Episode #11 | Supporting Transformational Innovation in Medical Device

This Solutionology episode is inspired by our work serving the medical device industry, which makes up over 50% of our business. We dig into the details of medical device applications but the takeaways apply to product innovation in many high-end applications where a manufacturing process that supports tight tolerances, exacting quality, unique geometries, design flexibility, and sealed surfaces is absolutely critical to success.

You'll hear our take on the ways additive manufacturing currently serves medical device applications and the opportunities it has to create transformational innovation when considered earlier in product development cycles. It's an important topic as we prepare to attend the Medical Design & Manufacturing (MD&M) Tradeshow in California which will initiate all kinds of problem-solving and exploratory conversations about additive manufacturing with medical device innovators.

Find us at MD&M:
https://www.linkedin.com/events/md-mwest7022977598309748737/ 

Schedule a 1:1 engineering consult with Carl Douglass at MD&M:
https://calendly.com/dilabs/am-eng-consult

Episode Topics:
01:08 Welcome
02:13 Phases of medical device development
03:14 Driving change toward additive
03:32 Materials
04:11 Functional aspects
05:15 Process controls and traceability
06:12 The speed of evolving technology
06:54 Types of medical device we can support
07:29 Cardiovascular applications
07:54 Enclosures for medical device components
08:15 Internal structures for medical device
08:54 High mix low volume
09:19 Applications in the operating room
09:38 Analogue or digital
10:50 Entire system - greatest advancement for additive
12:11 Benchtop trials and iterate in weeks instead of months
12:24 Design validation and clinical trials in months rather than years
12:42 Supporting the switch from traditional manufacturing to AM
13:40 Opportunities in concept phase for DFAM and components
14:19 Design validation - adapting legacy design to AM
15:22 Early-stage opportunities vs late-stage opportunities
16:34 Ground zero allows for innovation and timeline advancement
17:13 Supporting transformational innovation
18:04 Reducing timelines is our focus
18:20 Full-color printing for enclosures can build confidence
20:10 Enhancing the user experience
20:50 Parts we'll have at MD&M
21:42 Functional anatomical models
23:46 Consistently high tolerance production
24:26 Visual CMM for dimensional analysis and quality control
25:59 Preproduction analysis & predictive modeling
27:26 Misconceptions about what it takes for consistency
28:34 Quality is a core foundation
30:14 Bring us your pain points at MD&M - connect with Carl

Find us at MD&M:
https://www.linkedin.com/events/md-mwest7022977598309748737/

Schedule a 1:1 engineering consult with Carl Douglass at MD&M:
https://calendly.com/dilabs/am-eng-consult

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Transcript

Carl Douglass (00:00):
That's a significant advancement because now we're talking about going into an application where we're able to do benchtop trials, iterate in weeks instead of months, and then go into design validation and clinical trials and do the same thing. It's a dramatic shift, Solutionology's about being unyielding with perseverance to get to the solution.

Sean Douglass (00:20):
To not give up and to constantly drive for better. Even when we deliver 100%, I want to deliver 110 next time.

Brian Douglass (00:27):
For me, the constraints of that project are the most important because that's what drives us to a solution. It's all about painting a picture and getting all the details in.

Carl Douglass (00:35):
How do we develop a tool that helps share our journey, educate others, and bring more light to the realities of Additive Manufacturing? The Solutionology Podcast.

Carl Douglass (00:49):
Welcome to the Solutionology Podcast number 11, and we're here today to talk about medical device innovation. There's a number of reasons for this, and I know that we've talked about some components of medical device production with Additive Manufacturing and tolerance control in the past. There's a large event coming up, MD&M West, of course, we're going to have a booth there, and there continues to be a lot of questions and conversation around medical device and leveraging Additive Manufacturing, so we figured this would be a great opportunity to talk more about that, hopefully raise some questions for you that those are viewing the podcast and then spark some conversation for the event that's coming up in February, so thanks for joining us and good morning, Brian.

Brian Douglass (01:38):
Good morning. The discussion today, it's really a conglomeration of previous podcasts. We've done a deep dive into how DI Labs manufactures and why we do it and how we do it, today we want to really tie that together with medical device and with MD&M coming up, this is our chance to share ways that our clients are leveraging Additive and an effort to accelerate their innovation, and we're going to share some tidbits out of our experience.

Carl (02:12):
Well, thanks Brian. I agree. Let's dive right into it. There's obvious phases of medical device development and they're classified many different ways. FDA has their classification for the phases, and it's not unlike what we work with with our own product development for non-medical device applications. Additive Manufacturing's been used for a long time for the early prototype stage of medical devices. It allows you to get some form of fit and function, but traditionally, as you scale through the development phases, Additive is used less and less. Traditionally, that's because of the available materials, tolerances, dimensional control, and even just appearance, and we're driving change in that area. We're not the only ones of course, but what's your perspective on that and how we're driving that change further down the development pipeline?

Brian (03:14):
Well, some of the unknowns that may be, or misconceptions that are out there about what Additive can do and what Additive is not able to do and that that's rapidly evolving, so it's a pace that we're all trying to keep up with. One of the big aspects or the unknowns is material options, so being able to have a biocompatible material, which we have, it's important for certain applications. Being able to have a material that can be sanitized and cleaned after production. A material that can be sealed and used, in certain cases, multiple times rather than just a single use.

Carl (03:54):
Then be sterilized, of course.

Brian (03:56):
Be sterilized, of course, we're talking about composites and there's the metal side, which is its own undertaking, but on the composite sides it's been more challenging because those specialized materials isn't as straightforward as metals. Those are some of the key areas, of course, outside of the management and use of those devices, we have the functional aspects of it, material properties, tolerance precision over lots of parts and lot management, making sure that we have traceability through our system and if there's any questions, we know what the lot is, where those parts came from and controlling all that.

Carl (04:38):
What you've just outlined is really important. You're talking about the available materials, the available quality process controls, and the technologies to produce the parts, which ties with quality of course, and then of course, the traceability, and so we're really talking about manufacturing. We're talking about implementing many of the manufacturing controls that are in place for traditional methods in an Additive Manufacturing, and that is relatively new because Additive hasn't been used for that depth of manufacturing up until just recently over the last several years.

Brian (05:15):
When we think about the traceability or the process controls with Additive, managing that at scale when there's so many variables to control and also trace is really challenging without having a really powerful system that can track it all, and that's something that we have that we're able to trace those manufacturing steps, and it's really a key part to ensure that we have good quality parts out and we're able to have a feedback loop as we're continuing to produce. We're using not just our knowledge today, but our past data to ensure future production is correct and good.

Carl (05:55):
It's pretty powerful.

Brian (05:57):
It is.

Carl (05:58):
Well, maybe we had to take a step back and roll it back and you're talking the difference between metals and polymers and that in some cases polymers are still a little bit more nuanced and new to the scene of medical device manufacturing. As I think about it, today, we're in 2023, which is hard to imagine by itself, as short as six to seven years ago, the technologies that we're operating today, some of them didn't exist, so the technology to your earlier point has really evolved quite rapidly. In fact, today we've got some product on the table that was produced with our Multi-Jet Fusion, we're calling it Ultra White, but it's Multi-Jet Fusion that produces white parts. This didn't exist six months ago, so we're talking about rapid innovation and the manufacturing technology that is evolving in real time. There's a lot of changes and there's a lot to really catch up and connect with.

Brian (06:55):
The changes that are happening in the space of what can we produce and how can we produce it, that has a big impact on what medical devices that we can support, so maybe you can walk us through what are the types of devices that we could consider available today that may not have been, or maybe from the spectrum point of view.

Carl (07:14):
That's a good question, so it's easiest to talk about it in terms of the types of medical devices that we predominantly support, and probably more than half of our business, this changes depending on design cycles and whatnot, is medical device, and we find ourselves quite a bit supporting cardiovascular applications and even more specifically, the components that drive delivery systems for cardiovascular applications, and so that's one area, and I'd categorize that in terms of tools or surgical devices that are used in the operating room, that's one area. Another areas is perhaps enclosures that house medical device systems or components similar to the housing that's here on the table, and then also thinking about smaller components. This handle could represent the size of a housing for a device that may not be a surgical tool. Of course, we're producing internal structures for medical devices that house electronics, and they may not be the external housing, but they're the structural component that houses all the internals.

(08:30):
Taking a step further back from the operating room and surgical applications, we're supporting applications of mobility aids, so thinking about wheelchairs is the simplest way to think about it. Wheelchair applications where there may be some custom components that are adapted for the patient or for high mix, low volume applications where there may be a product line that's made up of many different variations, and those variations, the volume isn't high enough to be able to produce with injection molding, so that's a great example further from the operating room. Of course, there's the applications and the OMP field, which we don't do a whole lot of work in, but those are out there as well, and as we talk about medical device, we're really talking about components that are more central to critical applications generally, and the operating room and surgical applications that require a great deal of attention to detail and tolerance control, cleanliness, and then traceability.

Brian (09:38):
These devices, they can be analog where they're a mechanical device and there's no electronics involved. They could be digital with touchscreen buttons, not touchscreen buttons, but either a touchscreen or ergonomic buttons.

Carl (09:55):
What touch screens have buttons? They're built in digitally.

Brian (10:00):
It can either be the housing that holds all the mechanical components. It could be the mechanical components within a housing. It could be the electronics or mechanical components in here, or it could be the whole thing. What we find as the device gets bigger, we're serving different aspects of that product development or production tool or production parts, so if we're dealing with a large medical aid like a walker or a wheelchair or something, electronic wheelchair, manual wheelchair, we can serve components on that that are in contact with the patient, and we can also serve mechanical components, structural components, so as the device gets bigger, we're serving that grapefruit to basketball size component on those devices.

Carl (10:50):
It's interesting to think about the impacts that we have. Going back to talking about basketball size that are exterior and going back to the more comprehensive solution that are in the operating room and more mechanical, so a common application for us, which I think is really impactful for medical device innovation, is developing or producing the entire system, so that would be the housing, is talking about analog, so that would be the housing, the mechanical internal components, and then the interface components. It could be mechanical buttons or levers that come together to create the assembly, and that's where, from our experience where we've seen the greatest advancement with Additive Manufacturing, traditionally those components are injection molded with short run production and they're done so because precision and tolerance control is really critical, and what we've been able to achieve with Additive is a solution that is really close to short run injection molding.

(11:58):
We're able to produce assemblies that are of about this size that has a housing and then internal components, and those components are designed and also work together well as Additive manufactured components, and that's a significant advancement because now we're talking about going into an application where we're able to do benchtop trials, iterate in weeks instead of months, and then go into design validation and clinical trials and do the same thing, be able to iterate in months rather than years, so it's a dramatic shift in the timeline that we're able to shorten the timeline for these complex medical devices.

Brian (12:41):
Let's take an example of that mechanical analog device that you're working that you just discussed. We've got devices that's got mechanical components. There's lots of tolerance requirements and lots of fitting interchangeable components on the device. For a design engineer to switch from one technology, think about injection molding, thermoforming machining CNC to a new one, let's say they're learning a new design methodology for new manufacturing process, that can be quite the hurdle to overcome. Thinking about starting your next project or trying to add Additive into your current production line, so how can we support someone in that position.

Carl (13:27):
That's a good question, and the question that you just ask really covers a multitude of timelines where we would inject ourselves or become injected in the project, and I'll pull that out first. Projects that are starting from the very beginning and they're just getting past the concept, making sure they're committed to the project, at those early stages, we have a great deal of value to add because we can help steer that project down the right path from a defam standpoint and from a componentry standpoint, because we understand the Additive Manufacturing technology so well, and we understand the product development and the mechanical side of things so well, we can bridge that gap and become integrated with our customer in terms of design refinement and optimization through those early stages, and that's probably where we've seen the greatest impact, where we're able to partner with our customers early in the project and really have big gains that are carried through the entire project.

(14:27):
There's other projects where our customers, maybe they're past the concept phase and they're deep into the design validation, and in those cases where retrofitting, so to speak, a design that was made for injection molding or machining, and we're adapting it for Additive Manufacturing, in those cases, we're able to work with our customers to optimize those designs, build the tolerance constraints, build the process controls internally, and adapt that legacy design to an Additive design without completely undermining the function of the design, and what we've found is that there's a lot of benefits that carry forward, even with that conversion to Additive, there's a lot of benefits that carry forward if the client moves on to traditional manufacturing because we're able to add a different perspective, add color to it, so to speak.

Brian (15:23):
For early stage development activities, new device starting from ground zero, you're in the concept phase, there's a ton of opportunity and flexibility to find ways where Additive support that future product, and then in a late stage scenario where you're closer to the launch phase of a product, the opportunities for Additive to support are a little bit smaller, but where it's really powerful is if you're faced with a challenge at that late phase where there's a feature or a constraint that's changed and you're trying to navigate that, where injection molding and other CNC machining processes, they can't react quick enough, and we can go in and we can be very iterative with our time to part, and we can also be very supportive in making sure that those iterations, we maximize your potential, and then we're also ensuring quality at the same time, so either we're prepping you for an injection mold part, or we're prepping you for a long term Additive part that either way we want to solve your problem today, whatever the long term solution is.

Carl (16:34):
No, that's really good, and as you say that, it makes me think about the benefits that the client receives from those initiatives, so if they're coming in on the get go of a project, on ground zero, Additive is able to contribute in both innovation advancement as well as timeline advancement, and if we're coming in at the late stage where they're in design validation, the innovation advancement opportunities are nil because you've gone so far through those development phases, but we can still accelerate the timeline, so that's really critical.

(17:11):
That results in incremental innovation, but if we're able to get it at the beginning, we're able to have, in some cases, transformational innovation, so what we're trying to do is drive awareness and education for Additive so that we can work with clients earlier in the design and the start of the design so that we can start supporting the transformational innovation, even if we're not supporting them, that the call is, the request is start thinking about Additive earlier in the process so that you can uncover some transformational innovation opportunities and everything else is going to cascade from there. You're going to have benefits in timeline, there's going to be financial benefits because you're going to be able to get to the market sooner with a better product, and it just cascades from there, so the earlier you can start, the better off you're going to be, but it's never too late.

Brian (18:05):
Either way, timeline is a big reduction. That's what we do at DI Labs, we reduce timelines, we shorten timelines, early stage, late stage in the product development, that's our focus.

Carl (18:15):
It is, and thinking about some of these, I'm going to transition the topic a little bit, spinoff, if you will, so I've got this totem pole here with us that has nothing to do with medical device, I'll just go out and admit it, but this was printed on one of our color printers. It's nylon, so it's strong, it's structural, and another area that we've seen some, what I'd call incremental innovation is leveraging full color 3D printing, or in some cases pad printing on parts and post-processing, but using full color 3D printing for enclosures that are going through the design validation in clinical trials, and you can think about it in terms of having a white housing that has maybe branding or a logo on it for the client's brand, and perhaps it even has some instructional visuals for the clinician or the doctor to be able to perform their activities.

(19:17):
What we've seen by adding those sorts of small details is it builds a ton of confidence with the clinician or the doctor because the device looks more final, it feels like it's a released product, and it gives a lot of confidence in executing that trial, and in a lot of cases, as we all know, part of it is the medical device, but the other part of it is the practitioner that's using it and making sure that we're able to deliver as much confidence as possible, allows them to put some of those potential confidence based risks on the back burner and really start to focus on the functionality of the device, and that has real impact. We've seen that that has real impact working with our clients and using full color 3D printing.

Brian (20:10):
The user experience, that first time that you have your hand on a new product, intuition usually tells us it's telling me what I need to know to operate it, or what the heck am I supposed to do with this, and having that full color component in there allows a layer deeper of user experience built into the product, that's variable too. We could test out 10 different. Do you think we can have some of these full color device covers available at MD&M that we can show our customers?

Carl (20:45):
We sure will. Of course, we will. At MD&M, we'll have some full color parts that have markings on them that would lend themselves to medical device applications. We'll have enclosures, we'll have assemblies, we'll have mechanical components. Of course, everyone that's in the medical device industry or even those that are in the product development industry full well that when you have someone manufacture a product of yours, you don't want that product shared, so we don't have client projects that we're able to share without, of course, that permission. Most of the clients that we're working with are still in the design validation clinical trial phases. The products haven't been launched yet, so we're not able to share those to protect confidentiality, but we will have components in our booth that show the benefits and features of Additive for some of those applications

(21:43):
Another area that we're leveraging Additive is for functional anatomical models. For example, in the cardiovascular applications, we're able to print a scan of a patient's heart as an anatomical model, and that allows the clinician to go in and perform the operation on that production of the heart so that they can get the lay of the land, they can install the valve in that case and be confident with it before they even open up the patient, so we're leveraging Additive Manufacturing for really all aspects of medical device innovation from concept through production, not just in the device itself, but also in augmentation to be able to produce things like anatomical models.

Brian (22:30):
That's a pretty nuanced solution that we provide. Thinking about hard, rigid plastics, we have in front of us, those anatomical models, we work with our clients to ensure that we've got the right material properties. We do test samples with them. We ensure that they're comfortable with the look and feel of those anatomical models as they're preparing for their trials, their test phases, so working with our clients closely, making sure we're meeting their requirements.

Carl (22:58):
That's a good point, and there can be a lot of effort that goes into a lot of work required in order to get into those sorts of applications there. What I've discovered is that there are different preferences that development groups have for the way that their anatomical models are produced, and everybody has a little different approach to tissue responsiveness and what they feel is appropriate, so working with our clients and really understanding what the need is so that we could reproduce those anatomical models with a tissue responsiveness that's important to them is important.

Brian (23:43):
We do it.

Carl (23:44):
We do it. We do it good, real good. We talked a little bit about the fact that Additive has evolved and we're able to achieve consistently high tolerance production, and that doesn't just happen out of the box, so that's something that we've learned quite a bit through our journey in manufacturing with Additive, and we've recently just onboarded some new equipment to help us collect another layer of data and be more predictive with our process control and ultimately tolerance management. What does that look like today for us?

Brian (24:24):
Our visual CMM allows us to do everything from a dimensional analysis to dimensional quality control on products that helps us at multiple stages in a product to make sure that we are delivering the quality that's expected, whether we're an early stage concept development, where we're helping our clients teams understand the tolerance requirements for Additive and make sure that we are producing it to their spec.

(24:57):
Or if we're dealing with late phase where it's really about trials and production batches. In effort to do trials, we can ensure that quality matches build after build, part after part, so that the lot of parts that they get are all functional and it meets their dimensional requirements, so with the CMM, we're collecting real-time data on our production, we're making sure that the specs meet the actuals, and then we're continuing to evolve our processes with the information that we're collecting there so that naturally the parts are going to get better, scrap rate is reduced, and ultimately what that does is that allows us to deliver in a really quickly time. If we are managing a high defect rate, we simply can't deliver in time because a three day lead time and a high quantity, it all has to be right.

Carl (25:59):
One of the questions that we often get, and this is really applicable to this conversation, is what are the standard tolerances for various printing technologies? I always answer that well, it depends and it does depend, but what we've discovered, especially with the CMM, is that those tolerances are so dependent on the specific geometries, of course, we can have standards that work for general applications, but when you really get down into the details, the tolerances are dependent based off of the particular geometries, so as I understand it, on critical projects, we're doing some pre-production analysis to understand what those variations or tolerances are for those particular parts, and then we're able to build predictive modeling to provide guidance to our clients on how to assess and incorporate those variations into their design so that the final product meets the requirements.

Brian (27:00):
It's giving us a leg up to have a decision before we're collecting data even, so let's drive some dimensional changes based on our historical data, and then we do a test model. We've already a step closer to having meeting all the requirements the clients ask us to meet, and then from there, the changes we make are pretty minimal. The work that we've done is our data that we've collected and we're not having to learn from scratch.

Carl (27:24):
Thanks for sharing that. One of the big misconceptions, there's many misconceptions about Additive Manufacturing, but if you were to believe everything you were to read and see in the promotional materials from the equipment providers, you'd think that the parts that come out of these machines are always the same every time, and they're always ready for production.

(27:44):
There are companies that operate their equipment with that understanding. They basically just put files in and parts come out, and that that's simply not the case. The technology has come a long way, 3D printing and Additive Manufacturing has come a long way, but it's not hands-off, it still requires a great deal of attention to detail, process control, in that closed loop that you were talking about that is absolutely critical to ensure that the parts that come out are consistent every time, and there is no doubt that that is underappreciated in the industry, and I'd say especially as those that are providing parts to customers, I'll call them service bureaus, and that's something that we had learned the hard way ourselves, but it's really important to understand, especially if you're a medical device developer.

Brian (28:34):
Quality has to be a core foundation, and it is for us, everything that we do is we think about optimizing our production line, putting in new environmental controls, the way we orient our equipment, the way that we structure our workflows, it's all around quality. We're checking quality every step, and we're managing our facility with quality mindset first.

Carl (29:00):
That would be, if someone were to say, what's your biggest suggestion or cautionary note for someone who's looking to get into Additive Manufacturing, leverage it for medical device innovation, I'd say the biggest thing is really make sure that you are conscientious of the realities of Additive Manufacturing and what's possible from a tolerance standpoint, and just know that because you're providing a 3D model to a parts provider, doesn't mean you're going to get that part with the standard tolerances. There may be some variation, and one thing that we've been doing working with our clients is really stressing the importance of prints and having critical to quality dimensions and quality aspects called out, because it doesn't just happen automatically, we've got to be intentional about it, so that intentionality is really critical as the adoption of Additive takes place, especially in medical device, and that scenario where we've learned the hard way and we've really pushed ourselves to push the technology forward to serve these critical applications, and it's been fun, but man, there's a lot to it.

Brian (30:15):
If you're going to MD&M West, February 7th and 9th, that's in Anaheim, California, I encourage you, if you're interested in some of these topics or you're feeling pain points in your product development or even your ongoing production, you're trying to make changes and you're interested in Additive, I'm not going to be at the show, but Carl's going to be at the show, so you should go and talk to him. He'll have his time wide open. Carl doesn't get much time where he can just have free conversation about really cool opportunities with products, talk through challenges that you're faced with. Carl is our mastermind and vision for how we accomplish things and would love to have you go talk to him and see if he has feedback to support your objectives.

Carl (31:05):
Thanks for that, Brian, so we're going to be distributing a digital calendar that allows you to sign up and schedule an appointment and allows us some time to talk about the application that you have, provide guidance, and just share with you our feedback and the opportunities that we see and helping you leverage Additive Manufacturing. Even if you don't work with us, the goal is to help advance the adoption of Additive Manufacturing, of course, we'd like to work with you, but we'll be there, and if you're not going to MD&M West, we'd love to be able to support you. We've built a really strong foundation and a deep set of capabilities to support these applications. It's an area that we're very passionate about and we take very seriously and we see a lot of opportunity to make significant impact and medical device development for the benefit for humanity. Not to get all philosophical, but it has real impact, and what you're doing as medical device developers is really important and has real impact, and Additive Manufacturing is an extraordinarily powerful tool to help you get there faster and better.

Brian (32:27):
We hope you'll join us at MD&M West, and if we don't see you there, reach out, we're here to help.

Carl (32:33):
Thanks for tuning in, and we'll see you soon.

Brian (32:35):
We'll see you soon.