EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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manufacturing 20 | Spring 2015 European Medical Device Technology emdt.co.uk manufacturing Risks of Additive Manufacturing: A Product Safety Perspective Additive manufacturing offers myriad benefits for the medical device industry. But there are still certain risks and unknowns associated with the burgeoning technology. C urrently a $4-billion market primed to grow to $20 billion within the next decade, additive manufacturing (AM) for medical device applications is a rapidly growing field that is unlikely to slow down any time soon. That's because it's enabling manufacturers to produce complex medical devices and components from poly- meric, metallic and other exotic materials more cost-effectively and quickly than with many traditional processes. Applications within "commercial capability" now include patient-specific orthopaedic instrumentation; maxilla- facial, cranial and dental implants; and preoperative planning and simulation aids that entail reconstruction of patient regional anatomy from CT and MRI scans. And an increasing number of inves- tors, academia, healthcare providers and manufacturers are continuing to develop new applications and prototypes for the technology at a breakneck speed. The concern is, however, that as we expand into the medical technology arena, we do so with more "risky" appli- cations at a pace at which the science may not corroborate the art. In addition to the fact that these products are custom-made and therefore not easy to regulate under current worldwide regulatory frame- works, there are very real product safety risks that need to be taken into account. The Benef ts of AM From a design perspective, opportuni- ties in additive manufacturing are often centered on the customisable aspects of product design for individualised patient anatomy. This is generally achieved through the combination of imaging, establishing CAD models and postpro- cessing software to interact with a printer that will undertake the final 3-D print- ing of the product. Evidence is emerging that further benefits are derived from the actual joining technologies associated with AM; early evidence from the aero- space industry supports the possibility of beneficial mechanical properties of AM components in certain materials. From a manufacturing perspective, AM is considered a "clean" process, with opportunities for almost silent, contained, highly environmentally con- trolled manufacturing. In the medical technology area, contact materials used during the manufacture of product and the complexities caused by costly and environmentally unfriendly detergents are a specific area in which AM could present a solution. The Risks of AM In 2015, there is very little independent scientific and technical data available to corroborate technical safety in regards to additive manufacturing. Even when data is available, safety and performance requires standards, validation science and accurate test methods. However, there is a distinct lack of international collabora- tion within the medical technology realm on that front. These facts present a clear problem for companies wishing to commercialise AM medical products when moving into higher-risk categories of devices. In light of this issue, the technical community needs to address how it can underpin AM in medtech with the necessary science. Positive steps are being made to do so, however, led primarily by industry and FDA. In October 2014, FDA held a work- shop specifically discussing the appli- cation of AM to medical technology products and generated a list of specific areas where AM products require regula- tory science answers.

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