Stephanie Benoit November 24, 2016

This year, our office in Japan opened a brand-new medical 3D printing facility in order to provide our customers in Japan with localized service for patient-specific surgical guides and anatomical models for orthopaedic and cranio-maxillofacial surgeries. But what does it take to set up a new production facility for highly regulated 3d printing in medical devices? We talked to our colleagues at the Japan office to find out.

3D-printed bone model sample

Together with Hiroaki Ozaki, business development manager for the Japan office, Medical Production Manager Toshihiko Kawamura has been the main man of the project. The decision to open a production facility in Japan was motivated by the possibility of providing better service to local customers – instead of shipping printed parts from our headquarters in Belgium, production is localized and won’t have to travel such long distances. And by eliminating shipping distances, there is less exposure to obstacles that prolong the shipping time.
 

Blowing the remaining powder away
Blowing the remaining powder away

We already have a strong backbone of software services in place, so our Japan office was able to implement this workflow to start running the processes in the facility more quickly. The first step in setting up the facility was to find a location near our office in Yokohama. After deciding on a spot, the longest part of the process was getting approval from various institutions. This included getting approval to set up a medical device manufacturing facility from the Kanagawa Prefecture Governor, then installing and validating the equipment, getting audited for the ISO 13485 certificate, receiving PMDA approval and finally being audited by the customers on-site. Toshihiko also spent one month at our headquarters in Belgium to prepare the set-up of the facility and meeting everyone involved in the project.

It was a lot of hard work to get everything ready, but Toshi managed to get everything working smoothly on time. Once everything was up and running, tested and validated, we could start transferring Japanese medical cases to the local facility! Our software backbone was easy to implement in the workflow of the new facility, meaning we can now offer our Japanese partners and customers medical products with a high level of quality. Hopefully the facility will inspire local manufacturers to start implementing 3D Printing in their own production by relying on the Materialise software backbone for 3D Printing.

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