INDUSTRY
- Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- A global leader in developing and manufacturing best-in-class medical device technologies, Terumo Americas realized the need for digital transformation in manufacturing.
- Its legacy systems stored information on paper-based mediums and 90% of audits of potential manufacturing issues identified were paperwork errors that were difficult to spot, and not product issues.
- Transforming Terumo’s manufacturing processes, incorporating electronic device history records, would unlock the power of its vast institutional knowledge through access to – and analysis of – data.
- TCS conducted an audit of Terumo’s operations and recommended the integration of a new manufacturing execution system (MES) that could meet the firm’s needs.
- The MES implementation increased data accuracy, allowed for better use of labor, material, and resources, and offered operational management complete visibility of the manufacturing process.
In this article
Overview
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.
Challenge
The automation challenge
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.
Our end-to-end MES transformation was not just about the technology. Process and personnel played critical roles. TCS helped us successfully orchestrate all three.
Solution
Building greater futures
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.
Benefits
Positioned to innovate
Having complete, readily available data gives Terumo real-time clarity on any manufacturing issues that may arise and reduces the time and cost of delivering data to satisfy compliance needs. The critical decision to move forward with an end-to-end MES system through the production process was the key component to maximizing the value that the overall ERP system upgrade now delivers.
The benefits from an operational perspective were numerous. The MES implementation increased data accuracy, as it was collected at all stages of manufacturing. It reduced human error by moving to a digital system that was simpler and more streamlined. Together, this allowed for better utilization of labor, material, and resources, with operational management having complete visibility at all levels of the manufacturing process.
Terumo’s partnership with TCS on the MES was an unqualified success. Organizations have been moving to similar systems with varying results, but TCS helped Terumo implement a holistic structure that delivers far more.
As more data is generated by the new digital MES, and as its ERP system evolves, ever more insights will be generated. Terumo plans to expand the MES to more factories and value streams, looking to continue leveraging the ongoing benefits for clients, staff, doctors, and patients
The commitment of the entire organization was critical to generating the value we knew MES could deliver. The opportunities it has created are clear to everyone.
What Made it happen
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TCS ADD™ is a suite of modern and open technology platforms for clinical research and drug development that helps make clinical trials more agile and safe.
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