EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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emdt.co.uk European Medical Device Technology Spring 2015 | 23 Process Control and Product Release Process validation is a tool used within the medical device industry when it is not easy to fully verify through inspec- tion that product characteristics have been achieved. A medical device product specification includes process limits and controls that, when validated, mean that features such as mechanical integrity, fatigue, chemical degradation and sterility can be esti- mated with a high level of confidence. The single, custom-made nature of AM products—including subsequent cleaning, packaging and sterilisation process parameters—are such that it may be difficult to demonstrate that chang- ing the size and shape of an implant, for instance, will not drastically affect the degradation of the implant through fatigue or other means. Establishing standard methods of inspection and test systems, includ- ing the development of nondestructive technologies for AM products, should be considered. These methods will need to be internationally accepted within the global medtech industry. Summary Additive manufacturing and 3-D print- ing are generating a great deal of excite- ment in the medtech community for their potential to improve patient outcomes. However, it is imperative that these inno- vations are firmly supported by scientific knowledge and safety considerations. Consider the recommendations and discussion points presented in this article when commercialising your AM solution to ensure that you have the necessary sci- ence to corroborate your art. James Pink is the medical devices, vice president at NSF Health Sciences. New applications for additive manufactuiring in medical technology are developed at a breakneck speed. The concern is, however, that as we expand into the medical technology arena, we do so with more "risky" applications at a pace at which the science may not corroborate the art.

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