BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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75 BONEZONE • December 2016 Superior Finish Superior Biocompatibility finding a better way... Rosler Metal Finishing USA is the leader in mass finishing, shot blasting, automated processes and media - made in the USA. Visit www.rosler.us or call 269-441-3000 for more information. Rosler is the global leader in supplying superior finishing equipment for the medical supplies industry. Our system solutions provide precise, repeatable processes to meet the strict requirements of the orthopedic implant industry. Rosler's line of Wet Blast Machines are ideal for finishing medical instruments and orthopedic implants. Having issues with your finishing process? Send us your parts and we'll help you find a better process. There has to be guidance or validation of this sensor system that helps us makes this decision. Just the data doesn't do anything. René: Absolutely. You need to validate the validation tools. Kumar: Exactly. P. James Burn, MB, CH.B, FRACS, ortho- paedic surgeon: Magnus, if you were to grow a rod of material at the same time as you are building the parts and then you have a layer issue, would it not come out in the rod, which is going to be a test part that you could analyze? René: Not necessarily, because you could have an issue at a certain position of the build chamber which wouldn't hit the rod, but would hit the part. You would find it with the layer inspection. What I was going to add is that you can see not only the discrepancies in the melting process, but you can actually see discrepancies in the material. You have an opportunity to look with XPS (x-ray photoelectron spectroscopy) to see exactly what kind of material is melted and at each point, and you can actually track not only how the material is melted, but also what the material is. Christensen: I'm assuming as we move forward that you'll see more areas encroaching on higher fatigue sensitivity. Ear- lier, [Naomi Murray of Stryker] touched on in-process moni- toring, and that being a key part of convincing folks [about higher fatigue applications]. What else is there? Is it design driven, is it bulk material driven that's holding us back from moving more quickly into fatigue-sensitive areas? René: It's more of a perceived risk than a real risk. We have technologies today that are used for making high fatigue parts for airplanes, so why wouldn't it work for hip stems? There are already high fatigue parts like hip stems made today. Van Cleynenbreugel: With the high purity machines now available on the market, the bulk mechanical properties of the material are not a concern. Obviously, in order to get good fatigue strength you need smooth surfaces, and that might conflict with a desire to have an orthopaedic implant that has a rough surface for tissue adhesion and bone ingrowth. I imagine that we will move in the direction, where you need high fatigue strength you would do machining or polishing to bring down that surface roughness and maximize the fatigue strength. Kumar: I have asked surgeons what it would take for us to convince them that we can start doing fatigue prone implants. They always ask: Is it as strong as what I use today? Can you MANUFACTURING

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