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Pursuing the Pulse
Pursuing the Pulse takes you behind the scenes at Resolution Medical, where bold ideas become breakthrough devices. This podcast series follows the full arc of medical device innovation from concept to commercialization with candid insights from the experts shaping each phase. Learn how our integrated approach, technical depth, and scalable systems make us the go-to partner for complex catheter and IPG development.
Pursuing the Pulse
Additive Manufacturing in Medical Devices: Resolution Medical x Carbon
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Medical device development requires balancing speed, quality, cost, and regulatory requirements, all while moving innovative technologies toward commercialization.
In this conversation, experts from Resolution Medical & Carbon discuss how additive manufacturing is helping medical device companies accelerate development, reduce design iteration timelines, and support programs from early prototyping through clinical builds and mid-volume production. They also explore material selection, biocompatibility, manufacturing tooling, and how additive manufacturing can complement traditional manufacturing methods throughout the product lifecycle.
Whether you're developing a new catheter system, active implantable device, structural heart technology, or another complex medical device, this discussion provides practical insights into how additive manufacturing can help streamline development while maintaining flexibility and quality.
Riley, so great to see you. Glad that we're able to have this conversation today talking about uh carbon and resolution medical. Um, maybe I can kick it off with a bit of introduction about me and carbon, and then hand it over to you to hear your introduction and learn a little bit more about resolution medical.
SPEAKER_00Yeah, that'd be awesome.
SPEAKER_01Awesome. So I'm Isabel Palumbo. I'm a senior strategic account manager here at Carbon. I work closely with original equipment manufacturers as well as carbon partners like yourself. I've spent nearly a decade in the healthcare space working at GE Healthcare and Amazon, but the last four years I've spent at Carbon. Carbon is a Silicon Valley tech company that takes customers' ideas and brings them into production via additive manufacturing. What makes carbon different and unique in the additive manufacturing space is not only that we develop the hardware, the software, and the materials, but we leverage digital light synthesis. So we build layer by layer, but we also have a unique oxygen permeable layer in our cassette that allows us to grow our product or grow our applications from the liquid resin. So that's allowing us to print at a much faster speed. With that, our materials are absolutely incredible. Our team of material scientists have spent a lot of time and are constantly developing and iterating to create these engineering grade materials. They have similar strengths, durability, as well as biocompatibility to some injection molded plastics. You've definitely seen some of our work on people's feet with our partnership with Adidas. We have the Adidas 40 Forwards, as well as this year, Adidas launched the Climate Goals, which are 100% uh 3D printed shoes leveraging carbon's technology. We also are seen in the helmets of many NFL players, uh, Radell, Visis, Shut, leverage our technology in their helmets for foam replacement. Um, but at Carbon, I'm focused on med tech and life sciences. So I work with companies to, again, take their ideas and bring them into that production level, be it in um jigson fixtures to support uh applications or in-end use medical products. I'm very passionate about carbon and how this technology can simplify supply chains and get their designs and iteration or designs uh to market that much faster. So excited to talk to you today, Riley.
SPEAKER_00Yes, thank you. Uh super cool technology that you guys have over there, and it's really cool to see uh what you guys are actually doing outside of resolution as well. Uh, we want you to succeed and being able to see your guys' success as well. Uh, has been super cool over these last few years. Um, I guess now following up on Isabel's uh introduction, my name is Riley Sagmo. I'm the component supervisor here at Resolution Medical, which basically means that I oversee all of our carbon 3D printing, our injection molding, as well as our laser cutting and welding. Um I've been here for just about three years now, uh coming up on that, uh, which is exciting. Time flies when you're having fun. Um, but that's enough about me. Uh, I guess how to start uh Resolution Medical. We're based out of Minneapolis, Minnesota, and we were founded in 2012. Today we're a contract services provider focusing on designing and manufacturing complex catheter systems, mainly for structural heart, um, but we've also been continuing to grow in areas like neuromodulation and active implantables as well, which has been super cool to see uh since I started here. Um but yeah, it's just a little bit about us, but uh super cool.
SPEAKER_01So recently I saw the official announcement uh Resinetics acquired Resolution Medical. What does that mean for you in the carbon department?
SPEAKER_00Yeah, it's it was super exciting news for us to hear. Uh just being able to grow uh in the snap of the fingers is uh is pretty rare and pretty cool to see. Um it really just it expanded our scale, right? So we're about 275 people uh in two different locations, and since the acquisition, we're now at 3,000 employees with 21 facilities all over the globe, uh, which opens the door for so many more opportunities and gives us access, and our customers access to a much broader set of capabilities, uh more manufacturing depth, more global resources, more technical expertise, all of these things that our customers are relying on us for, we're now able to provide even better than we were before when we were just resolution medical. However, at the same time, we're still keeping the responsiveness and the hands-on approach that people have they expect from us and that they've seen since our founding in 2012. So we're all just super excited for what this means, not only just to the carbon department, um, but for the company and our customers as a whole.
SPEAKER_01Awesome. Super exciting to hear about all of the changes and growth at Resolution Medical and Resinetics. We're so excited to continue our partnership and collaboration with you. But let's go back to the beginning. Can you share why Resolution Medical chose specifically to offer Carbon's technology?
SPEAKER_00Yeah, of course. So uh when we were first evaluating our additive partners, uh, carbon really stood out early on. One of the biggest reasons was their willingness to work with us on advancing their breadth of materials, especially to a biocompatible leadable. This is critical for us for first in human work, clinical trials, um, and just overall ensuring that the uh the products that we're putting into human bodies aren't doing any harm, but rather are doing the exact opposite. I believe at the time that they that we started partnering with you, you didn't have any certified biocompatible materials, um, which is crazy now that you've grown all the way up to having about 12 of them with three of them, which are USP class six, um, which is super cool to see. Uh, and along with that, uh just the different range of materials that you offer and the different applications we can use them in, and also how uh committed you guys are to continue to innovate your materials, like you said, with your material scientists who do a great job, which is super big for us that we're able to even make our devices better, um, and just being able to continually innovate alongside of you guys. Um, and honestly, one of the main things was the support that you guys do offer us. Um, you're not just buying a printer when you're working with carbon, uh, you're but you're you're buying a relationship. Uh, being able to talk with Isabel every couple of weeks just to kind of gauge where we're at, how we're feeling, it's super, super helpful for us. We never feel like we're left stranded on an island, and there's always somebody uh who is willing to help with us, whether that be just from an ordering standpoint, um from a technical standpoint, or just somebody that you want to chat with as well, uh, like Isabel. Uh, they're really, really invested in helping us succeed, which is super, super cool and super, super helpful for us as well.
SPEAKER_01Yeah, I mean, just seeing all of your growth and change and you're reminding me of some of the the changes that that Carbon has gone through, I think maybe MPU 100 was uh released prior to you to our partnership. But yeah, to see the the growth and the expansion in the biocompatible materials, but then also now we have um you know letters of access if our our customers are requesting that when they're going to file for their 510Ks. Um, you know, and those 12 resins don't even cover our our portfolio of dental resins as well. So really, really cool to see the the growth, not only on the material side, but then we've launched um you know new iterations of our printers too. And I think that's what makes carbon unique as well, is our subscription agreement. So, you know, with that, you're subscribing to the printer, and we're constantly launching um, or I wouldn't say constantly, at a at a good cadence. Uh we have our software updates, and that's allowing you to have additional drop-downs for the new resins that are launched or um updating print parameters or supports. And we're always constantly trying to improve the print platform. So the printer that you installed in 2018 should be even better today with all of those uh software updates. And you know, at the end of your subscription term, if you want, you're able to upgrade to the next generation of our printer. And, you know, with you all, you're able to see, okay, well, we have this number of printers right now, but we foresee growth, and we're and you're able to bring on an additional printer as needed, which is really cool to be able to flex like that. Um you know, and I I think too, we've we've done a lot of work around the IQOQPQ, so installation qualification, operation, uh, operational qualification, and process qualification, um, and supporting you all as you are ISO 9485, um, to ensure that you have those quality processes in place uh for your customers. And you know, to that point of pushing ourselves and growth, uh Carbon recently got their ISO 9001 certification, which is really exciting for us. And you know, uh I'll continue on here. The the partnership has continued to grow, and we've seen some really interesting applications that have come across. What benefits does having additive manufacturing at resolution medical bring to your clients?
SPEAKER_00Yeah, it brings a lot. Uh at a high level, we brought additive manufacturing in-house for speeding costs, being to vertically integrate as much as possible uh just to make sure that we're able to do things fast. We're not relying on external suppliers who you're crossing your fingers they can meet their ship by date, uh, whereas we actually have it in our hands and we can produce it uh the day of if need be. Um the market already kind of saw carbon as kind of the gold standard in terms of quality and fidelity. Uh, and we just it just made sense to build around that, right? We're building medical devices, quality is one of our core values here, as it should be for uh anybody that is making a medical device. Um but uh from a practical standpoint, I guess the the biggest advantage, right, is speed. Uh, for RD prints that we do here at resolution, um, multiple a day, all you need, all we really do need from you is a 3D file. Once we have a 3D file, we can add it to the carbon UI, and within two days you have parts in hand. Um, whereas it takes that long for FedEx to even bring a package to you on some normal days. Um but uh we can iterate your design two or three times a week if need be, which is super super cool. Whereas if you were to be using injection molding instead of uh 3D printing, it can take that long, it can take a week, two weeks, three weeks to even just modify a tool. Um, and in that time we could provide you tens of different revisions to your part, which is super, super cool. Uh, it just gives our customers um the most flexibility possible, uh, which a lot of them are looking for, uh, especially in early stages of device manufacturing and development. Um it gives them the flexibility, like I said, you can start with prototyping, like I've kind of just discussed, but it's also going off of what Isabel said with qualifications, it allows them to move into production using that same platform, that same that same technology without without having to reinvest in another technology or more tooling and whatnot. Um from a cost perspective, right? Like I've kind of alluded to, there's no tooling investment here. Uh we have the printers, we have the platforms, we have the consets, the materials. Um you're not throwing tens of thousands of dollars at uh at these mold manufacturers, um, which also takes weeks to produce the initial mold itself as well. Um and then if you were to be looking at machining parts, right? The time it takes to machine and the expense of doing that as well, um, especially on parts that may be small and super complex, uh, it can be hard for that to be an option for them. Um, whereas carbon, we've seen a lot of success in smaller, complicated parts as well. Um, we also see it as a bridge. So we start doing RD, uh test samples, all those type of things, but we're also able to move it into mid-volume production as well while they are waiting on their regulatory approvals. So customers they don't have to start with one thing, which is us, and then completely move to a different technology for the rest of their manufacturing up until they come into production. You can continue to use carbon even throughout your clinical, your DV, your biocompatibility builds, all of those builds can be done using carbon, which has been super, super crucial and has helped save our customers a lot of money and time by doing so.
SPEAKER_01Yeah, you're hitting the nail on the head with that time point. Um, again, I don't want to misquote any of your leadership, but I know at one point John mentioned that um because of having carbon, he's able to see some of your clients go from instead of 18 months to first in human, knocking that timeline down to six months. And that timeline is so incredible, especially for some of these seed stage early startups, because time is money and they don't have the weeks it takes to wait for the um molded part to the mold to be made, the molded part to come back, and then having to iterate on that again and wait another couple of weeks. You know, you you hit the nail on the head with, you know, you might have these small, complex parts, and again, depending on the size of the part, uh to the size of the cassette and the platform that y'all have, you're able to maybe print five to ten different iterations, um, different orientations of the part, different size of a through hole, and see which one, you know, is the best. So maybe it's a couple hour print, you have that post-processing and fake cycle. The next day, your clients can be evaluating parts and selecting, you know, how they want to proceed forward, which is so exciting and and so unique to um additive manufacturing. Um, you also hit the nail on the head, too, with some of that that biocompatibility and um you know bridge protect bridge production and clinical trials. It's really exciting for us. We, you know, as far as of what we've been tracking, there are um 10 class two medical device, at least 10 class two medical devices that are leveraging carbon technology for part of the final assembly, which is really, really exciting. And I'm waiting anxiously for the day that we have a class three medical device, so I can point uh to that 510K filing and say, hey, look, there's carbon. Um, but for now I'll I'll let those OEMs and those clients remain anonymous that have those class two devices and just wait for you know the next marketing, the the customer that's willing to share that marketing story. Um, you know, we we talked about why you brought additive manufacturing and why you brought carbon, but can you share uh some of the applications that have been developed at Resolution Medical and are leveraging the carbon platform? Now I know not everyone, like I just said, likes to share their secret sauce, but I know that there are some cool case studies and things that you you can share.
SPEAKER_00Yeah, absolutely. We've seen a pretty wide range of applications of our parts. Uh I guess one example to start, uh, if you go to Carbon's website, you'll see uh a case study uh for a company called Perceptus Medical, uh, who has been manufacturing their device at Resolution Medical for some time now. Um but it all started with printed parts, printing parts on our carbon machines to get them all the way through their development. They got through development, they were ready to go into manufacturing, passed all their testings, and then they decided to switch to injection molding, which for a higher volume it can make more sense. Um, helping them drive that decision as well is something that uh that we're proud of doing, but we're also able to now mold those parts for them as well. Um, so just taking it from one of our cool technologies here at resolution to another has been pretty cool to see, but we've also seen other projects here who have just recently moved into production who are still planning on using the Carbon's RP70 resin for the foreseeable future. Um it takes time to develop molds, it takes time to right drive the demand or to grow the demand of a device. Um so just being able to see how customers are either they have the the option to switch it up on how you're doing it, or you can stay uh with a reliable process, which is the carbon printing. Um so that's super, super cool. Um another super cool thing that we were able to do is uh while uh most of us were at home uh just during that COVID pandemic, we produced 1.4 million swabs to help diagnose those infected with the coronavirus. Uh so being able to help detect this early on, make sure you're not and you're quarantining yourself. I know a lot of people don't even want to think about that time. Um but uh it is super important to our success in the carbon department. So um definitely something cool we've done there. Um and beyond that, not every component that we print is for people that we uh work with day to day here at Resolution and are actually building their final devices. Uh, we do ship parts out to external customers as well. Um, so if that is something that people are interested in as well, you do not have to bring your full device to us. Uh, but we can also just take on a couple components if that's uh what makes the most sense to you. Uh we may not see these customers every step day to day, uh, but we know that we're helping them get to market, and that's what really matters to us is that we're providing them high-quality parts in a timely manner that helps them achieve their goals.
SPEAKER_01Yeah, that's awesome. Um, and it's really cool to see all of the applications um, you know, that that you all are working on. Um there's so many consumer uh applications that we see at Carbon in partnerships with different consumer brands because obviously they're direct to consumer or they're consumer products, so we're able to talk about them, people see them, um, applications like I mentioned earlier with the footwear and the helmets, bike saddles, and most recent and excitingly, and peripherally, uh in our world, the the wheelchair cushions. Um, you know, what are some other applications? I know you can't share, you know, exact things uh that you're seeing that are coming through Resolution Medical, and maybe you hope to see um come from some of Resinetic's uh clients.
SPEAKER_00Yeah, so a lot recently what we've kind of seen kind of grow and jump here really quickly was uh the use of carbon to print catheter handles. Catheter handles can be quite large and they require expensive tooling and lots of material. Um we're able to kind of like what we discussed earlier, we can print if you're printing handles vertically and you're not going past the the uh the max y that carbon allows us to print at, we're able to print um quite a few handles on one platform, um, multiple iterations had we at like we previously discussed, um, which makes it super easy for our customers to kind of look at all of them at the same time, decide which one feels the best, decide which one works the best. Um And then from there, kind of pick a design, stick on it, and then right use that that file moving forward as you kind of continue to develop your device and go through all of these different testings. Um, another thing that we see a lot of uh in carbon is the use is using it to create tooling and fixtures. Um so obviously, being a manufacturer of some of these complex devices, we go through a lot of fixtures and tooling and all of that kind of stuff just to make our manufacturing process as seamless as possible. Uh utilizing carbon to create these fixtures and toolings has been super beneficial because the materials can be strong, they're reliable, uh, it's cost effective, and it's also very, very fast. We don't want a line going down because you we lost a fixture or it fell on the floor and broke or any sort of thing like that. So if that were to happen, uh we're able to print new fixtures, have them back out onto the line in one to two days, uh, which has been huge in making sure that we're keeping up with our demand here, but also our customer needs. Um there's a lot of lot of our customers with uh very strong set dates for things like sterilization and testings that need to be done, and we need to hit those time points. And having that additive manufacturing and that vertical integration really, really helps us when something does go wrong. Um, it's we're able to quick pivot, get them on the machine, get them back out on the line, make sure we still hit those dates, which has been super, super, super critical. Um, and then kind of like we've discussed earlier, Isabel, with those small, really complex parts, and you kind of alluded to it, we can print a hundred up to some parts, a hundred different designs, hundred plus designs on one platform. You can test them out. Carbon gives us labeling options on it as well, so we don't know we know which ones are which, uh, which is super, super cool. Um, but instead of having to do a hundred different tool modifications or a hundred different machine runs, uh, you're really only doing one platform that could take anywhere from 30 minutes to six hours, and then you have every part you need to decide what the best path forward to take is, um, which is super super cool. Um, and then there's also some cases where these are the parts that are super critical to the device's performance, that without these devices or these parts functioning correctly, then there is no end product. So being able to use this technology to produce such critical components to some devices, it's really cool to see how it kind of stands up and still works. Um, like some may think, molding only can.
SPEAKER_01Yeah, that's awesome. And you know, I recognize it. Carbon is incredible and it has, you know, all of these benefits, but there are you know drawbacks too. Nothing is nothing is perfect. Um, and you look at there's so many different additive technologies. You at Resolution Medical offer so many different manufacturing technologies. So when you have a client, how do you steer them towards the right manufacturing process? And in and sometimes it's not always carbon.
SPEAKER_00Right. So, like I said, I kind of oversee the whole the molding, laser cutting, welding, and the carbon. So I guess speaking from a carbon versus molding standpoint, right? There's certain things that we want to learn about the part, and it really does all start with communication. We spend a lot of time understanding what the customer actually needs so we can pick the best option for them. Things that we're considering are what is your timeline, uh, what are your cost considerations, what stage of the product development cycle are you in, which features of your part are absolutely critical? And then also looking at it: does it have printability? Does it have moldability? Can it be machined? All of those things are different factors that we take into consideration when deciding whether we should be going with injection, molding, machining, or carbon. Um, and if carbon so happens to be that best route to take, our team, along with carbon support, like Isabel, uh, brings a lot of experience with both the materials and the technologies. Um, so this relationship together, it helps us guide customers, uh, especially if they're new to additive manufacturing and 3D printing technologies. But at the end of the day, it's just it's a very collaborative process.
SPEAKER_01Definitely. I mean, there's so many decision points, like you were saying, the materials, the probably sterilization that you have to think about. Is it single use, multi-use, um, you know, the rapid aging, what other testing do you have to do? So so many different decision points. And and I think it's it's been fantastic to I'll I'll bring it back to our material scientists, and they're constantly learning from the feedback that you and other OEMs and other carbon partners are giving around, okay, well, we need a we need materials that stand up to X or to Y. And so, you know, having our our newest, uh, one of our newest rigid materials, EPX 150, hearing that there's a big push towards multi-use. Um, they've done a lot of work so that it has a high enough heat deflection point that it can be autoclaved and still biocompatible. It's a USP classics material, which is really exciting. Um, but I'll get back to the point here. Um, what's the best way for someone to get started with exploring application development with Resolution Medical?
SPEAKER_00Yeah, so the easiest way to get started is to reach out to our business development team. If you don't already have a contact, uh you can just use the contact us form on our website, www.resolutionmedical.com. Um, from there, we'll set up a conversation. We want to learn what you're trying to do, uh, and we just want to figure out how we can support you best. And from there, we'll continue pushing our relationship forward. And um, if we ever need anything from Carbon Side, we know we can reach out to them. Um, but yeah, just making sure you reach out. Let's start a dialogue. Uh, we're always excited to see new uh new customers, new applications, new devices come our way. Uh it's kind of what what keeps us going around here. So uh it's been super awesome talking to you, Isabel. Um I'm super excited for our relationship going forward and all the the new things that that carbon is implementing. Um, and we can only go up from here. So uh I appreciate you taking some of your time of the day to uh to talk to me and uh kind of let me give my spiel on um how awesome carbon's been for me uh and uh and our company as a whole. So thank you.
SPEAKER_01Awesome, and thanks for chatting with me. I'm glad that you evangelize carbon so much. I really appreciate it. And I know um it's been you know such a great relationship, and I look forward to to working with you for many more years.
SPEAKER_00Absolutely. We'll talk soon.