ОТНОСТНО ТОЗИ ЕПИЗОД
Elad Einav is a mechanical engineer, entrepreneur, and Co-Founder and CEO of Medibrane, a medical-device contract development and manufacturing organization specializing in polymer covers, membranes, coatings, and components for stents and other implantable devices. His work sits at the intersection of mechanical design, polymer science, manufacturing-process development, quality, and medical-device commercialization.
Elad began his career as a mechanical engineer before moving deeper into medical-device R&D, where he designed implants and delivery systems and later managed multidisciplinary programs from concept through commercialization. Over the years, he has founded or co-founded several medical-device companies and has worked across engineering, clinical development, manufacturing scale-up, and business leadership.
At Medibrane, Elad works on an engineering challenge most product developers never get the opportunity to see firsthand: how the polymer covering of a stent is actually created and attached to the metal frame. A particularly important decision is whether ePTFE is joined through sintering or through an adhesive-assisted lamination process. Both approaches can result in a covered stent, but the manufacturing choice can influence adhesion, polymer microstructure, permeability, stiffness, crimp profile, fatigue behavior, delamination risk, and even the regulatory strategy for the finished device.
Elad's perspective is that these manufacturing decisions need to happen much earlier in product development. The way a stent is covered isn't simply something to hand off to manufacturing after the mechanical design is complete. It's part of the design itself. In this conversation, we'll explore those tradeoffs, look at what engineers can learn from real-world failures, and discuss how design teams can better connect material selection, manufacturing processes, testing, and regulatory requirements from the beginning.
LINKS:
Elad Einav LinkedIn: https://www.linkedin.com/in/eladeinav/
Medibrane website: https://www.medibrane.com/
Book 20 minutes with one of our covering engineers: https://www.medibrane.com/booking-calendar/rsvp-your-consultation
PDX 2026 is October 20-21 in Phoenix, AZ. Learn more and register at https://pdexpo.engineer/
Subscribe to the show to get notified so you don't miss new episodes every Friday.
The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.us
Watch the show on YouTube: www.youtube.com/@TeamPipelineus
ВИЖТЕ БЕЛЕЖКИТЕ 🔗
ТРАНСКРИПЦИЯ 🔗
00:00:00.000 --> 00:00:15.128
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.
00:00:15.909 --> 00:00:25.769
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.
00:00:39.411 --> 00:00:42.331
Hello and welcome to the Being an Engineer podcast.
00:00:42.420 --> 00:00:58.551
Today we have Elad Enav, a mechanical engineer, medical device entrepreneur, and co-founder and CEO of Medabrain, a medical device CDMO specializing in polymer covers and membranes for stents and implantable devices.
00:00:58.841 --> 00:01:06.771
His career has taken him from hands-on R&D and product development through clinical trials, manufacturing, scale-up, and company leadership.
00:01:07.210 --> 00:01:32.570
Today we're going to dig into a part of medical device development that many design engineers rarely get to see, how a covered stent is actually manufactured, why processes like ePTFE, sintering, and lamination can produce very different devices, and why the covering process itself should be treated as a design input rather than a downstream manufacturing detail.
00:01:32.751 --> 00:01:35.730
Elad, thank you so much for joining us today on the podcast.
00:01:36.183 --> 00:01:37.084
Thank you so much.
00:01:37.103 --> 00:01:37.703
Happy to be here
00:01:38.888 --> 00:01:45.629
So this is gonna be an interesting episode because we typically don't get super deep into the technical details.
00:01:45.629 --> 00:01:53.349
But today, we are doing a deep dive into coated stents, and we're gonna learn all about them from you.
00:01:53.349 --> 00:02:04.528
So I would guess this episode is going to be most useful to those of our audience who are in the medical device space and specifically working with, with stents.
00:02:04.828 --> 00:02:06.819
So I'm excited to get into this with you.
00:02:07.069 --> 00:02:13.468
Before we jump into the technical details, can you tell us, Elad, how-- what made you decide to become an engineer?
00:02:14.127 --> 00:02:24.757
So first of all, my, you know, my, my grandpa is, um… Was actually, he was, um, a plumber in Warsaw, Poland.
00:02:25.646 --> 00:02:28.086
My father is a, a car mechanic.
00:02:29.877 --> 00:02:42.676
Uh, so plumbing is practically in the family for generations, uh, and most of the medical device, you know, at least the, the vascular side of it, and, uh, uh, plumbing.
00:02:42.917 --> 00:02:48.866
You know, plumbing of my… Of, uh, uh, you know, of, uh, cars, plumbing of people.
00:02:49.336 --> 00:02:50.956
Concepts are very much the same.
00:02:51.016 --> 00:02:52.706
I'm a very technical person.
00:02:53.467 --> 00:03:01.776
remember, you know, working with my, uh, uh, with my father, um, for, you know, as a kid.
00:03:02.826 --> 00:03:04.877
So, uh, that, that's what I do
00:03:05.620 --> 00:03:06.129
Nice.
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