Osstem Implant, a Korean dental medical device manufacturer, has set a goal to become the world’s number one implant provider by 2023. But competition is intense and customer needs are very specific and diverse. The company has been able to provide high-quality implants due to strong investments in research and development. But in order to make it to the top of the market on a global scale, they needed to overcome business process challenges such as effectively complying with national and international regulatory requirements.
Osstem Implant had already taken the first step toward streamlining regulatory compliance processes by establishing a unique device identification (UDI) system to identify medical devices throughout their distribution and use. This enables the public to search for information on the device in question, helping to improve patient safety and device traceability.
But having the system was not enough: they needed to globally manage not only the UDI information but also details on design change and quality control. To do this, Osstem Implant chose Dassault Systèmes’ 3DEXPERIENCE® platform and Medical Device industry solutions. Thanks to the solution’s collaborative and integrated business framework, Osstem Implant gained real benefits immediately. Processes that were previously managed separately become connected and integrated in a single system. This integrated approach allows for end-to-end tracking of UDIs resulting in improved patient safety and modernized surveillance of devices. As a result, quality issues can be addressed in a timely manner.
With a single source of up-to-date product development data that is directly linked to quality and regulatory information, various departments, such as quality, production, licensing and R&D can now effectively collaborate. The result: accelerated delivery of innovative, safe, and fully-compliant medical devices.
To read more about Osstem Implant’s improvements in business efficiency, product quality and regulatory compliance and about their plans to increase the use of the 3DEXPERIENCE to help them achieve their market leadership goals, click here.