In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions.

Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.

Key Timestamps

• [00:01] Introduction: Why device descriptions are foundational for regulatory submissions.
• [07:15] Common challenges: Why device descriptions are often poorly written.
• [14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways.
• [25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences.
• [36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA.
• [50:30] Final recommendations: Testing the efficacy of your device description.

Memorable Quotes

1. Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively."
2. Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."
3. Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."

Key Takeaways

MedTech Trends

1. Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.
2. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.
3. Visual aids, like images and videos, are becoming standard tools to enhance submissions.

Practical Tips

1. Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you.
2. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.
3. Incorporate visuals or videos to clarify complex mechanisms or testing processes.

Future Questions

1. How might advancements in AI reshape the expectations for device descriptions?
2. Could the FDA eventually require interactive or multimedia submissions as standard?
3. What new tools or technologies can help manufacturers streamline the description-writing process?

References & Resources

• Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more.
• Stephen Covey: Seven Habits of Highly Effective People—inspiration for improving communication practices.
• Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now.

MedTech 101: Device Descriptions

What is a device description?

A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:

• Anatomy: Components and materials.
• Physiology: Function and mechanism of action (MOA).
• Pathology: Risks or potential failures.

Why it matters:

• Guides regulatory classification and testing requirements.
• Establishes a clear understanding for reviewers, ensuring smooth approval processes.

Audience Poll & Call to Action

Poll Question:

What challenges have you faced in creating a device description?

• Ambiguity in regulatory expectations
• Balancing technical detail with simplicity
• Miscommunication with reviewers
• Other (email us at podcast@greenlight.guru)

Feedback & Sponsors

We value your feedback!

• Leave a review on iTunes to help others discover the podcast.
• Send suggestions for future episodes to podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.

Etienne Nichols: Welcome to the Global Medical Device Podcast.

Mike Drues: Where today's brightest minds in the medical device industry go to get their most.

Etienne Nichols: Useful and actionable insider knowledge direct from.

Mike Drues: Some of the world's leading medical device experts and companies.

Etienne Nichols: When it comes to bringing a medical device to market, you need more than a generic document management system. You need one designed specifically for you. That's where Greenlight Guru comes in.

Purpose built for the medtech industry, Greenlight Guru helps you ensure compliance, reduce risk and achieve faster market access with a quality system tailored to your needs. It's time to leave outdated systems behind and join the best in MedTech.

Visit www.greenlight.guru to see how we can transform your approach to quality management worries.

Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I am the host for today's episode and with me today is Mike Drews, likely a familiar voice you've heard on the podcast before if you've been listening for very long.

He is the president of Vascular Sciences and has a wealth of knowledge when it comes to the regulatory affairs world for medical devices and a few other industries as well.

But we won't necessarily go into that. So today I wanted to talk about device descriptions. But before we get into that, how are you doing today, Mike?

Mike Drues: I'm well, Eddie, and thank you for asking. And thank you for those very kind words of introduction.

Etienne Nichols: So, device descriptions, we were kind of kicking around a few different topics when we were coming up with the idea for this topic or for this episode. So before we get into what it is and all the different subjects, all the different things we can discuss around device descriptions, why, why are we talking about this?

What. What is important about this topic?

Mike Drues: Well, great question, Eddie, and as always, thank you for the opportunity to have this discussion with you in your audience. To many people, you know, the topic of the device description would be, you know, pretty seemingly straightforward if not boring topic to discuss.

So why are we talking about it today in this podcast? Edien Very simply put, because the device description is one of the most poorly written parts of any regulatory submission, whether it's a pre submission, whether it's a 510k or de novo.

One of the most poorly written parts, need I say any more than that?

Etienne Nichols: No. That if that's true, we got to fix that. Absolutely.

When I was a student, I always wanted to fix the things that I was absolutely worth worse at and I would expect the industry to want to do the same.

So that makes sense. If it's one of the poorly written sections of Pre subs and those final submissions to the fda, how would you support this? How do you support this claim?

No pun intended there.

Mike Drues: Pun intended, actually, yeah. Very good. So again, very simple. In my 30 plus years of experience as a. Not just as a professional biomedical engineer, but as a regulatory consultant, the vast majority of questions that I see coming back from FDA reviewers, or for that matter, reviewers from agencies in other parts of the world upon reading a pre sub or a final submission is indicative of the fact that they do not understand the device.

That is what it does, how it works, its mechanism of action, and so on and so on. And the burden of proof, the burden of convincing, is on the manufacturer to make sure that the FDA understands their device, not the other way around.

In other words, it's not FDA's job to make sure that they understand your device, although I would like to think that they would. But it's your job as the manufacturer to make sure that the FDA understands your device.

So simply put, and some people in our industry might not like this, Etienne, but this is my opinion. Simply put, if FDA does not understand our device, in other words, what it does, how it works, its mechanism of action, and so on and so on, it's the manufacturer's fault.

It is not FDA's fault. It is the manufacturer's fault. In other words, the manufacturer and the FDA are not communicating. Just because you say one thing doesn't necessarily mean somebody else hears or understands the same thing.

And I'm a little hesitant to use this metaphor in a public discussion like this, but I think it's a very appropriate metaphor. The same thing happens between spouses, between husbands and wives.

I'll use myself as an example. Many times I will say one thing to my wife and she will hear something completely different. So of course this never happens to you, Edien, or none of the other guys in our audience, only to me.

But everybody knows we kind of make a joke about that. But why don't people understand that the same thing happens in communication between the company and the fda? So just because you tell FDA how your device works doesn't necessarily mean that they heard it or they understand it.

And then the last thing that I'll say, Eddie, and I love to hear your thoughts on this is quick example.

I see this happening now more and more in the artificial intelligence world. In other words, as you know, I spend some of my time working as a consultant for the FDA and I sit on their side of the table.

I can't tell you how many times I've seen people Come in with medical devices who have artificial intelligence software in them in one form or another, and they don't really explain how the AI works.

And when FDA asks, how does your AI work? They're basically their response is, well, we don't really know how it works. It's kind of like a black box. It's magic beans.

But just take our word for it, it works well. I don't know about you, Edian, but that's not going to, as an FDA reviewer, that's not going to instill a high degree of confidence in me about your product.

And more importantly, as a medical professional and a potential patient, it's not going to really instill a high degree of confidence to want me to use your particular device if you can't explain how it works.

Etienne Nichols: Yeah, absolutely.

You mentioned at the beginning about that communication and it makes me think of a phrase, I wish I knew who to attribute this to. But one of the biggest problems with communication is the assumption that it has occurred and oftentimes that is not the case.

And so I think that's really important.

Mike Drues: That's a great one. I'm going to have to add that to my repertoire, Eddie, and I've not heard that one before, so thank you for helping me.

Etienne Nichols: I used to have sticky notes on my wall, just all those different ones that I needed to keep in mind, but just that were important in communication. But when we're talking about these device descriptions, I'm curious, and you've already alluded to this, maybe you've even answered this question outright.

What is the purpose? Or maybe, maybe I should borrow the language. What is the mechanism of action for a device description in regulatory submission?

Mike Drues: Yeah, great question. So the most obvious purpose of the device description is to explain your device. But as we just talked about, make sure that everybody, including the fda, understands your device, what it does, how it works, and so on its components, in some cases even the manufacturing processes that are involved in making it.

In the 510 world, that's not a requirement. In the PMA world, it is a requirement. In the de novo world, it sometimes is a requirement. FDA can ask for it, but sometimes we need to include manufacturing information.

And if we do that, I usually like to put it, if not in a separate section in the device description. But the more important reasons why the device description is important from a regulatory perspective is it will greatly determine the classification of your device.

For example, if I write the device description one way, it might be a class two, if I write it a different way, it might be a Class 3. And based on the classification determination, it will also influence your pathway to market, whether it's a 510 or de novo or a PMA or an HDE or something like that.

It will also influence the kind of testing that you have to do. Benchtop testing, maybe animal testing, maybe computational testing, and in some cases, you know, whether or not clinical data is required.

So the device description is important for a lot of different reasons, not the least of which is just, you know, the basic understanding of the device. So coming from a medical background, I always like to use medical metaphors, think biology.

So describe your device first in an anatomical sense and then in a physiological sense. So anatomy is about structure. So what are the different components of the device, what are they made of, the different materials and so on and so on.

And then physiology is all about function.

You know, how does the device function, what does it do, how does it achieve its moa, either in a mechanical or electrical way or in a biological way? And if you want to take that metaphor even a step further from anatomy in physiology, I would go to pathology and pathophysiology.

Anatomy is about structure. Pathology is about abnormal structure. So if you have some, say, a physical problem with your device, what are the likely harms and, you know, risks that would result from that?

And physiology about is about function. So pathophysiology is about abnormal function. So what are the possible things that can go wrong with your device if it doesn't function properly or if it's not used properly, or, you know, something like that.

But we can learn a lot from, from biology just in, you know, thinking of those terms and applying it to some mundane activity like creating a device description. One other thing that I'll mention, Eddie, and then I would love to hear your thoughts on this as well.

As we talked about a moment ago, when it comes to communication, just because you explain it doesn't necessarily mean they understand it. Let me say that one more time. Just because you, as the manufacturer, explain how your device works doesn't necessarily mean that they, meaning FDA or any regulatory authority is going to understand what you're saying.

So I'm a big fan of using very, very simple metaph force. You know, Einstein much, much smaller than I, than I am, Einstein, said if you can't explain something simply, you don't understand it well enough.

So I don't care how complicated your device is. If you cannot explain it simply, at least at the beginning, and then go into more detail later, ideally using a simple metaphor to illustrate, then I would Suggest maybe you don't really understand your device as well as you think.

The second thing is, if you want, and I sometimes do this edian, but not often, maybe be a little professorial. In other words, if you're doing a pre sub meeting, for example, instead of at the beginning of the meeting, taking a couple of minutes and reiterating the device description, what it does, how it works, its MOA and so on, why don't you ask the FDA audience to explain it?

You know, just, you could do a little tongue in cheek. You could say, well, we've submitted our pre sub. Hopefully by now everybody's had a chance to read it in pretty and notice I'm parsing my words carefully because I'm saying hopefully everybody has read it.

I am not so naive is to think that every single reviewer before walking into the meeting has read the complete submission. That's just, you know, I would like to think that's true, but that would be like, you know, thinking that my graduate students, you know, read everything that I give them.

You know, I didn't fall off the turnip truck yesterday. So ask the FDA just to kind of test to make sure that we're all on the same page. Can one of you please explain to the rest of us your understanding of our device, what it does, how it works, and so on and so on.

I don't know about you, Etienne, but some people might think that would be a little bit aggressive on the regulatory side. After all, I'm one of the more aggressive regulatory folks around.

That's my style. But do you think that that's being a bit pedantic?

Etienne Nichols: I like that personally.

That's, that's one of the ways. Well, you mentioned a marital explanation illustration in the past and I do that sometimes in marriage and it's not, doesn't always go over well, but it's one of the ways that I like to under make sure that we've communicated.

So I definitely would agree with it. I suppose in some situations maybe I fall into the category of aggressive. I'm curious, in your, in your experience, has that gone over well or what is the reception typically?

Mike Drues: It's definitely unusual. Most people at FDA are not used to doing that, putting them on the spot.

It really depends on who's sitting on the other side of the table. If the people on the other side of the table are, let me say, relatively self confident and they know what they're doing and so on.

I don't think people like that are going to feel threatened about such a thing. Unfortunately, though, not everybody is in that camp. You know, there are many people who. And again, this is not a criticism, just an observation.

People that are less experienced or people that are not used to being challenged a little bit in front of a group, especially in front of their peers, they might not respond to that as positively.

So you kind of gotta feel out the audience in advance, you know, maybe before doing that, which again, is something that I do. I, as you know, I do a lot of pre sub meetings at the fda, probably like once a month, if not more.

And every group at the FDA is different. You can't, you know, treat them all the same.

Etienne Nichols: Absolutely.

Mike Drues: And just one other quick comments. This is not, you know, an original idea for me. It's sort of a riff on if anybody in our audience is familiar with Stephen Covey, who wrote Seven Habits of Highly Effective People, among other things.

Terrific book, I highly recommend it. But one of Dr. Covey's seven habits is, pardon me, is seek first to understand and then seek to be understood.

So I'm doing sort of a riff on Dr. Covey, I'm asking FDA, what is your understanding? And then if necessary, I can correct it, I can adjust it, I can fix it, but there's no point of proceeding with the meeting or the submission unless everybody is on the same page.

In other words, understanding the device, specifically the device description.

Etienne Nichols: Yeah, if it is a foundation to that conversation, there's no point in building on it if you're not actually building on the same foundation. That makes sense. I'll just. You already mentioned some awesome points about the criticality of getting this.

I mean, even changing the class of your device, that, that is. I would expect companies to really sit up and take note when they think about that, but if your description is ambiguous or inconsistent, I can see it creating uncertainty.

And, and that's a. Uncertainty is going to result in more questions, more review, maybe even rejection. I think it's something everybody would want to avoid. So that's a really good point.

Any other pieces that you feel like are real critical about or why it's critical?

Mike Drues: Just on that last piece that you mentioned about uncertainty. Uncertainty is certainly a problem, but to be honest, Eddie and I don't know what's worse, uncertainty or misunderstanding. In other words, it's one thing not to know for sure what the device does or how it works.

It's another thing to assume that the device works one way when in fact it does not. It works some other way. So I'm not sure which of those two scenarios is worse.

Etienne Nichols: Unknown, unknowns, I would believe are worse. That's where I would fall.

Mike Drues: But yes, but the answer to your original question, if we don't make sure, or in other words, why is it critical that FDA understands it? Again, a multifactorial kind of an explanation.

First of all, we're not going to be sure how to bring it onto the market classification, pathway to market, and so on. We're not going to be sure what kind of testing that we're going to need to do if FDA misunderstands our moa.

If they think it works one way when in fact it works another way. They might be expecting a certain kind of testing that we're not planning on doing because the device doesn't work that way.

And so it's not appropriate.

Do we need clinical data? As I said before, you know, so there's a lot of reasons why getting the device description correct is important. But bottom line, Eden, if you don't have sufficiently detailed and understandable device description, and those two things are together sufficiently detailed and understandable device description, you might end up going into the right in the wrong direction.

You might end up having to do testing that you don't have to do, or doing a de novo, for example, when you could do a 510.

Or you might risk actually, you know, not, not getting anywhere, you know, kind of spinning your wheels in the mud, so to speak. So those are just some of the reasons why not only, you know, why the device description is important, but why it's so important to get it right.

Etienne Nichols: I think I would expect those listening would agree to that point. If all of those are true, I hope we will have convinced them by now. So let's talk about how you know that you did get it right.

How you know you got it adequate.

Mike Drues: Yeah, again, great question. So another way to kind of spin that question, Edin, is how do you measure the efficacy of your device description? You know, we're all used to thinking about measuring the or demonstrating the efficacy of our device, but how many people think about measuring the efficacy of portions of your submission in this case like the device description?

So here's my recommendation, and it's amazing to me how few people do this. Take your device description and give it to somebody who is not familiar with your device and then ask them to read it.

And after a minute or a couple of minutes, literally yank the paper out of their hand and ask them, can you please explain to me what you just read? And if they paint a verbal picture of something that looks like your device, what it does how it works, then terrific, great, you're communicating.

But if they paint a verbal picture that is different from what your device is, or worse, if they paint a verbal picture, or sorry, if they're so confused that they can't even paint a verbal horrible picture at all, then you're not communicating.

It's simple as that. So measure the efficacy of your device description. And the other related suggestion that I would make, Eddie, and I'm trying to make all of these suggestions as pragmatic as I can.

Another thing that drives me nuts about so many medical device companies is why do they treat the FDA as their beta tester? In other words, who is the first person or people outside of the company to see their submission, their pre sub, their device description, whatever it is, it's usually the fda.

Well, in my opinion that makes absolutely no sense. So one of the things that I do with my customers, I'm not trying to be self serving, I'm just simply trying to share some of my best practices with our audience is before the company submits their pre sub or submits their 510 or PMA or whatever it is, have me or somebody like me come in, put my FDA reviewer hat on, temporarily read through their submissions, sit through their presentation and if I can be a little bit blunt, Eddie, and bash the hell out of it.

Because I don't want to go so far as to say that if somebody can get past me, they can get past the fda. However, I can make a pretty good surrogate biomarker, if you will, for the fda.

So you know, it's, it's kind of, obviously you're, you know, you lot know a lot about the, the quality world, Eddie, and there's tremendous precedent for these ideas in the existing qsr.

You know what I'm talking about here is essentially a manufacturing audit. You know, Absolutely. Where you have somebody come in and kick the tires. Or another quality metaphor is the concept of an independent reviewer.

Most of the time we think of an independent reviewer in the technical or engineering sense. What I'm describing here is an independent review from a regulatory sense. The, the, the, the details may be a little different, but the underlying purpose, the philosophy is exactly the same.

Etienne Nichols: Yeah, like having an internal audit prior to having your notified body show up. Absolutely, you'd want to do that. Or some cases you have to do that.

Mike Drues: So exactly.

Etienne Nichols: What about some of the, so it's interesting because when you talk about that, putting it in front of somebody and having them explain it, there's two situations there. You could Prove that they don't understand it.

So there's a negative, and that's a broad spectrum. You know, there's lots of different ways to do things wrong. But then how do you prove that they can?

How do you get it to a point where they can communicate it back correctly, which is a narrower, a more difficult, stricter field? I don't know if that makes sense any or not that I'm asking.

Mike Drues: It does make sense, to be honest. That's a very subjective kind of determination. I guess at the end of the day it's, it's a feeling, it's a gut response. Do you think that the person understands it?

Perhaps people that are less experienced might have a difficult time doing this, but for somebody like me doing this for now, 30 plus years, I have no problem. As a matter of fact, not to be arrogant here, but I'm usually pretty good at sizing somebody up in the first few minutes or sometimes even in the first few seconds of the conversation as to whether or not I think that they know what they're talking about.

As a matter of fact, sometimes, and I don't do that just, just professionally, but sometimes if I go to, to shopping for a computer, for example, I'll ask somebody a question that I already know the answer to already myself, just to kind of see if the other person knows, you know, what they're talking about.

You can apply those same, I don't want to say tricks, but those same techniques here.

Etienne Nichols: If I were to, to think about that myself, I mean, is it clear, is it concise when you're talking about the actual device description and you fill in whatever gaps leave here, but completion, I mean, is it complete?

That's, that's another area I would want people to, to cover. And consistent with the rest of your submission, you know, I can imagine people getting inconsistent and then defensible. Can you actually defend it?

All these different sections?

Mike Drues: And the other thing that I would recommend, Eddie, and you know, I, I recommended, you know, having somebody, you know, read it and describe it to you and so on, but maybe I should amend that recommendation a little bit and not say somebody singular, rather somebody's plural.

Because if you do this exercise with an engineer, you might get a very different kind of a response, kind of an explanation than if you do the same exercise with a physician or a surgeon.

And so maybe in some cases it might be a good idea to do this exercise on a couple of people, but not just three engineers, three different people, maybe one engineer, one clinician, and, you know, something like that.

So there's another suggestion for you, and.

Etienne Nichols: That'S a really good segue into a question I have, which would be how do you, how do you find that right balance between technical detail when you talk about those engineers and how they talk and simplicity.

So when you speak, CEO speak, for example, when crafting that device description, especially if it's a complex device, so many.

Mike Drues: Things in regulatory and many things in life in general, you're right, it's about balance. In this particular case, I would say no, it's not about balance because if you try to write a job description.

I'm sorry, job description. If you try to write a device description that is balanced for everybody, you run the risk of quite frankly ticking off everybody because some people are going to be totally underwhelmed.

Maybe the engineers are not going to have enough technical detail to really understand it. At the same time, you run the risk of ticking off other people who are overwhelmed because you're giving them more information.

Like a Kinlanshin most of the time doesn't really care about the mechanical or electrical details of what's happening inside of the device, whereas an engineer obviously would. So rather than writing one device description, my suggestion is to write the description in layers.

So you have like one very, very high level description, maybe just, you know, a few sentences or a paragraph that you give to everybody. And if this is in a pre sub, for example, you put this in the body of your pre sub, but you know, there's not enough engineering or technical detail in there or not enough perhaps clinical detail in there.

So you provide that additional device description information as an appendix at the back of the submission and you just put a little pointer in the body of your document that if you want more technical detail or clinical, biological detail, see appendix C or something like that.

What I like to do when I write regulatory documents, whether it's a pre sub or a submission or an additional information request or whatever, I try to make the body of the document as short as possible.

But then I will put additional information in there as an appendix. Whether or not anybody reads anything. The appendix. That's a whole different discussion. But at least you put it in there.

Etienne Nichols: Yeah, that makes sense. So basically what I'm hearing is you're not wr. Think about the audience you're writing this for and you're not writing it for an engineer somewhere, but you are writing it for a reviewer.

It doesn't directly impact safety, efficacy or substantial equivalence. Maybe it doesn't.

Mike Drues: I would say, I would say you're writing it For a mixed or a broad or a diverse audience, some people are going to be all of those people that you just mentioned.

And so you definitely want to read write this with the audience in mind. But you might, depending on the portion of your audience that you're addressing at the time, you might want to tailor or present that information in a slightly different ways.

Maybe in some cases more detail, in other cases less detail, and so on and so on.

Etienne Nichols: Thinking about the audience and who you're talking about during that pre sub meeting, do you recommend, I mean, how much time do you recommend spending on this?

Mike Drues: Yeah, great question. So sometimes when my customers, when I work with my customers preparing for a pre sub and I always spend a lot of time preparing for the pre sub, I'll suggest to them, you know, we should include a small amount of time, giving them sort of a recap of the device description, what it does, how it works, its MOA way and so on.

And many times customers will ask me the question, and I understand why. Well, Mike, we've already given them all of this information in the submission. Why are we wasting this valuable meeting time reiterating what we've already told them?

And I say that's a very valid question. In the ideal world, I would agree that's probably not necessary. However, let's be honest, we don't live in the universe of rainbows and unicorns.

We live in the real world. And as I said before, it's just not simply realistic to assume that everybody has read and understand everything that we've given them. So this another reason why it's important to spend a little bit of time.

Again, I'm not talking about, you know, hours and hours, but maybe three minutes or five minutes max. I would say closer to three.

Another why the reason why it's important is because to you in your company, you're used to thinking about your device probably every single day, maybe even every single minute of every single day.

Whereas, you know, to the FDA reviewer, they might have dozens, maybe even more devices that they're thinking about at the same time. And it may very well be that, you know, they hadn't read your pre sub, for example, for several days or possibly even a week or two before the meeting.

And they might not remember exactly some of the details or worse, and I've seen this happen before, they confuse your device with somebody else's device that they happen to be, you know, dealing with at the same time.

So I don't want to make assumptions about what people read or understand or what they remember. And like I said earlier, if you want to be a little bit cheeky, if you want to challenge back the fda, if you want to, you know, make sure that they've done their homework before they come to the meeting.

Because, you know, I consider myself to be a medical device professional. And professional means, you know, something very important to me. And one of the things is when I go to a meeting with the fda, I am prepared, you know, **** well prepared.

And I expect that same level of professional courtesy back from the fda. Now, I'm, I, I don't mean to overgeneralize. Some of my friends at the FDA are very professional and very prepared.

But some people at fda, let's just be honest, they walk into a meeting and they are, let me just say, not adequately prepared. And that's putting it very, very politely.

Very, very politely. And if the. And if the company feels that a particular reviewer is not adequately prepared, I think they should call them out on that. I think they should say, you could be polite, you could be respectful, but you can say, well, we explained this in our documentation.

Either we weren't very clear about it, or perhaps you missed it or something like that, you know, so you don't have to flat out say you didn't do your homework.

You know, why are you wasting our time? But you want to demonstrate to them that, you know, that we're responsible here.

Etienne Nichols: Yeah.

Mike Drues: And one last thing along these lines again, sometimes customers will ask me, should we bring one of our devices to the meeting? Or now that we're, you know, we're still doing most meetings by zoom, should we hand, should we hold up, you know, one of our devices, or should we demonstrate one of our devices to the fda?

Well, this is an interesting question. What I would say is this for most devices, and there are no, there are a few exceptions, but for most devices, I have no problem showing the FDA the device.

I have a big problem demonstrating the device in real time. Why? Because I have seen, I've been sitting on the FDA side of the table when the company comes in and they try to demonstrate their device, but for some reason, it's not working the way that it's supposed to.

Well, suffice it to say, that's not a good scenario when you're sitting in front of a group of FDA reviewers trying to demonstrate your device and you're having problems with your device.

I mean, suffice it to say, that's not going to make it easier to get your product out to the market. So here's my suggestion. If you want to hold up your device and say, here's my device, and maybe point to the different parts and so on.

I have no problem with that. But when it comes to demonstrating it, I highly recommend creating a video.

It doesn't have to be a Hollywood quality production. It could be something shot from a cell phone. But create a video demonstrating your device for lots of reasons, not the least of which, if necessary, you can shoot the video 25 times over again until you get it to the point that you want it to be.

And if something happens, or if you're not satisfied, if you get some little fluky thing, an unexpected result or the voiceover, the narrative is not as clear as you would like, you can just hit it, you know, delete and do it again.

So I'm a big fan of using the device in your meeting, but doing it in a very sort of a. I don't want to say a contrived fashion, but certainly in a controlled fashion.

Etienne Nichols: Yeah. And I totally agree. And I can just picture someone out there saying, well, our device, we're far enough along. But depending on how close you are to engineering, you may not realize how feverishly they are working on the device to work out the kinks that will inevitably show up during a freestyle meeting.

Mike Drues: Exactly. You know, like they say, a picture's worth a thousand words, a video's worth a thousand pictures.

Etienne Nichols: Yeah. Oh, that's. That's good. I haven't heard that one. I'm gonna have to add. That's my repertoire. So we've covered a lot. What. What specific recommendations do you have on how to write?

Or maybe we even say design that device description.

Mike Drues: Okay, great. Great question. So, first and foremost, I always like to begin with the labeling. Now, we've talked about labeling in other podcast discussions, and I've done webinars on labeling for Green Light.

As a matter of fact, one of my webinars I did on intended use and indications for use, which is what I'm going to refer to here, that's actually posted on CDRH's training website for their reviewers to watch.

Because there's so much confusion even within FDA about intended use and indications for use. Simply put, I have pointed out in submissions that have gone through and have been cleared or approved, I've pointed out to the FDA that the labeling is flat out wrong.

And FDA says, yes, Mike, we agree with you. However, it's already gone through. There's nothing we could do about it. It's like there's our US Government hard at work, but that's your question how it relates to the device description.

The intended use is about the device, what it does, how it works, its mechanism of action, and so on and so on. The indications for use is about what disease, injury or condition is the device intended to prevent, diagnose or treat.

So let me say that last part one more time again for those in the audience that are interested. Further, I've done a lot of other podcasts and webinars on labeling.

I talk about this in more detail, but in a nutshell, intended use is about the device, what it does, how it works. Indications for use is about the patient, the person.

What disease, injury or condition is the device intended to prevent, diagnose or treat. Now, how does this relate to constructing a device description? Very, very simple. If you start out by simply reiterating your first, your intended use, what it does, how it works, and then your indications for use, the patient, you know, what disease, injury or condition, and so on and so on, that's probably a good 70 or 80% of the beginning of your device description right there.

Now, all you have to do is add some levels of detail in terms of the different components, the different materials, how it works mechanically. If it's software, how the software works.

Even software has a mechanism of action. MOA is common across the board. So as we talked about before, add the technical or the clinical details as necessary in that sort of layered approach.

You know, have a basic description in the body of your audience. Sorry, in the body of your, of your document, Mitch. Might only be the intended use and the indications for you spliced together with a tiny bit more detail.

And then in an appendix or another section or something like that, provide the, you know, provide the additional detail that an engineer might need or a clinician might need.

And remember, as we talked about before, once you do this, Eddie, and make sure that you test the efficacy of your description to make sure that it's working. And then one other test that I sometimes recommend, and some companies are receptive on this and sometimes companies are not.

But what do you think is the ultimate test of a device description?

Not just to understand what the device is and how it works, but some people might say the ultimate test of a device description is so that after reading it, somebody can sit down and literally reverse engineer and build your device.

Now, obviously some companies are not going to want to write an SOP that somebody can copy, but let's be honest, Edien, I mean, patents are very much this way. You know, I remember I spent when I started out in this Business as an R and D engineer.

I spent a lot of my time reviewing other people's patents for no other reason than to figure out a way to get around it. Right.

So the same logic can be applied here.

Etienne Nichols: Sure.

Mike Drues: You know, a device description could be used, I suppose, by one of your competitors to, you know, reverse engineer or copy your device, especially in the 510k world. But there are ways that you can mitigate that risk.

Etienne Nichols: So I, I actually came up, I have came up with one just to use as an example. We don't have to use it though. If you have another example you want to use.

Do you have an example of one that you like?

Mike Drues: I do, but I'm curious. What do you think? What are you. What are you thinking?

Etienne Nichols: Sure. I wrote it out for myself here and you can bash it. So you. This is me get my peer review. Okay. The device is a handheld battery operated blood blood glucose monitoring system intended for home use by individuals with diabetes.

It measures glucose levels in capillary whole blood using an enzymatic biosensor. The system includes a lancing device, test strips and a digital display unit that shows results in milligram per deciliter.

The device employs electrochemical detection to provide accurate results within five seconds with data storage for up to 500 readings.

Mike Drues: So, first of all, I think that's a terrific example and thank you for being willing to be sort of our test side.

Etienne Nichols: You don't have to be polite to me.

Mike Drues: No, no, I think I'm being sincere. I think it's a great description. As a first step. As a first step. In other words, that is exactly the kind of description that I would put in the main body of my document.

However, without going into all of the details that you mentioned, like the electrochemistry and so on and so on. Clearly there are a lot of the technical details and also the clinical details that were not included it.

So what I would suggest in this case is use that description that you just shared with us in the body of your document, probably even in your 510 summary. But then in your full document, put it in as an appendix or if it's a final submission, add it to the device description in your PMA or de novo or whatever it is.

By the way, another big mistake that I see companies make, Eddie, is they'll look at, if this is a 510k, for example, they'll look at the 510k summary of the predicate and they'll read the description there.

And sometimes it might only be 2, 3, 4, sentences. And so they give to me, to me a description of two, three, four sentences. And I throw it back to them and I say, this is not enough.

And they say, what are you talking about, Mike? This is in their 510k summary. I say to them, well, you must be missing one of the most important words and that is summary.

This is not the entire 510. I guarantee somewhere in that document they had a hell of a lot more description in there than just those two or three or four sentences.

This is what I mean by writing in later. So I love that suggestion, Elian, but let me give another suggestion, and I would go so far, is to encourage companies to put this in their quality system regulation.

Sorry, not the qsr, their qms, their quality management system system, so that they have an sop, if you will, for writing device descriptions. I would take, I mean you could take a medical device like the one that you just mentioned if you wanted to, but I would take a simpler device and a device that most people are, are familiar with off the top of their head, for example, like a garden hose.

You know, I mean, the device, I love the device that you gave, but some people might not be that familiar with it and you're going to have to spend time explaining to them what the device is and blah, blah, blah.

But with a garden hose, I think most people probably understand what a garden hose is. So how would you write a device description to explain a garden hose? You start out with the anatomy.

In other words, it's a long, flexible cylindrical tube made of maybe rubber or something like that.

That's the intended use. What's the indications for use? It's intended to transport water or some kind of fluid from one location to another and back to the intended use for a second.

You might say the MOA has a pressure gradient. In order for the fluid to move from one end to the other, there has to be one end that's higher pressure than the other end, and so on and so on.

And then you can get into what kind of material, okay, what kind of rubber, what are the material properties, what are the mechanical properties? And then finally, remember I said not just anatomy and physiology, but pathology and pathophysiology.

So what if you get a kink in the hose? Or what if you get a burst in the hose? You know, for those of you that are working on aneurysm devices, this should be a very spot on metaphor.

You know, if you get a, a, a fusiform aneurysm, like a domino aortic Aneurysm, you get a, you know, a bulging, and ultimately that aneurysm might burst. So the garden hose is an interesting metaphor.

Anyway, the reason why I like to use a simple product like that is because everybody can understand it, and it's a good tool to use to help you refine your procedure in order to convey what it is that you want to convey about your product.

Eddie. And in other words, if you can't do this for a simple product that everybody can understand, like a garden hose, how can you possibly do it for a much, much more complicated product like the ones that the people in our audience are developing every day?

Etienne Nichols: Absolutely. I love that. Is there anything we've missed or what else do you feel like is important that could be relevant to this topic?

Mike Drues: So I think we've covered a lot, but just a couple of other miscellaneous things to mention before designing your device description for your device. Do it for a garden hose or a paper clip or a coffee mug or something like that to develop your process.

Again, coming from a medical background, I use a lot of medical metaphors, Eddie, and there's tremendous medical precedent for this in the. In the surgical community. For example, most surgeons, before they do a surgery for the first time on a person, they're going to do it on a cadaver or on a simulator or something like that.

So I'm just simply suggesting that we take, you know, the same logic here and apply it in the regulatory fashion, you know, for the device description. Because, you know, I don't know about.

About you, Edian, but it's not going to instill a high degree of confidence in me as a patient. If my surgeon, just before rolling me into the or says to me, oh, Mike, I'm really looking forward to doing this procedure on you for the first time.

Etienne Nichols: No, absolutely not. Oh, man. I remember in college, inserting a chest tube on a kid. It wasn't a cadaver. It was just a.

I don't. What do you call it?

Mike Drues: A model. A model.

Etienne Nichols: And I can't. I. I would not want. If I were the patient, I would not want Etienne doing that in real life without a lot more practice.

Mike Drues: Well, that's a topic of a whole different discussion, but I hear you on that one.

And also, we talked about this a little bit already, but I think it's worth reiterating once more. Where is it written that the device description needs to be in writing or needs to be only in writing?

I'm a huge fan of including pictures. And by the way, a lot of people will Include like engineering drawings, like schematics with tolerances and stuff like, okay, fine. If you want to include that, you know, that's fine.

I'm not saying it's a bad thing, but I don't think that's the real purpose here. And even though I do have a PhD in engineering, I'm not going to spend time looking at your dimensions and your tolerances and stuff like that.

So I think a picture, and if you're early on, you know, if you just have a crude prototype that's particular, that's fine. Just mark it as, you know, we're not at the design freeze yet, it's a prototype.

Or if you want to just provide an artist sketch, you know, a rendering or, you know, a 3D model that you, that you generate from Pro Engineer or AutoCAD or something like that, I'm perfectly fine like that.

If you're a little bit further and you can include a picture of your device actually in use, doing, you know, if it's a scalpel, you know, cutting through something or, you know, whatever it is.

And finally, don't forget the video. You know, like I said, a picture's worth a thousand words and a video is worth a thousand pictures. And by the way, one other suggestion for videos that I don't see many people do, but I use them frequently.

Not just a video in the device description section, but a video in your testing section. In other words, instead of just describing in words how you're going to do this test, maybe the person that's reading it is going to understand it.

Maybe they won't if you give them a video. And I'm not talking about, you know, like a three hour, you know, video, but if you can give them a two or three minute video, even if it's shot on a, on a, on a cell phone, that's perfectly fine, demonstrating exactly how the test was conducted.

I think that takes you a huge step in the direction of making sure that everybody is on the same page. And finally, one of the reasons why I recommended the video is because it's very, again, I don't want to use the word contrived because that sounds a little too unethical, but controlled.

Because if you don't get it right, or if it doesn't go the way you want it, or if you don't think it's clear enough, you can always delete it and do another, do it another time, do another.

Take two, if you will.

Etienne Nichols: Absolutely, yeah.

Mike Drues: And by the way, Eddie, and one of the things that I really Enjoy. About our podcast is on very, very rare exceptions. We always do it on the first take.

Etienne Nichols: It's amazing. Sometimes people ask, how many times does it take? Yeah, just once. Most of the time. That's the goal. I was going to throw one last thing out too. I know we're close to time here, but you need to write for clarity, which you've already said, and not to impress.

I, I was guilty. When I first came out of college, I started one of my, my big boy jobs. I had to write a big long, I think it was 500 page report.

I handed it to my boss. He turned around in his desk and he says, etienne, I want zero fluff. Okay? So I'm not going to read this. I want you to take it back.

And I went, zero fluff. And that was new to me because, you know, when you go to college, you have different, different mind.

Mike Drues: It's funny you mentioned that idiom because that's exactly the lesson that I learned when I was in college and especially graduate school, especially if you do a master's thesis or ultimately a PhD dissertation.

And I teach part time, so I know both sides of this equation. And I teach at an Ivy League institution at the graduate level. I remember as a PhD student writing my dissertation, I was essentially encouraged to write on and on and on ad nauseam.

In other words, if I gave my major professor a 500 page document, he might turn around and say, that's not enough, that's not enough.

But when I first got into industry and first working into companies like you, I quickly realized that, no, it's not quantity, it's quality.

So it's a completely different kind of writing than we often teach in academia, which I think is kind of unfortunate.

Etienne Nichols: Yeah.

Well, I hope that those listening got a lot of value out of this. I think we covered a lot of ground.

There are a lot of different takeaways. To me, one of the biggest takeaways for me is that the device description can be and should be a cornerstone, not just a formality of the submission.

So anything you want to add to that before we close out?

Mike Drues: No, I think we've done a good job. And just to amplify what you said at the end, I like the way you phrase that cornerstone rather than a formality. To put it a little more succinct, if you don't get the device description right, in other words, if you, you can't get everybody at the table to understand your device, what it does, how it works, its MOA and so on, is there any point of wasting time talking about anything else.

Etienne Nichols: That's right. Absolutely. Absolutely. So those of you listening, thank you so much for listening. Go to Mike's LinkedIn. Go to my LinkedIn. Leave us some comments. Let us know what you think.

Did you like this episode? Do you want to see something different? What topics would you like to see in the future? We'd love to hear that. We always love hearing.

At least I do. I'm sure you're the same way, Mike. Love hearing any kind of feedback. Good.

Mike Drues: Absolutely.

Etienne Nichols: Yes, absolutely. Thank you so much. We'll see you all next time. 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 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.