#386: The Danger of In-Home Use Medical Devices, Pt. 2

Mike Drues: 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.

Etienne Nichols: Medical device regulations can be amazed. Greenlight guru software makes it simple. Our purpose built quality management system platform helps med tech companies get to market faster and stay compliant. Our electronic data capture system, or EDC, helps make managing clinical investigations that much easier. No more headaches, no more surprises. Just a system that works for you. If you're ready to streamline your quality processes, visit www. Dot Greenlight dot Guru and request a free demo today. That's www. Dot Greenlight dot guru. Documentation is key to a successful quality management system. Rook quality systems helps you create and maintain clear, compliant sops and other essential documents. Their experts ensure your documentation aligns with regulatory standards, making audits a breeze. Start optimizing your qms today@rookqs.com. dot that's rookqs.com dot, everyone. Welcome back to the global medical Device podcast. My name is Etienne Nichols. With me today is Mike Drews, a familiar voice on the podcast. Now, this is going to be a part two of an episode around home use medical devices. So if you're interested in going back and watching part two, we'll put a link in the show notes. Feel free to go back and listen to that first. Otherwise, if you, if you have listened to it, or maybe you don't have time to listen, you want to go straight into this episode. Maybe we could do a quick recap. Mike, do you want to just give a quick rundown of what we talked about?

Mike Drues: Yeah, absolutely. And once again, Eddie, and thank you for the opportunity to have this discussion with you and your audience about a very important topic. So, as you just mentioned in part one, we discussed a little bit about home use devices, what exactly a home use device means and what it does not mean. We talked about why this was important, and we, we talked about a couple of examples of home use devices. One in particular, the Philips respironics case of the CPAP and the ventilators that had some problems in the coming discussion. Today, we're going to take this further. We'll talk a little more about the labeling of home use devices, some of the technological concerns, some of the regulatory concerns, and then we can also talk about some additional examples as well. So I'm looking forward to continuing this discussion from last time.

Etienne Nichols: That'd be great. And I wonder if maybe it makes sense to start with. Well, do you have any additional examples, first of all, or do you want to go into some of the different aspects around the home use medical devices?

Mike Drues: Yeah, I do have a couple of examples at Ian, but I'd like to do that a little bit later because some of them will relate to some of the other technological and regulatory challenges that we're going to talk about today.

Etienne Nichols: Well, how about maybe we could talk, we talked briefly about intended use last time. I wonder if we have. Do you want to talk about examples of a device intended to be used in the home that has had problems?

Mike Drues: Sure. Well, let's talk about the labeling, because as you just mentioned, etienne, we've talked a lot about labeling in many previous discussions, focusing on what I call high level labeling, which is the intended use and the indications for use. Just as a quick reminder, and we've done many discussions on this in the past, intended use focuses on the device, what it does, how it works, its mechanism of action, and so on and so on. Whereas indications for use that focuses on the patient, what disease, injury or condition is the device intended to prevent, diagnose or treat. What I'd like to talk a little more about here, which is a little more new relative to home use devices, is the intended user and the intended use environment, because these are aspects of labeling that are not often explicitly stated in the label, certainly not in the high level labeling. And maybe that's a problem. Maybe that's something that we should get into. So let's start out with the first one, Adian. When somebody uses the phrase intended user, what does that mean to you?

Etienne Nichols: Well, I assume it's the one who's going to be interacting with the device on some level, correct?

Mike Drues: The person who is going to be using the device. Now, historically, the user of the device was typically some sort of a clinician, a doctor, a nurse, a surgeon, a pharmacist. But now more and more with home based devices, the intended user is the patient. And that brings up all kinds of issues, not the least of which is usability, because healthcare professionals, hcps, we assume that they've undergone some kind of a training, you know, they've gone to medical school or nursing school or what have you, but with people, you know. John Smith, Main Street, USA we cannot make that assumption. And so I think it would be a good idea for us to define who our intended user is. Is it only, I mean, some devices is obviously right. If it's a cardiopulmonary bypass machine, for example, most people are not going to be, you know, doing that on them. On themselves. But obviously, there are a ton of devices now that are intended to be used by the patient, or possibly by the patient or the clinician or both, you know, a combination of the two. How about the intended use environment? What does intended use environment mean?

Etienne Nichols: Well, I mean, it almost sounds silly because it seems self explanatory. The environment in which the device is going to be used, both immediate and maybe extended. You know, how whatever may, it may impact, and whatever may impact it.

Mike Drues: Exactly. So intended use environment, as the phrase implies, is that is the environment, the room, or the area of physical space where the device is intended to be used. It could be in a hospital, and even more specifically, it could be in an or ICU or something like that. It could be in a doctor's office, it could be in an outpatient clinic, it could be in an ambulance, it could be in somebody's living room, and so on and so on. We gave a number of examples in part one, I think, of those different intended use environments. But when we're talking about the intended use environment and we're also talking about intended user, we have to take a broad view of the universe. As I said, it doesn't necessarily have to be HCPS healthcare professionals. It could be individual people. And those people, depending on your device, they might have physical or cognitive disabilities. They might have language or communication challenges. They might have a limited knowledge or level of education, either in general or about that particular device specifically. So we always have to take all of this into account. And taking this a step further, Adian, because you know that one of the things that differentiates my approach from so many others is I'm not focusing on just what we did today or what we did in the past, but what we may be doing in the future. So what about what is the intended user with robotically assisted devices, with artificial intelligence and so on, where it is certainly conceivable that a device is intended to be used by a person, but it's not a human being. The person, and I'm using the word person in air quotes here, might be a robot. Simple example. A plain old scalpel is intended to be used by a surgeon. What if I put a scalpel in the hands of a robot? What does that do to the intended user? With artificial intelligence and everything else, that obviously is the topic of a much more advanced discussion. But just throwing it out there for people to think about that, what the regulation says right now may or not be applicable in the future. Bottom line, my recommendation to companies and also to the FDA and I've made this recommendation to the FDA before. I think in our submissions, 510s, de novos, pmas and so on and so on. We should not just simply list the intended use and the indications for use. We should also include in our high level labeling the intended user and the intended use environment. And by the way, one of the benefits of doing that idiom, and I'd love to hear your thoughts agree or disagree, is from the manufacturer's perspective, that will limit them as to the testing that they have to do. So, for example, if my device is intended to be used only by the healthcare professionals and not by individual people, then I don't need to do testing like usability testing in individual people because that would be off label. So I think there's a lot of advantages to doing that, even though thus far we have not been doing that. Do you think that idea has merit?

Etienne Nichols: Definitely. I haven't explored that necessarily from a thought experiment for a regulatory submission. It makes a lot of sense to me, but I've talked a lot about that from a design controls perspective. When you're talking about your user needs, I mean, that question is, who is the user? Is always one that we have to answer. Absolutely, exactly. So, yeah, no, I think that's a really good point and has a lot of merit. When we talk about that intended use environment, the intended use I get to, if you go a little bit further down that rabbit trail, I start to think about the different technological limitations of a home use medical device in comparison to maybe a hospital grade equipment. What factors contribute to those differences? Because when I think about that intended use environment from a hospital setting, for example, that's maybe more tightly controlled than if you were at a home use environment. So what ways do environmental variations in homes impact the performance medical device?

Mike Drues: It's a great question, and I have a number of examples I'm going to tick through quickly. But before I do, I just want to remind our audience one of the things that we talked about in part one of this discussion is how that FDA defines a professional healthcare facility. In other words, the intended use environment would be a professional healthcare facility. But do you happen to remember, I don't mean to put you on the spot, Eddie, and how FDA defines a.

Etienne Nichols: Professional healthcare facility, it's one monitored by a healthcare professional.

Mike Drues: Exactly. Correct. Good for you. So they define this as any environment where personnel with medical training are continuously available. Personnel with medical training are continuously available. Notice, you know, it's important not just to read what the regulation says, it's equally important to read what the regulation doesn't say. It doesn't say anything about environmental conditions like temperature, like humidity, like lighting, like all of these other ambient conditions. It's defined solely by the personnel that are there. Right? So this issue of technological limitations in home use devices is a challenge across the board. So some of the examples that I thought, and this is some of the that I've started with, the list of examples that FDA has provided in their guidance that we referred to in part one of our discussion. But I, as a biomedical engineer and a regulatory consultant, have added a lot more things that we should consider that are not in FDA's guidance. And I'm hoping that when my FDA friends listen to our discussion, maybe they'll consider adding some of these. But some of the obvious ones. Things like temperature, things like humidity, things like, if it runs on electricity, is the device subject to voltage spikes or power outages? Or is a device that's intended to be used here in the United States with our electrical system, versus in the EU, where we have different currents and different volt, different voltages and so on, and lighting conditions, atmospheric conditions, can we assume that all of our devices are going to be used at sea level? What if you have a device that's used on top of a mountain? Or what if you have a device that's used on an airplane? Atmospheric pressure can be a challenge. Airflow and ventilation can be a challenge. Water quality can be a challenge. Contamination, if you have dirt or dust or fluid spills. Electrical interference. There are electrical interference requirements for devices in hospitals, but what about in the home use environment? If somebody turns on their microwave oven, for example, is that going to cause their device to go haywire or something like that? What about interference with wiFi? If your device needs to be in communication with the outside world, and it's relying on Wi Fi or bluetooth or something like that, and there's something that's causing interference. What about having a battery backup? You know, if you have an electrical device and for whatever reason, you lose power, especially if it's a critical device, a life supporting or life sustaining kind of a class three device, a cardiac assist device, for example, and you lose power and you don't have a battery backup or some other contingency plan, that can be a problem for all the obvious reasons. Storage conditions. Is this something that maybe the user needs to store for a period of time and not use it? And if so, if they store it in their garage where it gets really hot or really cold or really dirty or really humid or something is that going to affect the future safety and efficacy and performance of that device? Device disposal. Once they don't need to use the device anymore, are there certain things that they need to do? Can you just throw this in your regular trash or can you, you know, do you need to make special arrangements to get rid of it? Is it intended to be reused or is it a single use device? If it's intended to be reused, does it need to be reprocessed or cleaned in some way? This is a nightmare for healthcare facilities to monitor, and we can talk about this more in a moment, but when it comes to cleaning or disinfecting devices in the home, where it's being done by an individual user, that's a whole other bailiwick. So, as I said, some of these examples are from the guidance, but many of them are not. Many of them I added, because as a responsible medical device professional, I think it's incumbent on all of us to know what to consider for our particular device.

Etienne Nichols: Absolutely. And some of those are. It's funny because it blurs the lines between home use and what the medical or the FDA definition of clinical use, I guess, is, because I'm just thinking like, okay, there's that home use medical device that you also have vibration requirements, potentially. And I know one submission that required, I think the FDA came back and wanted certain Humvee conditions because it was a department of Defense contract so that there were certain vibratory requirements or, you know, we talk about the cleanliness of at home, but that's the same with clinical. And if you're in a country like Malawi, Africa, if you've ever seen the conditions of the hospitals, not to negate any of those, the things that they're doing, but some of them are not quite to the sanitary standards that you might expect in certain places of the world. So. Yes, absolutely.

Mike Drues: Well, indeed, Eddie, and those are terrific examples, and I'm glad you added them. I'll have to add them to my list. But just a quick reminder, one of the things that you and I talked about in part one and one of the recommendations that I made is we talked about this home use guidance that FDA put out over a dozen years ago. In my opinion, that's myopic thinking. I don't think we should have a home use guidance or a healthcare facility guidance or anything like that. I think we should have an intended use, sorry, an intended use environment guidance that includes all of these different things, regardless of what part of the earth you happen to be standing on at the time.

Etienne Nichols: Right. No, absolutely. It makes sense. Yeah. It's almost, it's almost a question because, and I'd be curious to see what your take is on this, instead of asking, is this at home user, is this clinical? This is the way we've approached, or at least in my experience. Instead, we say, okay, well, what are the conditions that are controlled and what are broadly variable? And that's where we focus our design efforts on the parts that are tightly controlled. If it's going to be in a clean room environment, I mean, not a clean room, but an operating room, for example, in a certain region, okay, there's certain controls that you have, but I will focus on the ones that are not controlled. But I'm curious what you think.

Mike Drues: And I loved your reference, by the way, to design controls a few minutes ago, specifically, the user needs and so on. Who is the user? But I would also encourage our audience to consider, even though I don't think they're explicitly stated in the design controls, the intended use environment, because that obviously could influence how you design your device to, to function and so on. So all of these are important throughout the entire regulatory and development process.

Etienne Nichols: Absolutely. So you mentioned cleaning and reprocessing. Did you want to go deeper on that or.

Mike Drues: Yeah, a little bit, because this is a big challenge. I mentioned a moment ago that cleaning or reprocessing of devices that are intended to be used over and over again, a CPAP machine is a perfect example. As a matter of fact, one of the biggest reasons why many patients do not use CPAP machines is because, quite frankly, they are a pain in the you know what to clean. And so, and we talked a few years ago in some of my podcasts on the duodenoscope fiasco that happened at UCLA and a few other places where, because these particular devices, these duodenoscopes, were not reprocessed properly, future patients got infected and in some cases die. So reprocessing of medical devices is not easy thing to do. Even in healthcare facilities. When you talk about doing it at the home, it's even more critical. It's got to be a no brainer. It's got to be simple, it's got to be easy. Otherwise, people are not going to do it. And basically, your device, depending on who it's intended for, your device needs to be able to function perfectly after it's cleaned or reprocessed by a 70 year old person, possibly with diminished physical or cognitive abilities. Because if it's not, then that could cause problems for the person that's using that device, if it's a CPAP or something like that, you have to be concerned about things like foreign body contamination. If it's being used by multiple different people, you have to be concerned about residual cleaning materials. So if you're using a particular solvent, even something like alcohol, to clean it, and you don't get all of the alcohol out of there, and some of that alcohol ends up in the patient, what are the potential consequences there if you have pathological bacteria, viruses, fungi, and so on and so on, and you don't get all of them. So there are a litany of things that you need to be concerned about when it comes to devices that are intended to be used in the home and also be reprocessed. And one of the things, the last thing I'll mention on this one, Erin, is after the UCLA fiasco occurred, one of the recommendations that FDA made in the reprocessing guidance, which I agree with, is that every company has to have a validated cleaning or reprocessing procedure. I'm 100% in favor of that. The question is, an FDA did not address this in the guidance. Who does the validation? Oftentimes, it's the people in the manufacturing company that do the cleaning validation. But unless those people are actually doing the cleaning or reprocessing out there in the real world, that validation is, in my opinion, totally without any merit. It should be validated. If your device is intended to be cleaned or reprocessed by a 70 year old patient, when you do your cleaning validation, you should validate it using a 70 year old, perhaps disabled patient.

Etienne Nichols: Yeah.

Mike Drues: Does that make sense?

Etienne Nichols: Yeah. And I think it goes right into the. If you were to do a human factor study, that should be part of that human factor study, just to determine how maybe we can jump right in. I mean, is this a good segue, do you think, to go ahead and talk about human factors, usability as far as home use?

Mike Drues: Absolutely. And it is a good segue. Thank you for bringing that up. So, usability or human factors is another thing that we've talked about in many podcasts. As a matter of fact, I did a webinar focusing on human factors and usability for green light. Maybe we can provide a link, but at a top level, here's the first thing that I say. Usability testing is important virtually for all medical devices across the board. I'm not saying every single one, but virtually every single one. Human factors or usability is important in, say, traditional devices, devices that are going to be used in a hospital by a clinician. But human factors is just as important, maybe even more important, for home use devices that are going to be used by regular people. Because remember, regular people didn't go to medical school, they didn't get the training. They didn't probably go, you know, get a training from even the manufacturer either. And so usability is even that much more important. And it's not. So. So one aspect that we need to take into account is the intended user. If the intended user is a non healthcare professional, that's a different thing than a healthcare professional. But the other thing to keep in mind, Eddie, and especially for more critical home use devices, even if your intended user is a non healthcare professional and something happens, something goes wrong, and they're using this in their home, they're probably not going to have the benefit of a healthcare professional, a nurse or a doctor or something sitting in the next room over that could come in and help them if they need it. So this is another thing that needs to get factored into usability as well. And then the last thing that I'll mention, because there's a lot of things that we can talk about when it comes to usability of home use devices, but the last thing that I'll mention quickly is training. It's challenging enough to get physicians to go through trainings for our devices. I mean, just look at the Da Vinci surgical robot. I mean, that's a quintessential example of that. But how do we make sure that we train non healthcare professionals, people that are gonna use this in the home for some kind of devices? I've made recommendations, if it's an electronic device, if it's got a computer interface, for example, that the device will not allow a patient to use it unless and until they have some evidence, you know, a code or a certificate or something, that they've gone through the training. Remember, you know, we've talked about risk as well, many times. ISO, and I agree with them on this, says that labeling should never be your primary way to mitigate risk, that you should do all that you can via design or other things. And I think, by the way, the reason why they, they say this, Eddie, and although they would never mention this publicly, but I think it's true, is because it's a simple acknowledgement that most people never read, let alone follow, you know, whatever it is on the label. So, putting a line of software in there, a question, you know, have you been trained to use this device? And if you have, enter a coder or get a, you know, get a. A prescription or something like that. I think it's a reasonable recommendation, especially for devices that are a little more critical than others.

Etienne Nichols: When you talk about those risks, you said you have to think about risk management. I think of them as essentially the same. Usability being a subset of risk, risk management. Honestly, it's interesting how we've broken it apart as its own thing, which I suppose it is its own discipline to a certain degree, but. Yeah, yeah.

Mike Drues: I mean, without quibbling about terminology, I'm not sure if I would consider a subset or not, although there clearly is an awful lot of overlap. But these are two obviously very important pieces of the puzzle that we need to consider individually, but then we also need to consider them collectively. How do they interact one another? And I give you an example, usability. This is actually technically this is not a device, it's a combination product. But you're probably, most of our audience is probably familiar with the EpiPen, the epinephrine auto injectors. Well, you may remember a few years ago there were a whole litany of user related problems associated with Epi pens. And one of the things was in some cases, and keep in mind, Erin, that unlike in a lot of devices, this is a device that's used in a very, very acute situation. In other words, the patient is having a severe allergic reaction. They might be going into anaphylactic shock and if they don't use the product properly and immediately, they could die. Right. So this is clearly, you know, a serious problem. It's not a class three device because it's not primarily a device, it's primarily the PMOA of the EpiPen is a drug. So we don't use the classification system here, but nonetheless it's an important problem. Well, there were reports, among other things, of problems, sorry, of people, of patients injecting the pen, but they were holding it upside down. In other words, instead of the needle sticking into their thigh, it got into their thumb. Now my question to you, Etienne, and some people might consider it as a rhetorical question, why do you think that this particular failure mode, if you will, was not detected pre market? Why do you think it was? Because we have, for straight up devices and for combination products, including the EpiPen, we have a litany of requirements for usability testing and yet this particular problem was not detected. And any speculation as to why?

Etienne Nichols: Well, my guess is it relates back to the human factors and who was involved in those human factor studies. But yeah, what's the real answer?

Mike Drues: You're close, you're close. This is, in my opinion, the answer. Let me share with you a scenario that I think I shared in that. In that webinar, I was involved giving a presentation at a conference a few years ago, and coincidentally, the person just in front of me was talking about a human factor study that they did for a particular device. I think it was a laparoscopic surgery device. I don't remember. Doesn't matter. And one of the things that she said is, before beginning the study, the surgeon had to read and follow the directions for use. And I purposely wanted to get some discussion on this. And I said afterwards, I asked in the forum, I said, well, you realize that you have now totally invalidated your entire usability study, because we all know that most people don't read, let alone follow, what's in your directions for use. And she says to me, yes, Mike, I agree with you 100%, but it passed mustered at the FDA. The reason why I'm sharing that with you here is because the same logic applies. If we force people to read and follow the instructions for use, holding the pen upside down would never in a million years happen. Right? So my advice to companies, when it comes to usability testing, if you really want to do realistic usability testing, I'm not talking about ticking boxes off of some regulatory form or guidance. Realistic, then. All of my usability studies have two, and only two steps. Give your device, give your product to the user, and then, as my wife would say, you can stop talking now. Give your device to the user, and then you can stop talking. And if one of the first things they do is they take your device out of the box and they take the DFU and throw it right in the trash, then that's what you write down. Now, of course, as you can imagine, Eddie, and I don't think I've come across any company that's willing to do that in the real world, for all reasons. But if you're really interested in doing true usability testing, it's something that you.

Etienne Nichols: Might consider that's interesting that you haven't come across it. So, I learned human factors under Shannon Hosi, who is the human factors team lead at FDA. Proud of coming to the company that I worked for. And that was one of her things, you know, who really listens to the IFU? Who really reads it? So that was part of our study. So anyway, that's.

Mike Drues: And by the way, one other thing, quickly, before we move on to the next topic on usability, going back to the usability guidance, and again, we've talked about this in other discussions and in my webinar, FDA has put out a handful of guidances on the usability of medical devices and combination products and so on. But unfortunately, in not one of those guidances do they distinguish between a home use device and a device that's intended to be used in some sort of a clinical environment. And in my opinion, that's a huge oversight. And just one very last thing about usability, and I think we can move on, is most of the time when people think about usability, they think about premarket usability, in other words, formative testing or subjective testing. However, there's a whole other part of usability that is post market usability. As a matter of fact, FDA has a section on their website, on the CDRH website, specifically dedicated to post market usability testing. This is something that I talk about in my post market surveillance and my complaint handling course, perhaps as a future topic of discussion, Eddie. And we talk in more detail about post market usability testing, because that's something that a lot of people don't think about. Perhaps it's because usually the R and DA engineers are not involved with that because it's post market. It's usually the complaint handling and the post market surveillance people that handle that. But that's another aspect of usability that I think is often overlooked.

Etienne Nichols: What about data security challenges or cybersecurity? That's been a really big topic over the last year, especially from the FTA.

Mike Drues: Absolutely. And I did a podcast with greenlight on cybersecurity. It was actually, I think it was in the top ten list of podcasts listened to last year. And one of the things that I differentiated is we have to be a little careful when we refer to something like cybersecurity. So in FDA's involvement in it, what I'm not talking about here are things like identity theft, like if somebody steals your address or your credit card information. That's obviously it's a concern, but it's not a concern to the FDA. What I'm talking about here is things that could directly impact the safety, efficacy, performance of your medical device. And the reason why I bring that up is just one of many things that I talked about in the podcast. But sometimes I think people, they don't understand that the FDA context of cybersecurity is a little more limited than the, than the broader context. I'm not trying to suggest that things like identity theft are not important. Of course they are, but not in the context of FDA. That said, cybersecurity is a big issue in home use devices. It's an issue in hospital based devices as well. But think about it this way, in most hospital or clinical environments, you have some sort of like it department or it staff, you know, as a backup that is supposed to be monitoring such things, making sure, for example, your virus software is up to date, monitoring for people trying to hack into the system, and so on and so on. But in a lot of home use devices, I don't know about you, Eddie, and, but in my company, I'm a very small company, so I provide my own it support. And suffice it to say, it's not my full time job. So I don't think it's reasonable to expect people who are using devices in the home to have to jump through a lot of hoops to worry about things like cybersecurity and so on. That should all be done behind the scenes as much as possible. That should be all, you know, that should be out of the minds and the thoughts of the user applying software patches or fixes or stuff like that. For example, one of the recommendations that I give to companies, especially for more critical fixes or more critical patches, is don't just rely on the user to periodically check to see if there's an update, but do a push instead of a pull. In other words, push that to them. Have your device, assuming that it's always connected to the Internet or something, have your device send a signal to your device that says, hey, you need to be updated. Don't rely on the person, the user to do it. And one of the other things that I mentioned is when you have a device that is constantly on the Internet, you constantly have to be worried about things like cybersecurity, because it's not a one way valve. In other words, if your devices is sending out information to the world, it stands to reason that other information or other people can be traveling that road in the opposite direction. So one of the recommendations that actually a lot people liked I made in that, in that podcast was, if you truly don't want to have to worry about cybersecurity and hacking and identity theft and so on, just make sure that your device has no capability to connect to the outside world. In other words, don't plug it in, don't hook up with Wi Fi or whatever, because if it ain't connected, it's pretty hard to, to break into it. So again, cybersecurity is like, like usability and reprocessing and so on. These are all important issues for virtually all devices but when it comes to home use devices, they do present some similar challenges, but also some different, some unique challenges as well.

Etienne Nichols: And just going one step further, when you talk about building up that cybersecurity, there's the maintenance and calibration of those medical devices in that home setting. What strategies would you put in place for those unique risks?

Mike Drues: Absolutely. And I've had several companies that were customers of mine where they had problems with their devices that were being used out of, you know, in a hospital or in somebody's home, and they started going whack a doodle because of calibration. You know, they were either miscalibrated or they went out of spec or whatever it is. So once again, we have to take. You talked about risk a little bit earlier. We have to take a risk approach. The more significant the harm is because of calibration problem, the more we have to do to mitigate it. So if it's the potential for a significant problem, and again, this is a critical kind of advice. I don't necessarily mean critical in the class three sense of the word, but there are many class two devices that I would call critical. Things like, for example, devices that measure your glucose or your act or activated clotting time for people that are on heparin. These are all, these happen to be ivds, in vitro diagnostics, but they're class two. They're not class three s. So for devices like those, if the recommended recalibration schedule, let's say, is once a year or once every six months or whatever, if you have a little clock in your device, then add a little code in there, this would not be hard to do. That actually disables the device such that after that period of time, whether it's a year or whatever it is, if the device has not been recalibrated either by the user or in some cases, it might have to be sent back to the factory or something like that. But if the device was not recalibrated, then they physically could not use the device even if they wanted to. So there are things that we can do to mitigate these risks beyond just simply labeling. I mean, to me, if you put a label on it that says your device has to be recalibrated, but five years later, the person is still using it and it has not been recalibrated, and it does go out of whack. And I had a case like this, a product liability case, where this exactly happened. The device was used well after it was supposed to be recalibrated. Other than a label warning. The company did nothing to mitigate that risk. Long story short, that particular patient was harmed because the device was giving them more wrong information. The company got sued, and it was very easy for me to make the case. Well, in spite of the fact that you, on your label, it said to recalibrate this once a year. You allowed the patient to use this five years after, and the result, they became harmed. And Eddie. And you don't have to have a JD after your name from Harvard Law to say or to hear ka ching, kaching, kaching. That's exactly what happened here.

Etienne Nichols: It's an interesting balance when you talk about product liability versus patient safety or. And hopefully they should always overlap. You know, if you do the right thing for the patient, you'll be safe from a liability perspective, but just a counter residual risk that I was thinking of. Let's suppose someone is out in the wilderness or something like Arimati, or one of those third world situations where they need something, even if it's more out of whack, and suddenly it just is disabled because you're past the date, there's an issue there, too. So you have to.

Mike Drues: Of course there is. And, you know, as they say, there's an exception to every rule, and there's an exception to every exception. You know, as I often like to say, average regulatory professionals know the rules, but the best regulatory professionals know the exceptions, so. You're exactly right. But we're. For the purposes of our conversation, we're talking in more.

Etienne Nichols: Yeah. And I can't help but. Yeah.

Mike Drues: One last recommendation, though, is I remember years ago when I. When I was working on my MBA, one of my professors was fond of. Well, he said something that was very simple, but at the same time, very profound. He said, if you want more of something, you create incentives. If you want less of something, you create disincentives. So here's another suggestion I've made to medical device companies, not all medical device companies across the board, because I don't think that these requirements in the QSR should be agnostic to the device. Some things are going to be dependent on certain kinds of devices, other things are going to be dependent on other kinds of devices. But if you're working on a more critical kind of device. Again, I don't want to limit myself to class three, because there are a lot of class two and perhaps even a few class one devices that I, as a biomedical engineer, would call a critical device. But if you're working on a critical device and it needs to be recalibrated or it needs to be checked to see if it's still, you know, performing according to the spec and so on. Maybe if you create an incentive where if you, if, if the patient sends this in, and by the way, you should give them a, like a prepaid, you know, box or envelope or whatever to make it easiest possible for them to do it, then that, you know, if it uses a disposable, like a CGM or an INR monitor or something like that, you give them a week's worth or a month's worth of free consumables as a little bit of an incentive for them to send it in. Is it going to guarantee that they're going to send it in? No, of course not. But if you want more of something, you create incentives. If you want less of something, you create disincentives. It's as simple as that.

Etienne Nichols: Yeah, the James clear method. Make it easy, make it obvious. You mentioned the post market at one point, but I would expect to be that, to have a unique challenge with home use medical devices, especially if there's no, maybe no incentive to report back on how things are doing. What's the challenge there?

Mike Drues: That's a humongous challenge, Eddie. And the simple example I like to use, and I use this in the Philips case that we talked about last time, is how many people, when they go to Walmart and buy a toaster, how many people fill in the product registration code and send it in. You're laughing. And of course, I'm dating myself, because nowadays you don't have to do it on the postcard. I think you could do it on a website. And so, but nonetheless, most people don't do that. The same thing applies to medical devices. One of the biggest challenges that Phillips had with their home devices is a reminder from our previous discussion. This was the largest class action lawsuit in the history of the medical device industry, leading to a $1.3 billion billion with a b settlement. Is because they had a heck of a time notifying the people that were out there with their devices. And in many situations, keep in mind, Eddie and the company received more than 100,000 complaints over the period of just a few years. Those were from the people that they knew about. What about the people that they don't know about? So again, if you're working on some sort of an electronic device that is somehow connected to the outside world, from an engineering perspective, this is an easy solution. This is an easy fix. When they turn on the device for the first time, force them to go through the registration process and not allow them to do whatever it is that the device is supposed to do until they do that, until they have an active registration. Now, if you're working on a device that's not connected to the outside world, or if you're working on a, say a mechanical device or something, then yes, you're. Exactly, you know, it's a bigger challenge. How do you get people to, to register these things? But nonetheless, I think with a little bit of imagination, like creating an incentive, you know, with, once we receive your registration, we give you a 10% rebate or we give you some consumable or disposable for free, or we send you a, you know, a $25 gift card or whatever, whatever it is, you know, some incentive to do that. I think it's incumbent on us as medical device professionals to make it as easy as possible for people to do it and give them some motivations to do it. Does that make sense?

Etienne Nichols: I think it does. We talked a little bit about this last time, I believe, if I'm remembering correctly anyway, about how, who should this have been fallen on? Yes, the manufacturer really should have been reaching out to those customers. Maybe they didn't do as good a job as they should have because I mentioned, well, the FDA or the doctors, and that doesn't necessarily make sense to fall on them. However, this has sort of been solved in other industries. Yeah, you mentioned learning from other industries, and I've always tried to look at other aerospace, steel, whatever. Even sub niches within medical device pacemakers, for example, have. Typically you would have something that sits on your bed next to you and monitors that pacemaker as you sleep. Sends a warning to your doctor when the, maybe when the battery is getting low. Seems like there could be a very simple application as well, or cross pollination of industries here. And it could be the difference in the, the seriousness we, we give cardio, cardiology and the lack of seriousness we give to maybe a sleep doctor, maybe just a respiratory person who is ready to hang it up, but.

Mike Drues: Well, as I said a moment ago, idiot. And I strongly believe this. You know, one of the downsides, not a downside, one of the big criticisms that I have of the quality system regulation, I think there's a lot of good stuff that's in there, but I think there's some stuff that's not, is there totally the QSR. And it makes it very clear it's totally agnostic to the class of the device. In other words, whether you're talking about a class three life supporting or life sustaining implant or a, you know, or a class one exempt, you know, like a band Aida. The requirements are the same. And of course, the degree of the requirements, you know, is different, obviously, but the basic requirements of the QSR are exactly the same. I think that kind of gets people in trouble when they try to treat a band aid like an artificial heart, because I see that happen a lot. And so I think we need to take a, not to use an overly used cliche, but a risk based approach. The more risky that your device is, the more we have to do. The less risky your devices, the less that we have to do. If you have a very, you know, a very, very simple band aid. I'm just trying to use band aid as a simple metaphor. I don't want to hold companies to the same level of testing and responsibility as a. As an artificial heart. That would make absolutely no sense.

Etienne Nichols: Right. You know, it's, I think about the current examples of regulatory requirements and so on. And you make a good point about the class three, class two, class one, and the various risks that are, that are inherent or exist within each of those classes. There are risks in a class two medical device that could kill you, for example.

Mike Drues: Of course. Absolutely.

Etienne Nichols: What are the regulatory frameworks, or how do you feel like they could be adopted to address the unique risks associated with the operation of home use medical devices?

Mike Drues: Well, so, first of all, the question itself sort of already assumes that the regulatory framework for home use devices is lacking or inadequate and that it needs to be strengthened or it needs to be fixed. In other words, this is another way of asking the question that I've asked many, many times, do we need more regulation? And if we created more regulation, does that mean that we would have fewer problems in the future? Well, suffice it to say I have never made the assumption that regulation, the amount of regulation, whether it's a lot or a little, correlates to the number of problems that we have. In other words, I would not assume that if we have more regulation, we have fewer problems, or if we have less regulation, we have more problems. So even though I work, as you know, Etienne, as a regulatory consultant, I'm not a big fan of creating more regulation because we've already got thousands and thousands of pages of that. I think what we need is people who don't take just the literal interpretation of the regulation, but they understand what I call the regulatory logic of why do we have that regulation and what is it trying to achieve in the real world. We've talked not only in this discussion, but in part one, many examples of using regulatory logic, like why, for example, do we have a guidance on home use devices? Why don't we think about them in a more general sense, like the intended user environment? And you know, one intended user environment might be a hospital, another might be somebody's living room, and so on and so on. So in my opinion, we don't need to have more regulation. I think the regulation that we have is good. I think much of it is applicable to home use devices if we approach it in the, in the proper way. A couple of other things that I would just like to mention very, very briefly before we wrap this up is we mentioned a little bit about post market challenges of home use devices. Like for example, reporting and adverse events and recalls and so on and so on. But how about change management in home use devices? In other words, if you want to make a change to an existing device that's already on the market, let's say it's a 510k device and it's a home use device. Do you need to do a special 510k or can you get away with a letter to file if it's intended to be used in the home? There's no specific verbiage on that. We've talked a lot about post market changes and how to best handle them because as a reminder, Adian, one of the single biggest reasons why companies get in trouble from the FDA is because of change management or the lack thereof. It's a big source of my business, to be honest with you, but when it comes to home use devices, this is a particular challenge. What about the off label use of home use devices? And I know many in our industry don't like to talk about off label use, but these are the same people that are like ostriches sticking their head in the sand pretending this doesn't happen, because it does happen all the time. It's one thing to talk about a, a healthcare professional, a doctor, surgeon, nurse, whatever, using a device off label, but what about, you know, Mary Smith in her living, living room or her garage or her car using her medical device in some off label way? There have been a number of problems that, that have happened in those areas as well. So bottom line, there's a lot of similarities between devices that are intended to be used in healthcare environments, but there are also some differences. And sometimes there are potential problems that can happen in a home that are even more significant than if the same problem happened in a hospital. And over the course of both parts of our discussion in this series. I hope that we did a pretty decent job of talking about many of them. Certainly not all, but many of them.

Etienne Nichols: I would expect foreseeable misuse to handle some of those issues and then complaints from the field, potentially. But I recognize the challenge with getting those complaints from the field. That makes sense.

Mike Drues: Just remember, you used one of my favorite phrases from the design controls is foreseeable misuse. Foreseeable misuse is not necessarily off label use. And the reason why I'm mentioning that very, very quickly is because oftentimes the off label use of a device, or a drug, for that matter, oftentimes the off label use is the standard of care. In other words, it's what we teach in medical school. So are we going to try to argue that if somebody uses a device following the standard of care, that it's foreseeable misuse? I personally think that's a weak argument.

Etienne Nichols: Well, I'm not saying you would justify it, but I'm saying you should make that risk mitigation or recognize the off label ability and expand the umbrella of your intended use. Yeah, well, I'd love to talk more. I guess we're close to being out of time. Any other things that are important that you feel like we should cover or important takeaways?

Mike Drues: I think. I think we've covered a lot, certainly not everything, but hopefully we've provided some benefit to people. And if you're listening to the second part of this discussion and you haven't listened to the first, please go back and listen to the first as well. I think it'll make a lot more, more sense. And obviously, you know, if. If there's anything that, that either of us can do to help, you know, feel free to contact us.

Etienne Nichols: Awesome. Thank you so much, Mike. Really appreciate you coming on the podcast, sharing all of your knowledge, your experience, and all of the examples. Thank you. Those of you who've been listening really appreciate it. We look forward to seeing you next time. Until then, take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says, leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us, and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.