Topic 1: Manufacturing site tour
On Day 4 of the seminar, we took a bus to go on a trip to a medical device factory and an affiliate training center for the actual use of those products, located near Mt. Fuji.
At the factory, after brief introduction of the company, we were led to the manufacturing lines of those devices like oxygenators, coronary/peripheral stents and balloon catheters, all of which were produced with state-of-the-art technology and sophisticated craftsmanship, and their qualities were comprehensively managed. It was a very good opportunity to recognize the high level of technology and quality of Japanese manufacturers.
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In the afternoon, we visited the training center for medical professionals. This center provides hands-on experience based on simulations of various scenarios in hospital or in home-care situations. The mock patients and simulators are very finely tuned to reproduce actual situations, and the feedback from doctors, nurses and medical engineers on their medical devices used on these scenes are actively reflected in their development of improved or next generation products. Such kind of supporting technology behind R&D is truly remarkable.
One setback, though, was that we could not enjoy the breathtaking view of snow-crested Mt. Fuji because of bad weather, however, participants from southern countries enjoyed the touch of snow.
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Comments from participant
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It's a good experience for me in my vocational training. On-site visits are really important practices for reviewers and inspectors to understand the whole picture of products. I appreciated PMDA to hold an international training seminar for foreign authorities to share the precious management experience. Ms. Szu-Yu Lee, FDA, Taiwan |
