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 and provides innovative medical solutions in over 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. However, many of Terumo Americas’ legacy systems were following a paper-based record keeping system, which had significant limitations.
Terumo Americas realized that 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 device tracking and demonstrates that the device was manufactured according to its approved design. This record is critical 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, it but 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.
It was imperative to move beyond a system with reams of paper records requiring years of physical storage, 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 streamline compliance processes and unlock the power of its vast institutional knowledge through better access to, and analysis of, data.
Terumo’s commitment to quality and the greater good of society aligned perfectly with TCS’ purpose of building greater futures through innovation and collective knowledge. This alignment was a driving factor in Terumo selecting TCS as its growth and transformation partner.
TCS conducted a thorough audit of Terumo’s operations and analysis of its needs. Understanding that Terumo was looking to overhaul its existing enterprise resource process system, including implementing 45 new programs all at once, TCS was able to advise how integrating a new manufacturing execution system (MES) could holistically meet the firm’s needs.
TCS helped guide Terumo on a path where the MES could deliver a complete eDHR. TCS’ strategy was to implement the MES from the very beginning of value streams, capturing far more information than is typical in other organizations—digitally.
This reduced the physical space needed to keep years’ worth of paper DHRs, and improved access to reliable and data-rich records, instantly. No longer would resources be dedicated to storing years of paper DHRs or to manually searching and retrieving historical data through rooms full of files. Rather, the firm’s energies could be spent on looking forward.
But getting there was not going to be easy—the plan was comprehensive, complex and would require a commitment by the entire organization. TCS’ process experts worked with Terumo’s technology leaders to clearly communicate the value proposition, and there was soon full buy-in from Terumo’s people — from global leaders to the production line.
What Made it happen