Integer, one of the largest medical device outsource (MDO) manufacturers in the world, has selected Critical Manufacturing’s Manufacturing Execution System (MES) to enhance quality and efficiency of its global production processes. The company provides innovative, high-quality medical technologies in the cardiac, neuromodulation, vascular and the portable medical markets.
Integer intends to implement the full suite of Critical Manufacturing MES modules following a pilot project that will take place at an Integer site in Ireland. If successful, the Critical Manufacturing MES will roll out as an enterprise-wide product and value stream solution to Integer’s manufacturing sites worldwide.
Jennifer Bolt, senior vice president of Global Operations at Integer, said, “We selected Critical Manufacturing following in-depth evaluation of solutions available, covering product functionality, service, pricing, and system support. This is an exciting step on our journey to excellence as we digitalize our production processes and add new levels of quality, efficiency and traceability to help us serve our customers and their patients.”
The focus of the Critical Manufacturing MES deployment at Integer will be to enhance quality and remove manual and repetitive paper-based steps from production processes. The inherent traceability within the MES will further provide electronic device history records (eHDR), enabling greater control of manufacturing data and documentation and a seamless connection between production and quality.
Mohamed Benkirane, VP, Medical Device Practice, at Critical Manufacturing, commented, “Medical devices are becoming increasingly sophisticated with complex production processes. Our MES has been designed with specific features to serve this market. It enhances quality through tighter process controls and by replacing outdated error-prone manual processes. This also increases productivity, lowers costs, and provides manufacturers with more agile production capabilities, enabling them to react more quickly to customer and market demands.”
Inherently modular and scalable, the Critical Manufacturing MES provides a pathway to Industry 4.0 manufacturing. It delivers advanced integration capabilities, bringing together data from legacy equipment and new, distributed edge-processing devices, and then adding the context needed to reveal powerful insights for continuous improvement. All product and process information are collected and stored in complete, self-auditing eDHRs, making quality and regulatory compliance a natural outcome of the manufacturing process instead of a reactive procedure, easing the pain of audits.
Benkirane stated, “We are delighted to be working with Integer and look forward to a long and successful relationship.”