Hello and welcome to Sedater. Kayleen Brown. I'm so excited to share today's presentation with one of my favorite companies, Integer. We're going to be talking about the changing landscape and how our experts are going to be able to help us navigate those changing landscapes and those waters a little bit easier. A few pieces of housekeeping before we dig into the fun. Please feel free to ask your questions throughout today's webinar. You're going to do that in the Q& A box. We have two separate areas for you to engage and I really hope that you do. We get energy from that and I hope you get some energy back. Part of the fun of webinars is that engagement factor. Please, if you have a question, put it in the Q& A box so that I can see it and then I can share that with our panelists and our speakers today. 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All right, huge thanks of course to Integer for sharing your insights with us. We like this is what we live for. This is what Tom Salemi, our Editorial Director, and myself live for. Thank you, thank you, thank you. I love to take a second to introduce all of our presenters today. We have Erik Sorensen who'll be joining us, Michael Gianfrancesco, and then Stefano Longo. Erik is our Senior Director of R&D. Stefano is the Business Development Manager, and Mike is the VP of Engineering and Technology. If you want to learn more about our presenters, please look at their presenter profile. It's on your console, your interface, and you can directly email them as well. Feel free to use the Q& A box. Those questions will go to the presenters, but if you want to connect with them directly now, feel free to do so. All right, I off essentially what we're going to talk about, but I wanted to give you a higher level of, you know, who Integer is. For those who don't know, Integer is one of the largest medical device CDMOs in the world. I like to think of them as your one stop shop from concept to coating. They also recently acquired VSi Parylene, which has expanded their already really impressive coating capabilities. Now with Precision Coating and VSi Parylene, and now that is under the Integer umbrella, you have PTFE, hydrophilic, and Parylene coatings. You also have R&D and high volume manufacturing all in one place. That is a serious win for medtech companies looking to move fast, solve tech challenges, and get to market with confidence. With that, I am going to pass on the presentation to our esteemed presenters and look forward to learning a lot. Thank you. All right. Thanks Kayleen. It's great to see so many industry colleagues on today's Device Talks Tuesday webinar. We're going to have kind of an interactive format today. We're going to present some information, take some questions, and then if we don't get to anything in the time allotted, we'd love to connect with you individually on some of those. We're looking forward to the discussion today. We're going to break it down, dive into a few key areas, and hopefully everyone benefits and learns something from this. I think everyone on the call would agree that all aspects of the med device industry have become increasingly complex over the past few years. Certainly coatings are no exception to this. Really our goal for today is for everyone to come away with a better understanding in three main areas. A majority of this activity in the past few years, coatings, stems from increased environmental awareness and regulatory challenges. We want to give an update on this so that we're all looking at the same sheet and we're all on the same page where things are currently so that we can best look ahead to the future. The second are alternatives. PTFE has become a hot topic and we want to dig into some potential other options that you could use, whether those are close derivatives or completely different. Lastly, maybe some of you are ready to make a change or investigate other areas but aren't sure how to make that happen. We want to just offer some advice on how you can incorporate this into new designs or existing and make that happen. Hope to give you some good information over the next hour. As Kayleen mentioned, if anyone isn't familiar, Integer is one of the largest contract development and manufacturing organizations in the med device industry. Broadly, we have two product categories. We have Cardiac Rhythm Management and neuromodulation, which covers things like implantable pulse generation, implantable pulse generators, excuse me, batteries that you see on screen. Cardio and vascular is the other segment, which is things like guide wires, catheters, sheaths and the like. Across these product categories, we have offerings that span the entire value chain. Whether it's simple things like marker bands all the way to devices like complex electrophysiology catheters and packaged labeled sterilized stent delivery systems, we have tremendous depth and breadth of expertise across the whole product life cycle. Really, over the past few years, we've seen a critical and growing need in the coatings space. In response, we first initiated a comprehensive program to address the multifunctional challenges surrounding this dynamic environment. As most would presume, it started with supply chain and the problems that we all dealt with. We quickly learned that required expertise from other functions like regulatory affairs, quality assurance, engineering. Now we have gotten to the point where we have a multifunctional program working with customers and providers to continue providing solutions. It has really become a project structure in and of itself. We are leveraging that program structure to minimize risk, ensure that we continue to have production supply, and maintain our development speed and agility. Now, specific to coatings, Integer has a long standing history and expertise with both hydrophilic and hydrophobic coatings. Our strategy has really been to continue improving upon the legacy platforms while investing in new coatings. Those include VSi and Precision and Stefano and Mike will talk more about those. This table really just covers the main offerings and they're going to dive deeper into some of those. We know that your products require unique performance combinations. It's always that trade off of lubricity and durability and barrier properties. Hopefully the information that we provide today helps you balance those and sends you in a good direction. If when you're ready to partner and you need more information, definitely reach out and we'd love to be able to help you. Generally the two main areas we're going to dive into include Parylene and PTFE. You can see on the screen there are many options, these are just a few that we're going to dive into and give you more details about these. It's always that trade off. Obviously the two main ones being lubricity and durability. There's no one size fits all solution. Hopefully the information that we provide today is a starting point or gets you off in the right direction, based on the information that Stefano and Mike will share. With that, I'll turn it over to Mike. Thanks Erik. Appreciate the intro. Before I touch on why PFAS is under scrutiny, I think it's important to note that polymeric PFAS is generally considered a polymer of low concern and water insoluble PFAS used in medical device coatings today are generally considered inert. However, the pressure to transition away from PFAS is due to the evolving regulatory perspectives related to potential health concerns which are still under evaluation. This is in addition to the known environmental impact generated through the polymerization process of PFAS and the end of life disposal of medical products. These concerns are driving the regulatory changes that we're seeing and we are keeping a very close watch on what that impact may be on the medical device industry through our PFAS program that Erik touched on earlier. I'm not going to get into what PFAS is, but we are going to be looking at how we are approaching alternatives and provide some more insight into considerations to think about as we go forward. Understanding the regulatory landscape, as we look at that regulatory landscape, we need to really understand its impact on the medical device market. There are many industry reports available out there that have some more detailed information, so we're not going to get into too much of those specifics here. Suffice to say that regulations are still evolving. There doesn't appear to be global alignment on proposed timelines or impact on the various classes of devices, and medical derogations are expected and timeline delays continue, which are driving continued uncertainty for the industry and our overall approach going forward. I'd say we all wish we had a crystal ball to know which way the industry is going to be going, which way the regulations are going to fall. Due to potential timelines associated with device approvals for material transitions from PFAS, we really need to take a proactive approach as an industry and really to remain ahead of those changing regulations. It's essential that the medical device industry as a whole proactively plans for both scenarios. We can't have that supply chain disruption because we're waiting. We need to ensure that devices are compliant, market ready, and available to patients worldwide. Mike, you made me think of a question. When you're talking about there's two different camps. One of those believes that PTFE, PFAS coatings will be regulated out of the medical technology industry. The other one, they believe that PTFE and PFAS coatings will be available for use in medical device industries. Can you clarify what your position is on this? Yeah, it's a great question. Again, like I said, I wish we could see into the future. Right. Only have one direction to go forward. I'll start my answer by saying regardless of which direction, we're still Integer. We're still going to continue to provide the known PTFE coatings. There's no intention on changing that unless it's required through regulated changes. However, we must be prepared to offer those potential alternatives for the future. We are committed, like I said, we are committed to providing our customers with the known quality and reliable PTFE coatings that they've come to trust. Also recognizing the importance of staying ahead of regulatory changes, ensuring that our customers have access to both solutions should it be needed in the future. Great. Preparing, but still providing. Correct preparing. Great way preparing and providing. We need to be ready for both. Thanks, Mike. Yep. As we look at the industry implications from those regulatory changes, we are monitoring the impact of the global regulatory landscape on potential supply chain disruptions, regulatory timelines, as well as product design and development requirements. As we evaluate these three elements, a common theme that's arising through our evaluation is general uncertainty. Uncertainty in the industry, uncertainty in the supply chain as we go forward. That uncertainty is really what's driving that proactive approach that's needed regardless of which way the regulations shift. Our industry as a whole really thrives on stability. We must be prepared for a future, like I said, with or without PFAS based coatings, by working on solutions today and ensuring that the industry has optionality in the future. As we peer into the future of what potential alternatives may look like, we are assessing what's commercially available as well as what's on the horizon. What we're showing here are both of those options, the commercially available options that are ready for use and development solutions that contain no intentionally added PFAS. These options are intended to satisfy specific use cases. We're going to get into more of those details as we go forward. I'm intrigued to understand why Parylene was initially selected as a PFAS alternative. Can you help me understand that? Can you tell me what other materials you are planning to bring to market? Sure. Yeah. Mike, I can second here. Yeah, let me answer that first portion about Parylene. Yeah, we selected Parylene for its proven track record in the medical device industry. It provides reliable performance and regulatory familiarity. For customers who are trying to move away from PFAS materials to alternatives, it provides a solid foundation while maintaining high standards of functionality and compliance. I'll pass it up to you, Mike, after I ask that second portion of the question, the other materials. Thanks, Stefano. Yeah, so in those other materials that we have listed here, we know Parylene is not a solution for all use cases for all applications. As the industry shifts from PTFE to, there's no doubt that the surface technologies are going to require a portfolio approach to solutions. What we're showing here are two alternatives. We're calling it Alternative A and Alternative B that are meant to satisfy those other use cases that Parylene may not be appropriate for. We'll get into more of those trade offs as we go deeper into the presentation here. Unfortunately, the Alternative A's and B, they are early stage development, so we're not able to share much about what that material is. As they get further along, we're happy to have separate conversations and talk more about opportunities for samples and for further discussion on what those materials are. Mike, to get the answers to those questions. Once you're allowed to start talking about that, do we just contact you directly? How do we, how do we get that opportunity? Yeah, you can contact us directly. As we get at the end of the presentation, you'll see our contact information. You can reach out, you can reach out through our company websites as well. Perfect. Just a reminder to our audience that if you want to contact them directly right now, our presenters, you can just go to the presenter profile and email them directly from there. Thanks, Mike. Welcome. Okay, as we're looking at how we're expanding that coating landscape, what we're showing here are those multiple PFAS alternatives as they relate to known materials like PTFE. We even have hydrophilic listed on here. Our current focus is in that boxed region outlined in red, which we are defining as high potential PTFE alternatives. The chart is intended to reflect average expected performance, though actual performance may differ because it is relative to use case and the conditions at the time of the application. We find that the performance characteristics can be modified and optimized. Although there are trade- offs, which we will be getting into as well. I do want to reiterate, as I just said, the attribute for performance is relative to the use case conditions. The key thing to really remember there is that selecting the right PFAS alternative requires a strategic balance between competing performance attributes. Meaning in some scenarios the optimization of lubricity may reduce coating durability depending on its use case or it may impact its dielectric properties or thermal stability. Really understanding the product requirements beyond just the incumbent coating performance becomes critical as we move away from PFAS, and the earlier coating applicators are involved in the device development, the more streamlined and efficient that transition process will be. As we transition from PFAS based coatings, I'll be handing off this. Oh yeah, sorry about that. Thanks, Mike. Hi everyone, I'm Stefano Longo. I'm the other face and voice you've been seeing throughout this webinar and in my day to day I help medtech teams find the right Parylene work in conformal coating for their solutions. Today I want to start my portion of the discussion talking about timing. As many of you know, in the product journey there are different challenges at every stage. As you see here with the five phases of development, from concept to commercialization, we get it, that speed, compliance, performance, they're always top of mind. Here's what we've seen over and over again. When those coating considerations, like Mike just mentioned, when those are brought in early, the whole process runs a lot smoother. That applies to all coating options, not just Parylene or the PFAS-free alternatives, but at Integer, we're built to support this. Whether you need those proof of concept units or you're scaling to commercial volumes, we're tried, tested, we're ready to jump in. Again, the earlier we're looped in, the more we can help guide you towards solutions that truly fit the performance and the product needs. Next, let's talk about those PFAS-free coating alternatives. Right now there is no plug and play swap for PTFE, not yet at least. Transitioning from PFAS-free solutions is not just a material change. You're also looking at trade-offs in durability, lubricity, process compatibility, and regulatory alignment. Like the other presenters have touched on, that's going to be a main consideration. This matrix here is giving you a snapshot of those considerations. It's not meant to overwhelm. I know there's a lot going on here. It's just a tool to help frame the conversation and prioritize what matters most to your application. From my experience from talking to customers day in, day out, what tends to happen is there's a legacy coating or a coating requirement of unknown origin and that just remains on a drawing and it's there for years. If you can identify the attribute needed, from that left column there that you see, we can then help easily identify an alternative solution for your product needs. Again, don't worry about memorizing this. We'll make this available after the presentation so you can dig into it later and share it with your teams as well. Next, another chart for your reference. This shows different coating alignments across industries and device types. This is based off real experience. These are areas where we've supported customers directly. You'll see coverages across neurovascular, structural heart, electrophysiology, and more. Integer has deep experience with these types of products, and that includes understanding how coatings play into their unique demands. Based off this chart here, we'd love to hear from you if something has sparked an idea. Whether you're in that early stage development where it's great to get coatings involved at that early stage, or even if you're revisiting a legacy product, we're always open to exploring and providing guidance. Stefano, you mentioned alternatives. If the adoption of alternatives to PFAS accelerates, what new possibilities or applications might emerge that are not widely considered right now? Hmm. All right. Actually, I'm wearing it right now. A ring. Everyone's got some kind of health sensor of sort, a watch, ring, something that you. Oh, perfect. There you go. Yeah. I think those kind of wearable health tech sensors are gonna be the next big phase for these alternative coatings with Parylene and these PFAS free alternatives being biocompatible and highly moisture resistant, it's going to be a pretty easy transition from bringing those sensors on top of skin to under the skin. Whether that's in, you know, personal use from day to day, or it's also in the hospital during surgeries and after surgeries, implanting a device that we can get accurate readings for patient health, I think that's going to be the next thing. Thanks, Stefano. Yeah. Actually, I would like to ask Mike if he's got anything from his perspective, since mine's mainly Parylene. Yeah, sure. I'd love to add on. Thank you. As far as other PFAS alternatives, what we're seeing that would be accelerated is a lot of the sustainability initiatives and reduction of or reduced environmental impact as the industry goes forward. Also on the supply chain side, as we shift away from PFAS and other PTFE, it could be an opportunity for broadening of that supply base of materials that would be going into these alternative coatings. Thanks, Mike. Thanks, Mike. Yeah, back to the slides here. Exploring the coating options during that new development phase. With our new expanded coating capabilities, which now include PTFE alternatives, coating and hydrophilic coatings, Integer is more than just a supplier. What we're really trying to express here is that we're a true partner through every phase of your product development, and that's from concept to scale. We can support your team with material insights, process integration and proven scale. That makes us a one stop solution, not just for the coatings, but for ensuring those coatings fit the device, the regulatory path and the end user needs. When you're switching, it's not just about checking a box, making sure you got the right documents for the FDA, it's also about real performance value without compromising anywhere else. We understand switching to an alternative coating can be daunting, but when partnered with a team that has a complete coating platform, decades of experience, that transition is much smoother. That concludes actually, so thank you very much for your time. I know everyone's very busy. I know these topics are complex and the PFAS transition is moving quickly and differently by different regions. Luckily for you, by attending this webinar, you know you do not have to navigate it alone. Integer is here to help and answer questions. We are here to dig in with your team, guide you to solutions that are robust, compliant, and future ready. If anything today has resonated with you, or if you have something unique in the works, we would love to hear from you. Like we mentioned, our contact info is here. We'll be sharing this slide deck at the end for you and we are looking forward to building what's next with you. I believe we're going to be opening up to Q& A now. Thanks so much, Stefano. I'm going to just reiterate your point one more time. If you want to contact our speakers directly, our presenters directly, go into that speaker profile, click the email icon and you're welcome to email. You can also connect with them on the Q& A box. They will see those questions. For those who are tuning in on demand, you can still ask your questions. The presenters will receive all of those questions in perpetuity. Huge thanks so much Erik, Mike and Stefano for walking us through today's presentation. Here we go. I just wanted to ask our audience if you would please take a quick moment to complete the survey that just helps us bring you the best medtech conversations in the most engaging way. I wanted to do a friendly reminder and a little bit of a Kayleen pitch here. We have our Interventional Innovation webinar series coming up July 14th through July 18th. I'll be hosting. If you are interested in interventional technologies, please join us then. We talked about how you can reach out to the presenters. We talked about what's upcoming. Now, I think the exciting time for webinars is opening up to Q& A. Presenters, are you ready? Absolutely. Yeah. Okay. All right, perfect. I'm going to take a quick look at our audience questions here and I will get right, let's get cooking here. I have a question here from Steve. Steve asks, does Parylene have precursors that might fall under regulatory scrutiny like those of PFAS? Good question. The three that we mentioned, we've got C, N, and F. C and N, no problems whatsoever. F is currently under review under the TSCA 8a requirement. The reason for that is it has those fluorine molecules on it. It is a sigma bond, so it's very strong. There's no risk of it leaching into the environment. Right now it is being restricted to medical and R&D. Perfect. Any other thoughts? Okay. All right, let's see here. We have Matt. Matt asks, can you explain a little more about the specific issues with PFAS and PTFE? Is it PFAS contamination within the PTFE material or suppliers moving away from manufacturing PTFE because they are concerned about using PFAS in their manufacturing process, or is it something else? That is a biggie. Yeah. Thank you for that question. Now I'll address it as best as I can. There's a lot to unpack there. PTFE is a PFAS and there are two different groups at a higher level. Right. There's a polymeric PFAS and non-polymeric PFAS. PTFE falls in the polymeric PFAS category, which is considered a NER and a lower concern, like I mentioned before. However, it still is a PFAS. The more potentially hazardous PFAS is that non-polymeric PFAS, which is really generated in the polymerization process of PTFE. It's more of a byproduct of the process and that's where that contamination is coming from. It's inherent in the manufacturing process of PTFE. There are other chemical reactions that occur at high temperatures. When you look at the end of life cycle of a medical device product that contains PTFE or another fluoropolymer, there is the potential of that non-polymeric PFAS, those byproducts being released into the environment, which is another potential contamination source. I hope that helps address some of that question. Kayleen, it looks like you might be muted. Thanks team. I was really focused on the questions. Thank you. Let me start that all over again. It was my best question yet. Stefano, this is for you. Great. Given Parylene's conformal nature, are there any misconceptions around durability or adhesion that you see requiring a mindset shift in the industry? Hmm, good question. Yeah. It is very durable and adheres very well to certain substrates and that kind of lends kind of the issue there, and that is rework. What I hear a lot from customers is they're kind of scared of Parylene because once they put it down, it either has to work or they have to scrap the board. Wholesale removal of Parylene, yes, definitely can be tricky. Spot rework and component rework, that is something that's possible with Parylene. That's something I'd like to kind of change in the industry. Let's test it out. There are ways to mitigate potential fallout of those units. Thank you. Stefano. Anything else to add? Okay, we have Merritt asks, I believe Michael touched on timing and portfolio solutions as a construct. Could you expand on your perspectives here? I'm especially interested in what you are hearing from customers or industry for the cardiac and millions catheter based devices that would be significantly impacted and I would imagine would take many years to change over. What are your thoughts? That's another deep question there and very impactful and something that we're acutely aware of as well. I'll be as cautious as possible in my answer. What we're finding, and it's not necessarily application specific, is that it'll need a portfolio of solutions. What we're saying is as we're touching many different product types, or there's many different product types in the industry. Let me take a quick step back. PTFE has always been a bit of a silver bullet solution for many applications, many interventional products where it has great lubricity, durability, temperature stability, thermal stability, so many different attributes that are. It checks a lot of boxes and as PFAS alternatives are being developed, they don't check all of those boxes. For a specific application or specific product type, one solution may be sufficient. In order to encompass all of that interventional market, there will need to be or likely need to be many different solutions that either optimize lubricity or flexibility or durability as needed for that specific use case. Perfect. We have a couple of audience members asking, is Parylene coating application process continuous or batch? Parylene is a batch process, so you are going to be limited by the chamber size. We have varying chamber sizes to fit all types of units. Yes, it will be a batch process, kind of, regardless of how you do that. Okay, thanks, Stefano. Jamal asks, what are some of the drawbacks of Parylene coating when not used as a process aid? In other words, cost and device to placement of the device? Sure, yeah. When not used as a process aid, I'm assuming you're talking about like a mandrel to create another device or something. When it's on the actual device that's going to make patient contact, there just has to be a little bit more handling considerations and then also thermal capabilities. We do have those three types of Parylene that we mentioned, C, N, and F. They each have a different thermal limit. Beyond that, you'll start to degrade the Parylene itself and then potentially craze it. Those are some of the considerations. The primary one for that is going to be like an autoclave or when you're sterilizing your product. That's where you'll have to know exactly what the limit is. Thanks, Stefano. Erik, I have one for you. Let's see here. When do you—Fred asks, when do you expect new FDA regulations that restrict the use of PFAS materials for implants and surfaces in contact with the body? Ah, great question. I wish we knew. We would be very far ahead of everyone if we knew that. That's the magic. We don't know if it goes anything like EtO is gone. There could be dates and deadlines and they get pushed back. Really where we are now is to create that portfolio of solutions just to be ready. We don't know. Could be next week, could be 10 years from now. We know that we need to keep advancing the science and the processes and the materials to be ready for that when it does happen. Perfect. All right, let's see. Okay. Gosh, there's so many questions. Audience, thank you so much for engaging and engaging our presenters. I actually get to do a job today. Thank you. All right, so Fred asks, are you more concerned about regulatory or about supply chain restrictions of PFAS materials? What might impact us earlier? Yeah, I can take that, Kayleen. Thanks for the question, Fred. We can't really answer what may impact us earlier, but as we said in the presentation, we're prepared for or becoming prepared for PFAS to be regulated out. I'd say we're concerned with both directions. Right. It could be either regulatory or supply chain, or it can have a bit of a cascading effect from either. We know medical devices or the medical device industry is a small consumer of PTFE in general or fluoropolymers in general. It is something that's closely monitored. The best thing we can do is continue our effort to be proactive in what we're developing and really not wait for either of those scenarios. Understood. Thanks, Mike. Anybody anything else to add? All right, let's stick through some more of these. Okay, so, Stefano, I'm going to ask you another one. Mike asks, how do you address nodules in Parylene coating? You've done Parylene coating before. You know about nodules. Yes, nodules are an unfortunate phenomenon of Parylene. What we typically see and when they really occur are on very smooth surfaces. Kind of like wafer discs, that's where they'll appear the most. I wish I had a way to say I know exactly how to mitigate it. One thing that we do know is slower is usually better for the deposition process to mitigate those nodules. Beyond that, it's more of just testing out your surfaces, ensuring you have the proper adhesion method as well. Thanks Stefano. It has got like five questions in a row. All right, so let's see. Okay, here we go. Asks, hi, can you go into the details of why PTFE is being moved away? What is the problem with it that makes us need to find new alternatives? Sure. There's nothing. There's no functional reason as to why PTFE, and I would phrase it as, is potentially being moved away from. It's more potential regulations on its environmental impact and the potential health hazards that PFAS causes, which, like I said before, it's more of the byproduct. The hazardous PFAS are more of a byproduct of the creation of the PTFE material. It's not that PTFE is necessarily going away immediately. It's more potential of it shifting out due to those PFAS issues. Thanks, Mike. Steve asks, is Parylene compatible with the gamut of sterilization modality? There it is. Is Parylene compatible with the gamut of sterilization modalities? Yeah, there are a ton of sterilization methods that you can use. But yes, Parylene will have some impact or will be impacted by certain ones. The main thing you're going to see is swelling of the surface of that layer. But the best are going to be EtO and gamma, and those are the two that we would focus on. And then obviously there's autoclave as well that works functionally for it. Thanks. Jamal asks, what are the cost implications of choosing Parylene over PTFE? I can answer this again. Mike, feel free to jump in if you got something else. From Parylene, from what I've seen, the difference is going to be in the masking and demasking processes. That's going to be the highest cost driver, primarily because Parylene needs to have an airtight seal around those maskings, whereas potentially PTFE might, correct me if I'm wrong, you can do kind of like a shadow mask. It does not have to be exactly an airtight seal since it happens under vacuum. Parylene will sneak into every nook and cranny. Excellent. I have nothing to add there, Stefano. That's accurate and I'd say it's product specific. There may be scenarios where Parylene may be more cost effective due to the part configuration and size versus PTFE. Perfect. Erik, Matthew asks, how do you measure lubricity? Yeah, good question. It really depends on the specific product type, whether it's a guide wire or a catheter, what kind of use it is. We have a full range of testing in labs to do that. Some of it will be wet testing. It could be in a heated saline, some of it could be dry. For lubricity, a lot of it you can buy off-the-shelf testers. Obviously, we have both those and some developed in house. Standard friction type testers really looked a lot into the specific interaction. Not just what the tester is, but pad types. You know, you can buy something off the shelf that has silicone pads, but it might not really differentiate good from bad. We use alternative pads to contact, but it really depends on if it's hydrophilic or hydrophobic. Obviously, something that's used to test PTFE could just straight tear away a hydrophilic because it would just be much too rough. Optimizing all of those things in terms of what pad materials are, pinch forces for lubricity, and then of course, durability testing to match that with wrap tests and things like that. Thanks, Erik. All right, let's. This is great. Can you go into the. Oh, okay. We had a duplicate question. Try and feel free to ask your question again if you feel like you didn't get an answer to your question, just drop it in that Q& A box. Let's see. Daniel asks how soon feasibility samples using alternate A can be ordered. We can jump to another question if you prefer. Oh, sorry. Yeah. I say reach out to us. We can have a discussion about samples for the alternatives and see if it would make sense. Daniel asks what surface preparation is required for Parylene application? Yes, Parylene. It's much like any other type of coating. The surface just needs to be as clean as you can get. Parylene will coat over just about anything, even in oil. Unfortunately, what would happen is now you have an oil underneath a Parylene layer so you have poor adhesion. The cleaner you can get your board surface or whatever material you're using, that would be best. Perfect. All right, we're getting more questions in. Let's go with PTFE has been the go to for lubricious coatings for many devices and products have been tested based on PTFE performance. There is a lot of comparative testing associated with the design considerations that you've mentioned. Is there a recommended approach and will data be available to support these evaluations? Yeah, that's a good question. I'll try my best to address that. So. PTFE, I think this touches on a lot of the topics that we've discussed throughout. PTFE has been the go to solution and there is a lot of test data out in the market due to the decades of its use. What we're finding as we look at those alternatives is a needed refinement of test methods. Not necessarily something new, but something to supplement what we are, what we need, something a little bit more resolution, a little bit more functionally aligned with this use case. As far as recommended approach, like we said earlier in the presentation, it's don't think of a surface coating as an afterthought to the product. Really, surface technologies in general are an enabler of product function. Getting us or getting any applicator involved as early as possible and having that discussion of functional requirements will really help align that path forward and streamline that development cycle that includes functional coatings on that surface to help enable product performance. Just like with PTFE and its data, getting any applicator involved early would really help with generating that comparative data to look at incumbent material performance and find out what is the PFAS alternative performance needed, and that data would be provided as well. Perfect. Thanks, Mike. We have time for one more question, and this is a really good one. What challenges have you encountered while working with PFAS alternatives and how have you addressed them? Yeah, I can actually start here, Mike, and I'll pass off to you for your materials. Yeah, so what I've seen, like Mike mentioned, what we've talked about in the slide deck is that early integration. That's been a challenge. Parylene does work as kind of that retrofit kind of band aid solution, but when it's brought in early, that's where you can really drive down cost. That's kind of the challenge is we get an RFQ. It's late stage in the design and the quote's kind of high because it's been brought in at the end of the product. Like I mentioned, that masking and demasking are the highest cost drivers. Bringing Parylene or any other coating early on into that design stage, that's a challenge we need to mitigate. A second point. Sorry, Mike, here, I got one more would be that education. Parylene has been around since about the 1940s. It was commercialized in about the 1960s and 1970s, so it's got decades of experience, but it's definitely been underutilized. That's kind of my day- to- day is teaching customers all about Parylene, what it can do and how they can use it on their products. Mike, feel free to step in here. Yeah, just slightly different take on some challenges as we look at PTFE or PFAS alternative coatings. It's more aligned with what I mentioned before on test methods, but it's really understanding the difference between an incumbent coating performance versus a product need. The needed product performance for a specific application. I say especially for devices or products that have been in the market for many years, a lot of that performance is coming from the coating or what we, what's perceived as coating performance is actually from the incumbent coating, not necessarily what the product requires for its functional use. It's taking a bit of a step back and understanding what is needed, how do we measure it in order to move forward with sampling. Like I said, getting coaters involved early on would help with navigating that transition. Thanks, Mike. Stefano, Mike and Erik, last thoughts. What do you want our audience to walk away knowing? Stefano, we'll start with you. Yeah, thanks. For me it's really just reach out for questions. I love sharing Parylene knowledge. Whether you're in that early stage or you're revisiting a product, I'm more than happy to answer questions. Reach out to us. We'll be that partner and guide you in that transition away from PFAS materials. Mike? Yeah, I'll sound like a bit of a broken record, but the earlier involvement, the better. Really a bit of a change for many, many companies is to look at coatings as an enabling technology for product function. Taking that type of lens as we navigate the uncertainty in this industry would really help with identifying the right partners, the right processes, the right materials going forward. Thanks, Mike. Erik, round us home. Yeah, it's going to be nothing new here, I guess, more than anything, just we'd love to have more conversations. Obviously, we've enjoyed the Q& A and everyone wants a quick answer, but these things really depend on the product type and the application, whether it's a catheter or a guide wire or a machine part, if it's implantable or if it's single use. It's really tough to give solid answers without kind of understanding the greater context. If anyone, you know, if there's still open questions, I mean, definitely reach out. We'd love to have further discussion about your needs and what we can do to help. If we can't, we'll try and, you know, steer you in the right direction. Thanks, Erik. Another huge thank you to Integer and to our presenters for sharing your expert insights. Just a reminder for everybody in our audience that this is going to be available on demand. Please share the link to this webinar. You'll be receiving an email in the next few days that will include a link to that on demand. Please share that with everybody that you think needs to know this. You can still ask questions for those who are listening on demand. Huge thanks to our audience. I love how engaged you all were. Thank you for using the emojis and the chat feature and putting the Q& A in the Q& A so you all get a grade A. Last thought we have here is just again, thank you. Thank you, Integer. This is the privilege of my career to be able to share these stories and to learn about this great industry, med tech. If there's one last thought I want to leave everybody with, it's that partner, innovate, and accelerate with Integer. Thanks for joining us and we'll see you on the next Device Talks Tuesday.