Global Respirator "Big Fight": Medtronic Open Source, Tesla Crossover

The outbreak of the new crown outbreak in the world, medical supplies and equipment supply war from mask, protective clothing to "ventilator, kit."

On April 4th, Drew Cuomo, Andrew, M., New York, said at a regular epidemic conference that 1000 ventilators donated by Cai Chongxin and Ma Yun to New York will arrive at New York J.F.Kennedy.Apt Airport on April 4th, local time, in April 4th, April 4th.

New York is one of the most serious areas in the United States. Como has said that New York needs thirty thousand ventilators in the rush hour. In April 2nd, Como said that according to the time use and patient condition, New York had only 6 days of ventilator reserve. The state government ordered 17000 ventilators urgently, but because of insufficient capacity of manufacturers, it was unable to deliver, compared with the 10000 reserves of the federal government of the United States.

With the spread of the epidemic, a steady stream of demand has prompted the world's traditional ventilator manufacturers to operate at full capacity, and on the other hand, the relevant production line companies have "crossed".

In March 30th, Medtronic, a medical device giant, released its ventilation design specification for its ventilator, calling it "improving global respirator output". In April 6th, Tesla official released a video of making ventilator with auto parts. Its Engineering Department explained how to turn existing parts into respirators and meet demand without consuming medical material resources.

After responding to the domestic epidemic, domestic ventilator manufacturers' medical orders and MINDRAY medical orders received global orders for ventilator have been discharged until June and July. However, the supply of raw materials still restricts the difficulty of increasing production capacity. In addition, raw materials are also faced with links such as production line transformation, technical barriers, supply chain, approval and so on. Dongxing securities estimated that zero crossing cross-border enterprises may take 18 months to achieve mass production.

? ? In April 5th, at the press conference held by the joint defense and joint control mechanism of the State Council, Jin Hai, director general of the comprehensive business division of the General Administration of customs, showed that from March 1st to April 4th, the total value of the main export control materials was 10 billion 200 million yuan, including 3 billion 860 million masks, 7 billion 720 million yuan, 37 million 520 thousand protective clothing, 910 million yuan value, 2 million 410 thousand infrared thermometers, and 3.3 worth. Billion yuan; respirator 16 thousand, worth 310 million yuan; new coronavirus detection reagent 2 million 840 thousand cases, goggles 8 million 410 thousand pairs.

Productivity difficulties

Treatment of severe new crown virus infection has severe dependence and demand on ventilators. Patients with severe respiratory diseases (such as new crown virus) need to be supported by ventilator to maintain effective respiratory function. After the patient is connected to the ventilator, the machine will be responsible for oxygen supply and simulate the respiration of the human body, so that the lungs can be rested and gradually restored to normal function.

At the news conference held by the joint defense and joint control mechanism of the State Council in March 30th, Xu Kemin, director of the Ministry of industry and information technology, said that since the outbreak of the outbreak, the main production enterprises of our ventilators have resumed production for the first time. "Many land and credit departments soon realized 794 upstream and downstream businesses in 853 upstream ancillary businesses and resumed production in a timely manner to help enterprises solve problems such as shortage of parts and shortages of logistics and transportation. As of March 29th, the main ventilator enterprises have supplied more than 2.7 ventilator units to the whole country, including more than 3000 ventilator units.

There is a huge demand for invasive ventilators abroad. At present, there are 21 breathing machine manufacturers in our country, of which 8 of the main products (about 2200 units per week) have obtained the EU compulsory CE certification, accounting for about 1/5 of global capacity. At present, a total of about 20 thousand units have been signed. At the same time, there are still a large number of international orders to be discussed every day. According to incomplete statistics, more than 1700 invasive ventilators have been provided to foreign countries within ten days since March 19th, which has reached half of the total domestic supply this year.

The number of confirmed global diagnoses has increased the gap of ventilators, but it is not easy to meet demand in a short time.

Ventilator is mainly divided into several categories according to the application scenarios and the use of patients, including severe and sub critical care ventilator, neonatal ventilator, transhipment and emergency breathing machine, home ventilator and so on. Li Xinsheng, general manager of MINDRAY medical life information and support division, said in an interview with the twenty-first Century economic report, "the annual output of home respirators exceeds 5 million units, and it will be easier to pull up production capacity. But the severe and subacute respirators are about 100 thousand units a year in the world, and now there are hundreds of thousands or even millions of demands. It is not very realistic to rapidly increase production capacity in a short time.

Xu Kemin pointed out that "a ventilator has thousands of spare parts, and the main parts suppliers are not only domestic, but also abroad, including Europe. It is not easy to think of large-scale increase in production under the impact of the epidemic, and it is unrealistic to satisfy all needs. "

"The world's better ventilator manufacturers are in Germany, the United States and Switzerland." An industry insider told the twenty-first Century economic report that there are many parts involved in breathing machines. "Air compression module, for example, is a very special component purchased from abroad. A large part of the capacity constraint is the limited capacity of compressed air turbines. Even with alternative compression modules, the core components of the turbine module, high-speed motors, need to be imported from Switzerland. Without high-speed motor, turbine is not good. Moreover, suppliers of parts and components need to accumulate for decades to polish good components, which contain many technical know-how. So it is very difficult to pull up production capacity in a short time, whether domestic or foreign manufacturers are subject to this restriction.

In April 1st, Yue Yue medical bulletin announced that it received the emergency use authorization (EUA) issued by the US Food and Drug Administration FDA for its noninvasive ventilator, which is used for emergency use in the medical environment for treating patients during the COVID-19 pandemic. If the fish hopes to sell the product in the US market after the termination of the emergency, it is necessary to complete the corresponding FDA registration work in progress.

Fish jump said that at present, a large number of overseas orders for ventilators have been received. Due to the complexity of the ventilator technology and the stringent quality control requirements, the upstream supplier's capacity will take some time to climb. The queuing situation of ventilator orders is expected to continue. "At present, the climbing of the ventilator capacity is mainly controlled by the supply of raw materials, and the daily output has a certain fluctuation. Capacity increase is limited, pre accumulation orders are still being digested, and the specific impact of the approved FDA EUA on performance depends on the actual business situation. "

Cross-border difficulties

In March 30th, the Medtronic Inc announced that its PB 560 ventilator design document should be published for assessing the feasibility of accelerating the manufacture of ventilators in various industries. The ventilator was launched in 2010 and sold in 35 countries and regions worldwide. Its product service manuals, design documents, manufacturing documents and circuit diagrams are now published on Medtronic global official website. Medtronic will provide the respirator's software code and other information later.

This is an open source behavior announced by Medtronic in March 18th when it announced that it would double its capacity and supply of ventilators. Medtronic told the twenty-first Century economic report that "the idea of open design and intellectual property is simple: we build together."

"Medtronic understands that the current demand for ventilators is far beyond supply," said Bob White, executive vice president of Medtronic and President of minimally invasive treatment business group. "No company can single handedly meet the needs of the global healthcare system. But all manufacturers are working with global governments, hospitals and health organizations to increase the productivity of ventilators. By publicly sharing the design of the PB 560 ventilator, we hope to increase the production of ventilators worldwide, so as to resist the new crown pneumonia.

At the same time, Medtronic also said that the manufacture of ventilators is a complex process, which depends on highly skilled staff teams, global supply chains, and experienced clinical training teams. In order to ensure patient safety, ventilator manufacturing also needs to comply with regulatory requirements all over the world.

Although Medtronic calls the industry "everyone together", but the ventilator is not "who wants to build can create". Besides the spare parts that restrict the production capacity, the ventilator still has its technical barriers.

The technical barrier of ventilator is signal processing and control algorithm technology. "All parts used in ventilator are special standard parts in the industry, which are bought by everyone. How to use the same components to achieve the best ventilation control accuracy and man-machine synchronization effect is the core technology of every household. At present, the difference of product quality between each ventilator manufacturer on the market is embodied in ventilation control technology and man-machine synchronization technology. Li Xinsheng said that there is a strong production capacity to build cars and undertake production outsourcing, but its capability is difficult to transform into respirator capabilities in a short time. Because this product needs to be accumulated for many years in the ventilator industry, the establishment of medical equipment quality management system, the development of production tooling, testing and calibration technology, and the cultivation of professional talents will take a great deal of time.

Some governments have also called on non-medical technology manufacturers to transform production lines to create ventilators, and some manufacturers have responded positively. But the industry is worried that this underestimates the complexity of ventilators. Evaluate MedTech data show that in the past five years, no global leading manufacturer has approved more than ten new respirators, most of which are Resmed, approved 7, followed by Switzerland Hamilton (5) and Hill-Rom (5), the other giant Philips approved 4, Medtronic 3.

The number of approved listings is small, indicating that there are certain technical barriers to ventilators, but in the current environment, manufacturing capacity is more important. Medtronic and GE Healthcare, the traditional large manufacturers, occupy the leading position. But ventilator manufacturers also claim that a large increase in production may take three to four months.

What looks more promising is probably the combination of GE and Ford. In March 24th, GE Healthcare announced cooperation with Ford to speed up and expand the production of ventilators. Ford will provide expertise in its technology and production to simplify the design of GE Healthcare's existing ventilators. The new system will be specifically designed to address the urgent needs of the new crown pneumonia pandemic and provide the basic functions needed for the safe treatment of COVID-19 patients. Since the outbreak of the COVID-19 epidemic, GE Healthcare has said its breathing machine production capacity has doubled and plans to double it at the end of the second quarter of 2020 to cope with unprecedented demand without co operating with Ford.

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