abbreviated_fda_510k_pathway

3D printing can impact new product development and manufacturing.

It’s a technology that is hot in many different industries, including medical device development.

It’s been around for several decades, and now more than 85 devices are on the market that have been 3D printed, including a 3D-printed medication.

The lack of regulation in this area has really held us back.” -Mike Drues

While it’s not a new technology, there are new guidance considerations from the FDA on this subject.

Listen Now:

Like this episode? Subscribe today on iTunes or SoundCloud.

Mike Drues, President of Vascular Sciences, works with overseeing organizations including Health Canada and the FDA and helps companies in the medical device industry navigate regulations. He’s worked with 3D printing for a long time, and he has a lot of valuable insight to share.

3D printing is a form of personalized medicine.” -Mike Drues

Some of the topics that you’ll hear about on today’s episode include:

  • Why 3D printing matters from an FDA standpoint

  • Some of the advantages of 3D printing, and how it relates to personalized medicine.

  • Some of the potential ramifications of hospitals and other medical providers becoming “medical device manufacturers” by using 3D printing on-site.

  • A few common criticisms of 3D printing, along with Mike’s observations on how they can or will be overcome.

  • Examples of real-world ways that 3D printing is being used currently.

  • Tips for those who are considering using 3D printing technology for creating medical devices.

Additional Links and Resources:

Mike Drues on LinkedIn

Vascular Sciences

Technical Considerations for Additive Manufactured Devices


Transcription:

Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry, go to get their most useful and actionable, inside or knowledge, direct from some of the worlds leading medical device experts and companies.

Jon Speer: 3D printing is super hot, in the medical device industry, these days. I'm sure you come across stories, maybe on a daily basis about 3D printing and the impact that it is having on medical device technologies in some way, shape or form. In this episode of the global medical device podcast, I talk with Mike Drues from vascular sciences. Mike and I talk about several topics related to 3D printing, including how 3D printing can impact new product development, as well as being alternate means for manufacturing, something to really consider. So be sure to tune in and listen to this exciting episode of the Global Medical Device podcast.

Jon Speer: Hello, this is Jon Speer, the founder and VP of Quality and Regulatory at green light dot guru. And welcome to the Global Medical Device podcast. Today, I've got with me, on the podcast, Mike Drues. Mike is the president of vascular Sciences. Mike works with medical device companies. He works with FDA, he works at Health Canada. He is helping everyone in this medical device industry, navigate these regulations. And actually, that is one of the topics that Mike and I are gonna explore today, is there's a new guidance document, on 3D printing that FDA recently published and we're gonna jump into that. So Mike, welcome back to the Global Medical Device Podcast.

Mike Drues: Thank you Jon, it's always a pleasure to speak with you and your audience.

Jon Speer: So Mike, you and I have chatted a bit about 3D printing. I understand that you recently were part of a webinar on the topic and I know that you're keeping everything up to speed as far as what's happening on this exciting topic of 3D printing. So, if you could take a moment, enlighten me and help educate our audience a little bit about the topic and why it matters, from an FDA perspective, that would be fantastic.

Mike Drues: Sure, Jon, thanks again for the opportunity, happy to do it. So, 3D printing, the idea is actually not new, it's been around for several decades now. And specifically, in the medical world, we have now more than 85 medical devices that have been brought to the market here in the United States, that is through the FDA, that are 3D printed. And in the interest of full disclosure. I've had my fingers in many of them, certainly not all of them, but in many of them. So it's an area that I've worked in for a very long time. And separate from the device world, for a moment, what some of your audience may not know is that FDA actually approved the first 3D printed drug, just last August, here in the United States. So simply put, 3D printing, although too many people sounds like new almost Star Trek-y technology, it's really not and it's really been around and it's growing tremendously in popularity for all kinds of reasons that we'll get into today.

Jon Speer: Sure. So, FDA recently came out with a guidance document on this topic. Even though the topic... As you mentioned, 3D printing has been around for decades and now over 85 products have gone through the FDA process of getting device clearance, why the sudden urge or interest in this topic from the FDA, what's going on?

Mike Drues: Well, that's a good question, Jon. So to be fair, I wouldn't exactly say that it's a sudden urge. In fact, this guidance has been under development for quite a long time. It was just finalized just this past May, and for the benefit of your audience, the title of the guidance is Technical Considerations for Additive Manufactured Devices. Additive manufacturing is just a synonym for 3D printing or rapid prototyping. So the guidance was finalized on May 10th, and you can find the guidance on FDA's website. Or if you can't, send me an email, I'd be happy to send it to you. But it's been under development for a long time. I personally think, that this guidance should have been finalized an awful long time ago, probably at least 10 years ago. Because the crux of your question, "Why is FDA doing this?", as you and I have talked about in the past, often times companies are not keen or at the very least, are hesitant on pursuing new technologies before there's any real defined regulation or guidance on it. And so the lack of guidance the lack of regulation in this area has really held us back. On the flipside, me being the contrarian that I am, as we've talked about before, I love working in areas where there is no regulation or guidance, but most people don't look at it that way.

Jon Speer: Right, right. So, on that guidance document to Mike. I'll make sure that we provide a link to that in the blog post that accompanies this podcast, too. So we'll have a link to that. And again, you can contact Mike or myself, if you can't find that or the link's inactive for some reason. But let's dive into and exploit this topic a little bit further. For me, one of the things... I was at an event, it's called, a couple of months ago, Time Flies When You're Having Fun. But anyway, I was at an event and there was someone that was actually presenting on this topic of 3D printing. And this lady, I don't remember her exact title or role, but anyway, she was certainly presenting this as a viable option, 3D printing as a viable option for hospitals. And as she was speaking about 3D printing and the benefits of this technology being used in a hospital, to print medical devices, a lots of red flags started going off in my head. So, what thoughts do you have about that?

Mike Drues: Well, I think, Jon, you're starting to get into are what some of the true advantages of 3D printing are. And 3D printing is an example of what I call personalized medicine. When most people think of personalized medicine, they usually think of Pharma. They usually think of something called Pharmacogenomics. But some of my favorite examples of personalized medicine, are from the medical device world, like for example, 3D printing. So, let's think about it this way. Most of our medical devices that we make today, although we make them in maybe a few different sizes, they're really not designed for one particular patient. And when you think about it, we're all different, our anatomy is different, our physiology, our molecular biology, our biochemistry. So, why should all of our medical devices, essentially, be the same?

Mike Drues: One of the most significant advantages of 3D printing is that it truly allows us to make devices that are, if you will, customized for one particular patient's anatomy or physiology. We don't have to take the one size fits all approach anymore. So that's one significant advantage. Another significant advantage is why do we have to make medical devices, or for that matter, drugs, thousands at a time or millions at a time in some manufacturing facility, and then package them and ship them and store them until we actually use them. One of the advantages of 3D printing is that it allows us to take a truly just in time approach to manufacturing. In other words, literally being able to make the device moments, or maybe even seconds, before we need to use it in the patient. So those are just two of the advantages but as you can imagine, along with those advantages come some challenges as well.

Jon Speer: Yeah. And those are fantastic ways to look at it, from an advantage standpoint. I guess, the part where the red flag started going off in my head, is when I heard a hospital talking about how they are printing medical devices. And I didn't dive into the specifics with this particular person to find out why or why not or how they're dealing with regulations and things. But the red flag is once you start printing medical devices from a hospital level, doesn't that make that hospital now a medical device manufacturer, Mike?

Mike Drues: Well, that's an excellent question, and one can certainly make the argument in that direction. I can tell you that from a regulatory perspective, this question is actually not unique. It's the same question when hospitals do reprocessing, for example. Is that subject to FDA regulation, or oversight? When a pharmacist practices pharmaceutical compounding, something that we've been doing for hundreds of years, is that subject to FDA oversight? When we talk about things like lab develop tests or LDTs, is that subject to FDA oversight? Definitely 3D printing, especially in the scenario that you just described where it's done in a hospital, or never mind in a hospital. How about in a physician's office.

Jon Speer: Right.

Mike Drues: Is that subject to FDA oversight? And why should we assume that it's gonna be done in the hospital or even in a physician's office? What about the 3D printers that are becoming readily available for home use?

Jon Speer: I know.

Mike Drues: As a matter of fact, there's an example that I use in my 3D printing seminar, of a high school kid who made orthodontic braces for himself, just this past summer for sixty bucks.

Mike Drues: You're laughing, but... So, the question becomes; what if any FDA regulation or oversight is gonna be involved in there. Suffice it to say the jury is still out on that one.

Jon Speer: Yeah.

Mike Drues: I think that what our immediate challenge is; is how do our traditional medical device manufacturers, such as the ones that you and I both help work with, how will they struggle with the challenges of 3D printing?

Jon Speer: Right, right. And I laughed but my children... Well, my daughter is just finishing up her first round of braces on her teeth, and my son has already had braces on his teeth. So, 60 bucks sounds pretty attractive versus what I've been paying for orthodontics for my children. [chuckle]

Mike Drues: I can certainly imagine. From a company perspective, and again one of the things we wanted to get into is the guidance here a little bit. The Guidance sort of separates things into two general areas. And by the way, this guidance is very high level. I certainly, encourage your audience to read through it. It's not that long, but it's also...

Jon Speer: Mike, Mike, Mike, Mike, will you read it for me?

Jon Speer: I'm just kidding.

Mike Drues: No, Jon. I know that your audience is all very smart people and they've graduated from elementary school, I'm sure they know how to read.

Jon Speer: Yeah.

Mike Drues: But anyway, more seriously, it is... Let me put it... Let me make this comparison. I actually did this recently. You're obviously very familiar with the design control guidance that came out in 1997, and almost 20 years later, still has not been updated. And some people have argued that it should be updated. I've said at FDA many times, "Don't touch it.", it's written very broadly, as it should be, to allow companies to personalize it, so to speak, for their particular use. I view this particular 3D printing guidance very much in a similar fashion. I do have, and I've already made some suggestions to FDA on how to tweak it, a little bit. But that said, I think that it should not be overly specific, because 3D printing, kind of like the design controls, is a very broad topic. And we need the flexibility in order to take what the guidance is suggesting and implement it for our particular application. Any thoughts on that, Jon?

Jon Speer: I am a big fan of the FDA's Design Control Guidance. I think it is a, as you mentioned, a very well written document. I don't know, timeless may not be the right descriptor, but at least for 20 years, it's served its purpose, in my opinion. And I think the same can be said for this. It's early, but same could be said for this 3D guidance document, as well. Although, even though 3D printing has been around for decades, it seemed like a new thing for this industry. So I guess, it'd be interesting to see how 3D printing evolves. I mean, the scenario that you described where the high school kid printed his own orthodontics, and that's an interesting twist. Another interesting twist that I can see happening and I guess the fact that I'm even putting this out there might even inspire somebody to do this, but a company designing something from an electronic standpoint, a medical device or medical technology, and then being able to send electronic files to people at their homes, where the people at home could actually take that file, import that file and actually print on their home 3D printer. There's all kinds of different scenarios and I guess that'll be the interesting thing to see as 3D printing starts to become more and more popular, how this guidance will evolve, or if it will need to evolve.

Mike Drues: Well, that second example, Jon actually is not Star Treky.

Jon Speer: No.

Mike Drues: One of the many companies that I'm working with is developing the technology to do exactly that, to be able to design a medical device virtually, not actually make it physically. But then license or sell that design to an end user, which can then print that part, that device when they need it. So, it's from a business perspective, it's really going to change the business model of the medical device industry, because think about it this way, traditionally medical device companies, especially disposables companies, their revenue is a function of the number of devices that they sell. But once people are able to start printing devices themselves, how many devices do you think we're gonna be selling? So, it's a solvable problem from a business perspective, but it's a very different business model.

Jon Speer: And I think it's interesting to think about from the technology standpoint. Often time, technological advance actually makes something less of a commodity and actually increases value add, and makes... Often times can make... Allow a company to be able to charge somewhat of a premium from a pricing standpoint. But the interesting twist here is that 3D printing could actually make some things that are advanced from a technological standpoint and almost commoditize them. And I'm just kind of thinking about the whole economics around this. It's a very interesting topic to explore, a little bit. And I'm sure there's probably case studies and things that people have done on that.

Mike Drues: Well, that's right, and it's beyond the scope of this podcast to get into the technology too much. But I just wanna remind the audience that many people, and we're doing it in our conversation today, are using the phrase 3D printing and almost a ubiquitous sort of a fashion. And keep in mind that it's really not. There are a couple of dozen different technologies, a couple of dozen different iterations on this theme. As a matter of fact, for most versions of 3D printing, when you think about it, it's really not 3D printing, it's 2D printing, layer on top of layer on top of layer. And that's really holding us back. A couple of the companies that I'm working with now are taking a truly new approach to 3D printing, where you actually do 3D printing, all at once. Another thing people criticize 3D printing, is that it's slow. As a matter of fact, believe it or not, there are some mushrooms that grow faster than some 3D printers operate. But that's true for right now, like any new technology, speed will increase with time, cost will come down with time. So all of those are solvable problems, I'm not worried about that. But let's get back to the guidance. I think that's what's really of interest to your audience.

Mike Drues: So, as I started to say in that guidance, FDA breaks it into two general categories, one is on the design and manufacturing side, which obviously includes the quality requirements and so on. And then the other is on the device testing side. Now, I'll just make a quick comment on the device testing, and then we can come back to the design and manufacturing because I know you're a quality and design control guy, as well as much of your audience.

Jon Speer: Right.

Mike Drues: On the device testing side, one of the most important things that FDA reminds people and I agree 100%, is that additional device specific requirements are likely applicable based on the indication or the technology or the risk of so on. For example, if you are 3D printing a prosthetic knee, and in the interest of full disclosure, we brought the first implanted knee onto the market almost two years ago now, and I was one of the folks that was involved with that. There's already a litany of guidance, including testing requirements on prosthetic knees. So what FDA is reminding people of, is if you're making a device that already exists, like a knee for example, you're just making it using a different manufacturing method, then likely all of those existing testing requirements for, in this case the knee, are still gonna be applicable. So my bottom line recommendation is; do your homework.

Jon Speer: Yeah.

Mike Drues: Find out if you're making an existing device. What regulation, what guidance is applicable to that kind of a device already? Of course, if you're making a brand new device, something that's never been used before. Now, all bets are off, but I suspect most of your audience is gonna be in the former category.

Jon Speer: Yeah. I would anticipate and just to share a little bit of my personal experience involving 3D printing. My experience goes back almost in almost 20 years. I can remember the first 3D prototype that I had, and held in my hands, it was fascinating to me. It was a component... I did a lot of work early on my career, with Catheter type technologies, and the 3D prototypes that I had were different concepts for an insert molded hub, that would be part of a catheter assembly. And the advantage of that 3D prototype or model, in that case, was allow us to explore and make some proof of concept prototypes before we actually invested in hard steel tooling for injection and insert molding purposes. So that was a huge economic advantage to be able to do that, to do a lot of testing on different concepts. Obviously, that's not a product we brought to market.

Jon Speer: Some other experiences that you can explore from a 3D printing, Mike, just shared the prosthetic knee. To me, that's fascinating, that we're doing orthopedic implants, using 3D printed products, that's just fascinating. And we'll explore that perhaps a bit here, as well, some of the advantages of that. But other concepts will be plastic enclosures. I worked on a dental device a few years ago, that had some electronics and we needed to make some first units, basically, for some additional clinical testing. Well, we were able to... Again, instead of investing in steel tooling for the enclosure, we were able to 3D print the enclosure for that device, just made our path to the market so much faster, so much faster then previous beings. So that was pretty fascinating. The other opportunity that I've been involved with from 3D printing was for Aortic Aneurysm, being able to take a CT scan of a patient, a specific patient, model and image that and build a 3D model of that patient's aorta and then use that to custom design and manufacture a stick graph device for that patient. Those are some of my experiences, in addition to your knee.

Mike Drues: Well, those are all great examples, Jon, thank you for sharing them. Those with all due respect, are the easy ones. Those are ones that we've been doing for a while.

Jon Speer: Exactly.

Mike Drues: Just for the benefit of the audience, 3D printing now, as I mentioned, we have products that we're 3D printing that are permanent implants that are going into patients. We have products that are actually, combination products now, that we can load with drugs or biologics like for example cells, that are 3D printed and going into patients now. We have 3D printed drugs. I mentioned the first drug that was 3D printed, that I was involved with last year as well, brought through the FDA and on the market now. And we have a growing number of people that are developing ways to be able to print 3D print living tissue, for doing all kinds of things. Not just the obvious, like organ replacement, but for being able to turn the way we do drug clinical trials totally upside down. Instead of going from bench top testing to an animal test to a clinical test, we can go from bench top to what I call using engineered human tissue, tiny little livers organoids, if you will, to test new drug candidates and then go directly to the clinical trial. So 3D printing is truly a game changing technology in many ways. But again, for the purposes of the audience, I do think it's good to come back to the guidance before we run out of time.

 

Jon Speer: Sure. Sure.

Mike Drues: So on the testing side, as I said, make sure you do your homework and find out what applicable test methodologies are there out there, already for whatever kind of a device that you're working on. From the design and manufacturing side. And this is where the Guidance is much more nebulous, as I think it should be. From a quality, from a design control from a verification and a validation perspective. One of the most common questions that I get from companies that are considering using 3D printing technology not for printing a prototype or for printing some sort of a fixture, but for printing an actual finished medical device. How would you approach that kind of a product, Jon, from say a V&V, from a validation perspective?

Jon Speer: Well, it's really fascinating to think about that, too. You mentioned your prosthetic knee example, and the case and the experience that you had, being reminded that, "Hey, prosthetic bees have been around for a very long time." and FDA has established guidance and expectations from a testing perspective, for any prosthetic knee. And it's pretty clear, that it doesn't matter in that case whether you planned a design and manufacture one knee or a billion knees that the same criteria applies. And I think, that's the opportunity that we need to understand from a design control, from a risk standpoint. I'll dive into to the design control, maybe just a bit first. Each of those products that you're gonna 3D print, if it's gonna be a custom component or custom device specific to a particular patient that verification becomes, potentially, a bit of a challenge.

Jon Speer: From an engineering perspective, I'm trying to determine my upper and lower thresholds, so to speak, from a tolerance standpoint, and be able to define the borders, if you will, in order to control my verification activities. And now that we're talking about unique physiology and unique anatomy on a per patient basis, it kind of blows my mind to some extent. So that becomes a significant challenge. And from a validation standpoint, I think that becomes also somewhat unique. Design validation is about demonstrating that I designed the correct product, and how can I do that if it's a unique device? But I guess it begs the question or the thought anyway, mindset, that even as we go through Design control process on a mass produced device, we're generalizing the design characteristics to meet a specific patient population to begin with. So we never really know, and maybe 3D printing actually allows us to have more certainty.

Mike Drues: Well Jon, like many times in the past, I think you and I are singing exactly the same song, just maybe in a slightly different key. I agree with with everything that you just said, I would spin it a slightly different way. When I look at 3D printing, one of the ways that I think about it, is it's really just another manufacturing method. And so when it comes to things like design control and verification and validation, what we really have to do... Let me try to make this as simple as I can. You're exactly right, we cannot validate the size of the device in the patient sense, because ultimately that will be under the determination of the physician, but it's very easy for me to walk into the FDA and say, "You know what, it's not my job to validate the size or the shape of this particular device because that's practice of medicine.

Jon Speer: Right.

Mike Drues: The advantage of this technology is that it allows the physician to say to the machine, make a knee or make whatever it is specifically for this particular patient. Exactly like when a physician decides to give a patient a particular drug at either a 10 milligram or a 20 milligram dose or 50 milligram dose, that's exactly the practice of medicine and FDA has nothing to do with that. So, as engineers and medical device companies, when it comes to the V&V, our job is to make sure that once the physician enters that information into the machine. Let's say that the physician or the surgeon says I need a need that's 22 millimeters in size, for example.

Jon Speer: Sure.

Mike Drues: We need to make sure that our printer is going to print a device that is 22 millimeters in size, plus or minus a particular variants and so on. We need to make sure that the mechanical properties of the device are consistent from custom device to custom device to custom device. We need to make sure that the biomaterial properties coming off the device of the 3D printer are consistent from one device to the next, to the next, and so on. So this is exactly what I meant earlier, when I said "We really do not need more, specific guidance on this, in my opinion."

Jon Speer: Right.

Mike Drues: Just like we don't need more specific guidance on the design controls, because if you understand as you and I have talked about in the past, the philosophy of the design controls, then never mind so much what the regulation actually says. What is it that we're intending to do here, that's the most important part.

Jon Speer: Yeah. And from a risk perspective, same thing. The whole premise behind design controls and the whole premise behind capturing your risk management, is to ensure that the medical devices that you're designing and developing and manufacturing are safe and effective and meet the intended uses.

Mike Drues: That's exactly right. And just as a quick example, since you seem to pick up on the knee example, I'll go into that in a tiny bit further and then we can wrap this up. When we originally brought this need to the FDA two years ago, here was the regulatory logic. What if we can show that the knee coming off of our 3D printer is basically the same, ie substantially equivalent to the knee coming off of our traditional manufacturing process. Let me say that one more time. What if we can show that the knee coming off the 3D printer is basically the same as the knee coming off of the traditional manufacturing process. If I can do that, I can totally remove the knee from the equation. In other words, I don't have to say anything about the knee. And now, all I have to do is to validate our new manufacturing process.

Jon Speer: Right.

Mike Drues: And I can further hedge my regulatory risk, in other words, hedge my bets, so to speak, maximize my probability of getting this through the FDA, by at least at the beginning, limiting the sizes of the knee that the surgeon can print to correspond to sizes of the knee that are already commercially available. And then, we go back later with a label expansion to FDA and say, "Okay now we're gonna allow the surgeon to print any size knee that they want, as long as it's between X and Y. And where does X and Y come from, it comes from the minimum and maximum of the sizes of the knees that are commercially available. And then we go back a third time to the FDA, with yet another label expansion, and remove that criteria completely. So in the regulatory world as you know, Jon, this is what we call a series of label expansions. We do it in the drug world frequently. We don't do it in the medical device world as much, but I do it a lot with devices. And to use a very simple baseball metaphor, that I've used before, it's the difference between swinging for a single versus swinging for a home run.

Jon Speer: Yeah.

Mike Drues: I would much prefer to swing for a home run and get the product on the market with all the bells and whistles at the same time. But when we swing for a home run, it's a higher likelihood of striking out. So instead, we swing for a single, we come out with all due respect a dumbed down device, where the printer can only print a couple of sizes of knees. And then we get a man on first base, the second batter comes up, they get a base, the runner moves from first to second and so on, and so on. At the end of the day, we end up getting to the same place. It's just that we do it incrementally.

Jon Speer: Somebody likes what you're saying, Mike, because they wanna learn more.

Jon Speer: But Mike, this has been a fascinating topic, and I'm sure one that you and I will chat about in the future. I appreciate the insights and sharing your experiences with 3D printing. Again, if folks listening to this today, wanna learn more about 3D printing, Mike has significant experience taking many devices to the market, through the FDA process, using 3D printing. So he's the guy you wanna chat with. Mike Drues, D R U E S, find him on LinkedIn and he'll be happy to help provide guidance and direction as you're developing your new devices.

Jon Speer: Again, this has been Jon Speer, the founder of VP of quality and regulatory at greenlight.guru. We talked a little bit about design controls today. We talked a little bit about risk management. We didn't dive into quality management system per se, but let's just say, if you wanna learn a better, faster, easier, way to manage your design control, risk management, and quality management system, be sure to go to greenlight.guru to learn more. Request the demo and we're happy to help. Again, thank you for listening to this episode of the Global Medical Device podcast.

 


About The Global Medical Device Podcast:
medical_device_podcast

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.