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2020.05.08
The National Center for Innovation in High-Performance Medical Devices has been established in Shenzhen.
On May 8, Liu Fang, a reporter from Shenzhen News (a publication of China Youth Daily and China Youth Net), reported that the Shenzhen Municipal Bureau of Industry and Information Technology informed reporters that the Ministry of Industry and Information Technology has approved the upgrade of the Guangdong Province High-Performance Medical Device Innovation Center to the National High-Performance Medical Device Innovation Center. The center will be supported by the Shenzhen National Institute for High-Performance Medical Devices and will begin its establishment work. This is the only national manufacturing innovation center in the medical device sector, and it will become the most important hub for medical devices in China’s life safety and biosafety fields. High-end medical equipment is a critical support and reliance for the diagnosis and treatment of serious diseases. For a long time, China’s domestic high-end medical device industry has lacked core technologies, with weak innovation capabilities and significant gaps compared to international advanced technologies in areas such as technology, quality, and design. As a result, both international markets and even the domestic market share have been monopolized by global giants. Take, for example, the artificial device known to all during the COVID-19 pandemic—the ECMO (also called an artificial lung)—which is essential for saving critically ill COVID-19 patients. However, due to difficulties in overcoming challenges related to core components and materials, China currently relies heavily on imports. Localizing high-end medical equipment has become an urgent priority. Yet, since the research and development of advanced medical devices involves multidisciplinary integration and system-level integration, addressing the technological challenges in the innovative development of high-end medical devices requires strategic planning, coordinated collaboration among multiple stakeholders, and joint R&D efforts that combine cutting-edge technologies with general, foundational technologies.
2019.11.07
Wall-penetrating design for pharmaceutical equipment
The wall-penetrating design for pharmaceutical equipment refers to a layout in which part of the equipment is arranged across a partition wall into another room, thereby saving processing space. The equipment’s transfer, control, and maintenance areas are located in auxiliary zones. Through engineering and technical measures, this layout ensures proper separation between two different levels of cleanrooms. (1) Saving on Factory Space Costs Pharmaceutical production has strict requirements for the production environment. By reducing the area required for clean zones without compromising the production process or operational efficiency, environmental costs can be lowered. With the wall-penetrating design, the equipment itself occupies less process space, directly impacting factory utilization. (2) Promoting Self-Cleaning of Plants and Equipment Due to the maintenance needs of traditionally designed pharmaceutical equipment, components such as covers must be made detachable, which makes sealing difficult. In wall-penetrating pharmaceutical equipment, the side facing the high-grade clean zone is installed permanently and does not require disassembly after installation. As a result, the equipment can be designed as fixed or integral units, reducing the number of joints and connections, giving the equipment a neat appearance, and facilitating the purification of the process area through cleaning and disinfection. (3) Optimizing the Design and Manufacturing of the Equipment Itself In conventionally designed equipment, components may rust, lubricants from transmission parts may leak, debris may accumulate from friction between pulleys and belts, or necessary inspection doors may introduce contaminants into the process area. After adopting stringent isolation measures between the process area and auxiliary areas in wall-penetrating equipment layouts, these issues can be confined to the auxiliary areas. Consequently, the design of the process area can meet cleanliness requirements more effectively, while also addressing challenges related to strength, transmission, heat dissipation, and cost, thus optimizing the equipment design to comply with GMP standards. (4) Reducing Noise and Improving Workplace Comfort By placing transmission equipment in auxiliary areas and using isolation measures, transmission noise can be significantly reduced, contributing to a more comfortable working environment. (5) Convenient Equipment Operation The wall-penetrating layout allows for the installation of touch screens and other operating interfaces directly on the wall, freeing up space in the process area and making it easier to use and clean these interfaces. (6) Easy Maintenance The overall design of wall-penetrating equipment centralizes various auxiliary areas for equipment maintenance. On one hand, this reduces the length of pipelines for water, electricity, gas, and steam supplied by the plant, simplifying maintenance of plant facilities and lowering operational costs. On the other hand, dedicated maintenance areas specifically designed for pharmaceutical equipment facilitate the connection and installation of utilities such as water, electricity, gas, steam, and equipment itself, thereby promoting comprehensive maintenance of both the equipment and the plant. (7) Maintenance Work Does Not Affect the Process Area After isolating the main equipment, maintenance work can be carried out in the maintenance area, preventing communication between different levels of clean zones during maintenance operations and thus preserving the cleanliness of the process area. In this way, the wall-penetrating layout enables maintenance without disrupting the production of other equipment, ensuring that maintenance activities have minimal impact on product quality and fully comply with GMP requirements.
Leveraging technological innovation to build “national prominence” for medical devices.
On April 28, 2020, the Ministry of Industry and Information Technology approved the upgrade of the Guangdong Province High-Performance Medical Device Innovation Center to the National High-Performance Medical Device Innovation Center (hereinafter referred to as the Innovation Center).
The large-scale healthcare industry requires high-performance pharmaceutical machinery.
With the end of China’s one-child policy, the proportion of an aging population will continue to rise for a long time to come. Those just entering old age are more concerned about their health issues than their predecessors and are actively taking steps to improve it. In an era when the primary focus was on survival, physical health was little more than a luxury. Today, the situation has vastly improved. Compared with their elders, the new generation of middle-aged and elderly people not only pay greater attention to their physical well-being but also enjoy stronger economic means. The resulting surge in production capacity—and the accompanying growth of the large-scale healthcare industry—is unmistakable. Another troubling issue is that the physical condition of Chinese people is far from optimistic. Looking at children’s education, we can see that promoting robust physical health seems at odds with the demands of exam-oriented education. Teenagers of school age are subjected to exams and homework at all levels. After spending most of their day studying, my sleep has been severely curtailed—I can only play golf and occasionally swim. A wealth of data indicates that the physical condition of young Chinese people is indeed cause for concern. Some young people with weak physical foundations have developed many unhealthy habits. According to one survey, taking smoking as an example, the number of smokers in China is aging and becoming increasingly female. China has now become the world’s largest producer of tobacco—and also its biggest consumer. Moreover, an increasing number of teenagers are turning away from video games, especially left-behind children whose parents work in cities. The situation in workplaces is equally discouraging. Compared with those in developed countries in Europe and the U.S., Chinese workers face longer overtime hours due to structural imbalances and low productivity—not only in factories and construction sites, but even in office environments. Most restaurants and entertainment venues are bustling with business activities. Even those attending banquets feel overwhelmed; under performance pressure, many salespeople are forced to work until late at night—and some have already fallen ill. Rising housing prices are placing even greater survival pressures on young people from rural or less-developed areas. To afford down payments exceeding 50% of their salaries and monthly mortgage payments, those who have never enjoyed good physical or mental health since childhood—and especially only children—will naturally experience more physical and psychological problems. The most telling statistic is the declining success rate of conception among people of the right reproductive age. China, which has just stepped onto the threshold of modernization, is now facing the overuse and depletion of its national health resources. As suppliers of pharmaceuticals and healthcare equipment, industry players are benefiting from the rapid growth of the healthcare sector—a development that is both encouraging and heartbreaking. As GMP policies drive massive investments in pharmaceutical equipment, the issues discussed in this article are increasingly becoming a pressing need for the expansion of the healthcare industry. The growth in market demand has sharply contrasted with the industry’s supply capacity, and this gap is now aligning with the country’s overall strategic objectives. The situation is strikingly similar across the board: whether it’s pharmaceuticals and healthcare products or upstream equipment manufacturers, there’s an overabundance of low-end products alongside a shortage of high-quality ones. Promoting supply-side structural reform and steadfastly adjusting production capacity have thus become urgent challenges facing the broader healthcare industry. The vast majority of Western medicines sold domestically are generic drugs. Many of these generics on the market are wasting resources, suffering from overcapacity, low profits, and poor efficacy. Since 2016, China’s National Medical Products Administration has implemented a consistency evaluation program in the pharmaceutical industry. Industry leaders with high-quality resources have continuously passed the consistency evaluation, gaining a first-mover advantage. Meanwhile, these companies have embarked on another round of large-scale mergers and acquisitions. Generic drug varieties that have passed the consistency evaluation are also expanding production capacity and securing major orders. On the product strategy front, companies are continuing to increase R&D investment while simultaneously acquiring more advanced and intelligent production lines, further boosting efficiency and cutting manufacturing costs. The domestic pharmaceutical machinery market mirrors the downstream pharmaceutical market: foreign imported products command extremely high prices, and high-end domestic products remain scarce. Yet, the market is flooded with crude, low-grade products.
