EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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22 | Spring 2015 European Medical Device Technology emdt.co.uk manufacturing its packaging and the sterility method employed are all a function of its chemi- cal and mechanical characteristics when it interacts with a human. This can change dramatically by the mere nature of the duration, type and intended purpose for which the finished product will interact with the patient. Evidence from aerospace studies has already identified that the properties of 3-D printed materials are different than those properties found in materials processed via extrusion, mould- ing, casting and other conventional form- ing technologies. The slight variations in those properties can affect mechanical integrity, chemical integrity and the bio- compatibility of the medical part. Manufacturers also need to understand the effects of printing different forms and features with different materials and their binding agents, in addition to the ramification on the properties of those materials. Equally important are the less known properties—physical and surface chemistry, for instance—and how they affect biological processes. Manufacturers must gain assurance that the surfaces are still performing in a biocompatible way as intended—whether inert or bioactive, for example. Standards are well established for implant-grade materials; however, the powders and joining methods are not substantially equivalent to metals in cast and wrought forms, for example. Fur- ther scientific review and research is thus required to suitably gain confidence as to what the limits are for printed implanta- ble-grade materials. Specific Product Validation Requirements Cleanliness, sterility and packaging pro- cesses are all considered special processes that require a specific, internationally accepted series of studies to demonstrate that the product will be free from con- taminants and unintended organisms and that it can withstand storage and transportation factors. The processes are a function of the shape, manufacturing process and environmental conditions of the product as well as the design of the cleaning, sterilisation and packaging processes. Ultimately, the individualised nature of additive manufacturing products may have significant effects on maintaining validated process parameters. Conse- quently, during the design, you may find that the validation methods are vastly different from those of routinely manu- factured products. Guidance and standardisation are required for product validation activities associated with additive manufacturing, and the industry needs to collaborate in order to establish this guidance or adopt industry norms. What is clear, however, is that current standards, guidances and practices do not address the custom nature of these products. Therefore, any considered "safe scientific approach" will need to take into account the individual variables associated with AM products. Of course, doing so may require some intricate science, intricate parametric modeling and simulation—or, frankly speaking, a much larger and varied sam- pling rationale when validating products. Some people think there's an art to stripping wire with a razor blade. At Resonetics, we prefer to treat it as a science. Copyright © 2015 Resonetics. All rights reserved. Whether you need to remove 100% of a polymer coating to expose metal or only want to remove one layer of a multi-layered coating, Resonetics has the solution. Using laser workstations equipped with our patented ASSURE End Point Detection™ technology, we can compensate for changes in coating thick- nesses and concentricity to produce consistent results, in reel-to-cut or reel-to-reel formats. We mastered the science of polymer removal and combined it with reel-to-reel processing, improving yields and lowering costs so you can automate your downstream manufacturing SURFHVVHVVDIHO\DQGHIÀFLHQWO\ Learn more at www.resonetics.com/assure or call 603.886.6772. IDEAL WIRE Symmetric layers of uniform thickness REAL-LIFE WIRE With non-uniform layers REAL-LIFE WIRE Stripped by an open-loop laser ablation REAL-LIFE WIRE Stripped using our patented closed-loop end-point detection method

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