Dyne Medical Group: "Our Relentless Pursuit of Zero Defects Is Our Competitive Edge" — Leading the Leap to a Urology Platform Company
Advancing a quality management system that spans planning, development, and manufacturing as the product portfolio diversifies
High expectations for next-generation ureteroscope "URUS 2.0"; building global trust through open communication
By The Medical Newspaper
Updated September 29, 2026, 12:06
Dyne Medical Group (CEO Lee Sung-hoon) has put the advancement of its quality management system at the forefront as a key growth driver in its bid to become a world-leading urology platform company. With its workforce approaching 40 employees and its business areas diversifying, the company believes that building solid manufacturing and quality systems aimed at zero defects matters more right now than outward growth.
The Medical Newspaper recently sat down with Lee Tae-haeng, Chief Operating Officer (COO) of Dyne Medical Group, who has been part of the company's growth since its early days, to discuss the direction of its quality management and its future vision as the portfolio expands.
A veteran of global medical device companies, COO Lee leads a 15-member operations division covering planning, quality assurance (QA), quality control (QC), supply chain management (SCM), and production.
Embedding a quality philosophy comes first during portfolio expansion
Lee Tae-haeng, Chief Operating Officer (COO) of Dyne Medical Group
Dyne Medical Group has recently been expanding its business portfolio rapidly, moving beyond its original single urology product into an ODM business for stone treatment systems (EMS), Port-C accessories, and next-generation endoscopes.
COO Lee stressed that the more product lines a company handles, the more important it becomes to first streamline cross-departmental collaboration processes and clearly define quality standards.
"It goes beyond a simple numerical exercise of catching one defect in a million," he explained. "How well the company's systems are built, and how departments work with one another, connect directly to quality."
In other words, a quality philosophy must be embedded throughout the entire process, from planning and development to production, for the company to respond nimbly to market demands.
The customer and patient value built into next-generation "URUS 2.0"
Dyne Medical Group's quality policy declaration.
More items will be added going forward.
The first fruit of this strengthened quality management is URUS 2.0, a next-generation single-use flexible ureteroscope that is nearing completion of domestic regulatory approval. Launched about four years after its predecessor, the new product retains the company's signature "6 o'clock (smile-shaped)" design while widening the inner diameter from 1.2 mm to 1.4 mm, significantly improving ease of use for physicians working with instruments.
Notably, the resolution has increased roughly sixfold, while the scope itself has become even thinner. "Our philosophy is that even if a procedure lasts three to four hours, the device should always maintain the same angle, resolution, and functionality," COO Lee said with confidence.
"Even for patients with difficult cases, we want to give physicians the trust and confidence that using a Dyne product will get the job done," he added. Ultimately, he said, the steadfast trust of medical professionals leads to less pain and a better quality of life for patients.
Hands-on overseas engagement, and an open culture built on high standards
Lee Tae-haeng, Chief Operating Officer (COO) of Dyne Medical Group
Advanced quality management is also serving as a powerful asset in overseas expansion. Behind Dyne Medical Group's rapid foothold in global markets such as Indonesia and Uzbekistan are thorough preparation and fast responsiveness.
"Unlike other companies that hand full authority over to their distributors, when physicians don't understand a product or a problem arises, our people — including me and our R&D staff — go on-site ourselves to explain and resolve it," COO Lee said, highlighting the strength of the company's hands-on approach.
Internally, the company is focused on building a flexible culture where anyone, regardless of title, can freely raise and share issues and discuss them openly.
Wrapping up the interview, he said, "I hope we become an open company where anyone, whether a junior staff member or a team leader, can comfortably discuss problems or direction at any time. Raising quality is ultimately tied directly to our employees' working environment and safety, so internally, too, we will operate by precise, uncompromising standards."
Building on a transparent quality culture shared by all employees, Dyne Medical Group plans to prepare for its initial public offering (IPO) without setbacks and further strengthen its position in the global medical device market.
Dyne Medical Group: "Our Relentless Pursuit of Zero Defects Is Our Competitive Edge" — Leading the Leap to a Urology Platform Company
Advancing a quality management system that spans planning, development, and manufacturing as the product portfolio diversifies
High expectations for next-generation ureteroscope "URUS 2.0"; building global trust through open communication
By The Medical Newspaper
Updated September 29, 2026, 12:06
Dyne Medical Group (CEO Lee Sung-hoon) has put the advancement of its quality management system at the forefront as a key growth driver in its bid to become a world-leading urology platform company. With its workforce approaching 40 employees and its business areas diversifying, the company believes that building solid manufacturing and quality systems aimed at zero defects matters more right now than outward growth.
The Medical Newspaper recently sat down with Lee Tae-haeng, Chief Operating Officer (COO) of Dyne Medical Group, who has been part of the company's growth since its early days, to discuss the direction of its quality management and its future vision as the portfolio expands.
A veteran of global medical device companies, COO Lee leads a 15-member operations division covering planning, quality assurance (QA), quality control (QC), supply chain management (SCM), and production.
Embedding a quality philosophy comes first during portfolio expansion
Dyne Medical Group has recently been expanding its business portfolio rapidly, moving beyond its original single urology product into an ODM business for stone treatment systems (EMS), Port-C accessories, and next-generation endoscopes.
COO Lee stressed that the more product lines a company handles, the more important it becomes to first streamline cross-departmental collaboration processes and clearly define quality standards.
"It goes beyond a simple numerical exercise of catching one defect in a million," he explained. "How well the company's systems are built, and how departments work with one another, connect directly to quality."
In other words, a quality philosophy must be embedded throughout the entire process, from planning and development to production, for the company to respond nimbly to market demands.
The customer and patient value built into next-generation "URUS 2.0"
Dyne Medical Group's quality policy declaration.
More items will be added going forward.
The first fruit of this strengthened quality management is URUS 2.0, a next-generation single-use flexible ureteroscope that is nearing completion of domestic regulatory approval. Launched about four years after its predecessor, the new product retains the company's signature "6 o'clock (smile-shaped)" design while widening the inner diameter from 1.2 mm to 1.4 mm, significantly improving ease of use for physicians working with instruments.
Notably, the resolution has increased roughly sixfold, while the scope itself has become even thinner. "Our philosophy is that even if a procedure lasts three to four hours, the device should always maintain the same angle, resolution, and functionality," COO Lee said with confidence.
"Even for patients with difficult cases, we want to give physicians the trust and confidence that using a Dyne product will get the job done," he added. Ultimately, he said, the steadfast trust of medical professionals leads to less pain and a better quality of life for patients.
Hands-on overseas engagement, and an open culture built on high standards
Advanced quality management is also serving as a powerful asset in overseas expansion. Behind Dyne Medical Group's rapid foothold in global markets such as Indonesia and Uzbekistan are thorough preparation and fast responsiveness.
"Unlike other companies that hand full authority over to their distributors, when physicians don't understand a product or a problem arises, our people — including me and our R&D staff — go on-site ourselves to explain and resolve it," COO Lee said, highlighting the strength of the company's hands-on approach.
Internally, the company is focused on building a flexible culture where anyone, regardless of title, can freely raise and share issues and discuss them openly.
Wrapping up the interview, he said, "I hope we become an open company where anyone, whether a junior staff member or a team leader, can comfortably discuss problems or direction at any time. Raising quality is ultimately tied directly to our employees' working environment and safety, so internally, too, we will operate by precise, uncompromising standards."
Building on a transparent quality culture shared by all employees, Dyne Medical Group plans to prepare for its initial public offering (IPO) without setbacks and further strengthen its position in the global medical device market.