High reliability is required for medical devices related to the maintenance of life. In development meetings held repeatedly, therefore, the members review and discuss structure/function, manufacturing method and maintenance of the medical devices over and over again. We try to develop and improve the required technologies to find higher reliability. In addition, we assume possible problems with products during use as much as possible. Finally, analyzing risk management from the initial stage of the development of a product, our team tries to take the safety of a product into careful consideration.
Various verification tests are carried out repeatedly regardless of whether an improved article or a new product in the trial manufacture stage. We will confirm the validity through testing from many aspects: does the device show adequate performance and function? Does the device have any safety or durability problems? Does the device have efficient original functions in any situation? Is there any influence on the patient’s other organs? These results and test data used in producing products with higher quality.
With the advance of clinical medicine, active technical innovation is necessary for the consistent research and development of medical devices. This should provide better reliability that is brought about by cooperative activities between clinical study sites and medical device manufacturers. While deeply understanding the situation described above, we actively address the development of therapeutic medical devices directly related to clinical sites, based on our abundant experience and performance, including past results such as the development of the first heart-lung machine in Japan.