Acetabular cup for a hip implant, designed with Within Medical software and made with EOS DMLS technology.
research in a comfort zone removed from what they would experience if they tried it alone. Tough significant design freedoms are available with AM,
constraints do still exist, just as there are with any other manu- facturing process. One of the main goals of the collaboration, is to establish IMDS as a ‘center of excellence,’ so that this re- sidual knowledge focused on design for additive manufactur- ing 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 develop-
ment path that we’ve already structured and fine-tuned for traditionally manufactured products. Starting with the ide- ation 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 intellec- tual 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 phas- es—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. Aſter that, all that’s leſt is validation. Te product is now put in the cus-
tomer’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 submit- tal. 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 partner-
ship for the medical industry? Siemer: When we began exploring AM, we felt that the
technology was trying to play catch-up with traditional manu- facturing. Now the available laser-sintering systems, materials, and soſtware 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 some- time 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 busi- ness. 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.