The Trouble with Home-Use Devices, Pt. 1

October 4, 2024 ░░░░░░

#385_ The Trouble with Home-Use Devices, Pt. 1

In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings.

They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction.

The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance.

This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.

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Key timestamps

[00:01] – Introduction: Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message.
[02:30] – Defining Home Use Devices: Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint.
[07:50] – Why Home Use Devices Matter: Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI).
[12:15] – Case Study: Philips Respironics Recall: Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers.
[25:45] – Post-Market Surveillance and Complaint Handling: The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance.
[35:30] – The Importance of Intended Use Environment: Exploring how intended use environment should influence design and usability considerations.
[45:20] – Teaser for Part 2: Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices.

Top takeaways from this episode

Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience.
Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH’s 2025 strategic priorities.
Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices.

Practical tips for MedTech professionals

Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.
Emphasize Post-Market Surveillance: Develop strong post-market surveillance and complaint handling processes to catch and address issues early.
Communicate Clearly with Users: Create user-friendly labeling and instructions that cater to non-professional users to minimize the risk of misuse.

MedTech 101

What are home use medical devices?

Home use medical devices are defined as devices intended for use in environments outside of traditional clinical settings, such as homes, schools, and offices. These devices must be designed to accommodate non-professional users, accounting for factors like usability, environmental conditions, and ease of maintenance. Understanding these nuances is essential for developing safe and effective devices for a growing market.

Memorable quotes from this episode

“A home use device isn’t just a device that could be used at home; it’s one that’s intended and labeled for use outside traditional clinical settings.” — Mike Drues
“When post-market surveillance fails, it’s not just a compliance issue—it’s a safety issue that can put lives at risk.” — Mike Drues
“Regulatory logic goes beyond the written rules—it’s about understanding the intent behind them to ensure devices are safe wherever they’re used.” — Mike Drues

Audience feedback

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Transcript

Etienne Nichols

00:01:18.650 - 00:01:32.470

Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. With me today is Mike Dreus.

How are you doing today, Mike?

Mike Drues

00:01:32.950 - 00:01:34.710

I'm well Etienne and thank you for asking.

Etienne Nichols

00:01:34.870 - 00:01:55.270

Mike presented a topic on the idea of home use devices.

So, this kind of came out of talking about dangerous devices and some different aspects of what makes a medical device dangerous or what are some of the dangers that the medical device industry is faced with. But what are your thoughts? How would you like to introduce today's topic? Mike?

Mike Drues

00:01:56.060 - 00:02:13.580

Well, first of all Etienne, and thank you as always for the opportunity to talk to you and our audience today about a very timely and a very important subject. Maybe the first place to start is what exactly do we mean by a home use medical device and is this something that's really new?

Etienne Nichols

00:02:13.900 - 00:02:41.220

Yeah, that's a good question. Do you want me to answer the question?

When I think of what home use medical device is, I think of that as a device that's intended for a non-clinical or maybe an ambulatory setting, something outside the clinical setting that is going to be either managed by the user or only by the user and not a professional user of that medical device, if that makes sense.

Mike Drues

00:02:41.700 - 00:05:13.020

Well, I think that's a great start, Etienne. And you used one of the fancy regulatory buzzwords in there, intended.

And that is an important part of what a home use device is, at least from a regulatory perspective. And I'll get into that more in a moment.

But first of all, I just wanted to point out that although we are certainly using more and more devices in the home today, this is absolutely not a new topic. Absolutely not.

As a matter of fact, when you think about it, people have been using medical devices outside of the quote unquote traditional clinical environment literally since the beginning of time. Literally since people have been living in caves. So, it's not a new topic in that regard.

CDRH does have a website specifically devoted to the topic of home use devices, and we can certainly provide that to our audience as part of the additional information with this podcast. But also, FDA put out a guidance entitled Design Considerations for Devices Intended for Home Use.

The original draft guidance came out in 2012, and it was finalized a decade ago in 2014. So, this is not a new topic by any stretch of the imagination.

Some of the devices that are included in this particular guidance that I refer to include very simple devices like for example cold packs and wheelchairs and walkers and so on.

But they also include much, much more complicated devices, much more critical, much more risky devices, for example devices to generate and or supply oxygen, infusion pumps, CPAP machines. We'll talk more about those and the ramifications in a moment.

But we have to be really careful about over generalizing when we start lumping all of these devices within one guidance because obviously a cold pack is not the same as an infusion. And so, when we try to have a guidance that covers all of that, it becomes more and more difficult to do.

So obviously we're using more and more devices outside of the traditional clinical environment. They present some similar challenges to us as medical device developers, but they also present some important differences and some unique challenges.

And those are some of the things that I hope to get into our discussion today, which by the way is going to be a two-part discussion that because of the subject is such a broad and important topic.

Etienne Nichols

00:05:13.100 - 00:05:24.460

You mentioned this topic being an important topic, but not a new topic. So, I'm curious, why is this topic important to talk about now and why is this important to manufacturers and to patients?

Mike Drues

00:05:25.180 - 00:08:26.000

Well, great question. And again, if we can come back to the original question first of what is a home use device?

Because you got us is a great start, but I just want to fill in some of the regulatory blanks.

So, some people, and you even see this on FDA's website in a couple places, some people define a home use device as a device that could be used in the home as opposed to what you said a moment ago, a device that is intended to be used in the home.

There's a big difference And I have a big problem, not just as a regulatory consultant, but as a biomedical engineer saying that a home use device is a device that would be used in the home. Because when you think about it at the end, any medical device could be used in the home.

If you want to use a cardiopulmonary bypass machine in your living room or in your garage, you certainly can. Right?

So, we're talking about devices that are specifically labeled, that is intended, what we call the intended use environment to be in the home or outside of any traditional clinical environment. So, the way FDA defines a home use device is a medical device that's labeled or intended for use in any outside environment.

Sorry, in any environment outside a professional healthcare facility. Any environment outside a professional healthcare facility. That begs the question, okay, what exactly does a professional healthcare facility mean?

We'll talk about that in a second.

But these kinds of environments include things like outdoor environments, office environments, not necessarily a doctor or a dentist office, but for example, an office that you might have at Greenlight or something like that. A school. But once again, there are differences.

A school might not be a professional healthcare facility, but what about the nurse's office in the school? Or what about if they have some sort of like a, you know, first aid station in the school? Is that a professional healthcare setting? Vehicles.

But again, what we're talking about here is the car that you and I are driving around. What about an ambulance? Is that a professional healthcare environment? How about a boat?

Well, a boat that you might use for recreational purposes would not be a professional healthcare environment. But what about one of these great big ships that the Navy has, these, these hospital ships? That's basically a floating hospital.

So therefore, that is a clinical environment. Battlefields, outer space. I remember a few years ago I was invited by NASA to give a.

To do a workshop on 3D printing of medical devices and drugs in outer space. So, is outer space a clinical environment? Remember, as we've talked about before, opinion, average regulatory professionals know the rules.

The best ones know the exceptions. And what I'm talking about here are some of the exceptions. Does that make sense?

Etienne Nichols

00:08:26.480 - 00:08:44.260

Yeah.

And I'm curious if you have a definition for that, that outside the clinical environment, or if you have some different rules that you use when you follow, you know, just because it's in a moving ship or a moving ambulance, does that negate its clinical use or clinical environment? How do you define the environment?

Mike Drues

00:08:44.420 - 00:11:14.280

Excellent question, Etienne.

And I will give you FDA's answer to that because it might surprise some people in our audience the way The FDA defines a professional healthcare facility is any environment where personnel with medical training are continuously available to oversee or administer the use of medical devices. Let me read that one more time. Any environment where personnel with medical training, of course. What the heck does that mean?

Does that mean you have to have an md? What if you took a CPR course through the Red Cross?

Anyway, personnel with medical training are continuously available to oversee or administer the use of the medical device. Note that it's not defined by the location, it's not defined by the equipment they may or may not have it. It's strictly defined by the staffing.

If you have staff that is, say, stationed there, you know, that work there, and are continuously overseeing that environment, then that would fit FDA's definition of a professional healthcare facility. And by the way, they also include clinical laboratories.

And the reason why I think FDA singles this particular category out, and I agree with them on this, is, is because in vitro diagnostics, IVDs are more and more now intended to be used in the home as well. So that's blurring the lines. But I mentioned a moment ago, Etienne, this guidance that's been around now for more than a decade on home use devices.

My question is, why are we focusing on home use? I just gave you a litany of examples that are outside of a clinical environment, but not necessarily in a home. So why aren't we focusing on home use?

Why not instead focus on the intended user environment?

I would love to see FDA put out a guidance that specifically talks in detail about the intended use environment, whether it's a clinical traditional environment, or an ambulance or a ship or whatever the heck it is. Quite frankly, I could care less. So, I find it interesting how the title of the guidance itself refers to home use devices.

And yet within that same guidance, FDA has a litany of examples of devices that are intended to be used outside of the traditional clinical environment, but not in your home, not in your living.

Etienne Nichols

00:11:14.520 - 00:11:30.730

I recognize the difference the environment, because by that definition, the nurse's office at the school would be a healthcare environment or a healthcare facility. It could be, yeah. Yeah. Well, would it not be? But I mean, it seems like it is based on that definition.

Mike Drues

00:11:31.210 - 00:12:31.500

You know, it's, it's, it, it's, it's kind of like the law.

You know, one of this, one of the skills that we teach in law school, and we really should teach it in regulatory school as well, is no matter how you may feel personally on a particular issue, you have to be able to argue both sides of that issue. Just as Strongly just as, as vehemently so depending on which argument that, sorry, which side of that argument I'm on.

This is going to sound a little trite idiom, but it will detect, it will be determined largely by who's paying me.

In other words, if I'm getting paid by a medical device manufacturer and they want, they, they intend to have their device used in a school nurse's office, the manufacturer, you know, might make an argument that this does not fit, you know, the traditional clinical use, that this would be, you know, home use.

On the other hand, if I put my FDA reviewer hat on, because as you know, I work part time as a consultant for the FDA, I might look at it from the opposite direction. So that's why I say it could be, or it could not. It depends on.

Etienne Nichols

00:12:31.900 - 00:13:18.640

Yeah, yeah.

My immediate thought was that it is based on the environment description, but the healthcare description and the fact that there's ambiguity there allows the ability to say it's not. So, I get where he's coming from. That makes sense. The continuous monitoring of a healthcare professional. Professional. Okay.

So that being said, what about the differentiation or the subtle difference between okay, this environment because I, if I'm a healthcare professional and I'm continuously monitoring this device, now we're in a healthcare facility or versus home use. What, what is the difference in utilizing those subtle definitions?

And if, if you have a medical device that you call a home use or a medical device that's not used in a medical continuously monitored by a healthcare professional, what's the difference there? Does that make sense at all?

Mike Drues

00:13:18.640 - 00:15:23.180

Well, it does, and I have several examples that I'd like to get to. But I want to come back to the question that you asked a moment ago that I didn't get a chance to answer yet.

And that is where we started to talk about it. Why is this particular topic important to patients, but also important to us as medical device professionals?

First of all, as I said before, obviously we have more and more devices that are intended, that is being labeled to be used in the home that is not in a traditional healthcare setting.

Second of all, CDRH did list this as a strategic priority for them in 2025 home use devices in general, and specifically the safety of these devices in particular. And we can put a link on the website for the 2025 CDRH Strategic Priorities.

But the third reason why this is important is because you and I in some previous discussions referred to the annual report that the Emergency Care Research Institute or ECRI puts out every year. They are for those that are not familiar with ECRI.

They are an independent authority, independent of industry, independent of FDA, independent of government, independent of everybody. They're an independent authority on healthcare technology and safety. And every year they put out a top 10 health technology hazards list.

And if you look at the last couple of years, specifically 2023 and 2024, they identify the safety of home-based medical devices, devices that are intended to be used in the home, as the most pressing health technology safety issue in the 2023 and then again in 2024. That's a direct quote. The most pressing health technology safety issue for 2023 and 2024.

So, this is an extraordinarily important topic for a whole bunch of different reasons.

Etienne Nichols

00:15:24.860 - 00:15:51.370

Is that because…well, we're about to get into why that could be.

When I think about why that could be, I mean, if a professional is utilizing this equipment versus someone who's untrained, is utilizing a piece of equipment, it seems relatively obvious.

I mean, if you take this outside MedTech, put a table saw in this, in the hands of someone who's never used it versus a professional woodworker, I could tell you where it's more dangerous. It's in the home. And so, and so I would assume it's the same with a medical device.

Mike Drues

00:15:51.370 - 00:16:05.970

And so absolutely no doubt about it.

I don't use the table saw example, but I do use a similar metaphor, a scalpel, you know, a scalpel in the hands of a trained surgeon is a, is a wonderful tool. In the hands of somebody else, maybe not so much.

Etienne Nichols

00:16:06.490 - 00:16:10.650

I've used the same example with my 4-year-old. It becomes very dangerous when he holds it. Yes.

Mike Drues

00:16:12.250 - 00:16:21.090

So perhaps we can take a look at least one example to help, you know, the audience, you know, understand more of the, the details here. How does that sound?

Etienne Nichols

00:16:21.090 - 00:16:21.930

Sure. Yeah.

Mike Drues

00:16:22.650 - 00:17:31.750

So, one example of a device, probably my favorite example, a recent case study of a device that was intended to be used in the home, but for a variety of reasons went on to cause a lot of problems later on, was the Phillips Respironics case. The largest medical device class action lawsuit in the history of our industry.

And in the interest of full disclosure, I was an expert witness in this case for a number of years. The case recently settled, as you probably know, a few months ago for $1.3 billion. That's billion with a B.

So, I am now able to talk about it a little bit.

I'm only going to share obviously publicly available information, but this is probably one of the most famous or infamous examples of a device, actually several devices that were intended to be used in the home that for a variety of reasons became problematic and led to this big lawsuit and recalls and so on and so on. Do you think that's a good example to drill into a little bit, Etienne?

Etienne Nichols

00:17:32.070 - 00:17:37.110

I'm curious if. If it would not have occurred had it been in the hospital as well?

Mike Drues

00:17:37.990 - 00:19:30.230

Good question. Some of it, yes. Some of it, no. Excellent question, though. Let me come back to that in a second.

But for those in the audience that are not familiar with the case or not more familiar with, just like the, you know, the headline in the news, let me just share sort of a few of the details. First of all, this, technically or officially, this started back in 2021.

But in fact, there was evidence of these problems at least a decade, probably more than that beforehand. It led to the largest recall in the history of the medical device industry ever. The largest recall across the board.

Some five and a half million medical devices were in need of repair or replacement. These were all respiratory devices of one kind or another. I mentioned CPAP machines. It also includes some ventilators and so on and so on.

In a nutshell, I don't want to get to the.

Into too much of the technical details, but in a nutshell, the technical problem was that the manufacturer used a type of foam in the device to dampen the sound, because this is a device that people use when they're sleeping. And so, you want to try to make the device as quiet as possible.

So, they put this foam inside the device, was that this foam would break down in warm, humid environments. And obviously it doesn't take a PhD in biomedical engineering to understand that when you're breathing out, your expired air is warm and it's humid.

Unfortunately, and I'm being very, very kind here, that's why there was a $1.3 billion settlement. The company seemed to have missed this. They didn't anticipate that the comp that the foam would be, would.

Would break down, even though it had a known history of breaking down. And further, they didn't test for it until, quite frankly, it was too late.

Etienne Nichols

00:19:30.310 - 00:19:30.710

Yeah.

Mike Drues

00:19:30.710 - 00:23:02.810

And so, as a result, when this foam broke down, a couple of things would happen. One is you would get these volatile organic gases that would come out that would cause havoc in the patient's body.

And in some cases, you can get particles, you can just get chunks of this foam break off and end up in people's lungs and their alveoli. And these are cytotoxic. And in some cases, they're even carcinogenetic.

So, the foam that you, that they use to dampen these, the sound can degrade and emit small particles that, that that irritate the airways. The gases that were released by the degrading foam may also be toxic and carry cancer risks.

A recall as I mentioned a moment ago, was started in 2021, but it just sorts of expanded after that. Here's the, the important part, Etienne.

And by the way, as this was happening, the company lost about 70% of its of its value and some 10,000 people were laid off as a result of this. So, this was a devastating case in just about every possible way that you can imagine.

Well, unfortunately, and again this is public information now, there are a number of factors now that are known that tend to prove that the manufacturer was aware of these problems since at least 2008. I said a moment ago, the recall, the first recall occurred in 2021.

We knew that there were problems or that they should have known that there were problems since at least 2008. Without ever deeming it necessary to take any corrective action.

Fast forward to a little bit more current between 2021 and 2023, just over those couple of years, FDA received more than 100,000 medical device reports MDRs, more than 100,000. As you know, Etienne and I teach a course on post market surveillance and complaint handling. Imagine trying to manage more than 100,000.

And unfortunately, they also received 385 reports of death associated with this particular problem. The testing that the company did wasn't done until 2016. Even though these things were known since at least 2008.

They continued to manufacture the product all the way up through and into the recall just a few years ago. And so that's just, you know, that's just some of the backstory. Now one last thing and I'm happy to let you chime in.

I'm not trying to hold up Philips as a special villain here. On the contrary, they are a customer of mine. But you know, when something bad happens, the question is what can we learn for?

You know, one of the things that we talked about from time to time in the past was CAPAs Corrective actions, preventative actions. Right. The thing that bothers me about that approach is why are we putting the emphasis on correction?

In other words, after the problem has occurred, why not prevention? It's very easy for somebody to say, okay Mike, we don't make CPAPs or ventilators, therefore we don't need to be concerned about this kind of a case.

At all. Baloney sausage. Those who don't look for similarities. Sorry. Those who don't, don't acknowledge their history are doomed to repeat it.

So even though you're not working on a CPAP or a ventilator or something like that, there are still a lot of lessons to be learned from this particular case. Does that make sense? I know I went through a lot, Etienne, and let me let you chime in and then we can continue.

Etienne Nichols

00:23:03.690 - 00:23:09.610

Yeah, well, one of the things that comes to mind is what did the, what did the FDA do with that 100,000 complaints?

Mike Drues

00:23:10.410 - 00:25:55.190

I think the better question, Etienne, is what did the company do with those 100,000 complaints? Because remember, the burden here is on the company.

The FDA is only supposed to be sort of a safety valve to make sure that the company is doing what they're supposed to be doing. Right.

So, I mean, the short answer to your question is FDA went, you know, to the company several times through 483s and warning letters and so on, saying, hey, guys, what the heck is going on here? We're getting tons and tons of these complaints. You know, what are you doing about this?

And ultimately, this is why there was the class action lawsuit and the $1.3 billion settlement. Because a lot of people, Etienne, and they tell me they fear the FDA. I say, no, no, no, you should not fear the FDA.

You should have a healthy respect for the FDA, but you should not fear them. Who should you fear?

You should fear the product liability attorneys, because the product liabilities attorneys can do a heck of a lot more damage than the FDA ever could.

And unfortunately, Etienne, and this is the quintessential example of that, it wasn't so much the FDA and the regulatory issues that really caused the change, it was the liability issues that caused the change. Yeah, it's just an unfortunate reality of our world. Now, how does that relate to what we're talking about here?

Well, as I said, I don't want to get into the technical problems because you asked the question, if this happened, if the device was intended to be used in a hospital, would these problems have happened? Well, look, whether the foam breaks down or not is a function of a number of things, but location is not one of them.

In other words, if the foam is going to break down, it's not going to matter if it breaks down in somebody's living room or in, in a hospital room. But what does matter in this particular case are the post market surveillance issues and the complaint handling issues and so on and so on.

I have a feeling that if, hypothetically speaking, these problems happen to a device that was intended to be used in a professional healthcare environment, they would have been reported much sooner than devices that are used in the home. We all know how big of a problem underreporting is. Underreporting for home use devices is even bigger problem. So interesting question.

The technical problems, the phone breakdown that would happen regardless of wherever the location is, but the quality kinds of issues. Obviously greenlight, you know, provides a lot of tools for quality like complaint handling and CAPAs and post market surveillance and so on.

I would venture to guess that if this device was intended to be used in a clinical environment, we would have had the same problems, but we would have found out about them probably sooner. And probably it would have affected far fewer people than it actually did.

Etienne Nichols

00:25:55.510 - 00:26:06.150

I guess part of the reason I asked about what the FDA did with the complaints was I know sometimes the FDA will send out letters to physicians and I thought CPAPs are prescribed, so I would have thought that would have had some impact.

Mike Drues

00:26:06.230 - 00:27:57.910

They are prescribed. They are indeed. Although there is discussion. Kind of like continuous glucose monitors for having an OTC version.

And I personally don't have a problem with an OTC version of that. It's well-established technology. But here's the problem with that, Etienne.

And in this particular case, for a CPAP or a ventilator that's used in the home, you can notify the physician, but the physician is not the one using it in their home. Ultimately, you have to notify the patient.

Yeah, if you notify the physician now, you're essentially putting the burden on the physician to go through his or her Rolodex to try to find out, you know, which of my patients, you know, have this particular device. And then you expect the physician to use his or her resources to notify the patients. I think that's a totally unrealistic expectation.

I think the notification, the burden of notification is on the company, is on the manufacturers, on us.

And this is another thing that, that the company got continuously dinged by the FDA because there were a lot of people that didn't get notified, or if they did get notified, they somehow missed it. They weren't paying attention, you know, whatever it is. It's kind of like if you go to Walmart and buy a toaster, right.

How many people, you know, I'm dating myself here, fill in and you know, right on the registration form and send it into the company so that if there's a problem or a recall, you get notified in the Future. I don't know about you, Edin, but I don't usually do that. Right.

So, trying to know who has your device when it's out in the field hospitals and doctor's offices is a little bit easier. Not easy, but a little bit easier.

But when devices are intended to be used in the home, very, very challenging to keep up with who, you know, who has them and what version and what happens if somebody moves and you know, I mean there's a litany of possibilities here.

Etienne Nichols

00:27:57.910 - 00:28:36.410

Absolutely. And I guess part of the reason I asked this is so let's go back to the hospital use.

There are, there are devices that even, even the way they failed in the home, they would potentially fail the exact same way in the hospital. But not every device is going to fail differently in the home versus because the user, it's user dependent. The scalpel is a perfect example.

That's a safe device in the hands of a surgeon, presumably if he's a. But this, this CPAP would have had the same issue in the hospital.

So, it's interesting to me because you know, you've, we've defined these different areas, you know, based on environment, but it's, it's also based on who is actually implementing the, the device.

Mike Drues

00:28:36.810 - 00:29:36.570

Absolutely.

And again, to be clear, from a technological perspective, as I said, the foam is going to break down regardless of, you know, where the device is being used.

And I just find it interesting from a biomedical engineering perspective that somehow the company, the designers of this product didn't take that into account. Didn't, you know, you're, you're obviously very, very familiar with, with the design controls, anticipated misuse or anticipated risks.

I mean you have a device that is clearly intended to be used in warm, humid environments and yet somehow you didn't connect those dots.

I just, yeah, but, but, but anyway, the reason why I'm sharing this example is not because of the technical problems, because you're exactly right, they would have happened in the hospital as well, but because of the post market surveillance complaint handling CAPA.

In other words, the quality problems that I would argue would probably be picked up sooner if it was used in a hospital as opposed to in somebody's bedroom.

Etienne Nichols

00:29:36.890 - 00:29:51.850

Well, how do, how do manufacturers approach this as far as the technical technological limitations, do you think had they designed it for in the hospital use, I'm theorizing that they put the same device in there, but had they designed it for in hospital use, would it have had a different level of rigor?

Mike Drues

00:29:53.700 - 00:31:41.490

But to me, and I don't mean to Be unkind here, but once again, this is why there was a $1.3 billion settlement. I mean, to me, this is a, this is an engineering no brainer.

You know, we're supposed to take into account when we're designing our devices, the intended user, whether the user is the physician, a surgeon, a nurse, in some cases even the patient. But we should also take into account the intended use environment.

Now, intended use environment, the word environment in this, in this context can be, you know, can have a couple of different connotations. The typical connotation of intended use environment is what we talked about earlier. In other words, is it intended to be used in a hospital or an or.

Or in an ambulance or in, in somebody's, you know, bedroom?

But cannot one argue that the intended use environment also includes the environment around the patient, meaning the air that the patient breathes out that also will be warm and humid compared to the air that they bring in? I would also argue that that is the intended use environment, part of the intended use environment as well.

This is why I often say, Etienne, we don't need more regulation to try to minimize or prevent these problems. We've already got God only knows how many thousands and thousands of pages of regulation.

What we need is people understanding the intent of that regulation. What I call the regulatory logic.

When you look at a phrase like intended use environment, don't be so myopic in your thinking as to say, well, that's just contingent on, you know, where on the earth that you happen to be standing on. Environment can be, can have a much broader connotation to it. I don't know if I'm doing a great job of explaining.

Etienne Nichols

00:31:41.490 - 00:31:41.810

No.

Etienne Nichols

00:31:41.970 - 00:32:30.990

You know, in my past, when I've done FMEAs on that sort of thing or even gone through ISO 4971, I've done hybrid approaches. I've done them all.

And when we had an in-home use, it was typically we would have the humidity ranges, we would have lots of different vibratory ranges and stuff for ambulatory and so on. The thing that I'm kind of thinking about though, is it's less about in home versus in the hospital because I like, let's isolate our variables.

We got a hospital environment. The surgeon uses a device, okay, that is a. I'm, I'm more focused on the user versus even in the or.

Suppose there's a machine over there that they're not coders, they're not electricians. That is expected to work from an electrical safety standpoint. I'm almost delineating devices based on how they're used is a, is the intended user.

I don't know. You correct me where I'm wrong?

Mike Drues

00:32:30.990 - 00:33:21.830

No, no, no, you're not wrong at all. And as a matter of fact, I think you're making a valid, let me be honest here.

This is, I, I, I chose this particular example to share in this part of our discussion, and we can, in part two, we can talk about some other examples as well.

For a couple of reasons, not the least of which is it’s a, it's a, it's a tremendously devastate, devastating impact in, you know, a litany of different ways. It's a very common, sorry, it's a very, you know, high, high visibility kind of a case.

But most importantly, there's a lot of lessons to be learned here, not necessarily of what to do, but what not to do.

In the continuation of this discussion in part two, we can discuss some other examples that you might find to be a little more of a apples-to-apples comparison in terms of the user's role here, but I take your point.

Etienne Nichols

00:33:22.230 - 00:33:34.820

Yeah, no, I am interested in learning more about this in home use environment. So those of you who are listening, stick around. We're going to have episode two coming up shortly. So, any last words before we, we close this episode?

Mike Drues

00:33:35.220 - 00:35:25.930

No, I think, I think the discussion that we've had so far is a good one.

Just as sort of a prequel, some of the things that I think we're going to try to discuss in part two of this discussion is some of the high-level labeling. In other words, we've talked about high level labeling before, meaning intended use and indications for use.

But should the intended user and the intended use environment be part of high-level labeling? When A company submits a 510(k), De Novo, PMA, what have you, should they be required to define just like their intended use and the indications for use?

Should they define their intended user and their intended use environment? And then we'll get into some of the technical limitations that present challenges about home use.

Medical devices, for example, things like, and I think you alluded to this earlier, how do you control things like temperature and humidity and electricity and lighting and all those other kinds of things. What about if you have a device that's intended to be used over and over again? Cleaning or reprocessing? What about human factors or usability?

I've said in some of our previous discussions, and I did a usability webinar for Greenlight a couple of years ago, usability testing is or usability is important for medical devices across the board, but it's even more important for home use devices as opposed to devices that are intended to be used in a hospital or a clinical environment. We'll talk about that.

We'll talk about some of the data security challenges, we'll talk about some of the challenges about maintenance and calibration, and a little bit more in terms of the post market surveillance challenges for these kinds of devices. So that's just sort of a prequel. We've got a great start to this discussion at Ian, but there's still a lot more to come.

Etienne Nichols

00:35:26.330 - 00:35:43.160

Awesome. Well, I really appreciate you sharing all of your knowledge and willingness to put up with my pestering questions too, at times.

It's always interesting to go a little bit deeper with you, Mike. All right, those of you been listening, thank you so much for listening. We look forward to continuing this conversation in the next round.

Thank you all. Take care.

Etienne Nichols

00:35:44.440 - 00:35:53.040

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.

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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...