Introducing medical device for easy and early detection of diabetes!

Shinichi Yoshimura

Shinichi Yoshimura designs and produces liquid crystal panels, printed board inspection equipment, and so on. His product, plantar sensory evaluation apparatus, will enter into the medical device field by applying inspection equipment technology for liquid crystal panel which enables easy and early detection of diabetes. He is planning to obtain approval as improved medical device(*) for his product and enter into the market by spring 2014.

At OIH, I would like to get in touch with people from different fields in all directions to talk about our dreams. New networks through our conversation lead us to make the best of our characteristics to realize our dreams, I would like to create that kind of bond in this place.

From inspiration to development

It all started when Dr. Ino of AIST and I visited Prof.Luo at Kobe University five years ago, that I decided to develop plantar sensory evaluation apparatus. During the conversation on ankle impedance measuring device developed in research collaboration with Prof. Luo, I heard that Dr. Ino had been conducting research on tactile sense for hand at university. I knew by intuition that digitization combining sole sensibility and impedance by applying that technology, will be useful for fall prevention. Immediately within three weeks, I developed the system and the software, and I quickly decided to attend an exhibition “MEDIX Osaka”, as I heard it would be held at INTEX Osaka.
As a result, the product received high evaluation and was given subsidy by Osaka prefecture. That exhibition showed market’s reaction and gave me confidence in productization, and I continued to attend various exhibitions from then on. With further assistance by subsidiary of Osaka City towards practical use of prototype, it is now on track for manufacturing and distribution permission and medical device approval for productization.

Difficulties in gaining approval to introduce medical devices

How to finance the development funds, that is the most difficult part. This is a common problem for small and medium-sized enterprises, or rather, for small companies.
Apart from funding, the trouble with entering into the field of medical device is that it takes much time to actually start to sell the products. Unlike selling industrial machines, it does not always work just by creating improved products, in case of medical device.
Therefore, in the beginning, as I knew nothing about medical device and basic knowledge as how to enter into the market, I started this project from zero taking tottering steps, with the introduction and great help of people from Osaka Bio Headquarters. I gradually realized that it would actually take at least half a year to one year, or three to four years at the longest to complete applications for business and pharmaceutical license, however there were more necessary procedures. In my plan, I had three years for productization and was going to start selling products in the fourth year with official approval, but in reality, it was the fifth year that I finally reached the stage of clinical trial and pharmaceutical application.

Dream to the world from Japan

The first step is to make contribution to avoid further aggravation of diabetes symptoms by selling plantar sensory evaluation apparatus to domestic hospitals and medical facilities after obtaining the official approval as “improved medical devices”. With that achievement, I hope to prevent disease progression of 23.7million diabetes patients and people at risk and to stop the increase in the number of patients, by selling the system as personal health management device to 55 million domestic households. Currently there are 360 million diabetes patients in the world. The number is expected to reach over 500 million in 2030. My dream is to sell the system worldwide eventually and reduce the number of diabetes patients.

※Medical devices which are not equivalent to the existing devices and without obvious novelty such as structure, usage, effect, result and performance.
Approval categories include “new medical device”, “improved medical device”, and “generic medical device”.

(December 2013)