Examining the Untapped Potential for 3D Printing in Medtech

Nicole Black, Phd., Vice President of Biomaterials and Innovation, at Desktop Health, drops by to discuss how new technological developments are transforming 3D printing from a method primarily used for prototyping into a reliable manufacturing method for end-use medical devices. Black is also a keynote speaker at BioMEDevice Boston, an event showcasing emerging technologies and trends from the medtech market, set to be held Sept. 20-21 at the Boston Convention & Exhibition Center. (Editor's Note: Click here for registration information concerning BioMEDevice Boston!)

A transcript of the episode

Omar: Well, good morning, Nicole, and welcome to let's talk medtech. How are you?

Nicole: I'm doing well. It's great to talk to you, Omar. Thank you so much for having me on.

Omar: Thanks for coming on. I mean, this is an amazing opportunity and I'm excited to hear what you're going to be talking about today. And I really want to get all into Desktop Health 3D printing and what you'll be speaking about during BioMed Device Boston. But first, I want to ask you about a quote we ran in an article about this show, and you were discussing this in MDDI, and that was that sometimes easy problems are no fun. Can you kind of explain this logic? Because I love easy problems. I love fixing things that are very.

Nicole: Omar so, you know, really where I was coming from with this is that there's a lot of big challenges that we face in the world, from healthcare to climate change, global economy. And in order to make an impact in these fields, really, it takes a lot of creative minds coming together from different disciplines to solve them. And if a challenge is just so easy that one person on their own with their very limited life experience can solve it, then it's probably not going to be a great solution that's going to impact a lot of people. And in particular, I find challenges really fun. I think most people find puzzles fascinating. One of the reasons I became an engineer is because I was always getting frustrated, even as a kid, with how things currently existed, how current products worked, and thinking about how could we design something cooler or better in a new way. And so I really enjoy taking things that are challenges and trying to look through them from multiple lenses.

So, for example, the Phonographs project, which I'll talk about later on, is essentially a culmination of work from both engineers and also medical doctors and scientists as well. So really coming together to bring all of these diverse skill sets to solve what's a very complex problem at the end of the day. And I find it very rewarding to have a problem that other people have tried to tackle in the past and maybe haven't come up with a great solution and kind of flipping it around and trying something completely new and different. And often these new approaches take longer, they're more challenging, require years and years of iteration and also years and years of failure. And that's just something as an engineer and innovator that you have to get used to, is failure. And one thing I've really had to learn is how to try to find opportunities in the failure when things go wrong. So a lot of people try to say find the silver lining in bad situations. But one of my personal mottos and I talked to a group of 6th grade students a couple of months ago about this back in my old school district in Michigan was that really don't look for a silver lining, create the gold lining. And so if things aren't going well, if you're having a lot of failures, maybe there's a reason behind this and potentially you're being pushed in a new direction that no one has gone before. And oftentimes creating these gold linings can lead to an even better solution than if you had just taken the simple, easy way to solve the problem. And I think this is really the biggest way to make an impact is taking these challenging problems, facing them head on and trying your best to learn from your mistakes and encouraging support and insight from those around you.

Omar: Well, it's that engineering mindset too, right? Unfortunately I'm a journalist, so we have a pessimistic view of everything. This is kind of the opposite of how I think sometimes, which really gets me in trouble with my wife. A interesting, interesting. Well, let's jump into BioMed device Boston. Now, I understand you'll be keynoting and discussing desktop health phonograph device for eardrum repair and some broader issues of 3D printing. Can you kind of tease that keynote a little bit? Don't give too much away, but what can people expect or attendees expect from the keynote?

Nicole: Yeah, definitely. So I really encourage anyone that has an interest in Medtech innovation to attend. I had sort of an untraditional route into Medtech. I did a PhD and then ended up spinning out a company for my PhD work that was acquired by a larger company, Desktop Metal. And really in this talk I want to tell the story of how this came to be, how initially I wanted to go into the Med device industry and then realized a lot of this innovation isn't even necessarily happening at the big companies that you know and you hear and you dream about working at. But is actually happening at small companies and startups and academic environments as well. And a lot of times that innovation ends up getting brought into these bigger companies down the road. So I'm going to talk about my journey in discovering this pathway and how to make the biggest impact and specifically about our team's development of the Phonograph device, which is a novel device for chronic eardrum repair.

Also going to talk about 3D printing at large. And one of my hats in desktop health is to help some of these folks in large companies become more familiar with 3D printing and make it more accessible to them. A lot of people think of 3D printing as this big enigma and think also at the same time that it's a super easy thing. You just press play, print apart and come back in a few hours and you have something perfect. And that's not usually the case. There's a lot of caveats, but also a lot of benefits to it. And so kind of want to talk about where are the sweet spots in 3D printing to make a big impact in the Med device field and where some of these features that are coming out both from a material and manufacturing technology lens will be best utilized.

Omar: Well, let's talk a little bit about 3D printing because it's fascinating to me. Do we see it growing in healthcare? Do we see this space really blowing up? And if so, what are some of the key drivers and most importantly, additive manufacturing or 3D printing? What's the correct term?

Nicole: Yes, great question. So in the industry, additive manufacturing is more commonly used. But I like to use 3D printing because it relates to more people. People can visualize what's actually happening in this process. And so I think from a customer adoption lens and getting people to adopt 3D printing, I like using that term. But additive manufacturing also is a great one and conveys similar principles. So really I think 3D printing is going to be growing very substantially. And the reason for this is that your body is not made of one material and it doesn't come in one geometry. Everyone is different and even within a single person, there is a very complex arrangement of cells, of extracellular matrix proteins, of just connection points between these tissues as well. And a lot of med devices on the market. I think we're going to see a pretty significant transformation from these very simple one material devices that are injection molded and sort of one size fits all technique or oftentimes even manufactured by very labor intensive processes like sewing and cutting. Now becoming more automated and becoming more complex as well. As we start to realize some of these features that could be beneficial for patients, and so one great example of this is our team in desktop health is working with a 3D Bioplotter, which is an extrusion based printer that can print up to five materials at once. And we have a variety of different printhead configurations, including for high temperature materials, like thermoplastics low temperature materials that need to be chilled, like different hydrogels, also different printheads for doing core shell geometries as well to mimic vasculature. And I think that what we're going to see in the future is people wanting to impart different materials and different microstructural properties inside of a device. So rather than just saying, okay, well, we're going to design one thing and then injection mold it, we can potentially incorporate much more complex features inside of a single part using 3D printing as a technology. So I do think this multimaterial aspect is going to drive it, really, in addition to a lot of these benefits that you can impart with 3D printing to the end device itself.

Omar: Are there any concerns regarding the regulatory pathway for some of these applications that 3D printing will be used for?

Nicole: Yeah, that's a great question, Omar. So a lot of people, when they think of 3D printing and healthcare, they do think of customization matching things for patients. And I think this is going to be more common in the future. And so it is a bit of a regulatory hurdle because if you say, well, I'm going to customize this device for every single person, you now have an infinite array of designs that you're going to have to validate and say, yes, this works well for this patient, this device works well for this patient. And it just becomes very complicated from a perspective of actually validating all of these different suites of designs. But 3D printing is not inherently any riskier than other manufacturing technologies. If you're heating up a material to extrude it, you're also heating it up during injection molding. These are very similar things happening. Technologies like electro spinning where you put your polymer into a solution, or cast materials that is the same exact technique that's used in 3D printing. But really the benefit of 3D printing is that you have such fine control over where these materials are deposited. And one of the great things about where the field is heading is we're seeing the manufacturing technology improve just so much in terms of reproducibility. So printing parts on the micron scale and being able to replicate this hundreds of batches over is becoming possible now. So with the 3D bioplatter, one of the things we really pride ourselves on is this machine is a very robust machine. It's a manufacturing grade tool manufactured in Switzerland. And when we print parts out of it, there's also a built in camera to record every single layer.

So you have great traceability both of images and then the files as well, which in honestly, a lot of manufacturing methods you don't have in such an automated fashion. So there's even some med devices that are still, as I mentioned, being cut and sewn together. So I would say from a regulatory perspective, I would really like to see regulatory bodies understanding 3D printing as just another manufacturing mechanism and not specifically limited to patient matching, though it does have values there. But there are just so many other values that it can have for these devices, where as long as your parts are reproducible and you can validate that they work for their function and verify that their dimensions are the same batch to batch, it's really the same as any other manufacturing method.

Omar: Interesting. What I want to talk about now is with the price of everything increasing, with the inflation that we're seeing, and with materials being so high, how has this impacted 3D printing? Are we seeing 3D printing cost going up, or is it just the opposite? Is this kind of a counterpoint to those increasing assesses?

Nicole: Yeah, that's the great question, Omar. So I think we're going to see a lot of technologies coming out soon that allow for greater scale up in 3D printing. A big reason why it's not used for a lot of plastic parts versus something like injection molding is just your ability to scale the process. But new 3D printing technologies that have multiple print heads next to each other is going to speed up this process and make it more practical to have a print farm of 100 printers in the future, all working side by side on parts. One of the cost effective features of 3D printing as well is the materials that you use in the process are really limited to what you're actually putting into the device. You don't have a lot of material waste that you have with other manufacturing processes. So when you're working with very expensive materials, especially in the biologic space, thinking about things like collagen, growth factors that you want to incorporate into your inks, much more cost effective to deposit exactly the amount that you want, where you want it, rather than filling your entire device with a very expensive material or having waste that's cut off from the product at the end of the day. So I think one of the challenges is still scale up, and I think that we're getting there, but for even a lot of these biologic applications, it's often more cost effective just from a materials perspective.

Omar: Now, I can only imagine that Desktop health is helping out with this and is really at the forefront of 3D printing now. And one of the things that I've noticed is that the Phonograph device, it's amazing. We had one of our freelancers write about it last month in the Q and A with you, and I was reading about it and it just took my breath away. Could you talk a little bit about this technology?

Nicole: Yeah, thanks, Omar, it's very kind. So, yeah, this is a project that spun out of our work between Harvard and the V's Institute there, and also Mass Ioneer. And the Phonograph project was really motivated by the Boston Marathon bombing, which we just passed the ten year anniversary. And what a lot of people don't realize is that one of the most common injuries as a result of this event was chronically perforated eardrums. And so, in my first year of grad school, I met two surgeons at Mass Ironeer, DRS. Aaron Riemann Schneider and Elliot Cozen, while I was working in Jennifer Lewis's lab at Harvard. And in particular, Dr. Rieman Schneider treated a lot of patients as a result of this event and noticed that a lot of their outcomes are not ideal. They would have poor hearing after the fact, a lot of their grafts would retract and need a revision surgery. And so we started actually looking at what is the eardrum made of, what does it look like and how does it function, and can we create something better than what's currently used right now? If you perforate your eardrum, the most common solution is a Tim panoplasty under general anesthesia using autologous tissue. That is, tissue from your own body. This tissue from your own body doesn't look or behave anything like your eardrum. And you sort of have this superficial bandage of tissue on your eardrum from another part of your body for the rest of your life.

And so one of the things we realized pretty early on is that a circular and radial structure that's present in the middle layer of your eardrum, it's known as the laminopropropria, is actually very important for sound conduction. It gives it these isotropic mechanical properties, which anisotropic just a very fancy word that means different properties in different directions, but allows it to effectively behave like a soft material at low frequencies and a stiff material at high frequencies. And so what this means is that it can effectively conduct sound over a wide range of hearing. And we talked to a lot of patients during this process who had undergone typical Tim panoplasty, and a lot of them reported not being able to hear low or high frequencies well after this procedure with conventional graphs, a lot of this can be attributed to the fact that their eardrum just can't vibrate as well anymore. So we started thinking about how we can replicate this structure in the eardrum and use 3D printing to do so, but not only make it nice at the beginning and something that looks like the eardrum, but actually make something that could remodel into the eardrum structure. And so we spent a lot of time developing materials that could encourage the growth of native cells onto the graft as it degrades and start to regenerate that graft into tissue that looks and behaves more like the normal eardrum. And so a lot of our work is designing this set of materials that we're calling the Aligning system, and I'm going to be talking about this in the keynote as well. It's a very unique process because we're using 3D printing not for patient matching or really even for the multimaterial aspect at this point, but for microstructural benefits, essentially programming anisotropy into these graphs so that they can not only vibrate well initially, but start to be remodeled into anisotropic tissue in the body. And we really hope to use this technology in other areas of the body as well. So seeing a lot of interest in particular in vascular grafts and nerve conduits that also have an alignment of cells within them that could benefit from this.

Omar: What's the regulatory pathway like for this 510K or PMA? I'll tell you a quick joke before you answer that question. When I first started out in the industry, I didn't know a 510K from a PMA. And I remember putting something was approved in a headline when it was really cleared, it went through the 510K pathway and FDA jumped all over my behind really quickly. They were demanding a retraction. So it's always, hey, no worries at all.

Nicole: I think until I got in the medical device space, I thought like a lot of nomenclature, especially with the federal government to navigate. But yeah, so we've had two meetings with the FDA already regarding the phone graph device. These are called presub meetings. So essentially before you submit your package, you can ask them questions and confirm your pathway. And so they did confirm this 510K pathway for us, which is just basically showing substantial equivalents to a device that's already on the market. So it's just as safe and effective as something already out there. For these final studies, we're going to have to do a suite of biocompatibility tests, extractables and leechables animal study. And for most 510 K's, you don't require any clinical studies. But because we have this new design in phonograph to enable placement, FDA did note that they wanted to see a small human confirmatory study to just successfully show that it can be placed in clinic and operating room settings. So one of our goals with phonograph that I haven't mentioned yet is not only improving patient outcomes, but improving the patient experience. We saw early on when I was observing Timpanoplasty procedures, just how lengthy and invasive these are.

A lot of these patients go into the operating room, spend 8 hours in the hospital, it usually takes months to book a procedure, and especially during COVID we saw that a lot of patients had to spend multiple months and sometimes even years being able to book a procedure because it was considered elective. And once they're in the operating room, they have to be under general anesthesia in order to place these grafts. So it's just not entirely accessible procedure, especially when you think about patients in rural settings, war fighters abroad. And so being able to make Tim panoplasty more accessible and to improve placement of these graphs has been a major goal of ours as well. So in our new designs, we have some macro structural features that we've imparted with the help of 3D printing of support materials as well within these that can allow these to be placed through the ear canal in an awake patient. So rather than having the patient go to the hospital, spend 8 hours there, go under general anesthesia, bring someone with them instead. They could just go into a clinic based setting 20 minutes in and out, have it inserted and go home shortly thereafter without any incisions. And so this is another aspect we're really trying to innovate in and seeing it is challenging to try to innovate procedures. A lot of surgeons have been trained the same way for hundreds of years and they all know how to do things. And so I would say that's one of the biggest challenges is understanding what it will take for surgeons to adopt new technologies, especially when it takes new training as well.

Omar: So there will be no doubt a huge education piece attached to this.

Nicole: Yes. I wouldn't say necessarily huge. It's like implanting an ear tube. So any surgeon that is put in an ear tube can put in the phonograph device, but it is just slightly different than what they're used to and just preparing the patient slightly differently for the procedure. If they're not under general anesthesia, if they're awake, they just have to be aware of what's happening and use some local anesthetic, things like that. But the procedure itself is very straightforward and we're really hoping that this even improves the ease of use and even just ENT surgeons that aren't trained odolaryngologists. Oftentimes you'll have to go somewhere like mass ioneer to get a procedure. It's not super easy to get to if someone lives in western Massachusetts. So being able to go to your local ENT clinic instead and get this inserted could be a huge option in the future for people.

Omar: Exactly. I want to talk a little bit now. I want to go back to the broader topic of 3D printing and just want to ask you to get behind the crystal ball here for a second and where do you see this space? Where do you see 3D printing going in maybe the next five to ten years?

Nicole: Yeah, great question. So I think a lot of the new innovations in 3D printing are going to come down to materials. Materials are functionally, what the part is made of at the end of the day and what imparts the benefits into it. So I'm going to guess that there's going to be a lot of very exciting new biomaterials coming out, especially at this interface of natural and synthetic materials that can allow graphs to have sort of the best of both worlds, all the benefits of incorporation and biocompatibility that natural materials do. But the mechanical properties and robustness of a lot of these synthetic materials like PCL and PLA, I think that's going to be a huge growing market, is just developing new materials for these spaces. I think also enabling new geometries with 3d printing. We're going to see a lot of as support materials in different also add ons for 3D printers become available. So in Desktop Health, we recently released a system called the Print Roll Build Platform which is essentially a rotating mandrel that you can print on as it rotates. So you can create cylindrical devices for vascular graphs, respiratory graphs, nerve conduits, much easier than it would be if you were trying to layer by layer build these up from a circle all the way up to a cylinder. And so I think really combination of materials technologies and manufacturing capabilities of these printers that can do things that no one's ever thought of with traditional manufacturing techniques is going to be growing and really make this space more accessible so that folks that want to innovate can do this just from an academic lab setting up to a big device.

Omar: Awesome. Awesome. Well Nicole, if anyone wants to know more about Desktop Health or any of the great things you all are doing, how can they get in contact with you? Where can they go?

Nicole: Yeah, great question. So the link I will send you, Omar, and I don't know if you can incorporate that into the podcast, but if you Google desktop health 3D Bioplotter, that'll take you to our landing page. Our team specifically is the desktop Health Biofabrication Innovation office. So we're located in the Shrafts building in Charlestown, which is a neighborhood of Boston, and we have an R and D team here and capabilities to help people launch 3D printing projects and really bring their ideas to life. As we talked about, there's a lot of materials development that goes into 3D printing and also a lot of tuning it's not really pressing a button, hit go and coming back. And so helping companies access this better and lowering that barrier of entry is really one of our goals of ours. And we encourage anyone that's interested in learning more to reach out either about the 3D bioplotter, about 3D printing for Med devices in general. Love to talk.

Omar: Well, thank you for coming on to Let's Talk Med Tech and we will see you next month at BioMed Device Boston.

Nicole: Perfect. Thank you so much for having me on Omar. It was great talking to you and looking forward to seeing everyone at BioMed Device.

Black will give the keynote address, Moving the Nozzle: 3D Printing for Medical Device Manufacturing, at BIOMEDevice Boston on Thursday, September 21, from 1-2 p.m., at Center Stage.