Dr. Xu Ning: How far is the medical robot from the laboratory to the market?

On October 28th, the “Pre-Conference” of the 2016 World Medical Robot Conference organized by ROBO Medical Robot Research Institute was opened at the Shenzhen Convention and Exhibition Center. At the meeting, Dr. Xu Ning, a senior consultant from the ROBO Institute and with 27 years of experience in Chinese and foreign medical device products, brought us the theme entitled “The practice of medical equipment from R&D to production”.

Before the official speech, Xu Ning first made the following opening remarks:

"For many years in the industry, I have seen too many medical device projects. That is to say, the medical surgical robot we are talking about today is very limited from the laboratory to the clinic, and even less is going to the market. Medical robots have to be tested. There is a long way to go to the market and there are so many things to consider. Today I will share my views on this aspect from an industrial perspective."

In the following sharing process, Xu Ning mainly focused on the following four aspects:

Basic steps in the development of medical device products

Xu Ning said that the current mainstream development process for medical device robots at home and abroad is basically similar. From research and development, production to marketing, the overall can be divided into the following sections:

1. Concept evaluation of innovative research

2. Experimental or experimental prototype of preliminary research conclusions

3. Clinical research, marketing permit

4. Production

5. Listing

6. After sales service

Evaluation points for medical device products

Xu Ning gave very high priority to the review and evaluation of medical device products.

He said:

“The first thing we need to do is to ensure the composition of the assessment team. This includes not only software and hardware and system integration R&D personnel, marketing staff and production representatives, but also experts on laws and regulations, certification permits, and the use of patent applications. ."

Xu Ning said that most medical devices are now based on the improvement and re-creation of existing products. The industry has rarely seen any truly innovative results from 0 to 1. Under this circumstance, before actually starting to research and develop and produce products, it is necessary to analyze the domestic and foreign markets in more detail, conduct multiple research on core technologies and patents, ensure the use of patents and production licenses, etc. Nothing is lost.

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