Efective and quick discharge of residual fragments after minimal invasive stone procedures with “EPVL” modality: a new and promising approachTime of issue : 2021- 07-05
Residual stone fragments and/or gravel following extracor- poreal shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) constitute a real challenge to the endourolo- gists in clinical practice due to the high risk of stone re- growth, infection, obstruction as well as new stone forma- tion.
The first international medical device industrial park in Changsha Economic Development Zone startedTime of issue : 2020- 09-15
Changsha Evening News, September 10 (all-media reporter Wu Ling and intern Chen Zhangying) On the 10th, the biomedical industry in Changsha Economic Development Zone added new growth points, the first medical device professional park in the park-Haiping International Medical Device Industrial Park Project Work officially started. Vice Mayor Qiu Jixing attended.
Haiping International Medical Device Industrial Park project covers an area of 115 acres. It is a professional ecological medical device industrial park integrating R&D, production, technological achievement transfer, business incubation, transaction display, and industry exchanges. After the completion of the industrial park, more than 300 medical device companies and related supporting companies will be introduced to achieve an annual output value of more than 10 billion yuan, and strive to build a high-tech, high-output, high-tax medical device iconic professional park.
In August, Xiangzhiya International Hospital officially opened in Changsha Economic Development Zone, with a total construction area of more than 14,000 square meters. It was set up and constructed in accordance with the standards of a second-class hospital. At present, Changsha Economic Development Zone has introduced more than 70 well-known biopharmaceutical companies such as Zhongnan Yuanpin, Weizhi Medical, Sailong Pharmaceutical, Zhuoyu Technology, Pea Medical, and Sinopharm Group, most of which are involved in the medical device industry.
At present, the biomedical industry in Changsha Economic Development Zone has initially formed an industrial chain from raw material preparation to cutting-edge research and development, from mass production to market sales. The construction of Haiping International Medical Device Industrial Park provides a new carrier for the gathering of high-quality biomedicine projects and the cultivation and development of new biomedical industries. This also means that the biomedical industry is expected to become a new economic growth point for the park.
The development of brain science has entered a golden age, and the market for high-precision medical devices is hugeTime of issue : 2020- 09-15
The research of brain science is considered to be the last frontier of human science, and its business prospects are also considered to be a seriously underestimated field. In recent years, scientists and entrepreneurs around the world have made great efforts to explore and deploy in this field.
On August 29th, Elon Musk, the founder of SpaceX, Tesla and other companies, held a conference for his brain-computer interface company Neuralink, and announced the latest generation of brain-computer interface products: implantable brains. Chip, and a surgical device that can automatically implant chips.
Musk’s equipment can provide more cutting-edge technologies for alleviating human depression, addictive behaviors, helping to solve obsessive-compulsive disorder and treatment.
The China Brain Project (brain science and brain-like scientific research project) is also moving forward. Some Chinese companies and medical experts have entered a new stage of exploration in this field.
On August 25, CBN reporters exclusively interviewed Zhou Liangfu, director of neurosurgery at Huashan Hospital affiliated to Fudan University and academician of the Chinese Academy of Engineering, and president of Huashan Hospital at the “third annual meeting of the branch of neurosurgeons” held by the Shanghai Neurosurgery Association Mao Ying. The two experts discussed the current prospects for the development of brain science from the perspective of neurosurgery and medical device innovation.
Zhou Liangfu said that at present, my country’s equipment in the field of brain science is no different from abroad, and we have some of them. "Recently, the concept of digitalization has developed rapidly. It is used in CT and magnetic co-DSA. These are minimally invasive and non-invasive front-end treatments. From structural to functional diagnosis, it can greatly reduce the suffering of patients, but it has not been completely resolved. There is still room for improvement in the diagnosis and treatment of some neurosurgery diseases. The development of medical neurosurgery in the past 50 years has been greatly improved from the past, and the treatment effect has been better, but there is still room."
How will the neurology department develop in the next ten years? Zhou Liangfu believes that the development of brain science in the future is not only to be non-invasive and to be able to see clearly. Zhou Liangfu said, "Neurosurgery is a high-precision specialty, highly dependent on technological development, and it will continue to develop along this path in the future."
The era of integrated medicine is coming
The future of brain science should be understood with the concept of integrated medicine.
Zhou Liangfu believes that the future development direction of neurology must follow the concept of "integrated medicine". This concept has also been fully reflected in the diagnosis and treatment of new coronary pneumonia.
"The development trend of medicine must be more and more detailed, so that we can provide patients with high-quality and individualized diagnostic services. Unlike the past when a doctor sees the feet from the beginning, that model can only be done in the absence of medical development. , It doesn't work now." Zhou Liangfu told reporters.
However, integrated medicine does not advocate returning to general practitioners, but advocates the use of multidisciplinary consultations (MDT) to diagnose patients. Zhou Liangfu said that what integrated medicine requires is "patient" as the center, not just "disease" as the center.
For example, Zhou Liangfu thinks, “In the past, our multidisciplinary consultation (MDT) seldom paid attention to'people', and after the consultation, all the doctors left. Now our multidisciplinary consultation is mainly based on'people'. What diseases do patients get? How should we diagnose and treat him? We must pay attention to how to follow up. Family members, relatives and friends of the patient can also participate in the whole process and teach the patient our diagnosis and treatment plan. Then, what matters the patient will do in the future Feedback in time, which forms a whole."
So, how will drugs and devices work? "Devices and drugs will play a major role in the entire treatment process, but sometimes there will be side effects, but the human spirit always works." Zhou Liangfu said.
In this new coronary pneumonia treatment, the "one person, one policy" treatment plan implemented in Shanghai is the best embodiment of integrated medicine. Zhou Liangfu recognized this. Under the "One Person, One Policy" program, patients receive comprehensive medical services such as clinical diagnosis and treatment, nutritional supplements, spiritual comfort, and psychological counseling.
Create a medical innovation "Silicon Valley"
Medical device innovation is considered to be the first element of the development of brain science.
Mao Ying told reporters, "The innovation of neurosurgery in medical equipment i
How to obtain eight major commercial benefits in the medical device manufacturing industryTime of issue : 2020- 09-15
In the medical device manufacturing industry, eight major commercial benefits can be obtained by achieving transparency in product information management
The medical device manufacturing industry is undergoing a data evolution. Business leaders need to understand that mastering their data is critical to achieving leadership in a highly competitive market.
The pertinence and popularity of the digital supply chain are increasing. Manufacturers are building new processes to connect back-office with front-office systems, and even directly to the customer’s operations department. The industry is moving towards becoming more digital and data-intensive.
Building a digital supply chain requires collecting the raw materials that make up it: data
The medical device manufacturing industry faces three major challenges, among which data transparency helps: Under the increasing competitive pressure brought by low-cost alternatives, discover new ways to provide value to customers; and through regulation that keeps up with industry practices And coordinated development to ensure patient safety; invest in digital transformation, build a more cost-effective supply chain, and respond to changes in medical procurement and delivery models.
The road to business transparency starts with data transparency
You need to confidently act on key business data facts (such as product or customer data) throughout the enterprise, which requires data transparency. You can achieve data transparency by implementing business-led processes that manage the ability to collect, enrich, and share clearly defined, accurate, consistent, and up-to-date information inside and outside the enterprise.
Data transparency replaces ambiguity with actionable insight.
Although data transparency brings obvious business advantages, it is difficult to ensure that your product information is transparent. Separate organizations, applications, and technologies all manage their own truth. As a result, product information becomes fragmented. In addition, there is often no clear organization responsible for its structure, accuracy, continuity and provenance.
Unified Product Information Management (PIM) adopts eight methods that can help your business development
1. Improve patient safety
Obtaining clear and complete product information plays an important role in preventing adverse events related to information error handling. In the event of equipment failure, the regulatory agency requires that its agency be notified through a centralized reporting system in electronic format to ensure a timely and appropriate response.
PIM (Product Information Management) solutions can help by the following ways: Provide centralized, business-led control capabilities for the completeness, accuracy and availability of product information for adverse event management.
Behind the surge in medical equipment: core parts stuck, hidden crisis in international supply chainTime of issue : 2020- 09-15
The semi-annual reports of the A-share two cities have been announced, and the medical device industry has become the biggest winner.
Data show that affected by the epidemic, as of August 31, 3,972 A-share listed companies achieved total revenue of 23.52 trillion yuan, a year-on-year decrease of 2.65%; a total of 1.85 trillion yuan in net profit, a year-on-year decrease of 17.78%.
But in the case of the overall market decline, the medical device sector has skyrocketed against the trend. According to statistics, only 4 of the 71 medical device companies have suffered losses, and all the others have achieved profitability, and 26 companies have increased their net profit by more than 100%. The total revenue of the industry sector increased by 43.86% year-on-year, and the total net profit increased by 340.53 year-on-year. %.
But behind the rapid growth, there is a crisis in the international supply chain of medical devices.
Cai Tianzhi, deputy secretary-general of the China Chamber of Commerce for Import and Export of Medicines and Health Products, recently stated at the 2020 China Medical Device Industry Development Forum that certain core parts of my country’s medical device manufacturing still rely on imports. This epidemic has also exposed some Chinese medical devices. Weaknesses in the equipment supply chain.
Medical device industry becomes the biggest winner
According to the statistics of Zhongcheng Medical Devices Research Institute, from the perspective of quarterly performance, the growth of the medical device industry in the second quarter is still accelerating. In 2020, the total revenue of A-share medical device companies increased by 5.15% year-on-year in the first quarter and 43.86% year-on-year in the second quarter; total net profit increased by 120.02% year-on-year in the first quarter, and increased by 340.53% year-on-year in the second quarter.
As for the reasons for the growth in performance, many medical device companies all agreed that they were “affected by the epidemic”.
The outbreak of the new crown epidemic has turned medical device products such as masks, testing reagents, and ventilators that are not very present in daily life into the most sought-after "hard currency". As long as the concept of epidemic prevention is contaminated, the stock price can skyrocket.
According to Wind data, as of the close of September 3, the mask index has increased by 88.63% year-to-date. Among them, Intech Medical (300677.SZ), which is the leader in the increase, was only an unknown medical care product manufacturer before the epidemic, but in With the support of concepts such as masks and protective gloves, the total market value has now easily crossed the 30 billion threshold, with a year-to-date increase of 725.23%. In the first half of the year, Intech Medical achieved revenue of 4.45 billion yuan, an increase of 352.09% year-on-year, and realized a net profit of 1.921 billion yuan, an increase of 2611.87% year-on-year. The profit scale reached nearly three times the sum of the past seven years.
The increase in net profit is even more amazing than Incorporated Medical's Shengxiang Bio (688289.SH), which officially launched on the Sci-tech Innovation Board a week ago. In the first half of 2020, Shengxiang Biotechnology achieved revenue of 2.1 billion yuan, a year-on-year increase of 1159.39%; realized net profit of 1.232 billion yuan, becoming the "king of net profit growth rate" in the first half of the A-share market with an increase of 147 times.
Daan Gene (002030.SZ) and Oriental Bio (688298.SH), both of which are on the same in-vitro diagnostic (IVD) circuit with Shengxiang Bio, also increased their net profits in the first half of the year by more than 1,000%.
Mindray Medical (300760.SZ), which has the most complete product line in the industry, is still the "stronger Hengqiang", leading the medical device sector with 10.564 billion yuan in revenue and 3.454 billion yuan in net profit, and is the only half-year revenue in the industry Enterprises with a scale of over 10 billion.
The core parts are "jammed"
Riding on the east wind of the epidemic, my country's medical device industry has been advancing all the way in the first half of the year. The spread of overseas epidemics has caused the export volume of related epidemic prevention products to rise sharply. According to relevant customs data, as of July 14, my country’s total export volume of medical masks has reached 107.9 billion, 387 million sets of new coronavirus detection kits, 161,000 ventilators, and the export value of major epidemic prevention materials reached 288.79 billion yuan.
However, medical and health researcher Yang Li told Times Finance and Economics on September 3 that the domestic medical device industry as a whole is facing problems such as weak technology and homogenization of product competition. Coupled with the restrictions on technology transfer from the United States to China, the "stuck neck" pr
What materials are required for the filing of Class II medical devices?Time of issue : 2020- 09-15
Many people are unfamiliar with the filing of Class II medical devices, and they do not even know that the medical devices they produce belong to Class II medical devices. This article mainly introduces the materials and related content required for the filing of Class II medical devices. What are you waiting for? Come in and take a look!
What is the second-class medical device
Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-ultrasound, microscopes, biochemical analyzers, etc., all belong to the second category of medical equipment.
Article 30 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that for those engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the municipal people’s government at the districted level and submit it to the 29th Proof of the required conditions.
Article 29 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that: to engage in medical device business activities, there should be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and a Quality management organization or personnel.
Information required for the filing of Class II medical devices
The enterprise submits an application to the (food) and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located, fills in the "Medical Device Manufacturing Enterprise License (Opening) Application Form", and submits the following materials: 1. Basic information of the legal representative and the person in charge of the enterprise And qualification certificate; 2. The notice of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce; 3. The resume, academic qualification or title certificate of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and skilled workers, and Indicate the department and position; the proportion of senior, intermediate, and junior technical personnel; 4. The scope of the product to be produced, the variety and the introduction of related products; the production site certification document 5. The main production equipment and inspection equipment catalog; 6. The product to be produced The process flow chart of the company, and indicate the main control items and control points; 7. For the production of sterile medical devices, the production environment test report should be provided.
Class II medical device filing application process
1. If the application matters are not within the scope of the authority of the department in accordance with the law, the decision of disapproval shall be made immediately and the applicant shall be notified to apply to the relevant administrative agency; 2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot 3. If the application materials are incomplete or do not meet the requirements of the formal examination, a "Notice of Supplementary Materials" shall be issued to the applicant on the spot or within 5 working days, and the applicant shall be notified of all the contents that need to be supplemented and corrected at one time, if the notification is not given after the deadline , The application will be accepted as soon as the date of receipt of the application materials; 4. If the application materials are complete and meet the requirements of the formal examination, or the applicant submits all supplementary application materials as required, it will be accepted. 5. If the (food) and drug supervision and administration department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for the establishment of a medical device manufacturer, it shall issue a "Notice of Acceptance" or "Not Accepted" with the special seal of the department and the date indicated. Acceptance Notice". 6. After reviewing and complying with the regulations, a written decision shall be made to approve the issuance of the certificate, and the "Medical Device Manufacturing Enterprise License" shall be issued within 10 working days. If the requirements are not met after review, a written decision shall be made not to issue a certificate and the reasons shall be explained.
Precautions for the filing of Class II medical devices
1. For registered Class II and Class III medical devices, if the contents stated in the medical device registration certificate and its attachments change, the applicant shall apply to the original registr
The first "National Medical Device Safety Promotion Week" started in OctoberTime of issue : 2020- 09-15
(Reporter Man Xue) On September 11, the National Medical Products Administration issued a notice stating that the 2020 "National Medical Device Safety Awareness Week" (hereinafter referred to as Publicity Week) will be carried out nationwide from October 19 to 25. This is the first medical device safety publicity week organized by the State Food and Drug Administration. The theme of the event is "Safe use of equipment to protect health". It aims to promote the scientific supervision of medical devices, promote the high-quality development of the industry, and effectively ensure the safety of public use of equipment.
This publicity week event is sponsored by the State Food and Drug Administration, undertaken by China Health Media Group, and co-organized by the China Food and Drug Administration and the Food and Drug Inspection Center of the State Food and Drug Administration, the Drug Evaluation Center, the Medical Device Technology Review Center, and the News Center. And invite medical device related industry associations, societies, enterprises, and experts to participate. Local drug regulatory agencies will also carry out various forms of popular science publicity activities during the publicity week in light of the actual conditions of the region.
This publicity week focused on "promoting the main theme of reform and innovation and enhancing the new momentum of industrial development", and carried out publicity in four aspects. They are: publicizing the regulatory innovation work and regulatory policies in the field of medical devices in my country in recent years; launching various forms of publicity activities to fully demonstrate the vigorous development of my country's medical device industry under the promotion of policies; and helping the public to further understand medical treatment through scientific medical device related knowledge Equipment, prevent the risk of medical equipment use, and ensure the safety of equipment; focus on the innovative medical equipment approved in recent years, medical equipment for epidemic prevention and emergency approval, etc., to show important achievements in the field of medical equipment.
The State Food and Drug Administration also released the key activities plan for this publicity week. According to the plan, the launching ceremony of the promotion week will be held in Beijing on the morning of October 19. During the event, medical device innovation and development seminars, medical device online sales supervision seminars, national medical device manufacturers quality management standards online seminars, innovative medical device online cloud exhibitions, medical device safety science video competitions, and the first 16 activities including "National Medical Device Safety Network Knowledge Contest". (Full of snow)
Medical equipment is a double-edged sword, do you agree?Time of issue : 2020- 09-15
In recent years, medical devices have been widely used in disease prevention, diagnosis, treatment, monitoring or alleviation, helping medical workers to solve various disease problems. However, with the weak supervision of various departments, the occurrence of medical device adverse events has also increased. In order to ensure the safe and effective use of medical devices, reducing the continued occurrence of adverse events has become one of the focuses of medical institutions at this stage.
How to understand medical device adverse events?
Medical device adverse events mainly refer to various harmful events that cause or may cause harm to the human body during the normal use of qualified medical devices approved for marketing.
Why do you think medical devices are a double-edged sword?
As a modern science and technology, medical equipment is a double-edged sword in a sense. When performing normal functions, it can effectively help medical workers improve work efficiency and strengthen the treatment of patients; when malfunctions occur, they will cause great harm to patients and deepen the conflict between medical care and patients.
Therefore, the use of medical devices has certain risks.
So, how to minimize the risk?