by Matt Giza, Executive Vice President & General Manager
This article is worth a read by anyone involved in medical device design or medical device manufacturing. The article discusses the various trends in medical device recalls, leading causes, growth rates by percent and category, and more. It also digs into software controls and reminds us how important the proper design discipline and risk management processes are. In an industry where a flaw in hardware or software design can provide catastrophic results, it’s critical to incorporate and abide by the regulations for design, including risk management and mitigation – and most fundamental, learning from mistakes and not repeating them. It’s alarming to see the trends of recalls and the high frequency of recurrence. One sentence I found very interesting in the article is, “Therefore we must again ask whether the information provided in this article indicates a problem that is more behavioral than technological.” What can you and your firm do to reduce recalls, execute industry leading risk mitigation strategies, and develop, manufacture, and distribute safe products for all to benefit from? Does your company promote a culture of proactive continuous improvement and risk mitigation?
The article can be found in MDDI (Medical Device and Diagnostic Industry), July 2016 issue or a more detailed version online in 4 segments.