Some clinical trials are difficult to do, "rely on personal relationships

Tube serviceIn order to ensure the safety and effectiveness of products, clinical trials are required for the registration of Class 2 and Class 3 medical devices. The interviewed companies reported that some clinical trial institutions lack enthusiasm, and clinical trials are time-consuming and labor-intensive, which makes some companies reluctant to develop new products. A medical device The person in charge of the company said that the company has conducted clinical trials on several new products, and several 3A hospitals were reluctant to accept them. Although the state has issued relevant policies to encourage medical institutions to carry out clinical trials, most of them are in principle and rigid and positive. Incentives are not enough. Therefore, some hospitals believe that clinical trials are to contribute to the enterprise and have little to do with their own development. At the same time, they are afraid of medical accidents. The mentality of doing more is worse than doing less has made medical institutions have no incentive to conduct clinical trials with enterprises. Sometimes you have to rely on personal friends to ask the hospital to do it." The clinical trial requirements are strict, and some tube services take several years to complete.

Guo Yijun and Xie Yufeng believe that when some mature products are being upgraded, or technologies that have already undergone clinical trials in other countries are introduced, a clear clinical exemption system should be formulated to simplify the clinical trials and speed up the application of products. Xie Yufeng introduced that in the past Some of the X-ray machines produced by the company do not need to be clinically tested. These products of tube services have fallen behind and need to be replaced. Now it is required to conduct clinical trials. In one or two years, the cost of clinical trials of millions of yuan has discouraged the company. Power to launch new models.