Advanced medical devices are playing an important role in diagnosis and treatment in clinical settings. However, it is extremely difficult for these devices, especially for high-risk therapeutic medical devices such as artificial organs, to be put into practical use from their developmental stage. This difficulty is mainly derived from immature systems and environments for smooth and seamless processing from research and development to clinical application and commercialization. There are various hazards and obstacles in this process including national character and public trends such as points-off system and medical bashing, negative company posture and refusal of materials supply against possible damages caused by PL and harmful rumors, insufficiency in human resources and investments for research and development, excessive reduction of national medical expenditure, immaturity of venture capitals for appropriate evaluation of investments, and regulatory affairs such as translational research, clinical trial and government approval. This paper describes the details of these problems, as well as countermeasures, based on the author's experiences in research and development, clinical application, and commercialization of advanced circulatory medical devices and artificial organs.

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The review process of medical devices in Japan has been claimed as "device lag" compared to foreign countries. It is improving based on the action program for accerelation of review process, which is composed of increase of the number of reviewers, classifying devices in three tracks, and introducing modular review etc. They would shorten the period of review. Recent review cases in surgical robot and artificial heart are also reported as practical information.

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The Pharmaceuticals and Medical Devices Agency (PMDA) has focused on the three areas for adverse health effects, reviews, and post-marketing safety measures, encompassing the entire life cycle of drugs and medical devices from development through post-marketing surveillance. Although regarding the review process of medical devices, the activity of PMDA has been well-known, regarding the post-marketing safety measures for medical devices, the activity has not. The post-marketing safety measure means taking measures for minimizing the risk of the adverse events in medical devices use. In this report, the author explains especially the post-marketing measure for medical devices, and it provides topics of interest for the development and modification of the new medical devices.

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This paper describes a method for going up and down stairs with a stroller. Japanese stroller makers are prohibiting that we lift the stroller. which a baby is riding on. But we often disregard the matter because it is inconvenient. And the accident that unexpectedly drops the stroller is occurring. Moreover, we must not put strollers to escalators. In this case, we should use the elevator. However, there are a lot of facilities in Japan without the elevator, or it is difficult to go to the elevator. Moreover, because the stroller is used only two years, it is no good policy that the installation of an expensive, electric mechanism on the stroller for going up and down in the stairs. In this research is developing the stroller that achieves safe going up and down stairs with an easy mechanism..

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A standing-style transfer system that enables a person with lower limb disability to perform activities of daily living without the need of special infrastructure has been developed. This system comprises three modules: a powered lower extremity orthosis, a pair of telescopic crutches, and a pair of mobile platforms. This paper proposes a novel transfer system, ABLE II, that was improved for better operability and stability when traveling. The electric shoulder-type telescopic crutch was replaced with a manual elbow-type crutch, which is lightweight. An ultrasonic motor, instead of the previously used DC motor, was used for steering the mobile platform. The ultrasonic motor enables the reduction of backlash when steering the new platform. A supporting plate and an active ankle joint attached to each mobile platform provide stability when traveling in the standing position. Experimental results have verified the effectiveness of the new system.

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Multifunctional home electric appliances enrich people's lives, but menu operation by remote control can be difficult, especially for the elderly, due to the devices' many functions. This paper presents an improved remote control unit for a popular DVD recorder. We focused on designing a menu structure that facilitates straightforward use of multiple functions. Using the Kawakita Jiro method and Latent Semantic Analysis (LSA), we constructed a mental model of elderly users which considers the flow of menu item selection. The menu structure was set on the basis of this model. A touchscreen interface was introduced to solve the problems of small buttons and the difficult-to-read letters printed thereon. We produced a prototype remote control that had a touchscreen display, and evaluated its usability for the elderly through a comparison with a commercial remote control.

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