Elad Einav | How To Engineer Covered Medical Device Stents の全文書き起こし

00:03:06.180 --> 00:03:06.889 Yeah, I love it. 00:03:06.919 --> 00:03:09.360 It's plumbing applied to the body, right? 00:03:09.419 --> 00:03:10.449 That's all it is. 00:03:10.909 --> 00:03:11.270 Yeah. 00:03:11.729 --> 00:03:12.139 All right. 00:03:12.139 --> 00:03:15.740 Well, we're gonna talk about, uh, covered stents today. 00:03:15.789 --> 00:03:25.270 So before we even get into covered stents, for those of our audience who might not know, can you describe what is a stent? 00:03:25.520 --> 00:03:27.569 Just by itself, what does a stent do? 00:03:27.580 --> 00:03:28.449 How is it used? 00:03:29.241 --> 00:03:30.730 Pr-- So, okay. 00:03:30.751 --> 00:03:45.881 So stent is a stru-- metal structure that is delivered in a very small, diameter into the vascular system for different application, and then you open it up in the vessel. 00:03:46.661 --> 00:03:56.580 The idea around it is-- was starting in, in practically opening clogs, which we talked about, uh, plumbing, so it's really the same concept. 00:03:57.098 --> 00:03:57.437 Yeah 00:03:57.550 --> 00:04:07.050 and it's-- and that's a, that's stent for, you know, as a, as a starting point to, to understand. 00:04:07.061 --> 00:04:21.600 But it's all about minimal invasive and getting into the body in a very small diameter, and then, uh, doing the action in the body which require diameter, let's say 00:04:22.730 --> 00:04:29.259 So you have, uh, an artery, for example, that has a bunch of plaque, calcium buildup inside of it. 00:04:29.269 --> 00:04:31.399 Blood flow is not what it should be. 00:04:31.769 --> 00:04:46.779 You put this compressed stent inside that area, and then you allow it to expand, which effectively opens up the diameter of your plumbing line, your artery, right? 00:04:47.214 --> 00:04:47.685 Exact 00:04:48.790 --> 00:04:51.069 And, and what is a covered stent? 00:04:51.079 --> 00:04:52.980 Why do stents need to be covered? 00:04:53.050 --> 00:04:54.470 What is the covering? 00:04:54.529 --> 00:04:55.800 How is it used? 00:04:57.067 --> 00:05:02.557 Okay, so this is a, it's a great question, and we need to start from the beginning. 00:05:02.877 --> 00:05:06.867 Uh, at least the way that I see covered stent, it's a composite material. 00:05:08.216 --> 00:05:18.557 Like what we have in cars and in, um, and in airplanes because it's a, a, it's a reinforcer and a matrix. 00:05:19.466 --> 00:05:24.187 metal part, it's a reinforcer, and the, the polymer is the matrix. 00:05:25.026 --> 00:05:41.047 And in our case of covered stents, it's usually been done uh, be able to compress it into a lower, as we said before, to a lower diameter, in- and increase it while it's sealing. 00:05:42.067 --> 00:05:43.237 It's sealing the stent. 00:05:44.146 --> 00:05:44.526 So- 00:05:44.670 --> 00:05:53.269 the, the covering is the mechanism by which the stent diameter is initially decreased to place it into the body 00:05:54.254 --> 00:05:58.334 The covering is, the covering is the mechanism to seal

the stent. 00:05:58.776 --> 00:06:00.237 OK。 00:06:00.595 --> 00:06:03.995 y- y- you know, we talked about, uh, opening a clogs, 00:06:04.336 --> 00:06:04.786 Mhm 00:06:04.944 --> 00:06:33.800 say, but now we are talking also about, uh, we take it to plumbing, about leakage So instead of replacing the, um, you know, the ves- the blood vessel, which you do in surgery, you practically open a, a, stent with a, which, uh, which is a seal in this, specific, uh, uh, case, and you hold the, the leakage. 00:06:33.821 --> 00:06:34.360 You stop the leakage 00:06:35.913 --> 00:06:52.434 So does that infer then that sometimes the purpose of the medical procedure is not just to open the diameter of the artery or the vasculature, but it's to, um, stop a, a leak? 00:06:52.434 --> 00:07:03.163 Like there's a small tear or a perforation in the artery, and the coated, um, stent seals that perforation, that hole 00:07:03.502 --> 00:07:04.492 Yes, exactly. 00:07:04.702 --> 00:07:25.673 There's a-- today there's a procedure to, you know, for cardiovascular stent, which is very standard procedure in a lot of cases, and sometimes there's a kind of a tear over there due to the stent or due to the procedure, and they open a, another covered stent to stop the leak over there. 00:07:26.259 --> 00:07:27.189 Hmm. 00:07:27.543 --> 00:07:28.062 But these 00:07:28.089 --> 00:07:28.470 do the, 00:07:28.812 --> 00:07:29.252 Sorry 00:07:29.879 --> 00:07:31.850 where do the tears typically come from? 00:07:31.850 --> 00:07:36.769 This might be getting outside of the scope of what we planned to talk about, but I'm just curious. 00:07:36.779 --> 00:07:40.620 Where, where do these tears or holes or perforations in the arteries come from? 00:07:41.295 --> 00:07:45.084 So, uh, there's a… First of all, I'm not a physician. 00:07:45.165 --> 00:07:46.074 Let's start with that. 00:07:46.639 --> 00:07:47.060 Sure. 00:07:48.334 --> 00:08:06.745 Um, my, my mother did want me to be, uh, uh, if we look about, if you look about it, uh, we'll, um, tears can come from the procedure itself, from the catheter, from the delivery, but most of the time it's coming, there's a aneurysm. 00:08:07.654 --> 00:08:16.295 It's about to leak or explode, whatever you call it, you try to solve it with a covered stent. 00:08:16.774 --> 00:08:23.384 There's, uh, multiple cases that you actually use covered stent in order to direct the blood flow. 00:08:24.574 --> 00:08:30.795 There's, know, uh, multiple different, you know, intended use of covered stent. 00:08:31.555 --> 00:08:34.095 But the basic one is sealing, in my opinion 00:08:34.610 --> 00:08:35.259 Okay. 00:08:35.350 --> 00:08:43.000 So typically, if you're just trying to open up that artery, it's not necessary to use a covered stent. 00:08:43.009 --> 00:08:44.700 You could just use a bare stent. 00:08:44.700 --> 00:08:49.419 It's, it's when you're trying to plug a hole, plug a leak, that's when you use the sealed stent 00:08:49.774 --> 00:08:50.134 Yeah. 00:08:50.184 --> 00:09:03.455 When you try to plug a leak, when you try to create barrier, when you try to alter the, uh, the, the flow of, or where the, the blood will flow, these are the main, uh, uh, cases 00:09:04.168 --> 00:09:04.648 Okay. 00:09:04.758 --> 00:09:05.168 All right. 00:09:05.217 --> 00:09:05.618 Got it. 00:09:05.998 --> 00:09:10.977 So the stent its- itself is often, uh, a laser cut piece of what? 00:09:10.977 --> 00:09:12.177 Is it stainless steel? 00:09:12.177 --> 00:09:13.378 Is it nitinol? 00:09:13.503 --> 00:09:15.072 can be stainless steel, it can be nitinol. 00:09:15.743 --> 00:09:18.533 difference between them that nitinol is self-expandable, 00:09:18.985 --> 00:09:19.505 Yeah 00:09:19.513 --> 00:09:23.663 and the s- the, the stainless steel is practically balloon expandable. 00:09:25.232 --> 00:09:28.673 But both of them we are covering 00:09:29.524 --> 00:09:29.964 Got it. 00:09:30.083 --> 00:09:30.514 Got it. 00:09:30.984 --> 00:09:40.673 So there, uh, the, the, the metal frame of the stent is, is typically laser cut, and then from there, what's the process of covering it? 00:09:42.447 --> 00:09:45.937 So there's-- it depend, you know, what they, what they need. 00:09:46.177 --> 00:09:51.937 But eventually the, if the laser… Let's talk for a second about nitinol laser cu- uh, laser cut. 00:09:51.937 --> 00:10:00.616 So you practically take a nitinol, uh, tube, it into a laser cut machine, the laser, cutting it. 00:10:01.356 --> 00:10:05.947 you need to deburr it, electropolish, and then you do shape setting. 00:10:07.586 --> 00:10:14.866 So you can create it, uh, take the shape of the, the stent itself and increase its diameter or its shape. 00:10:15.907 --> 00:10:20.937 And after that you go, you start, you start to, uh, to do the covering. 00:10:20.966 --> 00:10:25.537 And covering can be done in multiples methods and multiple materials. 00:10:25.557 --> 00:10:37.047 It can be if, if, you know, the, the, the interesting part of it is that it's twenty twenty-six, and today I think still of the covering is being sewn. 00:10:37.287 --> 00:10:42.697 Uh, it's a fabric that is being sewn manually by a lot of people 00:10:43.658 --> 00:10:46.707 The cover is being sewn onto the metal frame. 00:10:46.863 --> 00:10:47.602 Yes 00:10:47.768 --> 00:10:50.658 Wow, that is a labor-intensive process 00:10:50.863 --> 00:10:52.753 This is a labor-intensive process. 00:10:52.773 --> 00:10:59.212 You'll be-- I was amazed actually to, to see how much, you know, it's, it's common. 00:11:00.113 --> 00:11:14.033 And, um, and, you know, we always thought we are in the area that we talk about AI, robots, and et cetera, and here you look about things that, you know, still manually handmade sewn. 00:11:14.033 --> 00:11:18.543 So a huge gap in this, uh, industry. 00:11:19.403 --> 00:11:35.442 And, and it's coming, you know, for, for what we are trying to do, and we do, developed a, a method to try to bond to scaffold, membrane to, to scaffold

with a binding polymer, so you don't need to sew it. 00:11:37.123 --> 00:11:41.643 B- And you don't need to, uh, um, suture it. 00:11:41.712 --> 00:11:49.613 There's, there's multiple-- Let's say that we are not the only one, and this movement started, uh, uh, long ago. 00:11:49.633 --> 00:11:58.763 Because today there's materials that you are, doing a polymer deposition on a, on scaffold or frames. 00:11:59.253 --> 00:12:03.023 You're doing sintering of ePTFE of frame, on frame. 00:12:03.033 --> 00:12:09.052 Um, each one of them have advantage and disadvantage. 00:12:09.993 --> 00:12:20.363 I think that, uh, you know, there's not a lot of, uh, uh, CDMOs that are able to bond fabric to, to scaffold without, uh, uh, sewing it. 00:12:22.222 --> 00:12:48.673 And we are trying-- The, the way that I look about, what we are trying to do is to give engineers more tools to use when they are coming to design covered or covered stent, um, in order to do it in, in the best way, which is-- and that will be best way in terms, in terms of clinical results 00:12:49.940 --> 00:12:54.950 Let's talk about the, uh, the anatomy or the architecture of a covered stent. 00:12:55.019 --> 00:12:56.889 You have the scaffold itself, right? 00:12:56.889 --> 00:13:08.220 Which is just the, the, the cut metal, and then you have, uh, I guess there's a fabric layer that goes on top of that, and then there's a polymer that's bonded to the fabric. 00:13:08.230 --> 00:13:09.350 Is that how it works? 00:13:09.390 --> 00:13:20.726 It's, there's a on the, on the laser cut stand And, uh, and this polymer is binding the fabric to the scaffold. 00:13:21.354 --> 00:13:23.134 Binding the fabric to the scaffolds. 00:13:23.163 --> 00:13:23.484 Okay 00:13:23.756 --> 00:13:28.157 it's intermediate, uh, uh, material, let's say 00:13:28.745 --> 00:13:32.535 So the polymer is in between the scaffold and the fabric? 00:13:32.750 --> 00:13:33.341 Yes 00:13:33.596 --> 00:13:34.025 Okay. 00:13:34.066 --> 00:13:36.155 And the fabric is needed why? 00:13:36.196 --> 00:13:40.615 To, like, uh, adhere to the anatomy of the patient? 00:13:41.894 --> 00:13:50.684 To the s-- the, the old stent, so when you look about co- stent or covered stent, it's always need to, uh, do the anatomy of the, of the patients. 00:13:51.644 --> 00:14:04.684 And, you know, it's, it's an interesting question that you ask because- One of the thing that, uh, eh, that we can see and there's still, you know, evolution to be made. 00:14:05.544 --> 00:14:10.914 the stent neces- don't necessarily move, uh, like the vessel. 00:14:11.977 --> 00:14:12.138 Okay 00:14:13.605 --> 00:14:19.014 Um, and this can create, you know, stress points, 00:14:19.283 --> 00:14:19.683 Hmm 00:14:19.845 --> 00:14:29.955 weaken the, the vessel, and we all trying to be, you know, to do-- to make the stent as, as flexible as the vessel in order not to hurt 00:14:30.793 --> 00:14:31.163 Ja 00:14:32.615 --> 00:14:32.634 it. 00:14:32.634 --> 00:14:54.654 Um, but

when we are-- when I see designs of, uh, of covered stent, one of the important thing is to understand, you know, where are you gonna place it, what its role, what kind of movement and elasticity it needs to allow And what-- A lot of time people look at it and say, "Okay, I have stent. 00:14:54.664 --> 00:15:15.054 Let's put a covering on it." And these are two different element, but it's not, because eventually it's one material, it's a composite material, and the covering and the stents are-- need to work together, need to be able to adapt each other properties and to adapt the blood vessel properties. 00:15:16.914 --> 00:15:33.302 So i-it's a kind of We need to find a, a, a compromise between three different materials Which is, uh, has its own-- each one of them has its own properties. 00:15:34.173 --> 00:15:40.283 the other side that is interesting is that the actual blood vessels are, are composite material as well by themself. 00:15:41.413 --> 00:15:49.423 And their mechanical properties, I think, again, I'm not a physician, but from the best of my knowledge, changes between one person to another. 00:15:50.004 --> 00:15:50.533 OK 00:15:51.192 --> 00:15:55.293 So now you get to a very complex challenge 00:15:55.354 --> 00:16:03.323 Y- you, you talked about a couple of different methods of connecting the, the, the polymer or the fabric to the scaffold. 00:16:03.323 --> 00:16:09.274 There was sintering, and then there was this adhesive-assisted lamination. 00:16:09.323 --> 00:16:11.484 Can you talk about the difference between those two? 00:16:11.886 --> 00:16:12.466 Yes. 00:16:12.527 --> 00:16:23.557 So sintering, first of all, we l-let's, you know, be focused on ePTFE because this is-- There's two-- Uh, take you one step back. 00:16:23.557 --> 00:16:32.506 There's two major materials that are used to being covered vascular, uh, stents or scaffold structural heart devices. 00:16:33.246 --> 00:16:46.017 One of them is, uh, uh, ePTFE, which is Teflon more or less, porous Teflon, and the other one is fabric, which is usually made of Dacron, which is polyester. 00:16:47.076 --> 00:16:50.697 These are the two main, uh, material for this 00:16:50.761 --> 00:16:52.631 So it's, it's one or the other. 00:16:52.652 --> 00:17:00.721 It's a scaffold plus EPTFE or a scaffold plus polyester, not both of… Got it. 00:17:00.792 --> 00:17:01.211 Okay. 00:17:01.331 --> 00:17:02.490 of the cases, by the way. 00:17:02.981 --> 00:17:03.392 Okay. 00:17:05.490 --> 00:17:09.310 Um, and when we look-- So in polyester, it's very simple. 00:17:09.330 --> 00:17:32.141 There's, there's the sewing, and there's what we call sutureless termination, which is binding with a, a polymer, which we are, um, creating a bi-- a intermediate polymer, and then bond the, the metal to the, fabric through lamination, heat, and pressure. 00:17:32.911 --> 00:17:45.221 And the most important part in this equation is that we create a surface activation to all each one of the materials to be able to bond to the other material in a, in a chemical way. 00:17:45.631 --> 00:17:51.201 So it's not a mechanical interlocking, which is what sutures do practically. 00:17:51.857 --> 00:17:52.248 Right 00:17:52.270 --> 00:17:59.111 And if we go to the ePTFE side, so the-- there's two main ways, actually three. 00:17:59.121 --> 00:18:15.611 Some of the, some of the stents are still sewing also ePTFE, um, which is more challenging because it's more, let's say, uh, there's less su-suture retention in ePTFE for sutures. 00:18:16.411 --> 00:18:49.391 the most common one is sintering, uh, which means that you are taking two layers of, uh, green ePTFE, put, put the first one on a, on a mandrel, wrap it the stents on, wrap the second one, uh, apply pressure, and put it into, you know, over three hundred and forty, three hundred and sixty C oven, which in this case usually affect also the nitinol. 00:18:51.211 --> 00:18:51.540 And 00:18:51.632 --> 00:18:52.751 The training of the Night Knoll 00:18:53.340 --> 00:18:53.711 Yeah. 00:18:53.711 --> 00:19:08.421 And the other side that when you do sintering over, um, over a stent, the-- First of all, you don't have any bond to the, to the scaffold. 00:19:08.790 --> 00:19:10.851 The ePTFE is bonding to itself. 00:19:10.861 --> 00:19:30.222 Um, and this it's- It's not strong, which means that near the, uh, the struts of the stent, you can have void after you load it and deploy. 00:19:30.232 --> 00:19:36.823 Um, the third method is the, the same sutureless termination that we use for fabric. 00:19:37.553 --> 00:19:50.173 are using it also for ePTFE, which again, we do the same, uh, we create a bond between the each strut to the membrane, to the ePTFE material. 00:19:51.563 --> 00:20:00.442 You know, there's-- the sintering process have much more, um, let's say, clinical validation. 00:20:00.492 --> 00:20:02.413 It's been used for many years. 00:20:03.593 --> 00:20:07.873 The method that, you know, that we are doing is here for the last ten years. 00:20:08.212 --> 00:20:16.623 It's already been in clinical use and commercial, it's still, you know, it doesn't have thirty years of, uh, experience. 00:20:16.633 --> 00:20:22.583 Um, and I think that there's places where it's not like one or the other. 00:20:23.452 --> 00:20:32.313 places that sewing will be best, there's places where the sintering will be best, places where sutureless lamination will be best. 00:20:33.163 --> 00:20:37.512 It's, know, each case we need to, to look at it 00:21:18.442 --> 00:21:26.942 What are some of those situations where s- sutures are better or where lamination is better, uh, or where sintering is better? 00:21:27.856 --> 00:21:32.776 So it's, it's, it's a very good, you know, very good and interesting questions. 00:21:32.866 --> 00:21:38.116 So when we look about, let's say, heart valve, which have a skirt. 00:21:39.006 --> 00:21:47.596 So the skirt is a fabric, and the skirt doesn't have the elongation that the frame, the nitinol

frame have. 00:21:48.716 --> 00:22:00.866 So in order to be able to load it, if the f- if the fabric doesn't have elongation, you need to sew it then the, um, the frame can slide through the 00:22:01.981 --> 00:22:03.141 Mm. Okay 00:22:03.276 --> 00:22:03.456 sutures. 00:22:03.456 --> 00:22:06.876 Uh, while when you bond it with a polymer, it can't slide. 00:22:07.996 --> 00:22:15.626 But if you want to use a knitted fabric which do have elongation, so you can use a sutureless termination. 00:22:17.896 --> 00:22:36.234 Um, in terms of, you know, E- I think most of the, um-- i- in a lot of cases when you are doing a, um- It de-- let's say it depends. 00:22:36.264 --> 00:22:52.674 If we look about compar-comparing between EPT, in EPTFE between sutureless lamination to sintering, it really depends how much do you want, how small you want your parts to go, uh, uh, your profile need to be. 00:22:52.894 --> 00:23:12.605 Because with the sutureless lamination, because we do the membrane not on the stent itself, we create the membrane before, so we have more flexibility in adjusting um, the ability of the EPTFE to extend and for which direction. 00:23:13.754 --> 00:23:19.464 So we are-- have more flexibility with the sutureless lamination. 00:23:21.164 --> 00:23:30.664 With the, with the, uh, the sintering, there's less flexibility, but again, it's-- you don't have any other material in the process, so it's 00:23:31.163 --> 00:23:39.913 And the sintering i- is basically, uh, the, the EP- ePTFE gets, gets, like, bonded via heat to the scaffold. 00:23:39.993 --> 00:23:40.593 Is that right? 00:23:40.976 --> 00:23:48.817 It's not-- It's getting-- have to use two layers, the ePTFE doesn't bond to the scaffold, it bond to itself. 00:23:48.826 --> 00:23:49.086 So 00:23:49.417 --> 00:23:49.927 Okay 00:23:50.396 --> 00:23:52.256 you have to li- t-two layers and you bond it. 00:23:53.746 --> 00:23:59.446 you bond one to itself, and it's create a mechanical interlock of the stents between those layers 00:24:00.329 --> 00:24:01.509 Oh, I see. 00:24:01.509 --> 00:24:12.449 So one layer of EPTFE is on the inside of the stent and the other layer is on the outside, and it-- I see, it bonds to each other in the open areas of the stent 00:24:12.625 --> 00:24:13.074 Exact 00:24:13.240 --> 00:24:16.439 mechanically joins itself to that stent. 00:24:16.490 --> 00:24:17.039 I got it. 00:24:17.079 --> 00:24:17.509 Okay 00:24:17.840 --> 00:24:18.500 Exactly. 00:24:18.510 --> 00:24:27.240 While the sutureless lamination, we actually bond the ePTFE to the stent a binding polymer 00:24:28.019 --> 00:24:28.509 Okay. 00:24:29.829 --> 00:24:33.619 And that binding polymer, is it like a coating on the stent? 00:24:33.659 --> 00:24:36.929 Or that polymer like its own sleeve or tube 00:24:37.048 --> 00:24:37.488 No, no. 00:24:37.488 --> 00:24:39.148 It's like a coating of the stent. 00:24:39.148 --> 00:24:40.308 It's a few microns. 00:24:40.308 --> 00:24:42.388 It's really very low wall

thicknesses 00:24:42.803 --> 00:24:43.363 Got it. 00:24:43.403 --> 00:24:43.963 Okay. 00:24:44.403 --> 00:24:51.053 So the coating is bonded to the scaffold, and then the EPTFE is bonded to the coating. 00:24:51.312 --> 00:24:51.903 Exactly 00:24:52.743 --> 00:24:53.153 Got it. 00:24:53.213 --> 00:24:53.683 Okay. 00:24:53.743 --> 00:24:54.033 All right. 00:24:54.033 --> 00:24:56.043 I'm starting to, I'm starting to catch on here. 00:24:57.808 --> 00:24:59.778 It's not a simple one to visualize 00:25:00.323 --> 00:25:01.203 Yeah, yeah. 00:25:01.713 --> 00:25:04.593 Uh, and then of course, the sutured version is just, just sutures. 00:25:05.043 --> 00:25:06.793 Someone is manually suturing 00:25:06.896 --> 00:25:07.516 Yes 00:25:08.003 --> 00:25:12.333 um… I- is it, is it, uh, the, uh, polyester in that case? 00:25:12.333 --> 00:25:13.963 They're suturing polyester 00:25:14.064 --> 00:25:14.375 Yes, 00:25:14.433 --> 00:25:14.973 to 00:25:14.984 --> 00:25:20.394 Most of the time they suture you polyester, but some of the cases they suture you also ePTFE 00:25:20.925 --> 00:25:21.395 Okay. 00:25:21.455 --> 00:25:21.925 Okay. 00:25:22.395 --> 00:25:33.165 And so if I'm an engineer who is developing a stent, at what point do I need to start considering the, the, the cover for this stent? 00:25:33.185 --> 00:25:36.485 What-- at what point in the development process do I start thinking about this? 00:25:36.895 --> 00:25:51.605 And, and what are some of the criteria by which I would choose, uh, sintering versus sutureless lamination versus, um, can't remember the, the third one that we talked about now. 00:25:51.728 --> 00:25:53.588 The, the sewing practically that, 00:25:53.685 --> 00:25:55.505 Sewing, right, or suturing, yeah. 00:25:56.176 --> 00:26:09.776 So it's, it's, it's interesting for I think, you know, first of all, when you are designing a covered stent, if you know that you need to, to cover a stent, you need to start thinking about it on day first. 00:26:10.766 --> 00:26:45.036 before we even talk about how to, to, uh, choose for that, um, we need, we need to talk about when you look about, uh, what do you want, what are the of the device at all, a lot of time I see companies design the stents, get the specific specification, and then send it to us to be covered, but they say, "Hey, I don't want it to affect the radial or the loading forces, and et cetera." It doesn't work together. 00:26:45.086 --> 00:26:46.307 It doesn't work like that. 00:26:46.346 --> 00:26:49.006 We have to design those elements together. 00:26:49.466 --> 00:27:03.666 I think, you know, that actually in our case, be- the AI can help us a lot to simulate it because there was a lot of challenges to simulate a, a covering before, but I think it's getting better. 00:27:04.546 --> 00:27:10.366 Um, and, and you have… What's important is to do it together. 00:27:11.506 --> 00:27:19.317 The second point of it, it's to understand that, you know, covering is not a, a… it's not machining. 00:27:20.166 --> 00:27:27.156 It's not like you, you don't say, "I want two thousandth of an inch wall thickness," and you get two thousandth accurately. 00:27:28.057 --> 00:27:32.557 It's a, it-- All of those processes are more, you know, are complicated. 00:27:32.576 --> 00:27:44.916 A lot of time, a, a, a lot of customers start with, uh, because it's simple and a lo- a lot of time they can do it themself. 00:27:44.926 --> 00:28:21.824 Um, it's not necessarily the right, uh, div- the correct approach because… And, and the reason is that you make your design decisions at the starting point, not necessarily because of the goo- of good reasons So need to… Eventually, there's a compromise in, in everything because a, a lot of time there's a consideration of budget, of time, which dictate a lot of the development. 00:28:22.984 --> 00:28:33.724 Um, I think most of, uh, the CDMOs today, uh, know how to operate in a relatively sh- uh, time and provide a, a prototyping relatively short time. 00:28:35.125 --> 00:28:38.944 But it's still not, um, not simple. 00:28:39.094 --> 00:28:51.524 About choosing between the material, the different materials, it really depends if you want to… The-- It really depends what, uh, what the application is. 00:28:52.304 --> 00:28:57.524 each materials have its own, uh, uh, advantages and disadvantages. 00:28:58.394 --> 00:29:01.865 of time there's a consideration of, uh, thrombogenicity. 00:29:02.974 --> 00:29:12.964 There's consideration if you need it to be completely sealed, um, or you want to allow some, uh, uh, flow through the cover. 00:29:14.865 --> 00:29:18.004 Um, there's no one rule, let's say, for that 00:29:19.179 --> 00:29:20.549 It sounds pretty complicated. 00:29:20.549 --> 00:29:25.029 There are a lot of different branches that will lead to different results. 00:29:25.779 --> 00:29:36.089 Um, let's talk about if you can think of a failure that you've seen where during the development process everything looked correct. 00:29:36.119 --> 00:29:54.869 You know, it was done by the book, but then this covered stent got deployed and there were failures due to, you know, whatever, crimping or deployment conditions or cyclical loading or, or some other real world situation that just wasn't apparent during development. 00:29:54.879 --> 00:29:57.059 Do you have any examples like that that you could share? 00:29:57.516 --> 00:29:59.817 I have multi-multiple examples. 00:29:59.886 --> 00:30:00.456 I think, you know, the 00:30:00.498 --> 00:30:01.779 OK。 00:30:02.476 --> 00:30:07.396 The first role of a medical device engineer is to know that he's gonna fail and embrace it. 00:30:08.496 --> 00:30:11.936 So I'll give, you know, some of them it's, it's a funny one. 00:30:12.576 --> 00:30:22.446 So one of, uh-- When we started, uh, actually to work with the sutureless laminations, so we did a work with, uh, with an amazing American company. 00:30:22.456 --> 00:30:28.557 Um, and we, we covered them. 00:30:28.567

--> 00:30:30.726 They got into design verification stage. 00:30:30.736 --> 00:30:31.606 We covered the stent. 00:30:31.606 --> 00:30:36.096 It was a, balloon-expandable stent-like device. 00:30:37.057 --> 00:30:49.236 And then they sent us, uh, images after, you know, they implanted it for chronic animal, and the stent was broken, but the covering stayed intact, 00:30:49.942 --> 00:30:50.631 Wow. 00:30:51.116 --> 00:30:55.036 which was very funny to, to look at it. 00:30:55.036 --> 00:31:00.516 It, not-- It was-- Un-unfortunately, it was funny for me, not for the others, but 00:31:00.807 --> 00:31:01.567 Yeah. 00:31:01.627 --> 00:31:02.327 Ouch. 00:31:03.236 --> 00:31:27.366 but it was, um… It-- You, you can see a lot of time what happened is that I, I saw cases that just, you know, before a clinical trial, companies need, uh, needed to do-- to stop and evaluate the different densities of material because they saw some kind of a thrombus on the chronic animal. 00:31:28.216 --> 00:31:37.366 one of the challenges that we always get to the chronic animal very late in the process because it takes time to get results, and it's costly. 00:31:39.226 --> 00:31:54.406 And I think, you know, a lot of, a lot of the customer that I know changes between gen one to gen two, and some of the time they do changes also after chronical, um, animal trials. 00:31:55.276 --> 00:32:02.636 um, it's very challenging to, uh, to nail it in the first iteration. 00:32:02.646 --> 00:32:07.046 But I think, you know, we're getting-- all of us are getting better in it 00:32:09.353 --> 00:32:14.933 Well, you're, you're a CEO now at, at MetaBrain, and which is a CDMO, right? 00:32:14.933 --> 00:32:17.043 Contract development and man- manufacturing. 00:32:17.533 --> 00:32:28.183 Um, what are some decisions that you wish engineering teams would pull you and your team in on much earlier than they actually do? 00:32:30.520 --> 00:32:35.360 I think on the, on the conceptual desi- um, phase. 00:32:35.400 --> 00:33:11.330 Because I'm, um, I… A lot of, uh, a lot of time I've been the, um, you know, the… Let's say that the customer that they've been known us for long years, or the customer that already used us, the second time they c- they call us practically first, uh, you know, al- already in the co- in the conceptional, uh, stage because we can give feedback, because honestly, I've seen, I think, at least 50% of the stand project in the last 10 years, and, and we can provide feedback. 00:33:11.330 --> 00:33:27.880 It doesn't matter, by the way, it doesn't mean that you have to work with us or, you know, it just… the case that you do work with us, it's better to get early into the process than late, uh, because you adapt expectations. 00:34:11.050 --> 00:34:21.540 Um, I think this is the main, the main one, and I think that the most important understanding, if you are developing covered stand, take two things, bear two things in mind. 00:34:22.030 --> 00:34:23.920 First of all, it's a composite material. 00:34:24.820 --> 00:34:37.444 You can't develop only one or, uh, only half of it And I think, you know, and, and the second one is try to understand what type of the-- We talked about plumbing. 00:34:38.525 --> 00:34:46.434 What type of the, um, of the tube or the, the, that you are trying to adapt to, what it, its properties 00:34:49.027 --> 00:34:59.597 Now that you're CEO, I imagine you don't get a chance to work in the technical details as often as maybe you used to. 00:35:00.137 --> 00:35:02.398 How has that transition been for you? 00:35:02.398 --> 00:35:12.947 Do you, do you miss, you know, getting deep into the technical side of things, or do you still have opportunities to work in the very technical aspects of projects even as CEO? 00:35:14.431 --> 00:35:22.391 So I do work on technical things, but I do miss being in the lab and do the things with my ha- my bare hands. 00:35:22.471 --> 00:35:22.840 That's the 00:35:22.873 --> 00:35:23.304 Yeah 00:35:23.550 --> 00:35:24.690 I'm, uh, I miss. 00:35:25.520 --> 00:35:32.721 It's a It's a tough, y- you know, from one end, it's a tough transition. 00:35:32.890 --> 00:35:41.050 On the other end, it's, uh… I do like, uh, um, I'm a people person, so I like to meet with the customers. 00:35:41.050 --> 00:35:44.830 I usually really enjoy that and try to help. 00:35:46.390 --> 00:35:57.530 with the time, I learned that even in the most things that were looked boring to me before, can find the, uh, the challenge, and you can find the, the, the part that is interesting 00:35:58.201 --> 00:35:58.581 Yeah. 00:35:59.711 --> 00:36:11.621 Well, any advice that you might give to engineers who are listening to this right now who are contemplating a project in which they have to cover a stent? 00:36:11.881 --> 00:36:19.442 Where… I know you kind of talked about them before, but if you could sum it up again, what, what, what are the main points of advice that you would give to these engineers? 00:36:20.138 --> 00:37:00.456 I can give it, you know, uh, I don't know if it's specifically for covered stand because I think we, we covered that, but I, I can give you a, an insight, a, a general insight that the f- one of the question that I love to, to ask in a, in um, in a job interviews tell me about a glo- glorious failure And it's not, uh, and you know, I've, I've been interviewing a lot over the years, and there… I had it not necessarily about work. 00:37:01.216 --> 00:37:11.446 It could be about a lot of different ways, but I never hired a person that didn't know to m- to talk about, uh, at least one failure 00:37:13.251 --> 00:37:19.331 Well, Elan, I have to ask you now, can you tell me about one of your most glorious failures? 00:37:19.588 --> 00:37:23.648 Oh, I've so… Honestly, I had so many. 00:37:25.988 --> 00:37:38.706 But, uh, I think, you know, there's… First of all, there's the, you know- Let's say that, uh, I overpromised in the 00:37:38.763 --> 00:37:39.193 Mm. 00:37:39.936 -->

00:37:42.456 and I learned the, the, the capability. 00:37:42.466 --> 00:37:52.416 It's very tough not to overpromise when you stand in front of a, a, a customer, and he needs something now, and you want to, you want to do that. 00:37:53.567 --> 00:37:53.576 Uh, 00:37:54.457 --> 00:37:55.967 It's human nature, right? 00:37:56.256 --> 00:37:58.836 it's human nature, but it's not the, the right thing to do. 00:37:59.036 --> 00:38:01.256 And, uh, but 00:38:01.273 --> 00:38:02.773 It works against us, yeah 00:38:04.806 --> 00:38:04.836 tough. 00:38:04.836 --> 00:38:08.366 It's, um… And, uh, and I, I think, you know, we- I'm getting balanced over there. 00:38:08.366 --> 00:38:24.136 I have a very good team, so, uh, I think, you know, the… Currently there's… I, I found the people that will balance and, uh, will, uh, will not, uh, will not… Will stop my overpromising nature. 00:38:24.866 --> 00:38:26.516 Trying to please the people. 00:38:27.586 --> 00:38:39.022 I think- Let's say that, um It's allocating the, the, and the focusing and prioritizing. 00:38:40.232 --> 00:38:47.192 I've been failed, you know, in early stages in, in, uh, in a lot of cases. 00:38:48.492 --> 00:38:56.822 So say that I, I'm pretty sure that I have more failure than successes, but, uh, I'm still optimistic. 00:38:58.073 --> 00:38:58.373 Yeah. 00:38:59.603 --> 00:39:01.783 What's, what's something that you're trying to learn? 00:39:01.813 --> 00:39:06.603 I mean, w- you've got a, a lot of engineers who are listening to this episode right now. 00:39:06.933 --> 00:39:20.683 Uh, outside of, you know, we're looking for new customers and come work with us, of course, that, but is there anything, I don't know, maybe you're looking to meet some technical subject matter expert, or you're trying to learn about a new technology or something like that. 00:39:20.913 --> 00:39:29.263 What are, what's something you're trying to learn right now that perhaps, um, uh, a member of our audience listening to this episode right now could help you with? 00:39:30.494 --> 00:39:36.994 So I am actually, let's say that I'm not gonna be original, so I apologize in advance. 00:39:38.554 --> 00:39:51.952 I'm, you know, one of the things that we are doing currently is trying to, uh, uh To introduce the AI into our work, and it's fascinating. 00:39:52.452 --> 00:40:00.272 Um, I'm trying to build even to design tooling with it, build simulation of covered stent with it. 00:40:01.322 --> 00:40:03.322 It's, it's amazing. 00:40:03.602 --> 00:40:11.442 I'm not sure that the, uh… You know, if there's someone that is expert in it, I would love to, uh, to learn. 00:40:11.452 --> 00:40:29.342 I think there's, there's a lot… Let's say that in terms of how to, um, a design e-e-evaluate designs, I think we can use it, uh, extremely. 00:40:29.572 --> 00:40:30.632 We need to learn how 00:40:31.545 --> 00:40:31.846 Yeah. 00:40:32.395 --> 00:40:39.435 Yeah, I think there's still a lot to learn as far as how to integrate AI into engineering, hardware engineering. 00:40:39.576 --> 00:40:43.195 Software engineering, I think, you know, that's pr- that's pretty easy, right? 00:40:43.195 --> 00:40:46.425 That's already a thing that works quite well. 00:40:46.805 --> 00:40:54.155 Um, but hardware engineering, we're still trying to figure out how AI fits into the mix and, and what the tools are. 00:40:54.415 --> 00:40:57.515 And there are several tools being developed right now. 00:40:57.515 --> 00:41:01.065 I've spoken with several different companies who are working on them. 00:41:01.065 --> 00:41:09.485 So the, the next several years will be pretty interesting in, in hardware engineering to see how those tools come to fruition and actually help us do our jobs better. 00:41:10.206 --> 00:41:11.556 Yeah, absolutely. 00:41:11.556 --> 00:41:20.396 I, I think you know that we are going to be measured, a lot of our work how, how are we going to-- can we be more efficient? 00:41:21.376 --> 00:41:28.636 And also, you know, one of the things that we are trying to, to implement at MediBand is to be right first time. 00:41:30.317 --> 00:41:37.086 And the idea is how do you make it… You know, we are… How do engineers-- It's a lot about iterating. 00:41:38.986 --> 00:41:56.286 So how do you get it right first time from one end, but on the other side of it, because if, you know, how do you still keep creativity and ke- still keep the ability to, to try things? 00:41:58.047 --> 00:42:00.626 How do you go with those two? 00:42:00.746 --> 00:42:04.396 You know, you, you need to do this and the other, and together. 00:42:05.176 --> 00:42:15.266 It's, um, I think one of, one of the things that we all need to learn is not to be, uh, let's say, single-minded and to hold complicated approaches. 00:42:16.946 --> 00:42:20.026 um, AI can give us a lot. 00:42:20.166 --> 00:42:36.456 Let's say even today we can evaluate things with AI, which is great, but we need to hold in the other side of it, is that, you know, probably there's a, let's say, fifty percent chance that it's correct or seventy percent chance that it's correct. 00:42:37.736 --> 00:42:45.246 So holding a complicated, uh, approach, that's, uh, that's the next gen 00:42:46.253 --> 00:42:46.573 Yep. 00:42:46.743 --> 00:42:47.063 Yep. 00:42:47.723 --> 00:42:54.413 Well, Elad, thank you so much for sharing your time with us and giving us this, this crash course on covered stents today. 00:42:54.413 --> 00:42:56.153 This has been super fun and valuable. 00:42:56.463 --> 00:42:58.213 Uh, I appreciate it very much. 00:42:58.653 --> 00:43:00.343 How can people get ahold of you? 00:43:01.214 --> 00:43:07.875 So the most easiest, uh, um, way to get a hold of me is via LinkedIn. 00:43:08.944 --> 00:43:17.344 That's the, the easiest way, and also, you know, ph- uh, my email at Medibrain, elad.einav@medibrain.com. 00:43:18.154 --> 00:43:23.814 I usually-- These are the two channels that I'm, uh, I'm the be- I'm actually answering to. 00:43:24.554 --> 00:43:27.524 My wife said that I'm not that good in answering phone calls. 00:43:28.224 --> 00:43:28.654 So, 00:43:30.051 --> 00:43:31.311 My wife says the same thing 00:43:31.744 --> 00:43:32.294 you see. 00:43:32.414 --> 00:43:51.884 So, um, so emails re- emails and LinkedIn DM are practically the best way, and I'm, uh, always happy to, to, you know, to, to talk with people, uh, and to try to see if I can help or even to give some feedback about new ideas. 00:43:52.364 --> 00:43:54.934 You know, you learn best by teaching others eventually 00:43:55.737 --> 00:43:56.447 That's right. 00:43:56.567 --> 00:43:57.057 That's right. 00:43:57.057 --> 00:43:58.267 I agree 100%. 00:43:58.957 --> 00:44:02.157 All right, Elad, thank you again so much for being on the show today. 00:44:02.167 --> 00:44:04.817 Anything else that you'd like to cover before we sign off? 00:44:05.286 --> 00:44:08.376 No, thank you very much for having me, and, uh, 00:44:08.427 --> 00:44:09.007 All right 00:44:09.086 --> 00:44:10.336 uh, we'll see each other 00:44:11.233 --> 00:44:11.763 Excellent. 00:44:11.803 --> 00:44:12.223 All right. 00:44:12.463 --> 00:44:13.093 Thank you again 00:44:13.872 --> 00:44:14.372 Thank you