Compressor industry review after the mask ventilators are snapped up globally, relevant technical information has been made public
The ventilator is a vital medical device that can prevent and treat respiratory failure, reduce complications, and save and prolong the lives of patients. Facing the increasing number of patients with new coronary pneumonia, many countries are facing a shortage of ventilators. Many governments are calling on major companies to help purchase or produce ventilators. It is reported that Medtronic has released the drawings of the ventilator. So, after getting the drawings, will you switch to production? Today we will talk about the ventilator:
01. The invention and principle of the ventilator
In modern clinical medicine, the ventilator, as an effective means to artificially replace the autonomous ventilation function, has been commonly used in various causes of respiratory failure, anesthesia breathing management during major operations, respiratory support treatment and emergency recovery. It occupies a very important position in the field of modern medicine. The concept of the ventilator was first proposed by the British scientist John Mayow in 1670, but it was pioneered by the Americans Philip Drinker and Louis Agassiz Shaw. It was made into a commercial product in 1928, namely "iron lung".
The ventilator is used for mechanically assisted ventilation to help patients breathe normally. When the patient's respiratory function is abnormal, the ventilator uses pressurized air (power source is mainly oil-free air compressor or gas storage tank) to imitate the human breathing rate and send gases with different oxygen content (21%-100%) into the lungs It also conducts gas exchange regularly to help patients improve the state of hypoxia and carbon dioxide retention. Medical ventilators are Class III medical devices, and conventional household ventilators are Class II medical devices. Invasive ventilator is mainly used to treat unconscious patients with severe respiratory failure, and non-invasive ventilator is aimed at high-risk patients with respiratory failure who are breathing consciousness. The key chip technology barrier is high, which determines the clinical use effect of the ventilator.
The reason why the ventilator is a high-end device is that it needs a global supply chain to support its production. The key components are all first-class players in the industrial circle (such as SMC, Honeywell), and the major producers have Good inheritance. Most of the team members of these companies have good experiences. For example, the founder of ResMed, Peter Farrell, has a PhD in chemical engineering and biological engineering from the University of Washington in Seattle and a PhD in science from the University of New South Wales. Before founding ResMed, he served as the Vice President of Research and Development at Baxter Healthcare in Japan and established the Baxter Medical Research Center in Sydney.
In addition, the ventilator needs the support of interdisciplinary knowledge, and is a product that integrates machinery, structure, air circuit, control, software, and algorithm. Especially for the control of breathing mode algorithms, it is necessary to achieve 5ML gas precision tidal volume control on emergency ventilator under the condition of controllable cost. If you look at it, ResMed has more than 5000 patents.
02, global ventilator manufacturer
Major foreign manufacturers include: GE Healthcare, Dr?ger, Philips, ResMed, Medtronic, Hamilton, Hamilton, Sweden Getinge (Getinge), Germany Law Weistein (L?wenstein Medical).
In the 1990s, ventilators began to enter China. According to company search data and data from the National Medical Products Administration, there are only 31 domestic companies that have ventilator registration certificates, and 22 of them include "import and export." It accounts for more than 70%, and the more famous ones include Beijing Yi'an, Shenzhen Mindray, and Suzhou Yuyue Medical.
03. What is the difficulty in producing a ventilator?
After the epidemic broke out, a large number of companies in Europe and the United States have joined the "cross-border" production of ventilators. However, the production of ventilators, masks and hand sanitizers is different, and there are higher technical barriers:
1. There are many parts demand. In the case of masks, two main raw materials, non-woven gauze and lava cloth, are mainly required. A ventilator has thousands of parts and components from all over the world. The ventilator is developed in Europe, manufactured in China, and supplied globally. For example, a ventilator product is designed in Germany, assembly and production are in China, and the intermediate parts are purchased globally. For machines that are used for 20,000 to 30,000 hours, stable hardware and durability are particularly important. Among the key components, the turbofan may be produced in Germany or Switzerland (such as the Swiss micronel), and the sensors may come from Switzerland or the United States. Honeywell, for example, the miniature proportional valve may come from Germany or Japan (such as SMC), and the software may also come from India.
2. Long certification cycle. Forehead thermometers belong to the second category of medical devices, and ventilators belong to the third category of medical devices. The classification of the second and third categories represents the level of danger, and the third category is the highest level of medical devices. The registration time is generally one and a half years, and some clinical trials take longer.
In addition, exporting to foreign countries must obtain the exporting country's license: the United States needs the US Food and Drug Administration (FDA, Food and Drug Administration) certification, the export to the EU requires a free sale certificate or CE mark, and the export to Japan requires PMDA registration. The rules of each country are slightly different. So at present, the only companies that have opportunities are those that have been deeply involved in this field, and those who enter the market across industries have little chance (unless special approval is obtained in the local area).
Even in extraordinary times, countries have opened green channels for approval. However, "cross-border" production of medical equipment is not that simple. It may take up to 40 days to produce a ventilator. Assembling the ventilator also requires well-trained staff. Complex processes, certifications, and the complexity of the industrial chain all limit the increase in the production capacity of ventilators.
04, Medtronic ventilator drawings released
According to foreign media reports, Medtronic has already released the technical information of the ventilator, which is an opportunity for other people who want to engage in ventilator production, but it is still not easy for unfamiliar companies to enter. Production line and system establishment, product clinical and registration It takes a lot of time. It is recommended that this is more suitable for companies with similar products to produce.
Ford said on March 30 that its Ford plant in Ypsilanti, Michigan, will start production of ventilators from the week of April 20. The goal is to produce 50,000 units within 100 days, and then 30,000 units per month. station. General Motors released photos of its plant in Kokomo, Indiana on March 29, showing that the company has begun production of ventilators. General Motors stated that its current goal is to produce 10,000 ventilators per month by the summer. This production plan only guarantees costs and does not seek profit.
In addition to the aforementioned Tesla, Ford, and General Motors, there are a total of more than 12 multinational automobile manufacturers in the United States, which have begun preparations and production of ventilator equipment.
British Cabinet Secretary Gove also said on Tuesday that the British manufacturing giants have formed an alliance, and many companies, including Rolls Royce and Dyson, will quickly launch ventilators and put them into mass production.
The Israeli missile production line was changed to produce ventilators. Earlier, the Israeli Ministry of Defense stated that there are only 2,000 ventilators in the country. To make up for the shortage of medical equipment, the missile production line has been modified to produce ventilators. In addition, it also stated that Israel Aviation Industry Corporation has cooperated with a medical equipment manufacturer to further expand the production of ventilators, and has already delivered 30 ventilators to the Israeli Ministry of Health.
Can non-professional manufacturers stop cross-border production, can it alleviate the current global shortage of ventilators? The person in charge of Yuyue is not very optimistic: "You cannot place hope on non-professional manufacturers. "
The first is the time limit. The treatment of patients with new coronary pneumonia races against the clock. "But ventilators are high-end medical devices, and non-professional manufacturers cross-border production. They will face restrictions on production line transformation, supply chain guarantees, personnel training, and authoritative certification. Only. The transformation of the production line may take a week, and the personnel training will also take 1 to 2 months."
In addition to the time limit of the production link, the R&D cycle is the most critical speed limit link. The person in charge of Yuyue said, “The development cycle of the ventilator is at least 10 months, ranging from filter cotton to air duct design. Any hardware change will have an impact on the flow, and the software will need to be adjusted for a long time. As an example, our product software in the past four or five years has been updated to the 8th generation."
07. How about China's production capacity?
Xu Kemin, Director of the Department of Industrial Policy and Regulations of the Ministry of Industry and Information Technology, said at a press conference held on the morning of March 30, 2020: Fully promoting the resumption of work and production of medical equipment companies has always been our top priority in ensuring supply for the epidemic. The ventilator is the most critical medical equipment for the treatment of patients with new coronary pneumonia. Since the outbreak of the epidemic, my country's major ventilator manufacturers have resumed production for the first time. For example, on the second day of the Lunar New Year's Day, Shenzhen Mindray urgently called back technical backbones who went home on a fake day to resume work and production. We organized multi-location industry and information departments to quickly realize the resumption of work and production of 794 of its 853 upstream national supporting suppliers under the premise of preventing and controlling the epidemic, promptly helping companies solve problems such as shortage of parts and poor logistics and transportation. As of March 29, major ventilator companies have supplied more than 27,000 ventilators across the country, including more than 3,000 invasive ventilators. Although there was some strenuous situation in the process, overall, it effectively guaranteed the needs of my country's epidemic prevention and control, especially to win the defense war in Hubei and Wuhan.
Recently, the epidemic has spread rapidly around the world, and the demand for medical equipment in foreign countries has increased sharply, especially the demand for invasive ventilators. At present, there are 21 invasive ventilator manufacturers in my country, of which 8 main products (with a weekly production capacity of about 2,200 units) have obtained the EU mandatory CE certification, accounting for about one-fifth of the global production capacity. At present, about 20,000 units have been signed, and at the same time, there are a large number of international intention orders being negotiated every day. According to incomplete statistics, in just ten days since March 19, while ensuring domestic demand, it has urgently provided more than 1,700 invasive ventilators abroad, which has reached half of the total domestic supply since this year. It can be said that our company has been working non-stop and working overtime to prevent and control the global epidemic. As far as I know, most companies work in three shifts, producing non-stop, and even some R&D personnel are sent to the production line.
There are thousands of parts and components for a ventilator. The main parts suppliers are not only domestic, but also some abroad, including Europe. Under the influence of the epidemic, it is not easy to increase production on a large scale, and it is also unrealistic to meet all needs. In order to continue to provide timely assistance within our capacity to relevant countries, on March 29, we held a video conference on the collaborative expansion of the key medical equipment industry chain, and organized key domestic invasive ventilator enterprises and local relevant departments to find out the problems faced by enterprises And difficulties, we will study the coordinated expansion measures of the industrial chain. At the same time, we also require companies to strictly control quality and strengthen safe production.
