Quality is the #1 concern for OEM engineering and purchasing managers in all industries, but nowhere is quality more critical than in the manufacture of medical devices.
Because the reliabilty of medical devices can be a matter of life and death for patients, medical device manufacturers cannot tolerate defects or quality problems in even the smallest part or metal stamping.
Kenmode is developing a blog article series entitled "10 Metal Stamping Quality Indicators for Medical Device Manufacturers" to help medical device manufacturers evaluate the level of quality in their metal stamping suppliers. The series will consist of 10 articles, published weekly. Each article will focus on a single quality indicator.
The issue of medical device quality was raised in a report published by the United States Food and Drug Administration (FDA) in October 2011. The report indicates "serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001."
The FDA study entitled Understanding the Barriers to Medical Device Quality, points to the growing innovation and technical complexity of new medical devices as once cause of the growth in adverse events. The FDA's findings also fault quality control in design and manufacturing. The report states "...failure in product design and manufacturing process control caused more than half of all product recalls."