Ohara: From the viewpoint of project management, I was confused by the fact that "business as usual" would not get along. Nikon has been mastering the microscopy technology and quality for more than 100 years, but this expertise is not always applicable to medical devices. Therefore, we unraveled the quantitative evaluation items required for medical devices one by one, examined the process, and advanced development having discussions with the staff. We will keep up the world-class Nikon quality.
Watanabe: I was in charge of working on the product concept of the ECLIPSE Ui, including its user benefits, interestingness, and use cases. In particular, we were at a loss to see if the ECLIPSE Ui functionality conforms to the intended use of the medical device. That is to say, the intended use that we manufacturers must clearly specify.
Suzuki: Being in charge of mechanical design, I felt the high level of difficulty unique to medical equipment. For instance, in order to shorten downtime in the event of a failure, a good entire configuration allows the unit to be smoothly replaced. The system is fully motorized, yet compact in a box-shaped housing. There were many other points to overcome.
Iwama: ECLIPSE Ui uses a space-saving electrical system. It integrates CPU and FPGA devices that operate typical Windows computers, as well as multiple electrical modules, on a single board. I was in charge of developing the board and the electrical hardware design required for its integration. This computer-assisted system is regarded as a device with monitor. This concept raises the hurdle of the safety standard test criteria. It was very difficult to take measures and optimize the entire design. Thanks to the cooperation with the external certification test center for long periods of time, we could give it shape.
Murai: In the software development that I was in charge of, it was difficult to formulate the development process for medical devices and to reach a conclusion at its initial stage. It was also hard to determine the life cycle of the product. This was the first time for the Healthcare Division to adopt a remote-controlled cloud system. It was indeed a new challenge, and we made a lot of effort studying the operation method and feasibility. The embedded software is also a long-awaited new development. Many things were first for me. The project turned out to be worthwhile.
