How to Ensure Your Quality Management System is Effective and Benefits Patients

April 19, 2018

Effective Quality Management SystemWhen it comes to quality management compliance, would you consider yourself a box checker or a true quality professional?

On today’s episode, we talk with Mike Drues, president of Vascular Sciences, about what it means to be a true quality professional and how to ensure your quality management system is effective and benefits patients.

Do you want to offer medical devices that improve your patients’ quality of life? Don’t wait until an FDA audit to make changes or try and fix problems.


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Some highlights of this episode include:

  • Data does not lie and medical device companies are not doing enough.
  • The number of warning letters issued by the FDA.
  • Consent decrees are issued when companies keep doing the wrong thing or don’t take action.
  • Reasons why companies receive 483s.
  • Companies continue to make the same mistakes and not follow the rules.
  • The value of training: What to learn and how to retain it.
  • Measure the efficacy of your medical devices and training.
  • Make sure your quality management system works and is effective by testing and validating it.


Related Resources:

Reviewing FY2017 FDA 483s

FDA Warning Letters

FDA Consent Decrees

Quality vs. Compliance


Memorable quotes by Mike Drues:

I hate to say it, but maybe our industry is not doing as well as we would like to think.

There’s a big difference to get between memorizing versus learning. When somebody learns could never forget it, even if you want to.

A lot of companies fear the FDA...No, you shouldn’t fear the FDA, you should have a respect for the FDA.


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:                  Are you a check boxer when it comes to Quality Management System compliance or are you making that leap and that shift to becoming a true quality professional? Well, I hope you enjoy this episode of the Global Medical Device Podcast where Mike Drues and I dive into the topic of how to be true quality professional and how to ensure that your Quality Management System is effective in helping you run your business in a smarter way that will help benefit patients.

                        Hello and welcome to the Global Medical Device Podcast. This is your host and founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. Exciting times in our industry. Well maybe not everyone would agree with exciting times. Maybe some would even say uncertain times in the industry with all the things that are happening in EU, Canada, FDA and so on and so forth. Lots of things that are happening in this world right now and sometimes it seems like there's a lot of things that are changing in front of us, but today, we're gonna dive into a topic that, are things really changing, because some of the data would suggest that maybe not.

                        And with me today, I have Mike Drues, President of Vascular Sciences and Mike and I are gonna explore some recent data on FDA 483s. Are these training failures or is there something that we can learn from the information from FDA? So Mike, welcome to the Global Medical Device Podcast.

Jon:                  Thanks, Jon. I look forward to our discussion.

fda 483

Jon:                  Well you shared an article with me the other day and we'll provide a link to it for our listening audience that was on Net Device online. And it was just an executive summary type of overview of FDA 483s from 2017 and it's pretty insightful. And I think the article was very well written. I thought we might dive into some of the things that are expressed in this article, but more importantly, what do we do about it? Sound okay with you?

Mike:                That sounds great Jon. And by the way, I would just add quickly, based on your introduction, it reminds me of the French philosopher who said, "The more things change, the more they remain the same."

Jon:                  So true. So true and I think industry we have ... The data doesn't lie. There's this old saying that I used to hear from an old quality engineer that I worked with years ago, "In God we trust, all others bring data." And the data is very clear here, but let me start with this question, how do you think the medical device industry is doing in terms of having good quality systems?

Mike:                Well you know Jon, that's a terrific question and obviously all companies are required to have quality systems in place, but here are some statistics that the audience may or may not be familiar with. So for the medical device industry in both fiscal year 2016 and 2017, FDA issued approximately a thousand 483s to companies in each of those ... These two last years. Now putting those numbers into context, and this where I was quite frankly surprised myself, that number of a thousand 483s per year is comparable to the total number of 483s for drug companies, bio-tech companies and veterinary companies combined. Let me say that one more time. The medical device industry-

Jon:                  Hang on Mike. Sorry I'm not trying to interrupt you but folks but this is really, really important so take note of this. Go ahead Mike, sorry.

Mike:                Yes that's okay. And again this a surprise to me, I think it's probably a surprise to you putting these number in context but about a thousand warning letters per year for medical device industries, that number is comparable to the total number of warning letters that drug companies, bio-tech companies and veterinary product companies have received combined. So I hate to say it but maybe our industry is not doing as well as we would like to think. And taking it a tiny step further, in a small, but unfortunately growing number of cases, the FDA is issuing more consent decrees which as you know Jon, is an even more extreme situation. In a nutshell oftentimes consent decrees are imposed on companies that have violations, oftentimes the same violations, over and over and over again and quite frankly, FDA is getting pissed off, pardon my directness, by going back to the same company and seeing the same or similar problems.

                        So when I alluded to what the French philosopher, sorry I don't remember his name, said, "The more things change, the more they remain the same," perhaps this is an example of that.

Jon:                  And that stand as real surprising to me too, because before I saw that in black and white and again this is a case, the data is there, don't believe me, don't believe Mike, go to the FDA data, it's very, very clear. Because before that I would have thought, oh well, pharmaceutical companies are getting way more observations and that sort of thing. I suppose there might have been a time, I'll confess I haven't [inaudible 00:06:16] back in the history of the past 10, 15 years, but what can we learn from this? I'm sure there are some common reasons that ... I know there are common reasons, this is a bit of a loaded question, but what are some of the most common reasons that companies are getting 483s?

Mike:                Well according to the FDA Jon and really none of this should be a surprise to our audience, some of the most common reasons that companies get 483s including things like having a lack of/or inadequate procedures for complaint handling, for CAPAs, for purchasing controls, for process validation, for MDR procedures, for handling non-conforming products. Those are right off of the FDA statistics.

Jon:                  Yeah.

Mike:                But again, this might sound a little harsh to some people in this industry, but in my opinion Jon, there's absolutely no excuse for this. These kinds of things should not be happening especially at this frequency. And also given the fact that we have thousands and thousands of pages of regulation but for some reason there seems to be a disconnect between what the regulation requires and what companies are actually doing.

Jon:                  It's true and I know we're just talking about kinda the last two years, but those reasons that Mike stated for the most common reasons why companies get 483 observations, this goes back at least 10 years. The lack of inadequate CAPA procedure has been like the top reason for 483 observation from FDA for device companies for like 10 years straight and it's not even close. It's not even close,  this is the most common reason. And as Mike said, these regulations have not been changing. These regulations have been in place for a good 20 years. And even before that, the expected best practices that pre-date the QSR, the GMPs and those sorts of things, these are not new. The practices, the expectations, this is old, old information and as Mike said there's thousands of pages of regulations. There's week long conferences on each and every one of these topics, there's webinars, there's content, so we gotta do something about it. And Mike, I'll ask, is training the solution?


Mike:                Well that's a good question Jon, because the last thing that I wanna do is just have again, pardon my candor here, but a bitch and moan and groan session of complaining and I certainly don't wanna be blaming the FDA or anything. The most important thing is what can we learn and how to move forward? So how do we ultimately make the world a better place?

                        So there's a number of ways that this can be done. There are for example software tools that www.Greenlight.Guru offers that makes these kinds of things easier. Training, obviously is an important piece of this as well, because any tool, I hope you would agree Jon, including software tools, really comes down to the person who's using it. Their ability to understand exactly what they're doing, in other words, what good is giving somebody a screwdriver if they don't know what a screwdriver is to be used for or how to use it. So training and the tools I think that people use are sort of two side of the same coin.

                        But delving into the training piece for just a moment. The reason why I bring that up because one of the most common things that companies agree to do with the FDA, when they get a warning a letter or in more extreme cases, when they get a consent decree, is to provide more training to their employees. And this sounds like an admirable goal, a good solution, but in reality it doesn't seem to be working because the statistics that we shared at the beginning of our conversation. And here are some interesting learning statistics for you and the audience Jon.

                        For a typical person, after they go through some sort of a training, just one hour after they've attended, they've forgotten about 50% of what they "learned." And after a month, that number goes to about 80%, in other words, after a month most people only remember about 20% of what they learned. And my question is, is that learning? There's a big difference between memorizing vs learning. When somebody learns something, in my opinion, you could never forget it, even if you want to.

                        So I think the emphasis, unfortunately, in a lot of training programs, is just simply memorizing or in this particular case, here's what the regulation says, step one, step two, step three. Follow it like a recipe, just like a computer executing lines of code, one after another without thinking. I don't know about you Jon, but to me that's not learning.

Jon:                  No. People that have worked with me and have joined teams that I been a part of, one of the things that I often warn them about from the very beginning is, I'm a baptism by fire, kind of person. And what I mean by that is that I think I can sit and talk to you for days and days about what this says, and what that regulation says, and what this procedure says, but the real proof is getting you in and hands on and applying the concepts and the principles, because that's learning, in my personal experience. For all those companies who are saying ... And this one of the things that I think through this there might be that, we've talked in the past about the root cause. Why are companies struggling with their quality system, and complaints and cap at procedures and all those items we mentioned a moment ago.

                        Maybe the root cause is more about our training program. Maybe it's because we're too laissez-faire about how we train people, we're not actually getting them to learn. We're just checking a box that says 'here they read the procedure, voila, you're trained.' Yeah, so I think application, understanding learning, is a very key point. Very key point.

Mike:                Well I agree completely Jon, and I'll share with you an example right out of my world. This might resonate with you and perhaps some people in the audience. A couple of years ago, I was invited to come into a medical device company, this happens to be a very large company, a fortune 500 medical device company, because they received approximately a dozen warning letters, a dozen 483s over the course of, I think, about 18 months or so. One of the things that they agreed to do with the FDA was to offer more training, specifically design control training, for their employees, and they asked me to come in to do this.

                        We offer, I think, a total of about 10 or 15 different sessions on design controls. This was mandatory for everybody working in [R and D 00:14:07], in manufacturing, and a few other areas. Mandatory training. Well, at the end of this, Jon, approximately 60% of the people who were supposed to be there, actually showed up. So, my lesson to be learned from this experience was, I guess mandatory can be interpreted in different ways, by different people.

                        The other thing that I thought I would share about this particular story is, they asked me to do design control training, Jon. I know you're a subject matter expert in design controls. They asked me to do this training in two hour sessions, in two hour blocks. In other words, they asked me to teach everybody everything they need to know about design controls in two hours.

Jon:                  Oh wow.

Mike:                I think you could imagine, that's a pretty [inaudible 00:14:56]. And regrettably, I had a few people after these sessions, that walked out, that shared. They were very candid with their feelings. They said that this is nothing more than the company's attempt to tick that box on the form, to say that yes, they sent their employee to this two hour design control training, therefore all of our problems are solved.

Jon:                  Well, you know what? There's a term that, maybe I should get a trademark on it, but we call that a 'check-boxer,' somebody that's just checking a box on the form to say, "Yup, we did it." But this is that real opportunity I think that we, in this industry, have is to really shift our mindset from just focusing on compliance.

                        I recall, and I'll paraphrase, something that you've said in the past, that if you're just focused on compliance, you're just focused on the regulations, at best, you're gonna be average. You're gonna be a C student, and the real opportunity here is to really elevate beyond just being a check-boxer, just being compliance-focused. We have an opportunity here to truly understand and apply these principles, these best practices in a way that's going to improve the quality of our products and processes. And guess what? The patients who receive our products will be the beneficiary of that, you know? What better scenario, and there's a great opportunity for people to be calm, focused on true quality.

Measuring the efficacy of quality systems

                        Which kinda gets in to the 'What do we do about it?' in some respects. How do we ... What can we do for our quality system perspective, how do we measure the efficacy? What thoughts do you have about that?

Mike:                It's a great question, Jon. And by the way, what you just shared reminds me of just something, yesterday you referred to my academic reference, that is, when you meet the regulatory requirements, you are essentially, academically, a C student. I mentioned that in a conference call to a company in California just yesterday, and they said, "Oh no, no, no. We don't wanna be a C student, we wanna be an A student." And I said, "Kudos to you for setting the bar that high. I just wish that everybody in this industry felt that way."

Jon:                  Yeah, for sure.

Mike:                So, coming back to your question, Jon, about the efficacy, we're all used to thinking about measuring the efficacy of our medical devices, but how many people think about measuring the efficacy of our training? Or as we'll talk about in a moment, the efficacy of our quality systems?

                        So, let's talk about how do we measure the efficacy of our training? What do you think, Jon? Here's a quick question for you. What do you think is the most common way that companies will demonstrate that they sent people to a particular training? Whether it's on 483s or design controls, or what have you?

Jon:                  I did this, once upon a time, when I worked for a large company years ago. There used to be the three day seminar on design controls, or whatever, you know, pick the topic. At the end of that, I would get this three inch binder, full of all the slides that the 'trainers' were presenting during the seminar or the conference. At the end, I got this wonderful certificate that said that I had been trained on this thing, and I'd punch three holes in it and put it in my little training binder and send a copy to the training manager, and that's all I did. So, I don't know if that's where you're going, but I would imagine-

Mike:                Well it is where I'm going, Jon. And actually, even a simpler place, when you attend a training, whether it's in-house, or outside somewhere, what typically happens when you walk into the room? Or when the training begins? What's one of the first things that you're asked to do?

Jon:                  I'm drawing a blank. First things that I'm asked to do ...

Mike:                So basically, to sign in.

Jon:                  Oh sign in, yeah. Sign in, so yeah ... That was right there in front of me. Sign the sheet, sign the sheet.

Mike:                Sign the sheet. And that basically demonstrates, that's the documentation that you attending this training. But why would attending a training and actually learning something be synonymous? Think about it this way Jon, if you needed surgery, would you ask your surgeon to see their attendance records to make sure that they showed up in medical school? I'm being a bit facetious, but I'm also being very serious. If it's not good enough for surgeons, why should it be good enough for us? I think that demonstrating somebody attended a training by simply collecting a signature is a pretty low place to set the bar, and it also explains why, not only we continue to have so many problems, but we continue to have the same kinds of problems over and over and over again.

                        You know Einstein, very smart guy, said the definition of insanity is doing the same thing over and over and expecting a result. Seems to me, we keep doing the same kinda thing over and over, and expecting a different result.

Jon:                  It's true. We certainly do. This is one of those things where, from a green light perspective, if you can let me wax philosophical for a bit. We started this business for that purpose, because my personal experience in working in the medical device industry, or I guess when I started this company about five years ago. I'd been in the industry for about 15 years, at the time. I saw the same things over and over. It was maddening, you know?

                        You and I were talking a little bit ago, that we were sharing stories from the trenches about how ... We were sharing war stories, so to speak, where clients ... They're in this precarious situation because they either ignored or just didn't know, or just being blatant about the application of what they need to do, as a medical device company. It's very clear, there are barriers to entry, if you wanna be a medical device company. There are certain behaviors and expectations. I always want the companies I work with to take this seriously because, I keep going back to it, but we are making medical devices. We are trying to improve the quality of life.  Everything that we're developing and manufacturing, there should be a purpose for it and it should be to save somebody's life or to sustain somebody's life.

                        Time and time and time again, I would be called in to a company like, "Oh, we got FDA coming next week, can you come and clean things up?" And it's like, "Dude, it's too late. If you haven't been doing this, there is not a damn thing that I can do in three days before the FDA inspector shows up to paint a rosy picture." This has to be your mindset. You have to flip the switch, so to speak, or shift the gear so that you really understand how important this is and don't just do it to check a box. If you're just doing this to check a box, then you missed the point.

                        That's why we built the platform is to help companies understand and give them visibility and to be that single source or truth so that as they are developing products and assessing the risk and then launching the products into the marketplace. You can be proactive. You can understand what is happening to your products and processes, but it requires a company to shift to that next level.

                        For those companies that wanna shift from being that C student, to just check the box, to the A student, like Mike's client in California, I would encourage you to reach out to us at Go to and you can request more information, you can request a demo. We'd be happy to talk to you. And if you don't want to go that channel, reach out to me directly, I would be happy to have a conversation with you.

                        So, anyway, I'll get off my soap box now, Mike. Sorry about that.

Mike:                Well no, no. That's all great advice, Jon. And I could not agree more. And by the way, that scenario you described, where somebody calls you in three days before an inspection or an audit, is an all too common scenario. It really is a band-aid solution at best. You're really doing nothing more that kicking the can down the road.


                        So, bottom line, when it comes to training, and I spend a lot of my time doing training. I know Jon, you spend some of your time doing that as well. There are a heck of a lot better methods that we could use to do more effective training and when it comes to the efficacy of our training, measuring the efficacy, we can do a heck of a lot better than just simply collecting a signature on the form. Let's move on to quality systems, similar questions. We talked about measuring the efficacy of your training program. Another thing that I find very interesting in our industry is, all companies are required to have quality systems, but they don't usually measure whether that quality system is working, whether it's effective. One of the suggestions that I've made to many companies, Jon, and I would love to hear your two bits on this is, I have suggested to companies that they purposely interject problems in various phases, various processes, whether it's manufacturing, or whatever, just to see if their systems that they have in place are working, are effective can detect that problem because, after all, what good is having a quality system in place, even if it does meet the regulatory requirements, if it's not working? In my experience, Jon, most companies say that's a great idea, but we're not gonna do it. Why? Because if they inject a problem, and their system does not detect it, now what have they done? Now they have totally invalidated their entire quality system.

Jon:                  Yeah. Wah, wah, wah.

Mike:                That's obviously a problem, so what do you think about this idea, Jon, of measuring the efficacy of your system, or validating your system, if you will?

Jon:                  That's really what the whole intent behind that is. I go back to wonderful stories and examples, not always one that you as a listener, should apply in your everyday life. I had another company call me the other day, and they're like, "Oh crap, we forgot to do management review in 2017. Can you just come over and spend a little bit of time, and make sure that we're checking the box.: I just kind of rolled my eyes, and I'm like, "You don't get it." Management review is one of those mechanisms, or times, where we are evaluating the efficacy of our quality management system, but all to often it is, "Oh, we gotta do this because we're supposed to do it once a yer, and let's just go through and say did we look at this, did we look at this, and look at this." It's so surface level. People aren't getting into the details, they aren't getting into, really, truly evaluating how effective their systems are.

                        I had a twist to it a bit, I think so many companies don't understand the value of internal auditing. Potentially, the key to all of this, to insuring, or measuring how effective your quality management system is, it comes with a robust internal auditing program. That's the best opportunity that you have, as a company, to evaluate, well, let's look at our CAPA process, how effective are we at that. But you have to scrutinize it, you have to go into the depth of it, and to really, truly understand what's going on you have to look at it from all facets. Be wholistic about it. Don't just look at how long it's taking you to close a CAPA, and do this, and do that, but truly understand the people who are involved in those processes. Do they understand how they learn how and what to do, or did they just sign in at the training session and put the sign in sheet copy of that in their training file and say they were trained? We have a wonderful opportunity to really elevate our performance at companies because a quality system, if you look at it in the right way, it's an opportunity to ensure that the practices that we have in place at our business are a well oiled machine.

                        A good quality management system that's applied correctly is the best ... for those who are more business minded, and looking at mitigating risk, a well oiled quality management system is the best risk mitigation, from a business perspective, that we can possibly do as business professionals.

Mike:                You know, Jon, as I'm sure many in our audience would agree, you're really preaching to the choir. I could not agree more with everything that you just said. Many of the examples ... one of many of the points you just mentioned would be topics of discussions in and of themselves. Some of those, you and I have talked about in previous discussions. To wrap this up, maybe we should share with our audience some lessons to be learned, and some specific suggestions on how to move forward because as I said at the beginning, I don't want this to be just a bitch, and moan, and groan session. I don't want to be pointing the blame game. Let me offer a few suggestions, and then, Jon, you can do the same.

                        First of all, having a quality system in place, in my opinion, is not enough. Everybody has one, but we need to make sure that it works. We need to make sure that we, somehow, measure the efficacy of our quality systems. In my opinion, just because the quality system meets the regulatory requirements, or the quality requirements, doesn't necessarily mean that your system works. Piece of advice number one for the audience, is test your system, validate your system, just like you would validate your product. Very similar idea. Do we need a regulatory, or a quality requirement to tell companies to do that? Well, I would like to think not. I would like to think that companies would do that because they know, from an engineering perspective, it's the right thing to do. Regrettable, as we both know, that just doesn't happen, so maybe we do need a regulatory requirement to do that.

Jon:                  Well, Mike, one could even argue, that we already do have a regulatory quality requirement to do that, and I think if you interpret the regulations and the quality system requirements ... I mentioned one example, quality audits, it's there. I think one could also say -

Mike:                Yeah, yeah. You're right. You're right. I stand corrected. It's in the interpretation.

Jon:                  For sure.

Mike:                None the less, I think companies can do a better job at measuring the efficacy of our systems.

Jon:                  Absolutely.

Mike:                The second pice of advice that I would leave the audience is, don't just think of this system as being something that exists on paper. You have to follow it. You have to believe it, as Jon was describing a moment ago, you have to live it. Let me tell you, a lot of companies wanna do this, or are concerned because if the FDA comes in to audit ... I'll tell you what my much bigger concern is, Jon, I've shared this with our audience, I think, in the past, a growing amount of my business is, actually, acting as an expert witness in medical device product liability cases. I have a couple of cases that I'm involved with right now where the company had certain requirements in their quality system that they company was not following.

                        The attorneys love that situation because if I can point out that they company is not following this particular aspect of the quality system. That opens up the door for the attorney to say, "Well, if you're not following that part of your system, what other parts of your system are you not following that we don't know about?" Again, a lot of companies fear the FDA, I say, "No, you shouldn't fear the FDA, you should have a respect for the FDA, but don't fear them." Who should you fear? You should fear the product liability attorneys because they can impose a heck of a lot more damage than the FDA ever could.

                        If the folks in our audience need justification to their senior management on why to apply resources to do the things that Jon and I are talking about, don't just use the FDA as a justification, use product liability as well. Those are my final thoughts, Jon. What else do you think the audience should remember from our discussion today?

Jon:                  Yeah. Folks, that data doesn't lie. It's very clear that we, as a medical device industry, have a lot of work to do, frankly, when it comes to implementing effective quality management systems. I think, to the point that Mike just made, a lot of people are just focused on, yep, we got the procedure, it's good enough. That doesn't cut it. You have to show that it's effective. As I mentioned earlier in the podcast, that's one of the reasons that Greenlight Guru is here, is to give you a solution that is designed for you, the medical device professional that, yes, of course, we address the compliance piece, but we give you workflows, and a system to help you better manage and evaluate the effectiveness of your Quality Management System. I would encourage you, if you have an interest in becoming a true quality professional, and to elevate your effectiveness of your Quality Management System, reach out to us. If you're just fine with being that C student, and you're happy with signing a piece of paper that says you're trained, and you're fine with your paper based procedure and going through the motions, don't call me. Do not call me if that's ... because we're not gonna line well with one another.

                        We're not Turbo Tax for med device, and I think that sometimes people what that automated thing. You gotta live it. It's gotta be part of who you are as a medical device professional.

                        Mike, I wanna thank you again. I always enjoy these conversations, and I had a real good time on this topic today. Folks, if you wanna learn more about Mike Drues and Vascular Sciences, I would encourage you to reach out to him. You can find him all over the place. Linkedin is a great example, a number of other industry publications, but be sure to go check out some of his content, some of his writing, some of his webinars. He's a very progressive thought leader of quality and regulatory, and a real great resource if you're working on creative regulatory strategies. Yes, you heard me, creative regulatory strategies. There's nothing wrong with that concept, so Mike, thank you so much for being part of the global medical device broadcast today.



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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