The representative jumped on his feet and got approval from the US FDA... Preparing a breakthrough in the global market

The representative jumped on his feet and got approval from the US FDA... Preparing a breakthrough in the global market

Korea XX Medical Co., Ltd., headquartered in Gumi, Gyeongsangbuk-do, started as a company specializing in mold making and plastic injection, and has successfully expanded its scope to medical equipment, showing remarkable influence on our society and industry. It is attracting more attention as it continues to grow steadily by expanding the market from Korea to the global stage.

In 1988, Chairman Kim Yong-chang laid the foundation for the company, and then CEO Kim Yu-shin, who took over the management rights, also obtained the title of a global small and medium-sized company through successful business expansion. CEO Kim said, “Currently, it is the largest in terms of production scale among the medical-related industries in Korea.” He said, “We are making about 55 million items a month, including various syringes.”

The company made syringe products using the original equipment manufacturer (OEM) method.

Currently, XX Medical is expanding its business focusing on syringe types, equipped with all systems such as molds, assembly machines, and injection molding machines that can produce medical devices on their own. In addition to general vaccine syringes, it is producing insulin, body blood, filter syringes, pen needles, general infusion sets and special sets, IV catheters, and masks. CEO Kim's extraordinary efforts were hidden behind the company's ability to move to the global stage. After studying marketing in the United States, CEO Kim returned to Korea and started working in overseas sales in 2006, such as managing foreign buyers. In order to obtain product approval from the U.S. Food and Drug Administration (FDA), he prepared the approval materials himself. It is usually entrusted to a consulting company, but he went directly to the practice in order to learn about it.


CEO Kim explained, “Many insulin syringes are exported to the United States, but as the demand for vaccine syringes has recently increased, the current annual export volume is 220 million units.” The success in the US market has increased both the company's position and status.


In order to further enhance growth potential on the global stage, it also has an overseas production base. Six years ago, the plant was built in Tam Ki, about an hour away from Da Nang, Vietnam. Currently, medical consumables other than syringes and infusion sets are made here. Although the company has enough land in Korea, it is making in Vietnam, such as infusion sets, which have to be done manually in consideration of the difficult manufacturing environment and competitiveness. In Korea, it mainly produces products with high added value, such as automation products.

CEO Kim is quickly catching and adapting to industrial changes caused by the novel coronavirus infection (COVID-19). It means that Shinchang Medical could not be free from the Corona 19 wind that had a profound impact on the domestic industry.


He said, "Before Corona 19, the goal was to increase sales and produce products with high added value, but now, we are focusing on the direction of making products by identifying customer needs." Shinchang Medical is also trying to diversify its products into special infusion sets, products with filters to prevent foreign substances from entering the filter syringe sets, and infusion sets that can be fine-tuned.


CEO Kim is also interested in pioneering the market through new products. Regarding mask production, it received approval from the Ministry of Food and Drug Safety at the end of last month. LDS syringes will also be supplied to Korea in the second half of this year and exported to the United States. CEO Kim said, "Because another virus may come out in the future, we should always study and think about it." He added that the company's executives and employees are devoting themselves to research while resolving the importance of R&D.


CEO Kim added, “We are constantly conducting meetings for productization. Employees are also checking and communicating with the sales status in real time to see what kind of response the product gets in the market.” Based on this passion, the hygiene department is also securing customer trust through clean room management.

s and employees continue to work with a sense of unity with pride and pride that they are also taking a part in the health of the people, they will be able to obtain growth opportunities.



When asked about the difficulties in managing a company, he said, “Small and medium-sized enterprises have to do multi-person roles, but there are too many manufacturing regulations and all of them are related to cost. said He continued, “There are thousands of products, and the process, such as permits and additional registration, is too many and complicated, so I hope it can be simplified.


CEO Kim said, “We will continue to maximize our existing strengths as a company capable of direct mold, automation, plastic injection, direct assembly, packaging, and sterilization.”

TC Ang ( Eric )

Continuous Improvement Manager

1 年

Our new clear room for medical parts

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