To succeed in a highly competitive global market, every manufacturing organization has to strive to simultaneously improve their product quality, reduce production costs and minimize lead times. Medical device manufacturers often face additional challenges on top of these related to the management of paper Device History Records (DHR), which are required by regulatory agencies to record production details for each product manufactured. Effort related to creating, maintaining, printing, tracking, reviewing and storing DHRs poses a significant cost and effort for most medical device manufacturers.
Electronic Device History Record (eDHR) systems are designed to streamline DHR operations and provide several additional benefits related to electronic management of manufacturing execution. This is achievable because eDHR is one critical subset of functionality provided by a broader solution called a Manufacturing Execution System (MES). An MES is a control system for managing and monitoring work-in-process (WIP) on a factory floor. An MES keeps track of all manufacturing information in real time, receiving up-to-the-minute data from robots, machine monitors and employees.
When leveraged together, MES and eDHR systems can provide a wide array of benefits to regulated manufacturers including:
The goal of a Manufacturing Execution System (MES) is to improve productivity and reduce cycle times while still enabling manufacturers to produce quality products. Medical device manufacturing customers who have partnered with Engineering for their MES and eDHR initiatives have seen the following benefits: