change to version of title

The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions were “hidden” and not disclosed to the public.

In this episode, Mike Drues of Vascular Sciences joins the show to discuss the pros and cons of the program and what’s expected to happen because of its discontinuation.

 

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Some of the highlights of the show include:

  • Depending on severity of malfunction, the program gave companies a specified amount of time to report it as part of a summary.
  • What created controversy, and why was program cancelled? Potentially fake news headlines, checkbox mentality, and regulatory micromanagement.
  • With or without a formal FDA program, companies should follow best practices and not wait for regulations to tell them when and what to do.
  • Did program “hide” information? Instead, it reduced redundancy and created a more efficient way to report information.
  • FDA needs to clearly identify what events need to be reported; encourage companies to investigate and act to minimize or prevent future problems.
  • Quality and Regulatory vs. Product Liability Perspective: Documentation is critical or the kiss of death. There’s never enough publicly available information.
  • Special 501(k) program will replace alternative summary reporting program to allow some companies to submit summary reports via spreadsheets.
  • Quality over Quantity: More isn’t always better. Program cancellation could do more harm than good and offers opportunity to truly “hide” information

Links:

FDA to end program that hid millions of reports on faulty medical devices

Medical Device Reporting - Alternative Summary Reporting (ASR) Program

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

The Special 510(k) Program

Global Medical Device - CAPA Happy<span> </span>

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health

MAUDE - Manufacturer and User Facility Device Experience

Freedom of Information Request

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes From This Episode:

“Depending on the severity of the malfunction, companies are given a specified amount of time to report it.” Mike Drues

“We shouldn’t be waiting on regulations to tell us when and what to do.” Jon Speer 

“It’s just creating a more efficient way to report that information. Nothing in fact was ever hidden; perhaps it was de-emphasized.” Mike Drues

“The information that’s publicly available, whether it comes from FDA or not, is never enough.” 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: Recently FDA announced that it's gonna end a program about Alternative Summary Reporting and there's been some really tough headlines on this topic frankly. Allocating that FDA is ending a program that hid millions of reports on faulty medical devices. Is that true? Is it spin? Well, enjoy this episode of The Global Medical Device podcast where Mike Drues from Vascular Sciences and I discuss this program and the pros and cons of it and what happens next. Hello and welcome to the Global Medical Device podcast, this is your host founder and VP of Quality and Regulatory at Greenlight Guru Jon Speer and today... Recently there was some news that came out that the FDA was canceling this thing called the Alternative Summary Reporting Program and I thought who better to talk about this than good friend and frequent guest on the Global Medical Device podcast Mike Drews from Vascular Sciences. Mike, welcome.

Mike Drues: Thank you Jon.

Jon Speer: So you and I actually talked about this, not quite a year ago but last summer in 2018 about this program from FDA that allowing med device companies to summarize malfunctions. Might be good to kinda start there with a little bit of a recap or an overview of what that program was about before we dive into why this program is now being cancelled.

Mike Drues: Yeah, a great opportunity to talk about this Jon and as always, thank you for the invitation to speak with you and your audience. So you're right. Last summer, you and I did a podcast on this topic when FDA announced that they were creating this Summary Reporting Program. In fact, that was a little bit deceptive in and of itself because Summary Reporting has been around actually for about 20 years. But some of the things that we talked about in that previous podcast we said that depending on the severity of the malfunction, companies are given a specified amount of time in order to report it. The company has an obligation obviously to report severe life-threatening events in a timely fashion. But here's the thing that was a little different than what's generated the controversy lately and what's now leading to the cancellation of this program today.

Mike Drues: FDA had allowed companies to instead of report malfunctions or problems individually, if there were similar causes of these problems, they can lump them all together into what's called a summary report and in some cases for less severe events, they could report these as summaries just once a quarter. But the most important thing that we talked about in that podcast, Jon, is that regardless of what the reporting requirements are, the company should be proactive. In other words, keep an eye not just on our device, but on our competitor's device to see if there are similar problems that could happen to us and so on. So those were essentially some of the takeaway messages I think from our discussion last summer.

Jon Speer: Yeah and regardless of whether or not there is a, "formal" program from FDA or not, doesn't that just seem like good logical sense, these are good practices that you would want to do anyway?

Mike Drues: Oh, I couldn't agree with you more, Jon. But of course, the underlining assumption of your statement there is that regulation is always logical and unfortunately that's not always the case.

Jon Speer: Yeah and folks, you probably know this by now if you've listened to any episodes, the Global Medical Device Podcast had an opportunity to hear Mike talk at any webinars either through Greenlight Guru or any other venues that Mike is presenting just because the... We shouldn't be waiting on regulations to tell us when and what to do, so we won't dive into that or we might but I wanna shift the focus and talk about why has FDA canceled this program. Was it not working? Why put it in place and then less than a year later say, "Changed our mind?" What's goin' on?

Mike Drues: Yeah, it's a good question, Jon because literally FDA announced the cancellation of this program within weeks of us doing this recording. So this is a very timely and important topic that is going to affect the entire medical device industry, all manufacturers in this business in one fashion or another. So the question is, as you just said, why is FDA cancelling this Alternative Summary Reporting? I hate to say it Jon but I think the root cause is very simple. It's because of the way this program has been reported in the popular press. There have been a number of articles over the last several months talking about this particular program and spinning it in a particular way. I'll just read to you the title of one article and we can provide these as links on the website for the audience to read themselves. FDA to end program that hid millions of reports of faulty medical devices. It goes on to say that the Food and Drug Administration announced... And this is a direct quote by the way. FDA announced it is shutting down its controversial Alternative Summary Reporting Program and ending its decades-long practice of "Allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public."

Mike Drues: One other quote to share from that particular article but there have been other articles saying essentially the same thing. It was revealed that the obscure program was vast, collecting more than a million reports since 2016. For example, in the first nine months of 2018, just last year, FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under this "hidden alternative summary program." Now again, I don't wanna bury your audience with a bunch of numbers, quite frankly, that's not the important thing. What's more important I think for our audience to understand is the spin here from the press. What does hidden mean, Jon?

Mike Drues: In other words, if I summarize a bunch of similar events into one particular report, is that hiding the information? In my opinion, no, it's just creating a more efficient way to report that information. So I would argue, actually, Jon and perhaps you might disagree that nothing in fact was ever hidden here, perhaps it was deemphasized or as I like to say, "Not draw attention to it," and this is something that I do in my regulatory submissions all the time, but it's not hidden. So were these summaries hidden? Were the information in these summaries, Jon, do you think when we summarize similar information together, assuming, of course that they're similar problems, do you think that's hiding information?

Jon Speer: I don't think so. And I know you and I, we had a chance to actually catch up face-to-face a couple of weeks ago and talk about a number of things, and we did chat about this particular topic briefly. But no, I don't think so. I mean, to me, if there's nothing new, nothing of "value," why do I have to be continue to just do it for redundancy sake? I mean, it's... I think if you do it for the sake of redundancy, even if it's the same type of event, but just a different occurrence of that same event, same issue and so on, actually, that can create, in my opinion, a lot of bad habits. It could start to drive more checkbox form type mentally, "Oh, I gotta fill out this form," and that won't make things better, it'd just create more of a paper blizzard, so to speak of. But no, I would want people to share new information, meaningful information, if it's another occurrence of the same event, I see no problem at all with summarizing this at all.

Mike Drues: Well, I agree, Jon and we'll get into some of those details as we discuss this further, but just to be clear, I do think that we have to be a little bit careful with our terminology here. Do we need to comment new or not valuable information? To me, whether the information is new or not, really it doesn't matter. Even if I have a hundred events that occur that are brand new, that have never happened before, if they're all very, very similar, in other words, if they are substantially equivalent to use a regulatory pun, then why can't I report all of that new information in one summary?

Jon Speer: Totally.

Mike Drues: So as a result, whether you and I think that this is hiding or not, I think that the FDA's response is 100% predictable. In fact, I would say that FDA had no choice, but to ban this summary reporting because of the way it's been portrayed in the popular press. The title that I read a moment ago was specifically designed to get people's attention and so from the presses perspective, they're doing their job. It's a classic example of spin.

Jon Speer: Yeah, I mean it's... And for the lay person who may not understand or get into the nuances of what's expected and required of a medical device company, if you read that headline and that first statement on that particular article that you mentioned, I mean, you may think, "Oh my goodness, what is going on in this industry?" I mean, it is, I'm in the industry, and I'm reading like, "Holy crap, what is going on?"

Mike Drues: [chuckle] Well, I couldn't agree more, Jon. And listen, you know me and our audience knows me. When FDA makes a decision that I agree with, I am one of the first to support them, but on the other hand, when they make a decision for whatever reasons that they don't, that I don't agree with, then I think that we need to have further discussion. In my not so humble opinion, this is the totally wrong decision. So back to the fundamental question of why is the FDA doing this? Well, part of it, as I said is because of the press. The other part of the explanation is because it's a very simple solution to implement. In other words, it requires absolutely no intelligence whatsoever to say to people, "You cannot summarize this information, you have to report each individual events separately, regardless if it's similar or different to what we already know." This is in fact the same reason why Jon many people you and I talked about this before, advocate the 10-year predicate rule and some of the other regulatory solutions because it doesn't require any thinking, it doesn't require any intelligence.

Mike Drues: I don't mean to be harsh Jon, but unfortunately you mentioned it, the tick box mentality. Is your predicate less than 10 years old? If yes, then you pass, if no, then you fail. Is your summary, sorry... Is your report describing only one event? If yes, you pass, if no, you fail, you fail. So it's easier to create and enforce these regulatory absolutes. In other words, tell people something that you can do versus something that you cannot do as opposed to allowing professionals like you and I to actually think to use our professional judgement to make decisions, the best decisions that we can, given the situation at hand. Regrettably, Jon, it's a classic example of regulatory micromanagement because it takes all of the decisions, thinking out of this process. And once again, some people might think I'm being overly harsh, perhaps I am, but I'm giving you my assessment of this change.

Jon Speer: Alright, it feels like there might be some things that aren't being discussed on this topic. I mean you shared your not so humble opinion that this is the wrong decision and so on. But what is... And maybe it is a knee jerk or a reaction to the popular press, but what are we missing here? What is not being talked about in these conversations?

Mike Drues: It's a great question, Jon. All of the discussion, at least in the context of this situation, is about summary reporting. But there's a whole bunch of other issues, ongoing challenges that are just important, or perhaps even more important, that are not being discussed. For example, what constitutes an event that needs to be reported versus one that does not need to be reported. Whether it's a manufacturing problem, whether it's a clinical problem that we find in post-market surveillance and so on. This issue of what constitutes a significant event is always been a very, very nebulous topic, at least to me, in spite of the fact that FDA has put out a number of guidances. It's about as clear is substantial equivalence and again, I'm using that regulatory pun on purpose. But again, putting things into perspective here of what's most important to me is not whether you report a particular event or not. At the end of the day, Jon, I think you and I would both agree that that's a matter of paperwork.

Jon Speer: Yeah.

Mike Drues: What's much more important for our audience to understand being the manufacturers is that the company needs to investigate the incidents and then act, if necessary, to minimize or to prevent these problems from happening in the future. And there are... As we've talked about a little bit before, Jon, there are product liability implications here as well. If you don't report an event, whether you're required to or not, one of the things that somebody like me as a expert witness can say is, "They didn't report it, they didn't investigate it and therefore, that just sounds bad to everybody." So that's one of the issues that I think needs more discussion. Another thing that people seem to be overlooking is the historical perspective on this, Jon. Because as I mentioned earlier, this program is not new, it's been going on for quite a long time. And when it comes to exceptions, we'll talk about that in a moment. What FDA has allowed companies for years to reach agreements for about 100 medical devices that allow them to seize public reports of certain types of problems and the only way that anybody can find out about this is by filing a freedom of information request, which is you probably know Jon is a pain in the you know what. It takes months, oftentimes years, to get that information which is a topic of a different discussion.

Mike Drues: I mentioned a moment ago, FDA's checkered history of granting exceptions to the alternative summary reporting. For example in 2016, there were 84 reports on surgical staplers causing harm that were disclosed in FDA's MAUDE database. However, when you look at the actual numbers, there were about 10,000 malfunction reports that were either summarized or not reported publicly. So, that's the kind of what companies are looking at and as a result, that particular device and similar devices have been subject to lawsuits, over patient deaths, and so on and so on. So, the product liability implications here Jon are just as important to me as the regulatory implications. And one last thing that I'll mention, and I'd love to hear your thoughts on this, Jon. Some of the folks out there are saying that more information is necessary to give product liability attorneys ammunition to go after some of these conference. Well, let me tell you from my experience as an expert with this. [chuckle]

Mike Drues: The information that's possibly available, whether it comes from FDA or not, is never enough, whether it's a summary or an individual report, and that might be the first step in discovery. But I rely on the documentation that I get directly from the company from the discovery process. Most of that is never reported publicly, and some of it is not even reported to the FDA, but that's a topic of a different discussion.

Jon Speer: I was chuckling because when you talk about information that a liability attorney needs, does it say there's a lot of criteria there in some cases. It can be a singular event. And if the company involved has deep enough focus, that might be enough motivation from a liability perspective. But anyway, that's a whole different conversation.

Mike Drues: It is and as you know, Jon, as a good quality and regulatory guy and quality and regulatory people are saying, "Documentation, documentation, documentation." But on the product liability side, as you and I have talked about before, that can be the gist of that.

Jon Speer: I also would say that the opportunity for a medical device company is... You and I have talked about this. I don't remember the exact topic, but we've talked about this notion before. It's pretty easy to identify a trend when there have been numerous events that are here, the opportunity here is to start to identify opportunities for improvement and to be proactive when there's maybe just one or a couple of events. Actually, this goes back to another conversation that we've had recently about PACA, be more preventive rather than corrective. But anyway, like I said, we've covered a lot of those topics before.

Mike Drues: Right, I couldn't agree more. So, thus far we talked a little bit about the program as it existed before and why FDA is cancelling it. Maybe at this point Jon, for our audience, we should move on and talk about the new programs that's being created to replace.

Jon Speer: Yeah, absolutely. So there's a new program. Talk a little bit about what that entails and why it's different or better or worse in your not so humble opinion.

Mike Drues: Well, I wouldn't exactly characterize it is a new program, but it's sort of a modification of what we already have. We are essentially, again, to use a purposeful regulatory paradigm here. This is sort of the special 510(k) that we're submitting or considering now to follow-up to make some changes to the previous program. And I hope, Jon, you appreciate my not so subtle use of regulatory humor. So basically, the changes that the audience needs to be aware of this newer summary reporting program now allows makers of over 5500 types of medical devices to send reports to the agency via spreadsheets logging the device malfunctions. Another thing that's changing is, I mentioned earlier, the exemptions that FDA has made in the past for companies to not be required to be part of this program. FDA is ending the exemption program which probably is a good thing although, I'm not 100% sure about that yet. But some of the things that have been exempted in the past, Jon, have been devices like breast implants. I mentioned a moment ago, surgical staplers, pelvic meshes, defibrillators and pacemakers. Many of these probably sound very familiar to you and our audience, Jon, because many of the devices I just mentioned are devices that were featured in The Bleeding Edge.

Jon Speer: Yeah. I mean, these are the ones that are seen to be the popular devices in the popular press that unfortunately, are being used to negatively characterize the entire medical device industry, absolutely.

Mike Drues: Correct. And of course, Jon, you and I both know that that's purely coincidence, right? It's only after... Sorry, it could... Nobody could have predicted that these devices there, described in the press as you just said, could have led the FDA cancelling this program. And again, I hope our audience appreciates my talk as I'm here. But anyway, so companies are now required to submit these reports to the MAUDE database, which I would argue is a very good thing. I think everything should be submitted to either the MAUDE database or one of the similar databases, because this is, in fact, what people talk about with transparency.

Jon Speer: Yeah.

Mike Drues: The question is, Jon, how much detail do we provide? This is a question that I get frequently with from companies is, "Okay, we've had an incidence. We need to report it. How much detail do we put in there?" That's the question, and I've actually suggested to FDA, we create a mechanism where we have, for X different databases, one database that's public like MAUDE, where we present a little bit less detailed information and another database that is only of use to, say, FDA and maybe some independent agencies that would have more detail. I think these are all solvable problems, but none of the current solutions take it that far yet. Perhaps the most important thing that our audience needs to be aware of when it comes to moving forward is that unlike the alternative summary program as it existed in the past, medical device makers will no longer be allowed to report serious injuries in a summary fashion. My response to that is, duh! But again, what constitutes a serious injury?

Mike Drues: That's still a very nebulous thing. But even taking it a step further, Jon, I still think that's an oversimplification, because even if we have serious injuries, serious reports, if they're all very, very similar, if they're all substantially equivalent, can't we still lump them together? I just think that it's a manner... It's not a matter of transparency, it's a matter of efficiency. Why do I have to have 100 different reports saying exactly the same thing? That just doesn't make any sense to me. And so as a result, here's the actionable item for our audience to take away. Manufacturers now, for better or for worse, are required to file individual reports describing each case of patient harm. You cannot lump them together. In my opinion, Jon, as I said earlier, this is an overreaction. I think it's perfectly appropriate to summarize even serious reports as long as they are similar, as long as they are substantially equivalent, as long as we include the numbers of patients that are being affected, the number of devices that are being effective, as long as we're very, very clear at the very beginning that this is a summary report, not an individual report. To me, as a professional Jon, I don't need to be micromanaged. I should be able to use my own professional judgment to make that decision. I don't need FDA or product liability attorneys or anybody else to micromanage me on that one. But that's just me, Jon. I don't know. Maybe you feel different.

Jon Speer: No, I don't feel differently at all. And let me just take a quick pause folks. I just wanna remind you. I'm talking with Mike Drues with Vascular Sciences, and we're talking about some of these recent changes in FDA regarding Alternative Summary Reporting, some of the nuances around that. But obviously, you've been great fans and hopefully listening to the Global Medical Device Podcast for a long time. If this is your first episode, welcome. We have over 100 episodes, so you got some catching up to do. But did you know that Greenlight Guru, we also recently announced and launched a brand new podcast. That's right. A brand new podcast focused on MedTech True Quality Stories. It's exciting for me to get to do all of these podcast episodes. I'm really enjoying the MedTech True Quality Stories as we get a chance to dive into the inner workings of a lot of med tech companies and talking to CEOs and founders and others who are involved with bringing products to market and some of the challenges and barriers and obstacles that these companies are faced with along the way, and they're doing to overcome it while embracing what true quality means. So wherever you're listening to this episode of the Global Medical Device Podcast, type in a search, you'll be able to go and find MedTech True Quality Stories, but check it out. It's really exciting.

Jon Speer: Mike, getting back to the topic at hand and you hit on it a little bit but it seems like there's still an opportunity to provide summary reports and to your point, maybe a knee-jerk reaction in some respects to what's happening in the popular press. As to why FDA maybe a little bit reticent to that but... I guess let's summarize... Or start to work towards summarizing this a little bit. What is the... Feels like the pendulum is certainly swinging back and forth somewhat rapidly but there is an impact on this so... And who's paying for this? What's the result of this? What are the consequences of this?

Mike Drues: Yeah, that's a great question, Jon and that's one of the things that concerns me the most. What's the result of this ban? So now we have more resources that are gonna be required both in the companies as well as in the FDA to sort through all of these individual reports. And many times these same reports are gonna have exactly the same or very, very similar information. In other words, we're reporting the same information over and over and over again and as a result it makes it harder in fact, not easier, to find the most important information. As a result, this leads to a very inefficient situation and quite frankly a lose-lose situation for everybody. So I think this is one of those areas where the proposed solution here to banning these summaries whether you wanna consider it micro-management or not, actually has the potential to do more harm than good.

Mike Drues: Some people might say that this improves transparency, but transparency aside does that improve the system? The most important... The most concerning thing that I have about this, Jon is that this... That these... Because we can't do summary reporting anymore, this is going to lead to a form of what I call over-report. In other words as I said a moment ago, having lots and lots of individual reports saying exactly the same thing. And not to be cynical, Jon, but I've considered using this strategy myself. This could actually provide a mechanism for some companies to hide information. In other words, to hide the tree in the middle of the forest so to speak if you understand the metaphor that I'm using. In other words, if we report a whole bunch of problems individually that are not that serious, and within them sort of buried in the mix so to speak, there is one problem that is more serious and we're certainly not drawing attention to that problem. One of the underlining assumption, Jon, is that why would anybody assume that anybody whether it's a FDA or anybody else reads and scrutinizes every one of these reports? I think it's just naive to have that... To make that assumption.

Jon Speer: Yeah... I was just gonna say it feels like this is setting up a situation for analysis paralysis, more isn't better.

Mike Drues: Yeah, more isn't better. To me or put it slightly different way, Jon, it's something that I say to my graduate students all the time. It's quality not quantity. So again, not to be cynical but I as a clever regulatory consultant could use this actually as an opportunity to not draw attention to certain information. It's not hiding the information. It's disclosed. The information is presented to the FDA or whoever else but not drawing attention to it. Something to think about and I'm not sure that my friends at FDA really thought about that particular possibility.

Jon Speer: Yeah. Alright, so let's bring it home, Mike. What are some takeaways and some lessons that we can learn from the situation?

Mike Drues: Yeah, so most importantly to wrap this up, here are some takeaways. Obviously transparency is of utmost importance. There's no question about it. But at the same time, I would say can we use a little common sense here? In the clinical trial world, clinicaltrials.gov, the website was created a number of years ago for exactly the same reasons, for transparency, for the putting out information so that everybody can have access to it, which on the surface sounds like a good thing but the question is, does it really work? It's very confusing nevermind to just the lay public but it's also confusing to professionals working in this industry to read through and really understand that information because I think you would agree with me, Jon, that any data can be interpreted in multiple ways and when we have multiple interpretations of the same data that leads to more confusion. So jettisoning the information out there, that's transparency. But the question is, does it really bias anything?

Jon Speer: Yeah, and I'm glad you brought that point out because I was just thinking about that earlier when if now we are required to submit a report for every single occurrence of an adverse event but likelihood that the same folks are gonna be reviewing that actually potentially could make the problem worse. It creates a lot more subjectiveness because there's still a human on the other end that is interpreting this information and if you have five different events and five different humans more or less interpreting the same information but on five different reports, it seems like it could spin out of control pretty quickly.

Mike Drues: It certainly could. Another takeaway as I just mentioned a couple of minutes ago is that all of these individual reports can in fact lead to a form of what I call over-reporting, which could be an opportunity for some companies to provide them a mechanism to... To, I don't wanna go so far as to say high, but certainly not draw attention to the most important information. Again, as I said, I don't think any of us including my friends at FDA should be naive enough to think that all of these reports are going to be investigated or analyzed in the same... To the same degree. That's just simply not realistic. But most important, and I think you and I, Jon...

Jon Speer: Do you mind if I chime in on that first?

Mike Drues: Yeah, please do.

Jon Speer: The other thing I think this has the potential to do is to drive some complacency practices, not so best practices within a company because if there are... It's back to that check box, fill out the form, the compliant perspective that we talked about briefly a little bit ago. If now I'm just going through the motions, I may not be so inclined to actually do a thorough investigation into what's really going on. I may just feel more compelled to fill out the form and submit it to FDA thing. So I don't think that's gonna promote positive behaviors.

Mike Drues: If you're correct Jon, and I'm not saying that I disagree with you, that would be very unfortunate. If we create new regulation that does not, to use your phrase, promote positive behavior, then we're actually going in the wrong, in the opposite direction.

Jon Speer: I hope I'm wrong. I hope I'm wrong. Let's just put it that way.

Mike Drues: And I hope you're wrong well, time will tell. But it's good that we're having this discussion and we need more people in our industry having these discussions as well. But the most important thing, Jon, I want to offer to our audience to keep in mind... And, again, you and I had talked about this in the past in different forums. The most important thing is whether we're talking about summary reports or individual reports. The most important thing is that companies collect the information and actually take that one step further. They should not do so just passively. That is rely on other people to report that information to them but actually actively go out and look for problems. Once they collect that information, analyze it, try to determine what the root cause was. You mentioned something that we talked about earlier on the quality side, why the heck do we call it CAPA? Perhaps it should be PACA. The emphasize should be more on preventative as opposed to corrective. And that's not gonna happen unless we're more active in getting that information, try to figure out, "Can this problem happen again? And if it can. What steps can we implement to try to minimize that chance of happening."

Mike Drues: And then, most importantly, Jon, is acting if and when necessary because, at the end of the day, all of this reporting is just simply a matter of paperwork. It's just simply a matter of words. And as they say, actions speak louder than words. So the most important thing is we have a professional obligation. Yes, medicine is a business. Yes, we're in this in part to make money but we also have an obligation to do these things as well. So that's just some of my thoughts overall on FDA's cancellation of this program and the changes to the new program, to the special 510(k) version of this program that's now being created. Any final thoughts from your side, Jon?

Jon Speer: No, it's one of those things that... Like you said a moment ago, we're just gonna have to wait and see how this unfolds. Honestly, I don't like these types of situations to be wait and see because it feels we could do more from a collaborative perspective between the agency and industry on designing programs that are actually good for industry, good for the FDA, good for patients. And it feels like we're missing something here but, like I said, this is one of those things where maybe this is a good move, maybe it could be tweaked. I guess the good news is the silver lining here is that with what we've seen with current agency practices is that they're, arguably speaking, pretty proactive in iterating and tweaking things. And it seems like there a more frequent basis that maybe historically has been the case.

Mike Drues: And along those lines, Jon, I would just add very quickly, you and I are extremely fortunate. We have lots and lots of people from industry who listen to our podcast but I actually know... As a matter of fact, I have a number of my friends at FDA, as well as at some of the other regulatory agencies around the world who listen to us as well although I'm sure they would never admit to that publicly. So I'm hoping that for those that are working in the regulatory agencies including FDA that they might take some of the suggestions that you and I have discussed today and at least talk about them, and say, "Hey, we've made some changes." But just like in quality where we use the concept of the continuous improvement, we should use that same concept in regulatory as well.

Jon Speer: Absolutely, I couldn't agree more. And, folks, a lot of things that Mike and I have been talking about today... You've heard us mentioned just focusing on compliance. If you've ever heard Mike chat about compliance before, that's the academic equivalent of being C-student. I hope I got that quote correct, but it is just bare minimum expectations. And if you are just focused on compliance, you're a C-student and I beg you to think about, "Are your patient's benefiting as much as they could if you were able to shift your focus from just compliance to focusing more on true quality?" True quality is what we're all about here at Greenlight Guru. We've built an eQMS software platform specifically for the medical device industry and it's designed by actual medical device professionals. There's no other eQMS in the world that has been designed by med device professionals for med device professionals. So if you want a better way, you want a true quality approach to your day-to-day operations as a medical device company, I would encourage you to go check out what we're doing at www.greenlight.guru.

Jon Speer: As always, I wanna thank my guest, Mike Drues from Vascular Sciences. Folks, he's a regulatory guru, he knows his stuff, he consults for not only industry but also with regulatory agencies including FDA and Health Canada, and others. So he is certainly a person on the knows. So reach out to him with any questions that you have on all things regulatory and I'm confident that he can help you get some clarity on your path. So, as always, this is the host, 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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