What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

FDA Pre-submissions: They're a hot, timely topic. Regulatory non-compliance is one of the biggest risks that medical device companies face, and it’s so important to have a good rapport with the FDA and any other relevant regulatory agencies.

We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information necessary to properly deal with the FDA.

Mike Drues is the president of Vascular Sciences. He’s an expert on regulatory topics, as he works with all different types of medical device companies in addition to working with the FDA and other regulatory bodies.

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Some highlights of this episode include:

• Why the pre-submission process has become such a hot topic.
• The mechanics of the submission process.
• The content of the pre-submission meeting and what questions should be answered.
• Why you should not have expectations as to how long the process will take.
• How early in the pre-development process you should contact the FDA.
• Why the majority of submissions are rejected.
• How this process can help you get through changes made post-submission.

Additional Links:

Pre-Submission Part One

Mike Drues on LinkedIn

Vascular Sciences

How to Make the Most of Your Pre-Submission Interactions With the FDA

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff

Memorable quotes by Mike Drues:

“The most important ingredient... is communication with the FDA.”

“At the end of the day, we want to demonstrate to the FDA that we are the experts.”

“FDA really doesn’t know anything that we don’t know.” 

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: Pre-submissions, the topic is very relevant, it's very hot, it's very timely, so much so that Mike Drues and I decided to do a part two podcast on the pre-submission process. We get into a few more twists, and turns, and other ways that you can use this vehicle of communication effectively with the FDA. So enjoy this episode of The Global Medical Device Podcast.

Jon Speer: Hello, this is Jon Speer, the founder and VP of Quality and Regulatory at greenlight.guru, and welcome to the Global Medical Device podcast. Ladies and gentleman, I know you're all excited about this topic of pre-submission. We're all dying to know, really, a lot more about it. And I've got the person on the podcast today who can answer every single question. That's setting the bar really high, but he can answer probably every single question that we have regarding the pre-submission process with the FDA. And that guest is Mike Drues. Mike is the president of Vascular Sciences. Chances are, you've heard him before on the Global Medical Device podcast. Mike and I chat every so often about those burning regulatory topics. Mike does a lot of work with medical device companies of all shapes and sizes all over the world. So if you need help with pre-submissions, I'm gonna tell you, he's the guy that can be your guiding light through this process, 'cause, Mike, guess what? He also works with regulatory agencies like the FDA, like Health Canada, and so on. So, Mike, good morning.

Mike Drues: Good morning, Jon, thanks again for the opportunity to be with you and your audience. Always a pleasure to speak with you.

Jon Speer: Yeah, we always have a good time, and I'm really excited to... We had a topic where we started to dive into the pre-submission on a previous episode or two back, and kind of excited to jump in a little bit more depth and detail. This is a popular topic these days. And what's interesting to me is pre-submissions have been around, really, for quite some time. So why do you think it's getting sort of a renewed interest and renewed... A rebirth, so to speak. Do you have any thoughts about that?

Mike Drues: Yes, I do, Jon. I think there's a couple of reasons. First of all, there was a new guidance that FDA put out about two years ago on the pre-sub process, describing it in some detail, and we'll talk about some of the mechanics of that a little bit later. That's one of the reasons why it's become more popular, but I think, quite frankly, the most important reason it's becomes so popular, is because more and more people in this industry are realizing that the way we do business, that is the way we interact with the FDA, is not very efficient. And I'll give you just one reason, one example, 70 to 75% of submissions, that is 70 to 75% of 510(k) and PMAs that are submitted to the FDA are rejected first time out of the box. I think, personally, that's appalling.

Jon Speer: Yeah, it's crazy.

Mike Drues: I think it's ridiculous. And so many of those can be eliminated... Perhaps even all of them can be eliminated with communication in advance with the agency. The pre-sub process is just one of many ways that we can communicate with the agency. So I hear, for example, a lot of my regulatory friends, they say their goal is to get their 510(k) cleared or their PMA approved. That has never been my goal, because, quite frankly, any monkey can do that. My goal is to get my 510(k) cleared or my PMA approved, ideally, the first time out of the box if I can.

Jon Speer: Right.

Mike Drues: If I can't, with a minimum number of Q and As and ping pongs, going back and forth, am I successful a 100% of the time? No, but I can tell you I'm in the 20 to 25%, not in the 70 to 75%, and the most important ingredient that goes into my secret sauce is communication with the FDA.

Jon Speer: And we're gonna jump into that quite a bit. And I think, for the audience, if this is your first time going through this process, then I'm gonna say, good, you don't have a lot of baggage that needs to be undone, or prior practices, or maybe a prior opinion. For those who have been through this many, many times before, like Mike and I were chatting just a little bit ago, we dated ourselves with some references, we won't do that on the podcast at the moment, but for those of you who've been around and dealt with the FDA over the past 10, 15, 20 years, the old school way of thinking is do not communicate with the FDA, do not bring attention to yourself in any way, shape, or form. And I guess that's the key thing, that you have to evolve, you have to change quite a bit, because the agency is there to be a resource for you, and I think this is one of those mechanisms, one of those tools we can use, that pre-submission process. So Mike, remind us a little bit more about what goes into that pre-submission process. You mentioned a guidance document, we'll certainly make reference to that, and the text that follows this or accompanies this podcast, but tell us a little bit more about what that pre-submission process is all about.

Mike Drues: That's a great question, Jon. So let me break it into two parts. First, in terms of the mechanics, what do we need to submit to make the meeting request, and then second, in terms of content. So, with regard to the mechanics, it's actually quite simple. There's only three things that you really need to provide FDA in order to make this meeting request. First is a letter, and in that letter, you basically say, "We want to have a pre-sub communication. That communication can be either via teleconference or in person. 99.9% of the time, I strongly recommend doing the first meeting in person. I do not like to do it over the telephone. Subsequent discussions can be over the phone, but the first one, I'd like to have in person. That's requirement number one. Requirement number two is the agenda. Basically, what FDA wants to know is what do you plan on talking about? And the reason why FDA wants to know that, quite frankly, is they need to know who, from their side of the table, that they need to invite to the meeting. So, for example, if you wanna talk about biocompatibility, if you wanna talk about an animal test, if you wanna talk about, I don't know, ergonomics or human factors, they need to understand, they need to know who to invite

Mike Drues: And, by the way, the agenda I use not just is a list of things that I do wanna talk about, but I will also include in the agenda what I do not plan to talk about. Because one of the things that goes into a successful pre-sub meeting for me, and as you know, Jon, I do a lot of these down at the agency, probably once a month or more, is keeping the meeting as small and as focused as possible. I do not wanna have a meeting with lots and lots of people. I was involved in a pre-sub meeting recently, where, between the FDA and the company, they had almost 50 people at this meeting.

Jon Speer: Yeah, that's crazy.

Mike Drues: And before the meeting actually occurred, I told the company this was gonna be a huge disaster, but they said, "Well, we're gonna do it anyway." And long story short, it was a disaster.

Jon Speer: Right.

Mike Drues: So, in the agenda, if I'm not planning on talking about human factors or something like that, I will say, we are not planning, at this time, to talk about it, that it is important, obviously, and we'll bring that up later at the appropriate time. So, the agenda is the second component. The third and final component, and this is the one that really makes my blood pressure go up when I think about it, is that the guidance asks us to submit to the FDA questions that we would like to ask the FDA. And for those in your audience that do not know me, the reason why that makes my blood pressure go up is because it violates one of my cardinal rules of dealing with the FDA, and that is never ever, ever, ever, ever ask FDA a question.

Mike Drues: My philosophy is very simple. Tell, don't ask. Lead, don't follow. Go to the FDA and say, "This is our plan, this is our device, this is the way that it works, this is what the labeling is, this is the testing that we've done thus far. This is what we're planning on doing next," and so on and so on. And I don't even like to end my presentations with FDA by asking, "Do you have any questions? Jon," because if there are reviewers in the room...

Jon Speer: They'll ask.

Mike Drues: They have questions, they will ask them, right, that's their job.

Jon Speer: Yeah.

Mike Drues: But nonetheless, because it is a requirement in order to get the pre-sub meeting, you have to ask some questions. So here's my advice. I phrase these questions very carefully to essentially create what an attorney would call a leading question, since that the only answer that anybody can come up with to this question is the answer that I want them to come up with. And, by the way, and I encourage your audience to read the pre-sub guidance...

Jon Speer: Yeah, it's pretty good.

Mike Drues: It's good. However, the questions that they list as examples, I would never, in a million years, ask those questions, because, quite frankly, you're opening up a Pandora's Box, and you'll have no idea what you're gonna get in return.

Jon Speer: Yeah.

Mike Drues: There are a lot of people, for example, they start out by saying, "Does FDA agree that... " Well, if I can be frank, it's not... I don't really care if FDA agrees or not. That's not the point of this. I will often start my questions by saying, based on my device, and my technology, have I demonstrated that the De Novo was the appropriate pathway to market? Have I demonstrated that no additional value will be provided in doing clinical testing that is not already obtainable in the bench top and animal testing that we're already doing? Have we demonstrated that Class II is the appropriate classification for our new device?

Jon Speer: Right.

Mike Drues: That kind of thing.

Jon Speer: Yeah, that's... And I like where you're going with those questions, because I've long been a... I don't know if my mother told me this or my dad or some wise person like Mike Drues along the way suggested this to me, but it really is, how you ask that question is very, very important. You can ask the question...

Mike Drues: That's exactly right.

Jon Speer: You can ask it three different ways, and depending on the words that you choose, you can get three very different answers. So, I like the advice, ask the question in a way that really frames the agency towards the answer that you're seeking.

Mike Drues: That's right. So, mechanistically, it's quite simple. It's just those three things. Just to recap, it's the letter asking for the meeting, it's the agenda, and it's the questions. Now, beyond that, there's the content, and this is the last important thing that I wanna say about this particular topic, and that is, unlike a traditional submission, a 510(k), PMA, De Novo, whatever it is, where FDA says, "We expect to see this information, we expected to see it in these kind of questions," the content of the pre-sub meeting is totally up to us, 100% under our control, not FDA. We tell the FDA, "Here is what we wanna talk about." Now, in order to do that, in order to make the most productive use of our conversation, we obviously have to give FDA enough information. We have to provide them a background of our device. Here's our device, this is the way it looks, this is the way it works, this is what it does, this is how it's made, this is the testing that we've done thus far, this is the draft labeling that we're planning on. We obviously... We have to put together, what I call, a pre-sub package to provide FDA the information in order to have an intelligent conversation, but, as I said a moment ago, unlike traditional submission, the content of the pre-sub package is up to us. We can follow the advice in the guidance, but we don't have to. Remember, as we've talked about before, guidance is only guidance.

Jon Speer: Right. Right. So, to say it another way, I can use that pre-submission in a lot of different ways, and I've got that jotted down as something to ask you about here in a moment. So there's a lot of different ways that that pre-submission tool can be a vehicle for communication. So you talked a little bit about what goes into what's required, gave us a little bit of a suggestion on some of the process steps, but basically, if I understand this correctly, you get this guidance document, and it's... Like we said, it's pretty good, but it gives you some tips and pointers and some things to... Some narrative of what to include in your pre-submission. You get your letter, you get your agenda, you determine what questions you're going to ask, and do so in a very smart way. And then you put the meat, so to speak, of that pre-submission together. You send it to FDA, just like it's any other submission. The good thing, that I like, I've really enjoyed about that pre-submission is there's no fees required.

Mike Drues: Yes, that is true, Jon, for the moment, anyway, and give Congress a little bit of time, but for the moment, there are no user fees associated with the pre-sub process, that is correct.

Jon Speer: And the turnaround time is... It's relatively quick.

Mike Drues: Well, it is. Now, that's actually a good point. In the guidance, there are about a half a dozen different types of pre-subs for medical devices, compared to drugs. Actually, drugs have a lot more types of meetings, but for devices, there's only about a half a dozen, and you'll see in the guidance there are numbers of days that FDA is required to respond or to have a meeting, it might be 15 days, it might be 30 days, it might be more, depending on the meeting type. What I'm telling to my customers, and I have been for many months now, is throw those numbers completely out the window, because one of the advantages or disadvantages of the pre-sub process is that it has become popular, more companies are taking more advantage of it, which I would argue is a very good thing.

Jon Speer: Yeah.

Mike Drues: But, on the flip side, it is creating a little bit of a backlog at FDA. Though, to their credit, as I said, I do a lot of pre-sub meetings, through this past summer, I've been very pleasantly surprised, I thought, especially in July and August with people's vacations and so on, things would really take longer. On the contrary, many of the pre-sub meetings have gotten scheduled much sooner than I thought, so, but as a ground rule, just to put a stake in the book, in the ground, I would figure about six weeks between actually submitting your meeting request and getting an actual meeting, if it's going to be a physical meeting. If you're willing to have a phone meeting, and I do not recommend it, but if you're willing to have a phone meeting, it might be a little bit sooner, but for an on-ground meeting, around six weeks or so is a good number.

Jon Speer: And, generally speaking, a pre-submission is something that you're doing, I'll say... Or I would recommend doing, not always, but in many cases, you're gonna do this early enough in your development cycle, where you should have six weeks, you should have enough substance in that pre-submission to make it meaningful. But it shouldn't be... This should not be a gating item, really, for your product development or your go to market strategy, necessarily. Obviously, it will have some influence. So I guess what I'm trying to say is you have enough time, if you're thinking a little bit strategic, about how to engage the FDA throughout your process.

Mike Drues: Yes, I agree. One of the most common questions that I get asked about the pre-sub, Jon, is how early in the product development process should we go down to FDA and have this conversation? And it's a little bit of a tricky question. It's a little bit of a double-edged sword. On one hand, I say we wanna do this as early as we possibly can, but on the other hand, there is an important caveat to that. I don't wanna do it one day sooner than I'm prepared. In other words, I wanna demonstrate, in no uncertain terms, to my FDA friends on the other side of the table that, at the end of the day, I know what the heck I'm doing. I'm the expert. Yes, I wanna work together. Yes, I value their opinion, and I will certainly take their suggestions, but at the end of the day here, I'm the expert, not them. And in order to demonstrate that, I wanna have a very well thought out plan that I can present, and not just present the plan, but I wanna be able to rigorously defend that plan when you ask me questions.

Jon Speer: Right.

Mike Drues: And so, bottom line, earlier is better, but make sure that you're prepared. A similar question that people ask me is what constitutes a successful pre-sub meeting? Anybody can have a pre-sub meeting. But in my book, a successful pre-sub meeting is when everybody walks out of the room, essentially, agreeing with what we present. That is definitely achievable. It doesn't happen often, especially with most other people. I don't mean to be bragging here, but I see so many times where a company will have a pre-sub meeting, and it turns out to be a disaster because they end up having to do more than what they thought they were gonna do before, mostly because they were not prepared to defend their plan. So it's easy to prepare for a pre-sub. It takes a bit of time, a bit of work to prepare for a successful... Just a real, real quick example, recently, I had a... Did a pre-sub meeting with a company. The meeting was successful. The Senior VP of Regulatory came up to me after the meeting, and said, "Mike, the meeting went great, we got everything that we wanted. Let me ask you a question. Do you think we over-prepared? Because we did spend a fair amount of time preparing." And I said, "Gee, that's a pretty good question. I can certainly understand why you asked me that question, but let me ask you this, if the meeting did not go so well, would you have asked me that same question?"

Jon Speer: You might have asked the opposite question.

Mike Drues: You might have asked the opposite question. That's exactly right. So I cannot emphasize enough, you want to prepare, because, at the end of the day, we wanna demonstrate that we're in charge, we're the experts. Yes, we wanna work together, but back to that statistic of 70 to 75% of 510(k) and PMAs being rejected, and I know much of your audience works in the 510(k) world, 85% of 510(k)s that are rejected, 85% of them are rejected specifically because of substantial equivalent.

Jon Speer: Yeah.

Mike Drues: That should never happen. That is a very amateur mistake. I've said this publicly many times, and this can be easily avoided by communication, whether it's via pre-sub, with something else, with the agency in advance.

Jon Speer: Yeah.

Mike Drues: I think it's... Quite frankly, it's embarrassing the way that industry now treats the FDA, essentially, as our elementary school teacher, here's our homework assignment, will you please mark it up, and grade, and give it back to you? That's not the way this game is supposed to be played.

Jon Speer: Yeah, I know, it's just a... I think some of that, as I mentioned earlier, some of that old school mentality is still lingering, unfortunately, where we're gonna... We're gonna put our head down, we're gonna put something together, we're gonna throw it over the wall to the FDA, we're gonna cross our fingers and hope that they, somehow or another, understand our rationale, our justification, our argument that we presented in a 510(k) or other submission. And even though that might be the very first time they've heard of or are aware of anything that we're doing. And, again, that's where I found that pre-submission to be so, so invaluable, because, let's face it, FDA gets a lot more exposure to a lot more types of devices and submissions than either you or I. They get to see everything, in some way, shape, or form, depending on the branch, of course. But...

Mike Drues: Sometimes.

Jon Speer: Yeah, sometimes, but anyway, they're gonna have a lot more, I guess, understanding of the kinda priority... They're gonna have a better understanding, these are things that have come across their desk, they're gonna have a better understanding, certainly, of agency policy, and thinking, and areas of concern, and all those sorts of things. So... Plus, they are a gatekeeper of sorts, and it's great to have them as an ally, as a resource, as someone who understands what you're doing, and why you're doing it, and understands the science behind what you're doing. And it's really our job... As you've stated very, very clearly today, it's really our job to communicate to the agency what we're doing, and why we're doing it, and why it matters.

Mike Drues: Well, Jon, I agree with you 100% on everything that you just said about the FDA, but I would also remind your audience of one very important and little-known fact, and that is that FDA really does not know anything that we don't know.

Jon Speer: Yeah.

Mike Drues: In other words, they haven't gone to different schools, they don't go to special meetings, they don't read special journals...

Jon Speer: They are people.

Mike Drues: They are people. Yes, you're right, they might be exposed to more devices than, perhaps, some of us are. And please notice I'm saying some of us, but on the other hand, we should know a heck of a lot more about our device than they ever will. So there is a balance. That's an important point. So, Jon, why don't we move on to our last question about using the pre-sub in other ways?

Jon Speer: Yeah. You and I talked recently... Of course, the pre-sub mission vehicle makes a lot of sense from a pre-submission standpoint, as I'm going through the design development process, but you and I had a recent discussion on when you make a change to a product that's already been released, already in the marketplace, and you threw something out that actually caused me... That I hadn't considered that, but I'm making a change to device, it's already got clearance. I go through the decision trees. I determine that the change that I'm making does not warrant a new submission, a new 510(k), for example. But you offered that, I could use the pre-submission as a means to communicate to the FDA what I'm doing, why I'm doing it, and so on. So, share a little bit more about that, 'cause that was a little bit fascinating to me, how you could use that as a communication tool in a post-market fashion as well.

Mike Drues: So, Jon, in a nutshell, for the audience that is not familiar with our previous podcast, we were discussing if you make a change to an existing device, either the design or the manufacturing process, how do you handle that change? Either in terms of keeping that internal, via letter to file, or letting the FDA know in the form of either a special 510(k), perhaps a PMA supplement. If we're working in that gray area, if we genuinely believe that it is sufficient to do a letter to file, but we're kind of in the gray area, and most of the time, we are, it rarely ever is a black and white, we might choose to go to the agency prophylactically, and tell them, "Look, we're not required to be here, but as a matter of professional courtesy, just because we wanna be good corporate citizens," blah, blah, blah, Kumbaya, here's the change that we've made, and here are the reasons why. I think one of the ways that we can do that is via the pre-sub process.

Jon Speer: Yeah.

Mike Drues: So you don't have to... Oftentimes, people ask me... Well, pre-submission, that means communication with the agency prior to your submission, right? Well, oftentimes, yes, but don't consider it so literally. Don't have such a myopic view of the form of communication. FDA does occasionally ask me for my input on new guidance and new regulation coming out. Unfortunately, they did not ask me on the pre-sub process. Had they, I would have said, "Don't call this pre-sub, because that's limiting. It's just another form of communication with the agency." So, simply put, another use of the pre-sub process, and of course, you will never see this written in the guidance or anywhere else, at least that I've seen, anyway, is we could use this as a mechanism of communication after the device is on the market in the scenario that you just described.

Mike Drues: And, of course, there are other creative ways to use the pre-sub process as well, but bottom line, Shakespeare said, "A rose by any other name still smells as sweet." So I don't care how we communicate with FDA, whether it's through the pre-sub, whether it's through a 513G, whether it's through a request for designation. There are a litany of both formal as well as informal ways that we communicate with the agency. The most important thing is that we communicate with them. And the important thing is that we communicate with them prophylactically, that is, in advance, while we're still in control, because if we wait until problems occur later, which is often the case, now, by definition, we're in a defensive position, and that's a tactical disadvantage. So, communication, whether it's via the pre-sub or whatever means that you want... 20 years ago, I used to do something I call a meet and greet, where we basically call up FDA, and say, "Look, we are not asking you for anything. We just wanna come down, shake hands, introduce ourselves."

Jon Speer: Right.

Mike Drues: Tell you what we're doing, tell you what we're planning on doing next. If all goes well, we'll come back in a couple of months with an update. Communication, regardless of what we call it, communication here is key.

Jon Speer: Yeah. This is just one of those examples. Obviously, we've been focused on the submission side, and pre-submission side, and being able to communicate. We often say, at greenlight.guru, that regulatory compliance, or rather non-compliance, is the single biggest risk that any medical device company faces, and that all starts pretty early on, during your design and development process, it's important to lay a proper foundation. And it's important, in my experience, to establish a good communication pathway with the agency as you're bringing new products to market. And there are plenty of companies that do this wrong. We read about them on the news, right?

Mike Drues: Unfortunately, that's true. And it happens a lot. The last thing that I would like to leave your audience with is... Well, there are several things, but I'll just limit it to one, communication, communication in advance is so important. If we had more time, Jon, I know you and I both have examples where companies have communicated with the FDA to their benefit and other situations where companies have not communicated and it's led to problems and delays. So communication is vital, but remember that caveat, and that is, tell, don't ask, lead, don't follow. It is our job to tell the FDA, here's our device, here's what makes sense to do from an engineering biology perspective. It is FDA's job to criticize it. I believe that if, for example, the company comes in and says, "The sky is blue," FDA's job is to say, "Okay, prove it."

Jon Speer: Yeah.

Mike Drues: That's the way this game is supposed to be played, and, in my opinion, that's the way it should be played. Is it, though, played that way today? I'm not sure, but communication with the agency with that tell don't ask, lead don't follow caveat is a good takeaway message, I think, from our discussion today.

Jon Speer: Yeah, I totally agree with you and, Mike, you and I, in our earlier conversation today, we talked about this opportunity that you're working on, and it's an opportunity that I may be assisting as well, so I'm thrilled to have a chance to see the maestro at work.

Mike Drues: You're being overly kind, Jon, but I do appreciate the kind words.

Jon Speer: But, in all seriousness, it'll be a great opportunity. Yeah, I'm really looking forward to it. I have a great opportunity to learn a little bit from you, and I know that this project that I'm speaking of, that there is a pre-submission that's involved. I'm sure there will be other regulatory interactions that are involved, and so, it's really gonna be a great way for what you do and what I do and what we do at greenlight.guru to be complements to one another, and I'm really excited about that opportunity, and I want the audience to know this. I mean, in all seriousness, if you have any doubts or questions or comments or concerns, whatever the case may be. And you're really not... Maybe you're not ready to go to the agency, that's okay. You can come talk to a guy like Mike Drues, you can come talk to a guy like Jon Speer, and we're really here to help you. And a phone call is a pretty quick and easy thing, an email is generally a pretty quick and easy thing. Now, don't use and abuse that privilege or that opportunity, but Mike and I are both accessible. You can get a hold of Mike, you can find him on LinkedIn very easily, last name, Drues, DRUES. If you want his email address, contact me at greenlight.guru, and I'll be happy to make an introduction, and ask those questions, because communication, communication, communication is so important.

Jon Speer: Everything that we're doing, from a medical device perspective, and that's why Mike and I do these podcasts, and that's why greenlight.guru has other podcasts and webinars, and the content that we put out, and that's why Mike writes amazing articles and content as well, it's really about trying to help communicate to you things that will improve your success in bringing new products to market.

Mike Drues: Well, thank you, Jon. Always a pleasure to be here, and thank you, especially, for your kind words about wanting to learn from my experience. I'm happy to do that. I've been very fortunate to learn from those that have gone before me. So that's an ongoing process. But just remember, when I look at what other people have done, sometimes I learn what to do, oftentimes, I learn what not to do. So, I suspect you'll be learning more of the latter from me, what not to do.

Jon Speer: Well, I'll be on the edge of my seat, and I'll leave the audience in suspense, at least for the time being, as to whether I learn the right way or the wrong way. But, no, Mike, I have a good time on these conversations and I want the audience to know that if you ever have a topic that's just... A burning question or topic that you want Mike and I to discuss, we would be happy to do so. Just contact me, contact Mike, and we'll put it out there. But we're bringing you information that's timely, that's relevant, that's important to your efforts and your endeavors in bringing new products to market. So, again, wanna thank Mike Drues from Vascular Sciences. And, again, you can find him on LinkedIn, is probably a good place. You can type his name into Google, and I'm sure that all sorts of wonderful content will surface, and great articles, and Mike has a really great content piece that I don't remember exactly when it was published, but it's still relevant, on this pre-submission process, it's very good. Do find that. Do read that. And again, I'll probably put that in the link to the text that accompanies this podcast.

Jon Speer: Thanks, Mike, and we'll talk again very, very soon. And just wanna let the audience know that greenlight.guru is here, we have a software solution, we have support services, and we help companies, basically, improve their efficiency and streamline their processes, especially when it comes to managing your quality management system, documenting design control, documenting risk management, and developing that single source of truth as you're designing, developing, and bringing new products to market. So if you're interested in learning more about that, go to greenlight.guru, and be happy to get you connected with the right people on our team, to have a conversation about how we might be able to help. Again, this has been Jon Speer, I'm the founder and VP of Quality and Regulatory at greenlight.guru, 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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