July 31, 2012
Kenmode Precision Metal Stamping has published a guide for medical device manufacturers to help them evaluate quality and identify best practices in metal stamping suppliers. The e-book, Ten Quality Indicators for Selecting Metal Stamping Suppliers, is based on findings published in the U.S. Food and Drug Administration (FDA) report entitled "Understanding Barriers to Medical Device Quality." The guide is available for free download at www.kenmode.com.
According to the FDA report, published in October 2011, the medical device industry has doubled in size in the last 10 years, while "serious adverse event reports related to medical device use have outpaced industry growth by 8 percent per annum since 2001." According to the report, "the sophistication of tools and practices used to drive quality and reliability through the medical device value chain does not appear to have kept pace with the increase in device complexity."
The e-book describes how metal stamping quality depends on such factors as a companywide commitment to quality and ISO standards, rigorous risk management and change control, prevention-focused process control that employs advanced metal stamping technology, and careful supplier selection. The FDA highlights seven major opportunities for improving quality in the medical device supply chain, covering enhanced operating systems, management infrastructure, and mindsets and behaviors related to quality.