Many medical device companies have expanded rapidly in both size and scope of products that improve peoples’ lives, but has their product data management systems kept up with their growth? It is not uncommon for companies to continue to take an ad-hoc approach, using Excel in many cases, to manage product data. However, they tend to experience errors related to Bill of Material (BOM) accuracy and a lack of data continuity across different functions, such as design, quality and manufacturing creates a challenging environment for traceability and regulatory compliance. To eliminate these barriers to growth, companies are seeking access to the latest tools and processes that support digital continuity and collaborative processes. Savvy companies that optimize product data management and shorten the time to market will have the advantage.
Discover in our customer story below how Osstem Implant embraced a digitally driven transformation of their business processes in order to ease the compliance and quality challenges they faced.
This well-known medical device company in Korea wanted their systems to keep up with their growth. They needed to improve change management and ensure traceabilty to meet the demands of regulatory compliance, especially US FDA UDI Unique Device Identification (UDI) requirements. Their ability to manage these demands was being limited by a patchwork of point solutions and excel spreadsheets. Understanding that achieving digital transformation is much more than just digitalization of existing processes and that the Dassault Systèmes ‘License to Cure for Medical Device’ solution covers the end-to-end development process from design, to quality and regulatory compliance, they realized that true business transformation was indeed possible. With a digital integrated platform, they have now connected all parts of their business with single-source-of-truth data and processes that have streamlined data-driven quality management, Bill of Materials (BOM) accuracy and traceability from DHF to UDI.
A fully integrated platform solution, specialized for medical device manufacturers, can offer new ways to manage BOMs, comply with the FDA’s Unique Device Identifier (UDI) requirements and accelerate products to market. The platform is for all parts of the business, connecting R&D, quality, manufacturing, sales and marketing with a single source of data, eliminating the need to duplicate work and the risk of error during data transfer. By removing the need to manage multiple point solutions for QMS, EDMS and PLM from different vendors, companies can avoid integration and implementation issues, and provide an environment of digital continuity, data integrity and truly embrace digital transformation. “License to Cure for Medical Device” improves product and process quality, and streamlines regulatory filing, accelerating the overall innovation process to deliver a product to market. This business transformation fosters global sustainable growth and allows companies to maintain and continuously improve a rich and diversified product portfolio.