Overcoming Submission Deficiencies due to Biocompatibility

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.

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Some highlights of this episode include:

• When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.

• If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.

• It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.

• Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.

• Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.

• When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.

• It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.

• Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations.

Links:

Chris Parker on LinkedIn

Labcorp

Etienne Nichols on LinkedIn

FDA - Overview of Device Regulation

FDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

ISO 10993-1:2018 - Biological evaluation of medical devices

Proposition 65

European Union Medical Device Regulation (EU MDR)

Medical Design and Manufacturing Event (MD&M West)

Greenlight Guru Academy

Greenlight Guru Community

MedTech Nation

Greenlight Guru MedTech Lifecycle Excellence

Greenlight Guru YouTube Channel

Memorable quotes from Chris Parker:

“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”

“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”

“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”

“Let’s try to keep out anything of potential concern that we can at any concentration.”

Transcript

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.

Etienne Nichols: Hey, everyone. Welcome back. This is Etienne Nichols, the host of today's episode. Today, I got to talk with Chris Parker from Labcorp. He's the associate department head of In- Vivo Biocompatibility at Toxikon Corporation, also known as Labcorp. Usually, we don't think about them as a in vivo biocompatibility office, but they do a lot of things besides take your blood, for example, for your doctor. We're going to be talking about submission deficiencies with Chris. What are some of the things that companies get dinged on in their submissions, for example, especially as it relates to their biocompatibility studies? These are some of the things that we got to discuss with Chris Parker in today's episode. Before we get to the episode though, quick note. This episode was recorded at our booth at MD& M West in Anaheim, California, one of the largest manufacturing trade shows in North America. We like to go to these trade shows, like to hear what's going on in the industry, and get the message out. So you may hear a little background noise in the audio, but hopefully, the message comes through loud and clear. We hope you enjoy today's episode. Thanks for listening. Hey, everyone. Welcome back to the Global Medical Device Podcast. This is Etienne Nichols. Today, we're coming live from Anaheim, California at the MD& M West show. Today with me is Chris. Oh, Chris, I don't even know your last name. We-

Chris Parker: Sorry. Chris Parker. I work with our biocompatibility program. I'm the associate department head within Biocompatibility at Labcorp. We used to be Toxikon. We joined the Labcorp umbrella last December which has been a huge transition for us since it opened up a lot of doors to really be able to serve a lot of the sponsors from start to finish on anything drug or device in their evaluation, CRO testing programs.

Etienne Nichols: Okay. What we're going to be talking about is some different biocompatibility and different assessments and ways you can maybe avoid deficiencies in your submissions. But maybe before we get into that, because this is interesting to me. I was walking around the show and I saw the sign at your booth, Labcorp. Now, let's just go ahead and get the elephant in the room out of the way. When I think Labcorp, I think blood draw testing. Don't hit me, but tell me where you guys are coming from now.

Chris Parker: Right. There's two major sides to the business. There's the what you know, the you go get your blood drawn in your doctor's office and they'll take it off and they'll do all your blood analysis and your doctor will get the results back and tell you that you're healthy and your liver's functioning perfectly. They also do a lot of more in vitro diagnostics. They've developed that COVID tests and things like that. We have the other side of the business, which is more on the CRO side of things, where we now offer for medical devices and drugs all the way from the early- stage discovery. To start, the initial evaluations, does this even work like it's supposed to? And then we can carry it all the way through your biocompatibility or your final GLP studies, and then we can also cover it from the regulatory, start your trials, and then post- market surveillance also.

Etienne Nichols: Okay. And it's funny from a company standpoint. Most of you, listeners, you know the Global Medical Device Podcast is powered by Greenlight Guru. When I run into people at shows, they'll say," Oh, Greenlight Guru, you guys are an educational platform," which is true. If you're familiar with our academy, you can see lots of different ways that we're training the industry and best practices for the regulations and so forth. But ultimately, we sell quality management software. That's one aspect of the software that we have is QMS function. So I'm a little bit familiar with the" Yeah, that is part of our business, but..."

Chris Parker: The division that I came from used to be Toxikon, and then it was back last December 2021 when we were purchased and folded into the Labcorp to really offer more, round out a lot of the medical device offerings that they have. We've had a facility at St. Carlos that does a lot of early- stage surgical modeling for vascular stent implantation and the cath lab all the way through wound healing and orthopedics. We work with a lot of companies in the area for doing those or bring surgical teams in for training and things along those lines. And we in Toxikon are more out outside of Boston. Now under our Labcorp, we can really take it and round out lot of services from both the device and the drug side.

Etienne Nichols: Okay. I wanted to get that out of the way, just to let-

Chris Parker: Sure.

Etienne Nichols: ...people know who you are, where you're coming from, and so forth. But what we really wanted to talk about maybe today is like you said, deficiency. Tell me, when we talk about deficiencies, what are we even talking about here?

Chris Parker: So when a sponsor, we call them a sponsor in the GLP world, but when a manufacturer goes and they put their package together for their submission into FDA, if they're lucky and they're one of those chosen few, their submission is able to sail right through in the first time because they went," Hey." They did their pre- submission process of the FDA, they knew exactly what was going to be accepted, they worked with good labs, and they got all the way through the end from the regulatory standpoint. But in a fair number of instances, there are cases where the FDA issues, we call it a deficiency. It's otherwise known as a request for additional information. But generally, what it is is they have a question or an issue with some part of the submission. And there could be anything from they have questions about the manufacturing process, something like if we had to go through a clinical trial, about a patient basis, but it also could be a manufacturing process about you didn't describe what mold release agent you're using well enough. Where we step in is let's say you did your biocompatibility and you had a failure on an end point, you didn't address it well, or you didn't address the entire scope about what needs to be done for the safety of your device. And so we'll help them with that aspect of the deficiency either with the risk assessment, writing a white paper of sorts, memo, to help address the specific requirement. Or in cases when retesting has to be done to meet what FDA's looking for, we can help them with that also.

Etienne Nichols: Okay. So someone goes through that situation, the deficiency is really when they've done that submission and some of those things maybe need to be redone or addressed in some way.

Chris Parker: Right.

Etienne Nichols: Okay.

Chris Parker: The scary thing is when you get a deficiency, in particular, when it relates to a lot of biocompatibility. And that can be from the parts of 10993 that are more on the irritation and sensitization and cytotoxicity side, but there's also the analytical chemistry, the chemical characterization side. There are some pieces that can bridge across both of them, may be specific to one or another. But one of the things we see from the FDA when they send these deficiencies out is they offer two ways to go about it. And they say," We can either address this through either a memo or a risk assessment," or go ahead and do retesting again to address it the way they want to see it. And so we get into a lot of the weeds sometimes in trying to help clarify exactly what avenue is going to be most efficient, whether it's be for speed or cost, or of course the science and the ultimate patient health matters most important to all this. So we'll sort out a lot of those details with the manufacturer, what's going to be best for their particular case. And then if we need to get on with FDA as like their partner in it, we'll help them along those ways also.

Etienne Nichols: Okay. The thing that comes to my mind is the phrase" cap". And I'll explain what I mean. So you have the corrective action, which it sounds like maybe what we just discussed. The two pass forward to correct your deficiency that was uncovered. What about the preventative way? Is there a way to prevent this from even being have to happen?

Chris Parker: Right. Of course. And one of the big things is having a lot of upfront dialogue, and that's going to be upfront with FDA as part of a pre- submission. And not everyone does that. Sometimes because of timing, or you weren't aware of the process, or they didn't have quite the consultant on board or the quality system to really push them into that path. The second way is to engage with, again, a consultant or a lab who's very experienced in your type of device. Because we've worked through a lot of the challenges that your particular device may have already, and we can start to ask a lot of the questions and mitigate some of these things upfront. So one of the things we come into very frequently is part of a biocompatibility is in some ways we can directly apply a physical device to a test system. But in some cases, for instance, you can't put a whole catheter onto a plate of cells or into a mouse. And so we have to extract the device. And so we mix some sort of vehicle cell media, saline, cotton seed oil, with a device, and we use that to extract out all the potential compounds of concern and we put that into the test system. Well, those vehicles that we extract with may not necessarily be compatible with the actual physical device. Some of the more common ones are with stainless steel. You think stainless steel is stainless. Well, there's multiple grades of stainless, and some of them, like 316 stainless, is going to be great. It's Marine- grade. You can put it in the ocean and it'll be fine. But on 304, there's a reaction that happens within the chloride that will all of a sudden cause lots of rusting. So then whether it's we're having particular changes or things like that, or if a clear tubing turns opaque, or we get particulate matter, or we get degradation during the extraction process, what does it mean clinically? And so that's where we can help assess upfront is is there a way to avoid some of these changes after extraction that happen? Or we can preplan for it and try to mitigate around it, or at least have a plan to attack it and address it so it's more proactive instead of reactive. And that's always what we want to do and how we love educating people, is to be proactive, not reactive, because then a little bit of time upfront will save you a lot of time on the back end.

Etienne Nichols: And I want to come back to that, but before we do, so you mentioned the example of 304 stainless steel.

Chris Parker: Yup.

Etienne Nichols: What about the processes, like post- processing? Let's leave maybe geometry out for just a moment, but if we talk about passivation, maybe I'm nitric passivating right now and I'm going to move to citric passivation. Is it a known processing thing that we can do through a white paper justification? Or does there have to be testing? What are your... I know that's broad, but-

Chris Parker: Well, the test or not to test, that is the question. That's what everyone wants to do. And a lot of the standards, the way a lot of the current biocompatibility standards are written, are that if you follow a good risk evaluation process, biological evaluation plan, chemical characterization, inform your biocompatibility and your biological report, is there are certain types of devices that because you're using no materials with known processes, you can document your way out of having to do testing. And there could be with a passivated stainless. It could be with certain fabrics. There was a new, I can't remember their specifically the name, but the FDA issued a guidance on fabrics that are used in medical devices a few years ago. And essentially what they introduced us that on fabrics that are well known within medical uses, whether it's a simple medical pillow case... The pillow case you use at home is exactly same one of the main in the hospital, but it says it's being used on a patient so you got to test it. But if you're not doing anything unusual to it, maybe you're putting on a microbial coating on it or something that could keep it cleaner, well, that changes it. But if you're working with no materials that have a long history, you can maybe get out of it, and they offer instances for that based upon certain fabric and material types. Another thing where they offer it up is if you use on your ultrasound machine. For instance, the keyboard that's on the ultrasound machine. Well, if you can show that you're using the exact same interface that's used, let's say, on a Nintendo, it's exact same materials that's used on consumer application that have long history of safe use, which is always like that. What does long history of safe use mean? Because process... But they do offer avenues, but you really have to show a lot of deep dive specifics to show how truly identical you are. And if you are different, it's that quantification that can really matter. And if there's too many unknowns, then you end up back with testing again.

Etienne Nichols: Okay, and that's always a question in my mind. In a situation where you may have to test knowing how to determine," Okay, well, I'd like to know for sure one way or another." And I guess that's why we leave it up to the professionals who are the scientists with chemistry and so forth. Any thoughts or additional how to figure that out before we even come to you? How do we make that determination? I don't even know what I'm trying to ask. Twist it into whatever you want.

Chris Parker: A lot of devices when they're being developed, you're doing it with an intent in mind. And either it's a completely novel, new idea, or you saw a product and you said," There's a greater market than a particular other manufacturer offers. We want to jump into it or we want to improve it." And so if you're going into the improving or the wanting to be another player in a market because it's wider than a particular manufacturer can service, well then, you got a great place to start from if you can get the information, because not all the information they have about it, the secret sauce, is locked away with Colonel Sanders still.

Etienne Nichols: Right, okay.

Chris Parker: So all those herbs and spices, you may or may not know. And it is with chemical characterization too. You may know 90% of an additive that's going in a release agent. Well, that 90% could be well and good, but that other 10%, they don't want to tell you, that could be certainly something of concern. Well, that's when you can get involved with the toxicologist who can act as your third party, go around and help get you some of that information. But knowing what avenue you're trying to target, if you're a me too or an improvement, the more you can get on the initial part going in as much as you can, and then seeing what is out there, whether they publish papers about themselves or whatever it might be. If they came out of a university, there may be a publication on it. But going that avenue is a great spot. Maybe you get lucky and you're working with a consultant who helped develop that other product. And then you're like," It's a win- win for everyone."

Etienne Nichols: Friend of a friend.

Chris Parker: Right.

Etienne Nichols: "I know a guy."

Chris Parker: Yeah.

Etienne Nichols: So how early would it make sense to start involving someone such as yourself in the design process? Does it make sense? I have a working prototype. I know the materials I'm going to be using. Now, let's talk about it. I can imagine a situation where we might have a failure, so maybe I would've liked a little bit upstream involvement. But what are your thoughts?

Chris Parker: Right. So early- stage in the prototyping when you've got a materials list and you're saying," These are the ones we know have really good physical properties are going to match with what we needed to do. It's got a certain durometer," or whatever it might be. You could also start to map out." Well, we think in the manufacturing, we've engaged with a CMO," or whatever it may be, and they've said," Hey, it may be good to use this sort of silicon oil," or whatever it might be. We can start to look at that from a material standpoint to just start checking boxes that you're not using anything that's of concern. So we get to the final product, because ultimately, you have your initial evaluation, but there's the final finished product. That FFP that is in all the... When you get the final biocompatibility where the rubber hits the road, where it's going to be more when you start putting everything together, you can get new compounds of concern and so on. But we can look at every single material and additive from step one and start to screen if there's anything of concern from the beginning so you don't add something that you shouldn't have, get to the end and wish you hadn't, have to do rework.

Etienne Nichols: Okay, yeah. That makes sense. I'm going to ask a question that's a little definitely outside my knowledge. So feel free to say," Hey, I'm not sure."

Chris Parker: I'm buckled up.

Etienne Nichols: California. If I'm going back to my manufacturing days, we were dealing with something. I think it was Prop 65.

Chris Parker: Yep.

Etienne Nichols: Can you speak to that? And from a medical device perspective, what do I need to know about that and how do I deal with it?

Chris Parker: There's Prop 65. Over in Europe, there's the CMRs. You have to worry about the compounds, the carcinogens, mutagens, and reproductive toxins. There's a whole host of compounds that at certain thresholds may be of concern or flat out don't want them included in a device at all. Or if they are in there, then you have to put some labeling on there. And so we can look at those from an early screening standpoint based upon concentrations and we can risk assess what's in there. Maybe you have that secret sauce of all the material components or we can do some initial analytical screening on that and look for a particular targeted analysis, and we can do that. So the Prop 65 and some of the new European regulations all say," Let's try to keep out anything of potential concern that we can at any concentration." Because when you get into a lo of Part 17, Part 18, and biocompatibility, it's your analytical thresholds and your toxicological thresholds. And you want to make sure you're not going above a certain level of concentration with your compound. Well, we obviously want to always keep that in mind, but there's definitely places where we want to keep them out, starting from zero. So working with those, we can take out a lot of that risk upfront if you engage with toxicologists or an analytical group to help you with that assessment.

Etienne Nichols: So from a quality perspective, I would hope that companies would maybe take these things, like you said, the carcinogens and so forth in Europe, or Prop 65, those material lists, and really be implementing that from a quality global standpoint.

Chris Parker: Yes.

Etienne Nichols: Is it a requirement in other areas though, right now? If I'm not going to sell in California, for example, or Europe, how have you seen companies handle that? Just out of curiosity.

Chris Parker: Well, one of the things we see with a lot of things is your initial indication may not be to enter Europe. Or we work with a lot of European companies and they say," We're just going for our CE mark now." And then we ask," Well, do you ever think about engaging with the US market?"" Well, we think we might get there in a few years, but we just want to do our CE mark now." Well, you can do it as an iterative process where you can attack the points that are specific to what you need now and then come back and do the rest later. But you may have an opportunity when you look at the total scope of what you might be getting into to lump it all into one big push and go and save yourself some time on the back end. Or there may be opportunities where we can offer up one set of platforms or risk assessments of what it might be that can look at it all at one time in one risk assessment. For instance, instead of having to do two, we can cover it all now. So you may be spending a little extra time or a little extra money now, but you may be saving yourself some time later so you're just ready to go from the get- go. And we see this with some raw material people too. They're developing a raw material but they don't know the quality system of the people they're going to sell to. Maybe some want to purchase a raw material that's been... The only one is a simple USP class 6. Other manufacturers say their quality system, they don't want to buy a raw material unless it's at least had some level of ISO 10993 testing done. Let's get it more relevant to how our final finished product's going to be tested. Some further want is see it," Okay, you're a resin. Great. But that resin may be used in a catheter or it may be used in a blood bag." Well, it goes more beyond just looking at the traditional material safety work, but let's engage it also into the specifics of how that material may be used in the final product. And so we can expand or contract some of those standards to meet not just USP or not just ISO 10883. We offer a combined study that takes the elements of both of those together into one study so you can kill two birds in one stone. So instead of doing five studies, we can do one and really work it out to the advantage of the sponsor.

Etienne Nichols: Okay. Well, one of the other things I'd say about that, sometimes we focus on the cost efficiency or," I'm only focused on Europe right now," or wherever it may be. But at the same time, I'll quote one of the longtime guests of the podcast. Mike Drew says," Quality is quality no matter where you stand on the earth. And our goal at Greenlight Guru and with the Global Medical Device Podcast is to improve the quality of life, and I would hope the medical device companies are doing the same." So that's interesting, and I think it's good advice. And from an economic perspective or even especially from a quality perspective, go ahead and kill those two or five birds with one stone. I love that.

Chris Parker: When it comes back to quality, one of those things we see with FDA is with biocompatibility, it can take a lot of units of device, final finish manufactured process sterilized device. And it could take a lot of them in some instances to complete your evaluations. And if you're a large device, like 150- centimeter long guide wire, for instance, you have some surface area to yourself so it may not require as many units. But when we start getting into really small things, let's say a stent or a vaginal prolapse tissue tack, those may be less than a square centimeter in surface area per unit, and so it may take literally 10,000 units to complete testing. Well, that's obviously a burden on the manufacturer. And so they may want to screw it around some of the standard ISO 10312, surface area extraction ratios. And well, this is why. A person's only going to get one, maybe two stents in their lifetime so I only want to put one or two stents in my extracts. Well, the FDA says," Well, that's not how the standards are written and that's not how the straight quality is." Because biocompatibility in a lot of sense is looking at things in exaggerated condition, so look for worse cases, whether it's an off- label or an overdose or whatever it might be. And so they don't necessarily look at it from the economic impact. They want it done the right way the first time, the best interest of the patient. And trying to skirt around for whether it's a timeline or an economic standpoint is of course a burden in some cases on the manufacturer. But we want to see it done right in the best interest in the patient the first time.

Etienne Nichols: And for the long term, if you think about it, if this device is going into your son, for example, or your daughter, you want that the very best that there could be. That makes a lot of sense. Did you have something to add to that? The other question I had about that was, so we mentioned the EU. Again, on the fringe of my knowledge, but the post- market clinical plans where you're now commercializing but you still need to do a bit of clinical testing and so forth, have you helped with that, or is that something you have any recommendations or thoughts on?

Chris Parker: Well, I'm the biocompatibility guy. But I will say as part of Labcorp though is we do have a tremendously huge regulatory group, clinical trials group, and then a post- surveillance group, a post- marketing group. And so we do offer that where they do engage in. Where they're starting to look for some of that feedback and then they're always working whether you engage us or any other provider is a lot of that clinical trial information or post- marketing information can feed back really importantly into design changes, into future studies based upon patient feedback. So for sure, we need to integrate a lot of those together. That is something that is very important for the device development.

Etienne Nichols: I had mentioned that I come back to this. It just popped into my head so maybe actually do it. We mentioned when we were talking about deficiency. We've come full circle and talk about our original topic, and I covered a lot of good ground and I appreciate all of your knowledge.

Chris Parker: Of course.

Etienne Nichols: One of the things we mentioned was these those two paths, the corrective action versus the preventative action. I don't know if we can attach a dollar amount necessarily, but if you have that delay due to a deficiency or that back and forth that maybe the company wasn't expecting, can you attach value to that? What's the value to the company?

Chris Parker: Sometimes with these deficiencies, you may have days to respond, you may have months to respond, and maybe you have to file for extensions. And so if you're a really early- stage company and you're hinging on your one first product getting through to start the revenue, and you've got investor expectations and you've got your own personal time and blood and sweat and tears into this, it means a lot. From a larger company, there's still a lot of expectations on there because it means revenue. It means jobs. It means a lot of different aspects. And so a single day can mean thousands or millions depending on what you're doing. And so I don't know if you can attach a specific, because a lot of the cases, but especially for those smaller companies not having to do those weeks and months of remedial work because remedial work also costs more money. Rework, everyone hates rework. And you're manufacturing line. You realize that your stamper, all of a sudden is off, then you have to do rework that has that attributable direct cost. That's where the quality system really comes in, to avoid a lot of those things. And we're engaging with the right people upfront. We can help even predict what may happen, and we can set those plans in motion to remediate it before we even get into it.

Etienne Nichols: Yeah. You mentioned that word remediation, and I just cringe. I hate it. Having had to manage aging CAPAs and so forth, just the dread. That makes a lot of sense. So the other thing you mentioned there was the quality management system, which of course, you're speaking our language, implementing quality from the beginning. Those well- defined user needs, well- defined design inputs that really require or define all the different things that are going to lead to the type of testing that you're talking about. That makes sense. That's cool. I am close on time. I wanted to know though-

Chris Parker: Beautiful.

Etienne Nichols: Before we end this out, any thoughts, advice, recommendations to our listeners before we shut it down?

Chris Parker: The biggest thing is know who you're working with and work with an expert. If you're engaging with a consultant, interview them, understand where their expertise may lie. Do they have expertise in your particular product? And that goes for any of your labs or toxicologist or anyone you may use. Make sure they understand your exact scenario and what you are trying to accomplish, and let them help you get there. Try not to reinvent the wheel, because we have standards. We have practices. There are other similar devices out there in some cases. And all can be learned from them. And the standard is called a standard. Similar to a standard operating procedure is a standard operating procedure for a reason, is because it maps out what's going to be expected up to what's currently the best science in regulatory and whatever it might be out there for your particular case. So know who you're working with. Make sure they understand you, and let them help guide you if you need that. And they'll be your partner along the way and really act as your partner versus just your service provider.

Etienne Nichols: Yeah, very good advice. The thing that I'm going to take away from that is like you said, don't reinvent the wheel. Everybody wants to be a breakthrough device, but really, you think about the aggregation of marginal gains. You want the small things that we're doing to improve the quality of life makes a big difference over the long, long haul.

Chris Parker: Absolutely, yeah.

Etienne Nichols: All right. I won't just keep repeating what you say, but it just sounds so smart, and I just want to. Thank you all for listening. You've been listening to the Global Medical Device Podcast. As I mentioned, we're at the MD& M West show, so if you hear that noise in the background, I started to say music, Yet, a manufacturing guy. I guess that's music tires. I don't know.

Chris Parker: Well, the auto stampers are out front, so they're making grills for trucks right now.

Etienne Nichols: Okay. So maybe-

Chris Parker: We're moving away from medical device in certain manufacturing areas, but all the same.

Etienne Nichols: Thank you for taking the time, Chris. It's a pleasure talking to you today. Appreciate you being a guest on the Global Medical Device Podcast. And we will see you all next time.

Chris Parker: All right. Thanks for having me.

Etienne Nichols: Thanks.

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