Migrating to a digital infrastructure

The more comprehensive a manufacturer’s understanding of their entire value chain is, the more effectively they can optimize production, regulatory compliance, and ultimately, profitability. To get such intelligence, more and more manufacturers are adopting a manufacturing execution system (MES) to digitize, optimize, and streamline manufacturing operations across multiple locations.

Nevertheless, many medical device manufacturers have yet to participate in this digital revolution, and some may be reluctant to do so, based on unforgiving validation requirements providing no incentive for continuous process improvement.

Medical device manufacturers are finding the maturation of Industry 4.0, also called the Fourth Industrial Revolution (4IR), provides a digital infrastructure to reduce costs, simplify operations, enforce good practices, and enable new heights of productivity.

Additionally, regulatory bodies are recognizing a simpler validation approach that’ll benefit everyone. Moving from computer system validation (CSV) to computer software assurance (CSA), a risk-based approach, will ease digitalization in factories, make adoption of MES simpler, and smoothly guide life science companies toward Industry 4.0.

Platform for an industrial revolution

MES solutions are advancing rapidly within Industry 4.0, benefiting from a more comprehensive and flexible digital infrastructure. Solutions are now seamlessly integrated to facilitate real-time connectivity across multiple applications and resources within the extended enterprise. These changes signify notable shifts in nearly every MES operation, offering these advantages compared to traditional MESs:

• Where traditional MESs are only one piece of the puzzle, Industry 4.0 extends real-time connectivity to multiple applications and resources, including smart devices, sensors, switches, and other things in the Internet of Things (IoT) ecosystem. This increases the context and the granularity of information sources.
• Where traditional MESs data analysis is siloed on specific manufacturing topics and becomes more challenging as data volumes increase, Industry 4.0 promotes using advanced data analysis, machine learning (ML), and artificial intelligence (AI) to cut through massive volumes of data in seconds.
• Where traditional MESs don’t always integrate easily with other applications, or the supply chain, Industry 4.0 encourages widely accepted integration standards such as OPC-UA to enable connectivity with machines. Industry 4.0 initiatives make for seamless integration to enable sharing data with enterprise resource planning (ERP) applications such as SAP, Oracle, Microsoft Dynamics, and Epicor or product lifecycle management (PLM) applications, such as Qualio or Master Control.
  
• Where traditional MESs depend on data from local servers, Industry 4.0 content could sit in secure cloud or hybrid architectures. This implies centralizing and simplifying global access to data and other content, while significantly reducing investment in hardware and data storage costs.

This list of advantages and related technologies will certainly change, but for now, there are plenty of use cases on how Industry 4.0 can support traditional MES functionality. Examples include production scheduling and optimization, quality control, traceability, inventory management, maintenance, compliance, and strategic business decision making.

Advanced production scheduling, optimization

MES software sits between the ERP system and machines or other devices to synchronize operations from receiving an order to shipping. It optimizes resource allocation by dynamically scheduling jobs, assigning tasks to equipment and personnel, and managing work orders. Furthermore, MES controls the manufacturing process by monitoring equipment performance and maintaining quality control throughout the production cycle.

Having these details accessible in real time takes the guesswork out of scheduling and ensures resources are used more efficiently. This is now possible with MES as it can leverage order details and real-time insights into current production levels. This integrated approach enhances efficiency across the entire manufacturing process.

In addition to controlling standard production operations, an MES provides the required flexibility to adjust the current manufacturing processes and growing demands for a more personalized product.

Quality assurance

High-frequency sampling typically translates into higher quality assurance and lower potential risk for patients. However, this level of quality is traditionally offset by increased time and effort that are labor and paper intensive. Regardless of this, ensuring quality assurance remains crucial and implementing appropriate tools such as MES can significantly simplify this process.

With Industry 4.0, individuals can make more informed decisions regarding quality. This involves conducting tests or sampling at preset intervals to assess product integrity. Industry 4.0 also promotes configuration of systems to monitor operations in real time, ensuring the immediate analysis of results using key performance indicators (KPIs) or other strategic metrics, allowing for prompt sharing of results with stakeholders. Even more important, manufacturing processes supported by an MES can provide more control and avoid variability. With this reduced variability comes higher consistency. Product quality is significantly improved, leading to greater customer satisfaction.

End-to-end traceability

Traceability was a major driver in the first wave of MES adoption, and it replaced paper-intensive usage – in Industry 4.0, digital replaces paper. Users can search in real time via individual lot or serial numbers and can instantly locate compromised products. The scope of the problem is identified, and potential recalls reduced.

Predictive maintenance

In traditional maintenance approaches, manufacturers schedule maintenance or parts replacement based on time or usage. With the huge amount of data collected, analytical tools can predict maintenance needs and schedule machine activities based on time or usage patterns.

Inventory cost control

High inventory management can negatively impact ERP profitability. Lean and just-in-time manufacturing initiatives underscore the importance of effective inventory control and ensure an efficient supply chain, enabling better preparation for changes in demand.

Industry 4.0 helps by increasing access to machine data through tighter integration with the supply chain, managing contingency plans, and real-time status of production equipment availability.

Compliance automation

In addition to facilitating current operational effectiveness, Industry 4.0 drives significant advancements in MES processes and technology.

The greatest potential impact on process improvement is the U.S. Food and Drug Administration’s (FDA’s) Computerized Software Assurance (CSA) regulations allowing manufacturers to prioritize validation based on potential risk to the patient. Legacy regulations were nebulous and manufacturers became over-cautious. They refused to adopt technology or validated every step in a process, regardless of the impact on quality care. Implementing a risk-based approach to selectively validate processes potentially reduces costs up to 70% and improves the time-to-benefit of healthcare technology overall.

The best way for medical device manufacturers to take advantage of Industry 4.0 is to begin or continue to migrate to a digital MES infrastructure. Even if regulations stall, manufacturers will still be empowered with a tool simplifying the achievement of business and operational metrics (KPIs) throughout the entire manufacturing process.

About the author: Rogério Ferreira is area manager at Critical Manufacturing for medical device implementation projects.

Critical Manufacturing
https://www.criticalmanufacturing.com