EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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Converting a Patient Image to a Solid 3-D Printed Model In order to successfully convert a patient image to a 3-D printed model, software is required to ensure that there are no specific conflicts within the image and to convert the images into a solid model that can be processed by the multiaxis printer. For reconstruction of a patient image for printing purposes, the manufacturer will have to demonstrate that the software has accurately converted the image data into the solid model. It will also have to con- firm that the printer software has rendered and processed the coordinates to lay-up the material in a reliable and reproducible manner. The Sunday Times recently reported that a team at St. Thomas Hospital, Lon- don had successfully 3-D printed a model of a heart from a toddler suffering from a hole in her circulatory system. The moti- vating factor behind printing the model was the small size of the anatomy coupled with the need for surgeons to determine the optimal technique for placing gauze to effectively repair the defect, thus reduc- ing the risk of complication during sur- gery. The 3-D model ultimately enabled the surgical planning team to effectively rehearse the operation and iron out any specific issues or concerns before theatre. This story is a wonderful example of the benefits of additive manufacturing and its potential to improve patient care. But from a product safety perspective, it is important that we challenge whether the software is technically robust enough to reliably and repeatedly produce these models if this technique is to be used in intricate surgery routinely and via com- mercially available solutions. Consider the possibility of a less favourable out- come in the future, for example, in which the surgeon is being sued due to patient injury or death because the AM heart he or she preoperatively planned was not adequately representative of the patient's heart in vivo. In regulatory terms, the software requires validation. The complexity of the validation increases the more accurate and precise the model needs to be. Stake- holders in AM therefore need to ensure that there are consistent expectations for the validation of this type of software. Furthermore, professionals involved in commercialising these technologies need to ensure that guidance and acceptance criteria are defined in this area. Materials The term medical-grade material has been used for several decades; however, we understand that the concept of biocom- patibility is more important than medical grade. For instance, although the 3-D printing material may be identified as medical grade, the finished component, EPflex Feinwerktechnik GmbH · 72581 Dettingen/Erms · Germany Im Schwoellbogen 24 · Phone +49 (0) 71 23 / 97 84-0 Fax +49 (0) 71 23 / 97 84-22 · E-Mail: info @ epflex.com www.epflex.com Nitinol baskets Dispenser Special Guide wires Guide wires Tipless baskets Hypotubes MRI Guide wires for medical applications We create flexible solutions See us at MEDTEC Europe Stand #7D04 Iftest AG | Schwimmbadstrasse 43 | CH-5430 Wettingen Tel +41 56 437 37 37 | Fax +41 56 437 37 50 | www.iftest.ch | info@iftest.ch Your partner for + electronic development + printed circuit board design + prototypes & industrialisation / NPI + electronic production MEDTEC Europe | 21. – 23. April 2015 Stuttgart | hall 3, Swiss Pavilion See us at MEDTEC Europe Stand #3F14

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