Management

Quotes:

You can’t make a claim that you’re preventing or treating a disease... but you can do so in a more subtle way.

My definition of a wellness product is a product with weak medical claims.

To separate usability from risk makes absolutely no sense.


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: Welcome to another episode of the Global Medical Device Podcast. On this episode I have Mike Drues, and Mike and I discuss general wellness products and what that means with respect to being a regulated medical device. 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 the VP of Quality and Regulatory at Greenlight.guru, Jon Speer, and welcome. With me is Mike Drues with Vascular Sciences. He's a guest at... Been at the Global Medical Device Podcast many times and every single time this date comes up, I circle it, I put a star on it, I put a smiley face, because these are exciting conversations that I get to have with Mike. So Mike, welcome to the Global Medical Device Podcast.

Mike Drues: Well, thank you Jon for that very, very kind introduction, it's always a pleasure to be with you and your audience.

Jon Speer: Alright, Mike. So, I know that you're a man of many talents, and experiences and today we're gonna talk about something that is... Well, I think it's pretty relevant. I mean, I could tell you right now, not to name... Well, I'll leave the name of the device out, but I'm wearing this thing on my wrist right now [laughter] that keeps track of my heart rate and the number of steps that I take all day and all these sorts of things. And what I'd like to dive into with you today is... Well, the topic is General Wellness Devices, what does that mean? And I think sometimes we're looking at a number of different types of products and technologies that could fit in that particular category. So, what... Help us, what it is a General Wellness Device?

Mike Drues: Well, that's a great question Jon. Would you like FDA's definition or my definition?

Jon Speer: Well, maybe it'll be helpful to have both.

Mike Drues: I think you're probably right. So let me give you FDA's definition first, and this is gonna use many more words than my definition. And by the way, for the benefit of your audience, this comes right out of the guidance that FDA put out last summer on General Wellness Policy for low risk devices. So basically FDA considers a wellness product to be a product that's designed to maintain or encourage a general state of health or healthy activity. In other words, and we'll get into this as we discuss in more detail, it really comes down to the labeling and the claims. So you can't make a claim that you're specifically preventing or treating a disease or injury or condition, but you can do so in a much more subtle way. So again, FDA definition is maintaining or encouraging a general state of health or healthy activity.

Jon Speer: That's pretty far reaching Mike.

Mike Drues: My definition... I'm sorry.

Jon Speer: I said, that's a pretty far reaching, or pretty broad, or pretty ambiguous definition don't you think?

Mike Drues: Well, it is a broad or ambiguous, but that's the nature of regulation, Jon.

Jon Speer: Sure.

Mike Drues: And a lot of people look at regulation when it's broad or nebulous, or vague to be a disadvantage, as you and I have talked about it many times. I see that as a huge advantage. In fact, I can manipulate it in whatever way that I think is appropriate. So anyway, my simpler definition, this is the Mike Drues definition, is simply a medical device, with what I call weak medical claims, weak medical claims.

Jon Speer: Okay.

Mike Drues: Really, as we'll talk about this comes down to not the technology, not what your device does or how it works, but what you say about it. And that product that you mentioned that you're wearing on your wrist right now, I can pretty much guess what it is [laughter].

Jon Speer: Yeah.

Mike Drues: So, you can't make direct medical claims, but you can infer or imply them. And I think, to be honest with you, whether FDA realized it or not, as we go through a couple of examples here, they've really opened up a Pandora's box. With some very, very clever wordsmithing and some advertising, we can do some very sophisticated things. But again, I don't wanna get ahead of myself. Let's continue on.

Jon Speer: Well, I think that's important, though, to understand. I know you get approach, I get approached quite often too by companies and inventors and entrepreneurs who have a new device, and they're kind of in this gray zone, it's a wearable technology, it's gonna monitor things like blood pressure or heart rate, or all these different things, but I'm gonna wear it on my wrist or as a necklace or what have you. And it's that ambiguity, and maybe it's important as you suggest, but I think it's getting people to think about, those who are developing this technology. You said some keywords a moment ago, "What is it that you claim your product does? That's a really important thing.

Mike Drues: That's exactly true, Jon. And by the way, one other thing I should also interject as we talk about what a wellness product is, another criteria. It's not part of the definition is that it must be low risk. Now, keep in mind, as we've talked about before, there are many different connotations of risk and for those in the audience that are interested, I would point them to the webinar that I did for Greenlight.guru just recently, specifically delving into risk. So, another criteria that we have to look at about when we consider whether our particular devices can be considered a wellness product or not, is risk.

Jon Speer: Yeah, I think risk is a... Well, obviously, it's an important context and a number of facets of our world, low-risk, remind those who have heard this or maybe those who have not, not necessarily wanna dive into the many connotations of risk information, all the details. But when you say low-risk can you give a little bit more context about what that means?

Mike Drues: So as briefly as I can, it needs to present as minimal risk to the user as possible, and in the context of wellness products, I'm really even reluctant to use the word patient, because patient implies somebody that is sick or injured or something. And by definition, these kinds of products are not intended for disease or injuries or that type of thing.

Jon Speer: Yeah.

Mike Drues: Risk here means for example of the product that you have on your wrist right now, that that particular product has a minimal risk of causing direct harm to you, causing, I can't imagine what it might do, but if the thing were to electrocute you or...

Jon Speer: Hey, whoa, wait, wait. [chuckle]

Mike Drues: But also remember another connotation of risk is the probability of providing the wrong information. So if that particular device that you're wearing is telling you, your heart rate, for example, and the number that it gives you is wrong, what are the consequences of that? If that particular device is being used simply to indicate your heart rate for the purposes of telling you "Hey you're exercising within your target zone," then that's one thing. On the other hand, if a cardiologist is looking at that information and says, "Oh, your heart rate is above 200 beats per minute, therefore you have a tachycardia or your heart rate is below 60 beats per minute, therefore you have a bradycardia." Now that's quite another. So that's the simple example of, as I said a moment ago, it's not the device, it's not the technology, it's not what it does, or how it works, it's what we say about it and what we do with that information.

Jon Speer: Okay, that helps quite a bit. So thank you for going into a little bit more depth. And I think this is maybe a good opportunity for us to talk about a general wellness claim versus a medical device claim. And let's continue with this example that I happen to be wearing on my wrist. I keep track of, I have a goal of how many steps that I wanna take, I just look at the heart rate. I'm curious what my heart rate is throughout the day and those sorts of things, but it's for my own a benefit. There's nobody that's prescribed it or so on, and so that clearly fits in that general wellness claim. Now, let's imagine that this device that I'm wearing now all of a sudden is transmitting this... Some vital sign data to my physician. Did I cross the line and become a medical device?

Mike Drues: Well, that's a good question, Jon. And that's actually not unique to wellness products. There are, as you know, a lot of telemetric kinds of devices that we have today, that transmit information to a physician. It could be something as simple as a Holter monitor for example that transmits your EKG. It could be imaging systems that transfer images to a core lab where a radiologist might read it. So the short answer is yes, that can, in some cases, constitute a regulated medical device. That's correct.

Jon Speer: Now, I guess it... I'm sure you have some examples that you can kinda walk us through, because there is some grey here. And that may be helpful in some respects, but for those who are developing new technologies, if they continue to play in the gray zone so to speak, and they don't appreciate that what they're claiming is actually crossed the realm into a regulated medical device, that could be bad news, or could be problematic for that company. So can you maybe give a little bit more context, maybe an example or two, or a couple of scenarios that might help paint that picture a little bit more clearly?

Mike Drues: Absolutely Jon. So a few things. So as I said, my definition of a wellness product, is one with a device with weak medical claims. I gave you a perfect example. And this is actually just sort of almost what's right out of that guidance that I mentioned a few minutes ago. So you can't, in a wellness product, make a claim to treat hypertension or high blood pressure, for example. However what you can do, and this is exactly why I said a moment ago, that I think FDA may have inadvertently opened up a Pandora's box here, is you can say that the product is intended to promote, track or encourage healthy choices as part of a healthy lifestyle for example, in order to reduce the risk of certain chronic diseases and conditions, like cardiovascular disease, like hypertension and so on and so on. So as I said earlier, with some clever words, methinks, you can make some very strong claims without having to go to FDA at all. Because another thing that we should point out, for your audience Jon, is that this is the lowest in the medical device spectrum. In other words, this is not even what we might consider a Class One Exempt device, this is what I would call a Class Zero device which basically means we don't need to go to FDA, for anything about this.

Jon Speer: You don't need to register your company. You don't need to list your product, you don't need to do any of those things if you're in this space. That's what I just heard you say.

Mike Drues: That's correct, yes, that's correct. Technically you do not even have to let FDA know that you're marketing this. Because you see products like this being advertised on the TV all the time. So, this is very very similar to on the drug side of the world, what we call Nutraceuticals, things like Ginkgo Biloba and Echinacea and St. John's wort. So we probably don't have time to get into those comparisons, but there's a lot of similarities between nutraceuticals and other areas like vitamins and supplements and so on, compared to wellness products. But as a result, I've got a couple of companies that I'm working with right now, Jon, we have two different versions of exactly the same medical device. In other words the device itself, the design, the materials, the way it works, and so on, everything is exactly the same. The only difference is the labeling and more specifically the label claims, in one particular case, in one version of the labeling we have it on the market as a wellness product, which as I said, requires no involvement from the FDA and a second version of exactly the same device. Again, there's no physical difference whatsoever, just a different label, is a 510(k), it has everything to do with what we say the device does, what I call the high level labeling.

Jon Speer: Sure. Yeah, that's interesting and I have a... I won't go into the specifics, but contacted a company a couple of days ago, that they have a device that's on the market right now, and the device that's on the market I would say fits in this general wellness category, but it's not a med device, it's a consumer, I use quotes around that, "consumer device" that they're selling, right now, they didn't have to register anything with the FDA, but something about what they wanna do is gonna change the claims. And good on them, they realized that that's and now puts them in the realm of, or will put them in the realm of being a regulated medical device. So they're trying to do the right thing, making sure that they've put the quality... Get a quality system established, and document their design controls on risk and all those sorts of things. So that's a really key thing. So, this guidance that you've mentioned and folks will provide a link to that in the text of, a company is this podcast. But this guidance that you mentioned, does it have decision trees or does it give... I know I have some examples and things like that, but what is your opinion? Does this give a pretty good clear path that someone who might be questioning whether or not they're a medical device versus general wellness, does this give them some clarity on how to determine that for certain?

Mike Drues: Well, that's a good question, Jon. Whether it gives them a clear path or provides clarity. I guess, clarity is in the eyes of the beholder. But to me, this guidance, like any guidance or any regulation, what's more important than reading what is said, is reading what is not said. And so there's a lot of gray area in here, in this guidance that, let's put it this way, as a regulatory professional myself, I can really take advantage of.

Jon Speer: Sure.

Mike Drues: And I just wanna take that example that I shared with you a moment ago a step further because this is got some, I think, some real potential advantages to many in your audience. And maybe even in the product that you are involved with right now, here's a little free consulting even for you, Jon.

Mike Drues: I love the idea of using the wellness product, as a label expansion...

Jon Speer: Oh, wow it's good, yeah.

Mike Drues: In other words, using, as you just described, this other company has a wellness product, you called it a consumer product. I personally, I don't like to use phrases like consumer product or medical device, it just gets even more confusing. What I tend to think about is whether it's a regulated medical device or not. If a regulated medical device would obviously require some involvement from the FDA, as opposed to an unregulated medical device would not. Because let's be honest, this is just a matter of semantics. All of these things are medical devices, even that little gizmo that you're wearing on your wrist. It's a medical device, there's no question about it, but it's an unregulated medical device or at least it can be.

Mike Drues: So anyway, back to the label expansion. So if we have a product already on the market, and I was involved this past year with a company that had a sort of an in vitro diagnostic that was already on the market, and then we wanted to do nothing more then beef up the label claims to make stronger, more bolder claims, which by the way is also an advantage from a reimbursement perspective. Then you can go to the FDA and say, "Hey here's our device, we're gonna do it as a 510(k), or a De Novo, or what have you. And oh by the way, we've already had it on the market for the last three years or five years or whatever it is, and here's the history of it. Here's the data that we have on it," not just on the regulatory side, when it comes to things like safety, and efficacy, but also in your world, Jon, on the quality side in terms of complaints in manufacturing defects, and so on and so on. So you can use that to your advantage, but, and this is probably beyond the scope of our conversation today, as you can imagine, Jon, you do have to be a little careful how you present that information. You don't wanna say, "Oh by the way, our device has been on the market for the last five years, we're just kind of getting around now, to telling you about it."

Jon Speer: Yeah, that's probably not a very good tactic to employ for sure.

Mike Drues: Probably not.

Mike Drues: And one other thing that I will mention about the guidance since you ask, you know we talked about risk a moment ago.

Jon Speer: Sure.

Mike Drues: So in the guidance, it does talk a little more about risk and specifically what does low risk mean? In this particular connotation? The product has to be noninvasive, but again, the devil's in the details, average regulatory professionals know the rules, the best ones know the exceptions. So, in this IVD product that I mentioned a moment ago, it involved a collecting a blood sample. Well, long story short, if you stick a needle in somebody's arm that's considered noninvasive if you prick somebody's finger, that's considered invasive.

Mike Drues: It made absolutely no sense to me. You laughing?

Jon Speer: That is the funniest thing ever. Yeah, no, it's just, I... That's so funny.

Mike Drues: Hey, listen, I don't write the regulation, I just... Companies pay me to help them use it. So that's one criteria, the invasiveness. Another criteria is does it involve a technology that might pose a risk to the user's safety? In other words, you cannot use things like lasers, or radiation exposure. But once again, I have a device right now, that I'm working on that is exposing a patient to a particular wavelength of light. To me, that's pretty low risk because this particular wavelength of light corresponds to the light that you're exposed to when you just walk around outside.

Jon Speer: Of course. Yeah.

Mike Drues: So by definition that would be excluded from this particular category, but this is one of the reasons why I do not like tight regulation because it does not allow for the application of intelligence to be applied here. And then the third criteria about risk is obviously it can't raise questions about usability or biocompatibility that kind of thing, but the reason why I mentioned that, Jon, is because this brings us to usability testing. In my opinion, usability testing for wellness products is even more important than usability testing for traditional medical devices. And this, by the way, includes over the counter devices. So, even if you have a 510(k) but it's OTC, usability is very, very important in both OTC as well as wellness products for one simple reason: For traditional medical devices they're gonna be used, or at least theoretically be used, by a trained medical professional, somebody that's graduated from medical school or nursing school, or what have you, whereas wellness products and indeed all OTC products are gonna be used by regular people like you and I.

Jon Speer: Anyone. Yeah. Anyone you can imagine, with little or no training. And that usability topic is... I agree with you, it's so important in general, but you have to consider your user population, and if your user population can range from a child to a geriatric user, then that's a pretty broad range to consider from a usability standpoint. So, it's kinda...

Mike Drues: Right. Right. And one last thing that I'll mention about usability to link it back to risk, this I talked about a little bit in the webinar that I did for your company that I mentioned recently, to separate usability from risk in my opinion, makes absolutely no sense.

Jon Speer: I agree.

Mike Drues: One of the best ways to assess the risks of your device is through what I call real usability testing, not the artificial contrived usability testing that meets the standards of the FDA, but real usability testing.

Jon Speer: Yeah.

Mike Drues: And then the last thing that I'll mention, Jon, so that we can wrap this up for your audience. You mentioned at the beginning, and I think this is one of the most important points, how do you know specifically if your product, if your device falls into this category of a wellness product or not?

Jon Speer: Yeah.

Mike Drues: Well, like a lot of things in regulatory, we can talk about these things in our companies from now until the sun burns out, we're never gonna know for sure until we take it to the agency. So there's basically two options, one is we can take our product to the agency as a matter of what I call professional courtesy. In other words, we're not asking them for anything. We just wanna come down, shake hands, introduce ourselves, tell you a bit about our device, what it does, how it works, how we're gonna label it and for all of the following reasons, it is considered a wellness product, and therefore, we're not asking you for anything, we're just letting you know.

Jon Speer: Sure.

Mike Drues: And FDA is gonna say one of two things, they're gonna say, "Oh, that sounds great. We look forward to seeing it on the shelf when we walk into CVS or some place like that", or they're gonna say, "Hold on a second here, we don't quite see it this way", and this is when the discussion begins. So, that's one approach that companies can take. The second approach that companies can take is don't take it to the agency, but be prepared to defend it if they come knocking on your door in the future and they say, "Hey, you seem to be marketing a medical device here. We don't remember you ever coming to talking about this. What the heck is going on?" And the strategy that I would imply here, Jon, and we've talked about this before, as well, is exactly the strategy of the letter to file. You put together all of the documentation that we need, the testing the show that it's low risk, the logical arguments as to why it qualifies and we just simply other than we don't take it to the FDA prophylactically, but instead we put it in our file, in that way, if somebody does come knocking on our door, we're not in a situation where we have to say, "Oh gee, I'm sorry, we forgot," or worse, "Oh, you caught us? Oh no, Come on in Mr or Mrs FDA."

Jon Speer: Right.

Mike Drues: So let us pull out our folder, or essentially our letter to file. Here are all the reasons why we did not take it to you, and by the way, if you have other companies that have done similar things that you can point to that will be icing on the cake. I just wanna like everything in regulatory, I wanna demonstrate to my friends on the other side of the table that I know what the heck I'm doing.

Jon Speer: And I think what I want the listeners to understand is whether you're a general wellness device that's not a regulated medical device, or you are a regulated medical device, hear the message that Mike is conveying. And one of those messages, or multiple messages, actually, but one of the messages that he's conveying is document your decision-making process. If you determine that, "Hey, we're in this gray zone and we were gonna put a stake in the ground that says, 'We're an unregulated medical device,' we're not gonna go to the FDA and we're just gonna do our thing. I'm gonna bring this product to people who are gonna use it," document that decision. And don't just say, "because we said so." Support it with evidence. Review regulations, review guidance documents from FDA and other regulatory bodies. As Mike suggests, compare your product to maybe some other products that are already on the market.

Jon Speer: It's not that you're doing a full substantial equivalence rationale, but you're basically making a case for why you made your decision and that's important. The other thing I want people to understand through this is even if you have a non-regulated medical device there is still. As Mike so well stated about usability and the connection between usability and risk, there are still risks that are involved with your product, there's still issues that you need to address from a usability standpoint. And that it would imply or suggest that you should also be documenting those decisions and documenting those types of situations, you may actually have to do testing, you may actually have to do some performance criteria, it may make sense to go through a design and development process. Something, a procedure or process describing the user needs and the inputs and the outputs, verification, validation, have designer views. So don't hear that, I have a general wellness device that is a non-regulated medical device, therefore throw all of that good regulatory best practices for your whole system and your design controls and risk and usability; I'm gonna throw that out the window, that's not what is being said here folks.

Mike Drues: I could not agree with you more, Jon. And especially to your last point, that's a very important thing for the audience to remember. This is not an excuse to do sloppy engineering. Just because we're working on a low-risk product, which might not require taking it to the FDA because it's a wellness product. Or for that matter, even if we're working on a low-risk Class One medical device that is exempt from design controls. All of those things that are part of the design controls, the quality system, the regulatory system and so on. As you and I have talked about before, Jon, it's all what I call prudent engineering.

Jon Speer: Exactly.

Mike Drues: All what we should be doing anyway.

Jon Speer: Exactly.

Mike Drues: Please don't use this as an excuse to cut corners. We didn't get into it here, but regrettably, there are some very, very recent examples of wellness products, devices that are brought to market, there's a blood pressure one in particular that I'm thinking of that has an inaccuracy rate of greater than 80 percent. In other words, less than 20 percent of the time accurate.

Jon Speer: That's crazy. That's crazy.

Mike Drues: Crazy is putting it politely, Jon. [chuckle] And I don't wanna mention the specific product here, but if anybody wants to send me an email, feel free I'd be happy to talk to you about it, but this is again, I think, Jon, you and I are singing exactly the same song. Maybe in a slightly different key.

Jon Speer: Yeah.

Mike Drues: This is not an excuse to take shortcuts or to do sloppy engineering. We still need to make good, safe, reliable products. Whether they involve the FDA or not.

Jon Speer: Right.

Mike Drues: And the last thing I just wanna remind the audience as we wrap this up, is wellness products, in my opinion, make a wonderful opportunity. At least for some companies, obviously if you're designing coronary stents, you're probably not gonna come out with a wellness version of a coronary stent.

Jon Speer: Right. [chuckle]

Mike Drues: But for a lot of medical devices it does represent or it does offer the potential for that label expansion, where... As I said, you bring it on to the market initially with no FDA involvement in it sort of dumbed down configuration dumb down in terms of labeling and then you go back to the FDA later with a similar device. Or maybe even exactly the same device, but with different labeling. I think from a business perspective, that has a lot of advantages.

Jon Speer: Yeah, exactly. Mike, I appreciate these insights. And folks I want you to know that if you have any questions about your device, or technology, and wonder if it might fit as a general wellness device or a regulated medical device, or you need some guidance navigating this process, you can always reach out to Mike Drues. Mike D-R-U-E-S, Drues. You can find him on LinkedIn. Again, he's with Vascular Sciences. You can also reach out to us here at Greenlight.guru. And if you wanna get some little bit of council, we'd be happy to get you on the right path. The other thing is, as I mentioned a few moments ago, the FDA does have a guidance document and as with guidance documents, some are better than others. I think this one is pretty good considering the topic.

Jon Speer: It's not prescriptive, per se, but it does give... This one is a good guidance document in my opinion because it has a lot of examples and sometimes, at least for me, I'd learn from those examples. So we'll provide a link to that too. But don't just be a cowboy with your product and think that you can just proceed with reckless abandon. Do be strategic. Do apply that prudent engineering that Mike mentions. And as I wrap this up, let me encourage you that if you're not really sure how or what to do or maybe you've got processes in place and they're not quite as efficient and streamlined as you'd like, contact Greenlight.guru. You can go to our website. You can learn more about our EQMS system and our workflows that are designed specifically for medical device companies, including how to manage and maintain design controls, risk management, among a number of other workflows. Do the right thing; reach out. Get a hold of us and we'd be happy to talk to you about how we might be able to help. So Mike, thank you once again for being the guest on the Global Medical Device Podcast.

Mike Drues: My pleasure, Jon. Thank you as always for the opportunity.

Jon Speer: And as I mentioned, this is your host, founder and VP of Quality and Regulatory at Greenlight.guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


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