Hany Abdel-Motaleb

1. What is the best way to start with data management for medical device manufacturing?

Collect data electronically. This may be the single easiest way to cut down inspection time and eliminate operator errors compared to manual data collection. Mitutoyo customers see a 50% reduction in inspection time when sending data directly from the tool or machine. In addition to improved efficiency and throughput, the risk of handwritten or keyboard entry errors is eliminated.

But electronic data collection is only half the story. Whether you run a large-scale operation or are a small-to-medium enterprise, consider where and how to store the data. Having all quality data on Mitutoyo’s MeasurLink® database supports quick and efficient reporting and analysis. Engineers and managers can monitor and analyze production data in real-time to take immediate action as well as identify areas for improvement. Easy backup and restoration of the company’s historical data further mitigates risk. This is essential if parts are subject to federal oversight such as U.S. Food and Drug Administration (FDA) 21 CFR Part 11.

2. What are the advantages of a quality data management systems? Data management identifies issues, making them easier to track and fix. Users have reported:

  • Reduced inspection, rework, and scrap costs
  • Overall process improvement
  • Better part quality and consistency
  • Greater data visibility and accessibility
  • Ease of use in quality and manufacturing
  • Data retention for relational databases

The biggest advantage is when real-time data collection is implemented at the point of manufacture, allowing instant analysis, troubleshooting, trend spotting, and efficiency improvements.

3. Can plant-wide data collection systems be rolled out on a budget?

Not only can plant-wide data collection be implemented on a budget, utilizing electronic data and performing statistical process control (SPC) reveals a quick return on investment. Plus, many companies already own and use high-quality Mitutoyo gages equipped with SPC output so they are ready for use in a new system, eliminating the cost of replacement gages.

4. With technology advancing rapidly, will I have to consider replacing measurement and data collection systems in a few years?

Solutions can be flexible enough to meet current needs while preparing for the future. All of Mitutoyo’s data management products are modular and independent from the tools, allowing for use on different gages as needed. The same data management hardware can be repurposed for future applications. Our software options are also scalable, allowing users to increase usage easily as required.

5. US FDA-regulated medical device makers mostly validate manufacturing hardware and software. How can data management systems ease that process?

FDA-regulated industries implement controls so electronic records are trustworthy and reliable. Mitutoyo’s MeasurLink® software and data management hardware are system components that collect and store all critical measurement information. Mitutoyo works with medical device manufacturers to provide all the necessary documentation so that validation can be performed easily, efficiently, and to FDA requirements. MeasurLink® also works on virtually all electronic Metrology equipment and eliminates the need to validate multiple software pieces.

For more information: https://www.measurlink.com