The automation challenge
For nearly 100 years, Terumo has been a global leader in developing and manufacturing best-in-class medical-device technologies. Operating globally, Terumo employs more than 25,000 associates, providing innovative medical solutions in more than 160 regions.
At the heart of its business is a commitment to quality, instilled in Terumo’s people and incorporated into its manufacturing processes from the top down. Terumo Americas, which manufactures interventional systems, injection and infusion therapy devices, and drug delivery devices, maintains this proud tradition as it grows and innovates into the new century. However, many of Terumo Americas’ legacy systems were built on paper-and-pen record keeping, which had significant limitations.
Terumo Americas realized a move to a modern, digital system was in order.
Working in the highly regulated healthcare industry, every product Terumo Americas produces has a unique device history record (DHR). This DHR contains all documentation related to manufacturing and tracking the device and demonstrates that the device was manufactured according to its approved design. This record is critical for its role in quality control as well as affirming that devices are compliant with regulatory standards.
Until recently, this data was input manually, on paper, during every step of the production process. Not only did manual entries leave a scope for discrepancy and errors, itbut it also meant pouring through inches-thick paper files page by page if a discrepancy was found. In fact, 90% of audits of potential manufacturing issues did not bring to light the issues with products, but rather paperwork errors that were not so simple to identify.
Clearly, it was vital to not only move beyond a system with reams of paper records requiring years of physical storage, but also to help Terumo use leading digital technology to drive innovation. A move to transform its manufacturing processes and incorporate electronic device history records (eDHR) would not only streamline compliance processes but would also unlock the power of its vast institutional knowledge through better access to, and analysis of, data.