In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product’s journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point of patient use.
Dr. Katzenmeyer-Pleuss highlights the significance of the upcoming ISO 10993-1:2025 standard and its renewed emphasis on life cycle-based risk assessments. She explains how the transition between global markets—particularly between the EU and the US—can lead to unexpected FDA deficiencies when manufacturers rely on justifications that worked for notified bodies but do not meet more stringent FDA testing expectations for reusable or in situ curing devices.
The discussion concludes with actionable advice on early design decisions, such as narrowing down material suppliers and reprocessing options to reduce testing burdens. They also explore the critical need for cross-functional communication and quality system integration to ensure that learnings from one project or regulatory interaction are captured and applied across a company’s entire portfolio.
Love this episode? Leave a review on iTunes!
Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
01:45 – Introduction of Dr. Kristy Katzenmeyer-Pleuss and the mission of KP Medical Device Consulting.
04:12 – Defining the Medical Device Life Cycle: Concept to decommissioning and the "hidden" phases in between.
05:30 – ISO 10993-1:2025: The impact of the new biological evaluation standard on risk-based approaches.
09:15 – Global Regulatory Discrepancies: Why a device approved in Europe might face hurdles at the FDA regarding "worst-case" testing.
13:40 – Reusable Devices & Reprocessing: Managing the "permutation explosion" of cleaning agents and sterilization cycles.
17:22 – Early Design Decisions: How limiting options in the IFU can significantly decrease your regulatory testing burden.
21:05 – In Situ Curing Devices: The unique testing challenges of materials that change states during use.
25:10 – Quality System Integration: Strategies for linking regulatory deficiencies and materials across multiple projects.
In this episode, Dr. Katzenmeyer-Pleuss mentions In Situ Curing. Think of this like a medical-grade "liquid bandage" or dental filling. The device starts as a liquid or gel and is applied to the body, where it then hardens into a solid "in the spot" (in situ).
From a regulatory standpoint, this is complex because you aren't just testing one device; you have to test the safety of the liquid, the safety of the solid, and any chemicals released during the hardening process. It is essentially three devices in one when it comes to testing.
"The life cycle is really the concept of the medical device from when it’s a concept all the way through to the end where you are disposing or decommissioning... shelf life and transport are steps that usually don’t get a lot of focus, but they are very important." - Dr. Katzenmeyer-Pleuss
"You might have one device where literally they don’t ask these questions at all, and then other times they’re very, very picky... the longer you go in that process, the harder it is to pivot without spending a lot of time and money." - Dr. Katzenmeyer-Pleuss
What are your biggest hurdles in managing the full medical device life cycle? We want to hear from you. Whether it's a specific regulatory challenge or a topic suggestion for a future guest, send your thoughts to podcast@greenlight.guru. We read every email and pride ourselves on giving personalized responses to our MedTech community.
This episode is brought to you by Greenlight Guru. When navigating the complex life cycle of a medical device—from the initial risk assessments discussed today to post-market surveillance—you need a unified system. Greenlight Guru’s QMS (Quality Management System) and EDC (Electronic Data Capture) solutions work together to ensure your data is linked, your testing is documented, and your clinical trials are seamless. By connecting your quality and clinical data, you can avoid the "disjointed" project management pitfalls Etienne and Kristy discussed.
Etienne Nichols: Hey, everybody. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols.
I'll be the host for today's episode.
That's the line I see in every episode, and I forgot how to say it right today. But anyway, good to have you all with us today. Today I want to talk about what I'm kind of titling and you know, maybe the title changes.
We talk through this, but the hidden physics of the medical device life cycle, or really the lifecycle of a medical device. The things that you need to be thinking about in the early stages, things you need to be thinking about as you come onto the market and then as you pull the device off the market, some of the things you need to be thinking about.
With us today to talk about this is Dr. Kristy Katzenmeyer-Pleuss. She is the President and Founder of KP Medical Device Consulting, which is a boutique firm built by former FDA reviewers and senior industry experts.
She spent her career on every side of the table, the FDA, the global consulting now advising companies from early concept through post-market. And her expertise spans regulatory strategy, biocomp, sterilization, risk quality, clinical investigation, clinical evaluation, and so in this episode, what I'm hoping for is that Kristy can bring that end to end view of the medical device like medical device lifecycle, what regulator’s expect, where teams stumble and how to build it right from day one.
I think I'm also expecting and hoping that she will be able to talk better than I can Talk today. But Dr. Kristy, thank you so much for being with us.
How are you today?
Kristy Katzenmeyer-Pleuss: Yeah, good. I just love how it's like you; you're my name you pronounce perfectly. Which is probably the most difficult part of that.
Etienne Nichols: Well, my mom tells, you know, she tells me I don't say my name right, but I recognize the importance of saying name people's names correctly. So, appreciate that. I'm glad I got it.
Kristy Katzenmeyer-Pleuss: Yeah, yeah, it’s a very long German last name and I lived in Germany for a while and I used to get compliments that I had a very beautiful last name. So, I thought that was a little interesting.
Etienne Nichols: Yeah, yeah, absolutely. Own it.
No, let's talk about the medical device life cycle. When we were talking about doing an episode, talked about the life cycle and it, it took me back several years to when I was a manufacturing engineer, particularly the end of the life cycle.
I remember a product manager who said, I have 150 SKUs that80 per. 80 of them or 80%, I don't remember which. He said, I would love to get off our catalog, but I don't know how to get rid of them.
And so, I systematically just started hacking away at this as a manufacturing engineer.
Some people liked it, some people didn't, but I don't think we always think about that. And. But let's start at the beginning. I don't want to just skip to the end, but maybe we could talk about where we're going.
What is the definition in your mind of a medical device lifecycle?
Kristy Katzenmeyer-Pleuss: Yeah, yeah. And I, I was gonna say one reason we're kind of, I guess, I think we got on this topic when we were talking previously was the. The new ISO10993 part one.
That's coming out soon. And I, I think you said that you'll have another podcast focusing on, solely on that. So, I don't want to go too much into the standard as a whole, but basically that's related to biological evaluations of devices.
And so, part of that standard is really a renewed focus on this medical device life cycle.
And basically, in that standard, at least there is a definition. So, if anyone wants to look at it in more detail.
But basically, yeah, it's just the concept of really the, like, medical device really from when it's like a concept, then all the way through to the end where, you know, you're, you're disposing the device or decommissioning, whatever, that stuff would be the last step and then everything in between.
So, use, obviously, in the patient, I think is pretty much like the focus of what everyone thinks about all the time, you know, but there's also, like, what about the shelf-life part of it? You know, when you're sitting on the shelf for a while, you're going through transport, which could be a whole host of different things.
And then after, you know, use in the patient, are you then reusing the device to be used on another patient? Or, you know, are you actually discarding the device at that point?
So, there's a whole lot of steps, I think, that usually don't get a whole lot of focus, but they're very important.
So, this new standard really like, focuses on that a lot.
So that's kind of, I guess, where this idea came from.
Etienne Nichols: Yeah, and so, I mean, that's a really good point. I mean, if, If companies don't know what the lifecycle of the devices are if they haven't defined it for themselves. Obviously, there's the definition for 109931-2025 but they, they're not going to be able to, to meet that standard at some point.
So, what would you say, are there areas that you feel like companies really underestimate the risk? I know 109931, the new, the new version is really thinking and focused about a risk-based approach the way a lot of, a lot of the industry is moving towards.
But are there any areas that companies are really underestimating that risk?
Kristy Katzenmeyer-Pleuss: Yeah. And it's interesting because so for the 2025 standard, it's not yet recognized by FDA, so there'll be sort of an interesting transition period where there's a whole host of things to think about with this new standard.
So, if you're like a global manufacturer especially, it's going to be really complicated for a while. So, it'll be not just looking at biological safety, all that testing, but kind of like a regulatory strategy perspective too because okay, say you've thought about all these things for like the EU market, for example, now you're going to FDA.
Well, you just send them your risk assessment type documents without modifying them and go straight to FDA. It might open a whole can of questions.
But I would say like from a high level maybe there needs to be more of like a public service announcement to even think about this idea because, and that's I guess what the standard is.
But I would say mainly the risks are just there's really a lack of thought about it is what I see quite often.
And so, a lot of times people don't really start thinking about it until they get, you know, FDA deficiencies or you know, maybe they get non-conformities from their notified bodies.
So, then they start realizing, oh yeah, you know, we, we do have a device that you know, goes through say reprocessing cycles. So that's, you know, a reusable device. You may have like cleaning, disinfection, sterilization processes, you know, after it's used on a patient. So, then they start realizing, oh actually that can affect quite a lot of my device and all the testing I've done.
Etienne Nichols: Yeah.
Kristy Katzenmeyer-Pleuss: So yeah, it, it can really be pretty eye opening for a lot of companies.
And so, if I would say it also affects, you know, you'd probably think like, okay, maybe this is affecting smaller companies more.
You know, they maybe don't have as much expertise in house, but I've seen even pretty large companies get surprised. And, you know, had colleagues, even from pretty large, you know, companies like Medtronic, colleagues say, wait, do we really have to do this testing? So, I mean, I think it's pretty much catching a lot of people off guard.
But yeah, so I think that's kind of more the risks is really like, you know, getting so far down the cycle before you realize that that maybe an issue.
So, the longer you go in that process, it's harder to pivot later without spending a lot of time and money. So that's kind of when you get.
Etienne Nichols: After you're on the market and you maybe, let's say you've missed the test or something, you realize, oh, there's, there's something that, you know, maybe we didn't evaluate correctly. Is it a matter of retesting or, or is it a matter of.
Because at that point it's not a matter that doesn't seem like it would be a matter of just testing to show that you are safe. It's really a matter of, well, now we've the real world, the testing has happened in the real world, and now we know that there's a problem, we need to change our design. I mean, and maybe I'm missing something there, but what's the cost of doing that?
Any thoughts?
Kristy Katzenmeyer-Pleuss: Yeah, and actually that's a really good point because especially for like global manufacturers, you know, you may have a device on the market, say in Europe, and then now you're going to the US.
So, I've actually seen this quite often where that is the case. They start getting questions and for the FDA about these topics, like the life cycle.
And it wasn't really a topic of concern in Europe.
I would say in general, like in the European market, they're usually a little more lenient towards like risk assessment justifications.
So, they may have a device on the market where maybe they didn't go through all of that testing and it was based on really, you know, solid justifications. They haven't seen any issues.
They may come to the US market and then be surprised when they're asked for additional testing. So that's kind of where it can be a pretty big surprise.
And I would say it also is really variable at FDA, unfortunately, like depending on the review team you get and the reviewer, I mean, you might have one device where literally they don't ask these questions at all.
And then other times they're very, very picky, you know, asking for pretty much all of your testing in the submission. So, like performance testing, which could be mechanical bench testing, know electrical safety. You can see all that after this. Like I'm kind of more thinking reusable devices where they go through like a reprocessing step.
So, I've seen that from FDA where you know, they're asking for, okay, you did all your testing and your submission on a new device, but this device could be used say 100 times, you know, or it could be unlimited uses. That's also another.
So how do you estimate, what is that max use life?
So, then I've seen a lot of questions, you know, saying, well, can you prove to us this device is as safe and effective at that maximum use life as it is in the new, you know, the very first patient use.
So, I think that's where it can be quite shocking to people because if you did have to repeat testing like that, that's very, very expensive.
And yeah, and I've also seen some cases where, thinking again more, this is more like reusable devices. But you know, if you have sayin your instructions for use, you say, okay, this device could be, you know, cleaned after it's used, but a whole array of different cleaning agents. So, they may ask for like, okay, well let's test after each combination of those which can be quite.
Etienne Nichols: Yeah, yeah, your permutation gets high.
Kristy Katzenmeyer-Pleuss: Yes, exactly, exactly. And it's really burdensome.
So yeah, I think there's some cases where like if you can think about that early on, you know, you just really want like it's easy to adjust your IFU later, but it's not easy to adjust your testing scheme that you did. So, if you already went through that process, then to go back and say, oh wait, I didn't think about that.
So yeah, that's why it's good to think about this. In the early concept stage, I would say.
Etienne Nichols: I remember when I was working on a UDI project for the direct part marking, we did some of that testing and we built a matrix that said, okay, all these different conditions and all the different types of materials and these are the tests we're going to do.
And oh, it's crazy how much we, we almost need to eliminate. Okay, we're not going to allow these different scenarios to happen. So maybe we've already answered one of the questions I want to ask, but I'm going to ask it anyway because there's probably something that we haven't covered yet.
But early decisions that companies are making that have big long-term impacts on whether it's testing or your regulatory burden or you’re the risk in the real world.
Um, what are some of those early design decisions that you feel like maybe get overlooked?
Kristy Katzenmeyer-Pleuss: Mm, yeah. Yeah, I think, like, that's a really good question. And it sounds like whoever. Yeah. You were working previously sounds like you're pretty thorough. So that's.
Etienne Nichols: We tried to be. But yeah, at the same time, you get these whole nuts cut the science.
Kristy Katzenmeyer-Pleuss: Project, and that's exactly what happens. You start seeing these questions. You're like, thinking, well, is it really worth it to have this additional cleaning agent? Is it going to really help the user or not to do, you know, this extra testing?
And, and I want to say, like, every single case requires like this extensive testing. Sometimes it is reasonable to have some, you know, risk assessment and justifications.
But yeah, I think that early on it makes sense to, like, look at.
Okay, is the design of the device in terms of, like, the materials is a really good example that you already brought up. You know, do you.
Like. A lot of companies I see they're very worried about different suppliers for. For the materials. And it totally makes sense. Especially after Covid, you know, you have all these, like, supply chain issues.
So, I, I get that.
But then they also want to give, like, a lot of options to the user for.
Especially for like, this reprocessing idea for reusable devices. They want to give them, you know, you can use whatever cleaner you want. You can sterilize in five different ways. You know, all of this.
And so, I think it's like, trying to narrow that down, like, what's actually needed. You know, if.
Is there anything you could justify to combine some of that together?
If not, then, you know, is it really worth adding some of that?
But yeah, I think just thinking about.
I think just for people to be aware of that, that that could happen is kind of pretty eye opening from the beginning.
And I think the other, you know, we've. I guess I've been talking a lot about reusable devices, but the other aspect of this life cycle is, you know, shelf life and transportation. Like, do you.
And then. And the other ideas for a lifecycle is sometimes the device itself changes, like, while it's in use. So, you might have devices that here in situ, like you apply it as a liquid and turns into a solid on the patient.
So, there's like, a lot of things to think about throughout that process. And basically, at least for FDA, like, they're going to ask you, okay, we need testing throughout those phases that you just told us about.
So, there's been thinking about, what are you trying to accomplish for the device like therapy, does it need to be cured in situ, or could you apply it as more of a solid?
You know, there's a lot of those kinds of thoughts as well.
And then it all gets very circular. You know, see how its pans out, quite complicated.
So, you know, you might think like, well, if I don't do that, you're basically like, if I now have in situ curing device and it's a liquid, then it turns into this intermediate, then it's a solid and you have basically three times the amount of testing that you would have.
So, it's really thinking about that from a, you know, cost perspective. You know, what are you trying to achieve in terms of your actual like product intended use and all that?
Etienne Nichols: So yeah, you know, that's, it's interesting. We, we're talking about kind of reducing some of the testing so that. Or reducing in your IFU at the beginning or those decisions. What about future options?
How do you keep those future options open instead of locking into one outcome, any, any common pitfalls you've seen with that like information?
Kristy Katzenmeyer-Pleuss: Yeah, that's a good question. So, I think, I think that's good to think about. Like if you, if you maybe start with like what your ideal situation is. Like you were exam, you know, giving that example of the whole matrix of these materials and you know, and thinking about, okay, are any of these absolutely necessary? Or you know, if, if we would like to, in the future we'd like to add on these different materials, different suppliers.
You know, maybe you do have a reusable device, and you want to add on different sterilization modalities to make it easier for the user.
Kind of good to think about early on still that maybe you can design the testing where it could be a worst case for all of those options.
And what I mean by worst case is usually FDA, when they're looking at your testing, they want to, they don't usually look at like averages, you know, like, oh, this is commonly how it's used. They're like, what is the worst case that could happen? You know, and what's most sensitive patient.
So that's usually what they're looking at.
So, I think it's good to just think about that aspect. Okay, what's your best-case scenario? Like we really want to get X to market, but in the future, you know, we really want to add this other design feature. We want to add this additional reprocessing chemical whatever.
If you could design your testing that way to maybe include, include that or what would be the worst case of all of those options? So, you're not kind of limiting yourself later.
And then I think also like, and maybe, actually maybe we'll get into this a little bit later too. But just discussing with like the regulatory agencies early too, so you can kind of get a sense of like how, you know, how strict are they going to be on these life cycle requirements, you know, and in some cases, like I said, they're, they're much more lenient than other times.
Etienne Nichols: So, I like that idea too, because if you get, if you get that information early, it could impact your strategy in a few different ways. And I'm going to you pressure test, pressure test this for me. But if I'm thinking about, okay, I get in there, I've got one set of testing requirements that I plan to go through and they say, well, we'd really like to see XYZ and, and there's no way out of it necessarily.
If you think, okay, well I'm gonna, that's gonna take me 90%of the way to where I want to get for a future iteration. Well, if I just go that extra 10%, could you do something like a PCCP where you say, we're planning to roll this into a future change, we're not gonna do a special 510(k)in the future. And then you now you've added to your regulatory strategy for a future indication.
Does that make any sense at all what I just said?
Kristy Katzenmeyer-Pleuss: Yeah, yeah, no, that's exactly right. Like, I, I totally agree that, you know, there could be, with one small tweak in your protocol, you might be able to cover that future change possibly.
And so, it's good to talk with FDA about that early. I know a lot of companies are pretty scared to do that, but they're really there to help you. That's kind of what they're trying to do in the end.
And so, then you might get a, like an early sense of like, okay, how serious are each of these issues to them? And what, like, if you're, if they're thinking the testing is going to be much more extensive than what you thought, it's very good to know that.
Then you also can be prepared if you do want to like, go back and try to justify things more that you're like a little more prepared.
Because a lot of times what I see is like, companies go to FDA, haven't thought about this at all. They get questions and then they tell, you know, basically their response may be, well, we didn't think about the shelf life, you know, and how this affects the device. But we know our device or we know our materials are stable and that's kind of like a one sentence answer to the agency, which they don't always agree with.
Yeah, you know, you have like a little more, you know, scientific, like justification from literature or data or maybe they have, do have devices on the market, you know, globe, some, some somewhere else, say like Europe or Asia. You know, they could gather all that, you know, post-market surveillance data or you know, maybe they have some kind of durability testing for those materials.
So, there could be a whole host of different things and it's just good to kind of be aware of that early to adjust the plan.
Etienne Nichols: Yeah, yeah, that makes sense. And, and I, I agree, I think talking with the FDA early, I mean, and maybe just changing in our mind what we see the FDA as is not so much a hurdle to overcome, but a partner that can help you make sure that your device is going to be safe and effective when it's on the market so that you don't have issues later.
I know a friend of mine, Mark Duvall, has talked to me about, well, just from the legal side, you know, less of the regulatory potential issues you may face, maybe more important than that, or the product liability issues you may face if you don't do it right.
Kristy Katzenmeyer-Pleuss: Yeah, yeah, that's very true. Yeah, let's say he would be definitely one to know about that. So.
Etienne Nichols: I'm curious if you have any thoughts about maybe a, how quality system could impact how a company approaches this when it comes to planning out the life cycle of your medical device and so on.
Kristy Katzenmeyer-Pleuss: Yeah, yeah, that's actually a good question because you know, I've just seen lately there's a lot of like disconnect in the activities the companies are doing and it especially is affected by this, you know, this life cycle, the device ideas.
You know, you're, you're doing one risk assessment totally on this other team and then you're not realizing, oh, how does that impact this other like risk assessment? So, for example, this standard we were talking about, the ISO 10993 part 1, you know, that's specifically for biological evaluations. So more commonly like biocompatibility devices.
So historically a lot of companies haven't really looked at that as a risk assessment. They've looked at it just like check list of testing.
And so, I think when there's some other changes in the company that are happening and it could even actually be from say like a regulatory agency interaction, it could be, you know, your notified body asked you, hey, how is this shelf life affected?
Or you know, is how's your device affected throughout the shelf life?
You know, may have responded directly to them, but did that feed back into your risk assessments, for example? And especially like if it, you know, did it flow into this biological evaluation?
So, I think if there's like ways where your quality system is really clear to link all of those things together, you know, and especially if you do get deficiencies from regulatory agency, like are you able to track that well with all of your internal documentation so that in the future if you have that, say that risk assessment is updated for different reasons, like, are you keeping all of those questions in mind as you're thinking through this process?
Like say you, in the future you decide totally unrelated, you just change a supplier for one of your materials or you change the material itself.
You know, this agency asked you these questions in the past.
You know, how do you kind of track that together? So, I kind of see sort of a gap there a lot of times where there's people are more. Keeping track of that more in their heads or just.
Yeah, yeah, in somewhere or like, you know, and if that person leaves the company, then you're, you really have lost all that knowledge. So, if in your quality system, if there is, you know, usually have some tracking, but like it's not always as clear, I feel like for how that all fits together.
Etienne Nichols: So, if in a, in a perfect world, how would you, how would you make that happen, do you think?
Kristy Katzenmeyer-Pleuss: Yeah, that is a good question.
Etienne Nichols: And I can, I can. Well, and I, it's, it's funny and I don't mean to put you on the spot necessarily with that, although I guess, I mean, if you have a. Let me buy you a little bit of time because when I think about, you know, your quality system is your approach to quality, and I do think you should document how you have learnings and findings.
So, when I was a project manager, I got my PMP on that UDIDPM project, by the way, direct part market. And so, I went on to a product development company, and I did learn a lot about how to do the risk management, the design controls and all those things.
But linking is still hard. And even though we have our approach to quality, that I think is a. It was really good, was strong. We really focused on trying to meet the regulations, the spirit of the law, not just the letter of the law, which I think is one of the keys to really doing a good job.
And I could think of maybe a few ways to.
Because again, we were disjointed as well, where there was this team working on this project and I was working on my project and occasionally we would talk and I'd say, oh, you're not using that supplier because of this anodization process is issue or okay, maybe that we should do the same thing.
And you know, we get into the argument, is that a preventive or a corrective action? I don't know, you know, but. And really start utilizing the findings from other teams, other product lines, maybe even other medical device companies out there and then put them in.
But, but, but making sure that stays together or linking them somehow is difficult. And so, I don't know if you have a suggestion.
Kristy Katzenmeyer-Pleuss: Yeah, I know. Yeah, I agree with you because it gets, it gets complicated because like you said, there's multiple teams working on different aspects and then everybody has their own areas of expertise.
So, like even if you were, you know, on one team and you switch to another, like you're going to have a totally different viewpoint from everybody.
So, yeah, I feel like there's obviously the general communication, you know, trying to get those teams together.
But I think like from almost from like the software perspective in your quality system, you know, that's the part where it's like, it's a little hard because unless you're making your own quality system like yourself, you know, maybe you could do that. But yeah, I think relying on, you know, experts that do develop that and you know, have, you know, some linking there available and I don't know if there would be like a good way to sort of like say something if you could like flag something in the system if you have a specific type of change to.
Okay, yeah, reevaluate these specific aspects. Even though you, from a general sense, you know, you have to update risk assessment, but you might not think, oh yeah, but I actually should update this more specific biological evaluation plan, for example, I think.
Etienne Nichols: Yeah, go ahead. Sorry.
Kristy Katzenmeyer-Pleuss: Oh, no, no, yeah, I think that's just an interesting idea because it's like, it's like you're trying to like you have all these like to do lists everywhere and that's. I have to see how this is all working together. So.
Etienne Nichols: Yeah, well, it is one of those things where we shape our tools and then our tools shape us and you kind of paint yourself in a corner sometimes. I will say, just because I don't mean to just shamelessly plug, I guess, Greenlight Guru and the software that we produce, which is the eQMS platform for Those listening if they're not familiar and just.
I'm sure other companies have a similar way of doing this, but the way I would do it in Greenlight Guru and incidentally, I guess before I talk about that, when I was managing my project as a product, a project manager, it was in Excel and I used Microsoft Project as my project planning software but everything else was in Excel and that was tough.
And that's actually one of the things that I think, wow, Greenlegger does a such. I would, I would have been such a good project manager with this tool.
If you get into the design controls matrix and in your user needs or actually, I suppose it'd be in your design inputs when you have that material specification selected or maybe the specification would be an output and you have your whatever wherever you wind up being.
I would tag that to another project that uses a similar material. So anywhere who uses that material, we would tag across all of these different projects. So, then you search, you'd say okay, I'm going to change this because we had a supplier issue, we had a biocompatibility issue.
I know these other three projects use the same material. Do they potentially need a similar biological evaluation or change? And that's the way I think I would handle that with our software.
Now again like I say we shape our tools, that our tools shape us. We figure out how to do it in different ways.
Kristy Katzenmeyer-Pleuss: Sure.
Yeah. And I, I guess I'm curious to your insights about the like the. I think that's great that linking of a really great idea. And then I'm kind of curious your thoughts too of linking.
Like if you do get a say, we'll just say FDA deficiency on this lifecycle testing idea.
You know, if you have any ideas of linking that in the quality system that would be kind of alert or keeping track of that I guess is one. But also, like trying to think of.
Okay, is that an alert for. Yeah. Other projects at all?
You know, definitely. If you have one that's like on the pre-market side and you're using similar device design or materials or something. Seems pretty obvious but like.
Yeah. Do you I guess be interested in your thoughts there?
Etienne Nichols: Yeah, well, I'm just thinking about. So, if you had a deficiency letter. I think if I had a deficiency letter there would be obvious.
I think I would maybe open a kappa and then that way you could do a root cause investigation. You, you could see all the different places this could potentially reach and do that.
I mean search and destroy mission. You just essentially you search all the different potential places this document or this, this material or whatever deficiency could arise and then link that deficiency letter to that particular design control item, whether it's your design input or design output, so that every project that has that potential and you do that evaluation, you may decide, no, we're not going to change anything.
But you go back and you see there's a link to this deficiency letter so that in the event of an audit you could always have the history say yes, we had this efficiency letter.
We linked it to this; we did an evaluation through this CAPA. We decided it actually doesn't need to change. And this was our decision at the end of the CAPA because you know, maybe the CAPA covered four different projects.
This was the decision A, this is decision B, and across all four. And I think I would document it that way.
Kristy Katzenmeyer-Pleuss: Yeah, yeah, that makes sense like that linking of the deficiencies because.
Excuse me. Yeah, there's like, I think on the audit side a lot of companies do a better job on that. But on the pre-market side with the questions where it's, you know, you're just responding either interactive.
Etienne Nichols: Right. Yes.
Kristy Katzenmeyer-Pleuss: You know that I feel like. Gets lost a lot of the times and then there's no like, I want to say never but like there's, I feel like there's less of a chance for that to kind of carry forward to other projects. So, I think.
Etienne Nichols: Yeah, that's true, that's true. And so. Okay, I'm sorry, I was, I did get kind of into the post market mind. I'm thinking like end-of-life cycle type stuff and, and you know, but no, the deficient seller early on during your regulatory submission, you could include that in the.
Well, I would, I think I would include that in the DHF or at least the com. Compilation of all those documents associated with that project and, and link that with that.
Link it also directly to that material specification.
Kristy Katzenmeyer-Pleuss: Yeah.
Etienne Nichols: Always know how you, how you arrived at decision.
Kristy Katzenmeyer-Pleuss: Yeah, yeah. And especially if you had any. Say you had just like written a justification, you know, how are you, are you documented documenting that in any type of controlled document or is it.
Was it just sent to FDA and that was, you know, one response or you know. So yeah, I feel like it's, it's just the documentation side is very helpful and I think, I think there's just like a saying with FDA like if you never wrote it down, was never thought done, you know, so it's like written down and it's, you know, linked there appropriately. Then there's a less, much less chance that Somebody will miss this in the future.
Etienne Nichols: So personally, for me, when I come on a project and you know, I've had the opportunity to come from the very beginning, but I've also been dropped in the middle of projects and when you're dropped in the middle of a project, you want to know everything that came before you.
Because that is so helpful. If someone documents. That is so helpful.
Kristy Katzenmeyer-Pleuss: Yes, for sure. Yeah.
Etienne Nichols: Yeah.
So anyway, no, that's fun conversation.
You know, I, I just think it's funny. I mean traceability is really what it comes down to for me personally and I, if you have other thoughts on the quality system and what it really does is. But for me the traceability is, is really how a quality system, it's just like the, I don't know, maybe it's the arteries, not the heartbeat of the quality system, but it seems to be the heart of the, the veins and the arteries.
Kristy Katzenmeyer-Pleuss: Yeah, totally. Yeah. I was just laughing thinking like, you can tell we're a bunch of engineers like talking about like right, documents.
Etienne Nichols: Well, yeah, I remember, well I remember finding myself in the middle of a, a guided FDA inspection one time where it was kind of a whistleblower moment situation. It wasn't my product line, but I remember having to work, I don't know how many hours we worked, but it was all hands-on deck. We were all in the back room, like papers were everywhere. We're lining this out and I did a, a trend analysis to see the amount of injuries that happened after a certain thing came out or whatever and trying to find more documentation and more documentation like, so we've got to make this thing look as good as possible. I mean accurate. But I mean we just, we just want to fill it up with documents so that we know what we're presenting is accurate and just the more information you can have, the better informed your decisions are. So yeah, saying the, speaking the obvious probably here. But anyway, how do you think teams should be thinking about post market and end of life planning?
Any other thoughts about that? Any other things that you recommend?
Kristy Katzenmeyer-Pleuss: Yeah, yeah. And I think in relation to this standard too, I know you're going to have another, you know, podcast about it, but one idea that's just like, I think comes kind of from that standard is really like again like a risk assessment approach. So, if you're, you're already marketing the device and you're, you know, you've done clinical studies or maybe you just have now like post market surveillance data in humans, it's really like taking that data and like Feeding it back through this whole idea again, like the circular life cycle, you know, where say, say you, you get some information from complaints that users are using your device in a different way than you thought.
Well, now one of the concepts of this new standard is really looking at reasonably foreseeable misuse. So, you might have to take that information, go link it back to this risk assessment or biological evaluation. And what does that mean now? Does that mean any additional testing, you know, it could cause a recategorization of your device?
Possibly.
So, like a good example is like, maybe you get a lot of complaints that you have particulates from your device that are coming off and you know, getting implanted in patients, or maybe the device is breaking and you know, you never evaluate or you never thought about that in the, in the initial risk assessment because, you know, you have other testing that may, you know, be using to show that doesn't happen.
But once you get into humans, maybe there is something that the user is doing differently than you expected. So, it's trying to take that information then and like feed that back through this risk assessment process.
So that's going to be a really interesting thing with this new standard because I think on the European side, like, you know, they're already doing like clinical evaluations that are a formal, like requirement of the EU MDR, whereas on the US side there isn't really those requirements pre-market.
So, and even, even these, like, some of these risk assessments aren't really required necessarily for the FDA submissions.
So, there's like a little more of, I would say, like a gap on the US side for pre-market and post market. So, they're handled by like totally different teams.
So, you can see how some of that information may not be totally linked together in the same way.
So, that's also why if you are like a global manufacturer, it really helps to think about the different markets and how they're handling this data. Because if you're in Europe and you're, they're very used to looking at clinical evaluations and all this data feeds back in and then you send that directly to FDA and they're not used to seeing that.
You can see how that would raise a lot of questions.
So, it's just really good to think about your strategy with this whole process. So, I, I feel like there's.
Yeah, there's a whole lot of things to think about, I guess, with that, with all of that.
Etienne Nichols: Yeah, that strategy thinking is really important. You know, I mean, if you think about, I mean, I, I think kind of in Graphs, but I almost feel like this might be a 3D graph. So, you want, want the life cycle of your device. You've got to think about that, but you've also got to think about where you're taking it across the different markets and then the depth might be the amount of testing you have to do across for each one of these.
I mean it's just; it is a really, it is a strategy that you have to be thinking of not just, oh, we're going to do this, we're going to take it to this market and then eventually we'll come here.
You might be better off flipping that going to one place first or the FDA first, for example, or something like that.
Kristy Katzenmeyer-Pleuss: For sure. Yeah. Or just strategizing. Yeah. What types of documents you're sharing and why and you know, how you're wording it and in different markets and things like that. So, it's, yeah, it's a very interesting thing to think about.
Yeah.
Etienne Nichols: Any, any last piece of advice for companies as they're planning their, you know, and, and I asked this on a previous episode actually, if you were to give advice to three companies, three different companies, particularly as they start doing their end-of-life planning.
So, they're, they're or, or going through their end-of-life planning. If, if it's company A who's just now has an idea and they want to go through a prototype, they're just right there.
Company B is one who's, they are about to get the irregulatory approval from the FDA or about to submit to, to the FDA and then maybe, or, or wherever and then you have another company that's on the market.
Is it the same advice? Is it different piece of advice? What, what advice would you give those three companies?
Kristy Katzenmeyer-Pleuss: Yeah, I, I would say like I guess the early-stage company, Company A, I think that's where there's really a good opportunity to, to speak with people that already have that experience.
So, if in this case it would be a smaller company, but I guess even if it's a large company, but you know, a new device type, new project, for example, just speaking with the people either internally that have already had that experience or if you don't have the, you know, that team available, reaching out externally to people that have gone through that process because there might be something really obvious that they can see and they could really help make that process a lot smoother for I guess B, where they're about to get the approval. I guess in that case, like, you know, if you're already, I would say Continue the approval process if you're already in that and don't rock the boat.
Yeah, you know, just get through that phase and then you know, look at what types of questions came up during that process. And you know, maybe it doesn't affect your market launch per se, but it might affect other projects you're planning or already have started.
So, to really take that feedback and think about it rather than just thinking, okay, yeah, that's feedback for that one project.
But if, especially if you're going to the same review team at FDA, for example, I mean you might likely get that same question or if you for example, have that same device, you're planning a new indication or you are planning a material change, something like that, kind of looking at how those questions will be affected by that plan and then I guess the company C.
So that would be the one on the market ready is kind of more, I guess what we were talking about where if you're already in one market, maybe you're going to plan a different market now.
You know, looking at, I think that's really like opportunity again for strategy and making sure what you've done already is going to keep working.
Etienne Nichols: Yeah.
Kristy Katzenmeyer-Pleuss: Anticipate changes there. I mean like again, the standard that's coming out is a really pretty huge change.
So even if what you're doing is working, like you have to be constantly monitoring for that to see what impacts it may have.
And then again it may require reaching outside of the company if you're not quite sure, you know, which direction things are going.
Etienne Nichols: So yeah, I think that's great advice. You know, companies can definitely everybody sometimes we look at ourselves and we think, okay, well whatever advice you give that company, I'll just apply that to mine.
But really, I mean, you need to be kind of a little bit more specific. It's not a one size fits all.
Kristy Katzenmeyer-Pleuss: For sure. For sure. Yeah, for sure. And it's like even if it's the same exact company but a different device, it may be a completely different situation. So yeah, angry. It's, it's something to not take like the general advice even what I'm saying today, honestly, like take it from general's perspective but really think about how your specific device is impacted.
You're not just.
Etienne Nichols: Yeah.
Kristy Katzenmeyer-Pleuss: What somebody else is doing.
Etienne Nichols: So, you know, I have a theory and if I've said this publicly or not, but with AI coming on so heavily and everybody utilizing it so much, I think the how-to generation is going to change a lot.
You know, I mean we used to have YouTube. We used to have. We still do obviously, but my wife's.
We had a problem with our washer and dryer and my wife looked at the manual, she looked at all these different things and she called the manufacturer, they didn't get back to her.
And I just pulled out my phone, and I talked to ChatGPT, said, hey, I have this thing and it's doing this problem. They said, oh, do XYZ. And that solved it. You know, it's like it's thrown a narrow code. And I thought, wow, that's going to change some things, I think.
And I think how where we get the information is going to change and so on. So, the reason I said that is you said something about, well, even the advice I give today might not necessarily apply to you.
So, you got to think about that. I mean it's really; I think that philosophical approaches are where regulatory and MedTech professionals are going to shine through in this age of AI.
And I don't know, I'd love to hear if you have any thoughts on that.
Kristy Katzenmeyer-Pleuss: But yeah, that'sreally interesting.
Yeah. And I'm curious how, you know, at FDA too, if they're starting to use AI more in the reviews, like how is this going to shape everything? So, it's definitely like a constant changing landscape.
So, I feel like at any point where you feel like, oh, I'm feeling comfortable, I just want to like relax a bit, you know, I feel like regulatory is like never that, like always like emergency mode or like very busy mode. Like I don't know if there's ever relax mode. I don't know.
Etienne Nichols: Yeah, I think you're right. You know, I think. What was it? I think when I was engineering, one of my engineering classes, they said leadership, part of the job of leadership is to comfort the disturbed and disturb the comfortable. And I think that's, you know, in all industry really is what we ought to be thinking about.
Like am I comfortable? Maybe I should disturb a little bit more.
Kristy Katzenmeyer-Pleuss: I know, not that you should be.
Etienne Nichols: Anxiety, you know, full anxiety, but just, but just be aware and not that I'm anxious. Yeah, right, right.
Well, this is great. I really enjoyed the conversation. Kristy, any last piece of advice or where can people find you and learn more about what you're doing?
Kristy Katzenmeyer-Pleuss: Oh, sure, yeah. Yeah, I guess anyone that has follow up questions, yeah, you can feel free to reach out on. I guess we have a website you can go to. It's www.kpmdc.com so that's short for KP Medical Device Consulting.
But yeah, you can Reach out to me there.
Happy to connect with people on LinkedIn as well. So, yeah, I think there's gonna be a lot of more discussions here coming up with this standard as it. Especially as the FDA recognition comes out.
And then I'll also watch for your upcoming episode too. Cause I'm excited to.
Etienne Nichols: Awesome.
So, yeah, absolutely. No, appreciate you coming on the show today and appreciate you sharing your experience and your expertise. Always enjoy hearing different perspectives and it helps, I guess, shape my own perspective.
And so, yeah, those who are listening, we'll put the links in the show notes so that you can find Kristy and definitely reach out to heron LinkedIn if you get a chance.
You know, that's one of the things I love about this industry is people are typically willing to interact with other MedTech professionals on different levels. So, it's always.
I remember one time I just, I keep. I don't know, I.
When life cycle, the. Just the whole concept of life cycle just put me back into manufacturing mode. And yeah, I just remember I was working on a cap at one point and the threat.
I can't remember exactly what the deal was, but there were like threads that just were not making sense. Everything, everything should have been working right. But there were some issues.
We kept having the systemic issue and stuff. And so, I called the guy who wrote the standard, the ANSI standard for the screw threads, and he answered my call and he was willing to talk to me about all this stuff.
And it just blew my mind.
And it just. Yeah, it opened my mind.
Kristy Katzenmeyer-Pleuss: I was going to say, yeah, so many people in the industry are. They're really highly involved in standards committees and all those kinds of things. So, I think most people are, and even FDA, honestly, that's. The other thing is like, most of the people that work at FDA, I mean, the reason they went and got that job is because they want to help people.
So, I think there is this concept of, you know, FDA is scary. And I totally get why they. Why, like, sure, you know, when.
Etienne Nichols: Yeah, they're human.
Kristy Katzenmeyer-Pleuss: They have a lot of. Yeah, yeah, exactly. They're human. And so, they you know, I think everybody likes interactions. I think I'm hoping that will kind of change a little more too, over the year.
Maybe that's one benefit of AI. Maybe it will help reviewers have more time. I don't know.
Yeah, you know, have more like human interactions there. So sometimes it's like you just get on a phone call with one of the FDA reviewers and you're like, no, I think, you know, there might be some misunderstanding.
Here's actually what's going on and you know, discussing through risks, like I did that recently with one of the clients in this TAP program they have at FDA now. But just talking through some of the risks, they were like, oh, yeah, I understand that's not as high of a risk as what I was thinking, you know.
So, I think that's a really important point. So yeah, yeah, yeah.
Etienne Nichols: Well, awesome. Appreciate it. And like I said, I'll put those links in the show notes. Those of you who've been listening, just definitely check that out. Definitely check out Kristy's website and what she's doing on LinkedIn.
And so, we will let you all get back to the rest of your day but thank you so much for listening.
Hopefully it was valuable and we will see you all next time. Take care.
Kristy Katzenmeyer-Pleuss: Thank you.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
Email us at podcast@greenlight.guru.
Stay connected. For more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru.Until next time, keep innovating and improving the quality of life.
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.