Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

June 14, 2021

GMDP-header-Mike Drues (1)

Looking at data from 2020 FDA 483 Forms, what did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.



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Some highlights of this episode include:

  • The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.

  • Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.

  • Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 2020.

  • Of the 197 times that CAPAs were issued last year, manufacturers either did not document or cite procedures. Medical device companies must have a quality management system (QMS) and follow a CAPA process to be compliant.

  • CAPA should be changed to preventative and corrective actions (PACA). Put the emphasis on preventing problems, rather than correcting problems and complaints when they happen.

  • Almost 200 complaints were cited because manufacturers didn’t document procedures for maintaining files.

  • Also, 139 complaints were filed due to medical device failures not investigated, not containing required information, or lacking rationale to not conduct an investigation. Every complaint requires some level of investigation.

  • Design validation of design controls gets most 483 observations for not having procedures, not performing or documenting risk analysis, not having software validations, or not using a production equivalent device in validation studies.



The Top 10 Most-Cited Issues in FDA FY2020 Medical Device Inspections

FDA - Inspection Observations

FDA - Medical Devices

FDA - Corrective and Preventive Actions (CAPA)

FDA - Form 483 Frequently Asked Questions

FDA - Premarket Notification 510(k)

Code of Federal Regulations (CFR) - Title 21 Part 820

CFR Part 820:30 - Design Controls

The Bleeding Edge Documentary on Netflix

Mike Drues on LinkedIn

Greenlight Guru Academy

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable quotes from this episode:

“When the number of findings is down, is it because we in companies and we as an industry are doing a better job? Or, is it because of something else?” Mike Drues

“Apparently, FDA doesn’t have a mandate or I’ll use the word, permission, or something of that nature, to do remote inspections for med device companies.” Jon Speer

“Our job as medical device professionals is to make sure that the products that we design, develop, manufacture, sell, so on and so forth, they’re as safe and effective as they can possibly be.” Jon Speer 

“I have a responsibility, certainly to the patients, to do an investigation when I learn about something.” Jon Speer

“Average regulatory professionals know the rules, but the best ones know the exceptions.” Mike Drues



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: On this episode of the Global Medical Device Podcast, I catch up with Mike Drues with Vascular Sciences, and we talk about the FDA 2020 Inspection data and kind of digest and evaluate the top three areas of 43 observations. I'm going to spoil it for you. It's CAPA. It's complaints. It's design control. We talk a little bit more about some of the why's and maybe what you can do about it. Enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me today is a familiar face and voice. Remember, the Global Medical Device Podcast powered by Greenlight Guru is now available on video. I hope you're checking that out. Joining me is Mike Drues, president of Vascular Sciences. Mike, welcome.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and especially to see you today. I can't help but point out that I think my forte is the content. None of my customers pay me for what I look like.

Jon Speer: If somebody is paying Greenlight for what I look like, then thank you. We'll just leave it at that. I'm not going to touch that one.

Mike Drues: Fair enough.

Jon Speer: One of the things that we've talked about from time to time over the years is just some trends and what's happening from the FDA perspective. You sent over an article the other day. It was a pretty good one on Med Device Online, and we'll provide a link to that, but I think the author did a really good job on this article. The article covers the top 10 most cited issues in FDA fiscal year 2020 from medical device inspections. I thought we could unpack that a little bit and explore that a little bit. The first thing was interesting to me. I mean, this is not a big surprise, but the volume of inspections is down a great deal. Now that's not a huge surprise, but any thoughts about that before we start to talk about some of the issues that were cited?

Mike Drues: Yeah, I think it's a great place to start, Jon. The volume of inspections for 2020 was down by about that. It's not any surprises why. It's primarily because of COVID, but basically, it's not just the volume of inspections down, but the number of findings, specifically 43 observations and warning letters. My question is, why, because COVID aside, more inspections are being done remotely. When the number of findings is down, is it because we in companies and we as an industry are doing a better job, or is it because of something else? It kind of begs the question, Jon, how effective are these remote inspections when you do, for example, a desktop audit? Is that just as effective as if somebody was in your facility auditing the old- fashioned way, as people would say? This is a classic problem in epidemiology and medicine. If the number of diagnoses of the disease has increased, is it that more people are getting the disease, or is it that we're just better at diagnosing the disease? Can we conclude, Jon, that because the number of observations is down that we are, industry, doing a better job?

Jon Speer: I think that's an inaccurate conclusion. I think it's... Who knows at this point in time? I think my opinion is, 2020 was such a weird year for audits and inspections. Of course, the volume was down. I know FDA did resort to some remote activities, but someone was telling me recently, and I tried to look this up and I have to believe this person, they seem to be an authority, but apparently FDA doesn't have mandate, or I'll use the word permission, or something of that nature, to do remote inspections for med device companies. That was intriguing to me. I wonder if that's part of why we saw that reduced a number of inspections, in addition to the COVID, is that they didn't have a mechanism or a means to do remote inspections.

Mike Drues: Well, I can't comment as to the legalities of that. I'm not an expert in that particular area, but according to the statistics shared in this article, which I assume are valid, the number of 483s that were issued against medical device quality systems was half. That's a pretty significant decrease.

Jon Speer: Huge, and I think it would be naive for someone to say," Oh, half from what it was the previous year. Yeah. There's reduction in the number of inspections, but the percentage, we're doing much better year over year." I think that's a little premature.

Mike Drues: This is the proverbial, Jon, is the glass half empty or half full. Both are factually correct statements.

Jon Speer: Yeah, right.

Mike Drues: You can't argue with either one. Is it that this number is decreased by 50%? Is that a good thing or a bad thing? All right. I think maybe it makes sense, Jon, to move on to those observational letters and those warnings. According to the reference, the top three cited claims are probably no surprise to you, Jon, CAPAs, complaints and design controls. Those three things, those three areas, CAPAs, complaints and design controls led to approximately 35% of all 483 observations that FDA issued last year.

Jon Speer: Well, I don't remember the exact percentage from previous years. I do remember, though, that this is no surprise that for many years, CAPAs, complaints and design controls, sometimes they jockey for number one, two or three position, if you will, but for years, these have been routinely the top three things that result in 483 observations, so this is not a huge surprise. CAPA has been the winner... I don't know if that's the right word... here, but the winner as far as 483 observations for, I think, something like eight out of the last 10 years or something crazy like that. Yeah, those aren't a surprise, really

Mike Drues: Well, just to peel back that onion a little bit further, Jon, and it's kind of ironic that we're talking about CAPA, corrective action, preventative action, because we're trying to get into the preventative year of trying to keep these things from happening. But it says of the 197 times that CAPAs were issued last year, manufacturers either didn't document their procedures, didn't cite them, or they didn't... Sorry. They didn't document them. That was the majority of the times, about 105 times, or in about 30 cases, they didn't even site them.

Jon Speer: That's crazy.

Mike Drues: To me, what's the point of having a CAPA system or a quality management system, in general, if you're not going to document it, if you're not going to site. I mean, this-

Jon Speer: That's crazy. I mean, almost 200 483s for CAPA, 165, so if my math is correct, let's call that roughly about 83 or so percent of the CAPA citations, just because they didn't have procedures documented. It's like," Oh, it's 2021." That's a little mind blowing to me that companies still don't have procedures to describe how they do corrective actions and preventative actions. That's a little concerning.

Mike Drues: One of the things that I've talked to many of my customers about, Jon, and I know you and I have talked about in some of our discussions before, just because a company has a quality management system, and of course, all medical device companies have, and just because it ticks all of the regulatory boxes, I've never made the assumption that that quality management system works, for a whole bunch of different reasons.

Jon Speer: Right.

Mike Drues: One of the things that I see missing in a lot of quality management systems, Jon, is specific criteria for when, for example, a complaint, which is the number two reason here, should be transitioned or elevated to a CAPA. I got to believe that some of this is embedded when they say that they didn't even have the procedures to implement them.

Jon Speer: Would have to believe that, as well. I've observed similar sorts of issues with a lot of companies. They may have a CAPA procedure that describes what to do when somebody decides that an issue is CAPA- worthy, but I think it's the inputs into that CAPA process that are questionable or need some work. To your point, if you have a complaint, what do you do? Is there ever a time, or situation, or circumstance where you need to escalate that in the CAPA? If so, what are those conditions and criteria to do so? Not just complaints, but just other practices, as well, maybe manufacturing, or purchasing, or whatever the case may be. Clear definition, I think, is missing or a lot of company procedures with respect to determining if and when a CAPA is necessary. Then I think, in those circumstances, I mean, maybe it's a little unfair to scrutinize the CAPA process too much. At the same time, I mean, this shows that to your point, just because you could put it down in a procedure, doesn't necessarily mean it works. You have to kind of live those procedures. This is sort of, I think, the essence of implementing quality systems and implementing the subsequent processes and procedures that comprise that quality system, because this is how you do business. If you don't follow through with that, you're just checking that box, then, well, no wonder, there are so many issues being cited for things like not having a procedure, because it didn't do it.

Mike Drues: I've got to point out the irony, or maybe even the hypocrisy of what you yourself just said, putting down the procedure assumes that you have a procedure. The majority of these companies cited here are companies that didn't have a procedure. If they don't have a procedure, how could they put it down?

Jon Speer: Yeah. I mean, I want this to sound tongue- in- cheek. I don't want this to sound like a prescription to folks that are in that situation, but, Mike, it is so easy to find procedures these days for a couple of hundred bucks.

Mike Drues: Yeah, we're not even talking about evaluating or debating whether or not it's the appropriate procedure, whether or not it's an effective procedure, because I'll be the first to admit that just because you have a procedure, doesn't mean that it's effective, that it works. Just like I said a moment ago with the quality management system, just because you have one, doesn't mean that it works. But here, we're talking about companies that don't even have a procedure.

Jon Speer: Yeah. That's just, like I said a moment ago, it's 2021. There's no excuse. I mean, if you're a medical device company today, and you don't know the need to define your processes and procedures on things like CAPA, complaints, and all the other elements that are defined, pretty well- defined, within 21 CFR Part 820... I know there's a few other sub- parts, too... but these have been around for, well, 25 years, give or take. This is not new stuff. It's not new stuff.

Mike Drues: Definitely not new. As I think you and I have talked about before, Jon... and these are all things by the way that I advise my customers of, even though I don't mark it as a mock auditor or somebody that writes quality managements... with all due respect, Jon, there's not enough money on earth that a company could give me to write a QMS for them. That's when I refer them to people like you-

Jon Speer: Well, thank you.

Mike Drues: ...but what I do do is I will evaluate companies' QMSs to make suggestions, not just how to make sure that it's fine in a regulatory sense, but compliant in the real- world sense. But one of the things that bothers me about this whole CAPA system is we call it a CAPA, a corrective action, preventative action, which means we're putting the emphasis on correcting problems as opposed to preventing problems. With all due respect, I think that's bass- ackwards.

Jon Speer: Oh, I totally agree.

Mike Drues: I think we should be calling these a PACA, a preventative action, corrective action. The emphasis should be on preventing a problem from happening, not correcting a problem once it did happen. Obviously, both things are important, but I think the emphasis should be on preventing rather than correcting. Do you agree, Jon?

Jon Speer: For sure. I mean, still, this baffles me a little bit, too, because you and I have talked about that very thing many times before, and I know that's been the subject of plenty of content and webinars that Greenlight, and Vascular Sciences, and many, many others who are in this space for a long, long time. It sort of begs the question. I mean, if you look at this, clearly, we as an industry, we're still struggling to understand PACA, or CAPA, or however way you want to say it, but we're struggling to understand that. We're struggling to understand complaints and how to properly handle those, for sure. I'm not naive. I know these things are somewhat complicated and having worked with a lot of different companies in my career, I know there're varying interpretations of these things. Some people like," Oh," they've reserved a CAPA for a super special circumstance, because in my opinion, the wrong mindset, when they think about these things, quality management system elements, they're looking at that as bad news thing," Oh, we got a CAPA. That's a bad news thing, or," Oh, we got a complaint. That's a bad news thing." Don't mishear me. It's neither good nor bad, necessarily. It's input. It's data. It's information about something that's working or not working as well as it should, with respect to your process, your product, et cetera, et cetera. But the whole point is to learn from it, to gather this information, to properly investigate it, determine ideally a root cause or root causes, and then take the necessary actions to prevent that from being an issue again. Now, I know it's way easier for me just to say that. It's a little bit more challenging in practice, but we're not reinventing the wheel.

Mike Drues: Indeed, Jon, we're not reinventing the wheel. History does tend to repeat itself. I mean, whatever cliche you want to use, they have a lot of... Why don't we move on to the second most common source of 483 observations, according to the article and the FDA's statistics here? That is complaints. Here's an interesting, I thought was an interesting little factoid. Of the almost 200 times that complaints were cited, manufacturers did not document... once again, we're back to documenting... their procedures-

Jon Speer: That's crazy.

Mike Drues: ...or maintaining their files and so on. I mean, what happened to the old GMP adage, Jon, from years, if not decades ago," If it wasn't documented, it never happened."

Jon Speer: Well, that might be the problem, Mike. Maybe, a little bit of a contrarian here, but maybe folks are thinking," Oh, if we didn't document this thing, then it didn't really happen." I hate to think that. I mean, I know a lot of medical device professionals, and I think, generally speaking, folks in this industry want to understand how to make the products as safe and effective as possible. I feel like a broken record from the CAPA portion of our conversation. This is basic blocking and tackling. This is just basic stuff here.

Mike Drues: Well, just to illustrate to our audience that it's not just a matter of semantics, it's not just a matter of filling out forms as you and I have talked about many times before, dotting I's and crossing T's, let's throw a little more gasoline on this proverbial fire, Jon.

Jon Speer: Okay.

Mike Drues: 139 times there were complaints of medical device failures that were not even investigated. Now to be fair, I don't know what the nature of these failures were. I would assume that if the failure was never investigated, that nobody else does either. That's the purpose of having an investigation, right? That's one problem. Another problem that they cite in the article here, did not contain required information, eight times. Complaints weren't investigated or lacked rationale for not conducting an investigation. If the company decides that for whatever reason it is not worth investigating... I'll be the first to admit, Jon, the frustrations that I have with FDA, this idea that all complaints have to be investigated equally. To me, that makes absolutely no sense.

Jon Speer: Agree.

Mike Drues: It's like in medicine. We use the triage system. If somebody goes to the emergency room, and they're having a heart attack, they're going to get treated, we hope, much quicker than somebody that gets a splinter in their finger. A device that has a little cosmetic defect, maybe a scratch or an abnormal coloration, the housing of the device, with all due respect as a professional biomedical engineer, I could care less. That's not the kind of complaint that I worry about, right?

Jon Speer: Right.

Mike Drues: But if you have something that can definitely impact the safety, the efficacy, performance of the product, that is something that not just biomedical engineers and regulatory professionals should care about, I think that everybody should care about-

Jon Speer: Absolutely.

Mike Drues: ...yet according to these FDA statistics, Jon, they were not documented. In some cases, they were not even investigated. How do we explain that?

Jon Speer: I don't have an explanation for it. I mean, to your point, I mean, every complaint requires some level of investigation. To your point. They don't all require the same depth and detail and level of investigation, but they all require something. I believe, my interpretation of the regulations is, if we have, I'll say, a repeat infraction, something that we've observed before, learned about previously, that we did already investigate, there's an opportunity to tie that previous investigation to this new event, but you shouldn't do so just carte blanche, say like," Oh yeah. That thing happened before. This is exactly like that thing before." I mean, you want to have some confidence, I think, to do that, but that is a level of investigation. To echo what you're saying, I mean, our job as medical device professionals is to make sure the products that we design, develop, manufacture, sell and so on and so forth, they are as safe and effective as they possibly can be. I have a responsibility, certainly to the patients, to do an investigation when I learn about something. Hey, I've been there. I understand. It's easy sometimes to throw your hands up, say," We tried. We called a few people. We didn't learn anything." I don't think that's a good excuse.

Mike Drues: Well, the thing that bothers me most thus far with our conversation, Jon, is we're not quibbling over the details of if they did a thorough enough investigation.

Jon Speer: Right.

Mike Drues: We're not quibbling over the details of the amount of information. We're not quibbling about the details of a procedure that a company's using, and is that the adequate procedure, or can it be done better? When it comes to CAPAs, or now complaints, we're talking about whether or not the company even did some of these things, whether the company had these procedures in place, whether or not they investigated a problem. Can you imagine, nevermind about... I applaud your altruistic motivations for wanting to do things for the greater good, for the protection of the patients... nevermind from altruism, nevermind regulatory, can you imagine, Jon, what in a courtroom an expert witness like me, if I can say that not only did the company have reports of a problem happening, but they didn't even investigate the problem happening? I mean, it doesn't take an MD or PhD or a JD after, or RAC, it doesn't take any letters after anybody's name to appreciate, cha- ching, cha- ching, cha- ching. Altruism aside, FDA consequences aside, if our colleagues in our industry that are listening to us, if they're not paying attention from a pure product liability perspective, I don't know what greater motivation we can offer than that.

Jon Speer: Yeah. I want to try to see if we can highlight a few tips and pointers for folks before we wrap things up here in a few moments, but before we do that, I want to take a short break. I want to remind everyone I'm speaking with Mike Drues. Mike is President of Vascular Sciences, probably a voice you've heard before on the Global Medical Device Podcast. If you have, then you probably know how I feel about the guy. He is the best in the industry when it comes to regulatory strategy, and building out roadmaps and pathways, just things that they might be a little bit different than what you're used to, and that's okay. Mike's got a very pragmatic way of doing things. He does think about the problem, probably differently than most regulatory professionals in the industry. I would encourage you to check out Mike Drues. You can find a number of places, LinkedIn. He's writes content for a lot of different publications. He does webinars for Greenland quite often, and obviously, podcasts, so check that out. While I'm taking a short break, I want to remind you all about Greenlight Guru. We do have a medical device success platform that helps you manage CAPAs, and complaints, and the next thing we're going to talk about, design controls among a lot of different areas of quality management systems, so it's a little bit simpler. We have templates and procedures. We have gurus on our team that have been there, done that, that can walk you through and help you get everything where it needs to be from a process perspective. If you're still learning more about how Greenlight Guru might be able to help, go check it out, All right. Mike, I think let's hit that third item on the top three list, and then maybe see if we can give some tips and pointers on things that folks can take home and maybe change about their ways, so that here in a year from now, we're not talking about the same thing.

Mike Drues: Absolutely, Jon, happy to continue the discussion.

Jon Speer: All right. The third item was design controls. This one's always interesting to me. Most folks that know me know that I'm a design control nerd. It's always design validation. I mean, so the design control ones is a little bit complicated, I suppose, in that Design Control 820-30 has multiple sub- parts, but it always seems like design validation is at the top of 483 observations with respect to the topic of design controls. I don't understand why.

Mike Drues: Well, I would also remind you, as well as our audience, Jon, that what originally brought the two of us together many years ago was the topic of design control.

Jon Speer: Yes. Yes, it was, and validation was part of it.

Mike Drues: For those who are not familiar with that story, then maybe we can, as part of this particular podcast, maybe we can point to some-

Jon Speer: Sure.

Mike Drues: ...references back to those days. Yeah, I mean, design controls continues to be sort of the thorn in the rose bush for a lot of companies. Let's get into the weeds a tiny bit more on this. You mentioned validation. Validation is apparently the part of the design controls that leads to the most number of 483s and specifically, observations range from not having procedures... once again, back to the same-

Jon Speer: Basics.

Mike Drues: ...basic root cause, not having procedures to not performing or documenting a risk analysis, not having software validations, or not using production equivalent device in the validation studies. I mean, to me, as I said many times before in our conversations, Jon, to me, design controls is nothing more than a synonym. It's substantially equivalent, if you will, to root engineering. I mean, take just for example, the last example. I mean, shouldn't it be common sense that if part of your final verification and validation of your device, whether it's packaging, sterility, abilities, shelf life, whatever it is, that you would use production equivalent devices as part of your final validation study? Isn't that common sense?

Jon Speer: Mike, it seems to be, because I mean, let's remind folks, hopefully this is repeating information for everybody listening, but design validation and demonstrating that you've designed the correct product, that it actually works in point of use, this is the whole reason you enter into design and development to begin with, is there's a need, clinical need of some sort. You go through the whole design and development process, and design validation is one of those final steps in that process to demonstrate that the damned thing works the way it's supposed to with the actual user and the actual clinician. Well, it seems like that is common sense. If we're trying to prove that the product works, shouldn't I prove that the product that I've built is what I'm going to continue to manufacture? One way to do that is," Well, why don't I manufacture those products in that environment and use those units to do this, as well?" It just seems basic to me. It's frustrating that we're struggling with the basics as an industry.

Mike Drues: Well, it does seem basic to me, as well, Jon. It's not just as a regulatory professional, but as a professional biomedical engineer, but let's take this a step further because the devil is in the detail. As I'm fond of saying, average regulatory professionals know the rules, but the best ones know the exceptions. You and I both know very well that what we're talking about here, specifically using production equivalent devices in our final VnV testing, that's what the regulatory textbook says. That's what the theory says, but that's not always the reality. There are many cases, and I advise this to my customers all the time, where you can justify using non- final product as part of your-

Jon Speer: Sure.

Mike Drues: VnV testing, as long as you can justify it. In a nutshell, basically, the regulatory logic or the engineering logic is, I have to show that if I were to conduct the same test on my final production device, I would get the same result as whatever version that I'm testing it on. This is one of the big differences between how startup or small companies operate versus large companies, especially when it comes to things like sterility of validations, or shelf life, which can take a very, very long time. I think it's important, Jon, on one hand, we are being a bit critical of our industry here and our many colleagues and friends working in this industry, but on the other hand, I don't think we should over- generalize. There are exceptions to all of these rules. It's very different going by the regulatory textbook to theory versus the everyday reality. Does that make sense, Jon? Would maybe you have a different way that you look at it?

Jon Speer: Yes, it does make sense. I think that is a key point, because a lot of times what happens when you're still in development, I mean, you may be making, highly dependent on your type of product, I get that, but the volume, generally, of what you want to produce during development is substantially less than the volume, usually orders of magnitude less, of what you're going to do in full- scale production. I get, you may not want to have full scale production to address your design verification and design validation activity. I understand that. You need to be able to show that provenance, so to speak, I guess, and every time you iterate, or make a change, or refine your process, or maybe increase the volume, the manufacturing volume, and so on and so forth, there're numerous things along the way that you have a responsibility to demonstrate that change, whatever it might be, did not impact your previous results, that it's still a good product, and corroborates, and supports what you've done from a VnV perspective. Yeah, I'm right there with you.

Mike Drues: Just to recap though, they list 10 of the most cited issues in medical device inspections. We've focused on the top three, CAPAs, complaints and design controls. Collectively, those represent 35%, or a little bit more than a third, of all of the 483s. One other one that I just wanted to point out just very, very quickly, and then we can wrap this up, Jon, is purchasing controls. They point out here that another of the common cited issues is purchasing controls. The reason why I bring this up is because the other day I had one of my customers, a small startup company, they have limited resources, they're in the process of building their quality management. They don't have the time or the resources to build an entire QMS. They asked me, is it appropriate for them to not worry about purchasing controls right now and cross that bridge later on? I said," Well," and you might appreciate this example, Jon," well, you can do that, but here's the dilemma. Purchasing controls, which a lot of people think is just a bunch of you- know- what, that was the root cause to the single largest medical device class action lawsuit in the history of our industry, and that is the whole gynecological mesh fiasco." Purchasing control, so my point is, it's easy to kind of dismiss something like," Oh, who cares? Purchasing controls, no big deal." That can cause significant problems by itself. Would you agree, Jon?

Jon Speer: A hundred percent. Well, whenever I talk to companies, and if they're smaller or earlier- stage companies, oftentimes I'm asked," What is the strategy for implementing my quality management system? Do I need it all right away, or can I do it in phases?" My response, generally, is," You can do this in phases. Is that great? What are the first things that I should focus on? What's in that first phase?" Well, it is design control. It is risk management. It is document management and records management, and it's supplier management, because chances are, especially if you're a small startup, you're probably going to be relying on third- party resources, whether they be design firms, or contract manufacturers, or testing houses, or whatever the case may be. It's pragmatic to get that house in order from the jump, because you're going to be reliant on suppliers. I think that's been the evolution of our industry for decades now is, the brick- and- mortar businesses, they still exist, but more and more they're outsourcing different aspects of their business to third- party resources. So, absolutely, I totally agree.

Mike Drues: I would just remind you, Jon, because you and I have done a lot of podcasts over many different topics over the years, but one of them in particular I remember was, I think, the one that you may have just been referring to, and that is one that you and I did last year on what I would call triaging your quality management system. It's interesting that, as I listen to you identify what you thought were the top three or four areas of the quality management that you should start with, I think I gave different ones.

Jon Speer: Yeah, but I think if you combine yours and mine together, it comprises the top 10 issues.

Mike Drues: There you go. Listen, to wrap this up, Jon, I don't want this to be just a bitching and moaning and groaning session about how bad people are doing. If we were to end this on a final, positive note, what would be the one piece of advice that you would like people to walk away from discussion today? Tell us what you think yours is, and then I have one to share.

Jon Speer: Yeah, sure. Then the article goes on to do some summaries of the five takeaways, so I'm going to steal the obvious one. I think this says of 1, 191 times the top 10 clauses were cited, the lack of procedures accounted for 67% of them, or 803 of the 1, 191 items. It seems to me that the most obvious thing is, make sure you have a procedure, and not just have a procedure to check a box, make sure you follow that procedure, make sure people understand how to apply that procedure, make sure they know where it is, make sure the folks that are on the job know which things are important to them from a process and a procedure. Maybe that seems too obvious, but that would be the first piece of advice, because it's clearly a problem.

Mike Drues: Well, it might sound obvious, Jon, but it is clearly a problem because as you just shared, it'll bear that out. The most common reason is lack of procedures or documented procedures and so on. I think that's very sage advice, Jon. May I share-

Jon Speer: Sure, absolutely.

Mike Drues: absolutely last piece of advice. I'm going to put my sort of unique Mike Drues kind of a spin on this.

Jon Speer: All right.

Mike Drues: As a regulatory consultant, we don't need more regulation. We've already got tons and tons of that. What we need is people understanding the intent of the regulations. Here is a perfect example. Why don't companies... Let's say a company this past year did not get a 483 from the FDA, but what they should do is they should take a look at this article that you and I have been talking about.

Jon Speer: Agree.

Mike Drues: They should start a CAPA based on that. They should say," Okay, here are-"

Jon Speer: Sorry, you mean a PACA, because they're being prevented.

Mike Drues: Oh, thank you for correcting me, Jon, a PACA, a preventive action corrective action to take a look at these lists of 10 most- cited issues. Even if you haven't gotten dinged by FDA yet, take a look at these and see, could these happen to us and try to address these. Try to make sure that you have-

Jon Speer: I like it.

Mike Drues: ...these procedures and so on, in place. Take the number one in this list, CAPA citations in a reactionary fashion. Once you know that you have a problem, corrective action. Do it as you just pointed out, Jon, not a CAPA, but a PACA. Then use this information and prevent problems from occurring. Just like when The Bleeding Edge documentary came out, you and I talked about that, from Netflix, I said that should be mandatory viewing for everybody in our industry. Use that as a point of discussion within your organization. Even though you might not be manufacturing some of the devices that were talked about in that particular documentary, take a look at that documentary and ask yourself the question, could these problems happen to us?

Jon Speer: Yeah, that's good.

Mike Drues: That, I think, is part of what is truly being a responsible medical device professional.

Jon Speer: Yeah, I love it.

Mike Drues: You think that's realistic, Jon, or did I just fall off the turnip truck yesterday?

Jon Speer: I think you fell off the turnip truck. I hope it's not too Pollyanna- ish either for our industry, because I think it's good. It's the whole idea. I mean, clearly, FDA is probably going to be looking at your CAPA practices, your complaint practices, your design control practices, your purchasing and supplier control practices, and so on and so forth. In fact, it's pretty clear what they're going to be looking for, because QSR defines the requirements. I believe QSIT is still the method by which FDA does inspections. They tell you what they're looking for. It is no excuse to not have this in place. I think, yes, go scrutinize what you do and don't do from a business practice standpoint. Make sure that you do have these things addressed, because these will certainly be areas that FDA and other regulatory bodies are going to look for and expect that you have in place, and that you're managing those effectively. Yeah, I think that's great advice. Simple, too.

Mike Drues: Jon, you've obviously played this game for a very long time. Have you ever seen a company start a CAPA or a PACA based, not on problems that they've experienced, but problems that other companies in the industry have experienced and to try to prevent them? I have not, but I think now we have adjust the bar for our industry.

Jon Speer: Yeah. I was trying to think. It seemed like there might've been one time that comes to mind, because it was-

Mike Drues: Perhaps.

Jon Speer: But generally, yeah, yeah, yeah. I mean, here we have an article. It's in an industry publication. People may be scratching their head like," Should I do a PACA because of this article?" Yes, yes.

Mike Drues: Yes.

Jon Speer: Yes, you should.

Mike Drues: Absolutely, yes, absolutely.

Jon Speer: Good.

Mike Drues: ...happen to us, then absolutely, let's have a parade and wave the flag. Okay, but if not, it's an opportunity to fix some problems before they occur.

Jon Speer: It's always better to fix them yourself than to-

Mike Drues: An ounce of prevention is worth a pound of cure. Again, whatever cliche. The last thing that I'll mention, and then we can wrap this up, Jon, is as a regulatory professional, I'm constantly looking for precedent, not necessarily in a regulatory... I was going to say predicates... not necessarily in a regulatory or a 510( k) sense, but for example, having a 510( k) device on the market, and if there're problems with a predicate device, you should be investigating those. Here we have examples of problems that a lot of companies have faced in our industry. Taking a look at these problems and asking ourselves the question, could these same problems or similar problems happen to us? To me, Jon, that is the essence. That's the philosophy of why we have quality management.

Jon Speer: Yeah.

Mike Drues: Nevermind dotting the I's, crossing the T's, checking the boxes. It's the whole intent of that regulation.

Jon Speer: Absolutely, absolutely. Well, on that note, I can't say that any better than what you just did, Mike, so we're going to let that be the last thought on today's podcast. Folks, as I mentioned, check out Mike Drues with Vascular Sciences. Great guy to have in your corner if you're doing anything... well, not anything, well, maybe anything... regulatory- related. But I was going to say, if you want some novel, unique strategy and approach, well, Mike is your guy. Don't just follow blindly, and do what everybody else has done, bring people like Mike Drues and Vascular Sciences. Give us a call at Greenlight Guru, because again, we're trying to raise the bar, so to speak. We're trying to do something unique, novel, different, innovative, creative, all of those sorts of things. Yes, those are okay to say and be a medical device company, but you just need the right pathway and strategy to understand how to do that. As always, thank you for listening to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer.



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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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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