change to version of title

Regulatory compliance is critically important. However, some think product liability is just as important, if not more. Today’s guest is Mike Drues of Vascular Sciences and we discuss how companies shouldn’t fear the FDA and its regulations. Instead, they should have a healthy respect for the FDA.

Who should they fear? Product liability attorneys because they can cause much more damage to a company than the FDA.

 

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Some of the highlights of the show include:

  • You may not be limited to what the FDA requires. For product liability, passing FDA’s regulations isn’t enough or include everything that should’ve been done.
  • When designing a product, consider product liability. Would you recommend the product to a friend or family member? Would you use it yourself?
  • Product risks to consider include labeling. Does the device function normally and is it safe and effective when used according to its label?
  • Manufacturers are liable when a customer doesn’t follow instructions or intended uses for the device, if they knew/should have known it could be used off label.
  • Documentation is important from a regulatory/quality perspective. But for product liability, it can be the kiss of death. Be careful about what you document.
  • Companies should report adverse events with a device to the FDA in a timely manner. Or, they should face regulatory and product liability consequences.
  • Do you want to be proactive or reactive? Prevent issues, rather than have to correct them. Adopt a true quality culture.
  • Engage regulatory guidance into the product development process early on. It’s easier, faster, and cheaper to make changes sooner than later.

 

Links:

Premarket Notification 510(k)

International Organization for Standardization (ISO)

Mike Drues

Greenlight Guru

 

Quotes:

“Many of my medical device friends...fear the FDA. You should have a healthy respect for the FDA.” Mike Drues

“Who should we fear? Well, we should fear the product liability attorneys.” Mike Drues

“If it’s not documented, it didn’t happen. Be careful what you document.” Jon Speer

“We have an obligation to report problems, especially if they are serious problems, sooner rather than later.” Mike Drues


Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: We talk about regulatory compliance quite a bit on the Global Medical Device Podcast. Wanted to take this opportunity to share with you another perspective that might be equally, maybe even more important and that's product liability. So enjoy this episode of the Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is the host, founder, and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. I'm gonna confess right away, I am cold, folks. It is winter. I can look outside, I can see snow. It's been bone-chilling cold, and our guest on today's podcast, Mike Drues from Vascular Sciences has reminded me that where he is, there's nothing that he needs to scrape off his window in the morning. Mike, welcome to the Global Medical Device Podcast.

Mike Drues: Well, thank you, Jon. Always a pleasure to speak with you and your audience. And in terms of the weather, to quote a famous politician, "I feel your pain." I had cold and snow for my entire life up until very recently having relocated now to Southern California where we don't have that particular problem. We have other problems, but not that one. [chuckle]

Jon Speer: Well, Mike, you and I have talked a lot in the past about both tidbits on podcast, webinars, but also just in our frequent conversations about regulatory and how companies sometimes will fear FDA, our regulatory bodies. And I'll paraphrase you a bit, but I know that you usually chuckle when we talk about this topic because you're like, "You know, companies shouldn't fear FDA." Can you remind folks who maybe they should fear and then your statement around this topic of regulatory versus product liability?

Mike Drues: Sure, Jon, I think that's a great place to start our conversation today. So you're exactly right. Many of my medical device friends, they often tell me that they fear the FDA, and I say, "No, no, no, no, you should have a healthy respect for the FDA." As we've talked about before, Jon, as I like to say, that a physician can see go patients one at a time, but an FDA reviewer can kill patients thousands at a time. So without a doubt, FDA has a very, very important job to do. So we should, as an industry and as professionals, have a healthy respect for the FDA, but we should not fear them. So who should we fear? Well, we should fear the product liability attorneys because the product liability attorneys can impose a heck of a lot more damage to a company than the FDA ever could. And I know from first-hand experience, Jon, working on both sides of this fence that product liability attorneys are a heck of a lot better at finding documentation than FDA ever will be. So, have a respect for the FDA absolutely, but we should not fear them, we should fear the product liability attorneys.

Jon Speer: Yeah, and I read some stories recently and we'll leave the specific details of the company and the products out for the time being. And folks, you can find this, this is information that's really available. I actually have some different Google alerts that I have set up on my own so this comes to my inbox fairly often. And there's been a lot of recent documentaries or there have been recent websites, patient advocacy groups that are focusing on what happens when products go bad. And there's this one case that I... When I was reading it, it was talking about... Basically, it was pulling in the argument about regulatory clearance, and specifically 510 [k] clearance and how that relates to product liability and I would say the argument was that 510 [k] clearance doesn't really hold any water when it comes to product liability. Can you elaborate on that a little bit, Mike?

Mike Drues: Yes, absolutely. As we've talked about a little bit in the past, Jon, I have a small but growing amount of my business working as an expert witness in medical device products liability lawsuits. And one of the things that I like about working with my attorney friends is that they do not limit me to what FDA may or may not require for a 510 [k], or de novo, or PMA, or what have you. And I've said many times when a company gets a 510 [k] clearance, when they have a de novo that's granted, when they have a PMA that's approved, when they get a CE mark, when they get an ISO blah blah blah certification, that's the academic equivalent of being a C student. That does not mean that you're making a safe and effective product, it doesn't mean that you're making a good product. It just simply means that you're passing. And when it comes to product liability, that's not always good enough.

Speaker 1: What my attorney friends want me to say is as a professional biomedical engineer, did the company do what they should have done, whether it was required by the FDA or not? So it's interesting, Jon, in our field, I hear a lot of people, they say their goal is regulatory compliance or quality compliance. Well, compliance just means that we're passing, that's not a very high place to set the bar. I think that we, as an industry, can probably do better than that. What do you think, Jon?

Jon Speer: Yeah, I agree, and I think there's probably this intersection where our, at least, relationship between what we're doing during the design and development process that eventually getting that regulatory clearance or approval or whatever the case may be, depending on our product classification, obviously, that's the permission for us to be able to sell it to the market. But all the things that we're doing in design and development are important, not just to get that clearance or that permission, but we should also, to your point, be cognizant of how is this product going to be used. And I think there's certainly a relationship between what we do during design and development, risk management, and those sorts of things that need to be an important thing that we consider during the design and development and then as we make changes to that product, we need to factor this thing in, I mean... So what are some key things that we should be thinking of from a risk perspective, when we're designing and developing a product, not only for that market clearance, that regulatory clearance, but what should we be considering from a product liability standpoint? Should we be thinking about that when we're designing products?

Mike Drues: I think we really should, Jon, and let's start out with a very high level recommendation. Look, simply put, if we, as individuals, as professionals feel comfortable recommending whatever product that we're working on for a family member, for a friend, perhaps even ourself, then I have absolutely no problem taking it to the FDA and if necessary, I have absolutely no problem defending it if something bad happens and we get sued. So that's where we should start as opposed to, as you and I have talked about before, Jon, this tick box mentality where you're just simply following regulation like a computer executing lines of code. So that's probably at a high level, but maybe we can make this a little bit more specific, a little bit more actionable for our audience, Jon. What do you think?

Jon Speer: Yeah, I think that would be important and one thing that comes to mind as you mentioned that is the slippery slope of when I assess risk in my product, what is the scope of that risk? Do I consider off label use? Do I consider misuse? What are the benefits of doing so? What are the drawbacks of doing so? I'm sure you have some thoughts on that.

Mike Drues: I have many thoughts on that, Jon, as you and I have talked about in past conversations. So specifically, when it comes to labeling from a regulatory and even from a quality perspective, we're responsible to make sure that our device functions normally, it's safe and effective when it's used according to the label. But I didn't fall off the turnip truck yesterday, Jon, and I don't think you did either. We know for a fact that once our products leave our door, whether people use the product the way we intended to be used, I.e. On label or off, is totally beyond our control. So the question for us, Jon, as engineers, as regulators, as medical device professionals, do we want to live in that theoretical world where people just use our products the way that they're intended, I.e. That the way they're labeled? Or do we live in the real world where people are going to use those products? And let's bring this back to product liability, Jon. A lot of people think that if a device, for example, is used off label and something bad happens to the patient that the company cannot get sued, so let me use one of my not so hypothetical stories to illustrate, Jon. Imagine and I'm gonna put you a little bit on the spot here, if that's okay. I'm gonna ask you a question.

Jon Speer: Okay, sure.

Mike Drues: So listen carefully.

Jon Speer: Okay.

Mike Drues: So imagine somebody is using your medical device off label and the patient is injured, and you as a manufacturer gets sued. Can you, as the manufacturer, be held liable for a bad thing that happens to a patient, even from your device, even though it was caused by an off label use of your device? Do you understand the scenario, Jon? And then what would be your answer?

Jon Speer: Let me restate what I think I heard you say to make sure I understand. So, I design a device for indication XYZ and once somebody, a doctor or a physician, whomever, somebody buys my product, they don't use it for indication XYZ, they use it for a different indication ABC, one that I didn't plan or anticipate but anyway, they use this product for indication ABC not XYZ. And when doing so, patient who is the recipient of my product in this procedure for ABC, they get injured in some way, shape, or form. So your question is, can I be held liable as the manufacturer of the product even though I had no intention of that product being used for the way that it was being used? That's the question, right?

Mike Drues: Exactly correct.

Jon Speer: Alright. It feels like a trick question, but I'm gonna go with yes, I can be held liable because it was my product.

Mike Drues: Well, you're right, Jon. The short answer is yes, the manufacturer can be held liable if, and there's an important caveat here, if the opposing counsel can show that you knew or should have known, or as my attorney friends like to say, were thinking about the fact that these particular products could be used off label. In other words, if the opposing counsel can demonstrate that you knew or should have known that the product could be used in this off label way, regardless of the fact that it's not on the FDA cleared or approved label, it doesn't matter. You can be held liable. Now the question is, and I don't wanna turn this too much even to a legal discussion, Jon, but it is important for engineers and regulatory folks to at least understand the basics here. How does the opposing counsel show this? Well, I've been involved in many medical device lawsuits where we did exactly this. If we can show that it's the standard of care, in other words, that it's what we teach in medical school, even though it's not on your label, then you knew or should have known.

Mike Drues: If we can show that there are, for example, anecdotal reports or case reports in the literature of this particular device or this type of device being used in this way, even though it's off label, you would knew or should have known. If we can show that this particular device or perhaps a predicate device, if this is a 510 [k], is used this way in the EU or some other part of the world, then once again, we can show that you knew or should have known. And when it comes to thinking about, that's an interesting one as well. This gets into the quality requirements for risk management plans. I was in a meeting once where we were doing a risk brainstorming session, and we were ticking off all the risks associated with this particular new medical device on label risks.

Mike Drues: And then the topic of off label risk came up, and immediately the ranking person in the room who happened to be a senior VP, this was a very large Fortune 50 medical device company, Jon. He said, "This meeting is over. Don't let the door hit you on the you-know-what on the way out." And the reason is, is because if you anticipate risks associated with the off label use of a product, and you don't mitigate them sufficiently, and then a few months or a few years later, somebody is harmed because of the off label use, you identified that risk, and God forbid, Jon, if you include that in your mini notes, that is the kiss of death. Because now I can easily show, well, back in such and such a day, the company had this risk brainstorming session, they identified this risk associated with off label use, and they did not mitigate it enough.

Mike Drues: So bottom line, very, very simply put to my many engineering and regulatory friends that are in our audience, simply because you do not list a particular use of your device on your FDA cleared or approved label doesn't necessarily insulate you from product liability. I think there's a very important lesson to be learned there from that long story, Jon. Would you agree?

Jon Speer: Yeah. Yes, I do. And I'm conflicted a bit because, I think, where you are conditioned or somewhat taught to... Most people listening will be able to finish this mantra before I actually say the words, but if it's not documented, it didn't happen, which maybe is the point of this executive. [chuckle] Be careful what you document. And I know that you have a quote about that, that we'll get to hear in a moment. But as a product development engineer, I'm a bit conflicted because I want to do a proper due diligence, I want to document, I want to think about these sorts of things. But the moment that I do now means that I thought about it, or I did more than thought about it, I actually put it down on paper, and I presented it as a plausible way that this product can be used off label or misused, and that sort of thing. So what can I practically do? Any advice or tips to folks what should they be documenting on these types of things?

Mike Drues: Well, first of all, Jon, kudos to you because I certainly hear the concern in your voice, there is a bit of a paradox here. You are a very diligent, very responsible quality professional, and as a quality professional, obviously documentation is important. What I'm simply suggesting to you as well as to our audience is, obviously, from a regulatory and a quality perspective, documentation is important, but from a product liability perspective, it can be the kiss of death.

Mike Drues: Now there's a famous quote that you mentioned a moment ago, "Never talk when you can nod, never nod when you can wink, and never ever write an email because it's the kiss of death." You're giving the prosecution all the evidence that we need. So this is why I often facetiously, but also seriously, say to people, "Document everything and then as soon as you do, shred everything." Now, please don't take my words literally here, I'm trying to just simply point out that there's a balance. We have to be very careful on one hand what we need to document from a regulatory or a quality perspective, but on the other hand just keep in mind that if there is a problem down the road, one of the first things that the opposing counsel is going to look at is your documentation, and one of the first things that I ask for is all of the letter to file and related documentation, because that information, as you know, Jon, does not go to the FDA.

Mike Drues: And let's talk about documentation for just a tiny bit more, because I hear so many people in the regulatory and the quality world, they say, like you just did, documentation is important. Well, to me that's a statement of the obvious. The question is, what do you document and what do you not? Many times a company will call me when they're having a problem and they ask me to help them get out of their problem, which I'm happy to do and one of the very first things they say to me is, "We're gonna send you all this documentation." And I said, "Well, you're welcome to do that. I'm happy to review it. After all, you are paying me by the hour. However, pretty much right away I can tell you that that documentation is not gonna do many a good. Why? Because you've documented what you did and I already know what you did. That's why you're having problems. What I wanna know is what you didn't do and why you didn't do it, what you considered doing, and what you didn't do and so on." So in other words, most people when it comes to documentation, they document what they did, but how many people in your experience, Jon, document what they don't do and why they didn't do it? Perhaps there are a few, but I don't think there are many.

Jon Speer: Yeah, I would say that you can probably count it on one hand, maybe one finger at least in my experience. [chuckle] It's an important point. So keeping with the theme and I'm leading us to a point here in a moment, but I wanna highlight another story. Again, I'm gonna leave the name of the company out of this particular example. But there was a story I read recently on a med device industry publication and it was talking about or sharing this story about this company, and they had learned about their device being involved in an adverse event. I don't remember the exact dates. But go with me here for a moment. It was like August of one year, they learned about this device and it was burning a patient during an MRI or something like that, and then a month or two later, they learned of another event and they reportedly investigated the issue and dealt with it, but it was like they didn't report these adverse events to the FDA until like nine months later.

Jon Speer: And I'm like, when I'm reading this, I'm like, "Holy cow." You wanna talk about, number one, this is a case where, to me, there was regulatory issues with what this company did, but there's also a huge product liability issues with what this company did. I don't know if you're familiar with that story, Mike, but do you understand the scenario, and can you comment on that?

Mike Drues: Yeah, sure. So, again, without getting into too many specifics, I was not involved with that particular company, but I was asked to review that particular case after the fact that I have been quoted in a couple of the press publications about it so I am somewhat familiar with the case. Bottom line, you're right, there was a pretty extensive delay, almost a year between the time that the company first started becoming aware of problems and when this information was reported to the FDA. Now, to be clear, actually, the company was aware or should have been aware of the potential of these problems long before the first problem was indicated because, in my opinion, this particular type of adverse event was definitely foreseeable and should have been part of their risk mitigation strategies back even before the product was on the market as part of the development process.

Jon Speer: Yeah, and let me just interject. This is one of those things where you would expect a company to have documented that scenario because it's very foreseeable, because it was used exactly as it was expected.

Mike Drues: That's correct. And maybe, again, to be fair, as I said, Jon, I'm not involved personally with this particular case, so I have only access to information that is publicly available. Their risk mitigation strategy, at least the complete one, is obviously not publicly available. So maybe the company was aware of this, maybe it wasn't, I don't know. But in any event, what we're focusing on here is when the company did finally find out that these problems were occurring, there was a very long delay in reporting it to the FDA. Now, obviously, that's problematic from a regulatory or a quality side. This is a 510 [k] product, this is not a PMA. In the PMA world, as you know, Jon, the requirements are a little bit more rigorous although regrettably, as you and I have talked about before, they're not always enforced. But in the 510 [k] world, the post-market reporting requirements even for significant adverse events are not really that rigorous, let's put it that way. And so from a product liability perspective, what are the consequences here? Well, I'm not an attorney, Jon, nor do I play one on TV, but to me it should not take a JD from Harvard Law School after somebody's name to be able to make a pretty strong case that if the company did not report this information to the FDA for nearly a year, in the eyes of the jury, ka-ching, ka-ching, ka-ching.

Mike Drues: So, once again it's another example regrettably of when you follow the regulation, you're just being a C student. I think we have an obligation to report problems, especially if they're serious problems sooner rather than later. And by the way, I have no problem, Jon, with what I would call FYI reporting or partial reporting. In other words, and we do do this in the drug world but not so much in the device world, we make FDA and not just FDA but we make our customers, our surgeons, physicians, whoever the users, aware that there are some reports of a potential problem. We don't know exactly why the problem is being caused yet, and we don't know yet any specific advice to give you to minimize or avoid having this problem, but we wanted to let you know A, that we are having some reports of this problem and B, the problem is under investigation and when we do have more definitive information, we will definitely come back and share it with you. Whether that's required from a regulatory or quality perspective, Jon, personally, I think it's common sense, I think it's the right thing to do. What do you think, Jon?

Jon Speer: I think it's just a best practice, and I have, unfortunately, been involved in my career where we learn about an adverse event. And we took the stance where the moment that we learned about it, we tried to gather as much intel and information as we possibly could. Of course, when you know about an adverse event from a regulatory compliance perspective that the time is ticking, if it was involved in serious injury or death or had the potential to cause serious injury or death. And so, we we wanted to report that as soon as we possibly could with as much and complete information as we possibly could. And unfortunately, we didn't have the investigation complete upon our initial report and we felt that was okay. We felt that was the right move to make, because we wanted to inform the agency, we wanted to inform our user base of these challenges and let them know exactly what you just suggested, "Hey, we're aware of this, we were investigating this, this is our top priority," and it really was our top priority. And the moment that we concluded the investigation, and we have more data, more information, we made an addendum to our regulatory report to the agency, we updated our customer base. To me, that felt like the right thing to do because it felt like my responsibility as a medical device professional to say, "Yes, we're aware of this and yes, we're doing something about it." And that just felt like the right thing to do. I think that's the best practice.

Mike Drues: Well, I agree with you strongly, Jon, that it is the best practice. No question about that. The question is, would we consider it an industry standard? Regrettably, I would have to say probably not because, to me, industry standard means that most people would do this. And in my experience, and I think you said also in your experience, Jon, most companies don't do this. So for the benefit of our audience, to keep this fairly simple, the question comes down to really one thing: Do we want to be proactive? Or do we want to be reactive? In most situations, I would prefer to be proactive. I would prefer to get out there ahead of the story. And as the politicians like to do control the spin, so to speak, at least as much as they can, as opposed to being reactive and then having to do damage control later on and having to answer questions of what did you know and when did you know it? But again, Jon, that's my personal preference. Unfortunately, there is no regulatory requirement and correct me if I'm wrong, I don't think there's any quality requirement that says we have to be proactive as opposed to be reactive.

Jon Speer: There's not. And not to get too deep in the weeds on quality practices and 43 observations and warning letters and things of that nature, but year after year after year, one of the biggest, oftentimes the top reason why companies get inspectional observations from FDA and challenges during ISO audits has to do with companies being reactive, correcting issues rather than being proactive in preventing issues. But again, that's a whole different topic for a whole different conversation.

Mike Drues: And what's the old adage, Jon? An ounce of prevention is worth a pound of cure, or something like that?

Jon Speer: It's something like that, yeah. And so folks I think this is an important aspect of though what you should be putting in place from a quality management system, I want you to look at QMS as more than just satisfying compliance and checking a box to show that you meet different regulations or regulatory requirements for your QMS. I want you to think about it being more of a true quality professional building processes that have leading indicators, if you will, to help you identify and track and trend opportunities for improvement before they become big deals. This will help you from a product liability standpoint as well, being more proactive, so designing your quality management system in a way that allows you to do that and adopting this true quality culture will be helpful. And of course, you can go to www.greenlight.guru, we're happy to help you with that particular challenge.

Jon Speer: We are an eQMS software platform that's designed specifically for the medical device industry, by medical device professionals. We're very cognizant of and hopeful that you'll adopt a proactive mindset and to this true quality culture. But let's get back to the topic and wrap up today's conversation. We've talked about when to document a little bit, we've talked about what not to document a little bit, but there's something that we should be doing from a product design standpoint is, if we shall we be designing features or attributes or fail-safes, are there things that we can do a better job of, as medical device professionals with our products anticipating how it's going to be used, but also anticipating how it might be misused or off label used?

Mike Drues: Well, first of all, Jon, I could not agree with you more of what you said a moment ago on the quality side. And I would say exactly the same thing on the regulatory side. Our goal should not be just simply to tick off boxes on a form as you mentioned, but to try to do what we can to prevent problems down the road, whether they are problems with the FDA or problems with potential product liability, it really doesn't matter. As I said a moment ago, an ounce of prevention is worth a pound of cure and just because you meet the regulatory requirements or the quality requirements doesn't necessarily mean that you're doing all that you can to minimize the chances of having problems later. So that's something that we should all at least think about, if not act on as much as possible. And I'm sorry, Jon, what was the last question?

Jon Speer: Oh, that's okay. Is there something that we can do, for example, when we're designing a device? We may not to your earlier point, we may not document all of the ways that the product can be used incorrectly, or off label, or misuse. We may not document all the things that we chose not to do for hopefully reasons that are better understandable after we've talked, you and I have talked a little bit today. But is there something that I can do, for example, as a product development engineer, when designing my product to factor these scenarios and during that process?

Mike Drues: Yeah, it's a great question, Jon, and thank you for reminding me. I guess, I'm getting a little old, I forgot temporarily. Look, this is a very difficult question, this is not a simple question. And it is, to a large degree, paradoxical. So here's my best and my simplest advice. Yes, we can make sure that we can design our devices so that they work according to the label but we should not be so naive as to think that that's the only way that they're going to be used. And so we should, as designers and engineers, work closely, work hand-in-hand with our regulatory folks to do what we can to design our devices to be used in what are today potentially off label ways, and then one of the ways that we can sell this to our regulatory professional, and as you know, Jon, I work as a regulatory strategy consultant, is you can say to them we're gonna bring our device onto the market with this narrow indication first, but as soon as we get onto the market, then we're gonna go back to the FDA with a label expansion and add that off label use to it. And, oh by the way, from an engineering perspective, we won't have to do anything more, because we've already designed it, so that we make sure that it works that way.

Mike Drues: In some cases, maybe we've even already done the testing to ensure that it does that way. So every single week, almost every single day, Jon, I give advice to companies all the time that as an engineer, it pains me to give them but as as a regulatory professional, it's the least burdensome approach going to the FDA with your new device with a narrow label first, because let's be honest, it's just simpler, it's faster, it's cheaper, it's less risky to do that but then be willing to go back to the FDA a little bit further down the road with a label expansion. And this is one of many, many reasons why I think it's so critical for regulatory and engineering to work together hand-in-hand, literally from the beginning of the project. One of my many frustrations, Jon, with so many companies in the medical device world, is that they do not bring regulatory into the process until very, very late in the product development cycle, in some cases close to or even at the point of design freeze.

Mike Drues: And as you know, Jon, if the device is already frozen in design, to make changes at that particular time is very time-consuming and expensive. Simply put, one of the questions people ask me all the time is how early should we bring regulatory into the product development process? Well, my short answer is, it's never too early enough because for myself, not just as a regulatory professional, but as a professional biomedical engineer, I can offer so many suggestions, so much advice, so many different options in the design of the product, not just to optimize their regulatory strategy, but to mitigate their product liability down the road. Once again, Jon and I don't wanna overly use this metaphor but it is an appropriate one, an ounce of prevention is worth a pound of cure. Changes that we make early in the design process are much easier and faster and cheaper to implement than changes further down the road. Would you agree?

Jon Speer: Absolutely. There's this... I can't remember the name behind it, but there is this notion it's 1, 10, 100. If you catch an issue or an opportunity earlier, it could cost you a dollar, a little bit later it can cost you $10, a little bit later $100, so it's an exponential cost. So that the later that you address an issue, it's gonna be more expensive, quite frankly. And if you wait till the design freeze to engage your regulatory folks, and those regulatory folks identify different scenarios or, hey, what about this? What about that? And you have to go back and redo something, it's gonna be much more expensive than if you were to engage those resources at the beginning. So, definitely a good advice for folks out there, be sure to engage your regulatory team early and often from the beginning throughout the entire design and development process. It's just important, not only from the regulatory standpoint but also from a long-term big picture standpoint. And so, Mike.

Mike Drues: I could not agree more, Jon, and I would offer just one last quick piece of advice before we wrap this up. Oftentimes, and I think you and I have talked about this before, Jon, oftentimes if we're an R&D engineer, or a regulatory, or a quality professional, and for whatever reasons, we think that doing what the regulation requires is not enough and we should do more. That is, everybody in our audience can appreciate, that's not an easy thing to sell in your company. How do you convince your senior management to spend the time and the money to do more than what is required? So in those situations, and I don't like to play this part unless I absolutely have to, Jon, but if I'm in a situation where as a professional biomedical engineer, I think that what the regulation requires for our particular device is not enough, what I will often do is say to the company, "Look, you're exactly right. From a regulatory perspective, you're not required to do this, your competitors probably have not done it. FDA is not asking you to do it. So from a regulatory perspective, you definitely don't have to do it. However, if and when there's a problem down the road, when it comes to product liability, ka-ching, ka-ching, ka-ching.

Mike Drues: So again, I don't like to have to play that card but I will play it if I have to. At the end of the day, Jon, we wanna make sure that our devices are safe and effective. And believe me, those words are very easy to say. But what do they really mean? So that's the, I think, the last piece of advice that I would offer for our audience on this particular topic.

Jon Speer: Yeah, thank you so much, Mike. And once again, folks, I've been talking with Mike Drues with Vascular Sciences. And if you wanna wait till the bad stuff happens then call Mike, he does this work for a living. But I think, Mike, you'll agree that you'd prefer to engage a company before the problem happens sooner rather than later, and I guess...

Mike Drues: Absolutely. And as a matter of fact, I guess, in a sense, I'm trying to put myself out of business. [chuckle]

Jon Speer: But in all seriousness, folks, Mike is the best when it comes to regulatory strategy and regulatory strategy has, in my opinion, a lot more weight when you deploy that early in your process before you go to market rather than after the fact. And again, Mike can help you on either side of that equation, but my advice to you is to engage him earlier on rather than after the problems start to happen. That's my plug for Mike Drues with Vascular Sciences. I'm serious, he is one of the best out there on this topic so do reach out to him. And of course...

Mike Drues: Thanks, Jon, that's very kind of you to say.

Jon Speer: Oh, you're welcome. And of course, as I mentioned earlier, quality management system is important and for a medical device professional doing the right things and documenting the right things, those... Yes, there are cases and points in time when documentation is absolutely an asset and a friend for you and knowing what to do and when to do it, that's a big thing that we do at Greenlight Guru is to help companies with that. So go to www.greenlight.guru, learn more about the Greenlight Guru eQMS, award-winning medical device software platform to help you manage all things QMS-related. And this has been your host, the founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.


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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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