Controlling the 5Ms in Medical Device Manufacturing | Automating Product Quality

By Riccardo Consonni

This is a fundamental truth in manufacturing: delivering quality products means controlling the 5Ms of manufacturing – material, man, machine, measure, and method. If you are in medical device manufacturing, you appreciate how hard that can be. And it’s getting harder. The introduction of new products, pressure to accelerate clearance, demanding customer expectations and customization, orchestration across multiple plants, and increasing regulatory pressure are just some of the challenges facing your industry.

If you are operating with paper-based processes, even knowing whether the 5Ms are in control is nearly impossible in this environment of constant change and mounting complexity. Manufacturing errors, lack of visibility, and excess overhead associated with slow, manual processes are tying your hands behind your back in this competitive sprint.

The good news is that, while the need to control the 5Ms hasn’t changed, the ability to control them has. Today’s Manufacturing Execution Systems (MES) are built to control today’s manufacturing processes. And they ensure compliance as well. In this increasingly digital world, manufacturers must have systems that adequately support them to be flexible, fast, and reliable.

Siemens is helping manufacturers stay in control with digital Manufacturing Execution Systems that enable them to manufacture, test and inspect products exactly according to their specs and give instant access to as-built data and a self-auditing electronic Device History Record (eDHR), so they can make faster and better decisions.

We have posted a recent series of blogs around the importance of controlling the 5Ms, and how today’s MES systems are empowering manufacturers to do just that. Now it’s time to see Siemens’ state-of-the-art MES in action.

Siemens’ Camstar Medical Device Suite is the leading MES built specifically for the medical device industry, including discrete, batch, and combination device manufacturers. The Camstar Medical Device Suite digitalizes manufacturing operations, enforcing highly efficient, compliant manufacturing processes that accelerate the delivery of innovative products, at the highest levels of quality.

Watch our new video to understand why it is the MES of choice for the Medical Device industry. Understand how the Camstar Medical Device Suite:

  • Automates control of the 5Ms

  • Creates a paperless manufacturing environment across batch and discrete operations

  • Delivers a self-auditing electronic Device History Record (eDHR) and electronic Batch Record (eBR)

  • Eliminates non-value-added activities

  • Enforces good manufacturing practices and regulatory compliance

  • Error proofs manufacturing processes

  • Accelerates and controls configuration and change management

Explore the Camstar Medical Device Suite in 10 minutes! Watch the video

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This article first appeared on the Siemens Digital Industries Software blog at