Terumo Americas

Terumo Americas, a global medical device manufacturer of Class 3 devices, needed to integrate business logistics (ERP) with manufacturing operations (MOM) and connect with automation and sensors to build their Industry 4.0 framework. They needed to scale production of quality products and processes while meeting complex FDA compliance requirements.

Terumo selected Siemens as their strategic MOM partner, implementing Opcenter Execution for Medical Device and Diagnostics alongside SAP S/4HANA. The system was deployed simultaneously at facilities in Puerto Rico and Elkton, Maryland, achieving electronic Device History Records (eDHRs).

Both implementations were extremely successful with same-day go-live alongside SAP. Material batch release was reduced from a full day of reviewing 5-inch paper stacks to under 30 minutes. NCRs and complaints were reduced by 40-60%. Paper-based nonconformances were eliminated.

• Simultaneous MES and ERP deployment is achievable and reduces integration risk
• eDHR generation is the pinnacle MES goal for medical device manufacturers
• Eliminating paper-based processes removes a major source of product nonconformances