The pilot program for the registration system is expanding. How should medical device R&D innovation be approached?

Currently, China's medical device companies have relatively weak innovation capabilities. High-end products on the market are more often seen from multinational corporations. Compared to these large companies, our companies, doctors, and scientists are still somewhat lacking in innovation capabilities, and product research and registration are more difficult for them. I think an important reason for this result is the difference in innovative thinking.

In the product development process, the first step is functional research and development. Next, it needs to undergo tests of compliance, reliability, usability, and mass production.

First is compliance

There are more than 1600 national and industry standards for medical devicesOften, innovative products, after adding compliance requirements, cannot meet functionality. This is because companies only consider functionality during innovative research and development, not compliance. Even worse, some don't even know how many standards are related to their products, only discovering the problem during product registration and inspection.

Second is reliability

Most imported products are more expensive than domestic products, but doctors are willing to use imported products, a large reason being reliability. Some domestic products often havesymptoms of "catching a cold," and when they "catch a cold," they won't turn on. However, imported products from large companies don't seem to catch colds as often, which reflects reliability. Will the functionality of our domestic products be affected after adding reliability requirements?

Third is usability

Simply put, it's whether it's convenient for doctors to use. Don't think this is just the icing on the cake; if a product is inconvenient for doctors to use, it's very easy to cause accidents, meaning that poor usability directly leads to safety problems. How much functionality remains after meeting usability requirements?

Finally, there's mass production. Is the product the same whether you make one or one thousand, one kilogram or one ton? Design determines the process, and the process determines the consistency of mass production; therefore, this is actually an issue that needs to be considered from the design stage. After achieving mass production, is the product functionality still there?

It should be noted that the requirements for functionality, compliance, reliability, usability, and mass production are essentially parallel in the research and development process and are used as design inputs simultaneously. With so many inputs, being able to complete the functional output and implementation makes the problem much more difficult. This is why innovation is not easy.

Therefore, many blind innovations, orpseudo-innovations, are created this way. In fact, the engineering tests, animal experiments, clinical trials, and GMP required by the drug administration during registration are all outputs of the previous five steps of research and development. Many innovators and entrepreneurs in the product development process often only consider the first step, functionality, without considering the remaining steps, resulting in a large number of problems during registration, making the product registration process exceptionally difficult.

In addition, medical device products face applications for pricing, medical insurance, and Bidding after they are launched. During use, they also face constant inspections by the drug administration, and even product disposal needs to be considered by the company. This is a fully regulated industry; if the previous research and development process is not done well, problems will erupt in subsequent processes, greatly increasing the research and development and maintenance costs of the company.

Therefore, when we innovate, we mustmaintain an engineering mindsetOnly innovation under an engineering mindset is true innovation. Only this kind of innovation has low investment risk, high research and development returns, and truly stands the test of the market. Otherwise, it will only waste the innovator's time and money, and worse, hurt the heart of innovation.