What are the Opportunities for Improvement (OFI) for Quality?

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.

In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!

Jon and Mike share tips on what you can do to improve upon your medical device company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.

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Some highlights of this episode include:

• Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.

• If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.

• In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.

• The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.

• Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality’ means and whether what you’re doing is good or bad.

• Quality management systems (QMS) shouldn’t emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.

Links:

A Regulatory Gap Analysis of FDA's Systems & Policies

Ultimate Guide to 21 CFR Part 820

ISO 13485

FDA - Classify Your Medical Device

FDA - Premarket Notification 510(k)

FDA - De Novo Classification Request

FDA - Premarket Approval (PMA)

Mike Drues on LinkedIn

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from this episode:

“The problem I have with that simple explanation is there’s subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer

“For quality to be meaningful, it’s something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer

“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues

“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer

“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer

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: On this episode of the Global Medical Device Podcast, I'm joined by Mike Drues. You know and have seen Mike Drues in the past if you've consumed any of our Global Medical Device Podcast episodes. But Mike's with Vascular Sciences, and he's got a ton of expertise when it comes to all things regulatory. Today, our conversation was a little bit of a twist, so to speak. Mike was more on the questioner position and I was more on the hot seat. And we spoke a lot more about quality. And I guess, to put a description on the topic of quality, we talked about some of, really, the shortcomings or obstacles or challenges when it comes to quality. And hopefully, give you a few tips and pointers on things that you can do to improve upon your company's quality philosophy, as well as try to help implement and ensure that true quality becomes part of your company's culture. So I hope you 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. Joining me today is familiar voice and face on the Global Medical Device Podcast, Mike Drues with Vascular Sciences. So Mike, welcome back.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience.

Jon Speer: Absolutely. So, a few weeks ago, I guess, you and I had the chance to chat. And the topic that we explored then, let me remind myself of the exact title, was really about a regulatory gap analysis of FDA's systems and policies. And folks, we'll include a link to that for you to check that out. But while doing so, right after we did so, we talked about maybe there's also a similar type of conversation that we can have more from the quality side of things. And I thought maybe we could dive into that a little bit today and maybe do a little bit of role reversal, if you will. I know we've done that a time or two in the past. So what are your thoughts?

Mike Drues: I think that's a great idea, Jon. And I would be happy to. And incidentally, on a personal note, I just listened to that podcast that you referred to during my morning walk the other day. And I think it was a good one. So I would encourage our audience to listen to it. I'm not trying to imply that all of our conversations are not equally good, but that was a good one. And you're exactly right. That was sort of the motivation, the impetus for doing something similar on the quality side, Jon. And because you're, without a doubt, the quality guru, we thought we would do a little role reversal and I'll ask you some questions and then Jon and I will discuss them together. So I think that's the plan for today.

Jon Speer: Let's do it.

Mike Drues: So Jon, just starting out from sort of the basics, from the ground level, everybody uses the word quality, but what exactly does quality mean? What would be your definition of quality? And is it an over simplification of quality to simply say how good or bad something is? So what is quality in your book, Jon?

Jon Speer: It is one of those, I'll say ambiguous, esoteric words, to be honest. And it gets thrown around a ton in our industry in the how good or bad something is. I actually cheated a little bit and went to Merriam- Webster. I went to the online version, not the hard copy version, to look up the word quality. And that was actually one of the definitions. Actually the first definition in Merriam- Webster is how good or bad something is. While it seems that maybe it is an over simplification, there's a couple things there, I think it is important to use a simple definition for these types of things. But the problem I have with that simple explanation is, there's subjectivity involved to that. So what you think is good or bad might be completely different to what I think is good or bad. And I think it was Deming. Forgive me, I might have my quality guru misapplied here. But I think it was Deming that said something along the lines of, if you cannot measure it, you cannot improve it. And I'm definitely paraphrasing. So I think for quality to be meaningful, I think it's something we have to define in as least subjective terms as we possibly can. I think we need to make it as objective as we can. But I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.

Mike Drues: Well, I think that's a great response, Jon. Let me take it a tiny bit further. It's interesting that you point out, and apparently Webster also points out, that quality sort of implies good or bad. But at least in my view, Jon, and feel free to agree or disagree with me. In the regulatory, in the FDA world, that's in fact, not at all what quality means. Quality is not about good or bad. Quality, in the regulatory sense, is about consistency. Are you making your product consistent? You could be making your product consistently good, or you could make your product consistently bad. But the quality itself is not about the goodness or the badness. And the metaphor that I often like to use, Jon, is McDonald's. McDonald's is one of the most successful restaurants in the world. Is it because they make a good hamburger, probably not so much. They make a very consistent hamburger. You can go to a McDonald's literally anywhere in the world. And if you order a hamburger, you know exactly what you're going to get. You might like it. You might not like it. But you know exactly what you're going to get. So in the regulatory world, Jon, I would argue that quality is more about consistency as opposed to good or bad. Do you think that's accurate or do you think that's an oversimplification as well?

Jon Speer: Mm, I think there's some accuracy to that. But as you describe the McDonald's scenario, I totally agree. I mean, McDonald's can look at their process for producing and reproducing a hamburger consistently over and over again, at location after location, after location. That may be how they measure quality. But I look at that, it's kind of their process. So that's a measure of their process quality. Also to your point, five year olds aside, there are a few people who would say, aha, that hamburger I get from McDonald's is high quality product. So I think both are measures of quality. But one might be more from a product lens. Whereas another might be from more of a process lens.

Mike Drues: We're taking it just one step further. Speaking of consistency, what if we manufacture a medical device that's consistent, in other words, all the devices coming off of our assembly line fit within the specs, and yet all of those devices go on to kill people?

Jon Speer: Exactly. I mean, hopefully not.

Mike Drues: I would argue, Jon, that's actually a regulatory failure and not a quality failure. Why? Because one of the ways that I differentiate between regulatory and quality is, regulatory, their main job is to set the specs so that if we manufacture a device within the specs, it will be safe and effective. As opposed to, on the quality side, the quality professional's job is to make sure that the devices coming off the line fall within the specs.

Jon Speer: Right. And I think this is where we get into, at least in this example, there's definitely an overlap or a Venn diagram where both quality and regulatory play a part in quality. But the quality engineer, primarily, is responsible for making sure that product can be produced and reproduced consistently over and over and over again. But you're right, from the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional per se, and maybe more in the domain of regulatory. I would even charge maybe even a product developer or an engineer who's involved in that process too. But regulatory starts the whole game, essentially, as far as what we're trying to solve, what issues we're trying to address.

Mike Drues: Exactly. So once again, I think you and I are singing the same song, just maybe in a slightly different key. As I said, a moment ago, regulatory, or maybe even before that, product development job is to design the device at the spec, so to speak, so that if the device falls within those specs, it will be safe and effective. On the other hand, quality's job is to make sure that the devices that are manufactured fall within those specs. So let's move on, Jon. Sometimes people refer to levels of quality or types of quality. What's that all about? And what's the difference between product quality, and you just alluded to this a moment ago, versus process quality?

Jon Speer: You've gone back to the definition that we started off with, good, bad. I mean, that sounds like it's binary in some respects. And I think you try to make this as black and white as you can, where you define a specification, and you have some means to measure whether that be a product attribute or some output from a process. You try to define good or bad criteria so that you know if a device follows this step per this process, as it's defined, and it meets the acceptance criteria or what we define as good, then okay, keeps going. If it doesn't, then now we have to figure it out. We have to maybe do a little bit of an investigation. Maybe we have to categorize that as a nonconformance in some way, shape or form. So I'm stumbling a little bit here, but I think generally speaking, we have to define what acceptance criteria, what acceptance levels. And sometimes like with specifications, for example, oftentimes there might be a low end and a high end or a tolerance. Maybe we're shooting for a particular nominal measurement or a dimension or whatever the case may be, but we have some acceptance range. Well, maybe it can be 10, but we'll accept eight and we'll accept 12. So 10 plus or minus 2. So you try to define these things within your process capabilities. But at the same time, there has to be a connection between your process capabilities and what the device needs to do. So I think from this perspective, it's important to look at the product quality, as we talked briefly about. Defining that from a regulatory perspective, what is it that we're trying to solve? And hopefully there's a good relay of information to those engineers and product developers who are now going to define all the requirements and all of the specifics about that product, and try to set all the tolerances and the dimensions and so on and so forth. And hopefully, through their V& V activities, they're able to prove and demonstrate that a product that's made per these specifications, including the tolerances, will work, will perform, will be safe at the end of the day. And then that information gets translated or transferred into our quality engineering resources, people who are defining and designing the processes to manufacture that product. And so, we should be saying," Hey Mike, this is a really critical dimension. And we need to make sure we're measuring that. We want to catch those issues early on." And so on and so forth. So it's really about understanding your limits, your capabilities, what's acceptable, what's not acceptable. And as much as you try to make this black and white, sometimes it is gray. Sometimes it's super gray.

Mike Drues: Sometimes it's gray. I would argue, Jon, that it's always gray. I guess it's not gray if somebody sees something as black and white, then maybe that's indicative of a whole different problem.

Jon Speer: Fair enough. I mean, there's a lot of people that say," Well, it's really hard for me to define quality. I know it when I see it."

Mike Drues: The Supreme court justice, I can't remember the specific one, who defines pornography that way. He didn't know what it is, but he knows it when he sees it.

Jon Speer: And it's like, eh, okay. That's not helpful to anybody, especially if we're manufacturing medical devices.

Mike Drues: Well, apparently it was helpful to the US Supreme Court. But that's a different discussion.

Jon Speer: Well, yeah, I'm not touching that one. But I think in the spirit of knowing what our product is supposed to do, we have to define quality of that product. And it's not like, well, Mike Disco makes that product. And when you're done, I'll know if it's good or not. I mean, that's not helpful.

Mike Drues: Well, I was just going to say, as I listened to your response, it reminded me of a dinnertime conversation that I had a few years ago prior to COVID with one of my very good friends who happens to be a senior VP of quality for a fortune 50 medical device company. He and I were very good friends in graduate school. And we got into sort of a philosophical discussion of what does quality mean, and what's the difference between quality and regulatory? Basically, he said that quality means, does the device fit the specs? And I said," Okay, fair enough. But whose job is it to set the specs?" And he said," Oh no, no. That's not my job. That's somebody else's job." Speaking of that, Jon, this brings us to, I think another of my favorite questions, who's ultimately responsible for quality? In other words you hear in a lot of organizations, and I think it's probably cliche to say this, that everybody is responsible for quality. But is that realistic or are people just smoking their socks? Who do you think is responsible for quality? Is it just the people that have quality in their title and their job description, or is it everybody, or is it somewhere in between?

Jon Speer: This one's, for me, a little bit tougher to explain, I think, but I'll do my best here. Yes. It is cliche to say that everyone owns quality. And at the same time, there is a lot of truth to that. But I think in 2022, or certainly for the past 5 or 10 years, or maybe, hell, last 20 years or so, I think the quality department is oftentimes tasked with the quality of the product, the process, whatever the case may be, right, wrong or indifferent. I think the quality discipline over the years, not just in our industry, but just in general, it does seem like there's a lot of flavors of the month, if you will, like different methodologies. And I'm not maligning any of them, but just rattling off a few things that have been popular and then they decline. Things like house of cards and Six Sigma and TQM, total quality management and so on and so forth. I mean, they're all different spins or flavors. Essentially though, we're trying to do the same thing. But I think where quality has become sort of sometimes a dirty word in our industry, or maybe a misunderstood term in our industry, is because the quality professional is applying these different tools and methodologies and techniques and approach. And they're basically trying to apply that across the board. Many of these things that I just mentioned, they're intended to be applied to manufacturing processes so that you can reproduce and repeat consistency time and time again, whether you're making something at 08:00 AM in the morning or 08: 00 PM at night or on the 2nd of February or the 2nd of August. It's just being able to demonstrate that you have process capability that can yield the same, we'll you use air quotes around that, consistent quality product.

Mike Drues: Yeah. Back to that word consistency that I used earlier.

Jon Speer: Yeah. It's a good word. And so I think because of that, if you were to ask a design engineer, do you own quality? They may roll their eyes and like," Man, that's those guys over there." But come on, design engineer, don't get too caught up in the minutia or the baggage maybe, that the quality discipline, so to speak, maybe has created either intentionally or unintentionally over the years. Appreciate what the word means. Is what you're doing good or bad? And again, I'm going back to that really, really simple descriptor. You as a design engineer should know whether or not what you're doing, from the design of your product perspective, is good or bad. You have culpability and responsibility for quality at some level. So yeah, it sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality, and influence the decisions that are made. Or if they see something that doesn't seem like it is quality, be able to raise their hand and say so without reprimand.

Mike Drues: Looking at it a slightly different way, Jon, when I meet somebody for the first time, and they introduce themselves and they say they work in quality assurance or quality control or whatever it is, I'm often tempted to respond to them by saying quality as opposed to what, crap? Well, well you're laughing, Jon, but you'll appreciate my sense of humor here. Because if not just the quality and the regulatory people, but if the design people and everybody in the company, if they did their job, would we need quality people? Would we need regulatory people? Would we need the FDA? That's a topic of maybe a different conversation, Jon. But when we ask the question, who is responsible for quality? Yeah. On one hand, it sounds a bit cliche. But on the other hand, it's an important question.

Jon Speer: Yeah. Dive in a little bit deeper. Let's just, for hypothetical sake, say I'm a design engineer. Maybe I'm really good at designing or I think I'm really good at designing a product. Maybe that's a better way to say it. So my quality lens should be focused on my role and responsibility in the big picture of things. The quality engineer, and I'm using air quotes here, they should have more expertise in manufacturing related processes. So their quality lens should be around that. To the regulatory person, their quality contribution should be about making sure that the product we identified the need for, that the resulting product actually addresses that. So there are different levels of quality or different lenses or perspectives of quality just depending on what my roles and responsibilities are.

Mike Drues: Or going back to my very simple McDonald's metaphor from earlier, Jon, whoever designed the first McDonald's hamburger probably knew that they were designing a crappy hamburger, a crappy product. But from a quality perspective, I think we would be hard pressed to find any medical device company that can manufacture a product with the same level or greater consistency as McDonald's does their hamburgers.

Jon Speer: Yeah, I can't argue with that. I can't argue with that.

Mike Drues: Okay. So are there negative of connotations to quality? Is there a negative side to this coin?

Jon Speer: I mean, I hinted at a little bit of it. I think, just in the time that I've been in the industry, so that's like 25 years or something like that now. I forget every year that happens, it adds another year. But it doesn't seem like it's been that long. But I remember those early days all the time. Actually, the head of quality, the quality department would say," Hey, Jon, you need to check out this tool or you need to look at this tool or you need to use this tool." And they become almost like disciples of these different methodologies and approaches. And they try to push to implement it within the company, oftentimes unsuccessfully. So then every time they try that, their colleagues start to roll their eyes a little bit because it's like, try something, it didn't work. Try another thing, it didn't work. Try another thing, it didn't work. And so I think sometimes quality professionals within companies lose a lot of clout, a lot of credibility because of some of those types of things. I'm not saying they're entirely responsible or culpable for all of it. But nonetheless, I think there has been this shift over time that has caused some issues with respect to quality. I think the other thing that oftentimes happens within companies, not all companies, but oftentimes, the quality folks, the quality department, again, oftentimes has that responsibility for implementing things like quality management systems and procedures and things of that nature, that hopefully part of that is a compliance component that we're going to implement processes and procedures that meet FDA 20 or ISO 13485 or whatever the case may be. But the problem is, a lot of times these folks, they don't engage or interact with those who actually are involved with the process. We'll use the manufacturing, I've seen it so many times where a quality engineer will write work instructions and manufacturing instructions and inspection procedures based on how they think that a product needs to be manufactured, but they don't talk to the people who are actually manufacturing it. And so maybe they put this in place, they define it. And the manufacturing people are like," This is not how we do this at all." And sometimes the manufacturing people will speak up and say," Hey Jon, this isn't how we do this thing over here. Let me show it to you." The good quality people are listening and saying," Oh, I didn't realize that." But unfortunately, a lot of the quality people say," Yeah, well this is the way we're doing it." They're not willing to adapt.

Mike Drues: Kind of reminds me a little bit of the story that one of my professors used to tell when I was an undergrad in engineering about a thousand years ago. That is, the guy that designed a particular engine in a car clearly never worked on a car before, because in order to change the spark plug, you had to pull the whole engine out of the car.

Jon Speer: Yeah. And it's worse today with cars. I mean, you want to try to do it yourself and change your own oil, you have to remove a quarter panel to do that. It's just not practical.

Mike Drues: And so just kind of lumping together the last two questions that we just talked about, who's responsible for quality and are the negative connotations of quality? One of my other friends likes to say," If you're working in regulatory or quality and people like you, then you're not doing your job." So why do you think some people think that, Jon? And do you think that's the way?

Jon Speer: I've never heard that one. So if I'm a regulatory quality person-

Mike Drues: If you're working in regulatory or in quality and people like you, you're not doing your job. I think he's referring to what I often refer to the regulatory police or the quality police, telling people what they cannot do and so on.

Jon Speer: I mean, I see some of that. I'll continue the analogy with like a primary care physician or a general physician, like a family doctor. One of my relatives, a while back, we went to the same doctor. They're like," Oh, I really like that guy." I go," Why do you like that doctor?" They go," He's so nice." I go," Yeah. But did you ask him about this or ask him about? Like, I don't know that he's a great doctor, just because he is a good guy doesn't necessarily make him a good doctor." I want the guy or the gal who is going to tell like it is and not be afraid that they're going to hurt my feelings if it's a message that I need to hear. And so I think that might be what you're equating to, like the regulatory and quality person who is sugarcoating everything just to try to make friends or keep peace or what have you, are they doing their job? And I think that's a fair question. I hadn't thought about it like that. But I think quality and regulatory needs to push the envelope a little bit. They need to make sure that the folks that they're working with, their colleagues, the collaborators and so on, that they understand the importance of whatever that might be, the product quality, the process quality. But within reason. I mean, not just like be so hellbent on it's my way or the highway. But stand firm. I mean, if there's something like," No, Mike. This has to be made this way because of these reasons." And support it and corroborate it with evidence, whether it be per standards or regulation, whatever the case may be, but support your decision. Don't just be a contrarian. Don't just be so stuck in your ways that you have to control and be right about something. So I think there's a balance.

Mike Drues: Well, Jon, I could not agree with you more in the sense that quality and regulatory should be pushing the envelope. And that's exactly what I try to do in my practice all the time. But I think the simple reality is that it's actually the opposite. Most people in quality and regulatory, not only do they not push the envelope, they actually work really hard to seal the envelope up and make it much smaller than it was to begin with. But anyway, moving on, digging in further into the manufacturing side. Oftentimes, product quality, it seems to be something that's often added as an inspection step as the devices are coming off the assembly line. The question is, should product quality be a step or should product quality be a more integral part of the product design process? I'm guessing I probably know your answer to this question, Jon, but I would love to hear it directly from the-

Jon Speer: Yeah. So I'll answer it with a short story. Very, very early on in my career, I worked for a device company. And most of the products, let's just lump them into catheter based technologies. And some of the quality criteria was super subjective. These were catheters that were going to go over our guide wire. For those listening, if you don't know this, that's cool. It doesn't matter. But there's a taper on this catheter, which is essentially a plastic tube. I'm, again, over simplifying. But you want to make sure that, and the guide wire is a much, much typically smaller outside diameter than the outside diameter of the catheter, but you want to make sure that had what they called a smooth transition. And that's how they define the acceptance criteria. Make sure it has a smooth transition.

Mike Drues: What does smooth mean?

Jon Speer: What does smooth mean?

Mike Drues: Like you said earlier, if you can't measure it.

Jon Speer: Yeah. So then you start to get into, okay, well, should I measure the angle of that taper and the slap between the inner diameter of the catheter and the outside diameter of the guide wire and so on and so forth? But it got to a point where I started to realize, wow, how I define this is really important now. But just if I define it within a process, especially if it's a human type process, like if it's a manual step that I'm checking. I think I heard something once that a manual inspection is 80% effective. It's high error rate. And so the conventional wisdom in many of those cases is like, oh, well I'll just add another inspection step that measures the same thing further down the process. Well, that's not fixing the issue. That's actually making it worse despite what it seems to be. And so I think a lot of times companies or engineers or whomever has that responsibility. They're trying to put these inspection steps. And okay, there's definitely room for that in a manufacturing process, but it should be more of a verify rather than proving quality. Me, as design engineer, I should be factoring that in to the design of the product. Me, as quality engineer, I should be factoring that in to my manufacturing process. That should be where I start with so that at the end of the processes, whether it be design or manufacturing, I have high confidence that I'm going to get a quality result. Now I know that's kind of like motherhood and apple pie. It's a little bit high level. But that should be where I'm leading with. I shouldn't be just thinking about, oh, I need to add a step here to check for quality or add a step there to check for quality. No. That sounds maybe a little contrarian to what I've said earlier. You got to measure it to know how you're doing. So there is an element where you need to inspect things and measure things. But I should be incorporating that as part of my methodology, my design process.

Mike Drues: Well, it's interesting. I think there's a lot of precedent for the idea that you're describing here, Jon. From my perspective as a medical guy, out of what we do in medicine, I don't mean necessarily medical devices, but I mean, in the clinical medicine, the practice of medicine, is actually manual. When you go to a physician and they palpate or feel various parts of your body to see if there's some abnormality or a mass, like a breast exam or something like that. If they find something, then that is usually verified, they usually follow up some form of imaging or perhaps a biopsy or something like that. So I think even though you're describing medical device development and manufacturing, the similarities to the practice of medicine, I think, are spot on. So back to process quality, do you think then that process quality as a result of all of this gets ignored?

Jon Speer: I don't think it gets ignored. I think it gets misapplied. I think, generally speaking, there's an interest and an attempt to implement effective process quality. I think the intention is there. I just think it's missing the mark in some way, shape or form. And I can't entirely put my finger on it. I think it's not the fault, and I'm not trying to play blame game here, but it's not the fault of the quality department or that quality engineer. It's not the fault of the design engineer. It's not the fault of the regulatory professional. They all own some of it though. And I think it's kind of going back to what I mentioned a little bit earlier. It's a perspective thing. I mean, me, depending on what my role and responsibility or what part I play in this medical device company and the request to bring new products to market, I might not appreciate or speak the language of regulatory or quality or whatever the case may be. So communication. I know this also sounds cliche, but effective communication is probably where the issue is. I'm not effectively communicating as a design engineer to the quality engineer. Maybe I misinterpreted information that was transferred to me from regulatory. And so it's like we need to do a much better job of being transparent and open and trying to communicate, communicate, communicate to ensure that these things are more effective. But that's a real challenge. And, like I said, I think the intent's there, I just think the implementation falls down.

Mike Drues: Well, I would agree, Jon, and actually adding on a little bit to what you just said, the vast majority of the medical device industry, and I suspect the vast majority of our audience, works in the Class I and Class II medical device world. And in the Class I and Class II world, there are extensively no requirements, certainly no requirements in a regulatory submission to say anything about your manufacturing process or anything else.

Jon Speer: Absolutely.

Mike Drues: As a matter of fact, usually it's unusual in a 510K or De Novo, for example, to include anything about manufacturing. However, in the Class III universe, in the PMA, in the HDE world, we're closer to the drug world in the sense that there are actually manufacturing requirements that have to go into your PMA to get your PMA approval. So maybe, I'm not suggesting that it's necessarily a good idea, but maybe we should take a page from the Class III universe or possibly even from the drug universe and think about those process quality issues earlier, maybe even as part of the regulatory process.

Jon Speer: I agree with you. When I first started to understand design controls, for example, I only applied design controls to the design of the product. And the regulations are not explicit on this. And even the FDA's guidance document on design controls and even going outside the US to 13485, it does a little bit better job. But I believe the expectation is that design controls apply to both your product and your manufacturing processes. But it's vague. And it's a misunderstood thing for a lot of folks because, to your point, majority of the folks out there are involved with Class I and Class II. And really nothing about a 510 K is asking about anything to do with your manufacturing process. Okay. Now you might provide some label specifications and directions for use, and you might have some drawings. But you're not providing all the details of your manufacturing process. And I think that might be exacerbating or perpetuating the confusion here.

Mike Drues: I agree with you, Jon. And I like what you said about the product versus the process when it comes to design controls. I would actually take it a step further. The design controls say that we need to validate the product and to validate the process, but the design controls do not say that we need to put those two things together and validate them.

Jon Speer: Yeah, exactly.

Mike Drues: And that, I think, is one of the many significant limitation controls, because even in the Class II or lower universe, our devices become more complex. Our technologies become more complex. The processes that we use to make these devices become more complex. I think it's a gross oversimplification to separate the device itself, the product from the process that's used. I just don't. I mean, I wish that it would not take a PhD in biomedical engineering to appreciate that.

Jon Speer: Well, but I think that problem is going to continue, unfortunately, because so many companies are getting leaner and meaner. Like the brick and mortar company that has all functions and operations within the same building, let alone within the same company, is a bit of a dinosaur these days. It's a rare bird because so many, especially smaller companies, they're like" It's not pragmatic for us to bring in this manufacturing expertise in house. So let's partner with a contract manufacturer or whatever the case may be." And that makes the gap wider, the chasm bigger rather than smaller.

Mike Drues: Absolutely. And in those scenarios, I've seen it happen where people validate the product. And that's perfectly fine. They validate the process. And that's perfectly fine. Put them together, and it's not fine anymore.

Jon Speer: Well, skewed lines. They never intersect, but they're not going in the same direction.

Mike Drues: Yeah, absolutely. All right. The last thing to just talk a little bit about, and then I think we can start to wrap this up, Jon, is what about the overall quality management system? Is the quality management system, or the QMS, about demonstrating compliance to regulation? In other words, should the emphasis there be to simply make sure that our QMS ticks all the boxes that are required? Is that the approach that we should be taking, Jon? And again, I'm guessing I know your answer to this. But let's hear it directly from you.

Jon Speer: Well, the short answer is no. That's not what I'm trying to do with the quality management system. What I'm trying to do is to describe how I do business, and how we're measuring certain KPIs or objectives or criteria, how we're demonstrating quality both at the product level and at the process level, and make sure that we've defined roles, responsibilities, processes that are applicable and appropriate to our business so that we can not only produce quality products, but we can do so with consistency. And that's really the essence of what a quality system is intended to do. But here again, so many have been hellbent on the compliance. And it's a little bit of a chicken and egg. And I don't know that we'll get into the nuances of that today. But nonetheless, we have, as an industry, been conditioned to make our quality system check the compliance boxes. We don't implement quality systems to help us run better businesses. And that's just a big mistake.

Mike Drues: I couldn't agree more, Jon. It's a huge mistake. The way I like to describe the quality management system, it's not ticking those boxes, as you said. It's a philosophy of doing business. That's really the way that I liked it. And here's what I would add just to what you said. And this, I think, could be a topic of a whole different discussion. As you and, I think, some of your audience knows, I spend some of my time working as an expert witness in medical device product liability cases. And when an attorney talks to me about a product liability case, one of the first things I ask to dig into is their quality management system. Because it's very easy for me, even though the company's QMS probably ticks all the FDA boxes, it's very easy for QMS against them. Anyway, that's a topic, as I said, probably of a different discussion. But I know we need to wrap this up, Jon. So any last thoughts that you want to offer under this general topic of quality and improving quality and other things that we should add to our quality thinking?

Jon Speer: Actually for now, I think that's probably a good place to park this. I continue to be excited to see how'quality evolves'. I'm optimistic that some of the pitfalls and the obstacles and the drawbacks that we spoke about today, I'm optimistic that we're turning a corner as an industry. I have been accused of being a silver lining guy plenty of times in the past. And I'm okay with that. Especially if the outcome means that we're going to make safer, more effective medical devices at the end. So I hope folks listening realize that we have to interrupt the pattern. And right now, around the topic of quality, there's a pattern and it's not a good pattern. But I think it could be corrected with philosophy maybe a little bit, applying this more on the front end, making this a part of my culture. So I know that's one of the things that we've tried to do with Greenlight, we've tried to enable or trying to make your quality system more of an enabler instead of an obstacle.

Mike Drues: Or to perhaps, from my perspective, Jon, to end with a very common quality buzz phrase, and that is continuous improvement.

Jon Speer: Continuous improvement.

Mike Drues: Continuous improvement should not be limited to just our products, our devices, but our processes. Indeed, our thinking. So regardless of how well we think we're doing as a company or as an industry, I think we can always do better.

Jon Speer: Absolutely. I like that. So anyway, thanks for this.

Mike Drues: Is that a silver lining, Jon?

Jon Speer: I'm okay with it. I don't need to label it. It's the right mentality, continuous improvement. How do we get better?

Mike Drues: Practice what we preach. Absolutely.

Jon Speer: Practice what we preach. Absolutely. So again, thank you. I enjoy these role reversal conversations that we have from time to time. So the good news is, I didn't feel like I was in the hot seat too much.

Mike Drues: I hope I did a reasonable facsimile of filling your shoes, because they're big shoes to fill.

Jon Speer: I felt the quality was there, Mike. I felt the quality was there.

Mike Drues: Thank you.

Jon Speer: All right. Well folks, thank you so much to Mike Drues with Vascular Sciences. Obviously, he's a regulatory guru, expert and nerd. So for those of you out there who maybe, you're just trying to figure out how and what and when to address different regulatory facets whether that be pre- submissions or 510Ks or De Novos, Mike can help you build that strategy that makes the most sense for your company or for your product. So reach out to him. He loves this. He drinks regulatory for breakfast, I think. But I appreciate all of you listening. Yeah, he's got it in his butt right now. I appreciate all you listening. It's because of you that the Global Medical Device Podcast remains the number one podcast in the medical device industry. And I know, from time to time, some of you reach out to me or Mike. And I'm always humbled and grateful when you reach out and share that that you've found a particular thing that we talked about inspiring or insightful or whatever the case may be. But thank you for listening in all sincerity. And lastly, as we wrap things up today, on the topic of quality and true quality, and incorporating this as part of your business philosophy and your culture, that's what we do at Greenlight Guru. We've built the only medical device success platform in the medical device industry, designed only for medical device companies, by actual medical device professionals themselves. So we've got workflows to help you. Okay. I told you compliance isn't the goal, but it is an outcome. And some of those things that we've built into the workflow within Greenlight, they're going to help you achieve that. And even more so than that. So check it out, www.greenlight.guru, we'd love to learn more about your quality management system needs and requirements and safely have products and solutions that can address that. So, until next time, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.

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