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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76 BONEZONE • December 2016 vouch for that? Until we achieve that level of just-as-good raw material and fatigue, most surgeons will shy away from it. Christensen: Talking about verification versus validation and how companies have approached that for things like cleaning residual powder or cleaning residual materials, it would seem to be much like the counterparts in traditional machining and manufacturing. But we brought up CT scanning earlier. What are your thoughts on verification versus validation for 3D printing of metals? Kumar: From the legacy Biomet side, we have a lot of experi- ence machining a highly porous structure and then cleaning it. What we have learned from that, we've applied to 3D-printed parts. I think there is a solution depending on, like Naomi said, what you're trying to do, what is your porous structure, what is your cleaning material. You have to understand that, and then there is work toward cleaning. René: We as machine manufactures need to do a better job when it comes to characterization of the machines. We have machines that are very complex, where the outcome depends not only on the machine and how the machine is set up, but also the way that you orient the parts. For the industry to develop methods to characterize the machines, I think that is going to be important moving forward, because that will make it easier for our customers to set up jobs and also vali- date the jobs. Van Cleynenbreugel: When we start volume manufac- turing projects with our customer, whenever we install a new machine or a new material, we always do a thorough validation of the combination of the specific machine, the material and scan parameters so that it is validated to make sure that the bulk material properties that come out of the machine meet the requirements. Once we work on a specific project, we log the whole process flow starting from the manufacturing but also the annealing step, post machining steps, cleaning steps and so on. That is validated as a whole on the specific product, and that is typically done in very close collaboration with the customer. René: Exactly. That is how it is done today. I'm talking about making this more generic, because today it really is the char- acterization part of validation. Christensen: Insourcing versus outsourcing, how are you seeing OEM clients use the machines? Van Cleynenbreugel: Typically what we see is customers that are new to the technology prefer to start with outsourcing the production. That helps them understand the technology and the capabilities and also maybe to some extent optimize spe- cific product. Then once they gain experience and the volume justifies it then they can obviously in source the technology and start producing in-house. René: There is also another view that this is a highly strategic technology a highly strategic project because it is a new tech- nology, and because of that we see a lot of companies insourc- ing from the beginning. They want to control their product. Also remember that since they all more or less are putting products on the market that have trabecular structure, for example, they are redesigning their products and want to be close to the technology. But we see what you say as well, and what we particularly see is that we see customers jumping in and out of sourcing. They could outsource some parts, insource some parts. Kumar: We have capabilities in house and we have partnered with companies who provide the service. When looking for entities that can provide the service, the most important thing we look for is their knowledge base, because we absolutely believe that things can go horribly wrong. While it is easy to buy a machine, what you are doing with this machine is very critical. If there is a knowledge base, I feel more confident. MANUFACTURING Question from the Audience: What steps are the manufacturers taking to advance the support material removal process? You have a day or two of post-processing to remove support material and then finish with electro polishing, for example. Kumar: The way that we have been trying to solve that problem is through a series of design experiments. There are ready- made support structures available, but is that something you really need, and do you have to build it with those parameters? The question you have to answer is, What are you trying to solve? You are trying to solve a process where your part is going to lift off. If you have the time, you can do design experiments and figure out parameters that will hold down your parts. That is my best solution for you, right now. 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 vouch for that? Until we can achieve that level of just-as-good raw material and fatigue, most surgeons will shy away from it.

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