China Blossoms: Alignment with Western Regulations Stimulates Domestic Growth
US medical silicones manufacturer Dow Corning has written about China's burgeoning medical device market, its associated domestic manufacturing sector and how this sector is enjoying growth in global exports. The report is as follows.
Dow Corning has more than 50 years of experience in healthcare-related markets to improve the quality of life, transform patient care and pioneer next generation innovation through silicone advancements. Underpinning our strength is an intimate understanding of how global health care megatrends are shaping the future of health care for raw material suppliers, manufacturers of medical devices, end-users and patients. A rise in aging populations, increasing health care expenditures, greater attention to regulatory matters and increasing demand for quality health care in developing countries are all having a profound effect on the industry.
One example of how these megatrends are making an impact is the rapid pace of change in fast growing economies in Asia, particularly China, in medical devices. This can be seen from two angles—the growth in their domestic medical device market and the growth in foreign investment and exports overseas.
A rapidly growing middle class in China is driving growth in the medical device market by demanding and being willing to pay for better quality care. Domestic manufacturers of medical devices for the local market are responding to these challenges by making higher quality products using quality raw materials. The China SFDA (State Food and Drug Administration) has been continually tightening its regulatory approach to ensure the medical device industry follows and implements relevant laws and safety management policies. Increasing coordination with overseas regulatory authorities, such as the US FDA and the European Commission, is also resulting in improved harmonisation of medical device regulations. This is leading to remarkable growth in the medical device market with sales revenue in 2011 growing by 27% to reach US$22 bn—reference: China National Bureau of Statistics. While foreign-made products occupy the majority of the middle and high end market, local companies are upgrading their products’ technical and quality characteristics.
Based on a long history of successful use in many medical device applications and their low toxicity, silicones have been generally thought of as intrinsically biocompatible and suitable for many of the desired mechanical properties that medical device manufacturers are looking for. Suppliers such as Dow Corning that can provide appropriate silicones for medical device applications together with the regulatory, quality control and documentation required are experiencing strong growth in markets such as China.
In addition to the domestic growth of the medical device market, China is also increasingly exporting medical devices overseas. In 2010, exports rose by 20% to reach US$8 bn—reference: China chamber of commerce for Import/Export of medicines and health products, 03/2011. While many exports are made by local companies and are relatively low-middle tech products such as medical dressings, catheters, laryngeal mask airway (LMA) devices and other medical disposables, the level of foreign investment in China is increasing with Medtronic, St Jude, General Electric, Boston Scientific and others investing and expanding their R&D and production presence in China.
Major local companies are also growing their exports benefiting from Chinese nationals returning from overseas with engineering degrees, fluent in English and medical device industry experience to drive their export growth into developed economies. Companies such as Mindray, Weigao and Microport are leading the way in this drive to upgrade their products to compete with foreign multinational companies (MNCs).
China’s rapid growth of its domestic and export markets for medical devices are driving greater technical sophistication and stronger alignment to global regulatory and quality trends. Dow Corning’s 50 year expertise in silicone technology and our regulatory understanding for health care applications is well aligned to meet the needs of the changing China medical device market.
The image, courtesy of www.sinopaperart.com, is of a plum blossom—or Chinese Plum—a common Chinese plant. According to Wikipaedia, the fruit of the tree is used in Chinese, Japanese and Korean cooking in juices, as a flavouring for alcohol, as a pickle and in sauces. It is also used in traditional medicine.