Medical Device Manufacturer’s Continuous Improvement Approach Reduces Errors in Records

Quality In Manufacturing

MEDRAD: Critical Elements for Major Improvements

Situation Analysis

The MEDRAD packaging team worked 685 hours of overtime in 2007 and 443 hours in 2008. In addition, two temporary employees were needed each year to keep up with the workload. Overtime and expenditures on temporaries totaled $40,000 in 2007 and 2008.

In early 2009, Shawn Simpson, a Six Sigma Green Belt and process analyst and leader in the packaging area, assembled the Critical Elements improvement team to try to rein in these costs.

Quality Solutions

Looking for the “critical elements that lead to major improvements,” the team followed MEDRAD’s trademarked continuous improvement methodology, IMAGES®:

Identify the problem
Measure the current state
Analyze the root causes
Generate potential solutions
Experiment and then Execute proven solutions
Sustain improvements over time

During the early phases of the project, quality tools like an affinity diagram, time studies, and process mapping helped reveal areas for improvement. Solutions focused on reducing waste in staff time spent obtaining parts, putting parts away and moving parts to storage locations, working on the computer, and conducting necessary SAP (systems applications and products in data processing) system transactions.


The improvements the Critical Elements team implemented had the following tangible results:

  • Savings of $160,945
  • New layout incorporating six new products while reducing overall space by 48 square feet
  • Increase in packaging team capacity by 35 percent
  • Elimination of all SAP transactions
  • 24-percent reduction in cycle times

Reductions in waste and non-value-added steps also contributed to improved customer satisfaction and employee satisfaction.

Along with providing many benefits to MEDRAD, the Critical Elements project was a finalist in the 2010 ASQ International Team Excellence Award process.

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