3D-Printed Medical Devices

26 min reading time

Katie Weimer from 3D Systems gave us a gift: The most informative update on where we are with 3D printing for medical devices.

Katie explained 3D printing is now commonly used for anatomical models, personalized surgery, patient-specific implants, bracing and casting, mass customization of medical devices (like hearing-aids), regenerative medicine, and bio-printing.

Katie Weimer: Thank you everybody, it’s an honor to be here. So, what I’m going to talk about today is a pretty focus talk on 3D printing and healthcare. How many of you guys, as you know most of you from medical device companies have used 3D printers? A few, good. How many of you have you own them? A couple, yeah, good.

So I’m going to talk specifically on 3D printing and healthcare, really want to talk about the future but before you can talk about the future I think it’s our due diligence to talk about where we’ve been, what’s current today and then where things may or may not be going.

So you guys all know 3D printing, same thing additive manufacturing, digital fabrication, rapid prototyping, all of those mean essentially the same thing.

I think 3D printing has kind of taken over as the Industry’s standard term but when you look about, look at additive manufacturing 3D printing as you guys, most of you who know who raised your hands, it’s about layer by layer by layer addition of material, until you essentially grow the part, so it’s exactly the opposite of milling, right? Where you take a chunk of something, wood, metal for an implant and you waddle it down, 3D printing is the opposite, right? You grow it layer by layer only growing what you want.

So you look at the history of this, right? This patent, actually somebody else presented on this and I kind of stole the slide but the patent is back to 1892, contour relief maps, right? This is the very first pattern, you know, well over a hundred years ago, talking about creating a 3D dimensional object in a layer by layer fashion, I think it’s very analogous, very synonymous to what we are talking about with 3D printing. So where are we in medicine, right?

So, when you talk about 3D printing in healthcare, you cannot talk about it without talking about the invention of CT scanning as well, because most things in healthcare, 3D printing and healthcare is about patient specific models implants, and none of that exist without the invention of the CT scan. So, 1971, Sir Godfrey Hounsfield invented the CT scan. What came next, right?

Actually before 3D printing was invented, there was a surgeon Dr. Geoffrey Marsh, who, what he would do is take the CT scan, it comes in layer by layer, right? When you get a scan, and he would actually shape out each layer and then stack them in metal plates, cut out each layer, stalk them together to create an anatomical model, he did that back in 1980.

That’s really, I think the first time, this type of layer or fabrication was used in healthcare, 1983 of course Chuck Cole invented 3D printing and then you can see pretty quickly after that over 30 year evolution, we went from basic anatomical models that started in 1988 all the way to really sophisticated things like in 2003, I’ll show you Dr. Salia used a pretty remarkable anatomical model to separate conjoined twins and all the way through today where we are doing complex implant, complex anatomy models for training and simulation and many other healthcare devices.

So I thought that this was a pretty good snapshot of the history of 3D printing in one slide, so you fast forward to 30 years, you know that something is mainstream officially when it’s on Grey’s anatomy. So I know you guys probably saw this episode last year, right? I’m not going to make you raise your hands. But this is actually a pretty phenomenal moment, right? When it does go main-stream and it’s on something as popular as Grey’s anatomy.

They actually has a 3D printer in the hospital, a patient of course had a very exaggerated deformity of the heart and it printed out a model to be used in the operating room, sounds pretty farfetched but it’s done thousands of times a year now. Very, very common practice, so everywhere you look you see something else on 3D printing and healthcare, see you guys are pretty familiar with.

So how exactly is it being used today as a medical device, this is a medical device conference. It is very safe to say that 3D printing is now a common use for manufacturing medical devices, where? Anatomical models, personalized surgery, patient-specific implants, bracing and casting, mass customization of medical devices, like hearing-aids, I’ll talk about that and also regenerative medicine and bio-printing.

So I always steal this slide but do reference Mr. Mat D’ Prima who’s kind of an FDA specialist on 3D printing. He gave this slide or presented this slide last year and I think it’s a pretty phenomenal slide especially for this group, right?

So most of you, would you guys have known that there is over 70, and this was a year ago and so this number is much higher, over 70 additive 3D printed additive manufactured devices cleared through 510(k), right, that’s probably a lot more than most people would think, a majority of those 510(k) clearances are for orthopedic applications, I think most of us would believe that.

And a significant increase in 510(k) clearance, 2011,2012 , that’s really kind of the uptake of this, so five years ago, it really started to take off in the industry and you can see the different printing technology and I’ll talk a little bit about this, not to bore you but just to maybe educate you a little bit on what the technologies are but you can see a lot of them are powdered-bed fusion, so taking a powder and centering and melting it together and most of them are done in polymers and titanium, so those are the kind of the hot topics for 3D printed medical devices.

So, according to the FDA there’s 5 main types of 3D printing. And if you know this, great, if you don’t know this we don’t need to memorize it, it’s just more of an education because most people think 3D printing is like one thing, one platform and it’ not, it’s actually several different platforms that make up the industry, material extrusion, binder jetting, material jetting, sterile orthography, and powder fusion. So what the heck I’m I talking about, right?

So material extrusion is really, I think the cheapest and easiest types, I’ll start off with that. It’s really, might mind how I explain it; it’s kind of a glorified hot glue gun, so somebody in the front row can agree with that. It’s, you start with the solid material and you kind of melt it as it come out the nozzle on an X Y axis and you just, you know, with that contour you start to print out your part, increasing in Z, increase in your height.

What is a type, you know, so, this is a pretty common application for this, it’s a very cheap way to print detailed parts, this actually a prosthetic hand printed by a group called Ignable, so I’ll talk about this at the end. What’s another type, Binder-jetting, also known as color-jet printing. This is pretty cool, because all it is, it’s a pretty cheap powder, it’s just like printing on paper except instead of printing on paper, you are printing on a layer of powder and then the powder or the paper drops and you print on it again, you ‘re printing full color and a glue.

So essentially you are gluing together this powder, layer by layer. So what can you get from this, a pretty beautiful model right, so this is the full color model of the heart divided in 2, so you can see from an education and training perspective and even from a patient and surgeon perspective, this can be a pretty powerful model all done through this color-jet printing or binder jetting.

Material-jetting, a different kind and again, we’ll go through this pretty quick, but just to teach there’s a different kind, it’s an additive process with droplets of material are deposited on a layer by layer basis, typically with a support material as well. What you can get from this are some pretty advanced polymers, right? So this is where you can start to print inflexible materials, can be very cool especially when you are looking at things like organs, so this i
s a kidney tumor, right?

So the tumor is hard and the material around it is soft and I’ll show specific case studies on this in a minute. Sterile orthography, this is what Chuck Cole invented 30 years ago, so it’s a liquid vat of resin. Just a big box of resin and everything the laser touches it cures, so all the liquid around it will stay liquid, the laser will trace on the top of the surface and grow as the part goes down.

And what you can get from this is a really accurate model, also some, many have like we do have, cleared this for use in the operating room, so it’s passed cleaning and sterilization validations, you actually take this to the operating room. But another thing you can do is to add extra energy to part of this polymer, its UB sensitive and actually change color, so all in one print, you can get a pretty extravagant like this of conjoined twins where you want to look at the vessels between the two bodies, and so it used for pretty advanced surgical planning, I think it’s pretty phenomenal.

And then the last one is powder fusion, so that you tear this SLS or direct metal printing, that’s this powder fusion, so again in a layer by layer fashion, you are starting with bed of powder and you centering it or even welding it essentially together if you are using an electron beam and you can do some pretty sophisticated models and metals, which is really the cutting edge for medical devices in orthopedics today and also some powder, so in the bottom you see a cranial implant, that’s polymer based.

So that’s kind of the summary, so thanks for hanging with me, that was like the educational portion of the day so I’m glad we were able to hang through that.

You can see the different wide range of medical devices and these are all medical devices that were printed today using 3D printing. And of course as you guys know they range, 3D printers themselves, they range from, you know, a couple of thousand dollars up to a million dollars in price and all that varies with the different technologies.

So let’s dive in to the first one, Anatomical models, I think this is really the most basic and the most common use of 3D printing in healthcare today, so what I’m I talking about, so you start with the CT scan of a patient, again you know very few patient specific medical devices and something is, and uses the technology of 3D printing has much of a purpose unless you can start with that medical imaging data.

So what we do is you take that CT scan, you guys all know again, you go in and get an MR CT that comes in, in a layer by layer fashion, but you have to convert that into a 3 dimensional model before you can do anything with it, dimensional model before you can do anything with it, and that is why you are certain to see 3D printing and healthcare today, it’s a lot more than just the printer right?

So we take this CT scan and we go through this image processing, what we call, and I’ll show you the details of this later, and then you go into model design, because sometimes, let’s say you are doing a shoulder, if you just got the bony anatomy and you put it in a printer it may fall apart right? Because the ligaments aren’t there so it would just be this, you know, a couple of bones that fell apart, so you’ve got to add struts and color and labels and then you take it to the 3D printer, so again, this is that standard example I love to give.

You can see how powerful something like this is in something like conjoined twin separation, and this is maybe an extreme example, but actually there are kids all over the world that have this cranial, facial diseases and disorders and imagine being a surgeon and having a patient like this and not having the ability to preplan what you’re going to do when you’re going into the operating room.

So look how powerful, like in Petero’s case, he has a craniosynostosis so his skull fused together early and along a fused sutures and so the surgeon actually sees, can use the medical model to draw out where they are going to perform the operation, actually physically cut on the model, practiced before going into the OR and you can see a pretty phenomenal result, obviously a very talented surgeon as well but something like having a patient specific accurate one to one ratio anatomical model that can be sterilized and used operating room, how powerful of a tool that is.

Here is another example, Grace, also the same surgeon Dr. Salia, she had an extreme cleft of the face, as you can see now, a pretty difficult operation, so we got a 11:46 looked at this digitally and you can see he took this medical model to the operating room and used it as a guide in the OR to help perform this operation. So there’s all different types of medical models and we’ll talk in the end about how we really think this technology will be democratized to the hospitals and into the hands of the clinicians, a very, very powerful use of these models.

Another start-up company and this is very interesting one I wanted to be sure to show you guys, this is a surgeon who has a start-up company, he’s a plastic surgeon, so these people come in for plastic surgery and they want to visualize maybe what their nose will look like after wearing a plastic. Very hard to do, right? How do you project to someone and what they might look like after, and actually what they do is take a 3D scan of the face, full color, run it through a simulation program and then print out a model of that patient.

So you come in and you say, here is what you look like now, here is your simulated post-operative result, what you may look like after surgery, again a very powerful example of how 3D printing is used in healthcare, and I have a video here.

(Video playing)

When we saw the models, our imaginations just flew off the charts, and what these soft flexible models that are completely individualized allow us to do, is to really do the surgery that we are about to do on the patient, removing the cancerous area and preserving the healthy tissue on a model, rather than doing it for the first time on the patient, we were in the operating room one day, doing a robotic kidney surgery.

And we were thinking to ourselves, boy, it would be great if we could feel or see this 2 dimensional image that we’ve been looking at on a screen in our hands, and with our partners at 3D Systems, we were able to make it a kidney and the kidney tumor that not only looked like a kidney, that not only was 3 dimensional that we could feel and touch in our hands but it felt like a kidney.

Katie Weimer: So you can see this is a really powerful concept, not only for the surgical planning aspect of it but also patient education training, imagine being a resident and not getting to, you guys have maybe been, we are medical devices, right? So you’ve see the OR you’ve seen how difficult it is sometimes to participate but from a teaching perspective, this is really a game changer, so I think this last video really explained it well.

So let’s take it to the next step, so not just talking about printing and anatomical model but going in to what we call personalized surgery and how 3D printing is being used, so just, let’s think about the value proposition, so why is there a need for personalized surgery in healthcare, so from the patient’s perspective, right? They want the best surgery possible, personalized to them, makes total sense, that’s what I would want for myself.

The surgeon, they have to provide the best care possible to the patients but they have to optimize how much they can do on a day. The hospital to remain competitive they must still cut cost while still maintaining a high level of care and the Insurance company they want to continue to fund high level of care for the patients but at decreasing rates and new treatments must demonstrate value.

This is huge especially for technologies like 3D printin
g. And then the medical device company is like, us to remain competitive we must innovate provide better care at a diminishing selling price, so there’s really a good value proposition I think for the need for personalized surgery in healthcare. Who started it off, I really should attribute this to the dental implant industry, so before you go in to get dental implants, again, millions of these are done worldwide in a year, right?

Very, very common application, before they would just look at your teeth maybe do a CT scan, and visualize mentally, where they are going to drill to place those dental implants and now a majority of that is done using pre-surgical planning, where you actually pre-plan, you get the digital version of the implant you are going to use, you digitally pre-plan it, as you can in the upper left hand corner, that’s your plan, that’s what you say you are going to do and then the 3D printed drill guide that’s patient-specific, plan-specific, you put it right on the teeth it tells you exactly where to put those implants, this is really the start of it.

I’m going to give you an example of this, walk you through a case study of a boy named blessing through what we call a virtual surgical planning. So again, we start off with medical imaging data, you guys are catching on to that, right? And then before you hit print on the model, you go and you actually manipulate that data, somehow. You have it in digital format, so why not take and run through the full surgical plan and print out patient-specific model guides templates to use in the operating room, we have the ability to this now.

So here is a boy named blessing, I actually got the opportunity to meet him, a couple of months ago at our grand opening ceremony, a very bright young boy from Africa who unfortunately had a landmine explode sort of in his face, so he’s left with very little anatomy, very, very bright, actually an engineering student in Idaho now but obviously he can’t chew, he doesn’t have teeth, he can’t breathe very well, he can’t speak very well, he’s lost 11 nerve sensation in his face, it’s a difficult future for this young man.

So using what we call this digital called thread, he starts with a medical imaging data, you move into the medical image processing, you get online and do a virtual surgical plan where you pre-plan the entire thing then you do a 3D printing and then you can actually start practicing before going to the operating room, right? What a noble concept?

So here’s medical imaging data and finally I’m showing you what I’m talking about for imaging processing, since it’s a very typical CT scan and what we can do is to pick up the bony anatomy separate from airway, separate from the skin, using what we call thresh holding so each one of those is the little black or white pixel or everything in between.

So we are starting to pull out the anatomy of the patient because what we have to do is to create a 3D dimensional model so we have something to print, so you can see, we are pulling out the jaw bone, that’s the jaw bone, here’s the teeth, I think even if you are not familiar with CT scan you can recognize the teeth in this patient, and then here we are tracing the nerve, so you can see the power of what we can get from one good CT scan, one good set of medical imaging data.

And then what we do, we know the size of those pixels, we know the field of view, we know the slice spacing, what we can do is then calculate that exact patient anatomy in a 3-dimensional structure. So that’s what we do we start with that and then we take it virtual surgical planning, and this is a screen shot and I’ll show you, and this is actually blessing with the surgical team up in the screen, doing a surgical plan remotely, with a certain engineer from Golden Colorado.

So what are they looking at, they are starting with Blessing’s anatomy, so here’s that patient again, you can see, basically he had a piano wire holding his jaw together, he’s lost all his teeth in the bottom, so the first the surgeons are going to do is go in and resect out some bony anatomy to clean out the edges. So you’ve got a nice clean surface to do the reconstruction, and then what they going to do is actually take part of blessings fibula and leg bone, and use that to reshape his jaw, and we’ll talk about maybe, why things like bio printing in the future may enhance surgery.

But we’re pulling enervative data here, what you see in green is what a normal jaw should look like and then we are going to take the fibula bone and then digitally recreate what his jaw should look like. Now this seems like a crazy operation, you guys have to know that this operation is done without surgical planning, today, so the operation itself is very common, so what we are adding is digital tools, right, this looks pretty complicated. How powerful it is to have this digital preplanning before they go into the OR.

So at this point all we have are pretty pictures, we have Blessing’s anatomy, what you see on the right is the VSP post OPS so the simulated Post-Operative result. So this is what the surgeon says they want to do when they go into the operating room. So, very powerful, it’s the first time they’ve been able to visualize that.

So what we are going to do is to take that anatomy and we are going to design, patient specific, plan specific guides, that are exactly for blessings’ and we are going to print them and use them in the operating room, so the patient specific surgical tools. So pretty powerful concept, and here’s some of the examples we’re going to do, we’re going to simulate the plate, the fixation try to put it all together, the cutting guides and jigs that go on the bony anatomy.

And then we take that to the 3D printer and you can see, this is an example of sterile orthography, I think it’s a little bit dark but so you can see those models in there, so this is a pretty typical build overnight, we load up the machines they 3D print all night, so this is sterile orthography so everything the lazy is touching is getting hard, everything around it is not being touched, so it only draws out exactly the anatomy and some support structures, so it just dropped like a tenth or .15 millimeters.

And then it’s going to do it again, over and over again, thousands of times till at the end you have your 3 dimensional model in physical format and then it runs through a set of post processing that then allows that to be shipped as a medical device with instructions for use, how to clean it, sterilize it, use it in the operating room, so this is a pretty standard case, we’ve actually done thousands of these at this point, fibula free flab reconstruction of the jaw the craniofacial area and all of these are 3D printed medical devices with a cleared 510(k). They go and they are used all the time in the operating room.

So here’s an example I did put too many surgery pictures in here. You can see Blessing on the lower left, the medical device is being delivered to the hospital on the upper left, in the middle picture you see the surgeon using a 3D printed guide to cut the patient’s fibula bone and then you can see the reconstruction on the bottom right, with that medical model again being referenced in the operating room.

So, a pretty powerful concept. So here’s blessing holding his 3D printed model. So I don’t know if any of you guys saw this patient, pretty phenomenal man named Patrick, who’s a firefighter, at Tenaci, he received a full facial transplantation at the NYU hospital, just last August, we were fortunate enough to help Patrick, with the use of our digital planning and 3D printing technologies, through a virtual surgical planning, but what a powerful idea, those of you that don’t know, full facial transplantation is certainly not that common.

So Patrick has lived over ten years maybe a little bit long and he went through a lot of preoperative
counseling and testing to make sure he was a candidate for this, because this is an ethical moral type of operation that needs a lot of scrutiny before going into the operating room. So what they do is they take a donor, so much like you would donate your kidney or your heart, you can also donate you face.

And so, a young man at New York and this is all public information, so I’m not telling you something I shouldn’t, he was a bicycle messenger who got into an accident in New York and his family was generous enough to donate his face Patrick for this full facial transplantation. So he was a brain dead donor, and what you see on the left is his skeleton. So what they have to do is not only take the skin of Patrick, they are going to take some bonny pieces as well, and they take muscle and nerve and re-transplant it onto Patrick.

So what we helped with is we, one; we were able to digitally fit, how well is the donor going to march Patrick. Like we all come in different shapes or sizes and we are very complex, so we were able to digitally align every two patient’s anatomy to see how good of a fit was it was and then we made 3D printed guides that you can see would review the guide or what’s in that red color, then they we placed on a donor, placed on the recipient to dissect the bones.

So whenever you brought the face to Patrick it fit perfectly. It was really a time saver and really helped in the success of the operation but a really powerful use of the technology because we all know in the medical device company it’s all about the patient and seeing studies like this that keep us going. This is very common in knee-guidance as well, so many l knew that it comes from the orthopedic side, you’d be familiar with this and all of the major orthopedic companies have knee guidance and most of them are actually 3D printed.

Instead of doing a custom me, what they do is pre-size pre-fit and pre-place the knee X-ray to your CT scan, it is about; increasing the patient’s outcome for the person getting the knee replacement but it’s also about reducing the amount of product that is in the OR. So before I didn’t know if you were a size 8 or size 10 or size 1, so I had to have a range of five to fifteen, that needed to be in the OR when you went in to get your knee replacement.

But now I know you are exactly a size 8 because we took your CT scan and X-ray and converted it to a 3 dimensional model, we preplaced exactly where your knee, should be positioned for the best anatomical result and then we could reduce, maybe we have we have 7 8 9 in the OR, so reduced overhead, someone said up to 80 percent pretty powerful concept. And again they transfer that to operating room using this patient’s specific knee guide that will the drill this some pilot holes and cut some plains and then allow some standard instrumentation to finish up the work and you know where that off the shelf knee should be placed.

I think one of the most powerful concept of 3D printing and pre-surgical planning, is this idea that, for the first time ever, there is a 3-dimensional document that says you the surgeon, this is what you said you were going to do when you go into the OR. So know what we can do with post-operative imaging is we can said you are going to do and here’s what you actually did. And so that’s what this image is showing.

And for the first time you can actually take and say, so what you see in blue, let me explain it real quick, is what we said that we were going to do, this is the surgical plan, and what we see in green is the actual result. So first, surgeons, to get this feedback loop is very powerful, we gave them guides and jigs to cut exactly where they should cut, we gave them surgical plan before they went into the operating.

And then you get a result like this and then you say, wait a minute, where did I go wrong, what can I do in the future to do cases like this better, so I think this again a very powerful concept of the use of that technology.

So, one of the hottest trends in healthcare is printing in metals. So here’s a case example of a patient’s specific hip, so again we know that we can get a patient CT scan converted to 3-dimensional model.

What we can then do on that anatomy is 3D print or design a patient specific implant and then 3D print that patient specific implant in metal so that it’s exactly tailored. So not only when we have an anatomical models, we now have surgical guides, we have 3D printed long-term implants that are used in the operating room. One of the things we would like to say with metal 3D printing is complexity is free, those of you guys in orthopedics know that many of the implants that go into the OR are manufacturing steps.

It’s one manufacturing steps to a solid part, it’s another manufacturing step to add on a porch structure and then you may add on another biologics as well. But with 3D printing we say complexity is free, it doesn’t matter if they’re all the same size or there are slight variances, as they’re patient specific, complexity is free, so we can do this very economical today. And actually another one which is surprising, many standard implants, not patient specific implants, but standard implants with complex structures, like spine cages are 3D printed.

Because actually the economy the economics of 3D printing that complex shape is cheaper than doing it with standard methods. Here is another example of a patient specific spine implant, somebody had a collapsed disc, they needed to go into surgery and have this spine disc implanted, so what we were able to do digitally it was actually, take that patient’s anatomy, what you see in the upper right and actually move it apart a little bit to more simulate their normal spine structure because it has collapsed overtime.

Their disc has eroded and we actually digitally adjusted the spine with the surgeons input obviously and then designed a patient-specific spinal implant, this is a company out of Germany doing this. So I think it’s just really powerful case example about 3D printing is being used in metals. This concept is really fascinating, how you can use 3D printing in bracing and casting, so here is a patient population that really has it tuff, so this is a female wearing a scoliosis brace.

Those of you who are familiar with this scoliosis, typically it’s treated its most common in young females and it’s typically treated at that growth age when they are young women. So ages, maybe 12, 10 to 15 months say, during that high growth period and the only way you get better as a young female braces with scoliosis braces, if you wear this awful brace up to 20 hours a day, could you imagine, and some of you are shaking their head whether you’ve had it or know somebody. It’s all about compliance you have to wear the brace to get better.

The brace is hideous it’s hot its poky metal rods, imagine being a female having to wear this. But what if you can make the brace beautiful, what if you could use 3D printing to scan the patient, the young female could pick out the pattern, she loves flowers, she loves flowers at her scoliosis brace, let’s making low-fitting and breathable so it’s not so hot when she’s wearing it, if you make it beautiful what happens? She wears it more, it’s more comfortable, it’s patient specific, it’s made just for her.

So this is not only beautiful but she’s getting better because she’s wearing the brace more. So it’s a really powerful concept where complex design patient-specific imaging anatomy with 3D printing could do pretty phenomenal things with a really neglected patient population today. And let’s take this a step further to bracing and casting, a lot of us, whether you’ve had it yourselves or your kids have all being there, I had a 12 year old boy who broke his wrist, I mean by day 3 that thing smelled horrendous, right?

Like its awful, but what if you can have a brace like thi
s young girls are wearing this fracture cast that you could spray off with a hose that you could unhinge for a second and wash underneath there and then just place it back on. And what about this boy on their right again, this company called unique is doing pretty amazing things. He has a prosthetic on his leg, but what you can do is get a covering for that prosthesis, maybe he likes Iron- man and he wants to 3D print Iron-man prosthesis to wear around on his leg it’s cool as an expression of him.

We are doing this today with these medical devices, and again to go back to this group called Ignable. Has anybody heard of Ignable, this is a really powerful group? SO what they are doing, kids that need hands prosthesis, so what they are doing is providing a low cost alternative in fun and great alternative to traditional hand prosthesis. So what you can do and what I can do if I had a 3D printer like you guys that raised your hands before, could be a part of this. What they do is pair up people that have 3D printers with kids that need hands.

I have a 3D printer, I would love to use it for this purpose and I can sign up and help John who wants some Wolverine 2D printed hand prosthesis. And it’s a very fun and very exciting thought process and it’s done very cheaply, so this is maybe $25 worth of goods. You can do it certainly on a lower level and then you could obviously make it more and more extravagant depending on the printers and the technology that you have but this is the type of result you can get, all 3D printed with again some strings and wires attached at the end.

So they call it this maker, pay it forward, maker philanthropy and I think this concept is very powerful, now that we have this technology that can do very complex things at a very low cost I think it’s going to change the game for some of these, again this is a medical device, right? And then as we are winding down here, I want to talk about mass customization. So many of you guys, may or may not be aware of the hearing aid industry, so it’s actually been going on for a few years.

But most hearing aids they take a scan of your inner ear and then they 3D print patient-specific hearing aid shells that are designed and they print, thousands of these everyday same thing with Invisilign. So you guys all know this technology, so actually the aligner itself is not 3D printed but all the teeth mold that use, so it’s just like braces for those of you who do not know Invisilign, it’s like the new brace thing.

So instead of having the wire, you put in a series of trays that take you from step one to step 28, when your arch is perfectly in-line. And again you may have 12; you may have 50 of these different trays. So they use 3D printing on a mass scale thousand a day to 3D printing these teeth molds, and then they use to 34:45cast the aligners themselves, again I think it’s a great proof of mass customization.

And again, this is useful in this industry, so this is a hot one going on to, custom 34:56, take a scan or a picture of your foot and then 3D print a shoe in soul, and this is a startup company I wanted to add because I think it has the potential to be a part of this mass customization CPAP, you guys are familiar with the growing epidemic of sleep apnea most adults, CPAP, these custom, they are not custom, most of them are not custom today but these mass oxygen and essentially oxygen mask you wear at night.

But most of them are pretty hideous looking if I am to be honest and most of them don’t fit patients very well so they actually do not help the patient as much as they could because you are losing a little bit of oxygen, due the bad fit of the mask. So this company called Meta-Mason is using a scanning and 3D printing technology to cast out these silicon patient specific CPAP masks.

So the last kind of main area I want to talk through a little bit just to give it a full appreciation of 3D printing and healthcare is the pharmaceutical and bio-printing Industry and I’m just mention these briefly. It’s mostly the work of other people, but you guys saw this probably last year, the first 3D printed drug that was approved by the FDA, that’s seizure medication so, the idea of this is you can 3D print with the drug you can tune in on that patient-specific drug that they need and also can be an efficient way of manufacturing as well.

So this is the first 3D printed drug I think one of many that is to come, some pretty phenomenal work of 3D printing of organs, so Anthony Atala’s group out of Wake Forest, they are doing some pretty phenomenal 3D bio-printing of organ kidney and liver tissues. Organovo doing human liver tissue printing, I love this one, organ body on a chip, so what they can do is print these cells on a chip and they can use these cells structures that are representatives of many different organs in the body so essentially a make-up of the body.

And they can use this for testing cures for viruses or other drugs that, based on epidemics, large diseases that they want to test, they can test these one these body on a chip instead of testing on the animals or testing it on humans so it’s a pretty phenomenal idea and lots of very interesting stuff going on in skin 3D printing and then ears and then as well as and this has gotten a lot of attention from Scott Hollister’s group doing the tracheal stent, I think a lot of us have seen this in healthcare.

So that was just a snapshot. So I’m going to end with localizing the technology, although a lot is done at medical devices today, I really do feel that this technology is going to be localized to the hospitals. And how we handle that and how we collaborate and how we evolve as medical companies I think is very important. For example the Mayo Clinic has started a collaborative 3D printing in medicine, so radiologist are really taking this and owning it, because it’s kind of an extension of a CT scan when you go back to medical models, right?

And they’ve also started journal of 3D printing and medicine and we are seeing more and more hospitals that want to take 3D printers into their own hands, use them, and print their own medical devices in the hospitals, I was talking to the guy earlier about regulatory quality, hospitals aren’t necessarily known for their extravagant quality systems nor does the FDA govern hospitals, right? So I think it’s a really interesting evolution of 3D printing and healthcare.

But it’s going that way and we have to be a part of it, and then two more things to end on building evidence on 3D printing. So most of the things I talked about like anatomical models, they don’t have insurance re-imbursement codes, it’s a new technology, it doesn’t have insurance support, so many of the medical device company are coming together to help hospitals and clinicians to out on these studies to building evidence for 3D printing so we can get things like re-imbursement and then for rapid 3D printing.

(Video plays): “The objective has always been to disrupt conventional manufacturing….”

Katie Weimer: So this is really what I think the future of 3D printing in medicine is, taking what we do today and doing it 50 times faster, what used to take hours literally now grows in minutes, it changes the way that we make medical devices for patients, right? As technology become more local and as 3D printing technology become 50 times faster, it’s a whole different medical device industry than it was years ago, that’s a great ending note, so thank you guys for listening for the last 40 minutes.

Joe Hage: So, a few questions for the audience, who thinks it was worth my persistence to get Katie here today?

Katie Weimer: Thank you guys.

Joe Hage: Who thought, that was really cool when you saw things you hadn’t imagined before? Now importantly I want to ask this crowd in particular, who hear heard
an idea, that inspired you that you think you can bring back to your businesses? I expect fewer hands here, because of the, it’s not an immediate application for most folks, I guess my one question in the interest of time would be, how might you address the other 80% percent of the room that, saw what’s possible but right now they are not seeing how it works for their business, it’s a broad question but perhaps you can attempt it.

Katie Weimer: No, it’s a very common evolution of this technology, we do what we do today because it works in system medical devices are sticky, right, once you get something cleared, once you get it to market for good reason it’s difficult to change, so it does take time, and I think what you’ll see first is the evolvement from an engineering perspective how you used to think about designing something based on the constraints of a milling machine don’t exist anymore and it takes time for this evolution to take place.

So it’s a very common evolution but I think, keep at the back of your mind know that it’s not unknown, I think people in medical devices are scared of the unknown but I think what I showed today is it is a common tool in medical devices, there are people that can help, consult, there are people that can help you to use this technology in medicine, not just in aerospace and automotive where most of us thought 3D printing lived.

Joe Hage: Ladies and gentlemen, my new best friend, Katie Weimer.

(Applause)

Katie Weimer: Thank you.

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