Driving Medical Innovation with Additive Manufacturing
Leaders at EOS and Innovative Medical Device Solutions discuss the state of the art and their new partnership.
By Michael C. Anderson
EOS (Munich) and Innovative Medical Device Solutions (IMDS; Fort Worth, TX) announced a partnership in 2012 combining EOS’ expertise in direct metal laser-sintering (DMLS) systems, software and materials with IMDS’ experience as a full-service contractor for medical product development and manufacturing. The stated objective is to offer resources for conceiving and launching metal medical devices made with additive manufacturing (AM).
IMDS Manager of Additive Manufacturing Michael Siemer and Andrew Snow, regional director of EOS of North America Inc., recently discussed the nature of the resources being offered and what current joint activities the two companies are pursuing.
What value does this partnership bring to companies developing medical products?
Michael Siemer: Before we partnered with EOS, there was no single source for OEMs to go to and find the complete expertise needed to bring an AM part from concept to clinic. The suppliers that were familiar with laser sintering lacked a deep understanding of the medical side of development, such as the approval process, the actual needs of end-users, and so on. Organizations like ours could design, certify, and manufacture products, but to offer the full advantage of laser sintering, they needed to know more about available materials and the range of geometries and features achievable. Our partnership with EOS satisfies both sides of the equation, combining EOS’ AM expertise with our sophistication at walking customers through the development and approval stages.
Andrew Snow: On our side, it’s about a triangle of knowledge consisting of our materials, machines, and—this is important—the process-build parameters of each part. As with every patient, every application is different, whether you’re working with an ankle implant, a toe implant, or a hip cup.
Often the most challenging aspect of presenting our technology to the marketplace is educating the OEM on how to incorporate it into a complete end-to-end process chain as part of a broader manufacturing cell. That’s where IMDS is invaluable to us. Their experience with medical product development includes the major medical companies, and it expands beyond that to well-known clinics and even to hospitals and surgeons. There’s a natural synergy between their capabilities and ours.
Are projects involving the creation of laser-sintered medical products underway now?
Siemer: Definitely, and in several different areas. One is an acetabular hip cup with porous structures to promote osseointegration, or bone growth. Conventionally it can be cast, or cast and machined, and then made porous through extra finishing. With laser sintering, we can build the cup and pores in a single step. We can make the pores gradient, so that the cup is solid in one place for maximum strength, and variably porous elsewhere for different bone growth. We’re talking with various companies about similar implants, such as tibial trays, and also spinal implants, extremities, and products for sports medicine.
Snow: Each global region is different and regulations vary. Currently, Europe is further along than the US in bringing these types of products to market; they’ve had a great many successes already. They’re implanting around 8000 porous metal cups annually in humans. Also, EOS has a separate certified dental process for the manufacturing of patient-specific copings and bridges. Even titanium abutments are being manufactured in Europe via laser sintering, for example.
What helps people see the advantages of developing products with your partnership?
Siemer: We identify and work with the kind of people who are early adopters of new technology, so they’re quite open to considering it. Once we begin talking to them about their potential product, they nearly all ask first: ‘Are the materials the same as their conventional counterparts?’ EOS and its suppliers have worked long and hard for more than a decade to produce equivalent materials. For medical applications, two of the common materials for DMLS are titanium—Ti64—and cobalt chrome, close analogs of metals that are already in widespread use and meet ASTM medical standards. The material we procure from EOS is certified. IMDS has run stainless steel in the past, and we’re using titanium now. Our DMLS system has the capability to run other metals as well.
Snow: Not only is the material we provide IMDS medically certified, we go beyond that, testing it thoroughly in-house on both new and legacy systems for maximum consistency and repeatability of performance, from build to build and from system to system.
Siemer: Often the next thing we hear is, ‘How much does it cost to build my existing part geometry in additive manufacturing?’ Part of our job is educating customers that instead of asking this, they really need to look closely at the design freedom laser sintering offers and take full advantage of it. Once they make that leap, they create new parts that have enhanced complex structures, such as micro-expanding or locking features, that offer new biomechanical advances. The more complex the part geometry—for instance, a latticework to reduce weight—the likelier it is that it’s best manufactured with AM.
Beyond being early adopters, what convinces companies to partner with you?
Snow: The opportunity for mass customization is generating a lot of excitement in medical design. By far, the biggest impact laser sintering has on medical products is that they can be cost-effectively patient-specific, with no extra cost for manufacturing a part with a production volume of one. Everything from cranial implants to surgical instrumentation—like cutting and drilling guides—can be tailored to both the patient’s and the surgeon’s needs.
As with all business decisions, adoption always comes down to return on investment [ROI]. If we can demonstrate to a company that the ROI on their product is there, and if we also can reduce their time to market, they’ll be very open to our technology.
Siemer: Often competition is a motivator for companies. If they’ve heard of a successful product made with AM, they feel they need to explore the technology just to keep up. Since our partnership offers them a means to be informed about laser sintering and to ‘try before they buy,’ they can do their research in a comfort zone removed from what they would experience if they tried it alone.
Though significant design freedoms are available with AM, constraints do still exist, just as there are with any other manufacturing process. One of the main goals of the collaboration, is to establish IMDS as a ‘center of excellence,’ so that this residual knowledge focused on design for additive manufacturing can permeate throughout the medical device community.
If someone were to come to you with an idea for a new product, how would you help to develop it?
Siemer: We’d follow essentially the same product development path that we’ve already structured and fine-tuned for traditionally manufactured products. Starting with the ideation phase, we’d investigate the product concept, the business case model, and project activation plans. Next, in the design and qualification phase, we’d systematically review and rank all the concepts jointly with the customer, deciding which are most viable—including comparing them to existing intellectual properties to confirm their uniqueness. Prototyping and evaluation is part of this step.
Now the design is locked in, and verification begins. We subject the design to risk analysis and whatever ISO or ASTM standards that the FDA requires. During these last two phases—and even towards the end of the ideation phase—design transfer begins. It’s a step-by-step progression that includes testing of prototypes and initial qualification—IQ—of the materials, the laser-sintering system and the process, and it continues through operational qualification—OQ. After that, all that’s left is validation. The product is now put in the customer’s hands to confirm that the initial inputs, requirements and so on, are all matched and met by the outputs designed into the product. Once that’s done, it’s time to launch.
Snow: IMDS contributes vast experience in taking medical products concept-to-completion for major medical OEMs, including critical elements of IP navigation and FDA submittal. EOS augments that expertise during the early R&D and prototyping and testing stages, where our deep knowledge of our own processes and materials can guide and accelerate the product development cycle.
What’s the future of this additive manufacturing partnership for the medical industry?
Siemer: When we began exploring AM, we felt that the technology was trying to play catch-up with traditional manufacturing. Now the available laser-sintering systems, materials, and software are indeed catching up—and for some types of production, pulling far ahead.
We expect to take our first DMLS-manufactured medical product completely through validation and verification sometime in 2013. At that point, medical design and, in many ways, even medical practice will transform.
Snow: It wasn’t that long ago that interest in our systems in the medical industry was probably about 15–20% of our business. Today it’s at 30%, on a par with aerospace for the greatest market share. From what we’ve observed, that demand will only continue to grow.
For more information, contact EOS of North America Inc. at info-US@eos.info and IMDS at email@example.com.
This article was first published in the 2013 edition of the Medical Manufacturing Yearbook.
Published Date : 12/11/2013