Terumo Americas
Selected: Siemens Opcenter Execution for Medical Device and Diagnostics
Manufacturing context
Industry
Medical devices
Manufacturing type
Regulated medical-device manufacturing
Country
United States / Americas operations
Starting point
Type
Existing MES
What was in place
Terumo had previously implemented the Camstar Medical Device Suite at manufacturing facilities. In 2018 it began a broader digital transformation of business logistics and manufacturing operations.
Existing ERP
SAP S/4HANA (selected as the ERP standard)
What they needed
Reason for the MES decision
Integrate ERP and manufacturing operations, reduce paper and manual quality processes, improve compliance processes, and support digital factories.
Selection
Selected
Siemens Opcenter Execution for Medical Device and Diagnostics (Siemens)
Why it was selected, according to the source
The source identifies Siemens' medical-device experience, FDA and validation knowledge, SAP integration, prior MES implementation experience with Terumo, and a strategic working relationship.
Integration and operational requirements
ERP integration
SAP S/4HANA and Opcenter were intended to connect business logistics with manufacturing operations.
Quality
Paper-based and manual quality documentation and electronic device history records were central issues.
Regulatory context
Terumo manufactures Class III medical devices and operates under significant FDA compliance requirements.
Implementation
Rollout
Puerto Rico and Elkton, Maryland implementations are documented. The large Elkton site used a phased approach by value stream.
Internal resources
Terumo emphasized building knowledge internally rather than depending entirely on external partners.
Reported results
Siemens reports reductions in batch-material release time and documentation-related errors.
These outcomes are reported by a vendor-controlled source. They have not been independently verified.