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Concept to Prototype: How to Build a Catheter
But we’re really excited about this. please remember, this is a live webinar. It’s very unscripted, but it’s gonna be fun.
I am gonna introduce, Katie Karmelek She is one of the co-founders of Chamfr. for almost eight years now. before that she was re previously a mechanical Chamfr engineer herself at companies like Boston Scientific, Olympus Venture and other startups.
it’s been a while since she’s developed a catheter herself, so this will be interesting. Thanks there. we’re really excited about today. I have the pleasure of introducing our co-host.
I would like to, introduce Damian Carr, which Theresa [00:01:00] just talked about with his book. He’s the author of the catheter RD handbook. he’s also just a really lovely person. If you don’t have the chance to have met him previously, connect with him, give him a quick call, and talk about anything, but particularly catheter development.
He has dedicated. past few years really around educating Chamfr engineers on how to build complex catheters. He founded Eyedea Medtech Education, which is a company specifically whose mission is to take out some of the complexities and demystify catheter development as we know it today.
we’re really excited to have him. He’s coming in virtually today from Ireland. He’s gonna be helping supplement some of the work that we’re doing, help coach and guide us. And so we’re really excited to have him today. Our next co-host is Scott Hayden, who we have the pleasure of being in person with.
Come on over Scott. He is the founder of both 3TG Tech as well as Proton Medical. He’s also gonna be coaching us in person here while, and I physically [00:02:00] built catheters in front of you and we.
Scott has a huge background and he worked at Medtronic, Boston Scientific J&J, but really recently you’ve been focused on solving complex problems, bringing new innovations to market.
Mm-hmm. We wanna be able to come up with better performing medical devices, faster and cheaper also on the proton medical side. So that’s the other business that you founded? Yeah. You guys work in implantables and advanced leads and really electronic, internal electronic systems. Yeah. So any type of, implantable medical device, whether it’s a, a pacemaker, including conduction system, pacing defibrillators.
We have a heart pump blood pump project that’s fully implantable. We incorporate all the electronics for that. So we need the hardware, firmware, software. From beginning to end. Excellent. And that feeds really nicely kind of into talking about some of the sponsors of this [00:03:00] webinar, and one of which is Three TG Tech.
3TG primarily focuses on the components side of, a lot of minimally invasive surgical devices, catheter-based systems like liners, shrink, marker bands, nitinol tubing. I mean, I’ve been really impressed with the way that you’ve grown and scaled. Three tg.
Launched on and you’ve grown significantly. we started 3TG about two and a half years ago. And what I’ve been really impressed with Scott, is the different types of components that you’ve added.
You keep seeing unmet needs and saying, okay, I’m gonna fill this gap. And now continuously moving on to how can you innovate with not just existing materials, but manufacturing techniques and methodologies. Towards the end of this, webinar, we’re gonna talk about some of the new technologies we’re developing, right?
And these new technologies don’t exist today, and we’re gonna, offer them and market them exclusively through chamfer. I know that, that’s great. Yeah. And we’re really excited, right? I mean, it’s, it’s [00:04:00] all about rapid innovation, right? Being able to, you know, improve medical technology as fast as we can.
And part of that is coming up with new components. Excellent. So exciting. Yeah. We’ll allude to that towards the end of this webinar. Webinar and keep your eyes peeled on Chamfr. And we’re gonna, we’re gonna offer it first through Chamfr. Thanks, Scott. Yep. I’d like to now talk to about a couple other sponsors that we have for today.
one of which is Pilot Line. pilot Line, for those of you that don’t know, they sell their equipment on Chamfr and we are, blessed is the right word. Yeah. Yes. We’re pleased to have the pilot line, reflow, vertical reflow machine right here next to me. We also have a hydrophilic coating machine, which you may not be able to see, but right over here in the corner and a coil winder outside.
Yeah. we’re really impressed with the equipment that they’ve developed. I mean, Scott, you were just saying, I tell you what. People out in the webinar land, this equipment is top notch, right? And I think there’s actually one problem with it, though. It’s too cheap, right? They’re selling [00:05:00] it at a price.
I don’t, I don’t know how they do it, right? So it’s very affordable if you guys wanna get your own equipment in, especially for, you know, early RD, they’ve got high quality, very affordable equipment available today. So we’ll be showcasing that what you know, its capability right here. we won’t be physically using it to reflow our catheters today, but check them out on Chamfr.
They not only have that, but they’ve got Manl straighteners, they’ve got, you know, several other pieces of equipment, that you should check out on Chamfr and reach out to them if you’re ever looking for some equipment for your RD line. with that, our next supplier that is sponsoring the webinar would be Prince and Ison.
So they really specialize in precious metals, high purity, precious metals, I should say, on chamfer. They have a nice line of marker bands. They’ve really helped build out that platinum meridian marker band offering, complimenting the three, TG offering as well as some precious platinum wire. So definitely check them out and reach out even if you have some non [00:06:00] materials that you’re looking to innovate around.
these are the guys for sure. And then our final sponsor is MMT. MMT has really grown by a lot of acquisitions recently. I mean, we’re really excited to see all the brands that they’ve started to build and grow into this, vertically integrated company, but they’ve got Gen X Medical was a recent acquisition as well as the f peeler.
So just to name a few and you’ll be the first to know that the FE Peeler is available to purchase on Chamfr today. We have not told anybody else, so you guys are first to know. Go on, check it out. Not only do we have their FE peeler in from macro to Pico, so there’s like four or five size ranges of their f peeler.
We also have the auto skyr. So it’s not a manual, it’s an automated skying system and they have blades, blade dispensers, and even some roll cutters. So, you know, all of those are available on chamfer through MMT. And we’ll be showcasing the FE peeler as well today. The [00:07:00] manual one.
before we get our hands dirty, you can see here on the lab bench, we’ve got a lot of great parts to work with to start actually building a catheter. we wanted to just take a moment to, acknowledge the history of catheters. So Damian’s gonna walk us through a little bit more of where catheters are developed and why it’s important that we’re developing this catheter today and what it means to the market.
Thank you very much, Katie. Theresa, I’m Scott for the beautiful introduction. I’m here to give you a very quick view of 5,000 years of catheter innovation and medical device innovation. to start it off, we’re going back 5,000 years. Let’s start where medical technology really kicked off, which was in ancient Egypt.
So around 5,000 years ago, men had the problem of getting liquid from their bladder to the outside world. The reason for this is there’s around eight inches between the bladder and the outside world, whereas for women there’s around two to four inches.
they ingeniously used papyrus and reeds and other hollow plants, which they’d take up, hollow out the [00:08:00] inside, take away splinters for very obvious reasons, place it inside. And then this became the first insert non-invasive, surgical tool that we know of to history. Fast forward another 2,400 years, and Hippocrates was the first person to mention the word catheter, which means to sit down.
And that’s actually where we get the term catheter from today. And then the Romans had also used silver tin copper and lead to make these st straw looking devices, which were used to take out kidney stones, which are just minerals and salts and other things that build up inside of our kidneys, turn into these little rocks and just keep getting a little bit bigger and bigger until they’re too big to get out.
And then we also have the first known flexible urinary catheter, which was admitted by Benjamin Franklin in 1752 for his brother John. By going to a silversmith, wrapping a silver wire around and around, and being able to. Place another wire on the inside, and then when the other wire is on the inside, it’s very stiff.
As [00:09:00] you track this back, it becomes a lot more flexible. So well done bin. And then we have an absolute remarkable man by the name of Warner Forman and Warner Forman was the first person who actually placed a catheter into his own heart. at the time he was a German surgeon human testing was completely off limits.
he had a very, controversial way of actually going out, getting some local anesthetic. Placing a catheter inside of his own heart and proving to the rest of the world what we’re actually capable of. And as you can see here beside you, this is the x-ray that he had gotten taken off the first catheter inside of a human heart.
Absolutely remarkable man. Fast forward night to five years and we have met cameras that can look inside any existing orifice in the body. We have found ways of closing off wound wounds deep inside the intestine so we don’t have to make any more holes. Ways of opening up plaque that might build up inside the walls of our arteries on the upper half of our body, we can actually [00:10:00] mechanically ablate away that.
A plaque and actually suck it out called ation, or even go into the heart, burn away selective pieces of the heart without using heat to change how it beats. Or if you have a valve that might be calcified and not really open and closing like it should, we can place in an artificial valve right inside by making a small little hole in your leg, or even go inside of a tumor cell.
End up freezing the tumor, defrosting it, freezing again, defrosting again, freezing again, defrosting again. And this will break open the cells so that our immune system can actually go in and eradicate the end of that tumor. So a long, long way. Five thousands of innovation in two or three minutes. this is the secret that unlocks it all, which is the basis of a trial layer catheter construct.
So it has an inner liner, a reinforcement layer, and a polymer outer skin. And we are now going to take it to the team and all of us are actually going to go building and prototyping catheters and see what happens at the other end. This is a live [00:11:00] webinar, so interesting things will happen. So I’ll take it back to the team and see.
Are you ready? Bring it. Yeah, let’s go. We’re excited. Excellent. So step one of what you need to do is find your mandrel. This will be the basis of what we go building on. We’re gonna have to too, Damian and she has never built a catheter or really has any development experience in medical devices.
So we thought it was really exciting. Somebody that has never touched some of these parts really before, other than maybe at a trade show recently, right? Yep. so what’s cool about this is we both have two different kinds of mans, right, Scott? Yes. So we have stainless steel mans, which are commonly used and with a, with a PTE coating.
Yeah. This one. and for most catheter building, if you’re doing a guide catheter with the PTP learner, you don’t need the PTFE coating. Right. But this happened to be the right size. so we’re using one of the pt FE coating.
Yeah, that’s a mandrel. and then I have a glass filled [00:12:00] PTFB mandrel right here. This is from Medical Component Specialists. This is actually a really cool technology that they have recently launched to really solve the problem of being able to maintain precise IDs in your catheter. Because when you have to take it off a metal mandrel, you can often, disrupt the surface of the ID of the catheter, but this, you can pull and elongate
but you can elongate it and then it makes the diameter narrower and when you pull it out, it doesn’t disrupt that IV at all. So this has been game changers, especially in the space I. Okay. And then on my side I’m just using a raw stainless steel manl. So three different mandrels, three different approaches.
And let’s see what happens. So we have our manl. The first thing we typically do is usually clean the mandrel, especially if we’re using it outside of a lab, a little bit of IPA. So it’s pretty much pure alcohol as we can get and wipe this on. And this just takes off any little dirt or debris, which we may not even see with our eye, but it will actually stop us or prevent [00:13:00] us removing this later on.
So small little step, big difference. Then the next thing that we need to get is our PTFE liner. So this will look like a slightly browned maroonish looking tube If you place your madre into it, why is it a little brown and not clear? if it was a lot thicker, it would not be see true at all.
So it’s not exactly a transparent material, but when we have it so thin, this is just the incredible level of precision that we’ve been able to get with PTFE that you can actually see through it. So that is just testament how thin it is. If it was large, it would look like, almost like a brown paper bag.
You won’t be able to see through it or sometimes it comes out white. Yep. And, and the other thing is, this is etched, right? So they, they put it through a bath of, sodium naate. And it chemically etches the outside of the P tube.
So the inside is super slippery. You can actually stick stuff to it, [00:14:00] including, and that is because PTFE is the third flattest material in the entire planet. so how do we get stuff to stick to? It is essentially etching. And what etching is it’s like if you get sandpaper and rub it off, it just makes rough surface and then everything can sink into it.
So your liner is in, it might feel a little bit baggy on your fingers. So this part is a little bit challenging. You can do it two ways. The one way I do it is I start in the center and I stretch the liner. And this is not the easiest thing to do. It takes quite a hard grip and doing it two ways might be a little bit tough.
So what I’ll ask you to do is twist one end of the liner on one end of the mandrel, so at least we have a starting point and an anchoring point. Because what you will find is every time you stretch it, it will want to shrink back. So our trick is if we can spin one side.
Yep. That’s good. So like tying off the bag on my Exactly. [00:15:00] And now when you stretch, once you stretch that liner, once you go to the end, try to spin the mandrel so you can lock it in on the opposite side Also. Yeah. And this takes a lot of hand yoga, right? It’s like a handy wrapper right. On either side where twisting it.
Exactly. Now this twist alone won’t hold it down. So eventually we will have to tie knots. Does it matter if there’s like lines? Anything like that? Yep. So I think the thing that we wanted hear. Yep. Maybe. So once you tie knot on one end, you’ll be able to stretch out we’re a candy can. So that’s all we can, we can un twist that.
So you remember this? This is, this is live unscripted. Unscripted, Theresa’s. Never seen seen a catheter. You know, Theresa has some good grip strength is what we Yeah, that’s just it too. She’s, she’s got like that. So we should tie a knot on each end. So we should tie a knot on one end first.[00:16:00]
Okay. As close to the mandrel as possible. So you do wanna as close to the mandrel, if you can see my screen and I’m tying it over the end of the mandrel and I’m just gonna slide that down so I know it’s at the very, very tip. Yep. I’m doing that now. Yep. Alright. We, we do have a, a little bit of, We can stretch that out again, so you can keep stretching out.
PTFE is quite forgiving. They typically say around 15% elongation, but I’ve button it 13, 40% and it still worked. Yeah, yeah. You to make sure, disclaimer, these are not going into anybody’s bodies and, and we should be wearing gloves, right? Yes. But doing this without gloves is a challenge. Doing it with gloves is a whole other level of difficulty.
Yeah. So anyhow, this is, this is looking good. I have a knot on one end. Okay. And then you stretch down towards the other end so you can make sure that it’s ly thought with the mandrel. Yep. And then [00:17:00] you tie your second knot. Yep. Got it. Okay, so we’re gonna, we’re gonna get this, yeah, we’re gonna tie this off.
Keep pulling this thing. Wow. Should we have gloves? Oh, now it’s, oh, this is good. This is really good. I think we got it. And it feels like it’s, and the test is if you close your eyes and if it feels just like a man and you don’t realize something’s on top of it, we’re winning. Okay. We’re winning. Thank you, Teresa.
No, thank you. Alright, good. So yeah, tied on that, surprisingly, is training that would typically take two weeks for an operator or product builder to learn. Just trying to figure out how to hold and pull that because it’s etched every time we touch it, we’re damaging the etching. So trying to do it as.
That is the hard bit outta the way. Next step [00:18:00] is to get your braiding, and right now we don’t have a braiding machine in our rooms, so if we could ha end up, we’re doing a braid transfer, so we have a spool that the braid is on and we just wanna slide this over to our assembly.
You might have extra length of the PTFE on either side. You might want to cut that back to leave around an inch or less, just to make it a little bit easier to slide that braid on this.
Now for anyone who has worked with catheter technologies before, we have a poll that we can bring up to see what people are used to using when it comes to reinforcement layers, because they’re all very different processes. So, outta my own curiosity, I’d like to know what do you grading? Do you use coiling[00:19:00]
or do you use laser hyper tubes, or something completely different? And sometimes you can use multiple, right? Some groups are using both braid and coils, right, Theresa? Yep. How do you maintain like the, the braid pick count and like the, the orientation of the braid as you have this kind of like free floating braid on here?
That’s a good question. Damian, do you wanna give the first, first stab at that? So, one of the things you wanna do is to make sure that you have the pick count on the braid that’s consistent, right? And when you’re transferring it, from the acetyl core, right?
So it’s easier and less expensive to put it on acetyl core and you could do it reel to reel on the braider. typically you do kind of process development. So you take and you measure the, pick count and the braid really pick on, so the amount of crossings per inch
On the acetyl. [00:20:00] And then when you transfer it on early generation prototypes, then you count the number of crossings on the, fixed catheter, the final catheter, and make sure That count is consistent, but it’s so, I mean, it’s like an accordion, right? So how do you know that you’re, when you’re assembling, do you pull it tau?
Like do you pull it? you do thought and you do not on either end, similar to how you done for the liners and typically the coil, not typically the man that the grade was on is a little bit higher than your mandrel. So when you transfer that over, the pick count does get, lower. So it might have started off at 80 PPI and it might jump down to 65 PPI.
So you do have to pretty much trial experimentation. Test it out, put it onto your man. Yeah. Put it under a microscope and count it and, and Katie is actually making the knot. I’m gonna do something a little bit different, right? I’m, I’m gonna [00:21:00] Neil the, the braid, right? So I’m gonna take our selective ailer here, put a little bit of a.
you know, a burn, a short section of it, slide that close to the end of the mandrel, and then when I twist, twist that tight, right? It doesn’t spring back, right. So it, it kneels it, it makes it so that it’s, it’s no longer spring tempered, right? I’ve never seen someone ane with a lighter. I love it, Scott.
Yeah. I tell you what, man, if you’re doing RD you’re innovating, you need to create three different types of prototypes, per week. You’re iterating that fast. You get, you have to get creative sometimes. So absolutely have used dryers, but yeah, We can buy three selective annealers for about a dollar.
Right. Be careful you can burn your hands on that. Yes. Downside to brain. It’s loads of tiny little wires. They do [00:22:00] stick into your fingers from time to time. Yeah. I did mine with knots and it seems to be pretty well do.
So most people are used to direct braiding, discrete braiding, which is braiding onto each, individual catheter. So typically five to 10 minutes of a process. And that is how us Chamfr engineers love to develop prototypes, not having any consideration for the people who have to build them long term after that,
interesting for everyone who’s used to discrete braiding, the sounds operate transfer, it’s a lot nicer, a lot less noise in the background, a lot less headaches over time. So now in theory, we should have lined and braided mandrels. So this is two out of three layers complete. The next step is get our jackets.
If you have one jacket or if you have two jacket, I don’t dunno what you have in front of you. I have two jackets and my [00:23:00] materials are coming from Zeus for the liner, the jackets and heat drink ed for the mandrel, and then AllBridge and Spectrum where I help me out with the braid and Freud Berg Medical.
Damian, our liners, are, sorry, our mandrels, were medical component specialists, as well as, I don’t know. That was just a sample you had here. This, yeah. yeah. and then we have, we actually got it from Lightning cap. Oh, okay. And then your braid, you actually braided here, correct?
Yeah, yeah. we’ve got, a high speed 32 Kara Braider, and then our outer jackets are actually one medical extrusion, but Keystone Medical also gracefully donated some really nice extrusions. It just didn’t end up in the final configuration. But both of those are great extrusion houses and, yep.
Just wanted to make sure they got a quick shout. And again, lightning, Catherine also gave us the outer jacket, PBAs materials too. Excellent. Wonderful crew. It takes an entire village to pull together a crazy backyard like this. You remember you were gonna bring the materials here.
Yeah. And then [00:24:00] when they got denied, we had to scramble a little bit, but that’s fine. Yeah. That improvise. Yeah. Improvise. How far do you, the jacket, so you won’t leave around one or two inches on either side. You have the PTFE coated manual, so at least one inch on either side.
No, no, we, we split it before. Okay. Right. So, if your outer jackets are a little snug. So we were kind of working with the materials that we had, and so when we were laying up everything to size it, our outer jackets were just a little tight going over both the liner and the braid.
So we took a scissor and we just cut a little seam on our outer jackets to give us just a little bit more room. That’ll all reflow together nicely later. Okay. Yep, exactly. And you should pretty much fit one of your hairs between the space, the braiding and the jacket. So they do go on quite tight.
if you have multiple different jackets, if you can feel them and one field’s harder than the other, when you, we start going to the next step, we’ll be working from the hardest down to the [00:25:00] softest. Okay. And big thing is for the two of, so it’s actually pushing up against, so you want no gap.
Okay. Brilliant. Slick. But do we want, that’s perfect. Do we want to overlap them or have them just rest against each other? We usually put ’em together. What about, what about you Damian? put them, put them together. Yep. You want those going together to end of two by touching, there’s no overlap.
Exactly. There’s no space between. If there’s too much of a space between them, that will end up being in your final device. Okay. So that is perfect. Katie, you do have a little bit of section either in, so you can pull it later on when you need to stretch that man. We’ll be fine. Love it. The next thing we need is our FEP and the FEP can be around the length of our original man.
If [00:26:00] it’s a little bit longer, it’s okay. If it’s shorter, you will run into some issues. Okay. Yeah. Ours is a little bit longer, so that’s good. Yep. Yeah. Well we’ve got like a centimeter on the ground, so lemme do the whole thing. Yeah.
sometimes you need a pin, you have the scissors in front of you that you can use to push those jackets together. Yep. You what? My my tip material wasn’t like the Yeah, is, is pretty tight here. But you know, one of the good things about being at the three TG office is we have over a hundred different sizes here.
Well, it just run out on the floor and get some slightly larger stuff. Let’s try going load it from
what I think we have. We have more to
this, this is all part of the funnel. Yep. And [00:27:00] if you don’t run into this,
see this, this one fits on there. Did yours fit on there? It’s a little tight. And now my tip material got stuck in there and my layers are not in where they need to be. So I gotta take it out.
I’m gonna go with the two layer instead of a three today.
so these, this heat shrink is actually a lightning C, correct? or one of the two? It, one of the two.
You know what’s interesting is for so long we didn’t have any heat shrink and we had [00:28:00] all of these really long delays and now it seems like there’s a lot more heat shrink suppliers coming to market. And a lot more people have kind of gotten into the flow polymer space. That was actually a big motivation for us to start 3g.
That, you know, we’re making catheter systems so we could get our components. Just said, you know, let’s make it ourselves. Let’s not have to let, let’s control our own destiny. And so, you know, we have internal capabilities here.
out in the webinar land that wanna bring these capabilities, inhouse, let us know. We’ll be happy to set up, you know, whatever you need, extruders, expanders and all the rest of that stuff. Okay. I changed my catheter design because my tip material, my, so I have a two layer now. Okay. And we didn’t wanna be different.
It’s not making me feel so bad about that. Yeah. now becomes the bit where hopefully we have an office and no need for the use of a fire extinguisher, but it’s time to get those heat guns on. Yeah. No guarantee.
Okay. We might [00:29:00] do have a fire extinguisher in the background just in case. Yes. Perfect.
So if Theresa and Katie, you could turn on your individual heat guns. Do not touch the, that steel part that you were touching right now. Once it makes noises, don’t touch that part. The on switch is on the back. Yep. It, it is. Gonna get a little bit noisy here, so, if you have a hard time hearing this or vice versa is because he got, yeah.
So I’ve got, you cannot hear, I think the noise cancellation works brilliantly. This one, this one we’re reflowing about 2 2 10 C. And this one, I think I, put it on a little bit lower right. Yeah, so the sound is cut out, so it should be okay for everyone at home. And I’ll do the same on my side. And the goal of this is that you actually rotate the catheter while you’re heating it.
So you want a very, even heat the whole way throughout. It’s typically around one millimeter a minute. [00:30:00] So over the space of an inch, it can be quite slow.
can you also put these in an oven instead of like sitting there with hot air? What are some other reflow techniques you could use? So there is a pole yes, that can come up and that pole will go through the different ways that I, myself and Scott would’ve seen being used in the past. But if there was any other interesting ways and
Pilot line reflow machine would be ideal, for any type of early work. we’re reflowing with the heat guns, right? Using the pilot line machine right next to us here for vertical reflow is, a better alternative, right?
So if, your startup company or your company has the budget for it, I [00:31:00] would recommend buying one of those. The third option is using like a box oven, right? So taking it, and if you have a hole on the top, especially, you can lower the catheter, down into the box oven.
What about a hair dryer? Hair dryer doesn’t go high enough, unfortunately, to work it. So you need to go Yeah. What it takes to boil water Okay. Is, what it’ll take to melt it. There are others laminators, horizontal laminators that look like the machines that you, roast toast in at a hotel where you put them in, they go down chamber.
There’s also people using infrared bulbs to reflow in the FEP on the outside. And Theresa, would you be able to bring up the poll, the next poll that we have and we can see what people are used to using?
So the difference between using a heat gun for your first time or even the first few [00:32:00] times versus using the likes of the pilot line tools is trying to draw a picture with your bad hand versus printing out a picture with a. So the vertical laminators just have beautifully even lamination because doing this by eye, doing this by hand, unless you’re able to completely focus down on it, it can be quite challenging.
And considering we’re here on a webinar trying to do it and talk and present at the same time, I didn’t want to warn you about this beforehand, but well done. You’re in doing incredible. We got the noisy step out of the way. Right? Wow. Mostly vertical, horizontal lamination.
Hot box. Some oven, some other. That’s great.
So more like 66% of people right now use vertical, horizontal, actually 24% though. It probably depends on who’s innovating in the lab, just getting that first prototype and [00:33:00] just kind of figuring it out versus who has a little bit more robust of whether they’re in kind of a design in v and v and in phase three, or even on the, on a manufacturing line.
I have found out that every single way works so long as you are willing to spend the time making it work. Nailing down those parameters around speed and temperature and stuff. when you said spending the time, I mean like investing in understanding the rate at which the heat is applied, the temperature at which the heat is applied, things like that.
Exactly. And if you’re doing it by hand, just learning how to hold that catheter and how to move it at the right timing, the right pacing, if it’s with the vertical laminator, just understanding the speeds, the pressure, and the temperature. So there you’re three levers with a, a vertical laminator, speed, pressure time, sorry, speed, pressure, temperature.
And similarly with the hot box, with the oven. With the oven, it’s just temperature and time you put it in, shrinks [00:34:00] everything evenly and you pull it out again at the right time.
Usually sitting upright. And what I have found is if you’ve tried to put a hundred catheters into an oven, the outer ones heat up faster and the inner ones heat at different rates. So you can get a little bit caught out when you’re scaling up production.
The mandrel can act like a heat sink. Exactly. And, and so if you go from, you know, especially if you have big catheters, and this is relatively big, right? Mm-hmm. But some of the really large catheters, instead of using solid mandrels, you can use, hypo tubes and Yes. And, and then the, there’s, there’s far less of a heat sink and, you can reflow ’em faster.
But yeah, if you’re doing a hundred at a time and you’re using like a box oven, it, you’ll really have to be careful because there’s a lot of metal in there that has to be heated up. What size, man, what size catheter are we making? So this has an ID a little more than, 12 French. So it’ll be a 12 French id.
Yeah, it’s, [00:35:00] yeah, it’s about 160,000. So, that’s, yeah, so that’s 12 French on the dot. And then the OD will be in and around 14 French. Okay. Good to know. So that is pretty big, right? Yeah, it, it, yeah. It’s, it’s on a slightly bigger side. Middle, middle cardiology. yeah, so it’d be cardiology, arterial kind of size catheters, and then from that size up you’d be looking at more endoscopic stuff that’d be going down the path.
We didn’t even tell people what actually end catheter are making, but maybe we say that to the end. Once we make it, we can tell people what applications it would be used for. in terms of the heat sink, like you talked about though, you wouldn’t have that with the ptf, the glass field, PTFE man that we’re showcasing on this side that wouldn’t have that same heat sink because it’s not a metal.
Right. Yeah, that’s one heats up a lot easier.
So now that we have our liners or our FEP heat shrink all shrunk down, now we have to take off that FEP heat shrink because it’s just an assembly eight. All its job was was when we heat it up, it shrinks the plastic underneath turns [00:36:00] to liquid or almost liquid and just ties in with those other two layers underneath.
So I’m gonna showcase the FE peeler. This is the manual one that comes in a wide range of sizes and diameters, so it’s really compatible with any kind of catheter that you’re going to be making.
but we also have an auto skyr here. We’re not gonna be using it, but we can show you. So Scott’s gonna be our mite here and show our auto skyr right here. but for this example, we’re just gonna show the, the fe peeler in action. I dunno if you can see that, but really it’s as simple as kind of, of, of lifting up the Oh, actually I’m gonna go from, you don’t come from this side instead. Yeah. Maybe. Maybe the other side. Oh no. Yeah, we, yep. Start at the end and then you, end up pulling it backwards. Yep. Yep. And so now you can see the heat shrink is coming up. If you can see it’s, it’s, you push it forward maybe. Oh, sure. Yeah.
I might need to raise it up, but I don’t know if you can see the heat shrink is making a nice little curl at the top and has not touched the catheter shaft at [00:37:00] all. But I now can just easily just peel away. The rest of that heat shrink right here from that sky. Yeah. So that’s a really nice way. It really, the, the blade just hones in exactly to only touching heat shrink, but not the catheter shaft at all.
And one of the other really good things about this system, this is a really, you know, being an engineer, I love when things are well designed and this thing is really well designed, right? And this works for, catheters with an OD anywhere from 150,000 up to 375,000. This particular one. This one right here, right.
Then you can buy other ones for different size catheters, especially for smaller catheters. Mm-hmm. So there’s a lot of versatility there. So we have one ready to be removed here. Okay. but yeah, so, so because we didn’t, we have all different size range mm-hmm.
Catheters here. There we go. So you see if you can build the, FP off, just like with my hands. Yeah. Yeah. Absolutely. Okay. [00:38:00] Let’s see here. Let’s see. Oh yeah, it’s really easy. Yeah. If you have a good skyper, this process is a lot easier and some heat train are peelable too, so you can, once you kind of get it rotating, you can actually kind of keep rotating the FEP around and remove it.
I didn’t do a great job. Okay. This one was so easy, and although I have a lot of skiver on my end, I will be just using a raw blade, which is the very, very old school way of doing it. Yeah. And you know what? Surprisingly, in early RD you do that a lot, right? So you take a razor and you, you just kind of peel off the top layer.
A strip off the top layer. Peel it off. But this, this makes, this makes life a lot easier. Highly recommend if you peel it. Yes. Much, much [00:39:00] easier.
Katie, back in the lab. Yeah, she’s, it take, didn’t take her long. I wasn’t very patient with my, my heat gun though, so I didn’t reflow very well, guys. I’ll be honest. Yeah. You know what, A lot of times you don’t get everything right the first time.
We’re working with PBAs Outer jacket material, right? And PBAs is poly Ether Block Amid. the important thing to remember is that if you’re reflowing softer grades of PBAs 25 D 35 D, right?
they’re prone to degradation if two things happen. number one, you melt it completely which you do during reflow. And then the second thing is if there’s any moisture in it, So the bonds between the poly ether blocks, and the amid amid is nylon will break if you have both.
If you melted and you have moisture in it. So sometimes before you reflow, [00:40:00] especially in high volume manufacturing, you wanna make sure the material is dry. Alternatively, you can add a stabilizer to the material, right? And the stabilizer you’d wanna add is called heat and light stabilizer.
Some people call its to the resin. To the resin before extruding it. Yes. And it, it is all part of your compounding process. So if you add the heat and light stabilizers, to the pex, you’ll maintain, the molecular weight, right? So pretend the molecules is this long. Sometimes if you reflow it, you don’t have the Hals and you have moisture in your material, it might be shorter, right?
Then if you reflow it again during like a tipping process or something like that, it gets shorter again, and it can get so short that the material degrades easily. So. Either dry your PBAs or, and or add the heat and white stabilizer store. Why didn’t we incorporate a marker band?
We didn’t make it too challenging. [00:41:00] We’re gonna save that for the next, and America bands are expensive when you remove it from the man. We’ll see your competence of why we didn’t involve America Band. If we were going to design in a marker band, where would we have put it on our catheter shaft.
And at what point in this process? Over the braid? Underneath the jacket. So under the, so we to hide that marker band in under the plastic so that it’s not gonna leave any sharp edges that might tear away at the anatomy. So that’s the nicest place to place it. And as you’ll find later on, once you remove these from the mandrel, you will see some braid coming out the other end.
Normally we do a termination of that just so that that braid doesn’t actually stick out and it’s very soft, very, what we call a traumatic, so not traumatic, got it in in the other. So we have our liners off. The next stage is to cut off the tips off the end of your device. So that is the knot that we [00:42:00] made outta the braid and out of the liner.
Yeah. We’re gonna do a little roll cutting here. If you’re able to do that, Katie, that is fantastic. The braid is quite hard, so roll, cutting around braid is exactly what we do. Rather than sniffing it with the pliers, we want to try and put a blade down and rotate the catheter underneath so it just cuts the braid,
In theory, in reality, it cuts into the man, but it does take a lot of force. Yeah. And, and usually cut into the end of the man, right, because then, reuse the other part that’s not, not scarred up. So I’m, I’m gonna roll. Cut this. Mm-hmm. And this is thick. We we’re using thick braid here. So this, this is really hard because it’s very high tensile, and I think it’s 3000 round braid, so that it’s really, really hard to roll.
Cut. What’s a more commonly used material [00:43:00] or braid? Like what, what wire size? for most catheters, half a towel to three towel. Sometimes you might have a one by nine towel. So if you’re having a flat wire, but three towel would be up the upper end. Why would we use a flat wire over a round wire?
Because with the flat wire, the force and the strength goes outwards. So overall, your profile of that catheter will be a little bit smaller. That’s one of the main advantages, but also because the force, if you can imagine a round tube versus a rectangular bar, the rectangular bar, you can twist it left and right, clockwise and anti-clockwise.
So for torque ability, it helps a little bit more also. I’m convinced that’s, that’s ready to use.
Let’s take it to the next webinar where we go off and we do a simulated trial. Yeah. Yeah. this is, Theresa’s first catheter built ever. She did a great job. Congratulations, Teresa. So we have a liner, we’ve got a [00:44:00] braid. We’ve got an outer jacket.
What happens next to actually make it a catheter? We have the catheter itself as it stands, so that it, to make a simple guiding sheet, which would, what you’d have in your hands, you could just tip the very end. So it’s very soft. So you could put this over manl, another little bit of heat shrink, and just taper the end.
And then we can glue on a hub onto the proximal side, the side that’s in your proximity that you hold. And then you have a guiding sheath. if you wanted to make a bloom catheter, you could attach on a balloon, but typically you need another lumen inside that. But you can drill holes in it. You can electroplate onto the side of it.
You can take skives off the edge if you want a little port going out for a G wire or something similar. you can print onto it, coat it, maybe right? Hydrophilic coating. You can hydrophilic coat it. You can dip it in a coating and then it brings it into either UV or heat chamber and solidifies that coating.
You can, what [00:45:00] other interesting and fun things can you do to it? The electroplating is quite an interesting one. And pad printing or putting a heat shrink on the outside that could have the pad print already, which is just a little bit of a nicer process. And then you could stack this on top of another catheter and onto another catheter.
And then you’re essentially building an implantable delivery system. Yeah, telescoping systems. So catheter within a catheter.
The, outer surface of the catheter. Right. And, and again, I’m gonna mention, pilot line again. So Pilot Line has a hydrophilic coating machine. It’s right here. Mm-hmm. let’s walk over here. Hydrophilic machine. Right. And, if you’re gonna, go, up into the neuroanatomy, the brain, or if you have to go through, any other locations where they have the small and highly curved or tortuous vessels, hydrophilic coating allows you to navigate through that much more easily.
So it is very [00:46:00] useful in some indications. If you could imagine you’re entering in through the leg between the groin and the knee, and you have a device pretty much as long as your entire body going into another device, going into another device. So you have very little space between them. So that’s where these coatings are invaluable.
Exactly. And until recently, you couldn’t really get hydrophilic coating off the shelf. So Vita Coat has changed the game there, but a lot of other companies were doing a little bit more like royalty based, where you had to send them your product for them to coat and send back to you. So that’s been really great too, is to just have accessibility of these coating so that you can trial and see how that works for the lubricity that you need on the odi.
Right. Yeah. And the Vico is really good stuff, so I highly recommend There are some other ones, but, talk to Christian Killian on Vico. He’s, he’s, he’s a good guy.
Yeah, we’re gonna talk about that later. So we’re gonna talk about future technologies, right? And, and so, II don’t wanna get into too much detail now, but you’re gonna see more [00:47:00] innovation in the catheter industry over the next one year than I’ve seen over the previous 29 years. ’cause I’ve been doing this for 29 years, right?
And it’s, a super exciting time, to be in the med tech industry. So anyhow, keep your eyes peeled. It’s gonna be offered through, Chamfr, you know, our business focus at at Chamfr and guys, it people webinar land. You’re living in exciting times. Finally, I feel like there hasn’t been a lot of innovation.
It’s been the same materials and the same manufacturing methods. I mean, laser cut hyper teams first grade I think has helped change the game a little bit on the reinforcement side. but yeah, the game is changing. It’s changing fast. That’s good. We need it. So buckle up you’re gonna see some exciting things happen.
One thing I’ve noticed just when I’m playing with my catheter, my, my catheter, is the braid is like a little exposed on the end here and kind of like booking, what are some techniques for kind of encapsulating the braid and how would you make sure that that [00:48:00] doesn’t then, you know, end up coming through your, your tip or any part of your catheter?
So if you braid it directly onto your catheter, what you would have to do is place on a tiny little bit of PT heat. Under a microscope and with your snips, could each one of those 16 wires individually without scratching the liner and then using a tweezers, tuck the limbs back into that little kind of a one to two millimeter length of PT heat shrink, and then you have a terminator.
Then you can remove all the excess braid off the end. But with the way we’d done it, the braid transfer, you can actually just put the braid onto a metal pin and anal it. So that uses magnetic heat or magnetic induction to burn it to around 12,000 degrees, Celsius. And it essentially welds all the wires together.
And then we just slide it or we roll, cut off the excess and just slide it over to the catheter and that’s it. Done. No under the microscope. No little snips. Never gonna like [00:49:00] come up or. As long as we’re careful and delicate with it, we put a heat shrink over just to protect the movement over. but the last thing I wanted you to do on the prototyping, ’cause we’re outta time now in the prototyping, is did the liner and the jacket stick together or can you see them breaking apart?
Do they look like they’re one? Continuous It, it, you’ve joined me already, Scott, so, so there’s, you know, and it’s kind of hard to tell. I mean, pulling it here on the bench top, but I mean it, we can’t see Del lamination yet, right. We’d probably take like a little fiber scope and stick it through the id just that early processing, making sure that you have, high quality prototypes that to ensure that you don’t have to lamination.
right now it looks. Mine did not. Mine did not reflow. I just have to be totally honest, but I was very impatient with this little guy and so I think that was part of the problem was I wanted to move on. You shoulda used the pilot. I did not. I failed but we had a backup for [00:50:00] me, so I used this as my backup,
Never, it would’ve taken you, I’d say. Six minutes in total if you’re doing it perfectly. I’m very controlled, so it was an impossible task I gave you to begin with. The last thing, Theresa, there is a q and a or a little poll that I’d like to put up to see if everyone at home would actually be interested in doing something similar to this challenge or how you feel about it.
Because what we put the, the ladies in Scot wrote today was not a nice thing and I formally apologized for this suggestion of a webinar. Answering that, you know, one of the things that. Challenge Scott with before starting this was what are we actually building? Like why does this matter? What is this?
So maybe you can kind of give everybody an overview of like, what we actually made here. Now granted it’s just a, a sub-assembly, but what would this actually be used for if we were to get the hub and tip and everything on it?
So you gave a little bit of history and you talked about [00:51:00] some of the indications for which this is used. So, you know, it’s used for things like the neurovascular in the head, right? For doing, clot removal. So if you have an ischemic stroke. They can go up there and poke a hole in the leg, go through the aorta, up through the carotid arteries, and then they have to weave through the very small and, highly curved vessels in the brain to get to the target site for that blockage.
And then they go, that’s the gap. The guide sheath that we, or the guide catheter we made would be to facilitate that. That would be one of ’em. Right. So when you do like a stroke treatment, you typically use multiple catheters. So it’s a, a big catheter on the outside, a medium-sized catheter, inside of that.
And then the very inner catheter happens here is typically a very small. Microcatheter. Mm-hmm. And microcatheter is designed specifically to go through the really small vessels in the brain. So this would be one of the larger ones that would help facilitate access for that smaller catheter. Exactly.
Yep. So that catheter would probably be, navigated [00:52:00] through the aorta and into the carotid arteries. The femoral access exactly. Cool. So the whole results are 41% confident. I got this, 50% I, it won’t be perfect, but I’d give it a go. 5%. I’d try it, but have a fire extinguisher on hand, and then 4% for the safety of others and the building of this catheter.
Oh, that’s awesome. Oh no, this is great. Excellent. yeah, so I think we kind of covered really the tip to tail of this catheter and the more complex piece of it was what we kind of built here. Yeah. And there, there are a lot of variations for how to build catheter.
So this is one of the most common, but there are other, little changes that we can make. And Damian would cover that masterclass.
Excellent. So now Scott, I believe we’ll give the board to you. I feel like you have some interesting things to let us know about to jump in. Are there any questions, Damian, [00:53:00] that we should bring up from that we, and anything that we wanna highlight here, or we should move right into Scott.
I think we’re time to go right into Scott and that will leave us for a few minutes at the end to answer some of the brilliant questions that have been coming in. Okay. yeah. Thank you. I wanna talk a little bit about innovation, right? And we kind of talked a little bit about the way that med tech devices and the innovation within is accelerating.
I mean, it’s accelerating exponentially, and let’s talk about some of the reasons why that happens. Number one, when I first started building catheters in the 1990s, It took me eight weeks to get my components to build my first prototype, right? And so it took you probably, four to six months.
To get to design free because the iterations took so long. Right. But now we have Chamfr, right? Chamfr is like the Amazon of Med Tech, almost any component you need, they can get you almost overnight, right? that accelerates innovation tremendously. I mean, [00:54:00] for some of the projects we do here because of Tamper, we can prototype three different designs in one week, right?
Not one design in two or three months, but three in a week. So you can get to Design Frost and then design Freeze much more quickly. Design Frost. I like that. And we do not tell Scott to say any of this. I’m a huge fan. I’m so grateful, because, you know, it’s really helped us, accelerate innovation.
The second part is when I first started building catheters, everything I learned, I had to learn from somebody with experience that made the mistakes. So we call that tribal knowledge, right? So it’s passed from one engineer to another engineer to another engineer, right? But now you have access to education on how to build this stuff, what are all the little nuances, you know?
And so, this is one of the best resources Damian’s book here and really good. and it accelerates. Your knowledge on how to build these catheters. Right. So Damian [00:55:00] also offers classes and he will teach you how to do this hands-on stuff. So also exo med tech, they have a great resource and education piece of how to bring a product to market, not necessarily catheters and this knowledge like you’re speaking to, but there’s also a lot of know-how and just what to do.
how do you know what your biocom strategy is? How do you know how to get it to market? And there’s so much learned knowledge that, you know, is secret has been a secret sauce that people are really making more accessible. for sure. quick access to high quality components, getting the knowledge.
And then the third piece is the ai, right? We started integrating the AI into our product development process. it makes it so much easier and so much faster in the quality of our data, in our product development, process documents in our quality, artifacts. The information is so much better, and we can do it like this.
there’s no, let’s do a design FMEA and spend, a month or whatever. No, we do it [00:56:00] one day. Right. And that helps a lot. There’s a group called, inte you, that’s, led by, a young, innovator here in Minnesota, Johan, I’m sorry.
I Mispronounced name. Get ahold of us. we can connect you up with some of the experts in AI for med tech. Mm-hmm. One of the things you wanna make sure is that you don’t, like when we do the innovation here, there’s never, let’s wait, right?
I remember we took one project, right? The start of the design to first in human for a chronic implant, five months, right? And that’s because, you know, some of the guys here, I had the whole engineering crew work 36 hours in one weekend.
They’re phenomenal, right? Mm-hmm. So you have to be kind of dedicated to getting things done, and you, you don’t wait there, you get rid of all the bureaucracy. Mm-hmm. So again, get your components from Chamfr, high quality, fast, get your knowledge, you know, hook up with mm-hmm. Damian here, you know, he’s the master at Catheter technology.
Learn as much as [00:57:00] you can, as fast as you can. embrace ai. AI is gonna be incredibly useful for med tech and accelerating innovation. And then you have a culture where you get stuff done, get it done today fast. Don’t wait. And I think if you have any questions about what supplier or what component or what equipment or what, that’s a perfect, like, that’s us at Chamfr.
That’s our goal is to help you and connect you to the right people, the places, the things that you need. And so I would say, you know, shoot us an email, support@chamfr.com or you know, call us. If we don’t answer, we will call you back. You know, there, there we’re a small team, so just setting some expectations there.
But we are happy to connect you and we are also trying to do things internally, with AI to help get answers faster. because. The engineers out there, they’re very technical and they’re very specific on what they’re asking for. So it’s a great opportunity for us where we’re building some new solutions and tools that will be coming [00:58:00] to market very soon that will help you find things so much faster.
Yeah. And it, it’s where we’re going. we need to get on the bus or We’re gonna get left in the dust, right? Because that’s really where we’re headed.
And our industry tends to be a little bit more old school, but I mean, I’m really impressed even from when we started Cha and we had to explain to people what Amazon was, and they were just like, wait, don’t we already have that on our site? No, you don’t. You have a website.
The digital sourcing piece. As well as just kind of, you know, digital solutions in general. So I think we’ve just scratched the tip of the iceberg here and what we can do digitally to transform our industry. And I think the growth of the products, I mean, I’ve been at CHA for over a year now, and we started with 4,000 SKUs and we have over 13,000 SKUs now on the site.
exponentially, I think, a lot of what we hear from engineers is like, chamber is the first place. I think you even said it yesterday, Scott, you’re like. Chamfr iss the first place that you, an [00:59:00] engineer should go to source their materials. If they can’t find it, then go somewhere else. But, it’s gonna help you save a lot of time in the long run if you can find somebody right away that’s a qualified medical supplier.
Even if it’s not on Chamfr, put in a request. Say, I need this material it’s not on your website. Chamfr will find you a supplier.Faster than anybody else. And I mean, what we’re known for is the in stock, ready to ship, one to two business days. But we do have our quick turn, which is like the make to order where a lot of the suppliers we’re working with are saying, we don’t have it in stock, but we can make it in one week or less, two weeks or less, three weeks or less.
and then the ability to submit a quote is really a nice thing too, because while you’re early, you know, phase prototyping with something off the shelf, you then need something else. You can also reach out to us and submit a quote and we’ll help you find the right supplier too. So. Absolutely. Okay. Are we, is there anything else from that side?
I know there’s a lot of stuff that Scott, Scott can’t talk about. Yeah. Because it’s very proprietary. But yeah, we’ve got the patents written up. We haven’t filed some of the patents yet, but [01:00:00] a look towards probably the end of the summer, and we’ll have a lot of new catheter components available via Chamfr.
Right. And next year, we’ll kind of hold on the, some of this conversation, but there’s another new technology that I think the catheter industry in particular is gonna love. and we’ll talk more about that at a later time.
Okay. So do we wanna pull up some of the questions, Damian, I know you’re kind of reviewing them So the first question that came up was, is there an automatic way to get the PTFE on the man? And yes, there is. Doing this manually isn’t always the easiest thing to translate. So what people do is using something similar to the pilot lines lamination machine.
They hang the liner, connect on the tip, and hang a weight off the bottom of around a hundred grams. 3.7 ounces on the bottom, and then as the heat goes down, it stretches that liner so it comes tight with the man. And then we just take it off, twist the ends and tie it as you would.
[01:01:00] So the fingers don’t damage the etching, but the heat does damage the etching a little bit. So either way, it has its issues, but depending on how good you are, you can tailor it towards whichever suits best for process. The second one, and you may be able to show it, is how does the catheter hold on the reflow machine, the pilot line tools reflow machine in the back.so there’s, a little button here and a little clamp here. It’s like a V groove. Yeah, it’s like a V groove and you put the mandrel in it and you clamp it into place. There’s a heat source that goes from one end to the other, right?
You have to go bottom up or top down. Most people go top down and, then you can set the speed, you can set the temperatures, you know, change the temperature as you’re going through and reflowing because you might wanna reflow, the softer grades of p back at a lower temperature than the stiffer grades, slightly different, amount of temperatures.
But anyhow, very easy to use. it takes, less than five seconds [01:02:00] to take it off the bench and then clamp it into the, pilot. That is one of the neatest and quickest little clamps that I have seen on any the laminating machines. So, well done after all this equipment that pipeline makes.
You know, I love looking at things that are well designed like the FE Peeler brilliant, whoever designed that, brilliant. This equipment, same thing, very well designed. So kudos to the, line crew. And one of the other questions that come up is, other than glass built PTFE or stainless steel mandrels, what are the other material options?
so they’ve mentioned they’ve heard of silver SPC mandrels, which are silver coated copper. So my way of summarizing it down is you have stainless steel mandrels or nitinol mandrels, which are reusable. You can get coatings like EPTFE or PTFE and parlene to help slide off whatever components, especially if you don’t have a liner.
And then on the other side you [01:03:00] have plastic mandrels, polymer mandrels, SPC, mandrels. And with all these, you stretch them at the very end so you can pull off your device. So they’re single use, they’re not going to be a reusable option, but they are much cheaper. And for certain cases, like neurovascular devices where you have a very long device, very fragile, you don’t want to try and pull off that catheter.
You could stretch it, you could elongate it, you could break it. So single use. In the long term ends up being a lot cheaper than the reusable modules for those devices. Yeah. one of the other things that, we’ve used in the past that we designed here is that we’re able to, design a system where you can, put, compressed air, so, high pressure air right from the iv
Put it over the mandrel and underneath the idea of the catheter. Right. And you pressurize it and it breaks, it breaks the, catheter free, it stretches it a little bit, and typically you can pull that right off. Be careful. However, we have launched a [01:04:00] couple of man, so make sure nobody is standing in front and just be careful.
another question that’s coming up is, how would you apply an inner layer to a laser cut hyper tube? Do I want to leave that with you or I on this myself? Either one. So very same to how we apply the braids or we placed a liner onto the mandrel. That is when you’d actually get your laser cut hype tube and slide it on the exact same way that we slide on the braid.
Except you’re not going to tie knots out the end of it because it was very recently a solid steel tube. So we just leave it in place, place your jackets over it, and then melt those jackets in. But you leave a lot of little windows in that laser cut so that the plastic can actually get in and hold the liner and the outer jacket together.
Which sandwich and wedge that laser got have tube in place. How do you cut that? Cut. Cut. Do you have to cut laser? [01:05:00] You have set length, right? Yep. Like pattern, which you can, it’s actually really cool. You have infinite patterns with laser, gut, hypo tubes, right? All of the, those cut patterns like you’re talking about for reflow.
but those are the ones that are creating the torque ability, the pushability and everything that you get with the product. And it’s really impressive. I think all companies like Rese and Sublime Laser and, several other suppliers, this symmetry laser as well.
These guys are experts at it. you can kind of just go and be like, I want the catheter to do this. And they can help you figure out that cut pattern and what you need to do. because designing that cook pattern is a dark in itself. So if you can find laser cutting companies to help you send you in the right direction, it’s gonna be a lot of trial and error.
That is the beauty of RD. But you’ll have so much more resources and so much support out there that we wouldn’t have even had, or it’d be difficult to find even a number of years ago. So a question for the whole team. Are there any opportunities for improvement that you can give to material suppliers and in [01:06:00] brackets, specifically wire suppliers that can help Chamfr engineers develop next gen devices?
But I might open this up a bit. So how to help material suppliers understand what can help RD engineers. I think there should be a feedback. I think material suppliers are kind of left in the dust, right? So you go to them and you say, okay, I need this wire.
And then you go use it and it may or may not work. You might go to a different supplier if it doesn’t, but you’re not, there’s not this feedback loop. So really working as a partner and saying, okay, this was my design intent. This wire didn’t work. It’s not because they didn’t give them the right wire, it’s because they didn’t have the right design.
Or there was a, you know, something changed in the product. So I think really building those stronger relationships and taking the time to give the feedback will make the next project so much easier and better. That’s what a hundred percent agree. Yeah. Utilize the experts out there. I mean, we’re, you know, Damian and the Chamfr group myself, we’re super happy to help you accelerate your program and whatever.
So if you don’t really know what material you [01:07:00] have, ask. Right. Again, I’ve been doing this for 29 years. I’ve seen almost everything I can. Most likely, we, collectively as a team Can steer you in the right direction. And we on the chamber team can also help you do research if needed and things like that because we do have a holistic view of the market
So I think there’s an opportunity there to leverage us as a team and now partner to see it holistically as well. So, but don’t leverage us to build your catheters. I think we learned that. Nope. That’s actually a very good question. And two things I’d recommend to the RD engineers out there is one of them, just straight away get an NDA with, supplier.
So you can very, very freely just talk to them, be open, not be afraid of trying to tiptoe or walk around what you’re working on. And the other one is similar. If I have something stuck in my teeth, I would rather someone tell me than just try to be nice and not say anything. So if you do use material. Do go back and tell them why the material didn’t work.
you might feel like you’re kind of talking [01:08:00] down to them, but the reality is they probably have a lot more solutions out there, or a lot more tricks that they’ve seen other customers use or other applications being used in. And they’ll be able to guide you very quickly rather than you going back to the drawing board and having to go searching for another solution.
Yep. Agreed. A hundred percent. Is that all the questions or, I mean, we can also answer some of the questions offline or again, submit your questions directly to us and we can help you find some answers as well. can you speak to how Chamfr labs and material suppliers can work together on pricing, determining pricing for smaller quantities, while acknowledging that pricing will decrease in higher value.
I mean, I think Chamfer has kind of started to do that, right? Mm-hmm. So by being able to access components quickly, knowing that that’s not the finished price, you know, as you scale up in volume, but that’s a relationship management that needs to happen early on. unfortunately, I think as device designers, we often overestimate the [01:09:00] volume of what we’re gonna need later just because, you know, we’re managing various stakeholders and assessing a market and we don’t really know.
Nobody really knows. but I think being open and honest and transparent and sharing what you do know and working together collaboratively is the best way that. That device design development manufacturer and the material supplier can work together. And the other thing is, anytime that we’re making kind of a new size product, right?
There’s a lot of setup time and there’s a lot of process development time that goes upfront, So for us to make, 10 tubes is gonna be, I’m just gonna make up a number here, a thousand dollars. And for us to make a hundred tubes is gonna be $1,050, So, the setup costs super expensive and that’s why in low quantities, our components are typically expensive.
There’s one other thing I mention is that, you know, groups like Idea your group, Damian, and [01:10:00] groups like ours, you know, the three TG and proton, you know, We make medical devices and we design this stuff all day, every day, right? So if there’s a group that wants us to actually design, build, and test their medical device, there are plenty of really good options they can go to, to do that.
It’s great that you learn this, especially if you want to do it internally. If you don’t wanna do it internally, you know, let us know. We can do it for you. Excellent. We have, I think we have one more poll. Oh, we do have one more poll. Yes.
Alright. So the last call was a curiosity of where we should go in the future with these webinars. Because we are young, we are free, and we’re willing to actually just make more entertaining content that will help teach people without even realizing you’re learning.
Be honest, we want your honest feedback. And remember, by contributing to this, you could win Damian’s book. [01:11:00] What’s cool on LinkedIn for us is that’s where we often put up any recently added products that we’ve added because we have, as Theresa said, over 13,000 products.
It’s hard for people to know what we’ve added. So, keep a pulse on LinkedIn ’cause that’s where we’ll be talking about new suppliers, new products and, and all new, exciting.
So eight, 8% more prototyping challenges, more prototyping challenges, 27% device design and exploration. 60% technology process and material insights, and 6% meeting the minds behind the med tech industry. That’s awesome. Oh, that’s great. That’s a good direction to go with. Yeah. Yeah. That’s awesome. Thank you.
So if you keep innovating on these materials and technologies, that’s what 60% of people want that. Yeah, no problem guys. We’re, again, we’re in a new era, right? So, the things that in, in the length of time and the materials and the knowledge that we had last year to build a medical [01:12:00] device is gonna be completely different from what, what we mm-hmm.
What we do moving forward. Innovation’s gonna be a lot faster. You’re gonna have more materials, easier access to better materials. You’re gonna have new processes to build your catheter systems. And, so, so buckle up in innovation’s gonna happen at a much faster rate from today moving forward. And Scott will be launching his own podcast too soon too, right?
It’s mainly with, the clinical. So, you know, a lot of, lot of, clinician entrepreneurs hire us to design, build, and test their next generation medical devices. Most of, most of the medical devices we get hired to do are completely, fully implantable systems. but we do catheter stuff too.
But, as we close out, we just have on the slides to, if you wanna learn more about, Damian’s workshops, you can scan the QR code or go to our website and just type in idea. you can find a landing page with his information and a form and we send those directly to him so he can follow up with you.
Next, is that we have the [01:13:00] catheter handbook on our website that people can purchase directly. So if you don’t win it but also if you want, I mean, we’ve had companies. Of 25, 50, a hundred for their entire teams. and have had really great, reviews and ratings of it, that it’s like, Hey, this is something that needs to sit on every, catheter, RD and the sales teams too, like the sales members for BD purposes and really getting smarter on applications
And technologies. I, I haven’t fully read it and I clearly need to read it. You did great for your first job. Oh, you did great, Teresa. more to come on this, we’ll have more, webinars in queue and in process. We’re actually gonna be probably planning the next one, or we have one planned, in July,
But wanna just say thank you all for joining too, and, leave us any comments, feedback as well. subscribe to our emails, you know, follow us on LinkedIn otherwise we’ll send out a quick survey after this webinar
to get your guys’ Open, honest feedback and then we’ll see you next time Thank you Damian. And thank you Scott. Thank you Damian. Yes, Scott very much. Yeah. [01:14:00] Damian, thank you very much. I mean here the professor of catheter technology. Totally. It’s an honor to be, part of this.
Actually yesterday I was at a device talk and somebody said, oh Damian, is that the guy with the beard? I said, yeah, someone called you Superman at Batman, but I dunno who. I am still in complete admiration over all your skills.
Skills I never obtain in my lifetime. And I know that all too well. So thank you very much guys. Thank you to.