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Case study

Case 1- Good results from clinical trials on new medical devices contributed to advantageous M&A.
A U.S. artificial vein graft manufacturer and a guide wire manufacturer both applied for product approval under MIC support based on an In-Country Caretaker contract. Since both of products were novel, clinical trials were required for approvals in Japan. MIC took charges of whole steps including clinical trials and the regulatory application and successfully obtained approvals. Then both companies were acquired by a major manufacturer, and these approvals in Japan at that time, contributed significantly to higher value of each company.

Case 2- New medical device approval without a clinical trial
Medical devices using new technology usually require clinical trials for approval. However, in a product for our client, MIC using its know-how and strategic plan gained from the past experience, was able to obtain approval only with submitting animal test data and human simulation data using a phantom (human model).

Case 3- Smooth entry into medical industry from other areas
Because of conceptual differences in the system, such as safety consideration, it is extremely difficult to enter into the medical industry from others. By providing consultation for all legal steps including support for licenses, GMP and the Pharmaceutical Affairs Law, MIC was able to assist the company from totally different industry to enter into medical industry by helping smooth application of technology to medical area.