Jason McGlynn, commercial manager at industrial metrology specialist, The Sempre Group shares a model for success for unifying fragmented data throughout the product lifecycle and realising Industry 4.0, as well as the benefits that come with it.
Metrology is fundamental to ensuring a medical device operates to design intent and therefore meets the safety and performance requirements for the patient, such as measuring critical features of an insulin pen or inhaler device to ensure that it dispenses the correct dose. Medical devices are becoming more complex and less intrusive, bringing added complexity. Customers require nano and micro precision measurement equipment that is repeatable, reproducible and compliant. From dimensional to surface characterisation and contamination, there are many applications for measurement throughout the product lifecycle.
Though ISO 13485 and many other standards lay out how to maintain an effective quality management system in line with regulations, there are still many decisions for medical device companies to make. The two regulations are due to be combined soon, but historically the FDA has not mandated traceability between stages, while ISO 13485 has, so many companies will be looking for guidance on how to improve quality in line with the new, combined guidance.
The Quality 4.0 revolution
Industry 4.0 brings with it a data-driven, digital approach to quality, which can help medical device manufacturers improve decision making, traceability and reporting. Quality 4.0 would make clear if anything changed on the line, where, why and how it happened, providing complete data integrity and traceability.
The first component of Quality 4.0 is to integrate quality management into an electronic quality management system (EQMS) in line with ISO 13485 and 21 CFR part 11, to prevent any human errors or duplications that occur when working with paper. Then, incorporate programmable systems to automate key manufacturing and measurement processes, as well as to automatically collect data.
Connectivity is king — pulling together all data and integrating it with your manufacturing execution system (MES) means you can assess top level trends and take proactive decisions to decrease scrap and boost productivity. As a result, compliance is easy — users can automatically generate reports to comply with relevant standards.
Full visibility, total data integrity
Let’s consider some examples. A small medical device company is looking to bring its first product to market. It needs to make sure that what the measurement system meets the design authority intent as outlined in the drawings. However, it is unable to link the measurement data with the 2D drawing and 3D model accurately — if a failure arises, how can the manufacturing team tell where it occurred? Using artificial intelligence metrology software, you can now link the two together and overcome this challenge.
A larger medical device company can work with several contract manufacturing organisations (CMOs) globally. All CMOs are working from the same drawing, but the products are measuring differently across locations. The problem has occurred because the MDC is struggling to standardise its approach to measurement data and reporting from across the locations. A software platform could link all the sites into one interactive system, so the medical device company can support CMOs through continuous improvement.
A fully integrated approach to metrology and quality removes the challenges associated with integrating data from multiple sources. A software platform like High-QA and ProLink, can connect to all measurement and manufacturing systems, integrate with an MES, and provide a foundation for tracking and trending data throughout the product lifecycle.
A Quality 4.0 approach can help bring products to market more quickly. But many of the benefits come during manufacturing, by ensuring measurement systems are accurate, repeatable, and reproducible to the design intent. In addition, getting metrology equipment right first time during the NPI phase can drastically reduce the time it takes to perform measurements during validation, removing metrology bottlenecks and speeding up production. In addition, staff can move away from monotonous inspection roles into more productive ones.
The connectivity inherent in Quality 4.0 can also provide the visibility needed to improve yield. Manufacturers can identify and address anomalies, reducing the number of defective products.