#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

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hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etie Nichols. I'm the host for today's episode. Today we want to talk about the MOD Database. We want to dive into the Manufacturing User Facility Device Experience database.

We'll talk about what that is in a minute, but it's One of the FDA's tools for tracking device related harms and we want to kind of answer the question of the state of this database and what it means for manufacturers, regulators and patients.

Kind of cut through some of the noise around what we usually hear about this, but today to talk about this is a familiar voice on the podcast, Mike Drews. Mike, how are you doing today?

Mike Drues: I'm well, thank you Eddie.

Etienne Nichols: Great to have you with us. Maybe we could just start off with just talking about what the MOD database is.

Mike Drues: Yeah, great question, Eddie, and as always, thanks for the opportunity to talk about this topic with you and your audience. So, first of all, the MOD database is one of about 18 different databases that CDRH maintains.

And specifically the MOD database, as you said, is an acronym for the manufacturer and User Facility Device Experience. I'm not sure who came up with that acronym, but I'm not sure I would come up with that same acronym.

More importantly, what it contains is the list of medical device reports or MDRs of adverse events.

We could spend an entire podcast talking about what constitutes an adverse event and what constitutes a reportable adverse event and which adverse events need to be reported to the MAUD database in which do not.

But in a nutshell, an adverse event is when something bad happens to a patient caused by a particular medical device. When something bad happens to a patient, I. E. Adverse event.

And going further on this because this topic of adverse events is so important and it gets a lot of companies into trouble because they don't report certain events that they should.

One suggestion that I would make to our customers in our audience is that we include our particular criteria for what constitutes an adverse event in our own quality management system.

In other words, please don't just cut and paste or regurgitate a generic definition of AE into the qms because those generic definitions, first of all, they're meant to apply to all medical devices across the board, not just your particular medical device.

And those definitions can be construed or interpreted in lots and lots of different ways. So one of my recommendations on the QMS side is that a company should come up with their own working definition of an adverse event and they should also provide some examples of what constitutes an adverse event and what does not in their own quality management system.

In other words, using their own devices or perhaps a similar competitor's device, if it's a 510 predicate, for example, something like that. Let me go a little bit further with some more recommendations, Eddie, and I'd be happy to hear your thoughts.

As I said, the MOD database contains listings of these adverse events. Typically,

manufacturers and importers and medical device user facilities are most of the time required to report these adverse events directly to the fda. However, there is voluntary reporting that also goes on by usually healthcare providers, physicians and surgeons and nurses and so on, as well as patients or customers.

So it's not just manufacturers that reports this information, but it's physicians and patients as well. The couple of important things or limitations to understand about using the MAUD database. It's one of the more commonly used databases that I use for lots of different things, not just for regulatory due diligence,

but product liability. Due diligence is according to the FDA's website, and this is a direct quote medical device report or MDR data is not intended to be used either to evaluate rates of adverse events, evaluate a change in the event rates over time, or to to compare adverse event occurrence rates across devices.

And let me just read that one more time. MDR's data is not intended to be used either to evaluate rates of AES, evaluate a change in rates of AES over time, or to compare adverse event occurrence rates across devices.

The reason why I mentioned this EDIEN is because, at least in my experience, this is probably one of the most common uses of the MOD database, if not the most common use of database by manufacturers.

And yet here FDA is saying that it should not be used for this purpose. And quite frankly the reason why is that although the MOI database contains a lot of good information, it is by no means the complete story.

It is there. There are, you know, lots of examples we've talked off and on in the past about under reporting. There's lots of examples of things that don't show up in the mdr, I'm sorry, in the MOD database.

And I'll give you some examples of that as we continue. In addition, the publicly available information that's provided in the MOD database is usually very vague, very non specific, very, very high level because it's publicly available and obviously there are confidential.

One of the frustrations that I see a lot of people run into is when they do find reports in the moad database of MDRs involving their product or similar products, they're not detailed enough to be actionable.

That's just an unfortunate reality of the world. I have some thoughts on how we can improve that, but that's just the reality right now. The last thing that I'll say to kind of get this kick this discussion started Edian is another quote that I wanted to share from FDA's website is that 21 CFR 803.16 doesn't matter what the code is says a report does not necessarily reflect a conclusion by a company or by the FDA that the

report constitutes an admission of that the device the company or employees had caused or contributed to the reportable event. The company need not admit or may deny that the report constitutes an that the device the company, the employees caused or contributed to the reportable event.

I know that's a lot of legal verbiage, but basically what that means, in essence edien, is that just because something is reported in the MDR database, it's just a record of the report.

It's just saying, hey, this particular event happened. It does not say why it happened, it does not say whose fault it was. Was it the surgeon's fault that they used the device improper?

Was it the manufacturer's fault? Was there a manufacturing defect or a design defect or something like that? It doesn't say any of that. It's just simply a reporting, a historical record, if you will, without any judgments associated with.

So that's sort of the basics, the background of the MOD database. But the reason why I wanted to have this discussion with you and our audience today, Eddie, is because does the MOD database accomplish its mission?

Does the MOD database accomplish its mission? In other words, is the MOD database effective? Pun intended? You know, we're all used to thinking of medical devices in safety and efficacy terms.

My question is very simple. Is the MOD database effective? Any thoughts on that?

Etienne Nichols: Well, it's a good question. I, I'm still, I guess as you worded that question, I'm beginning to doubt that I know what the mission of it is.

Well, with the, the quote that you came from fda, that it's not really designed for early detection and malfunction or harm trends and so on. What would you say the mission of the MOD database is, aside from alerting the FDA that something's going on?

It sounds like a starting point, not a finishing and finish line.

Mike Drues: I think actually what you said at the tail end there I think is exactly correct, Eddie. And it's a starting point, it's not an ending point. It's a repository of information, if you will.

But it is not all of the information is just one,

one slice of the pie, so to speak. To put things in context, let me just share with you some statistics about the realities of the MOD database. Because one of the things that we've talked about many times, Eddie, and in our other discussions is the difference between what I call regulatory theory and the reality of the practice of medicine.

And unfortunately not all the time is theory and reality in sync with one another.

So in terms of is the MUD database reporting system, does it work? In other words, can we approve that it's effective? Pardon the pun, but pun intended. Here are some statistics.

over the four year period of: 2019

Now keep in mind that many reports that manufacturers become aware of are never reported to the FDA or to the MOD database because they are deemed non reportable events. So These are almost four and a half million for reportable adverse events, of which almost 5% of them, I'm not going to embarrass myself by doing the arithmetic,

but 5% of about four and a half million were submitted late. Manufacturers in most cases are supposed to submit their reports within 30 calendar days of becoming aware of the event.

And of course when exactly they become aware of the event, that's another regulation that the regulation can be interpreted in many, many different ways. And in some cases manufacturers are required to report the events within five working days before becoming aware of the event.

Depends on a lot of different things. But one of the things, probably the most important thing it depends on is the severity of the event and the likelihood that it could impact on other people.

If it's a not a very severe event and it's not likely to impact other people, then you usually have a little more time, probably 30 days. But if it's more severe and it's more widespread, then you likely have less time.

And that I think is common sense. But in any event, no matter how you slice it, almost 5% of these are reporting late, that is between one month and six months after the manufacturer was notified.

I don't know about you Edin, but if the, if the regulatory requirement says to report within one month and the company reports, you know, in three months or five months or six months, that's not a good thing.

And almost 10% of these four and a half million adverse events, almost 10% were reported very late, meaning more than six months late. I find it difficult to come up with any justification for that when the regulation clearly says within 30 days or in some cases within five days.

Almost 10% of these reports, 9.1% to be precise, are reported very late. Very late, meaning more than 6%, I think, quite frankly, and I don't take pleasure in saying this about our industry, edien, but shame on us, there is absolutely no excuse for that.

And about 15% of these reports had either missing or in some cases invalid data, missing or invalid data regarding dates or outcomes or something like that. Which means if you,

you know, 71% meet the MAUD 30 day deadline. But if you spin that statistic the other way, that means that 29%, almost a third of them did not, almost a third of them did not.

Remember, withholding safety information may be a cause of avoidable patient harm. Avoidable patient harm. And so even though, as we talked about, there are some significant limitations of the MOD database, I think this problem is further compounded by the fact that we as an industry don't do a very good job in reporting this information.

And let me just make one or two last comments about this Edin, and then I'd be happy to hear your thoughts. As you in our audience know, I spend a growing amount of my time as a expert witness in medical device product liability cases.

Well, you can imagine what a clever expert witness like me or somebody else can use with this information if we find out that either the company didn't report these problems on time or, or they didn't report them completely and so on and so on.

Ka ching, ka ching, ka ching. And the last thing that I wanted to share with you in terms of statistics, because again, I'm not trying to beat up our industry, I'm simply trying to acknowledge the realities of our world so that we can try to make our world, or at least our,

our industry a little bit better. Of all of these events that either have not been reported or have been reported lately, three medical device manufacturers, just three, three of them and 13 devices represent 55% of late reports.

Three device manufacturers, 13 devices represent 55% of late Reports, which means to me, Eddie, and that's a good thing, because the vast majority of the companies are doing what they're supposed to be doing, are responsible medical device professionals.

A small number of companies are not. However, here's the pun, the irony here. Those three device manufacturers and 13 devices that represent 55% of late reports are not three tiny little esoteric medical device companies that are operating in somebody's basement or garage that nobody's ever heard of before.

These include Beckton Dickinson with some of their infusion pumps, Amit with their Dexcom, their continuous glucose monitors, insulin pumps from Medtronic and Medtronic's artificial pancreas, and a dental implant by a company called BioHorizons.

So these are not exactly small companies. And again, I'm not trying to single these companies out as special villains. As a matter of fact, many of those companies I just mentioned are, in fact, customers of mine.

I'm simply saying that these are, you know, some of the largest medical device companies on earth. You know, they've been around for a very long time. They have dozens, maybe hundreds of regulatory professionals on their staff, and yet they represent 55% of late reports.

They're not, you know, following the regulation. My question to you, Eddie, and it could be a somewhat rhetorical question, is how do we explain this? How do we rationalize this?

We have the regulation. It's right there in black and white. And yet it's such a common problem that things are not being reported. Things that could directly impact patient safety, avoid additional patients from being harmed in the future.

Is it, for example, that we are not aware of the reporting requirements? Well, if that's the case, then I would say shame on the regulatory professionals, because how can you call yourself a regulatory professional if you're not aware of what the requirements are?

Or is it that we're aware of these requirements, but we're simply, for whatever reasons, not. Not following them.

Etienne Nichols: Oh, man. Where to begin?

Mike Drues: Where to begin?

Etienne Nichols: I'm curious, what are the penalties for being late?

Mike Drues: That's a great question. In terms of penalties,

first of all, a penalty assumes that you get caught, right? So in many of these cases, companies don't get caught, or they don't get caught until it's like, too late, right?

You know, so people start to get harmed. And then the retrospective or the forensic analysis, it comes to find that these companies didn't report certain events. They could get a warning letter.

They could get a 43 observation. We've talked about these things before. They can in some severe cases. Get a consent decree.

So the typical penalties, in some extreme cases, there might even be civil penalties. For example, if it can be shown that a company purposely withheld information for,

I don't want to say nefarious purposes, but for not legitimate purposes, then in some cases there are civil penalties. In other words, people could, could get fined individually. They can, you know, in extreme cases, they could go to jail.

But I would say the most common penalties would be either a 43 observation or a warning letter.

Etienne Nichols: Yeah. How often does that happen without something issue, some issue happening? Do you know? Have you thought of that?

Mike Drues: I'm sorry, say that again.

Etienne Nichols: How often do any of those penalties occur? Or would anybody get caught without anything, any harms having occurred in the field? There was an A reported,

but maybe it was fixed. Maybe they were late to report that. They're late to get the information to the FDA into the MOD database and nobody catches that for a while later and they say, hey, you were late.

Does anything bad happen at that point or is it purely an added on?

Does that make sense?

Mike Drues: Yeah, I think so. Thank you for restating the question. I think so.

It's a good question, but it's a little bit difficult question to answer because it's kind, you know, what we're essentially asking is how do we measure something that's difficult or impossible to measure?

You know, how do you know, for example, how many adverse events are never reported? Yeah, right. It's kind of like asking the question, how do we know how many people have thought about committing murder but have not actually committed murder?

Right. So it's a little bit difficult, but nonetheless, there are estimates. You know, people do statistics on some things. I think the more important question, Eddie, and for us and our audience to understand is why?

Why are these adverse events not reported? So I would like to go into that a little bit more. First of all,

there are several possibilities.

The reporting delays could stem from manufacturers knowingly withholding important safety information from the public. Because obviously that doesn't bode well for business purposes, for fundraising purposes, for sales purposes, and so on.

I would like to think that that doesn't happen.

I also am not naive to think that although it probably doesn't happen a lot, for us to think that it doesn't happen at all would be just, you know,

simply naive. So that's one reason why. Another reason why is that these delays could also represent the time required for manufacturers to verify that the adverse event occurred and to, when necessary, gather additional information before reporting this event to the fda.

And early in My career, Eddie and I started out as an R and D engineer and I spent a fair amount of my time doing what I call failure mode recreation.

In other words, a problem, an adverse event occurs with your medical device in the field. And we try to recreate the circumstances to understand what led to that failure mode.

Was it a design issue, a manufacturing issue, a user issue, and so on and so on. That does take time. But here's the thing, and this is probably at least in my experience, Eddie, and the most common reason why companies say that we're reporting late because we need to have time to investigate.

In my opinion, that is a poor excuse. And here's why. First of all,

the mdr, the acronym is Medical Device Report.

It does not necessarily imply. It's not like a CAPA where you have to have some correction or preventative action or something like that. It's a report.

So I don't think, and this is what I tell my customers, and by the way, I teach a three day course on post market surveillance and complaint handling. So I'm intimately familiar with not just the regulations but the realities of what companies do in these situations.

I think the company has an obligation to report the event within the 30 days or sometimes within the five days, regardless of why it happened or where their investigation is.

And you can always put a little caveat, kind of like you do with a capa, you little put a little caveat on there, say look, this, this event happened on such and such a day, you know, 10 days ago or whatever it is.

We, these are, you know, our current understanding of what happened and the events that led to this situation. We are in the process of investigating this situation further. Here is in a nutshell, what we're doing or we're planning to do in order to investigate this investig this, this incident and then we plan to finalize this report or come back with our,

you know, additional findings within 30 days or 60 days or whatever it is. That is, I think, what a responsible medical device professional not only could do, but should do.

Does the regulation say that directly? No. Should the regulation say that? Well, I would like to think. No, Edian, because I would like to think that we are medical device professionals and we can use a little common sense and handle things that way.

But according to the statistics that I shared with you, maybe we don't in fact live in the universe of rainbows and unicorns and we do need to include that kind of regulation.

Either way, and let me be crystal clear, either way, whatever reasons why you're Reporting late. Late reporting is not underlined, not permitted under any existing regulations. Regardless of intent.

Regardless of intent. So again, I don't mean to be melodramatic, but it's just a source of frustration to me when we have clear regulation. Now, I say clear in quotes because any regulation can be interpreted in many different ways.

But if the regulation basically says you need to report this within 30 days,

it's hard to, you know, interpret that in, you know, as six months. You can, you can file the initial report within 30 days and then file an update or a supplement or possibly even withdraw the initial report and replace it with a more complete report.

I have no problem with that. That's just paperwork. But when companies don't report this in a timely fashion for whatever reasons, there's no excuse for that. And here's the last thing that I'll mention to your question about the consequences or the ramifications is another problem with the MOD database.

The data in the mod database is, as I mentioned a moment ago, key details are often omitted or in some cases miscategorized. For example, reports describing patients dying are often categorized as injuries or malfunctions rather than deaths.

I mean, I,

as a good Brigitte professional ed in like a good politician, I think I'm pretty good at spin.

Well, to spin a patient death as an injury or a malfunction, that's a pretty extreme example of spin.

Etienne Nichols: Is that so? I'm just trying to understand who reports that, because my understanding would be the clinician reporting at that point, wouldn't it?

Mike Drues: So it could be, as we said at the beginning, there are several different people or entities. It could be the manufacturer, the distributor, it could be the healthcare provider, the clinician.

It could be the patient themselves. There's a lot of different things. But that's a good point, Edien, because let's consider a not so hypothetical scenario.

Let's say that a physician reports a problem, an AE with a device. Let's say that a patient reports the same problem with the same device, and let's say the manufacturer reports the same problem with the same device.

Well,

it doesn't take a lot to imagine that. I would like to think that somebody does a little fact checking. You know, kind of put these three reports next to one another and hopefully they're all going to be the same.

And if there are any differences, like one report said that the patient died and the other said that they were injured, that might raise some red flags. To be honest with you, Edian, I don't think that FDA does that, at least not on a routine basis.

I would like to think now that everything is pretty much computerized that would be relatively easy to implement from a computational perspective.

It could very well be that FDA does do this. I'm just not sure. But I don't think they do. I've not seen examples where that happened. If it's the case where FDA doesn't do this, then another of my recommendations to my many FDA friends is there should be some cross reference system so that if the same report is submitted multiple times then the similarities and differences are compared.

Kind of like a substantial equivalence comparison.

Etienne Nichols: Yeah.

Okay. So when I think about the MOD database from my time when I was working at a medical device company, I think about the good idea, I think about the mod.

Maybe there seems to be this understanding in the industry, like well it's the data hygiene is not all there, you know, so we use it but you know, there's like that whole wink and nod.

We, you know, we use it and I, and I wonder if that contributes to some of the flippant way of reporting that seems to be the case. I'd say the MOD is essential, but fundamentally outdated.

Built for maybe a paper based era, but not real time risk management in this digital data rich world. You know, we, you can't, like you said, as manufacturers we can't rely on it as a single source of truth or precision.

But it is our responsible at least to treat the MOD as a minimum compliance tool.

Mike Drues: I think that's a very,

very professional way to look at it.

It's not the single source of truth, it's one source. And I don't even want to say truth because the truth can be spun in many different ways. But it's a single source of information and a company should use that information in combination with all of the other information out there.

What my attorney friends like to call the totality of the evidence, you know, from all sources, not just from the MUD database or even other FDA databases, but from the popular press,

from the academic literature, from post market surveillance, from all those different kind of sources. And I think, you know, not to be redundant here Etienne, but that's why I highlighted those couple of quotes at the beginning of our discussion from FDA where it says this should not be relied on to estimate actual adverse event rates or you know,

that type of thing in terms of your comment. And I know obviously you know, Greenlight has software that will, you know, help companies, you know, manage a lot of the processes here that we're talking about.

I'M not sure, to be honest with you, any in the just for this particular problem, just making electronic is necessarily going to improve the quality or the completeness of the data.

Because even if a company and you might have, you know, a different view on this, if you do, please by all means share, you know, chime in. But even if a company uses an electronic system like Greenlight, and let me be clear, I mean Greenlight is a terrific system for managing this kind of stuff.

They might not report all of the information they should, they might not report it in a timely fashion and so on. So I don't know, Eddie, and maybe does Greenlight have a feature where if MDR is entered into the software that, you know, a few days before that, that time requirement,

you know, somebody you know hits you, whacks you with a big stick and say, hey, wake up because you need to report this within the, you know, by Tuesday, or something like that?

Etienne Nichols: Not yet, but it doesn't actually make sure that happens, but it could potentially help reduce litigation for the manufacturer themselves, I suppose. But no, I see where you're saying I totally get it.

It's kind of like I use a completely off the wall example in the Iron man and Spider man movie when Iron man took Spider Man's suit and he says if you're Spider man, if you're not Spider man without your suit, then you don't deserve the suit.

And I feel the same way about quality management system, you know, like tools. If you can't be a medical device professional without your tools, then you're not really a medical device professional.

I recognize.

Mike Drues: I couldn't agree with you more, and I think you are preaching to the choir on this. It's one of the main reasons why we continue to do these podcast discussions is to try to get additional people to join the chorus, so to speak.

It's not always easy, but I just can't help but point out just one more time that as you said, the more database, although it's a good start, it's a partial picture, it's not the full picture.

But there is some irony here, maybe even a bit of hypocrisy in the sense as we talked about that the whole purpose of the MAUD database and some of the other FDA databases is to collect this information and make it available.

And yet, as I said before, FDA is saying directly quote, MDR data is not intended to be used either to evaluate rates of adverse events, evaluate a change in rate of adverse events over time, or compare adverse event occurrences rates across devices I see this happen all, all the time with submissions,

especially 510s where people compare their adverse event rates. Where did they get this information from the MOD database. Oh, by the way, did you happen to see this part of FDA's website in the MOD database where it says don't do that?

Isn't that exactly what manufacturers and other people, including physicians and product liability attorneys don't? They use this information for exactly that.

Etienne Nichols: So, and I guess my pushback would be on that is what does FDA do with that? In that 510 submission, for example, or in the case of a litigation with the product liability?

They get away with it, do they not?

Mike Drues: Well, I don't want to see, I don't want to use the phrase get away with it because that implies sort of nefarious intent, which I don't think is, you know, the motivation of most people in our field.

Fortunately, what I would like to think, and I know that this happens to a certain extent at fda, but it happens much, much more with product liability cases is the company or the attorney or the fda.

Not the company, sorry, the FDA or the attorney would push back. In other words, okay, you've got this information that you've collected from the MAUD database. Great. What other information have you found out there from all these other sources that I mentioned before?

Etienne Nichols: Yeah.

Mike Drues: So that's what I would like to think happens. Elian, exactly what percentage of the time that happens, I can't tell you. But I can tell you in my own experience,

that's my sop. Whether I'm working on the regulatory side or as an expert witness, I'm always going beyond what's found in just one particular database.

Etienne Nichols: Yeah, yeah, that makes sense.

What would you recommend manufacturers do to really, I mean, we've talked about a lot just do the regulation, but any additional things that you recommend.

Mike Drues: So obviously it's going to be very trite for me to say, well, follow the regulation. You know, this is one of my frustrations and I, when I, when I go to the FDA with a pre sub and this happens surprisingly a lot, and FDA comes back and says, well, follow the guidance,

you know, it's like, gee, there's a good suggestion. I never thought of that.

So when it comes to the obvious stuff like we talked about before, if you are required to report within a certain time, then, gosh darn it, report within that time.

I mean, it is purely inexcusable, unless, God forbid there's some kind of a natural disaster and your company is wiped out or something. Okay, fine, that might be an excuse, but assuming that doesn't happen, report in the required amount.

Etienne Nichols: Could I interject something there? So I think a lot of companies are stretched thin. And I think as a medical device company, there are certain aspects of the medical device company that you just have in addition to other companies.

And this is one of the things that I think you have to understand that there are additional resources required for this.

Mike Drues: I could not agree with you more, Eddie, and I completely understand that. And look, we don't, regrettably, we don't live in a world where there are infinite resources. We don't live in a world, you know, where of, of the, of, you know, rainbows and unicorns.

However, it's a matter of degree. When I say report on time. If you don't, for example, have the time to fully investigate this, then submit at least like a one or two page sort of Reader's Digest, you know, here's the incident, here's when it occurred, here's a brief explanation of what happened,

here's what we're doing to investigate it further, and here's our timeline. We hope to have this concluded within 30 days or 45 days or whatever it is. At least make the report.

That way you can't get pinged for making the report. There's a big difference between FDA pinging you on not submitting a complete report, I.e. with all the proper information, versus not submitting a report at all.

Etienne Nichols: Yeah, that makes sense.

Mike Drues: Right. And to submit an abbreviated sort of a report like that. Edien, with all due respect, I could submit a report like that in less time than it's taking for you and I to have this discussion today.

Etienne Nichols: Right.

Mike Drues: You know, it's a, it's a frustration when some companies, they spend more time talking about doing something than actually doing it. And to your point about resources, again, I completely understand that all companies have limited resources, but on the other hand, it is a regulatory requirement.

So if a significant number of companies are going to try to argue that we don't have the resources to do this within this period of time, then I think we as an industry need to go to FDA and, or to Congress and say, look, this particular requirement is not realistic and let's have a discussion about how to change it to make it more realistic.

Because after all, as we've talked about many, many times in our discussions, Eddie. And what good is having regulation if it's not realistic?

Etienne Nichols: Yeah, yeah, you know,

and I interrupted you, I didn't know if you had additional. I also want to know what you would recommend for the fda, because there I think I even have some thoughts on how this could be improved.

Mike Drues: But yeah,

well, let's go on to the FDA side because I know that many of my FDA friends also listen to our discussions. And interestingly enough, and many times I get emails from, because I have a lot of personal friends at FDA and sometimes they'll send me an email not from fda.gov but from their Gmail address or something like that,

and they'll say, mike, I really liked, you know, what you said. I agree with you 100%, but I'm not the person that's going to bring it up, you know.

But on a more serious note, so what should FDA do? So the question is, do you want to focus on the carrot or the stick?

I prefer to focus on the carrot whenever possible. In other words, this might sound a little odd, but maybe we can present, maybe we can create some sort of a reward or bonus for companies that do a good job following the regulation.

Maybe they get, I don't know, a 5% discount on the user fee of their next submission, or maybe they just. FDA creates a list of companies, kind of like, you know, the bdp, you know, list, you know, here's a company, here's a list of companies that we think are doing a really good job.

There's a number of ways that, you.

Etienne Nichols: Know what's funny to me about that is I, I feel like that could be, I don't know, maybe this is a pessimist in me, which is unusual. We're talking about rewarding someone for reporting something that potentially could be their device, mis, malfunctioning and so on.

Mike Drues: That is true. You're right.

Etienne Nichols: Companies that have the worst might be the, the highest performers on that list.

Mike Drues: You're right. Or another way to look at that similarly is we're rewarding companies for following the rules, for doing the things that they're supposed to do anyway. But it's. Look, it's an idea, it's a suggestion.

Take it for what you're paying for it. On the other side, we can focus on the stick. In other words, as you asked before about penalties, maybe we do need to have more severe penalties.

Maybe we do. I mean, I have examples where I mentioned 43s and warning letters. I have examples of companies where, regrettably, companies have gotten the same company has gotten the same 43 observations over and over again, in some cases the same warning letter over and over and over again over the course of,

you know, multiple years, in some cases. It's one of the many interesting things about the Phillips Respironics cases where they got in trouble from the FDA multiple times for the same things over and over again.

You know, it's Einstein's definition of insanity, doing the same thing over and over and expecting a different result. So I do think that maybe we need to have some discussion about making the penalties more severe.

Especially if you remember the statistic that I shared earlier where about 55% of these late reports were submitted by the same three or four were caused by the same three or four companies.

Right. So clearly the synapses are not connecting there much of the time. As you can imagine, Adrian, most of the time these late reports are not submitted or released until there's a report in the media of the event.

In other words, a story on the news, on NBC or CNN or something shows up. That's often when important safety information is released or some cases it's not released until after a recall or some other high profile, how high profile event occurs.

I wish that wasn't the case. I really, I really do. But unfortunately that happens a lot. And the last thing that I wanted to mention before we start to wrap this up, edin, is and you said you had some suggestions as well.

Oftentimes the late death reports for BDP devices are disproportionately more common than they are for non BDP devices.

So I think we need to take a slightly closer look at the reporting requirements and not the requirements, but the realities of reporting, especially for BDP for the Breakthrough Designation Program devices because there's some anomalies going on there.

But maybe that's a topic of a different discussion and that's something that FDA can look at as well. But you said that you had some suggestions for FDA as well.

So what would you offer? Eddie?

Etienne Nichols: Well, I guess in my mind when I'm thinking about I, I, I, I would want to clear the path a little bit. I know that it's those of us who have been in the industry for a while, we know what we should be doing and it's relatively easy.

You could do it pretty simply. But at the same time I think it's not always clear to some companies. So obviously it's what we're doing right now. But if you clear the path, make the tool a little bit easier to use.

I know we kind of already talked about the, the tools argument, but increasing traceability might be addition something I would also do. So tying it to those other things, automatic automating that you have Three or four that look like they're identical.

An AI tool could come and suggest and then someone else could confirm, yes, those are all the three the same thing. And the last thing I do is I would make it worthwhile.

Right now I question what the purpose of the mod database is and I know we could, you know, semantically talk about that, but make it worthwhile to the industry. Make it where the industry says, hey, I'm putting something in here because my next 5, 10k I can use that data in a product liability case that can be used.

It is a worthwhile database to have with clean data. And part of the way you would do that is to make the tool useful to the industry, easy to use.

And I don't know, I don't know how to say it, but just make it worthwhile.

Mike Drues: I think that's an excellent suggestion, Edin and I would just add one or things to it. I agree with you 100% that I think we should make the tools as effective and easy to use as possible.

And to the part of the discussion earlier when we talked about potentially having multiple MDR reports on the same device with the same patient and so on, I could, as an engineer could easily see somebody, perhaps even greenlight, implement sort of an AI based bot, for example, where when an MDR is reported from any source,

whether it's the company or a physician or a patient or whoever, automatically in the background the bot will sort of, how do you say it, scan the existing mod records to see if it looks like there's something similar out there.

And if there is, you would get up a pop up or something. So I think that would be, you know, a wonderful tool.

Etienne Nichols: Yes, yes, we've thought of this and yes, I'm sure you asked, we talk more. But yeah, it has multiple benefits. There's from the post market surveillance, also from the design control side.

Mike Drues: But at the end of the day, you know, a tool, whether we're talking about, you know, some sort of a QMS tool or you know, whether we're talking about, you know, a scalpel that a surgeon would use, at the end of the day the tool is only as good as the person or the people that are using it.

And so that's something that I think we should, we should keep in mind.

Etienne Nichols: But I guess I would highlight one last thing and that is I, when we went, you know, I didn't know exactly what the mission was but I would go ahead and put this out as what I would say the purpose of the mod database is really to keep patients safe and keep these tools effective and to highlight these things.

And so when I talk about what's worthwhile, I think it's important to remember the true purpose here.

Mike Drues: I think exactly that is the true purpose, you know, boiled down to its essence, to its nutshell, to keep patients safe. I think the better question, though, to ask, as I talked about earlier, is what is the efficacy of that purpose?

You know, does it work? Because, again, I don't mean to be cynical here, but based on some of the statistics that I shared today, there is cause to at least ask the question, gee, maybe this is not as effective as it could be or it should be.

Etienne Nichols: Yep, absolutely. Anything else you would care to add or. I mean, I think that's a good stopping point.

Mike Drues: But no, I think that was a great synopsis. I think that there's a lot of commonalities that, you know, in the situations that we talked about today with many of the other topics that we talked about, have talked about in terms of, you know, 43 warning letters and, and design controls and CAPAs and complaints and all that kind of stuff.

My, my purpose here, and I don't want to be misunderstood on this, my purpose is not to play the blame, blame game. You know, not to blame specific companies or industry or fda, but just simply to try to take a open, honest look at what we do as an industry,

not just the things that we do well, because no doubt there's a lot of things that we do do well, but the things that we don't do so well in an attempt to try to understand why do we not do them so well and try to figure out ways to make them better.

And when I see the same problems happening over and over and over again within the same company over periods of years or sometimes even decades across our entire industry,

it's a little frustrating. It's a little frustrating. You know, it's, there's a, there's an adage, you know, practice makes perfect. Well, it's actually not true. Practice does not make perfect.

Perfect. Practice makes perfect. Right. So if you continue to practice and make the mistake, the same mistakes over and over again, you're going to get very good at making those same mistakes.

Etienne Nichols: No, I totally get where you're coming from. And, and sometimes I know there's a frustration with the fda. The evolution of the FDA and things like this almost are a step function.

It's not a gradual improvement. I mean, I say that I don't want to be discouraging. I feel like if companies start evolving and increasing the vigilance of their reporting. It will increase the cleanliness of the data, but at some point it's also something of a step function where there's a bit of an overhaul needed.

Mike Drues: I agree, and I know we're trying to wrap this up at the end, but just one last suggestion for both the FDA as well as the industry. This applies to MAUD and mdr, but it also applies to complaint handling in general.

I view MDR as a sort of a subset of complaints, if you will. Is that why are all of these things treated equally? In other words, why is a cosmetic defect in a device treated in many ways an equal fashion as a problem with the device that could potentially be a critical life or death situation?

I mean, to me that makes absolutely no sense. You know, when a patient, I used to teach medical school back in the day, when a patient presents to the er, hopefully a patient who is having a heart attack is gonna be seen first as opposed to somebody who has a splinter in their finger.

And I say hopefully, cause that doesn't always happen. But that's the theory, right? So we should not take a one size fits all approach here. Unfortunately, the current regulation does not really, and certainly not in any detail,

stratify or present sort of classifications, if you will, of, of. Of complaints or mdrs. I would like to see, I would like us to implement a system where, where we treat the most significant ones first and the ones that are not as important, those kind of go on the back burner.

And by the way, Eddie and you, as you know, I work with a lot of companies on the quality side. That's one of the suggestions that I make to companies in their quality management system.

Even though it's not required,

I say to them, it's common sense to me from an engineering perspective to not treat all of your complaints or all of your MDRs equally. And FDA does to a certain extent by differentiating between the 30 day versus the 5 day reporting requirement.

I would like to see them go much further than that. But a company can implement within their own quality management system criteria such that if this particular incident can cause significant harm or has the potential to cause significant harm, it gets investigated quicker.

You know, we have to pull people in, you know, on the weekend or something, if necessary than, you know, something else, or if it has a high frequency. It's not required per se, but it's, it's the right thing to do.

And going back to the carrot and the stick, one of the reasons why I make that recommendation on the quality side, Edian, is because if the device injures a patient and the company gets sued, and undoubtedly the company will get sued.

And if I as an expert witness can show the judge or the jury that the company had knowledge of this, they were made aware of it, but they just kind of treated it like all the other and kind of, you know, got got lost in the, in the shuffle,

so to speak. Doesn't take a JD From Harvard to hear a Ka Ching, Ka ching, ka ching, you know, so something to think about. There are solutions to all of these problems.

We just have to think a little bit, right?

Etienne Nichols: Absolutely. Thanks so much, Mike. I appreciate it. Great episode, great talk on this crucial topic. And yeah, look forward to the next time, everybody. Thank you so much for listening. We'll see you all next time.

Take care.

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