Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!
In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.
Some highlights of this episode include:
- Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements lead to inconsistencies and interpretations of laws.
- It takes time, often several years, for companies to transition to new or revised regulations and standards.
- Some companies are only beginning to implement, adopt, and change their quality processes in a way that they understand what risk-based approach means for their management systems.
- Some medical device companies have lost their way when it comes to quality, and some believe the quality profession is partly to blame as a result of being driven by tools, not data.
- Mark describes a "do" vs. "don’t do" mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.
- Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.
Memorable quotes from this episode:
“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer
“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert
“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert
“A lot of companies, I think their quest is towards compliance.” Jon Speer
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: When were hiring for a director of quality a few months back at Greenlight Guru, and the resume from Mark Alpert crossed my desk, I was so excited to have the opportunity for him to come join our team. And several months later we're making great progress internally and a lot of really exciting initiatives. But this episode of the Global Medical Device Podcast, I have a chance to catch up with Mark, a little bit on state of quality and our industry. And we talked a little bit about the philosophical approaches, and mindset and things of that nature, but I think it's really interesting to get his take because he's had an opportunity to work with notified bodies. He's been in quality for about 30 years in those early days of ISO 9001, and certainly at the beginning of ISO 1345. So he has a lot of context to share. 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, well, it's a newer face to Greenlight Guru. Mark Alpert. Mark is the director of quality at Greenlight Guru. So welcome to the global medical device podcast, Mark.
Mark Alpert: Thanks, Jon. Pleasure to be here.
Jon Speer: Absolutely. So from time to time, I've talked with some of our gurus in a meet the guru type of podcast. And I suppose this is a version of that, but I thought we could get into a little bit about who you are your history and quality in med device, but then talk a little bit more about what's going on in the world of quality in our industry. So, I guess maybe a great place to start is give folks a little bit of a background who you are, and I guess some of the highlights of how you came to be the director of quality at Greenlight Guru.
Mark Alpert: Sure. So thanks. So, it began a long time ago. I've been in the quality business, I guess, we call it for almost 30 years. I graduated as a manufacturing engineer and then quickly got volunteered for a quality project. And it's a funny thing about the folks in quality, once they get you, they never let you go. And so I kind of worked on this project and then there was another project, and another project, and was working on my master's thesis, and this new European community thing was opening up back in 1992. And the European community is to open the borders to allow the free movement of goods and services and product all across the European union. And with that came the introduction of ISO 9000 as one of the standards, product related, or management systems related standards to help bring some commonality across the European union. And then I jumped on that bandwagon and wrote my thesis about ISO 9000 and the opening of the European community. And right about that same time, this bow wave came from Europe there were very few people at the time that knew anything about ISO 9000 in the states, other than their European customers were requiring it. And so I started getting lots of phone calls. And so since then that was early nineties. And since then I've spent the rest of my career in sort of the ISO 9000. And that's what's just ISO 9000 state the certification body games, certification body, notified body industry. I was part of the North American startup for a notified body called TÜV SÜD from headquarter Munich, Germany. So, I was employee number six or seven there, and TÜV is a big global, large organization now. And it's just, the whole industry has just grown up the whole regulated, the regulatory affairs, regulated industry and products systems has just grown up, and I've had the opportunity to grow with it. And so after spending 25 years or 24 years on the certification side of the business thought, it'd be interesting to come to the industry side and see how the other half lives. And that's what brought me to Greenlight Guru.
Jon Speer: Yeah. And I know I speak for the team as well as myself, we're thrilled and happy that you're here at Greenlight Guru. Your leadership is taking us to sort of that next level, so to speak when it comes to true quality within our organization, lots of exciting initiatives that we're working on and you're leading within the company. So, folks, I guess here's the teaser. Stay tuned soon here in the next, I don't know, six or so months, maybe nine months or so, or you're going to hear some really exciting things coming from Greenlight Guru from our quality side of the business. So pay attention and stay tuned for that. But I want to get into quality. You mentioned something interesting that I think there's a lot of parallels that are happening in the industry today, from when you started your career. I mean, you mentioned really getting in on the ground floor of when ISO 9001 was first being introduced. And hopefully obviously from then, till now, there's been all sorts of derivatives and offshoots of the 9001 framework specifically in med device, there's ISO 13485, which has a lot of parallels to the quality system regulation from FDA, which came out in the late nineties and so on and so forth. I'll stop rambling and get to the point. I think today we're also at a very interesting crossroads when it comes to quality. For a number, or maybe there's a number of different facets. The first one I want to dive into is it seems like it's a hot mess in Europe again, when it comes to quality. So what are your thoughts there?
Mark Alpert: Yeah, I agree. It seems to be the tail of a couple of different tapes. Yes, they created the European community, one more unified continent, but a lot of different agendas. And so as the medical device directive was first introduced, it was up to the sovereignty of each individual country to adopt, and flow down those requirements of the directive for each country. And that led to a lot of inconsistencies, and a lot of different interpretations and a lot of different flow down as law in other countries, not so much flowed down as law. And I think that needed to be dealt with because it was creating confusion, and creating inconsistencies, and requirements around the world. And so of course if it comes to the MDR and the Medical Device Regulation, and so the regulations make it much easier for every country to sort of translate into law. During the transition period, and that transition period is creating a lot of questions in both in terms of the interpretation of what the new requirements are. And there is a lot of increase... There's a great increase to the requirements. So there's a lot of interpretation going on and what those requirements mean. And it's not just the medical device industry, and it's not just 1345 as any of the ISO standard are revised and then published through a transition period are procrastinators. And so if you're given three years to transition or you've got three years to for the product or the devices that are currently on the market till they need to comply with the new requirements of the MDR they're going to put that off as long as they possibly can. So there's a lot of companies that have existing product on the market that it's, to some extent, almost business as usual, until the requirements are forced on them, or there's changes or modifications to the products. Coming out in accordance with the new requirements. And so both of these things are happening at the same time, all around the world for anybody who's manufactured product into Europe, and it's causing quite a stir, it's a dynamic time.
Jon Speer: Yeah, absolutely. I mean, it's, to your point, we had this transition period and we've got a bonus year for the EU MDR, but even so, I mean as we're recording this, I mean, we're a little past mid year, 2021. This all went into effect in May, 2021, but I haven't heard a lot of success stories to date. I'm sure there are some out there, but I just haven't heard a lot. Yeah. And I think, to your point, I mean, not only is this new for the medical device companies, but it's new for the notified bodies, and auditing organizations. It's new to the government entities as well. So hopefully it gets a little bit clearer, because hey, guess what? In less than a year from now, the new EU IVDR is in full effect, too. So I don't know. I mean, I know you came to Greenlight from TÜV SÜD and was pretty involved in the activities of the notified body, but from then till now, I mean, have you heard any, trying to stay positive, but have you heard any success stories, or I guess even horror stories about this transition so far?
Mark Alpert: To be honest with you, not many. It's almost right now, the more things change, the more they're staying the same until everybody understands and really can sort of extrapolate the requirements or the interpretations of the new requirements and if ISO 9000 has taught us anything, which is sort of that granddaddy standard that we were talking about that first got published at 87, as that had been revised every, whatever it's been, five years, eight years, 10 years, it's taken companies, the three- year transition to catch up to the new requirements of the standard or the things that the standard is emphasizing. So, the latest revision of the ISO standard of 9001 standard, that's been emphasizing, risk- based thinking and risk methodology, same with 1345, but that's standards been out for several years, and companies now are just starting to really implement, and adopt, and change their processes in a way that they understand what the risk base really means. The risk risk- based approach really means within their management systems. And the previous revision of the standard, the emphasis was on the process approach. And that took companies five years to figure out what the process approach meant, and to really incorporate it into how they do business every day, same thing's happening now with the risk- based methodologies and the same thing's going to happen in the MDR versus the MDD. It's going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.
Jon Speer: Yeah. I want to transition a little bit and kind of a little bit, I guess, closer to home to the internal operations of a medical device company, and I'll throw out a hypothesis, and I'm curious to hear your reaction, but hopefully I won't get too long- winded in this, but one hypothesis that I think I'm seeing in 2021 is that medical device companies have lost their way when it comes to quality. And I have a few things I can speculate as to why, but I guess first let's start with that hypothesis is, do you agree or disagree or do you have a different hypothesis about where our industry is with respect to quality these days?
Mark Alpert: I agree. And just a couple of things... We could talk about that, just that, for a half a day or at least an hour, but a couple things just to throw out that I think, A, the quality profession is a little bit guilty here. We've done it to ourselves to a certain degree in quality becoming not so data- driven, but so tool driven and the basic tools of quality and it's really taken the gut- feel and some of the knowledge and the hands- on approach out of the hands of the quality practitioners. And it has just become very mechanical, and the move to downsize, if that's the right word, the traditional quality department, and incorporate quality into the organization is everybody's responsibility. And that's an interesting thing too, and it's everybody's responsibility is it anybody's responsibility, and it's easy to be a little bit out of sight out of mind, I think. And so, but I think the pendulum has come back and I've seen changes just over the last few years where quality the profession, I think, is the aims are a little bit different and they're starting to be a little bit more of a quality touch in organizations. I think we've got a lot of work to do, but I think the pendulum is starting to shift.
Jon Speer: Yeah. I have a couple other theories. So, one theory or question I wonder is, to your point, we've kind of done this to ourselves as an industry, maybe as a discipline, but do we complicate things by and equality it's sort of this ethereal, sometimes ambiguous concept. It's kind of it's like American as motherhood and apple pie. Some of these things that you hear, I mean when you know it when you see it, and you know it when it's not where it needs to be, but sometimes it's kind of hard to define. And so I think there's that. I think the other thing is it feels like at times we have complicated by things by wanting quality throughout our processes, or products, et cetera. But then we have this department over here who we call quality that's functional department. And while we say," Oh, yeah, everyone has a role to play in quality." A lot of times the response is" Not me, that's that department over there." So I think we complicate things.
Mark Alpert: Yeah, I absolutely agree. But I would just say mine is a little bit broader. It's not just the quality department that's complicated things. It's the entire organization that complicates things, and people, for some reason, are really good at making things more complex. And it's hard for people to simplify. And even if you go through the audit process, so here comes the notified body or a certification body they're in to conduct an audit. There's some nonconformances and what's the natural reaction? Well, okay, let's turn that. Three into an eight page procedure and nothing should be further from the truth. If it was a three- page procedure, it can remain a three- page procedure. If you've got to add some requirements or clarify some requirements, take the stuff that doesn't work out. If there's corrective actions to take people think that that means we have to make it more complex, more comprehensive, more whatever. The procedure has to be bigger. And I can say, in my experience as well, if there's one thing that complexity it's nonconformances, you're building... Once the complexity creeps into the system, you're just about guaranteeing mistakes will be made that will result in some nonconformances really where the focus should be on just the opposite. How do we simplify? How do we take the complexity out of the system and how do we bring back some of that creativity and stop with all the sort of the mechanical, robotic approach for this?
Jon Speer: Yeah. I'm glad you brought that last part up because I've heard this many times. Well before, and at Greenlight Guru, you might, I guess a little bit about me, so my background, my upbringing in the medical device industry, as I worked as an engineer, designing, and developing new products. I got into quality, functional quality area, a little bit later into my career, but I always kind of fashioned myself as a systems kind of thinker. I see things like flow charts in my mind. The pictures of my mind are flow charts, process flow charts. And whenever I got into quality and started drafting procedures and helping companies implement their quality systems, I was a keep it simple type of person and approach remove the complexity. If I could write a procedure that only included a flow chart, and it was a single page, but it was understood, and applicable, and appropriate to what we were doing, then I was going to try to keep it that simple. But the funny thing about that, it's the naysayers. It's almost like they're like," Ah, it's too simple. You need to make it more complicated, and you need a provision for this and a provision for that", and so on and so forth. And the regulations say," Thou shalt do this." And I'm like," Where does the regulation say that?" You challenge it? And the regulations are sufficiently vague, and I love that about the regulations because it leaves interpretation up to me. And so it's interesting that some people have this point of view that your procedures need to be tens of pages in length and super complicated. I'm right there with you. The more complicated that I make it, I'm going to have a compliance issue. Maybe not so much from do we need the regulations, but can we actually follow the practices that we've defined?
Mark Alpert: Yeah, you're absolutely right. And this might not come out right. But to be honest, when you go into an organization to audit, that's one of those rookie mistakes. If the company is creating procedures, creating flow charts, or whatever it is based on what they think the auditor wants to see, or based on what they think the certification body is expecting. Yeah, the flag's gone up again. That's no way to implement the management system, and you implement the management system, there are shall statements in and if you're not meeting those shall statements, you got a problem. You've got to meet those shall statements. You decide how to make those shall statements. And what works for you within the context of your organization. How sophisticated, or if it's even a word, how unsophisticated can you make it? And that's the trick. To your point, keep it simple, keep it as unsophisticated as your organization will allow. I remember when I was out auditing at a very large global organization, talking to the logistics, vice president of logistics, which was an automotive company. And this was the guy that was responsible for getting the cars to their destination all over the world. Huge, huge role within this organization. And we were talking about how to bring creativity back into the process. And I said," You know what? Just rewrite the procedures only on what you shouldn't do. You can do anything you want, do it any way you want, just don't do these three things." The guy loved the idea. I think he was going to take me up on it. I had to talk him out of it, actually. We wouldn't know how to audit that, but that's kind of the mindset. It's like leave the creativity, leave the objectivity, leave the ability to scale. Don't tie yourself down to some nine step process when you can do it in four, because that's really how we do it. Your auditor will love you for it.
Jon Speer: Well, a couple of reactions to that, that first reaction is I've been there on the sort of the receiving end and the audit where you get the auditor bias, and so much so that I've seen numerous companies do this and practice where, okay, maybe they're some of the procedures needed to be revised anyway, but they were taking what they were hearing from the auditor and almost regurgitating it verbatim to revise that procedure. Right? In a sense, what they were doing, whether intentionally, or unintentionally started to bias their procedures based on that auditor preference. But there was a positive reinforcement of that because the next audit cycle, guess what? Probably that same person is coming to audit during the surveillance audit, and they're like," Oh, wow, that's exactly what I was looking for", right? And so you go through this rhythm for a bit, but then all of a sudden you get a different auditor and then that different auditor has a different point of view or perspective. And so this creates this weird loop of activities. I think it disenfranchises a lot of folks in companies because they feel like they're just dancing this weird dance with an auditor, always trying to appease and satisfy the auditor.
Mark Alpert: Yeah, I think you're right. I don't disagree with what you're saying. And unfortunately, it's kind of true. And unfortunately, I don't think there's enough, in other words, enough pushback. There can be a partnership there and it's something that can be discussed with the auditor in coming to some sort of consensus or some better understanding. I mean, look, the bottom line is, is there's three aspects to it. There's an approach that you've defined within your company. There's a deployment on how you deploy that approach throughout your company. And then there are results. And if you've defined an approach that meets the requirements of a standard throughout the organization and the results aren't dictating any negative outcomes, or any trends in a negative direction, then what's an auditor to do? I mean, he might want to see something, or we might do it differently at his company, but at our company, there are no trends here. There's no data suggests what we're doing is resulting in any additional risk, is resulting in failure, is resulting in less efficiency, less accuracy all those kinds of things that's the reason we collect all... So, to me, my recommendation would be any of those little hints, or allegations that an auditor would make, that's why they created opportunities for improvement. Don't put them in that bucket, and see where or if, or how they would fit within the processes, and if they do, then, hey, maybe it's a great suggestion. And if they don't, then it's like, you know what? Great suggestion, but it doesn't fit within our methodology.
Jon Speer: Yeah. The other reacts that I've had enlisted into some of your comments is I think a lot of companies, I think their quest is towards compliance. And I think in doing so, they... It's like they almost architect, or design their processes, and procedures, and their approach in a thoughtless checklist type of mentality. And it's like they're trying to check the right boxes on the form so that they can pass muster and be able to demonstrate that compliance. It's like they lose the ability to think for themselves of what's good for them and what makes the most sense for their company.
Mark Alpert: Right. And that's another perfect example of how the quality field has done it to themselves, because it's become this, non- discussion, non- debate, it's black or white. Are we compliant? Are we not compliant? And it's kind of unfortunate and yes, you have to comply. And I mean, we're in the medical device industry, we're supporting medical device companies. It's no place to be fooling around when those products go on the market have to meet the essential requirements, right? They've got to meet the health and the safety and environmental requirements that are led me to pawn them. And that's where the conformity or that's where the compliance comes in. But as important that's the ticket to get into the game. That's sort of foundational and then what? It's as important, if not more important, in the long run is the continuous improvement piece. And if your methodology and your approach is just to be compliant. So, compliant it's building the foundation that meets the requirements of a standard, but building a process on top of that or alongside of that, that helps to drive improvement over time. And all those compliance issues go right out the window because they say," You know what, we're so far stuff's automatic."
Jon Speer: Yeah. I was talking to a partner of ours at Greenlight Guru the other day on a episode of the Global Medical Device Podcast. Her name is Christie Johnson, she's with Kasota engineering. She says something that was a little profound to me. And I think I'd always realize this, but I hadn't ever verbalized it. And when she works with companies, one of the things that she advises them is we're not seeking perfection, and I'm paraphrasing a great deal. I put my Jon Speer twist on it, but we're not seeking perfection. When we implement this, I mean, we're going to do the best that we can to make sure that our processes are as defined, and accurate, and appropriate as they possibly can be. But we're going to go into this implementation phase. And during the implementation phase, don't expect perfection. There's going to be things that, as we put it into practice, they're just not going to work. So, I'm glad that you're reminding us, OFI's, opportunities for improvement because a system, or a set of procedures that comprise the system. The intent there is that we're living it, we're breathing it, we're owning it. We're refining it. And over time, because our goal, I think is, I'll say perfection, but that's not really realistic. Our goal is optimization. Our goal is efficiency, and thoroughness and that sort of thing. So I think people should stop expecting that their processes should be perfect for all occasions, but that's just a point.
Mark Alpert: You're absolutely right. When you go to an Italian restaurant where it's been in the family for 110 years, and it's the same recipes, those meatballs start to get really good. Those are good taste... After a hundred years, they've got that recipe down and I mean, it's a loose analogy, but a little bit the same here. It's about the refinement. It's about adopting that mindset, that identifying opportunities for improvement, or even in some contexts, if it's not too major nonconformances as the opportunities for improvement. That's the input that you're looking for to help you drive improvement. It's not, again, it's another thing we did to ourselves. So the quality guys that got this year's bonus based on getting through an audit clean versus having a few nonconformances as nothing for the right mindset that says," Hey, you know what you just found there? That's darn good." There's an opportunity there for us to implement that and help to drive improvement within our system. And that's a good thing because it is a long and winding trail, and it can get muddy and bumpy and it's hard to travel sometimes, but that's the journey, that's the journey we're on towards achieving those corporate mission and vision and goals.
Jon Speer: Sure. So, as we're wrapping our conversation up today, mean, I know we've talked more on the philosophical side of things, but any pragmatic tips, pointers, or advice, or suggestions that come to mind that you want our listeners to take home and hopefully put into practice in some way, shape or form?
Mark Alpert: Yeah. I would just maybe, again, it's a little bit the philosophical side, but one of the things when auditors are coming into the facility, of course, again, they're looking for compliance against all those shall statements within the standard. The other thing they're looking for, though, is they're looking for a sense of confidence. It's that I'm from Missouri here, show me kind of thing. And if you, as an organization, can demonstrate your, that sort of plan, do, check, act that you're serious about improvement there's process in place to help drive improvement. That even if an auditor identifies within the system, he's walking out with that level of confidence in your ability to address that and make the system better, or make the system comply in certain areas. And that level of confidence for an auditor to me almost goes further for an organization than it does, trying to tweak all of the procedures to satisfy him only to have the next guy in, and say," Geez, why is this so over documented?" It's about how you operate every day and the discipline you sort of intertwined into how you can get business done every day. And if you can sort of put that out have the auditor absorb that and have the auditor notice that while they're in, that goes a long way. And I mean, for me, when I was auditing, there were plenty of situations where I was like," This is borderline stuff here, but you know what? I've seen what you've done over here. I've seen you do it in that part. I've seen you do it at your facility in Pittsburgh. I've seen you do it at the facility in Sweden. I've got pretty high level of confidence that this will be taken care of in the same way, and it sways me a little bit." And so for organizations to not worry so much about an auditor, be focused about their systems and how they operate every day, particularly, in terms of how they drive improvement and how they built a solid foundation that they're building upon.
Jon Speer: Yeah. I like that. To me, it's about intention. As a company, I may not have perfect procedures and there might be a few errors and mistakes that I've made as defining things, but what are my intent? What is my intent? Am I doing things for the right purpose, and the right focus? Which, I think, to me, gets to where I hope our industry gets, or starts to realize is this need to make true quality a part of their culture, part of their mindset, where it is... I know it sounds cliche because in the practice, the way we, as an industry have implemented this has been poor at best, but quality is everyone's responsibility. I mean, at the end of the day, we're making medical devices and these medical devices are going to save people's lives or certainly improve their quality of life. So every one of us in a company that's involved in designing, developing, manufacturing, selling products for medical uses needs to have this top of mind and front and center. And that should drive our decision making. It should drive who we are, how we are, and just like I said, our overall mindset, our culture with our companies.
Mark Alpert: Yeah. I completely agree. And you know what? When we get there, the pendulum will have come back to the center, and quality will be sort of an interest in demand, a function, or sort of job in demand again. And people will start coming towards it because the results will be tangible. You can see the results, and yeah, that's kind of what attracted me to it in the first place. Some things you drive some improvement and something got better. You reduced a hassle for somebody in some area, and it got more effective, more efficient, less non- conformance, more cost- effective, that's kind of cool within an organization.
Jon Speer: Yeah, absolutely. Well, I want to thank Mark Alpert. Mark is the director of quality at Greenlight Guru for being the guest with me today on the Global Medical Device Podcast, so Mark, thank you.
Mark Alpert: Thank you, Jon. pleasure.
Jon Speer: And folks, true quality, I mean, this should be like your north star, your guiding principle to improve the quality of life. That's why I'm in this medical device industry. I know this is why Mark is here. And I suspect that's why many of you are in this industry as well, because you want to have a positive impact on humanity. Well, if that is the way your function and your operate, and you think from a mindset perspective, well, your processes, your approach, your methodologies should align with that as a company. And this is in alignment with our philosophy at Greenlight Guru. So, if you'd like to learn more about the Greenlight Guru medical device success platform, the only solution that's been designed specifically, and exclusively for the medical device industry by actual medical device professionals, that I would encourage you to go to www.greenlight.guru, request a demo. We'd love to have a conversation with you, understand your needs, your requirements. And hopefully we have some products and solutions that can help you and your class to be true quality medical device companies, so check that out. As always, thank you for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry. And that's because of you, and keep spreading the word, sharing the news with your friends, your colleagues, we're going to keep producing great episodes, having great guests like Mark Alpert and others on the show, talking about things are really important in the medical device industry. So thank you very much. As always, 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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