3DEXPERIENCE platform helps dental implant company accelerate innovation and regulatory approval
Dassault Systèmes, the 3DEXPERIENCE Company, world leader in 3D design software, 3D Digital Mock Up and Product Lifecycle Management (PLM) solutions, announced that Osstem Implant Co., Ltd., a developer and manufacturer of medical device technologies, is using Dassault Systèmes’ “License to Cure for Medical Device” industry solution experience to expand its global market share in dental implant solutions.
The medical device industry has been plagued by safety and quality issues and product recalls that have led to increased regulatory scrutiny. As a result, many companies must dedicate more research and development expenditures to regulatory activities than to new product introductions.
Osstem Implant, with 22 offices worldwide and manufacturing facilities in the US and South Korea, looked to expand its market share by balancing regulatory requirements with innovation. Specifically, it sought a unified, digital platform to manage unique device identifier (UDI), design change and quality assurance information it submits to regulatory approval organisations such as the US Food and Drug Administration.
Based on the 3DEXPERIENCE platform, the “License to Cure for Medical Device” industry solution experience provides a collaborative, integrated business framework that accelerates the delivery of innovative, safe and fully compliant medical devices. By eliminating traditionally disconnected processes and data, Osstem Implant has access to a single source of information and an end-to-end, traceable and compliant product development process directly linked to quality management. This helps minimise time to market and regulatory overhead.
“We selected Dassault Systèmes’ “License to Cure for Medical Device” to help us better manage regulatory activities and new product development as we expand internationally and must meet different market requirements,” said Tae-Yong Kim, Head of Information System Management Team, Osstem Implant. “We can improve product development and project management efficiency and streamline the regulatory filing process for our dental implant solutions.”
“The “License to Cure for Medical Device” industry solution experience transforms regulatory from a constraint into an asset and allows the organisation to optimise quality and compliance efforts and reduce cost and time to market,” said Jean Colombel, Vice President Life Sciences Industry, Dassault Systèmes. “With a collaborative, end-to-end, fully traceable, fully compliant product development process that is directly linked to quality and regulatory information, companies can meet project challenges and accelerate the creation of advanced solutions for human health.”