MES for Medical Device Manufacturers
Product and DHR have to be perfect!
MES creates the basis for paperless manufacturing and closed loop manufacturing
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- Challenges
- Goals
- MES solution
Challenges in medical device manufacturing
Increasing regulatory requirements for the authorization and distribution of medical technology products, for example in the form of the EU Medical Device Regulation (MDR), represent the biggest challenge according to inter-branch organisations.
They represent a considerable cost factor and demonstrably slow down innovation. At the same time, complex and increasingly fragile supply chains as well as the growing number of product variants increase the pressure to digitalize the own processes for a paperless manufacturing.
In summary:
- Increasing regulatory requirements according to MDR, FDA
- More complex authorization and distribution of products
- Individualised mass manufacturing of complex products
- Cost and efficiency pressures from design to manufacturing for a fast NPI
- Global dynamic competitive environment
- Product and (e)DHR must be perfect
Paperless manufacturing for medical device manufacturers
The goal of paperless manufacturing in medical device production requires the comprehensive digitalization of available systems and processes. This includes the replacement or integration of available systems to avoid media gaps in the transfer of information and data between development, planning, production and quality management.
In addition to the fulfilment of specific and often urgent functional requirements, the future security and investment security play a decisive role.
These goals can only be achieved with a modern MES system that is a central component of a forward-looking solution platform which digitalizes and integrates a wide range of systems and processes consistently.
Goals:
- Paperless manufacturing
- DHF eDHF
- DMR eDMR
- DHR eDHR
- self-auditing eDHR
- Continuous, bidirectional real-time data exchange between development, planning and production (PLM, ALM, MES)
- Ensuring compliance of standards
- Absolute FDA/MDR compliance
- Cost savings without losing quality
- Accelerated innovation (NPI)
- Visualized performance data (OEE)
A modern MES system, such as Opcenter EX MDD, provides a future-proof platform to digitalize and integrate all solutions and processes. It is the centre of a strategic digitalization of manufacturing processes through seamless integration with PLM, ALM, MOM and APS.
Therefore it creates the basis for regulation-compliant paperless manufacturing. Production models such as Digital Twin, Digital Thread or Closed Loop Manufacturing can be realised in the medium term.
MES benefits:
- Paperless manufacturing:
- DHF eDHF
- DMR eDMR
- DHR eDHR
- self-auditing eDHR
- Digital Twin
- Digital twin of product
- Digital twin of production
- Digital Enterprise
= ERP + PLM + MES
- Closed Loop Manufacturing
- Continuous, bidirectional real-time data exchange between development, planning and production
- Digital Thread to continually optimize production
Benefits (based on chosen customer examples):
