The level of operational efficiency strongly dictates manufacturing profit. How can it not, as it is the ratio between output gained from manufacturing and the input required to produce it. For the Medical Device manufacturing industry, however, the relationship is a complex one, as increasingly sophisticated products and stringent regulations require multiple processes and checks. Moreover, increasing efficiency means nothing without maintaining, or even improving, quality.

Manufacturing Execution Systems (MES) have been gradually adopted over the last decade in the manufacture of medical devices. To meet the ever changing demands of the marketplace, however, MES also needs to change and adapt. The market now demands increasingly intricate and often customized or even personalized solutions. Quality expectations are also higher and compliance with requirements of agencies such as the FDA progressively stringent. And rightly so – the FDA has product quality at the top of its priority list because they must protect the safety of patients.

New technologies and ways of delivering healthcare, including proactive self-monitoring has led Individuals to expect much better medical outcomes at a lower cost. In addition, continued research as well as non-traditional competitors, such as Google and Apple making in-roads into the Medtech space is opening up many opportunities to deliver healthcare in more efficient ways. For example, the ability to produce patient specific devices provides a way to personalize and tailor care needs to the individual. ‘Lab on a chip’ (LOC) technology is another example. This greatly increases automation and throughput for screening – enabling faster analyses at reduced costs.

So what has changed to enable economic production of patient-specific devices at high quality?

The answer lies new Smart Manufacturing methods coupled with the ability to leverage the Internet of Things (IoT) to gather large amounts of data and turn it into valuable, actionable intelligence. A modern MES is the foundation required for manufacturers to fully realize the multiple benefits, flexibility and efficiency throughout the production process and keep pace with the constant change of the modern world.

Modern MES solutions are designed to reduce the need for human interaction with the production process. This frees up valuable resources for other tasks and reduces the risk of human error – adding to both efficiency and quality. They also make use of the masses of real-time data that is now produced from the shop floor. The low cost of sensors and electronics means there is more information coming from the production processes with materials, assemblies and production equipment communicating and passing data into the MES. This real-time data provides the intelligence required for swift decision making and enables operators to react more quickly to production problems. In turn, this means less re-work is required and fewer corrective action plans need to be opened.

Other areas where the MES can help improve efficiency include equipment maintenance. By integrating maintenance management into the MES, it can control activities to maximize equipment availability and minimize impact on production. Using data from plant machines, it can determine what actions are needed and even predict possible risk areas; deploying technicians when and where needed and optimizing the use of their time. Areas such as calibration can be monitored and controlled – ensuring calibration certification is maintained in a timely manner while, again, minimizing impact on production time.

Future-ready MES and Big Data

One of the big changes with a future-ready MES is its ability to make the use of the increasing masses of data available from a shop floor. First and foremost, this removes the need for paper records as all information can be held by the system and be made readily available when and where it is needed. By handling this data in new ways and treating the shop floor as a de-centralized production model, the production environment also becomes an inherently flexible one.

What does this mean? Well, this is where the ability to economically individualize products comes in. Production no longer need be a linear process but more like a dynamic marketplace where products or assemblies can choose their path through the shop floor based on what processing needs they have. This fundamental change in the approach to manufacturing also means that continuous adjustments and improvements can be made to processes – helping to build quality into a product rather than inspect it at the end.

Overall the next generation of MES are helping to redefine MedTech manufacturing. Their flexibility, dynamic nature and ability to handle and analyse masses of shop floor data (Big Data) dramatically increases operational efficiency. The intelligence gleaned from production of current products can also be used to facilitate more rapid introduction of new products. The ability to dynamically change production also means engineers are no longer constrained by the limits of the production line and the path is cleared for even more ingenious innovations to be realized. As all of these boundaries are lifted, who knows what wondrous technologies will be available for medical care in the future!

Über die Critical Manufacturing Deutschland GmbH

Critical Manufacturing empowers high performance operations for some of the most advanced manufacturers worldwide with innovative software technology and advanced services. Its new generation Manufacturing Execution System (MES) is an Industry 4.0 centerpiece, incorporating all necessary integration, mobile, connectivity and logical decentralization features. This deep, unified system increases performance, control and quality for complex manufacturing operations. The company is part of the Critical Group, a private group of companies founded in 1998 to provide solutions for mission and business critical information systems.

For more information, visit

Firmenkontakt und Herausgeber der Meldung:

Critical Manufacturing Deutschland GmbH
Maria-Reiche-Str. 1
01109 Dresden
Telefon: +49 (351) 4188-0639
Telefax: +49 (35205) 120020

Tom Bednarz
Managing Director / Geschäftsführer
Telefon: +49 (351) 41880639
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