abbreviated_fda_510k_pathway

In order to get your medical device to market, you will need to know about pre-submissions and the pre-submission process.

The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within the submission itself. The indications for use statement is not the same as within the submission itself.

There is no bigger fan of communication with the FDA. But, there is a caveat to that. That is, tell don’t ask, lead don’t follow.” - Mike Drues

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Today’s guest, is Mike Drues from Vascular Sciences. Mike is a professional in medical device industry for 25 years will talk about the importance of the pre-submission of medical devices to the FDA.

We need to be able to go to the FDA with a well thought out development plan.” - Mike Drues

Jon and Mike have a great discussion on how to use pre-submission to bring product to market.

Here are some of the specific topics you’ll hear discussed today:

  • What is a pre-submission and why is it important.
  • The power of pre-submission process and going beyond the guidelines.
  • Common reasons why the FDA rejects a submission.
  • How to properly communicate with the FDA.
  • How early should you go to talk to the FDA about your medical device.
  • How to prepare for a pre-submission meeting with the FDA.
  • What are some other ways that a pre-submission can be useful for companies.

If you found today's episode valuable, and need advice on pre-submission, Mike encourages you to get in touch with him. He is a great resource and is happy to give advice on how to use pre-submissions to get your medical device to market.

Links and Resources:

Mike on LinkedIn

Vascular Sciences

greenlight.guru

FDA guidance on pre-submission


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-submission, more specifically FDA pre-submission. How can you use this to your benefit during your efforts to bring new medical devices to market? On this episode of the Global Medical Device Podcast, I chat with Mike Drues of Vascular Sciences and we talk about the pre-submission and how this can be a useful vehicle and tool to aid you in your quest to bring a new product to market. So, enjoy this episode of the Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast, this is the Founder and VP of Quality and Regulatory at Greenlight.guru, and the host as always, Jon Speer. A familiar has joined us again today, I wanna welcome to the Global Medical Device Podcast, I wanna welcome Mike Drues. Mike is with Vascular Sciences. As you probably know by now, Mike is a rockstar in the medical device industry, so much so that he has FDA calling him for guidance and direction, he has Health Canada helping... Calling for his help as well, as well as medical device companies all over. And Mike, I don't know where we're talking to you from today, but I know you're traveling like crazy, going from coast to coast and probably not sleeping and all that sorts of things, all for the sake of trying to help medical companies get safer products to market.

Mike Drues: Well, that's right, Jon. Thank you for that very kind introduction. It's always great to talk with you and your audience. So thanks again.

Jon Speer: Absolutely, absolutely. So, Mike, I think the last time we had a session, we teased today's topic and I know it's something that I'll say, I've read a little bit about this topic. There's not a lot written actually on this topic, but I can tell you some of the best content that I've read on this is from you. And the topic today is "The Pre-submission". And specifically, we're gonna get into the power of the pre-submission process and going beyond the guidance.

Mike Drues: Well, thanks, Jon. That's... It is a very important topic. Just to sort of set the stage for you and your audience, here's an interesting statistic I thought I would share with you. And that is, 70% to 75% of 510(k) and PMA submissions made to FDA, 70% to 75% of them are rejected first time out of the box. I hear a lot of my regulatory colleagues, they say they're going to get their 510(k) cleared or their PMA approved, quite frankly, Jon, that's never been my goal because anybody can do that. My goal is to get my 510(k) cleared or my PMA approved or my de novo or whatever it is, ideally, the first time out of the box, if I can. If I can't, with a minimum number of ping-pongs of Q&A going back and forth. So, am I successful 100% of the time? No, but I can tell you I'm in the 20% to 25%, not in the 70% to 75%.

Jon Speer: Nice.

Mike Drues: And Jon, just out of curiosity, do you think... What do you think is the most common reason that FDA makes so many rejections? As an engineer, what would you call the cause to that?

Jon Speer: Well, if I were to guess, one of the things that I see so often is indications for use and maybe more specifically, that within a submission itself, the indications for use statement is not the same throughout the entire submission.

Mike Drues: Well, that's a great guess, Jon. And that does happen, actually, quite a bit. And we can certainly get into an example or two of that if you'd like. But thinking in more sort of a root cause in other words, that I think is just a symptom.

Jon Speer: Sure, sure, yeah, sure.

Mike Drues: Of a more deep kind of a problem. I think, Jon, quite frankly, the reason why so many submissions are rejected and not just submissions, but so many products are delayed, so many warning letters are generated, 483s, sometimes even recalls, they all have exactly the same root cause, and that is communication or the lack thereof. And one thing I've heard in being married, is I can say one thing and my wife can hear something completely different. And as a fellow man, I'm sure that most people don't appreciate that exactly the same thing happens between the company and the FDA. In other words, the company can say or write one thing and the FDA can hear something completely different.

Jon Speer: Yeah, I can imagine that. And I remember back to my first 510(k) experience many, many, many years ago, and that was a different time, I think. It was a different era from an FDA industry perspective. And not that FDA and industry are holding hands, walking down the street today, but let's just say those were times where there was a lot... It was a lot more of a contentious relationship. And I'm talking about the day where... Back in this time where you would put together a 510(k) submission, you would send it to the FDA, you wouldn't have any communication with FDA ahead of time, and you wouldn't have any communication with the FDA during the review process. Instead, you would cross your fingers and you would wait.

Jon Speer: And usually that meant that you would wait a couple of months, and then you would get in the mail a list of questions. Questions about your submission. And then like you said, you played this game of ping-pong back and forth. Well, they asked this. I wonder what they mean. So let's try to answer it this way, and you'd send your response, and back and forth and back and forth. I say that was from times in the past, but I suspect there's probably, based on your statistic, there's probably still a fair number of companies that are keeping that style and approach with their 510(k) submissions.

Mike Drues: Well, regrettably, Jon, you're exactly right. In fact, several of the companies that I work with, up until working with me of course, their policy is sometimes not to have any communication with FDA prior to the submission. And in a few cases, some companies that I've worked with, the only form of communication they have with the FDA is through the submission. I personally think that you're taking on a huge regulatory risk in that sense. You're just setting yourself up for failure. In this context, "failure" meaning getting questions back on your submission.

Mike Drues: As you know, Jon, it's become the norm for companies to make a submission to the FDA and for the FDA to come back to them with questions. I personally think, as a professional in this industry for nearly 25 years, that's embarrassing. We are essentially treating the FDA as our elementary school teacher. In other words, "Here's our homework assignment. Will you please mark it up and... "

Jon Speer: Give us a grade. [chuckle] Yeah.

Mike Drues: "And give it back to us?" And that is, in my opinion, not the way this game is supposed to be played. As you know, Jon, I set the bar very high. If I get any question back on a submission, I view that as a failure. Pure and simple, 100% failure, because I worked really hard to try to get all the questions answered in advance long before the submission goes in such that when the submission goes in, assuming that the data shows what I'm going to... What I say it's going to show, then now it's just a matter of everybody affixing their signatures and it works through the system and so on and when we're done. But unfortunately, that's not the the standard practice today.

Jon Speer: Right, right. And I think that really leads us to into our topic really well. It's a good foundation. So let's dive into this pre-submission topic, because in your context of communication being key to success in any submission process, 510(k), PMA, or other, I see the pre-submission becoming more and more a vehicle, so to speak, that industry is embracing, but more importantly I think FDA is embracing and encouraging as a potential vehicle to communicate between FDA and industry.

Mike Drues: That's correct, Jon. It is one of the ramifications of the pre-submission guidance that came out now about two years ago. Instead, it has increased the popularity of the program, and more companies are taking advantage of this, which is a good thing. On the downside, it is now creating a little more of a delay, a little more of a backlog in terms of meetings, but that's the nature of the game. But let me be clear. Some of us, myself included, and I suspect you as well, we've been communicating like this with the FDA for a very long time. As a matter of fact, I sometimes say I don't need any regulation or guidance, including the pre-sub guidance, to tell me when to communicate with FDA. I will communicate with them when I think I need to. And by the way, I communicate with them a heck of a lot more frequently than any regulation would ever require me to do so.

Jon Speer: Yeah, but you're Mike Drues. [laughter] You consult with the FDA so...

Mike Drues: No. That's very flattering, Jon, what I mean that...

Jon Speer: But I mean, you can understand how somebody can come with that perception, right, like the average start-up company, for example, or a med device company that's been doing things a certain way for a certain period of time, what can they do to engage in the FDA? Is it as simple as picking up the phone and calling, or is there...

Mike Drues: You know, it certainly can be. And listen, again your words are certainly flattering, but I want everybody to understand. Remember one thing: FDA works for us, not the other way around. We pay their salaries, both in terms of taxpayers as well as in terms of user fees from our industry. So they work for us, and as a result, we have a certain expectation that they should be responsive and so on.

Mike Drues: They don't necessarily have to agree with us all the time. In fact, they should not agree with us all the time. But they do work for us, and everybody, no matter what sort of a position you're in, should feel that they can have some sort of a relationship with the agency. And the pre-submission process, or the pre-sub, as it's now often called, is just one form of communication that we can have with the agency. There are other forms, which we won't get into in our discussion today, but the pre-sub is just one. And if your audience is not familiar, FDA did put out a guidance on the pre-sub process about two years ago. We can certainly provide a link from the website.

Jon Speer: Yeah, I'll include the link. I'll include the link to that guidance in the text that accompanies this podcast, for sure. Because it's... As with any guidance, I suppose some are better than others. That pre-sub guidance, I've just been giving you my opinion, I mean it's okay. It does a pretty good job of identifying the expected contents for a pre-submission, and I think that's good. And I know you and I have had a side bar conversation about one of those sections of a pre-sub that I expect that we'll get into here in a moment. But talk a little bit more about when I could use a pre-sub. When would that be valuable? Is it any time I have something that's on my mind? Or when is this vehicle the best time to drive?

Mike Drues: Well, that's a great question, Jon. One of the most common questions that I get from companies, especially engineers, and I know that your audience is primarily an engineering audience, is how early in the development process should we approach the FDA? And here's my simple response to that, we should go to the FDA as soon as we possibly can, but there's an important caveat to that, and that is as soon as we're ready. In other words, I don't wanna go one day sooner.

Mike Drues: We need to be able to go to the FDA with a very well thought out development plan. Here's our medical device. This is the way that it works. This is our draft labeling, this is the testing that we've done thus far, this is the testing that we're planning on doing next, and so on and so on. So we have to be able to have a well-thought-out plan that we can articulate and most importantly, that we can defend. Because FDA's job, whether some people wanna admit it or not, is to challenge us. Literally to challenge us on everything. If we walk into the FDA and say "The sky is blue," that's our claim. The FDA's job is to say "Prove it." So we need to be able to defend our plan. And I, personally, this is my approach, I like to begin with what makes sense from an engineering and a biology perspective, and then consider the regulation much later on. Unfortunately in this industry, it doesn't usually happen that way.

Mike Drues: Usually people begin with the regulation and then they sort of spin the engineering, the biology to fit the regulations. In my opinion, that's a mistake. There's an adage that we use in medicine frequently, "The surgery went perfectly, but the patient died anyway." Well, the medical device equivalent of that is we designed the medical device perfectly, yet, the patient died anyway. The regulatory equivalent of that, is we followed the regulation perfectly, that is, did all that FDA or Health Canada whoever asked us to do, and yet, the patient died anyway. Unfortunately these things happen more frequently than some people might like to think. Of course, these things never happen in the companies that your audience...

Jon Speer: [chuckle]

Mike Drues: They only work... And they never happen to the companies that you and I help, Jon. [laughter]

Jon Speer: Exactly.

Mike Drues: Only the other companies.

Jon Speer: Well, but I think that's a really important point, and I'll say it in a slightly different way. It's really about focusing on the indications for use. It's really about focusing on the clinical need. I know it seems so basic to say it that way, but you're right, so many companies do lose sight of that from time to time and the... When I talk to companies about pre-subs or I talk to them about 510(k)s or just product development in general, it's like, what are your indications for use, what are you trying to do, what problem are you trying to solve? And keep bringing them back to that because if you're not solving that problem, you're missing the point.

Mike Drues: You're exactly right, Jon. And again, because this is an engineering audience, let me give you a quick example what you're describing here, which really could be the topic of another conversation, perhaps in the future, is what I call high-level labeling. The indications for use, the intended use, your label claims, and so on. Now, when you look at the overall submission, the high-level labeling like the indications for use, if FDA is doing their job, and believe me, they don't always, but if the FDA is doing their job, that is one part of the submission that is parsed by FDA word for word, syllable for syllable, letter for letter.

Mike Drues: Other parts of the submission I'm thoroughly convinced, as a matter of fact, I have actual proof that they never get right. But the high-level labeling, the indications for use, for example, that's something that they really scrutinize. So I was in California recently working with a small medical device company, who's developing a medical device, and at the same time, they were developing the device, they were designing the device, I was designing five or six different intended use and indication for use statements, all for exactly the same device.

Mike Drues: And what we did was we presented those five or six different high level labeling statements to the senior management at the company and I did a regulatory burden assessment and a regulatory risk assessment on each one and we had a discussion with the company. If you want to say this about your device, this is what you're gonna have to do. If you wanna say that about your device, that's what you're gonna have to do. So to me, as an engineer, Jon, design is design. Whether I'm designing a physical medical device, whether I'm designing a clinical trial, whether I'm designing, in this case, high-level labeling or a regulatory submission, design is design.

Jon Speer: Yeah, and I think that's a good point to understanding a little bit more about what a pre-submission can be used for. We talk about it being a vehicle to communicate with the FDA. It's probably good to explain a little bit more about how and when to use that. We've talked about the timing, what should you... Where should you be sort of in the context of your development efforts of your device. And it should be a little bit more, just to paraphrase a bit of what you said, but a little bit further along than just a cocktail napkin sketch and prior to going to market for sure, but somewhere in the middle, so to speak. But there are other means to use this pre-submission vehicle. It's not just about getting guidance and direction on a 510(k), although I suspect that's probably the most common use. What are some of the other ways that that pre-submission, that communication piece can be useful to a company?

Mike Drues: Well that's a terrific question. Let me use as an example, what we just started to talk about in terms of the high-level labeling. So the pre-sub process is often what I will use to introduce the FDA to my high-level labeling. And I've described this, the whole relationship between the company and the FDA as a poker game, as a chess match in every sense of the word. And just because somebody understands the rules of poker, doesn't necessarily mean they're gonna be a good poker player and it certainly doesn't mean they're gonna win the game. I wanna do everything that I can, legal of course, I don't wanna be wearing any orange jumpsuits in order to win that game.

Mike Drues: So, the pre-sub process is often one that I will introduce to the FDA, my high-level labeling statement, like for example, my indications for use. But, because I view everything here as a negotiation, I will start out by going to the FDA with a very broad sort of an indication for use statement.

Mike Drues: The FDA might come back and say, "Nice try, Mike, but try again." So then, I will offer up another one and say, "Okay, you don't like this one. How about this one?" This is a negotiation. So using that poker metaphor, when I go in to the FDA, I have three sets of cards in my pocket. The first set of cards are cards that I put down prophylactically without anybody even asking. That might be my first indication for use statement. The second set of cards, I will keep in my pocket and I will only play them if I have to. So, I will have a back-up or a back-up back-up indication for use statement, I will have things that I can negotiate. And then a third set of cards that I can't play even if I wanted to, because perhaps the company doesn't have the resources to do it, like an extensive clinical trial or the technology doesn't exist or something like that.

Jon Speer: Right, right.

Mike Drues: So, I use the pre-sub process to introduce the FDA to these things and to make sure that we get into an agreement. Again, long before the submission goes in, because I really want to do as much as I can to make sure that once the submission goes in, it's a done deal, so to speak.

Jon Speer: And I think it's... That's really helpful. Having been a part of several pre-submissions, again, FDA does have a guidance document that we've talked about a little bit here today, and again, I'll make a reference to that in the text that accompanies this podcast, but that pre-sub guidance does for the most part, kinda dictate what the contents of a pre-submission would be. So, it's probably helpful to talk a little bit about that and not necessarily go through bullet point by bullet point, what's in that but the overall context. And I think sometimes when we look at things like 510(k) contents and checklists, and we look at pre-submission contents and checklists, sometimes we get into this mindset that really, we're just trying to check the right boxes for the FDA, but that's not really the intent at all, right?

Mike Drues: That's exactly right, Jon. And actually, you made a statement a moment ago that the pre-sub guidance essentially dictates the content. With all due respect, I would disagree. One of the main differences between the pre-sub process and an actual submission of 510(k) or PMA, is that the content of the pre-sub is totally 100% up to us, up to the companies, the manufacturers, the sponsors, not to the FDA. It is our meeting, we determine the agenda, we say to FDA, "We want to talk about the following things." And by the way, speaking of the agenda, I use the agenda very strategically. I don't just simply say what I'm going to talk about, I also will include what I do not plan to talk about. Because in order to achieve a successful pre-sub meeting, and my definition of a successful meeting is one where everybody, including my friends from the FDA, walk out of the room agreeing with us. In order to achieve that, I want to keep this meeting as small and as focused as I can.

Mike Drues: I'll share with you a very recent example. Just a few weeks ago, I was involved with a company who brought me into the game very, very late. Sort of in the bottom of the ninth, so to speak. They were going to the FDA with a pre-sub in about two weeks after starting working with me. Long story short, they had 18 objectives going into this meeting.

Jon Speer: Holy cow!

Mike Drues: And between the people attending from the company and the FDA, there were nearly 50 people in the room.

Jon Speer: Wow, was this a face-to-face?

Mike Drues: This was a face-to-face.

Jon Speer: Wow.

Mike Drues: And I said to the company before the meeting occurred, I said, "This is gonna be a disaster."

Jon Speer: Trainwreck.

Mike Drues: And they said, "Oh, we're gonna do it, blah, blah, blah... "

Jon Speer: Mike, did you take popcorn? [laughter] To enjoy the show?

Mike Drues: No. Ironically, Jon, I had a previous commitment. I was at the FDA at another pre-sub meeting at exactly the same time, so I was not able to physically attend. But I told them this was gonna be a disaster. They said, "Okay, well we're gonna do it anyway, blah, blah, blah." Long story short, I got that same evening, I got two or three emails from people from the company who said, "Mike, you were right. We should have listened to you. We're actually in a worse position now for the meeting." Because they caused so much confusion, they really did not give it a... Which, I probably shouldn't say this in a recorded podcast, Jon. But quite frankly, it was a very good thing for me because now I'm gonna have to do a heck of a lot more work for them in order to get them out of this great big hole that they dug for themselves.

Jon Speer: Well, the reality, Mike, both you and I have plenty of examples that we can point to. But the reality is that we would rather the companies that we work with and advise, that they take the simplest path forward. And as you just alluded to with that example, that doesn't... Isn't always the case. Sometimes companies have their own agendas and their own ideas and why trust the guy that's been dealing with regulatory issues in the industry for 20, 25 years, I'm just gonna do it myself.

Mike Drues: That's exactly right. So, I know we're coming short on time, so just to wrap up the last breath, my suggestion here, I like to have no more than three, at most, four objectives going into a meeting. And I like to have no more than three or four, maybe five people from the company and three or four or five people from the FDA. I think that is, at least in my experience, the optimal configuration. And I will use the agenda for example, if I'm going to the FDA with an early... With a device that's still under development and we are not planning on discussing about... Discussing usability for example, I will say in the agenda, "Although usability is certainly important, we will not... We do not plan on discussing that here." Because I want FDA to know that they don't need to invite a usability testing, at least in person, at this particular meeting.

Mike Drues: So we can use agendas. Most people think an agenda is just a no-brainer, it's just a bullet list that people talk about. But we can use it in so many different ways. So the most important thing I wanna leave your audience with as we wrap our... Wrap up this conversation of the pre-sub process, is a couple of quick takeaways. First of all, don't treat the FDA as your obstacle. I see too many people in our industry who just view the FDA as an enemy.

Jon Speer: But Mike, Mike, I can't go to market unless the FDA gives me permission. How can I not view them as an obstacle?

Mike Drues: Well, I personally, I view them as a partner in order to help make sure that I bring to the market the safest and most effective product that we can. Perhaps I'm a bit naive, I don't know, but that's the way I view it. I just think that you reap what you sow.

Jon Speer: Yeah, I think it's a good kinda change of perspective. Don't think of FDA as getting in your way, think of FDA more as an enabler, someone who can help you.

 

Mike Drues: Exactly. And one of my friends, I can't take credit for this myself, but one of my friends who used to be a senior reviewer at the agency was fond of saying that physicians can kill patients one at a time, but an FDA reviewer can kill patients thousands at a time. Quite frankly, that's something that more people in our industry need to remember.

Jon Speer: Well, I think the pressure on an FDA reviewer is intense. I had a chance to talk to a former reviewer a few days ago and we talked about that very same thing. And she relayed that when she was in that seat, yeah, she felt an awesome responsibility. One that if she made the wrong decision, it could have a huge impact on lives.

Mike Drues: Absolutely right. And another quick example, I'd like to compare the FDA and the CIA in the sense that when they do their... Sorry, when they do their job, nobody knows about it. When they don't do their job, everybody knows about it.

Jon Speer: Yeah, it's evening news.

Mike Drues: So that's one takeaway. Another takeaway is to... Don't just bring regulatory folks, bring engineers. Again, I know we have a lot of engineers in the audience, bring engineers to your meeting with the FDA. You might have to manage them a little bit in terms of what they say or whatever, but that's a solvable problem. We talked earlier about how it's never too soon to talk to FDA, go as soon as you can, but make sure that you're prepared. Most importantly, and this has become my regulatory mantra, is "Tell, don't ask. Lead, don't follow."

Mike Drues: It amazes me how many people I see, and as you know in my background, Jon, I work not just with companies, but as a consultant for the FDA, so I see this on both sides. It's amazing to me how many people I see walk into the FDA and literally ask them, "What do I do? How do I bring my medical device on to the market?" That has disaster written all over it in every language for several reasons. I'll just mention two.

Mike Drues: First is, it's not FDA's job to tell us what to do. It's our job as scientists and engineers to figure out what to do and then to go to the FDA and sell it to them. But the other and most important reason why it's not a good strategy to ask FDA what to do is because when you do that, you're opening up a Pandora's Box, and quite frankly, you have no idea what you're gonna get in return. So on one hand, there's no bigger fan of communication with FDA than I am. But there's a caveat to that, and that is "Tell, don't ask. Lead, don't follow."

Jon Speer: Absolutely. And those tidbits are important not only for pre-submissions, but for anything else that you're doing in this space for sure. So, Mike, I'm guessing you're happy to talk to people about questions that may come up on the pre-submission, and if so I'll steer people toward your LinkedIn page, Mike Drues, D-R-U-E-S, Vascular Sciences, you can also find him there. And again, Mike, as a guy that... I don't know if you invented the pre-submission process, but [chuckle] I'm quite sure it's probably perfected in more ways than one. So, he's a great resource to chat with about questions that you might have about the topic.

Mike Drues: But, Jon, I do also have a lot of scars and a lot of wounds [laughter] on my back as well so...

Jon Speer: Yeah, yeah, but...

Mike Drues: And I would be more than happy to talk to anybody in your audience. Actually, I would provide the same advice as we just talked about.

Jon Speer: Of course.

Mike Drues: Not to be self-serving at all. But the sooner that companies contact somebody like you or somebody like me...

Jon Speer: Absolutely.

Mike Drues: Quite frankly, the simpler and the easier, the faster and oftentimes the cheaper it will be to help them.

Jon Speer: Yeah, absolutely. Spend an hour or two with Mike or an hour or two with me, and we'll certainly do our best to leverage our years of experiences. And let's be frank, Mike, you get to see all sorts of different things from all sorts of different perspectives all the time. So, you have a lot more, I guess, visibility or data points, so to speak. So, people should leverage those types of experiences. But, Mike, thanks again for being the guest on today's episode of the Global Medical Device Podcast.

Jon Speer: And just to let the audience know, of course, you can check out Greenlight.guru. We have an awesome software platform to help you manage your quality management system. We've optimized workflows around design controls. We've optimized a workflow around risk management, and, oh yeah, and it meets ISO 14971 in the process. Not many, maybe any other software solutions can say that in the medical device industry. So thank you for tuning in and listening to this episode of the Global Medical Device Podcast.


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