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Automated MES System for Medical Devices

By Cody Remington

Medical device manufacturing is an extremely complicated process using advanced manufacturing techniques. However, the methods for tracking processes and keeping records in many companies has not changed since the industrial revolution. Handwritten travelers or shop travelers are still used today, despite the easy chance of human error. This was the case with one of the largest medical manufacturers in our region. The effects of the archaic system were making an impact on the company’s bottom line. They were seeing losses of $100,000 due to scrapped products,  human error, long training times, lost documents and processes that took much longer than they should.

The process was a proven six-step procedure for one product, and a four-step procedure for another product. There were critical times at each station to ensure the operation was successful. They were using kitchen timers at each step, rack numbers to track each batch, and handwritten notes to keep track of it. This manual process created many areas where human error could cause an expensive mistake by scrapping the product. Some of the common errors that caused scrapped products were:

  • Bringing the product to the wrong station
  • Pulling the wrong rack out of a step
  • Leaving a rack in a step too long or too short
  • Running the wrong process on the product

There was also the possibility of doing a process wrong and not catching the error.

Enasys MES provided a solution to automate their traveler process using RFID with readers set up throughout the process. With Enasys MES, each batch of racks is enrolled in a specific process with monitors set up throughout the facility showing  the steps the production assistants need to follow. From there, each station has a series of preprogrammed times that automatically start when the product enters that station. If the product goes to the wrong step, stays too long / or short, or the time to go to a new station takes too long, the Enasys software sends an alert that the production lead can correct to salvage or scrap.  

The software records all of the information and creates a series of custom reports to help management track the process, stay compliant, and optimize the process.  Instead of organizing mounds of papers work, the team can push a button and get the actionable intelligence. The ROI is less than a year just in reducing the scrapped product, not to mention the savings in time and compliance.

Enasys MES is fully configurable to allow for customized workflows and alerts. Each station can have alerts for time, batch tracking, product groupings, and customizable text fields for calibrations, notes, and additional information.

Contact us today to find out how Enasys can improve your efficiency by automating the tracking of your manufacturing processes.

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