What is a Multiple Function Device?

What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.

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Some highlights of this episode include:

• A multiple function device is a product that has at least one function that meets CFR’s definition of a medical device, and one non-device function that does not meet CFR’s definition of a medical device.
• A combination product is not a multiple function device. However, the device portion of the combination product could offer multiple functions that meet CFR’s medical device definition. 
• Examples of multiple function devices include smartphones with camera apps to detect skin cancer, while other functions could but should not impact the safety, effectiveness, and performance of the regulated version of the product. 
• FDA Assessment: Direct or indirect regulatory review of multiple function devices is confusing and complex. It’s not an excuse for not prudent engineering. 
• FDA Flowchart: Is there an impact on the safety or effectiveness of the device function under review as a result of the other function?
• Regulatory Strategy Recommendation: Decouple technologies and functions to consider each separately, then recombine and rebuild as a system.

Links:

Code of Federal Regulations (CFR)

FDA - Medical Devices

FDA - Medical Device Guidance Documents

Multiple Function Device Products: Policy and Considerations

Premarket Notification 510(k)

De Novo Classification Process

CARES Act

Mike Drues on LinkedIn

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from this episode:

“The essence of the CFR definition is something other than a drug that prevents, diagnoses, or treats a disease, injury, or condition.” Mike Drues

“We have one or more functions that meet the CFR definition of a device, and one or more functions that do not.” Mike Drues

“Understand the whole impact of regulatory strategy—the pros, the cons, the options.” Jon Speer 

“Consider all the different pathways and the different strategies. Determine what’s the best path, not just for the simplest, quickest, easiest, but what is the best path?” Jon Speer

Transcript

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 is a multiple function device? And why does this matter to you? Why should you care? What are the ins and outs, the pros, the cons? What are the details? Well, good news, have Mike Drues from Vascular Sciences on this episode of The Global Medical Device Podcast, where we talk about multiple function devices. Hello, and welcome to The Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and kind of excited about this conversation today. And the topic is multifunction device products. And who better to talk about all things new and exciting on the regulatory front in the medical device industry than Mike Drues with Vascular Sciences? So Mike, welcome.

Mike Drues: Thank you, Jon. Nice to speak with you and the audience, as always.

Jon Speer: You got it. So I have to confess, I don't know a lot about this. And as we usually do when we introduce topics, maybe a good place to start is: What is a multifunction device?

Mike Drues: That's a great question, Jon, and it's a great place to start. So simply put, a multifunction device is a product. Part of the problem that we're going to get into here in this discussion, Jon, is with terminology. But it's a product that has at least one function that meets the code of federal regulations' definition of a medical device. And one function, a so- called non device function, that does not meet the definition, the code of federal regulations' definition of a medical device. So for example, and I have several examples we can talk through, if we have a product, whether you want to call it a device, or multifunction device, or what have you, it doesn't matter. We have one or more functions that meet the CFR definition of a device, and one or more functions that do not. And the reason why FDA put out a guidance on this just this past July, Jon, is because part of the Cures Act said that FDA shall not regulate non device functions, meaning functions in a product that do not meet the CFR definition with multiple functions. But they can consider, the FDA can consider the impact of these non device functions on the device function of the product. And I know that sounds very, very complicated and confusing, but it's really in fact not. Jon, to me it's 100% common sense. So again, let me try to clarify that. The Cures Act said that FDA shall not regulate, at least not directly regulate, non device functions of a device or a product that has multiple functions. But they can consider the impact of those non device functions on the device portion, the regulated portion of it. And the guidance goes on to talk about how and when FDA would do that. But does that make sense, Jon, in terms of starting out with the answer to the question of, what is a multiple function device?

Jon Speer: A little bit. And I'm sure as we continue to chat, it's going to become clearer to me, as well as the rest of our listeners today. Maybe a regulated device per the CFR versus a non regulated device, or I guess one other way to think about non regulated would be more of a consumer product, I suppose. How can you compare and contrast what's" regulated," versus what's not regulated?

Mike Drues: Yeah. Again, great question, Jon. So simply put, a regulated medical device is a device that meets the code of federal regulations' definition of a medical device, which as you know, Jon, is many, many paragraphs long. But in essence, if we were to boil down the CFR definition in its simplest sense, the CFR definition of medical device says, " A device is something other than a drug that prevents, diagnoses, or treats a disease, injury, or condition." So once again, I'll say that a second time. The essence of the CFR definition is something other than a drug that prevents, diagnoses, or treats a disease, injury, or condition. So coming back to the difference between a regulated device versus a consumer product, or perhaps even a wellness device, a regulated device, the regulated device function, the regulated device portion of this multiple function device, and again Jon, the terminology here is very confusing, in part caused by the FDA and this guidance. The regulated portion meets the CFR definition. That is, it's something other than a drug that prevents, diagnoses, or treats a disease, injury, or condition. And the non regulated portion, whether you want to call it a consumer product, a wellness device, whatever it is, does not treat, sorry, prevent, diagnose, or treat a disease, injury, or condition. Right? So regardless of what portion of the product that we're talking about, it comes down to: Does it meet the CFR definition of a medical device, or does it not? Does that make sense?

Jon Speer: It does. Before you started to dive into the definition of med device, as we first started talking about multiple function devices, I was thinking, " Oh. Is this a surrogate or a special type of a combination product?" And I think you answered that. But do you want to clarify if a multiple function device is the same as a combination product?

Mike Drues: Yeah. Good question. Let me come to that in just a second, Jon, because there's one other thing that I just want to mention quickly about multiple function devices, that phrase. We have a litany of devices on the market that perform multiple functions. But each one of those multiple functions fit the CFR definition of a regulated medical device. So I'm already getting calls from my customers that are tremendously confused about this because they say, " Hey, we've got a device already out there, but a multiple function device. It does several different things. But all of them are regulated things. Does this guidance apply?" And I say to them, " No."

Jon Speer: Yeah, right, right, right. That makes sense.

Mike Drues: Whether the FDA realizes it or not, and this is by no means a criticism, but merely an observation, we are going out of our way to make this much more complicated than it needs to be, and that's very unfortunate. But coming back to your last question, Jon, the difference between a multiple function device, is not the same as a combination product because one could argue that a combination product has got multiple functions, multiple components, if you will. So the short answer to that question is, no, a combo product is not a multi function device. And for those in the audience that are not familiar with combination products, simply put, a combination product is not just a medical device, or a drug, or a biologic, but a combination of two, sometimes all three of those things put together. So a couple of quick examples of combo products would be things like drug- eluting stents, transdermal patches, pre- filled syringes, bronchial inhalers, and so on and so on. So a multiple function device is not the same as a combo product. However, and this is where it really gets interesting, Jon, on the device portion of the combination product, it could be a multi function device. So let's say for example, you have a combination product that it's a device drug combination product. And on the device side of the combination product, you have some functions in the device that meet the CFR definition of a device, and some do not. So in that particular case, Jon, in addition to all of the combo product regulation and guidance that would be applicable, now this multiple function device guidance would be applicable. But if your device, sorry, if your combo product does not have multiple functions on the device side, then this particular guidance is not applicable. Maybe to help clarify some of this, Jon, we can take a look at some examples.

Jon Speer: Yeah. I mean, I think examples will certainly clarify some confusion. But as convoluted as your last explanation was, at the same time, it was super clear, so if that makes any sense at all. But yeah, let's dive in. What are some examples of multiple function devices?

Mike Drues: It was convoluted, but also clear, Jon. Is that saying crosstalk.

Jon Speer: That's an oxymoron.

Mike Drues: inaudible and new and novel in the same sentence. I don't know.

Jon Speer: And like jumbo shrimp, yeah, it's an oxymoron.

Mike Drues: Jumbo shrimp and military intelligence.

Jon Speer: We're digressing, Mike.

Mike Drues: Anyway, we are. We are, so let's get back on track. So let's take a look at some examples. And I thought I would just share a couple of the examples that FDA provided in the guidance. And it's always nice I think when FDA provides examples in the guidance, although I'm not sure I would choose these particular examples. But let's talk about one or two of these. So one of the examples they provide in the guidance is a smartphone that has an app that use with the, sorry, with the camera to detect skin cancer. In other words, it takes a photo of the suspicious lesion, or a mole or something, and makes a determination of whether or not this is skin cancer. So the device function is the software app that detects the skin cancer. Right? That's clearly fits the CFR definition. That is, it prevents, diagnoses, or treats a disease, injury, or condition. And as you may know in that particular area, Jon, the area of skin cancer apps is very controversial. It goes back several years. But we won't get into that. But anyway, the device function is the software app that detects the skin cancer. But there are other functions in that same product. For example, the smart phone itself, the computing platform, the camera that's in the smartphone that takes the pictures and so on. So it's up to the manufacturer to determine if these other functions would impact the safety, efficacy, performance, and so on, of the regulated version of the product. And by the way, according to the guidance, I think the verbiage FDA uses is too absolute. My recommendation to the manufacturers is to determine: Can these non medical device functions, could they impact the regulated device? So again, back to the skin cancer app. So we assess the software. In other words, does it... It depends on the smartphone camera to get these photos. And then the camera and the computing platform are used to do the analysis. But bottom line, Jon, any changes in the camera, for example, in terms of resolution, or image processing, or other things like that, that could potentially impact the safety, efficacy, of the regulated device.

Jon Speer: For sure.

Mike Drues: And therefore, FDA should be concerned about that. That's my assessment, Jon. That's my recommendation. May I read to you what FDA's assessment is?

Jon Speer: Please do.

Mike Drues: Right out of the guidance.

Jon Speer: Yeah, no. Please do. And folks, we'll provide a link to this guidance with text that accompanies the podcast too, so you can read it for yourself. But Mike, yeah, please go ahead.

Mike Drues: So I just gave you my assessment. Now let me give you FDA's. "The smartphone platform and camera are not evaluated as part of the pre market review, though the testing outcomes of the device function under review, under the review performance related to using the smartphone and the camera are evaluated." So let me just read that again because I know it's a little confusing, but it is a direct quote. The smartphone platform and the camera are not evaluated as part of the review, if this is a 510(k) for example, though the testing outcomes of the device, the non function device, the non medical device component, are related using the smartphone camera. Those are evaluated by the FDA. Do you know what that means, Jon?

Jon Speer: No, go ahead. What does that mean?

Mike Drues: I have no idea what that means. That is about as clear as mud. Right?

Jon Speer: Well, it's confusing to me, though.

Mike Drues: To be honest with you, it's confusing when you try to look at this particular example. And again, to be fair, FDA is trying to help. I'm not trying to be overly critical here. But with all due respect, they're making this much more complicated than it needs to be. To me, forget about being a regulatory consultant, Jon. This is common sense to me as a professional biomedical engineer. If, and this is my recommendation because I'm already getting pings from my customers on this, Jon, and perhaps you are as well. But if the non device function, that is the non regulated portion of your product, if it can, if it could, if it has the potential to affect the regulated portion of the device, then we have to consider it. We have to do the testing. We have to do the risk mitigation. And FDA should include that as part of their review, regardless of what the guidance says. To me, that's common sense, Jon. In fact, there's nothing new here. What we're really talking about is compatibility. Right? When we talk about, for example, software compatibility or camera compatibility in this particular example, how is that any different than bio compatibility? How is that any different than usability? How is that any different in the litany of examples where you and I are familiar with, Jon, where we have to make sure that two things can work properly together? That's it. That's what it comes down to.

Jon Speer: Yeah. My confusion-

Mike Drues: Want another example?

Jon Speer: Well, just let me share-

Mike Drues: Go ahead.

Jon Speer: What was confusing to me, and I remember quite a few years ago, I was working on a product that required a PC. There was an application involved, but it required a PC. I distinctly remember there was quite a bit of concern from FDA about the configuration of the hardware and the operating system and all those sorts of things, so that's where my confusion comes in on that particular quote that you cited from the guidance. It seems like there's a different point of view, perhaps. I don't know. But yeah, let's dive into another example.

Mike Drues: Well, perhaps part of the problem for this confusion, Jon, Einstein, very smart guy, Einstein said, " If you explain something simply, you don't understand it well enough." So perhaps part of the confusion here is my fault because I'm trying to base our discussion on what's in this new FDA guidance, as opposed to just taking the sort of typical Mike Drues kind of common sense approach. And that's what I'm trying to do here. And just one last thing I would say about the skin cancer example app, Jon, that I just discussed. How is this any different than an MRI or a CT, where we come out with say, a new version of the CT or the MR that has improved resolution, or different kind of an algorithm for image processing, or something like that? So this is exactly what I mean when I say, if you understand the regulatory logic, there's absolutely nothing new here. So here's one other example, Jon. Again, out of the guidance, a handheld coagulation device. This is a device that means what's called prothrombin time, that interfaces with a hospital information system by using commercial off the shelf docking station hardware, and it already meets US consumer product safety commission standards of electrical safety and so on and so on. And it's using that to transfer the clinical data to the hospital information system. So the non device function of it would be the docking station and the interface to transmit the data to the hospital information system. So the question is: Would FDA in this particular scenario, Jon, would they formally review the non device functions of this multiple function device? Do you have thoughts on that, Jon?

Jon Speer: I want to say based on our discussion so far that the answer would be, no, they would not. And then I'm thinking, " Well, is Mike asking me a tricky question? Maybe the answer is yes." But my gut says no. My gut says no.

Mike Drues: Well, so let me share with you FDA's assessment right out of the guidance. And by the way, so many people, they make the assumption that whatever FDA says must be right or correct. I do not make such an assumption. When I agree with FDA, I will be the first to tell them. But when I disagree with them, I will also be the first to tell them. So their assessment is, and again, I'm quoting here, the docking station and the interface software are not evaluated, so the FDA agrees with you, Jon, are not evaluated as part of the pre-market review, meaning the 510(k) or the de novo, or whatever it is. Though, and this is the interesting part that is a quality that you might find interesting, Jon, though the hazard mitigation for the docking station, battery, and authentication features for data transfer and so on, are evaluated as part of the device function under review. Does that make sense, Jon? Again, what does that mean? So what they're saying is we're not formally reviewing this as part of the 510(k), or the de novo, or whatever it is. But we're informally reviewing it. I don't know.

Jon Speer: It's kind of like an accessory.

Mike Drues: It's just so much more-

Jon Speer: Kind of seems like an accessory almost, sort of, kind of. I mean, the product doesn't work without that. But again, it's confusing, so confusing.

Mike Drues: Yeah. It's very confusing. And just one last example that I would share, and again, FDA does, to their credit, list several examples. So I encourage our audience to take a look. I find it interesting, Jon, I think FDA is becoming a little bit too transparent with some of their examples that are going into guidance because I can tell you that some of the examples in this guidance are products that I've actually been involved with in the past. Anyway, the last example that I thought I would share is a device. Let me use the proper verbiage, a multi function device for traumatic brain injury determination using an EEG, and electroencephalograph. So this is a product that uses an EEG on a computer platform. It has specialized hardware, as well as obviously software, that uses the EEG data to determine if the patient has suffered from a TBI, a traumatic brain injury. So there are non device functions of this product. One is the general purpose computing platform. You mentioned the PC example a moment ago, Jon. This is exactly the same as that. The general purpose computing platform, as well as electronic administration of a questionnaire that the device algorithm depends on in order to generate part of the results of whether the patient had a TBI or not. And it's the questionnaire to the patient that I want to focus on here, Jon. Because what do you think FDA's assessment is regarding this particular example? Any guesses? And I know I'm putting you on the spot a little bit. So if you...

Jon Speer: Well, I don't know. I'm going to have to say you are putting me on the spot. And usually I'll take a stab. But so far, with a couple of examples that you've shared on multiple function devices, they seem to contradict each other, so I don't know.

Mike Drues: Well, once again, let me start out by sharing with you FDA's assessment right out of the guidance, whether you or I agree with them or not, that's something that we can discuss. So what they say is the computing platform and the questionnaire are not evaluated as part of the pre- market review. And again, what that means is not formally part of the 510(k) or whatever it is. Though the impact to safety and performance related to using the computer platform and the questionnaire on the testing outcomes and the risk mitigation for the device function under review are evaluated.

Jon Speer: Okay. I mean, it seems like maybe slightly a matter of semantics, maybe not, but clear as mud.

Mike Drues: Well, there is semantics to it, regrettably, Jon. And again, there's tremendous confusion with the terminology here, but I'm trying to simplify by focusing on my what I call regulator logic or common sense approach. But it presents a pragmatic problem to manufacturers. And that is if these things are not reviewed directly as part of the 510(k), but they're reviewed indirectly as part of your risk mitigation strategy or something like that, does that mean that you have to put this information in your 510(k) submission or not? Right? So it's complicated, but bottom line, and I know I've said this a couple of times, if I were to dumb this down, simplify it as much as I can, if your non device function can impact the device function, specifically the safety, efficacy, performance, blah, blah, blah, then both the company as well as the FDA should consider it. Whether we want to parse this, okay, it's not technically part of your 510(k) consideration, but it's part of your design control/risk mitigation, that to me is a difference without a real distinction. But again, Jon, that's just my opinion. At the end of the day, I want to make sure that we do what we need to do. That's what's most important.

Jon Speer: Yeah. I mean, to go back to other topics that you and I have talked about, this is not an excuse for prudent engineering.

Mike Drues: No, no. It's not an excuse for not prudent engineering.

Jon Speer: Right. Right, right, exactly. So if that technology, that platform, whatever the case may be is important to the medical device portion of my product, my multiple function device, then it's prudent engineering to do what's right and to make sure that I've done the proper due diligence, testing, requirements, definition, et cetera, risk assessment, all those sorts of things too, which I'm starting to connect some dots here. There might be slight differences in what Mike Drues from Vascular Sciences would advise and recommend customers who are pursuing multiple device functions, versus what it explicitly stated in the guidance, so which is not a bad thing. It's actually a very good thing that this just makes good common sense.

Mike Drues: What I think, Jon, just to spin it a slightly different way, I think that FDA and I, I won't speak for you or anybody else, but FDA and Mike Drews are singing the same song. We're just in a slightly different key. But anyway, let's continue on.

Jon Speer: Yeah. I'll put you on the spot now. Do you think that this guidance came out in a sort of a response from the agency acknowledging that there's a lot of products out there that technically meet this definition of a multiple function device, and that there might be some acknowledgment that it would be difficult or challenging for the agency to regulate all aspects?

Mike Drues: Well, here's the way I would answer that question, Jon, to be quite candid here. Obviously, we all know that the lines between a" regulated medical device" and a non regulated medical device, or a regulated medical device function and a non regulated medical device function, those lines are becoming blurrier and blurrier all the time. Right? We have a growing number of products that are coming out that have regulated functions and non regulated functions, and I've shared with you a couple of examples here, but there are a litany of others on the market and coming out already. And I think we as an industry are not doing a really good job, certainly not as well as we could, of separating those out and determining what information that we need to take to the FDA, and what do we not. And as a result, FDA put out this guidance to try to help clarify what at least FDA's expectations are. Anyway, maybe it would help to talk about some other things that are in the guidance that are important, and maybe wrap this up with some strategy recommendations.

Jon Speer: Yeah, absolutely.

Mike Drues: How companies can use this information moving forward. So just one or two other things I wanted to point out about what's in the guidance in addition to the examples. FDA does provide a flowchart to try to walk through how you handle these particular things. The flowchart to me, It's very simple. There's only about three or four questions. And to me, it's all obvious. But the first question that they ask is: Is there an impact on the safety or efficacy of the device function from the non device function? But as I said a moment again, Jon, I think that question quite frankly is very poorly worded. It should not be: Is there an impact? It should be: Could there be, or is there a potential for an impact? Or something like that. I see, regrettably Jon, a lot of folks in our industry are going to misinterpret this. They're going to say, " Is there an impact?" No. And therefore, stop at that point as the flowchart instructs. So I just, again, this is just my opinion, and as you know, Jon, I work as a consultant for the agency, I've already given them my recommendation. I don't like questions that are that absolute.

Jon Speer: And if I can chime in on that too.

Mike Drues: Please.

Jon Speer: Looking at the flowchart, if I answer no to that question, it's a straight line that says document. I don't have to do anything else. And the concern that I would have with this is that I suspect that a lot of companies where this multiple function device criteria may apply, they may not be medical device companies first. They may be consumer product companies first, and they may not be well versed in what the criteria and expectations and requirements are from a medical device perspective. So they're like, " Oh, no. This is simple. Let's just go this route." Maybe I'm projecting here a little bit, but that would be my concern.

Mike Drues: No, actually, that's an excellent point, Jon. And kudos to you because I didn't think about that possibility, when you have a company that's not coming from the medical industry, that's coming from consumer products. And again, we're seeing lots of examples of that with even the big names like Apple and so on, that didn't historically work in medical devices, and now they are. So I share your concern, Jon. I think that's another reason why that, in my opinion, that first question is poorly written because it can be so easily misinterpreted. A couple of other things that they mention in the guidance that I think are worth pointing out, and this is going to be something that I think you'll find interesting being the quality guy that you are. The guidance provides points to consider in the risk based safety assessment and any potential impacts on the effectiveness or the performance of the device. So this links to the risk mitigation strategy through the examples that we shared where FDA says, " Yeah, technically we're not going to include this particular function as part of the 510(k) determination. But we are going to include it in terms of our risk analysis and usability and so on." I just think that gets very, very messy. Anyway, that's another thing. But moving on to perhaps the most important thing here is the strategy recommendations. And that is if you have, if you're working on a product that is a multiple function product, as we're describing. How do you handle this? How do you determine? And remember, Jon, it's up to the manufacturer to determine this, not the FDA. But how does the manufacturer determine whether these other functions could impact safety and effectiveness of the device function? Well, my recommendation is very simple. And this comes right out of my, what I call combination products 101 because the regulatory logic is exactly the same. The first step is to decouple the technologies, or in this particular case, decouple the functions. And consider each function individually, whether it's a regulated function or a non regulated function, I don't care. Just consider each one individually in terms of risk, in terms of usability, and so on and so on. And then finally, step two, put the entire system back together again, and consider the risk and the usability and so on, of the entire system. Notice I'm not saying product, or device, or whatever. Just thinking about this as a system. And as you know, Jon, this is one of the most basic tenets in the design controls is to consider the entire system, to decouple the parts and then put them all together. I think if we were to take that kind of an approach, in my world I call that a common sense approach, then I don't think we're going to have any problems. Does that make sense, Jon?

Jon Speer: It totally makes sense, absolutely. Absolutely. Any other key tips, pointers, strategies, take aways, food for thought that you think is important to share with the audience on multiple function devices?

Mike Drues: Yeah. So great question, Jon. Just to kind of wrap this up, let me just reiterate what I think are a couple of the important takeaways here. Look, the bottom line is whether the function that we're talking about... Well, first of all, let me reiterate, so a multiple function product is a product that has at least one, maybe more, regulated medical device functions, meaning that it meets the CFR definition of a device, and at least one, maybe more, non regulated medical functions. And that is that it doesn't meet the CFR definition. And even though FDA says, as Congress said in the Cures Act, FDA will not directly regulate the non device functions. They will, as we looked at in several examples today, indirectly regulate them in terms of assessing the impact of the non regulated function on the device function. That to me is exactly the way the system should work. Right? Also, I think we talked about that first question on the flowchart. I think that the better way to think of it for our audience members is not is, or does it affect. But could the non device functions, could they impact the device functions? Remember the strategy recommendation that I shared a moment ago, Jon, and that is step one, decouple the technologies, decouple the functionalities. Consider each function separately and then put the entire thing, recombine them and consider the entire system, whether we call it a product, whether we call it a multiple function device, whatever the heck you want to call it, I don't care. Shakespeare said, " A rose by another name still smells as sweet." Put the whole thing together in a system and consider the system. My last recommendation, Jon, I'm wondering if you can guess. What do you think is my last recommendation here? And I'll give you a hint. It's certainly not specific to the topic of multiple function devices.

Jon Speer: I was going to say call Mike Drues. Well, I think it's from my perspective, from what you've shared, a strategy would be to really understand the whole impact of regulatory strategy, the pros, the cons, the options. Consider all the different pathways and the different strategies. And really determine what's the best path, not just for the simplest, the quickest, the easiest. But what is the best path for the patient, the person that's going to, or the consumer, whomever is going to be using this product, make sure that you're assessing the risk and the options, and not getting so caught up and worried about if it's this or that, but just doing the right thing.

Mike Drues: Well, first of all, Jon, I'm very flattered that you would say, " Call Mike Drues." That's a little too self serving, obviously, to say that. But if people want, I'd be happy to help however I can. But quite honesty, Jon, I'm a little disappointed that you didn't come up with my last recommendation, which is totally agnostic to the conversation that we're having today. And that is, once you do come up with your plan, your strategy, take it to the FDA in advance of your submission and sell it to them in the form of a pre submission meeting, or a pre sub, or whatever it is.

Jon Speer: Maybe that was too obvious.

Mike Drues: My opinion is... Maybe it was too obvious, yeah, perhaps. Maybe we've talked about it so many times. But you know what, Jon, it's still amazing to me how many companies don't do that.

Jon Speer: Yeah. That is true.

Mike Drues: Just to wrap this up, at least my portion of this discussion, whether it comes to a multiple function product, as we're talking about today, or something else. Once you come up with your plan, and once you're able to defend it, then take it to the FDA and sell it to them. And just make sure that everybody is on the same page, everybody's pulling in the right direction, whatever metaphor you want to use, Jon, I don't care. But make sure because you can minimize, if not eliminate so many of the problems that happen downstream, so many of the questions, so many of the delays, if you just simply follow that very simple advice.

Jon Speer: Yeah. That's great. Mike, thank you so much. I mean, I felt that I learned quite a bit about multiple function device products today. And I also, the gears are turning in my head. I have a lot of other questions that have come up in my brain on this particular topic. So I'll probably follow up with you crosstalk of this.

Mike Drues: Jon, would you still describe this as you did early in our conversation as complicated and simple at the same time?

Jon Speer: I think so. Yeah. The most common response to a question, at least in my experience, that a regulatory professional provides is, it depends. And it does.

Mike Drues: It depends.

Jon Speer: It's highly dependent, and there's no black and white answer. There's definitely shades of gray here. But that last bit, that obvious thing that was not in the moment obvious to me, build your case, tell your story, and get an audience with the FDA in the form of a pre submission. I think that's very wise, so it is confusing. And I think this is, folks, I think this is one of those topics, it's clearly not going away. I mean, unless you've been living under a rock, there's been for many years now this convergence with tech and med device, smartphone with the apps on it, wellness devices that have EKG functionality, all these sorts of things. This is only a theme that's going to continue. So I think from that perspective, it seems I applaud FDA trying to be somewhat proactive, and not necessarily get ahead of things per se, but at least getting more up to speed with the current state of the world in these areas. So from that perspective, I think this guidance is a good movement from that perspective.

Mike Drues: I would agree, Jon. And not to prolong the conversation too much, but the concern that I have quite frankly is as we have more and more of these" multiple function products," and as the functionalities get blurrier and blurrier, my concern is if we don't get off on the right foot from the beginning, or at least where we are right now, if we don't have an understanding of the terminology, if we more importantly don't understand the regulatory logic to be applied to the relatively simple multiple function products that we have today, it's only going to get worse as these products become more complicated and more fuzzy in the future. So I think that's one of the main reasons why we are having this discussion today.

Jon Speer: Absolutely. Mike, thank you so much. And folks, in all seriousness, Mike Drues with Vascular Sciences, he's a regulatory genius. And I know he's too modest to say so, and hopefully also at the same time, flattered by this. But I always learn things from him on regulatory every time he and I chat. And I can only imagine that if I had a product that was potentially in this multiple function space, I know the person I would call, it would be Mike Drues. So for what that's worth, I highly recommend that if you have anything regulatory related that you need a little bit of help, guidance, direction on, Mike is your guy. In the same vein, from a quality management system perspective, all the design and development, the risk and document management, and change control, and quality events and things of that nature, that's where Greenlight Guru comes in. And Greenlight Guru has the only medical device quality management system on the market today. And we just launched a really exciting feature, and I'm going to leave this as an intrigue frame, something, homework for you all to check out. But we just launched this thing called Visualize. And the snippet that I'll provide to us is it's a visual representation of your quality management system. It's revolutionary. It's innovative. Nothing like this has ever existed in the medical device industry, quality management system space ever before. And we're only just beginning. So go check that out, www.greenlight.guru to learn more. As always, thank you for listening to The Global Medical Device Podcast, the number one podcast in the medical device industry. I'm truly honored to be your guest, or your moderator, and to have guests like Mike Drues join us. So thank you so much for continuing to listen. Share this with your friends and colleagues. And as always, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to The Global Medical Device Podcast.

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