For the third episode of TCT's Additive Insight Innovators on Innovators podcast series, 3D Systems' VP, Portfolio and Regulatory, Healthcare Ben Johnson met up with Laura Gilmour, a Principal Consultant for AM and Regulatory Strategies for the Veterans Health Administration.
During their time working with additive manufacturing technology, the pair have been partners, been competitors and have both been a part of a range of successful medical projects. As they came together once again to discuss additive, healthcare and additive in healthcare, Johnson and Gilmour reflect on their early meetings, the medical applications that made them believe in 3D printing and the future of point of care medical manufacturing. They also discuss Gilmour's time at the FDA and the role regulators will play in point of care manufacturing, while also addressing the challenges facing AM in the medical sector.
Below, we have the full transcript of the pair's exchange.
Ben: Hey Laura, it’s nice to be on this podcast with you.
Laura: Yeah, Ben, likewise.
Ben: Thinking back on our history, I think we first met in 2015. Do you remember that?
Laura: Yeah, I think I was visiting your facility in Golden. And it was pretty new at the time, I think, right?
Ben: Actually, at that time, you were visiting our old facility in Golden. And I remember you coming in as a group that was focused on some implants that you wanted to make through our group. And we were in the older facility, and we had a smaller board room that we tried to cram everyone into. And it was quite the interesting meeting and a little bit intimidating for me. I don't know if you remember that or not?
Laura: Had you just started with 3D Systems at that time? Am I remembering that correctly?
Ben: Yeah, I was pretty new to my role at 3D systems and new to the role of welcoming a big contingent that you brought with you and the conversation around using additive for implants. So, it was pretty eye opening for me.
Laura: That's funny. Yeah, the folks, if I remember right, that I brought, they're great, great people to work with, but can be hard on suppliers [laughs].
Ben: [Laughs] Yeah, but it was great and it was at a time where we were launching capabilities and support to med device companies for making implants using 3D printing technology, so it was a really exciting time. But one thing we didn't get to talk about at that time was your background, at least, that I'm interested in and how you got into the medical device industry.
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Laura: Yeah, it's actually kind of a funny story. And I usually tell this to folks when I talk to young women and young men who are interested in engineering as a career. So when I was in high school - I don't know, maybe people still do this - we had an interest survey and you pop up from that careers that might be good for your personality and interest type. And the first one was a park ranger [laughs], which, although my extracurricular activities make that seem like a good idea, it didn't seem to be something I thought it was something you could live well doing, necessarily. So the second one was biomedical engineer, and, of course, I didn't know what that was. So, I had to look it up and learn about how biomedical engineering was used in the medical device industry. And then later at graduation, when I decided to pursue that and go to University of Pittsburgh to do biomedical engineering, a friend of my parents mentioned, 'Well, Laura, it seems like you combined your parents' careers' - my mom is a nurse and my father was a mechanical engineer - so it seems like I did [laughs].
Ben: Yeah, it's kind of similar for me, in terms of influences. I had my father who was an engineer, and then a chemistry teacher in high school. That I really enjoyed. That kind of propelled me into a chemical engineering route at the University of Minnesota. But through that time, I realised that, for me at least, what attracted me to the industry was the ability to work on products and technologies that have an impact on the healthcare system and have, at the end of day, an impact into patients and that's what really attracted me.
Laura: So, how did you go from chemistry to additive manufacturing?
Ben: I spent a number of years in the medical device industry and working on technologies that were used in the cardiovascular segment of health care, and had been working on a project to develop a transcatheter heart valve. So, a heart valve that can be delivered through the vasculature through a needle stick in the leg. And when you deploy these things into the body, you're typically deploying them into a very diseased patient and so an abnormal patient. But when you do testing of these devices, on the benchtop, or in preclinical testing, you're usually using an ideal environment for the deployment of the heart valves, so you're using perfectly round concentric deployment and annular rings in order to test the valve. And that's not really what happens in the clinic, and on these patients. So, I was looking for ways that I could create models of anatomy to deploy these devices into abnormal types of anatomy. Ideally, what I wanted to do was to take imaging data from these patients, and create a three dimensional model that I could put onto a pulse duplicator and deploy these valves and irregular shapes to see how they function. And at the time, I was working at a company here in Denver, Colorado, to develop this product, and had been seeking out some of the service bureaus that do additive manufacturing. So, I got my hands on some imaging data, and then actually got my hands on some 3D representations of that data and I was taking it to different groups to try to create essentially an anatomic model of these patients. That was my first introduction to additive manufacturing and what it can do.
From there, I was very interested in being able to prototype different types of heart valves, create more anatomic models. And the service bureau I was working with at the time said, ‘Oh you need to go check out this company called Medical Modelling, they do this exact type of thing that you’re looking to do. And it just so happened, they were in my backyard in Golden, Colorado, so I went to check them out and kept an eye on them for a while. And then the opportunity came up to join that group, and thankfully, I was accepted into the group and started really diving into what additive manufacturing can do and how it's applied in healthcare. So, my route came in through the med device industry, and how additive can be used to help with device development. I understand your pathway was a little bit different.
Laura: Yeah, it was and it's interesting. You mentioned the term rapid prototyping because at the time, when I was introduced to additive manufacturing, that was the term that was often used, but there were what seemed like 20 different terms that were used to describe the field. And in fact, when we were talking about and joke about it, we would say that the field had an identity crisis, because they couldn't pick a term to use to describe it. But at that time, I was looking into the metal technologies rather than the polymer side of things. And I was working for an orthopaedic company making large joints at the time and everyone was looking to compete with Zimmer Biomet, or I guess it was Zimmer then, now it's Zimmer Biomet, but Zimmer's trabecular metal, porous surface. And so we were looking to find a way to enhance the porous coatings on devices. The product that I was working on then now has been launched for several years. But figuring out how to do porous coatings with the additive manufacturing technology and in the metal space it was a pretty new idea at the time. So, I was definitely introduced to what felt like very cutting edge at that time as well.
Ben: Curious then, when you are thinking about a new technology at a large orthopaedic company. What kind of challenges did you encounter in terms of how do you test products from this type of technology? And how do you think about setting up manufacturing cells that can make products? I imagine that was a lot of your conversations too, right?
Laura: Right, exactly. Yeah, there definitely were some different considerations. So, I mean, to dive into the weeds a tiny bit, the porous coating has like guidance of what you need to test from the FDA and what's required. And of course, you have predicate devices that have some sort of porous coating on them. We compared to what was already done in the past, which is pretty common in the medical device field, you compare it to what’s called a predicate, as you know, and so we looked at that, but were some areas where the testing standards that were out there didn’t really apply. So for the porous structures, you\re building the solid material at the same time that you’re building the porous material, which makes it really nice for design, you can create different types of design line of sight, you wouldn’t need to take that into account, for example. And so there's not really necessarily an interface between the coating and the solid material. So you just have different considerations to think about in terms of how you're testing and making sure that it's behaving the way that you're expecting it to, in the body over long term, especially if you have a device that has fatigue needs or something like that, since you're putting it into the body and expecting it to last in a person for 30 or more years, you really want to make sure to do all that kind of testing, but it's the same basic concepts as what you've used in the pas, so you’re definitely comparing it to something you are used to seeing so it makes it a little bit easier to think through.
They would take the devices and sterilise them and bring them into the OR and conduct surgery to translate what they want to do digitally into the OR. And that was really 'oh my goodness, this is actually quite transformative.'
Ben: And after your work at the orthopaedic company, you went to the FDA. Right? I’m just curious if some of the work into the testing of these devices that were produced using additive technologies propelled you into looking into standards and regulations and potentially an interest in FDA?
Laura: The FDA move was a little bit unexpected in my career, I wanted to move closer to my family, which is in the East Coast. And it's funny, because there are several Pitt grads who are also at the FDA, so they kind of piqued my interest into well, you should consider this area. It was just an interesting time to come into the FDA because that was the time when some of the metal implants were coming through and so I was one of the few people that knew about the technology and knew about the differences or even what it was. So, I was part of the group which ended up becoming the additive manufacturing working group there, which looks at the devices that were being made with additive manufacturing and kind of thinking through how do we create a common review process and make sure that the folks who are reviewing devices have common things to think about? And so standards are definitely part of what that would look like, and guidance documents, which the FDA later came out with a technical guidance document around using additive manufacturing for the medical field.
Ben: I have to ask then, was it in industry or was it with the FDA where – as I talk to people in the healthcare world who are leveraging additive manufacturing, there’s typically a lightbulb moment of ‘Aha, I get how additive manufacturing can really impact healthcare and patients’ – was that lightbulb moment for you in industry, or was it at the FDA?
Laura: I think it was later on in industry in terms of like a really impactful full scope of what additive manufacturing can bring. And you're probably familiar with the tracheal splint that Dr. Hollister at University of Michigan designed and the reason I think this one is one of my favourite stories and applications is because it combines a lot of the different areas people talk about a lot with additive manufacturing: it had a unique material, patient specific design, and it was made with a clinical need that had to happen pretty quickly for the infant, to be able to survive and grow and grow their own trachea in the device’s place. So that one I think, was really impactful for me. But what about you, where do you see your light bulb moment?
Ben: Coming into medical modelling, I really thought that, hey, 'additive's a really cool technology to help with device design and development,' but really didn't think about it in terms of actually, you can use this technology in a production environment to impact patients lives. So when I came into the company, that was that was front and centre, where the group was focused on creating surgical plans and patient specific instrumentation that surgeons would use in the clinic. So they would take the devices and sterilise them and bring them into the OR and conduct surgery to translate what they want to do digitally into the OR. And that was really 'oh my goodness, this is actually quite transformative' to the world that I had been in previously. Then as I spent more time with the group, we ended up doing some really high profile, impactful types of cases where we were conducting those surgical plans, and providing the instrumentation that was used to say separate conjoined twins, which is a super rare disease, and takes a lot of coordination across the surgical team. And then also takes a very precise plan in order to do that successfully. And so we were working on cases to separate conjoined twins, we were working on cases to conduct full face transplants for a couple of cases and those types of things. Providing the tools to reconstruct people's faces was quite impactful. And then the light bulb moment of wow the ability to personalise the medicine and the treatment to the patient is quite impactful and has all kinds of far reaching implications in medicine, and so that's where it really hooked me into the technology and how it can be applied in the healthcare sector and widen my vision on these types of tools. That was really what keeps me coming back to this type of technology is its impact that can have and that’s quite meaningful to me and exactly what I was looking for in my career at least.
Laura: I think it's interesting, because we've worked for companies that are competitors in the additive technology space, but I recently listened to a podcast where Brené Brown was interviewing Simon Sinek and they’re both kind of in that company culture/ leadership type field and Simon Sinek mentioned how even if you don’t share a working history with someone, you definitely have people that you’re united in the values of trying to advance the greater good or, in our case, the medical field. I think it's really interesting that we both kind of have the same overarching goals, so at the end of the day we're on the same team, even though in the past we've been competitors. So, I thought that was a really interesting thing to hear in preparation for this podcast. It was something I thought was kind of neat to share along today.
Ben: Yeah absolutely. Since our first meeting, I have enjoyed our interactions. I’ve got to say, I was not as happy when you joined a competitor to us then having to compete against you. That wasn’t a great time, but I’m thoroughly excited that you’ve joined the VA Group and a group that we work with a little bit too, to help propel this technology. It’s nice to be on the same team again.
Laura: Yeah, it’s cool. And competition always makes you better, right? [laughs]
Ben: Have you ever, in additive, it’s typically described as a hammer looking for a nail, if you will. Have you come across any projects or initiatives where additive really just wasn’t a great fit and needed to be abandoned? I fine those stories to be quite interesting as well.
Laura: Yeah, it’s funny because when I was with EOS, we would talk a lot about if you have a product, a conventionally manufactured part that you make a tonne of, and the conventional process works really well and it’s really cost effective, maybe that’s not a great use of resources to try and figure out how you can make it using additive technology. And one thing that often came up in the medical field was screws. But for me, why do you want to print a screw? Is there something different about this screw that you want to make a new type of feature or find a different way to secure something, then maybe additive would be an interesting idea. But you can make a lot of screws with a turning machine and it’s really cost effective and people do it all day, every day. I don’t really see that as being a place. And that’s something people ask about a lot for some reason. I don’t know if you’ve seen that as well.
Ben: We have yeah, so a lot of interest in also fabricating the screws, which is just a difficult challenge for additive right now. And like you said, there's no advantage to printing screws. Another kind of funny failure, at least, to date that I've come across a few times now, because it keeps coming around every few years, is the ability to take 3D ultrasound of infants and utero, and creating physical 3D models from that ultrasound data has failed for a number of reasons multiple times over, mostly because the imaging data isn't great. It needs a lot of massaging. And then at the end of the day, you have a nice, potentially, model that you can put on here on your mantel at home, but doesn't really serve a great medical purpose. And so there's been a number of fits and starts around creating those types of models, which just hasn't really been a great use case for additive to date.
Laura: Yeah, I did see, I don't know if you saw this though, a blind woman being able to - like the model, you're saying, that you'd put on your mantle, that she was able to kind of feel the ultrasound, so to speak, because she obviously couldn't see it. I thought that was interesting, but it's not necessarily a medical use, it's more helping with patient overall care, which is interesting.
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Ben: Yeah, but that's an amazing story to allow an expectant mother to essentially see their child. It was top of mind for me, as well, as we've, again, had those initiatives over the years, and they really haven't gone anywhere. For us, at least.
So, in the short-term then, how do you think 3D printing will continue to make advances in healthcare?
Laura: I think we'll continue, obviously, to see patient specific implants and instruments and that, obviously, the best cases for that is in the hardest surgical cases, so really complicated surgical cases, being able to visualise the anatomy, like the woman could visualise her baby. It’s obviously a different reason, but being able to see things differently is definitely helpful for feeling and seeing the actual physical model I think is really helpful for those hard surgical cases and I don’t see that going away. I think there could be some reasons to do things more locally. I think that that is a way additive manufacturing can help and also a distributed model of healthcare – I think it would be interesting to look into how, with the distributed model that’s coming that we saw a bit with COVID, where patients are being seen virtually, how can you leverage that to use some sort of distributed healthcare model and how can additive manufacturing help with that too? I think those are all places that in the more short-term could see advances. Anything else you can think of?
Ben: Absolutely, I’d love to dive into the distributed model and your recent joining of the VA team to create medical manufacturing capability within the VA network. What are your goals for that? And what are your goals for how you’re going to be able to support the VA and their initiative?
Laura: I think the big overarching goal that has been shared pretty publicly is that they want the veterans to be able to go into any facility and be able to have their clinical needs met through 3D printing, if that makes sense. And so my role and goal for my time with the VA is to help them do that as safely and efficiently as possible. So, they’re working in a way where they’re basically becoming a medical device manufacturer as well, so helping them understand what the challenges might be and helping them spin up to that level. And I think if you listen to some of the presentations that the FDA gives around point of care manufacturing, that’s their main goal as well, to make sure that no matter where a patient gets a device, or no matter where that device is made, I guess, not where they get it but where it’s made, that it’s safe and effective. I think that’s the goal, to make sure that anything that being produced at point of care is safe and effective.
Ben: I think that’s great and actually quite fascinating to think about in the med device industry of how distributed manufacturing is going to impact patient care down the road. Certainly, your support of the VA is quite impactful for helping make that happen. I got to think that’s pretty exciting.
Laura: Yeah, it’s really exciting. It’s really fun to work with them every day. It’s a wonderful team of people. So, it’s a great mission and it’s a great group to be working with and getting to work with a lot of different types of technologies as well has been really interesting to me.
Ben: How do you think, at least in the short term, that the medical device industry changes as a result of the ability to democratise the manufacturing of medical devices and the interest in hospital networks and creating their own manufacturing capabilities to be more independent in their operations? The way I think about it, at least, is that it has some potential for tremendous impact into the industry, and I suspect that you will probably feel the same way.
Laura: Yeah, I think it’s really interesting that the hospitals want to take it on because obviously there’s a need that’s not being met if they’re willing to take on such a big lift. So, I think there’s a couple of areas where it really makes sense because you have the physicians right there interacting with the engineering technical team, you’re really getting real time feedback on what you’re designing and if you think about the way medical device manufacturing is historically done – and this isn’t necessarily in every single device, but in orthopaedics that I’m most familiar with – this is definitely where you have what’s called a surgeon design team, surgeon experts and key opinion leaders and they help the engineers understand the clinical practice and what’s happening in the surgery and what the needs are, what’s missing from the tools that the surgeons already have. Because you’re doing that altogether in the same place as the same team, you’re not hiring surgeons to help you, then you’re able to really quickly iterate on things and maybe even because you’re down the hall from the OR, you can go to more surgeries and see more things, because that’s where you really determine what are the big needs. So, I think that’s a big area that makes a lot of sense for advancement because you’re really getting involved right there.
Ben: Yeah, that partnership between engineer and surgeons is at a different level than I think you and I have been used to in the industry where you’re a little bit more at arm’s length and there’s a financial relationship there as well, but if you have engineers that are part of the same hospital system as the surgeon, that communication flows differently. And I’ve seen that quite a bit across different hospital networks, as well, and it’s eye-opening to me on the types of information that flows back and forth between the technical team and the clinical team.
Laura: Yeah, it’s been really interesting to see so far.
Ben: What kind of challenges do you foresee for point of care device manufacturing that are hurdles that we’re going to work on solving over the next couple of years?
Laura: Well, I think my favourite saying of all time is ‘you don’t know what you don’t know’, and so I think that the folks that are… their day to day is to take care of patients, and providing the best care for patients, they’re not necessarily thinking about a risk based framework for developing devices. They have the skills to do it, it’s not that they don’t, they just don’t know how to operationalise it and necessarily write it down in a way that we need it to be for the medical device side of things. So, I think that’s something that I’ve seen as a hurdle. And then, maybe 3D Systems isn’t the best example of this, but there are other additive manufacturing technology makers who don’t really understand what’s happening at the hospital and so the technology, the hardware, isn’t necessarily the best suited for that environment so far, right? So, there’s issues with the reliability and speed and you’re not a CT where you have someone onsite to do any maintenance or if it breaks down, so those types of things, I think, are doing to be challenging in the future of point of care manufacturing.
I really think that the technology is going to influence the way the practice of medicine is done in some way. And that’s going to be really interesting to see.
Ben: Yeah, absolutely. And I think that is true across the entire additive industry. I think a common misconception that we encounter is that you press go on a print and then... once the machine is done making the part there are additional steps that are needed in order to get a part into the clinic, or into the OR, and those steps are not well understood by a lot of the folks who are trying to onboard the technology. And there's definitely an opportunity for the additive industry to step up and provide the technologies that are stable and reliable and to provide the workflows across the board to essentially create an easy button for the clinical team, because at the end of the day, the clinical team doesn't want to be mired in the operation, or the maintenance and upkeep of the equipment that's used to make these types of devices. So definitely an opportunity for the for the additive industry there.
Laura: Yeah, I agree.
Ben: What role do you see regulators playing in point of care manufacturing?
Laura: Yeah, it's an interesting topic that I think has been around for several years now. And different people have different ideas of how this should go. To start, for those that aren’t familiar with the medical industry, the FDA does have jurisdiction over medical devices and the manufacture of a medical device and there’s definitions to that, but they don’t have any jurisdiction over what a physician does. So, you could make a device for a certain use and then a physician could decide, 'Well, this would work in my practice for this patient based on my specialty knowledge.' There’s a lot of conversation around how does that physician’s specialty knowledge and practice of medicine play into using 3D printing in point of care? And, going back to what I said earlier, the goal of the FDA is not to stifle innovation or to not give patients the best care that they physicians thinks that they need, it’s more to make sure that no matter where a device is made, that it is safe for that patient, they don't have to worry about it being different if it's made at point of care than it would if it was made at a 3D systems factory, right? That I think is the big question and so I think that there's still some communication to work out in terms of what that looks like, without limiting the way physicians and engineers interact to be able to do the great things that are going to come I think with having point of care manufacturing. There’s definitely a role because I think we do want devices to be safe no matter where they’re made and a surgeon isn’t an engineer just like an engineer isn’t a surgeon. So, it is a team approach, but having things like quality system either the exact way it’s being done in a medical device manufacturer or some way that makes sense based on risk and I think that’s still to be determined.
Ben: I think a common misconception is that the role of a regulatory agency like FDA is to say no, and, like you're saying, that's not really been my experience, or the experience of several folks in this this industry where FDA has been quite the partner and trying to develop the right methodology, the right standards, the right guidance on quality systems and regulations. I’ve been quite impressed with the FDA’s approach in this case.
Laura: And I think it has to be a partnership, doesn't it? Because again, you don't know what you don't know. The FDA isn't in the clinic, they don't understand necessarily that workflow. So, I think it's an education on both sides.
Ben: Absolutely. Looking ahead, then, assuming over the next couple of years we can figure out some of those issues, what most excites you about the ability to manufacture devices that are patient specific in the clinic and the potential for the future of that?
Laura: I think that it has the potential to push the practice of medicine a little bit and provide solutions to things that haven't been thought of yet. Because of that partnership between the engineer and the physician, because you’re really getting that feedback in real time. I really think that the technology is going to influence the way the practice of medicine is done in some way. And I think that’s going to be really interesting to see.
Ben: Yeah, absolutely. I think there are potential transformative capabilities that are on the horizon for us and the ability to not only make devices which we've done today, but then to think about how you could improve upon the interventions for patients and potentially make living constructs that are specific to those patients that helped to restore function. Or the potential for making pharmaceuticals that are matched to that specific patient's metabolic rate, ability to leverage that medicine and an ability to combine different therapies together into either one pill or one type of medicine to make things simpler for the patient, are all things that I see on the on the horizon that are quite exciting, and I think would probably be best deployed in a distributed way, like at the point of care.
Laura: It’s already starting, isn’t it? There’s been at least one 3D printed drug on the market and 3D Systems just made an acquisition in the bioprinting sphere, right?
Ben: Correct, yeah. We definitely have a vision of the ability to create whole organs for patients, again, to restore function and to meet the need of organ transplant shortages that we see in the market today. And again, I foresee that happening at the point of care, because at some point, you will need information about the patient and potentially cells or tissues from the patient in order to inform the construct that you're trying to build. Very exciting to think about.
Laura: Yeah, for sure.
Ben: And I guess, as you had mentioned previously, it's about the partnerships between the clinical teams, the engineers, and the vendors of the technologies to make this happen. And I got to say, Laura, I could not be more thrilled to be part of that partnership with you, as we as we launch these initiatives at the point of care in the future.
Laura: Yeah, it’s gonna be fun.
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