Centralized procurement in the pharmaceutical market has become the focus of attention recently. So far, a total of 218 drugs have been centrally purchased in 5 rounds, and it is expected that the collection scope will cover all drugs including proprietary Chinese medicines and biopharmaceuticals within two years. Collection of medical consumables followed. There are also many people who are concerned about whether medical devices will keep up in the future.
At the beginning of this year, China's "Administrative Measures for the Clinical Use of Medical Devices" was officially introduced, as an expert said "blue ocean in the blue ocean", how should the clinical use of medical devices be scientifically evaluated? On Friday, at the "Innovative Medical Device Evaluation Forum" hosted by the Shanghai Health and Health Development Research Center, experts discussed this issue.
China's medical device market grew at an average annual rate of 5%, ranking fourth in the world
In the past 20 years, China's medical device market has shown great growth, and the average annual growth rate has remained at about 5%. He Da, deputy director of the Health Technology Evaluation and Research Department of shanghai Health and Health Development Research Center, introduced: Looking at the global market share, China accounts for 5% of the global market share, and is the fourth medical device supplier after the United States, the European Union and Japan.
"The medical device market is a blue ocean in the blue ocean, and China has become one of the main producers and consumers of medical devices in the world." Jin Chunlin, director of the Shanghai Municipal Health and Health Development Research Center, commented. At present, there are 18,000 domestic medical device manufacturers, but there are nearly 600,000 operating enterprises, and the gap between production and operating enterprises can be seen, and there are still large shortcomings in the original innovation field.
As a specialist device application, scientific evaluation is essential. What is a medical device evaluation? Xiao Yue, director of the Medical Equipment Consumables Evaluation Research Office of the National Center for Comprehensive Evaluation of Drugs and Health Technology, made an image analogy. A public hospital already has 6 CT, and I want to match another one, is there a need for this CT in the end? A hospital introduced a da Vinci robot, in the end can be used in all departments, or is it open to gynecology and urology first? "Such a detailed issue involves the evaluation of medical devices, covering access, service efficiency, specific operations, and even device safety, effectiveness, how to manage, etc." Experts added, "As an emerging thing, in recent years, China has gradually paid more attention to the consideration of patient value and social value for the evaluation of medical devices. ”
Not only innovation, safe and effective economy is also an evaluation of the "one ruler"
At the beginning of this year, the Interpretation of the Measures for the Administration of clinical use of medical devices issued by the National Health and Health Commission can be seen: medical institutions and medical personnel, as the first responsible person, should follow the principle of "safety, effectiveness and economy" in the clinical use of medical devices, and ultimately achieve the purpose of rational use.
Compared with the traditional drug evaluation that is already quite familiar in the industry, medical device evaluation has different properties. Xiao Yue explained that traditional drugs have a long life cycle, but the medical device life cycle is short, the update iteration speed is fast, and there are many intergenerational products. Therefore, the evaluation of medical devices must look at the needs from the perspective of full life cycle management. From start-up to development to decline, any technology has to go through these three stages, and the same is true for device evaluation.
Experts take the Da Vinci robot as an example to carry out the specific operation of the evaluation. An analysis of da Vinci's costs and expenses shows that the results are interesting: robotic surgery is certainly more expensive than traditional laparoscopic surgery, with an average cost of 2.1-2.9 times the latter. The analysis of thousands of medical data found that for every day of hospitalization reduced by the robot group, the total cost of 15,000 yuan was increased (of which 13,000 yuan was self-funded). This means that although robots can improve medical efficiency, they have higher out-of-pocket costs. Such data-based assessments can serve as a reference for decision makers.
Yang Haili, director of the Human Resources Department of the Sixth Municipal Hospital, pointed out that many import companies have "tested the waters" in China, especially emphasizing innovative products, but in fact, the evaluation of innovative medical devices in the United States pays more attention to the role of treatment and diagnosis, and whether medical needs are fully met. He said that when Emphasizing Patents and Independent Intellectual Property Rights, China should also pay special attention to whether there are significant clinical differences in safety and effectiveness.
The assessment involves multiple dimensions, and government hospital enterprises should strengthen the concept
Medical device evaluation is based on evidence-based medical evidence, said Chen Yingyao, deputy dean of the School of Public Health at Fudan University, that evaluation involves multiple dimensions, such as clinical technology research, economics, doctor growth curve, and even the life cycle of medical devices.
In foreign countries, medical device evaluation is based on clinical research data, and then evaluated through comprehensive economics. Unfortunately, many medical devices in China have not yet had relevant clinical evidence. For example, how much blood is lost during surgery after the instrument is applied? How much is the difference from the doctor's estimate? Is blood loss too high or too low compared to the past? "The clinical evidence is insufficient, and the quality of the evidence and even the quality of the assessment are also affected." Experts say. In addition, the learning growth curve of doctors mastering technology also affects the application effect. Chen Yingyao said that the technical focus of doctors in tertiary hospitals and primary hospitals is different. In the team of doctors, the support of technicians is different... These will make a difference in the practical application of medical devices and should also be reflected in the evaluation.
When scientifically evaluating medical devices and leveraging their technical strengths, use limited resources on the cutting edge. He Da believes that this requires the joint efforts of many parties in society. At present, many medical institutions are still reluctant to invest in full-time personnel for the establishment of independent evaluation agencies, and their concepts will change over time. In addition, at present, many technical assessment reports are implemented by enterprises or third-party institutions, and the quality needs to be improved, and the talent team should also be enriched.
Experts also suggest that when innovative medical devices are "fledgling", it is really difficult to come up with clinical evidence, what to do? The practice that can be used as a reference is to be supported by government scientific research projects or talent projects, and at the same time through collective pricing, so that the cost of innovation will not be passed on to medical insurance or patients, and the sustainable and benign development of the medical device industry can be ensured.
Column Editor-in-Chief: Gu Yong Text Editor: Gu Yong Title Image Source: Figure Worm Picture Editor: Su Wei
Source: Author: Gu Yong