Talk of the promise of additive manufacturing and 3D printing often centers on aspects of cost, speed, advanced designs, clinical outcomes. With any technology used in our highly-regulated, patient-facing industry, quality—of the process, of the machine, of the finished product, of the knowledge overseeing the entire process—must be an important part of the conversation.
Device companies implementing or exploring the use of additive manufacturing must consider how quality applies to the technology. It’s a question that must be answered whether you’re utilizing additive in-house or outsourcing.
A panel comprising OEMs, suppliers and a surgeon—all at the forefront of additive—convened at OMTEC 2016 to discuss, among other things, the quality of the technology and the advancements that will make additive a widely-used manufacturing process in orthopaedics.
In the next five to ten years, additive manufacturing will be able to produce any orthopaedic part made through traditional manufacturing, machine suppliers said. OEMs were more cautious.
Here, we present an excerpt of the conversation. Our thought in presenting the transcript is that it allows you to better understand the technical and complex nature of the topic.
Andy Christensen, Additive Manufacturing Veteran
Andy Christensen, Additive Manufacturing Veteran: Let’s talk about tech. Quality is important, and everyone in this room knows how important it is to this industry. Thinking about in-process monitoring as a way to check another box and know something about quality, can you talk about how you see such tools being used moving forward?
Tim Van Cleynenbreugel, Ph.D., 3D Systems
Tim Van Cleynenbreugel, Ph.D., Director of Business Development, Healthcare, 3D Systems: In-process monitoring has a big advantage. Obviously it will not replace a thorough validation of your machine combination, but having thorough in-process monitoring gives a full documentation of what happens during a build.
If anything goes wrong, you will be aware of the problems and able to solve them. Tying that into a feedback loop where you do, for example, a melt pool control or melt pool analysis and then tie that back to changing or varying your laser power and laser speed, that can help get higher accuracy parts, a smoother surface. Whether that’s a necessity, I’m not sure, because we have shown that without it we’re consistently able to produce good parts that meet all of the requirements, but it will help to make the process even more stable.
Magnus René, CEO, Arcam
Magnus René, CEO, Arcam: Layer monitoring is underestimated. I think it’s fantastic. If you compare it to casting, which I think is a fair comparison; you will never know what is in the center of a casting, but here you have this new technology through which you can actually know, after the part is built, exactly what is inside the part. That brings ease of mind to the user or the manufacturer. It also reduces the need and the cost for validation after the part is built. If you know exactly what is inside the part; you don’t need to x-ray it or CT scan it or use dye penetrate. You can actually pass the part without validation, which will cut costs from the manufacturing.
Christensen: Can you touch on the burden of validation and inspection, and what this might mean for the future?
Mukesh Kumar, Ph.D., Zimmer Biomet
Mukesh Kumar, Ph.D., Director, Advanced Process Technology, Zimmer Biomet: I welcome in-process inspection. If you can see what is happening with your build while it is building, that is a great thing. The question I have for machine manufacturers—and everybody in the room—is, there is a huge amount of data that will be coming out and it will definitely have some blips that something went haywire…what do you do? How does one figure out, based on this information that is coming out is, whether this a good part or a bad part? Until we start answering those questions, just having this data doesn’t do much good for us. 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.