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History of the occurrence and development of medical machinery service projects

• Life Style
• Josie
• Jun 15,2022
• 59

Internationally, the definition of hris software medical machinery CRO is less common, the vast majority of large and medium-sized pharmaceutical companies have medical machinery business department or niche industry elite team; relatively speaking CMO will be more, Johnson & Johnson, Medtronic and other big players are also authorized to commission a number of goods handed over to CMO companies to do. Medical machinery from the development to the sale of the market is a high-tech, high-risk, high capital investment and long-cycle complexity of engineering projects. Technically specialized third-party development services project organizations play a key role in the entire project lifecycle of medical machinery development and design. In the pharmaceutical CRO sales market is rapidly progressing and the project investment logic thoroughly tested by the sales market, the medical machinery CRO field is as well as very desirable.

Refers to the key under the wireless noise cancelling earbuds form of contract to accept the authorization entrusted to undertake the implementation of all or parts of the medical machinery sales process of product development and pharmaceutical science experiments of the third-party professional services organizations. Assisting medical device companies in applying for registration of their goods for sale is the purpose of CRO service programs. They are usually composed of professionals who understand the product development process and the laws and regulations related to registration applications, have standard service specifications, and have a collaborative network within a certain scope. Their advantages are specifically reflected in the relatively high degree of professionalism and sufficient diagnostic experience, which can assist medical device companies in product development to reduce capital investment, reduce cycle time, improve efficiency, reduce the risk of unsuccessful, accelerate the release approval process is more cumbersome, thereby improving the competitiveness of enterprises. For CRO companies, the mastery and judgment of the field standards, the accumulated network resources in the field (including upstream and downstream companies, authoritative experts and government relations) and its function of obtaining order information are the fundamental elements of the competitiveness of the company.

It refers to the medical device prototype third-party professional service organizations that accept authorized commissions in the form of contracts and give R&D and design solutions for processing process products and production and manufacturing operations. Their functions are specifically reflected in assisting medical device companies to improve quality control, reduce trial production cycle time, reduce processing costs and increase productivity. There are more CDMO service project organizations in China, but very few of them are able to go from product development all the way around to the whole process of manufacturing, with the key gathering in the trial production and post-sale manufacturing stages for small-scale taxpayers.

China's medical machinery CRO started its business with foreign enterprises. At that time, the total number of medical equipment enterprises in China is very small, many overseas companies and Chinese regional agents will be immediately imported medical machinery to carry out marketing and sales, and then developed into a factory in China. And this link, must be very familiar with the laws and regulations of mainland China and medical machinery audit rules and regulations, otherwise it will cost a lot of time period and assets. Most overseas companies do not know about this, which presents an opportunity for CROs to grow.

The approach of Chinese startups is usually to start with entrepreneurs + key technologies gradually, followed by financing, building processing plants, and expanding R&D departments. Because of the uniqueness of medical machinery. It can be very difficult for a company to stress a full, working R&D department (especially for small and medium-sized companies). Also, it is very easy to lose your way and the cycle time is very long. The company spends its assets and physical strength on running factories and reporting licenses, while the vast majority of processing plants have extremely low utilization rates, even less than 10%.