There is a growing demand for flexible automation in medical device production. The key factors driving this need are increased production of assembled kits, cost reduction pressures and the requirement for shorter lead times and product life cycles, as well as FDA validation.

Keeping product yields high while maintaining consistent quality is crucial to successful medical device production. In addition to common manufacturing execution systems, the assembly process dedicated manufacturing execution system (MES) can help safeguard both product yields and quality by providing: product quality control; tracking and tracing; operator information; line flow control; production statistics; and automatic documentation for FDA validation.


To invest safely in MES, it is important to find software that suits the company’s process and covers all the information and logistics required in a step-by-step automated production, whether it consists of single serial lines or highly sophisticated logistical production systems.

“Successful MES implementations have led to dramatic improvements in assembly production.”

Product and process life cycle management is now possible using a modular step-by-step plug-and-play system that can adapt layouts – from manual assembly processes to fully automated lines – in line with business needs. Such a step-by-step approach to automation reduces a company’s investment risk and allows it to take a flexible approach to the automation process. A modular dedicated MES solution offers the following advantages:

  • It can adapt to future production mixes and volumes
  • Its plug-and-play software and hardware modules are highly reusable
  • It allows flexible production layouts and fast line reconfiguration
  • It is easy to introduce additional operations
  • It is possible to add build-to-order and full traceability functionality to the system
  • It can be developed in well-defined stages, thus reducing the financial and project risks


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The main requirements for assembly process MES manufacturing are: quality control; operator information; tracking and tracing; line flow control; automation cell integration; feeding and buffer control; dynamic enterprise resource planning connection; order execution; and statistics and reporting. The dedicated MES solution safeguards maximum utilisation of modular and reconfigurable assembly automation equipment.

Successful MES implementations have led to dramatic improvements in assembly production. These may include:

  • A reduction in work in progress of up to 90%
  • A reduction in manual documentation of up to 100%
  • An increase in production uptime of 30%–50% due to zero re-set time, no line clearance, through full batch control and dynamic line balancing
  • A decrease in order throughput time of 30%–90%
  • A reduced need for floor space of 30%–50%
  • An increase in production system reusability of 70%–80%

MES solutions should enable automatic data traceability throughout the production process, double redundant operator interface and individual/batch control line clearance. Furthermore, using an audit trail with password/user name handling, MES can support automatic documentation in line with FDA validation requirements.