Osstem Implant Aims to Expand Market to the US and Asia

Dassault Systèmes Korea (www.3ds.com/ko) announced that Osstem Implant Co., Ltd. (www.osstem.com), a global implant specialist, has adopted “License to Cure for Medical Device,” an industry-specific solution for Dassault Systèmes’ life sciences sector. Osstem Implant is building an integrated framework in collaboration with Solid ENG Co., Ltd. (www.solideng.co.kr), a PLM consulting firm and partner of Dassault Systèmes Korea.

Currently, as issues such as safety and quality problems and product recalls continue to occur in the medical device industry, regulatory standards are becoming increasingly stringent. As a result, many companies are facing a situation where they must spend more on regulatory activities than on launching new products.

Osstem Implant, which has established itself as a leading company in the field of dental implants in Korea and Asia based on 22 domestic and international production and sales subsidiaries, aims to increase its global market share by expanding its market to the Americas, Europe, and other regions through the introduction of this solution, while addressing the two challenges of medical device innovation and compliance with regional regulations, such as the U.S. Food and Drug Administration (FDA). In addition, with this introduction, a platform has been established to integrate and manage UDI (Unique Device Identifier) information submitted to the FDA, design change information, and quality control information.

Dassault Systèmes’ “License to Cure for Medical Device” solution is an innovative solution specialized for medical device development that integrates existing fragmented processes and data to efficiently manage industry regulatory levels in the global market. It also enables access to a single source of information and an end-to-end product development process directly linked to quality control. This allows for minimized time-to-market and efficient regulatory management.

"In order to expand the market internationally and meet diverse demands, regulatory activities must not affect new product development," said Kim Tae-yong, Team Leader of the IT Operations Team at Osstem Implant. "We expect to optimize resource allocation and the reuse of intellectual property rights, as well as streamline the regulatory reporting process for dental implant solutions, through Dassault Systèmes' 'License to Cure for Medical Device' solution."

Jean Colombel, Executive Vice President of Life Sciences at Dassault Systèmes, stated, “Demand in the dental implant market is expanding due to the global aging population, rising income levels, and increasing interest in health and aesthetics.” He added, “However, due to the stringent regulatory standards of the medical device market, the number of approvals remains significantly low compared to the time and costs invested. Dassault Systèmes’ medical device solutions turn regulations into assets rather than constraints by enabling companies to address challenges such as quality, regulations, and projects, allowing them to focus on solution development and research.”