Inside Quality at Resolution Medical | Pursuing the Pulse EP. 6

What does quality really mean in the medical device industry?

In this episode, Mark McCarthy sits down with Mark Dykoski, Head of Quality at Resolution Medical, to discuss how quality systems, regulatory standards, and continuous improvement shape the development and manufacturing of complex medical devices.

With nearly 20 years of experience in the medtech industry, Mark shares how Resolution Medical approaches quality through transparency, authenticity, innovation, and integrity. The conversation explores how regulatory standards guide operations, how technology supports quality management, and how customer feedback and risk assessment drive continuous improvement.

From certifications and quality management systems to validation, testing, and risk mitigation strategies, this discussion offers a behind-the-scenes look at how quality is built into every stage of medical device development and manufacturing.

Transcript

SPEAKER_00 0:02

Hi, this is Pursuing the Pulse. I'm Mark McCarthy. Today I'm here with Mark Daikowski, who is part of the quality group here at Resolution Medical. Welcome, Mark. Thanks, Mark. Before we get started, why don't you tell a little bit about yourself to our viewer audience?

SPEAKER_01 0:16

Great. Yeah. So uh I'm Mark Daikowski. I'm the head of quality here at Resolution. I have been with Resolution for almost a year. Um, and I have worked in the quality industry and med device industry for um almost 20 years. Uh like I said, I've always been in quality um and I've kind of moved up through there.

SPEAKER_00 0:34

Great. Why don't we get started? Um, how does resolution medical define quality and why is it so central to your mission?

SPEAKER_01 0:41

Yeah, so quality is what med device does. We uh at Resolution have a quality policy that defines what we do and how we show up every day. Um, there's a lot of words to it, but really when it comes down to it, I find that there are four things that I really want to focus on. It's transparency, authenticity, um, innovation, and integrity. And I think as long as we as an organization, and then we as our quality team really focus on that and how we present to our customer, how we present to the industry, that with that transparency, um, and then making sure that we are doing the right thing, even if it's always not always the easy thing.

SPEAKER_00 1:15

Uh what certifications or industry standards do you adhere to and how do they influence your quality processes?

SPEAKER_01 1:21

Yeah. So we fall under two, um, the ISO 1345 2016 and CFR 820. Um, both of these are industry standards that we follow. They're a set of guidelines and kind of a roadmap on how to have a quality system. Um, our quality system is built around these so that when uh we are audited by governing bodies or our customers or anything like that, there's a roadmap that we follow. So the roadmap is just that. It is a set of um how we need this is done, but this is doesn't necessarily how we do it. And so we have then created a quality system that follows it and then it's tailored for us so that we can be as dynamic as we need to be for our customer, but still hit all of those rules.

SPEAKER_00 2:05

Now, and to kind of incorporating quality with the design work, which you do a lot here at Resolution Medical, what role does technology play in driving continuous improvements in your quality processes?

SPEAKER_01 2:16

Yeah, so continuous improvement is key for quality. It is something that we really strive for in our quality world, but also as resolution, as you stated. Um, I would say that the technology we have, um the easiest one for me to point to is our quality management system, which is an electronic system called Grand Avenue. Uh, we have every module that Grand Avenue offers, so all of our quality elements are incorporated into that system. So our Kappa system, our non-conformances, deviations, and complaint and feedback are all in there amongst other, I think we have almost 18 of them. So these are all the things, but all of that feedback that comes from those systems, we leverage to make better decisions that are both good for our quality system, but also good for our customers to make sure that we're moving us always forward.

SPEAKER_00 3:01

How do you incorporate customer feedback in your quality improvement initiatives?

SPEAKER_01 3:05

Yeah, so we get feedback from our customers, and some of those are more official uh routes of feedback, and some of them are just in meetings that you know the customer's like, it would be great if we did this. We take all of that feedback, and sometimes it is how we can do a process better. Uh, sometimes it's how focused the processes need to be, and sometimes it's really about the products themselves. And we take all of that feedback in, and then we kind of have a risk-based approach as we're looking through that and saying, um, what processes are strong enough and we can move forward with those, and which ones aren't. And then also from the product say, uh, the customer might say, we really want this, and we'll look at that risk and say, Yeah, we can make sure that happens, or maybe this isn't the time for that and we need to do something else. But we definitely are always listening to our customer, and that is across the board, because I think uh back to that transparency that I brought up earlier. We definitely want the customers to understand where we're at and be confident that we know what we're doing.

SPEAKER_00 4:01

I have no doubt there's a lot of evaluation work uh when it comes to quality. Can you explain how quality testing and validations are integrated into your manufacturing processes? Sure.

SPEAKER_01 4:11

Yeah, no, that's great. Um, yeah, so we have to test or validate every part of our process. So the goal is at the end of this that we can prove that we have a safe and effective device. So there are requirements that we have from the FDA or BSI or governing body that say you have to either uh validate a process or you have to be able to verify it. And so anytime that we can't verify, which is what I would probably put under testing at this point, we will validate either the equipment or the process to prove that no matter what we do, we get the same outcome every time. The testing part of it is definitely based on risk and a risk assessment on um how risky this is. And then that kind of changes where our testing is. But we have incorporated that right into our process. So while we're building, we have tests in in line. Um and then if there's a reason we can't verify, we will validate that process or we can validate the equipment itself. But again, the whole goal of both of those is to, at the end, be able to say our product is safe and effective.

SPEAKER_00 5:12

And I'm sure for validation, for an example, would be something that if it's a destructive test or something like that that you couldn't verify, you'd have to validate. Um, what strategies do you use to identify and manage risks during product development and production?

SPEAKER_01 5:26

Yeah, so as I was just saying, we kind of evaluate that risk and that's decide, it helps us decide what we need to do from a testing. Our main tool for risk assessment is a tool called an FMEA, failure mode event analysis. It's a living document that lists out everything that can go wrong on it on a product or a process, and then it'll define it by either severity, occurrence, and detection. So how scary is it? How often does it happen, and can we find it? And then we take, we assign values to those, and then we merge those values until we get a number. And then depending on how high that number is, we have to take different mitigations. So if we have an identified failure, we will then maybe have to mitigate that with through of other testing, through verification, through validation. Um, we may have to, you know, have a different level of person on that. But it really is uh line by line of what can go wrong and how can we make sure that it never happens.

SPEAKER_00 6:20

Great. Um, how have your quality processes evolved in response to industry changes or emerging challenges?

SPEAKER_01 6:27

Yeah, I would say that one of the things that we're taking on right now, like I said, we have this Grand Avenue electronic quality management system that houses all of our documents and all of our processes. It's electronic, it allows our customers to see what is their stuff. Um, but as we're moving forward, right now we're a very paper-based quality system. We're bringing on a new system that uh incorporates with our ERP system called Fuse. And Fuse will now remove the paper from most of our processes out on the floor. So all of our DHRs, our uh device history record, um, and where that's where we write down who did what when is now going to be incorporated right into a system, an electronic system, where it's just you write down the value, you type in your username and password, and it captures it. I would say that for a contract manufacturer, contract design house like we are, this is rare. We don't see that a lot. A lot of them are still on paper-based systems. And this is showing um as the industry's maturing and advancing, we're trying to keep up, if not be ahead of it.

SPEAKER_00 7:27

Sounds like an environment conscious decision that you guys are heading towards that. That's true, yeah.

SPEAKER_01 7:31

That's another part.

SPEAKER_00 7:32

Um, how do you communicate your quality standards and performance metrics to your customers?

SPEAKER_01 7:37

So we have a couple different tiers of communication that we have with our customers. We have the, you know, the quarterly business reviews, the monthly reviews, and then we even have weekly conversations with our team. Uh, we have at that time we can talk about all types of metrics, more business manufacturing metrics, but in that same time, we get to talk about our uh quality metrics. So our non-conforming reports, non-conforming material reports, how many we're having, how close they are, any deviations, any uh kappas, which is corrective action and preventive actions. Um, all of those levels of detail we can talk about weekly. Um, the other thing that we do is we are audited by our customers, and they come in and then they're gonna look at all of that information. They're gonna come and see how many non-conformances we've had, what did we do about it? Um, if there was any other signals that they would be conscious of. Uh, we have that. We are again going back to that transparency that I brought up earlier. We're very transparent with our customers and we are really careful about making sure that they know what is most important to them.

SPEAKER_00 8:36

Sounds like all impressive work, Mark. Thanks. Uh one final question. What future trends in quality management do you see impacting resolution medical and how are you preparing for them?

SPEAKER_01 8:46

I would go back to that new system that we're putting in place. I would say it is going to allow us to be ahead of the game. A lot of times with the paper, you do all the work and then can look at it. You're a little behind that process. But with this new system, we'll be able to see it live. It is a as needed uh metrics, so we can get ahead of that. Um, I think that's really gonna push us, like I said, push us ahead and push us into the future that kind of may be differentiating us from other uh contract houses. Um, I think those were the the main ones that I that I had right now.

SPEAKER_00 9:18

Great. Well, Mark, I want to thank you for joining us on Pursuing the Pulse and providing a little insight to our viewer audience about the quality group here at Resolution Medical.

SPEAKER_01 9:27

Thank you. Appreciate it.

SPEAKER_00 9:29

This has been Pursuing the Pulse. Thank you for listening. For more episodes, visit us at resolutionmedical.com backslash pursuing the pulse.