Industry 4.0 could be the key to overcoming challenges for medical device manufacturers. Andrew Steele reports.
Comprising 3,000 companies, employing 71,000 people and generating annual revenues in excess of £17bn, the medical device industry is a major part of the UK high-value manufacturing sector, according to Innovate UK.
Against a background of a quickened pace of technological change, there is a need to control and manage production, and particularly new product introductions, to ensure product integrity is guaranteed.
Fast moving markets mean more frequent changes in manufacturing processes, therefore, the opportunity for error increases. The human element bridging production systems always has the potential to introduce errors. Industry 4.0 and the application of manufacturing execution systems (MES) can mitigate this risk.
Key characteristics of MES include:
- ERP driven configuration control;
- Data recording for a complete manufacturing digital fingerprint;
- Real-time analysis of production data for instant understanding of issues;
- Information is harvested on machine status and order progress to optimise the manufacturing environment;
- Role-relevant reporting so the manufacturing team can take action.
MES provides a fool-proof means of interfacing the different elements in the production process: document management, ERP, machine tools and other physical assets.
The management of manufacturing instructions, delivery to the workstation, execution of operations and validation of each stage in this process is fully recorded to give complete proof of process to guarantee component configuration.
This is not to say that MES systems are inflexible
Document management can have many recipes for different products and variations within the core specification.
Seamless links with the ERP system allows for this and for full automated version control and confirmation of certification. Errors due to human involvement, in bridging communication between systems at the manufacturing level, are avoided.
MES systems deliver many other benefits, as Forcam can attest from experience interconnecting more than 60,000 machine tools and processes worldwide.
Events such as unplanned machine downtime, material shortages or quality issues are pinpointed, allowing the production team to respond quickly and go on to develop systemic solutions to avoid recurrence.
Every manufacturing process has a digital footprint. Data directly from machine sensors can be used to characterise in-specification production. Deviations from this, give early warning of potential problems.
A well-designed MES system, such as Forcam Force, is easy to reprogramme to produce different components quickly. Small batch sizes and even a batch size of one are economic so development and innovation, in a real manufacturing environment, carries lower cost.
A large scale pilot project is currently running with a major international medical device supplier at a plant in Ireland. This will guarantee product integrity and create a more agile manufacturing system that will produce a wider range of products in response to market demand and help reduce inventory in the supply chain.
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