Osstem Implant, a developer and manufacturer of dental implants, is using Dassault Systèmes’ “License to Cure for Medical Devices” platform to expand its global market share.
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 looked to expand its market share by balancing regulatory requirements with innovation.
Specifically, it sought a digital platform to manage unique device identifier (UDI), design change and quality assurance information it submits to regulatory approval organisations such as the FDA.
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, claims Dassault Systèmes.
“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 the information system management team at Osstem Implant.
“We can improve product development and project management efficiency and streamline the regulatory filing process for our dental implant solutions.”
Jean Colombel, vice president, life sciences industry, Dassault Systèmes added: “The ‘License to Cure for Medical Device’ industry solution experience transforms regulatory from a constraint into an asset and allows the organization to optimize quality and compliance efforts and reduce cost and time to market.
"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.”