Registration and Inspection of Medical Devices
under the New Regulations

To innovate medical device products, we should pay attention to inspection methods and research. Why? Because for many innovative medical devices, there is no standards to follow, and the inspection methods are uncertain or absent, it is necessary to do research on inspection methods and inspection methodologies while innovating medical devices. For personalized and customized products, I can't use this product for destructive inspection, which will destroy the product. Correct inspection should pay more attention to our product quality control in the middle stage of the processing process. Also, we may pay more attention to rapid inspection methods as it is impossible for us to use some slow inspection methods, which require to wait for the inspection results before we release them, so we need to do some online inspection and rapid inspection methods.

Global planning and layout of clinical trials and leadership in science
for medical device companies with China joining the ICH

If you want to join ICH, this is a better opportunity, and also there are many challenges at the same time. Only when you go abroad can you become stronger and become a better enterprise. Second, the international layout of clinical trials comes with overall layout and individual layout, that is to say, this layout should follow many principles, for example, what is the clinical path, and achieving scientific top-level design, so that medical devices can successfully cope with the market. Third, the layout of scientific leadership for core products should be carried out simultaneously, because this is a very high and wide moat. If you have a good layout of this moat, it will be very fast to improve the products and global leadership of the company, especially such a very core and very effective one.

Transcatheter Technologies for Structural Heart：
Repair or Replacement？

Should mitral valve be replaced or repaired? Five years ago, it must have been a replacement, but now there are many people who are optimistic about repair. This is a dynamic situation. Today, five years later, is a different situation, depending on what direction the next equipment research and development is. If we answer the question on tricuspid valve, should it be replaced or repaired? This is even harder to answer. The answer may intend to be repair, just a little. It may not be such a situation in five years, but at least now I personally think it is such a situation. To sum up, to
repair or replace, we need to judge whether it is aortic valve or mitral/tricuspid valve. Replacement is the mainstream in terms of aortic valve, and repair accounts for a large proportion in term of mitral valve, but we must never forget the importance of TMVR in replacement of mitral valve. After all, not all patients are suitable for clip surgery.

Innovation in clinical trials and neurointerventional devices

I think nerve intervention can account for one fifth of the future nerve intervention now. We must find out where the next potential point is and who will explore this point? Clinicians shoulder a great mission. When we explore this point, I think the business community has invested more in all aspects. Of course, how can you innovate? Subversive innovation - doctors should participate in subversive innovation-is the point that you find, and then firmly do clinical trials towards while making subversive product research and development, which is the real subversive innovation. I don't mean that this will work. I just tell you, as clinicians, what are our thoughts on medical device innovation? What we have to do is to expand the scope of our industry.