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Digitalized Compliance for Medical Devices
Learn how we delivered a state-of-the-art MES to help a customer transform data collection processes on their factory floor.
The customer is a leading global medical device manufacturer that designs, develops and produces products for different medical fields including cardiology, interventional radiology, orthopedics, electrophysiology and surgical management. The manufacturer was named among the top 100 medical device companies in 2018. They are also the sixth largest multinational producer of orthopedic products, including knee and hip replacement solutions.
First, our team of medical device industry specialists led an in-depth analysis of the customer's requirements to better understand their most pressing challenges and recommend the right solutions to address them. The analysis identified electronic Device History Record (eDHR) Management as the best and most cost-effective solution to improve process efficiency while ensuring quality control and regulatory compliance at the same time.
In order to enable eDHR and digitalize Work-In-Progress (WIP) on the shop floor, our IndX team then designed, developed and customized an end-to-end MES solution to replace the customer's existing legacy system, as well as a new Direct Numerical Control (DNC) system to provide the link between engineering, manufacturing planning and the machines on the shop floor. Our scope of work for this enterprise MES initiative included:
So, what is the real, measurable value gained by companies going paperless in the Medical Device Manufacturing environment? This customer is just one of many manufacturers in this sector with whom we are working on similar projects. Simply put, the use of paper to meet the stringent data collection and quality compliance requirements in this industry leads to a significant waste of time and resources whose skills could be better utilized in more value-add tasks. By going paperless, not only did our customer ensure consistent quality compliance, improve efficiency and streamline processes, but they will now be able to reallocate more of their resources and personnel to more complex and value-driving activities within their enterprise.
