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Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
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Routine Improvement The medical device industry’s continual improvement starts with familiar processes and procedures wrought over time. After almost seven years of planning, writing and editing each edition of Medical Product Outsourcing, you would think that there wouldn’t be too many industry topics or themes that overly shock or surprise.Elements of any activity—no matter how creative or dynamic—are bound to become rote after regularly performing the same tasks. We get used to them. They become second nature. But that’s not necessarily a bad thing, is it? It could be argued that quality is found in the consistency and familiarity of a honed practice. But just when you think you’ve got it down pat, something will change. It always does. And maybe it has to. It forces you to get better personally and professionally. In the business world, it makes you more competitive. Adapt and improve or make way for someone else. Maybe the secret is in finding a balance between the two. Even the day in, day out of the magazine’s production process becomes routine—no matter how well you do it. Again, maybe that’s not surprising. We’re in the middle of a new production process requiring new software, procedures and training. Skeptical at first, I now realize—despite some minor growing pains—that the system is significantly improved. Our efficiency (not to mention our product) will improve because of it. We had to retool an existing procedure that worked and take a step back to take two steps forward. In putting together this issue of MPO, I had a bit of an aha moment. What weexperienced is a (forgive the word) routine part of life for medical device makers. It’s a balance of steady focus on quality, predictability and performance excellence, with the constant need (or maybe demand is a better word) for change and improvements— evolutionary, sometimes revolutionary. How companies manage the change is a big part of what we address with MPO’s coverage, in this issue in particular. For example, in this month’s extrusion feature, contributing writer Mark Crawford notes that, “OEMs and their customers’ clinical needs are driving demand for higher tubing performance in the field. In addition to strict dimensional requirements, more end-users want tubing that has increased performance criteria. Multiple-use devices also are being designed to last longer and perform more functions than ever before … Of course, medical device manufacturers want these innovative products to be engineered and produced during increasingly short timelines, which calls for the need to iterate tooling quickly.” Companies continue to push the limits of quality processes and tried-and-true manufacturing technology to create new and improved products. And as those limits are pushed, better manufacturing methods are discovered and the process begins again. It’s that tradition of manufacturing excellence and a history of innovation that has made the United States’ medical device industry the world’s leader, according to Chris Velis, chairman and CEO of MedCap Advisors in Cambridge, Mass. “We have the best minds and resources right here [in the United States],” he told me during a recent interview (catch excerpts from our chat on page 90). But those minds—even if left unfettered by the medical device tax—still are going to have to retool to compete successfully in a new global healthcare reality. “There’s absolutely no question that the number of patients on the planet is going to double and triple. There will be a huge need for medical devices, but a need for inexpensive and efficacious technology,” Velis said. “So we need to stop thinking about 90 percent-margin implants. We need to start thinking about three things: Does it save the hospital money? Does it prevent suffering? Does it save lives?” And as we prepare for our MPO Summit this June in Salt Lake City, Utah, the event’s theme of “helping medtech manufacturing move mountains” clearly is geared toward cultivating best practices and process improvement in the OEM-supplier compact. Industry professionals will share real-world, implementable tools and insight to help you perform your everyday tasks even better. We’ve organized such topics as Setting Strategy to Cultivate Win-Win Growth Partnerships; Risk Management, Supplier Controls and the OEM/Supplier Relationship; and Connected Health and Collaboration in the Value Chain: Beyond Traditional Models. Albert Einstein reportedly said, “Insanity is doing the same thing over and over and expecting different results.” Well, maybe in the case of medical device manufacturing (and in medtech publishing, it seems) doing the same thing over and over again in pursuit of improved outcomes won’t drive you insane, but it might make you a little crazy from time to time. Because, according to late writer and director Nora Ephron, “Insane people are always sure that they are fine. It is only the sane people who are willing to admit that they are crazy.” I’m fine. Aren’t you? Christopher Delporte Editorial Director
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