TÜV SÜD Korea’s VIP Customer Interview Series- #03. DIO
This third interview was conducted in Busan, the second largest city in Korea. The interviewees were QMR/SVP Operation Manager, Kang, Chang Hak, and Manager, Park, Sang-In of DIO Co., Ltd., the total implant solution company leading the world beyond the domestic implant market.
Q. Hello! Thank you for being the first Outstanding Customer of TÜV SÜD Korea interviewees in Busan! Please briefly introduce yourself.
A. Manager, Park, Sang-In (hereinafter Park.) Hello, I am Manager, Park, Sang-In of the Quality Management Team of DIO Co., Ltd. I have been working at DIO for eight years and am currently in charge of the product quality system certification and overseas authorization and certification. I maintain and manage the product quality management system to ensure that products of DIO are produced and sold according to the requirements of each nation.
A. QMR/SVP Operation Manager, Kang, Chang Hak (hereinafter Kang.) Hello, I am Kang, Chang Hak, in charge of the overall product quality responsibilities as QMR/SVP Operation Manager.
Q. Could you describe what kind of company DIO is?
A.(Park) DIO is a leading implant manufacturer, exporting to more than 70 countries worldwide. In 2002, we began operating 11 new direct sales branches by venturing into the medical device (dental implants) manufacturing industry. Our implant and medical equipment business have maintained a steady growth trend with a cumulative annual growth rate of 15% for the past 3 years. As the population ages, the implant is widely recognized globally as a high-value industry. Thus, we are also investing a lot of effort towed advancing into overseas markets. We have established overseas subsidiaries in the US, China, Taiwan, Canada, Iran, and India and have authorized dealers in over 60 countries.
Q. It seems that DIO is putting a lot of effort not only into Korea but also into overseas markets. Therefore, what are some of DIO’s flagship products?
A.(Kang) Our main product lines are 'Implant,' ‘DIO Nabi,' 'Digital Orthodontic Appliance,' and 'Digital Prosthetic Solution.' Among these, I would like to tell you about DIO Nabi, a product which was the first of its kind to be developed and released the world. DIO Nabi is a state-of-the-art digital implant solution that determines an appropriate procedure for a patient's condition via 3D computer simulation before being implanted. By complementing the disadvantages of the existing implant procedure, DIO Nabi secured high-level accuracy. Also, DIO Nabi provides the benefit of saving the implant time significantly, and reducing as much pain as possible, making the patient comfortable throughout the process.
Also, this year, DIO launched 3D printers for prosthetics and guides, printed materials, and milling equipment. As the entire implant process is digitized with this development, we plan to continue to gain market dominance in the digital field competition.
Q. I heard that DIO had acquired the MDSAP certification in all five countries. What is the significance of this certification to DIO as a global implant exporting company?
A.(Kang) We have already proved the excellence of our quality management system by acquiring ISO 13485 certification. However, with this MDSAP certification, we could satisfy all the quality management system standards of the USA, Canada, Australia, Brazil, and Japan. This will lead to smooth exportation to five countries. It is not easy to comply with all of the MDSAP requirements of five countries, but we can dramatically reduce cost and time by having a single audit every year.
Q. I heard that the preparation process for MDSAP Certification was complicated. How did you get prepared?
A.(Park) At the time of the very first MDSAP evaluation in 2018, there were significant difficulties because not many companies received the MDSAP certification. Because it was the first audit for us, a lot of time and effort were invested in figuring out how we were going to interpret and apply regulations to our various situations according to the FDA guidance. Besides, for MDSAP, we must follow not only the requirements of ISO 13485:2016, but the quality management system requirements for each country. Thus, it was difficult implementing the system that fulfills every requirement. So, numerous meetings between TÜV SÜD Korea experts and our team members were held, after which problems were identified, and preparations were made. Maybe because of all the hard work and effort, it felt very rewarding when the certificate was issued.
Q. I see. Then, can you introduce a project in progress with TÜV SÜD currently?
A.(Kang) The first surveillance audit will take place this year. Every three years, an unannounced audit is conducted. And we are going to have it this year. Thus, we are inspecting our quality management system by being focused and alert every day.
Q. Manager, Park, Sang-In has been working with TÜV SÜD Korea for about seven years. Was there an advantage unique to TÜV SÜD Korea you’ve experienced while working with TÜV SÜD?
A.(Park) The most significant benefit I felt while working with Mr. Min, Ki-Sik of TÜV SÜD Korea was that he ‘listens very well.’ Rather than just criticizing, it was very impressive to see him listening to every word of employees working in the field. I think that this part had the greatest influence on the perception improvements of our employees and executives.
Before that, the dominant opinion about an ‘audit’ among our employees was not positive. It was treated as something bothersome and tiring as it only increased the amount of work. However, as Mr. Min listened to the opinions of employees one by one, people started proactively finding improvements and opening in advance rather than hiding problems or modifying only the parts that had been pointed out. They began to think that a small, unsolved problem can cause a much more significant risk in the future. Whenever TÜV SÜD Korea audits us, every year, we see the improvement of the level of understanding among our executives and employees on the importance of the quality system of our medical devices – which is the highest achievement. I sincerely thank him for helping us to solve issues constructively and for listening well to our voice.
Q It is an unexpected yet good thing as the perception of employees and executives could be improved through the audits. Lastly, what is TÜV SÜD Korea for you?
A.(Park) I’d say "Lighthouse."
As I work with the ever-tightening legal requirements and regulations, there are moments of darkness and not knowing where to go. In such moments, TÜV SÜD Korea lights up our path as a trustworthy partner similar to the lighthouse.