IMC-2020 Presentation 18:21 Minutes

by Cody Remington, Enasys

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. 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. 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.