Buong transkripsyon ng Michael Brooks | How BayCath Medical Is Rethinking Catheter Development

hopefully quite a bit smaller. 00:05:48.790 --> 00:06:41.740 And what we're really doing with that garden hose is going from generally, I mean, point A to point B, point A being outside the body, point B being inside the body. Generally, that's the ephemeral artery, kind of inside of your upper thigh, into whether that's the heart, the brain, an artery or vein somewhere in your body, to deliver some sort of a treatment. Often, that is a stent, or you're removing a clot, or you know, in this case, the structural heart, you're putting in a essentially an implant into the heart to replace the valve. It it truly is a delivery system. It's very specific to the device, very specific to the application. A lot of people don't realize that even within medical devices, it is it's a lot of fine tuning involved in getting it right. 00:06:38.870 --> 00:06:45.699 But at the end of the day, it's in the body generally less than six hours. It's not an implant. 00:06:45.879 --> 00:07:39.589 It's relatively easy from an FDA standpoint, but still really fun to work on. Yeah, why why do you think catheters have gotten so popular over the years? There's a lot of procedures that we do right now, or physician surgeons do right now, that are, you know, state of the art, the best, the best medicine available. Something like open heart surgery. Absolutely, if you need open heart surgery, and that's the only way you're going to survive past the next six months, you're going to have open heart surgery, but when someone introduces a catheter-based approach for replacing your valve, which does the same thing potentially as that open heart surgery, just the impacts and the risk to the patient are severely diminished. 00:07:40.189 --> 00:08:19.980 It's not the most important factor. Cost is also severely diminished, and then recovery time as well. So, when you have when you have a surgery, generally the biggest risk to the patient is infection. Crazy enough, that's actually still the same thing for a catheter-based surgery, except that your infection risk goes from you know your entire open chest cavity and all of the stitching and sutures to close that up to you know a two inch slit in your thigh that yeah you have to keep it clean yeah you don't want it to get infected but it's kind of night and day when it comes to true risk of that procedure 00:08:20.250 --> 00:08:30.350 yeah huge benefits. My dad had open heart surgery back when I was in high school, and I remember that being a brutal recovery for him. 00:08:26.120 --> 00:08:42.669 He was in the hospital for five or six days, and then you know it was weeks at home, just taking it really easily before he could really start moving around again. And I imagine it's much much easier when it's a catheter-based procedure. 00:08:44.200 --> 00:09:01.889 Yeah, depending, of course, on the procedure, and also honestly, the surgeon, time of day, things like that. But most catheter-based procedures, you're home either that evening or the next morning. You know, overnight versus a week in a hospital is a huge difference. 00:08:58.629 --> 00:09:09.659 Better, honestly, for recovery as well, and you're generally, you know, up and moving and active pretty immediately as well. It it really is a huge difference to the patient outcome. 00:09:09.778 --> 00:09:12.448 Yeah, amazing. 00:09:09.778 --> 00:09:23.719 Okay, so you you work for various companies doing catheter development, catheter manufacturing. What was it that you saw in the market that made you think, you know, I think there's an opportunity to do this better, and I'm going to start my own company. 00:09:25.428 --> 00:09:32.089 Yeah, I was watching Lead Times Balloon, and they kind of a what I felt was a lack of customer communication. 00:09:33.229 --> 00:10:02.339 Really, just I like working really closely with customers, and there's obviously a limit to how many customers you can work with at a time. But what I was seeing within the industry is the best contract manufacturers within the catheter space were too busy, had too much going on, weren't necessarily hiring appropriately for that increased workload, and as a result, lead times were going from, you know. 00:09:57.158 --> 00:10:11.759 Going 2x, 3x, 4x what they used to be, and then you know customers weren't really getting told that their build was late until their build was already a week late, and I don't know. I think they already knew it was going to be late at that point. 00:10:12.809 --> 00:10:18.419 Right? Yeah. Okay. 00:10:12.809 --> 00:10:25.460 And so so bait cath was created to solve that problem, getting catheter development completed more quickly. Is that a right the right way to see it? 00:10:26.629 --> 00:10:28.580 Yeah, exactly. 00:10:26.629 --> 00:11:01.830 We we really are targeting faster cast faster iteration within the catheter development cycle, and then really trying to work closely with our customers collaboratively with our customers. Kind of going back to one of those earlier questions of, you know, working together makes such a difference to long term success of the project. In my opinion, I really like that collaboration. So really, really trying to work with our customers in person whenever possible. We have customers on site building with us all the time, which is very helpful as well. 00:11:02.100 --> 00:11:05.639 That's cool. So they'll come to your facility and and build there with you. 00:11:07.019 --> 00:11:10.860 Yep, I had two customers on site from Texas all of last week. 00:11:11.070 --> 00:11:26.120 Nice. Oh, that's awesome. In person, hands on together. Okay, so I hopefully there's some people out there listening to this who think, oh, we design catheters. We should know Michael and his company. 00:11:23.029 --> 00:11:31.519 Maybe there's some opportunities to work together. That'd be great if if that happens. I always I like connecting people. 00:11:29.570 --> 00:13:25.960 Right, that's one of the purposes of this podcast

is connecting resources and and those who need them. There might also be some people listening who develop catheters who who think to themselves, ah, well, we're not really ready to outsource any of this, but man, I sure would love to hear some of the best practices that Michael has developed or observed over the years. Are there a few best practices that you can share for those who just want to implement them into their own work developing catheters? You know, what what are some of the the common problems you see that that slow teams down. PDX 2026 is October 20th and 21st in Phoenix, Arizona. It is not a typical trade show. PDX is a practical training event for engineers who design, develop, test, and manufacture physical products, whether they be medical devices, consumer products, or automated machines, exhibitors teach hands-on sessions, run demos, and help attendees build skills they can use right away. If you are a mechanical engineer, biomedical engineer, product development engineer, manufacturing engineer, or engineering leader. PDX was built for you. See you there. 00:13:30.759 --> 00:16:11.330 Yeah, absolutely. I think so. Really early on, if you're building 123, parts, that often looks different than building 1000 parts. I think from the very first part, you want to have a plan for how you're going to build 1000. If it's a process that is unrealistic and unsolvable at that 1000 scale, I think it's worth really reconsidering what you're doing at that early stage. Not necessarily, you know, failing to build that first part, but starting to look at, you know, how do I get to 1000 immediately from that first point? And that's something I'll do a lot actually with customers when we have really, really complex projects. Is, you know, we only have to make one or two, but by the time that we've made that one or two, I want to have a plan for 1000. I want to know that we can get there. I want to know that we can get there at a cost that makes sense within the market. Because otherwise, I mean, the reality is that that doesn't really work as a product. That's a process problem, but process problems are where a lot of good ideas go to fail. What is catheter manufacturing like? Is it a highly automated process, or is a lot of this still done manually, even at larger medical device companies? Yeah, it is surprisingly manual. I think even for engineers within the catheter space, within the medical device space, I often have people be very surprised by how manual building a catheter really is, and it it comes down to it. Actually, it's a pretty hard process to give to a robot or give to an automated system, simply because there is a lot of variation from one part to another, especially when you're looking at like different types of catheters. But even within one catheter line, within one part, there is just a lot of I don't know touchy feely type parameters that a seasoned operator or seasoned. Has spent 10 years learning and knows exactly how much

force to put into that during that process, and then changes that according to different factors that they probably can't really speak to, but is absolutely a part of the process, which makes it really hard to automate. And there's there's really smart people working to automate catheter production. We've worked with a couple of those companies over the years, but it's it's not easy to do, and it's it takes a volume that not too many catheter projects really get to to make financial sense. Oh, 00:16:11.840 --> 00:16:18.860 interesting. Okay, what what are typical volumes for complex catheters? 00:16:20.658 --> 00:16:30.908 Yeah, it's a lot of our customers are earlier stage startups, often VC funded or something kind of in that realm. 00:16:30.970 --> 00:16:31.120 Okay, 00:16:32.259 --> 00:16:47.580 so a lot of our customers really are probably three to five years from true revenue or true sales. That's a combination of you know FDA and other approval processes, and then also just market adoption. 00:16:42.240 --> 00:17:08.750 Big difference that we went did a couple on-site visits actually with some of our local areas and did like a whole talk on just market adoption, how important that is in order to actually get physicians to buy into your product. But the key there being really, just because the FDA says you can legally sell it, doesn't mean that people are going to come and buy it. Sure. 00:17:09.109 --> 00:17:09.170 Yeah. 00:17:11.209 --> 00:17:29.229 And it takes a long time, often longer than people realize, to go from, you know, an idea to approval to really, I mean, hundreds a month is is a decent volume for a lot of these products early on. 00:17:25.568 --> 00:17:53.219 Obviously, everyone wants to get to super high volume, 1000s, 10s of 1000s a month, but it that often takes an acquisition that often takes someone like J and J, Boss Scientific, Medtronic, and there, you know, hundreds of people in the sales team that support those products. Yeah, and a lot of our customers are looking for the acquisition, and just looking for enough revenue to prove that they are acquirable and worthy of them. 00:17:53.339 --> 00:18:17.719 Sure. Yeah. So BayCath Medical moves pretty quick, right? You can produce prototypes quicker than some of the other contract manufacturers out there, but catheters, medical devices, are of course a regulated industry. How do you how do you balance moving really quickly with the documentation that needs to go along with that? 00:18:19.459 --> 00:18:27.609 Yeah, we put a really quite a strong line between R and D and production. 00:18:23.349 --> 00:18:37.629 There, there's of course a point where you hit production assembly where quality needs to be your number one focus, and those parts absolutely need to meet spec 100 of the time, or get rejected out if they don't. 00:18:39.519 --> 00:19:09.889 But the reality is, in R and D, we want to make high quality product, but our focus is going to be speed. Most of our customers are pretty happy with a little bit lower quality product at the expense of, or at the, you know, in exchange for really fast product. Yeah, I'd venture to say we are probably the fastest catheter contract manufacturer in the world. I no one's proving me wrong on that yet. Feel free to try. I'd like like the challenge. That's amazing. 00:19:10.189 --> 00:19:12.199 That's amazing. 00:19:10.189 --> 00:19:12.199 How do you think you got there? 00:19:12.289 --> 00:19:15.079 I mean, you're what like a year old, something like that. 00:19:16.429 --> 00:20:02.179 Yeah, we're only a year old, and really, the key there is just we work with the same suppliers as everybody else. I have really good relationships with a lot of those suppliers. So if something goes a little bit wrong, we can tend to fix it faster than I think a lot of the bigger companies can. And then you know if we get an order for 10 catheters, those materials are going to be ordered by the end of the day. Shipping speeds don't change. That vendor's time out the door doesn't really change. And then as soon as the parts arrive, we really are trying to schedule that build, you know, as quickly as possible, off to within a couple days. And then again, no one else can build those parts any faster than us. We just cut out the waiting, if you will. 00:20:02.449 --> 00:20:05.509 Got it. Okay, so it's a logistics game, kind of. 00:20:06.889 --> 00:20:38.379 Yeah, absolutely. I I really do look at contract manufacturing as supply chain management, and you know, controlling the customer's bomb for them in a lot of ways, ensuring that their suppliers are providing high-quality products, especially in production. But you know, managing a bunch of different people, bringing a bunch of different materials together, doing final assembly, final processing, and then getting out the door for for our customers, preferably whenever possible, on time or early. 00:20:39.119 --> 00:20:50.219 Yeah, so when a customer brings you a brand new catheter design, what are some of the early questions that you're asking before even getting into development R and D? 00:20:51.869 --> 00:21:18.859 Yeah, absolutely. The I think I would phrase this best is just how certain are you about this design? Really, that gives me a good feeling of, you know, I've spent the last six weeks sitting at a whiteboard drawing this out, and I'm very sure this theoretically works. Or, I don't, I don't know. Like, it might work. It might not. 00:21:20.179 --> 00:22:14.750 Different approaches to both of those. I'm gonna be honest; it's not always one better than the other, but it definitely changes our approach to it. If a customer is super certain that this is the design that's going to work, which I will say has never been the case, you have to be a little bit more careful about walking them Through potential updates, if you will, if they're not too sure about it, it's usually pretty easy. Be like, you know, I I'd suggest this. If

you're open to it, I'd like to try, you know, what you propose and maybe something else in parallel. Let's let's try both, and then between those two, it's probably one of those is a good option. Will steer the next direction, and it it tends to be pretty iterative, and it tends to take quite a few batches of parts to really get to that final perfect design. 00:22:09.019 --> 00:23:33.319 And I think that's a really good part of the process. And I think that's something honestly that most catheter CMs maybe hide behind a little bit, and and we try to be pretty straightforward about it. Is you're going to need a couple test products, and we need some test data to really show which one works better. Why can you get to where you need to go in the body properly? And I I don't think there's anything wrong with that. We try to do it faster and more efficiently, cost-wise, so that you can have multiple iterations instead of charging you hundreds of 1000s of dollars for the first one, and then if it doesn't work out, it that's a really bad spot to beat. Yeah, 00:23:34.039 --> 00:25:02.399 yeah. Is there like a very tactical skill that you can share? Something that you or your operators have used when they're they're building these complex catheters that audience members who are also doing R and D work in the catheter space could could try for themselves. You know something that one of these like pro tips that you've just picked up over the years. You know maybe it's you use this particular scalpel when you're manually skiving a catheter tube, or I don't know something like that, right? But something really tactical and specific that an audience member could take away and say, "Oh, I'm going to try that tomorrow in the lab. Pipeline now offers procurement of custom machined parts at significantly lower costs without sacrificing speed or quality. We design and build custom machines ourselves, so we consume a lot of precision machined components. Over the past several years, we developed a proven overseas supply chain to support that work, and in 2025 we successfully piloted that capability with select customers. Now we're opening it up more broadly. If you'd like to see how our prices and lead times compare, send us a drawing or two for quote. Visit teampipeline.us or message me directly on LinkedIn. 00:25:06.899 --> 00:25:47.379 Yeah, there's some really really easy like 3D printing options out there. So something like if you want to cut an extrusion straight, it's very easy as an engineer, to print a quick little fixture with a razor blade hole in it, and then your extrusions are straight every time. That's gonna save you some future issues. There's some other things in that realm that are pretty easy to get to as well, and we we're working on some fixtures actually that we would give you the design for, which is not quite there yet, but feel free to reach out. I can give them to you once we're ready. 00:25:49.599 --> 00:26:00.669 But there's just a lot of 3d printing has added a lot to the engineer's ability to make a really cheap fixture for something that doesn't necessarily justify five grand in stainless steel tooling. 00:26:00.698 --> 00:26:08.158 Yep. Yeah. Cool. 00:26:00.698 --> 00:26:18.178 What are some some decisions that get made early on in catheter design that end up having a you know could have a pretty significant effect on the the outcome long term? 00:26:20.159 --> 00:26:45.429 Yeah. Material selection tends to be huge. It's something that a lot of our engineers maybe overlook, if you will. But then once you get, you know, had a more to that production side, it has a huge impact in biocompatibility. And changing those materials has a often often stops you from being able to make design changes, so be very careful with materials early on. 00:26:45.579 --> 00:26:50.589 Yeah, what are a few of your favorite polymer polymer materials for catheters? 00:26:52.269 --> 00:27:27.379 Yeah, anything PBAX is really easy to work with, and I don't think most people realize this, but the reason you actually use PBACs in a catheter, it's it's not a great polymer for most most of the reasons you look for a polymer. Pvax actually is not not top level. The reason Pmax is so good is it bonds to different materials, so it can bond to softer and stiffer materials in a way that most polymers can't. We'll do nylons kind of more proximal end, and we'll go. I really like Newsoft up front, but there's there's a couple more options coming out as well. 00:27:27.799 --> 00:27:29.359 It's almost like you know what you're talking about. 00:27:30.769 --> 00:27:36.949 Almost like I also have this great reference poster right next to me that we sell on Champer that makes it quite a bit easier. 00:27:37.009 --> 00:27:41.199 That's helpful. 00:27:37.009 --> 00:27:52.149 Awesome. Let's see. How about how about design transfers when when engineering teams transfer designs to manufacturing? What are a couple of the things that you find often get lost in translation? 00:27:53.949 --> 00:28:23.299 Yeah, tribal knowledge is probably the the best word for it. It's it's that thing that the R and D tech knows that they have to do every time, but the engineer has never watched them do it, and therefore that one weird specific thing has never made it into the MPI, the manufacturing process instructions, and therefore it kind of just disappears in the transfer. 00:28:16.799 --> 00:28:43.869 Which one I think it's a huge, I guess, opportunity for the engineer to go and make sure the process is right. Have your tech, have your operator review the MPI, and I like to have them sit down, build one counter or two counters with the MPI in front of them, go exactly step by step before it's released, and tell me where I'm wrong because I I guarantee you I'm wrong somewhere. I just want to know where. 00:28:45.429 --> 00:28:50.649 We're all wrong on the first build, right? Like nothing ever works perfectly. 00:28:47.979 -->

00:28:50.649 Yeah, 00:28:50.919 --> 00:28:51.309 absolutely. 00:28:54.489 --> 00:29:16.439 Do you have any stories you can share? Where I mean, earlier you mentioned how customers will come to you with maybe completely unproven ideas, right? They just want to see if it's going to work. And any stories where you had to step in and kind of manage the tension between what a customer wants, what's technically feasible, and then what a customer can afford as well? 00:29:18.569 --> 00:30:11.549 Yeah, we we deal with that quite a bit. It it is it's a reason to go to a company like BayCath. Is we're used to being on a little bit tighter budget. We're used to having a little bit tighter timelines, and and we're pretty happy to play in that space. It's a hard balance. At the end of the day, I think it's really important to remember that everyone in that conversation is looking for the same end goal. We want to build, you know, long term a medical device that works for the application you're trying to build. Shorter term, we want to get you good workable parts at a price that you can afford. I'm not going to say like there are numbers that are unrealistic, but most people can get to numbers that are realistic, and often what that looks like is you know an engineering team wants 100 parts, and we can absolutely build them 100 parts. 00:30:11.639 --> 00:31:37.219 But I can build them 10 parts for you know 20% the cost of 100 parts. Let's really make sure the design is right before we build it. That's, I mean, first of all, please, please don't DB test something first run, but let's make sure it's really right. And then, if it's right, when it's right, then we go to 100 parts. But often, if you do, you know, overlap some testing, do your non-destructive testing before your destructive testing, you can get pretty far with 10 parts. Often about as far as you can with 100 parts on that original test plan. So let's be really efficient with how we're using the catheters. They can often be reused. Most people wouldn't tell you that, but as a single-use item in a medical, you know, future surgery is single use. You can probably use it 10 or 15 times if you had to, depending on what you're doing with it, depending on what you're testing. So just, you know, again, collaboration. Talk about the plan. Try to save money where you can, but also, I mean. I know I'm not a big fan of going super low quality on something like materials. We'll do it, but if you're sacrificing future quality of the device in exchange for cost, that tends to be where I try to draw the line. 00:31:33.799 --> 00:31:46.059 Yeah, something I think is interesting is this this cat and mouse game. It's not specific to to catheters, but that's certainly one field in medical devices. This cat and mouse game between 00:31:46.659 --> 00:31:49.209 the OEMs, right? 00:31:46.659 --> 00:32:41.079 The company that's originally manufacturing these devices, catheters, whatever it is, instruments, and then there there are these companies that have sprung up over the past I don't know 1020 years that reprocess these devices, right, and then sell them back to to the hospital in theory for a lower price point. So you mentioned in an R and D area, you could you know reuse these catheters. But what what what have you seen in the industry or in the market now? This cat and mouse game between the OEMs and and the reprocessors, is this becoming more and more prevalent? Are are OEMs getting smarter about like anti-reprocessing? I don't know features that they put into these catheters, or is is it not really that big of a deal? And I mean, I don't really know the space. I'm just tangentially aware of 00:32:42.519 --> 00:33:54.789 it, yeah. I'm only so familiar with with that part of it, and I do think it's a very small percentage of devices being used. And where I've heard it more is, you know, a device that was originally for sale in the U.S. was either used or wasn't used, and then gets resterilized, maybe repackaged, maybe reprocessed, and then gets shipped overseas. Whether that's Africa, South America, something lower cost, especially in that scenario. In my opinion, that's I don't know. I really like that. Just from a more more people having access to healthcare they wouldn't necessarily have otherwise, and then environmentally, if we can use the same part a second time, I really think we should. I know so companies like Intuitive actually reprocess internally and then send it out back out to the physicians. Okay, so unique concept, but that's a company who's taken it upon themselves to reuse them because their catheters, I think, are a little bit pricier otherwise. But that's a way that they've been able to still be in the market with that pricier catheter. 00:33:55.269 --> 00:34:10.529 That makes total sense. I'm surprised more, or maybe they do. More companies don't do that if reprocessors are out there doing it anyway, you know why not just take that in in house and compete with yourself and the reprocessors to the benefit of your company. 00:34:12.059 --> 00:34:18.989 Yeah, I definitely agree with that strategy as well. And then it's you know certified by the original manufacturer. This is in fact 00:34:19.319 --> 00:34:19.380 yeah 00:34:19.739 --> 00:34:24.739 good enough for the procedure. While also, I mean, ideally saving everyone a little bit of money as well. 00:34:24.829 --> 00:34:24.889 Yeah, 00:34:25.610 --> 00:34:39.829 yeah, and you would think that the OEM could reprocess for much less than anyone else because they have the tribal knowledge of how it was developed. You know what kind of validation, verification it needs to pass, all that stuff. They already have those protocols in place. 00:34:41.539 --> 00:34:48.969 Yep, and it's you're testing that part to the same protocols as the initial device being released, which makes me just feel a lot better. 00:34:49.389 --> 00:34:58.210 Yeah, yeah, as a patient, definitely. Okay, you mentioned

earlier that you were a lifeguard in a previous life. 00:34:58.449 --> 00:35:49.059 You also worked in emergency response and ski patrol, I think, and I'm curious. So those those can be high pressure environments when something goes wrong. Anyway, did you did you develop behavioral attributes that allow you to remain maybe a little calmer than the rest of us might under pressure, and has that translated into your your work now? Because although you're you're not you know resuscitating someone on the factory floor, hopefully, engineering work, especially owning your own company and and running it, can be very very stressful. Have Have you found that any of the skills that you developed in the emergency response areas have translated into engineering or even just business ownership? 00:35:50.828 --> 00:36:58.868 Yeah, absolutely. I so I spent 10 years as a certified EMT. Have been working in some sort of emergency medicine closer to like 14 years, I believe, at this point, and honestly, I just really enjoy that kind of as a side hobby. Still work a lot of concerts and races and other other other venues that need volunteer emergency help. But I think the really important thing there to remember is. You know, the most life-threatening emergency out there is probably not something you're ever going to see in an engineering manufacturing environment, which is a great thing. Most people don't want to deal with that in their daily lives, and I think that's important. I also think it's important to have that perspective when you go into, you know, your build is two weeks late, and you're, you know, $10,000 behind on budget, and all of these things are real issues. Don't get me wrong, but at the end of the day, it's not life threatening. We can sit down, we can take an extra five minutes to think about it. 00:36:58.958 --> 00:38:10.648 There's no reason to lose sleep over a lot of the issues that we see in engineering and in manufacturing, and I also think it's really important to say, you know, if you are an EMT or emergency medical worker, like working on an ambulance, working in a ER, you know, those people are dealing with very time-sensitive, very important, very stressful scenarios, and then they take a break and move on. Whether that's a new patient in the future or also just you know 15 minutes gap between things, and it's really important, I think, from a manufacturing perspective, to take those breaks to step aside for a minute. Remove yourself from the stressful situation, because again, it's not life threatening. It doesn't need to be. We can take the extra five minutes. We can take the extra day. I'm a really big fan of customer communication, making sure the customer knows what's going on. But most of your customers, you have a good relationship with. They're going to be okay with. Hey, I'm so sorry. This happened. This happened, and this happened. 00:38:06.328 --> 00:38:35.268 We're doing these things to fix it. I always like coming with a,

you know, this happened, and then we did this. Like we are actively involved in this process, but really coming at it from a, I'm sorry, it's gonna be five days late. Most of my customers, when I tell them things like that, it's like, oh, okay. Like, we know you tried your best. We've worked with you long enough to know that there was nothing you could have done. 00:38:32.509 --> 00:38:35.268 You would have already done it. 00:38:35.359 --> 00:38:40.789 Yeah, this is development, right? We're we're inventing things, and invention does not always go according to plan. 00:38:42.319 --> 00:38:58.629 Yeah, absolutely. I earlier on in development, sometimes we'll have conversation with customers on, you know, that I don't know, like why are we having to change this equipment for my device? 00:38:55.179 --> 00:39:14.099 Like, well, like we're really pushing some limits here. Like we are having to modify the equipment that makes 95% of catheters because yours is weird, and weird's good as long as weird works. But it does cost a little bit of time and money to make new equipment, and 00:39:14.339 --> 00:39:14.489 you know, 00:39:14.609 --> 00:39:19.199 really modify a process to do, you know, those edge cases. 00:39:20.219 --> 00:39:49.419 I remember early on in Pipeline, I had acquired a brand new medical device customer, and this is probably I don't know three three or four years into Pipeline. We're 17 years old now, so this was 1314 years ago, and it was I think it was still it was probably maybe just me plus a couple of contractors, maybe we had one full-time employee. I can't remember. Anyway, I was still building the business, right? 00:39:49.569 --> 00:40:12.689 There was working tons of hours, doing everything I could, being scrappy to find new customers, and we we had this land of this like I won't say the name, but it was a global medical device customer. Anyone in the medical device space knows this company, and they sent me a project, and I was so excited about it. And it was just like a simple reverse engineering project. 00:40:12.689 --> 00:40:20.579 They had this blade. It's a long blade that goes into a surgical instrument, and they they said we only have one of these. 00:40:20.819 --> 00:40:25.189 Please be very careful with it. 00:40:20.819 --> 00:40:28.459 It's like $2,000 to get another one of these. So just you know, be careful, please. No problem. 00:40:28.669 --> 00:40:39.230 So super careful taking all the measurements, right? And it came in this like like plastic, hard plastic sleeve, and I I put it carefully back into the sleeve. 00:40:36.709 --> 00:41:20.069 There's you know those red rubber caps that go on these clear plastic tubes, right? Had the one rubber cap on one end, and and I put the second rubber cap on on the other end, and I thought I don't know that that second rubber cap went on all the way. I don't want this to come apart, you know, in transit when it goes back to them. I better just push on that little rubber cap just a little bit harder. Make sure it's all the way on, so I push on it, and the whole thing, the tube buckles with the blade inside, and I was just beside myself. I was I was mortified that I let this happen because it kinked the blade, right? Plastically deformed this blade. I took it out frantically. Oh, can I bend it back into shape? Can I remove this? No, there's just no way. 00:41:20.929 --> 00:41:41.239 So I was like, "Ah, they're gonna fire me! Like, my life is over. This is the worst thing that could ever happen. And I let them know about it, and they're like, "Oh, that's not great. Yeah, that's too bad that happened. And then we went on to work together for another five years. After that, and did tons and tons of business together. 00:41:38.179 --> 00:41:57.069 So, like you said, right? These things can seem maybe not life-threatening, but like a significant source of stress in the moment. But most of the time, we make them out to be a bigger deal than they are in our own heads, and and usually it all blows over and it's fine. 00:41:58.750 --> 00:42:26.899 Yeah, yeah, I think for the most part, people understand that your intentions were right, and that you-I mean, just the fact that you brought it to their attention and understood that that wasn't what was supposed to happen is way better than you shipping it back and pretending it happened in shipping, or you know, whatever else slightly shady option you had. You probably had plenty that you. I doubt you considered because there's a reason pipeline's still around today. 00:42:28.038 --> 00:42:48.488 It's true. It's true. Had I tried to pull something shady and they found out, we probably would not have ever worked with them again. So, all right. Well, let's see, Michael. Let's let's do just a one one or two more questions, and we'll wrap things up here. 00:42:44.588 --> 00:42:54.398 What is one thing that you have done to accelerate the speed of engineering? Something you've done yourself or seen others do? 00:42:56.319 --> 00:42:59.199 Yeah, I'm a really big fan of planning ahead. 00:43:01.058 --> 00:43:01.078 It 00:43:01.199 --> 00:43:29.059 allows you to anticipate your future needs, plan for them, and then, really, I mean, from my point of view, I make a lot of systems and future documentation around knowing that I'll need them in the future. And I think a lot of people. So I have a PMP certification project management professional, and you can go really deep into the weeds, into project management, and spend three months planning how you're going to make this a month faster, and that's not helpful. 00:43:29.899 --> 00:43:37.819 Like that just doesn't make sense. There's a point where you have a project manager in your project, and that's great, but you know they're doing it in parallel to the engineering. 00:43:37.879 --> 00:43:40.189 Like you, you can't just stop engineering for three months. 00:43:40.219 --> 00:44:20.339 Yeah, I'm a really like I really like the concept of

rolling wave development. So you plan out a very generic, high level timeline for the full project, and then whether it's one stage or one month or one section of the project, you plan to a little bit more detail as it comes, and then when you in that section, you start to plan for the next one. So you have an idea of the total goals for the project, and then you really only focus plan on the that next step of the project, because inevitably something's going to change in the next month or two, and if your plan 18 months from now changes because of that, 00:44:21.119 --> 00:44:49.689 you've just you kind of wasted time planning for it, big time. That's great advice. What is something that you're trying to learn right now, or maybe a technology you're trying to discover, or a vendor you're trying to meet that potentially someone out in the audience right now could help you with the the goal is how how can we connect Michael and something Michael needs with knowledge that someone out there in the the audience already has. 00:44:51.518 --> 00:45:10.918 Yeah, so we are currently working on a BayCath Innovation Week for this October. We have soft launched it, but still working out with all of the details. We're having Damian Carr come into town from Ireland. He's do a two-day workshop. We have Tommy Broke coming from Irvine. He's going to do a little bit of teaching in the catheter space as well. 00:45:11.938 --> 00:45:57.218 Really, really good lineup for more of my side of things. So, you know, the engineering side of the catheter. What we're currently working through, and I'm really, really excited about is we're going to do also two advanced clinical days for anyone that's interested. And what those are going to look like is surgeons teaching engineers what they want to see in devices, answering questions from engineers, giving that surgeon perspective. And then what we're ideally going to do is also some you know live cases or recorded cases that those surgeons are going to walk us through, and the goal there really is you know customer feedback in the way of the surgeon being the customer. 00:45:54.728 --> 00:46:31.878 That's the person using your device. That's the one who has to hold it in that weird handle you built five years ago and never fixed. That surgeon is the one that has to deal with that every day. So, unique feedback, really clinical focused. Again, that's October, I believe, the middle week of October. So, really excited about that. But the we're still working on a couple more physicians. Surgeon connections, preferably at Stanford and UCSF, likely in the neuro and EP spaces. So, if you know anyone like that, if you are someone like that, would love to get in touch. 00:46:32.239 --> 00:46:40.759 Perfect, that's a great request. Well, I hope someone out there listening can make an introduction or or be that resource for you. That would be awesome. All right. 00:46:40.789 --> 00:46:53.589 Well, Michael, thank you so much for being on the show today. How can let's say someone out there in the audience does know such a physician that they want to introduce, or they just have a question for you, want to get in touch? How can people reach out to you? 00:46:55.179 --> 00:47:20.579 Yeah, my LinkedIn's really easy to get to, and I believe linked in the show notes. We also have the Bay Cathball website. We show up really high in results, so you should be able to find us Bay as in Bay Area, Cath as in Catheter, and then on our website I have my email, my phone number, and you can actually book directly onto my calendar, which is only slightly terrifying. And then no 00:47:20.699 --> 00:47:24.349 home address yet, though, huh? On the on the website, no, no home address. 00:47:22.489 --> 00:47:24.349 That 00:47:24.978 --> 00:47:34.068 we did have the home address on a couple supplier documents for a little while, just because we were receiving materials there. And yeah, I think I finally fixed that. Yeah, I 00:47:34.489 --> 00:47:35.449 remember that myself. 00:47:36.829 --> 00:48:02.759 Yeah, I I also have a networking group in the San Francisco Bay Area, called MedTech Bay Area, that I've been working with. Trying honestly, I'm just on a mission to meet every medical device engineer person out there. So, if you're in the Bay Area, come on by. I'd love to buy you a beer. It's all sponsored by suppliers, so that we can get you know engineer to engineer conversations and really grow the industry as a whole. 00:48:03.039 --> 00:48:08.894 Awesome, fantastic! All right, well, Michael, thank you again so much for being on the show. 00:48:08.958 --> 00:48:14.559 Congratulations on your success at BayCath Medical, and and best of luck moving forward. 00:48:14.579 --> 00:48:17.369 Thank you, Aaron. Really, really enjoyed talking to you as always. 00:48:18.230 --> 00:48:25.730 Likewise, I'm Aaron Moncur, founder of Pipeline Design and Engineering. 00:48:25.730 --> 00:48:28.759 If you liked what you heard today, please share the episode. 00:48:28.759 --> 00:48:49.744 To learn how your team can leverage our team's expertise developing advanced manufacturing processes, automated machines, and custom fixtures complemented with product design and R&D services, visit us at teampipeline. us to join a vibrant community of engineers online. Visit thewave. 00:48:49.894 --> 00:49:19.549 Engineer. Thank you for listening. Being an engineer has more than 300 episodes, and you don't have to listen to them in order. If you're dealing with a specific challenge right now, there's a good chance we've already interviewed an engineer who's been through it. You can jump around, search by topic, and listen to what's most relevant to you. See you on the next episode.