Up-Leveling Medical Device Manufacturing Through Technology

Richard Tree, Chief Operating Officer, CAI

The Manufacturing Execution System (MES) has been a hot topic for the last two decades across multiple industries. Manufacturing leaders recognize an MES’s role in effectively executing manufacturing operations and improving production output. MES is a powerful tool that can deliver process efficiencies, yield improvements, cost avoidances, and ensure that processes are done right the first time.

For the medical device industry, manufacturers face several challenges and factors that need to be considered – from problems with quality and product recalls to navigating a stringent regulatory landscape. And in today’s ever-changing landscape, traditional manufacturing systems no longer suffice.

This is where the MES plays a pivotal role. Leveraging a computerized system provides centralized authority over manufacturing process changes that can be rapidly and accurately deployed across an enterprise and improve “time to patient” without sacrificing quality. However, ensuring a successful MES implementation always starts with goal development and detailed planning in the beginning stages.

MES role in compliance

In the medical device industry, development can be a complex task. Not just from the design perspective, but there is an added layer of difficulty to ensure that manufacturing processes adhere to FDA compliance – and for international companies – ISU compliance. Before executing manufacturing systems, establishing operational readiness – meaning the facility, people and process are ready to meet market demand – is key to safeguarding any unforeseen hurdles and satisfying compliance guidelines.

There is an extremely narrow margin of error; thus, it is essential to understand the critical role risk management and traceability play in compliance. This should be evaluated at each stage of development. A properly designed and configured MES drives standardization and process improvements at each step while reducing human error due to individual interpretation of standard operating procedures and manual processes. Adding the electronic batch record (EBR) option to the MES provides enhanced data management and expedited batch release options.

Achieve customization demands

The importance of customization in the medical device industry is not new. But more recently, there has been an even more significant shift in demand for customized products. For medical device manufacturers, a variable often underestimated is the effort required to validate customizations. And when it comes to manufacturing processes, there is likely seldom discussion around how the customization may complicate life cycle support and product upgrades. Initial design and configuration can add technological debt, making ongoing customization prohibitive if the requirements for customization are not clearly understood and documented. To avoid these pitfalls, MES vendor selection is critical for manufacturers seeking to add new products on an ongoing basis. An MES helps foster mass customization of products and allows manufacturing to respond to rapid product changes.


Automation has grown in importance in today’s manufacturing landscape, shifting the industry to rely more heavily on technology’s role. New technological advancements, industry 4.0 practices, machine learning, and machine-to-machine communications are changing the medical device market and creating opportunities for manufacturers to seamlessly and efficiently error-proof complex production processes and de-risk the chances for common causes of manufacturing errors.

Through an MES, device manufacturers can improve production efficiency, enhance quality, facilitate compliance and meet demands. As the design for the MES progresses, corporate strategies for digital maturity, continuous improvement, new product introduction, and quality systems approach should be driven into the system design and selection. Change flexibility and the ability to pivot for regulatory changes and technological leaps quickly will be vital in maintaining and reducing the cost of goods sold (COGS) as in the case that a manufacturing issue is uncovered, these new technologies can quickly and effectively isolate products that must be recalled. As the adoption of MES becomes more prominent in the industry, it will impact the medical device industry in several ways.

Manufacturing Execution System, medical device, MES


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