How 3D Printing Is Transforming Medtech

(upbeat music) Welcome to this episode of Medical Design Briefs Podcast. I'm Sherri Trigg, Editor and Director of Content for Medical Design Briefs. Throughout the year, these podcasts, presented by the editors of SAE Media Group, explore topics that are at the forefront of the future of healthcare. (upbeat music) This episode is sponsored by Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. They serve over 3,000 customers across 12 facilities in the United States, Mexico, Asia and Europe. Nelson Labs offers a comprehensive array of over 900 laboratory tests and the expertise of regulatory compliance associates, a recognized leader in life science consulting. (upbeat music) In our continuing look at advanced manufacturing and healthcare, this episode explores how 3D printing is transforming the design and production of medical devices. My guest today is Etul Dahl, engineering consultant at Transatlantic Science. He will talk to us about the benefits of creating custom implants, prosthetics, surgical tools all tailored to individual patients, as well as the ability to quickly prototype new devices for testing and development. Welcome Etul. - Thank you Sherri. Thank you for having me, I appreciate the opportunity. - So let's start if you could tell us a bit about yourself and your role at Transatlantic Science. - Sure, I'm a biomedical engineer by training. My background has always been towards microfluidics and 3D printing or additive manufacturing. A lot of the work that I've done over the years in the industry or in academia is focused towards creating these custom devices that we can use to model diseases, to be able to handle patient data better and make sort of experimental platforms that can help us test patient specific information rather than generic information. So yeah, it's a pleasure to be on. - Well, so Transatlantic Science has been deeply involved in advancing additive manufacturing technologies. And so from your perspective, what makes 3D printing uniquely suited to MedTech compared to traditional manufacturing methods? - So the big plus with 3D printing is obviously the anatomy and clinical need differ from patient to patient. So additive manufacturing or 3D printing being one of the kinds of additive manufacturing typically builds objects layer by layer, which means that we can take a digital design, then we can build complex geometries out of it where something that traditional machining or molding can't really achieve repeatedly. Surgeons and engineers, they can typically design highly detailed anatomical models and then create these custom surgical tools that can be used directly to apply patient imaging data towards the patient. Unlike something like a traditional manufacturing process, typically they involve expensive molds, large production runs, long production runs. So 3D printing is sort of more effective in that niche space of a one-off implant or a one-off small batch medical device production. It obviously increases rapid iteration and helps with quick redesigns, overnight redesigns if needed. And then often this can be extremely useful, especially for patient comfort and usability. - And you mentioned customization, which is often cited as one of the biggest benefits. Can you walk us through how 3D printing enables the design of patient-specific implants or prosthetics or surgical tools and what kinds of clinical outcomes this customization can improve? - Yeah, absolutely. So it really begins with getting medical imaging data, 3D scans of a patient's anatomy. This could be within dental space or bone implants, knee implants, hip implants, stuff like that. Once a 3D scan has been developed and achieved, you can transform that into a digital design and then eventually 3D print it. These 3D prints can also have porosity to them. So you can actually encourage bone in growth, it's called, within the implants that are created and it's all designed with the purpose to be able to sort of seamlessly fit the patient. So let's say a jawbone should not be a one-size-fits-all opportunity, right? It should really be sort of made personalized to the patient. So increasingly also in prosthetics or in surgical or custom surgical guides, surgeons can develop these tools that have sub-millimeter precision. And this can really improve post-operative complications like reduction in healing time and improve long-term integration. So it's a very exciting field. - And prototyping, bead is another big advantage. So how has 3D printing changed the way that companies develop, test and refine new medical devices before bringing them to market? - Oh, absolutely. That's one of the original sort of highlights of 3D printing, right? It was rather originally probably the better name for it was rapid prototyping. And then one of the ways of doing that was 3D printing. So it's really shrunk timelines from I would say weeks or months to days. You can now, because traditional manufacturing each step can be costly, can be slower than rapid prototyping. So an engineer can now design or redesign parts of a medical device, have it print sort of overnight because you don't really need to be there babysitting the printer at all, right? And then have it test, form, fit and function. All of this can be done in a matter of days. So rapid prototyping is a significant advantage that we can achieve with 3D printing. It also means that occasionally companies now don't have to rely on these external suppliers or external manufacturers for all their designing needs. More and more companies can have small manufacturing labs within their own space. Gives them a little more autonomy. It gives them more freedom to be able to help bring these devices to market. And it can also help with rehearsal platform, the running dry runs. So surgeons can actually practice a procedure on a 3D printed model before they actually try the procedure on a patient. So that's another significant advantage. - So regulatory approval is a critical hurdle for medical devices. So what challenges do you see in navigating FDA or EU regulations for 3D printed devices? And how do you see the industry addressing these? - Oh, absolutely. So these regulatory concerns have to be paramount. They have to be kept front and center all the time. So a lot of the challenges that the 3D printing industry does face in general are with regards to quality control and traceability, something that traditional manufacturing has nailed down because it's been around for much longer. And a lot of the procedures are now standardized workflows. So we are starting to see some of that trickle into the 3D printing industry as well. The 3D printing medical device industry as well. So key issues like being able to trace what design parameters, what print parameters were used, whether these post-processing records are sort of linked to the printer used or the device being developed. Industry groups more and more are trying to build these standardized workflows for 3D printed devices as well. And that's great to see. I always encourage and I do see this often with a lot of companies that they try to collaborate more and more with the FDA early on through something like Q-submissions. The earlier you have that in, the better because you can then align expectations and be able to produce something which is ergonomically useful. It's obviously useful to the patient as well. And it really decreases the amount of iterative processes you need throughout the regulatory challenges. So materials are a major factor in safety and performance. What are the most promising materials emerging for 3D printed medical devices? And how do you evaluate them for biocompatibility, durability, important factors? So traditionally, titanium alloys have been sort of the gold standard, especially for hard tissue applications. For softer tissue, it's mostly stuff like peak medical grade polymers which can help with performance here. They're typically lightweight but also very durable. In particular, I think you mentioned biocompatibility. So those are typically through ISO 10993 standards that are usually assessed for cytotoxicity and long-term tissue response. Durability is typically measured through mechanical fatigue testing or repeated sterilization stability. It's an exciting time because material science is sort of like the basis for a lot of the medical device industry, not just the medical device industry, but definitely for medical devices, right? It's reached a point where promising materials-- there are a sufficient amount of materials that are already really great. But promising materials, we see companies putting in more and more efforts through R&D towards developing, let's say, bio-inks or 3D bioprinting hydrogels that can be used for regenerative medicine. So great times ahead. Let's wrap it up with looking ahead. Where do you see the most transformative opportunities for 3D printing in MedTech over the next five to 10 years, whether that's surgical planning, personalized drug delivery, or something we haven't yet imagined? Absolutely. So I would say one of the major steps forward, or one of the major goals to accomplish would be with 3D bioprinting for regenerative medicine. This, I think, may not be completely achieved within the next five to 10 years, but it is a long-term goal. And a lot of us in the industry really hope that this does come through because it is that promising and exciting. With implants, personally, I think drug delivery systems or being able to have what are now called smart implants might actually be very close to being achieved within the next decade or so. Surgical planning, I think, more and more we'll see commonplace, we'll see rehearsal platforms being standard practice across surgical teams, regardless of whether it's an environment which is research conservative or has a lot of resources to expend. I think rehearsal platforms are going to become more and more standard. Another possible opportunity is point of care manufacturing labs so patients can have new devices developed for them within their hospital visit. So more and more, we'd be able to see this integrated self within the hospital care system. And ultimately, it's a point of can it move from-- can 3D printing move from just device fabrication to something where it's biologically integrated as well, right? So if we can get that full biology integration, then that's a great step forward because that gives us a lot more power on being able to help patients with their journeys, very personalized journeys in the health care. Atul, thank you so much for joining me today and for sharing your guidance and expertise with our listeners. Yeah, absolutely. Thank you, Sherry. Thank you for having me. Thank you to Nelson Labs for sponsoring this podcast with a comprehensive array of over 900 laboratory tests and the expertise of regulatory compliance associates. Nelson Labs supports customers from initial product development and sterilization validation through regulatory approval and ongoing product testing for sterility, safety, and quality assurance. Nelson Labs is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. [MUSIC PLAYING] Join us for our next episode where our guests will explore automation, robotics, and AI integration. If you'd like to provide feedback on this episode, please email me at [email protected]. You can listen to this podcast at medicaldesignbrief.com/podcast or on your favorite podcast apps, such as Apple Podcasts or Spotify. Thank you for listening and watch for more coverage of exciting new technologies in the coming weeks. [MUSIC PLAYING]