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About Effect of Medical Device Quality Performance on Business Performance


A company’s quality performance can affect its business performance in multiple ways. For example, quality issues or the lack of them can enhance or impair market reputation; quality failures or failure prevention efforts affect costs; and the impact of quality on customer satisfaction can alter revenues. In extreme cases, quality issues can force the removal of a device, or a company, from the market.


The industry’s transformational growth and innovation have placed new burdens on quality systems. Evidence of this includes an increase in serious patient adverse events reported to the U.S. Food and Drug Administration (FDA) - those resulting in hospitalization, disability, or death - which is about twice as fast as the increase in the overall medical device market.


Quality issues rightly concern every stakeholder in the medical device value chain, from manufacturers and regulators to payors, doctors, and patients. Media attention
has increased, and investors have severely punished some companies with quality issues. In the past decade, an average of one company per year has seen a 10 percent drop in share price after a single, major quality event.


The medical device industry is approaching a tip-ping point where the increasing likelihood of a quality event, the rising costs of such events, and the public nature of quality performance will force companies to focus on quality and reliability throughout product design, manufacturing, and marketing.


The good news is that companies in a wide range of industries have developed approaches that help them build quality into processes at every step of the value chain - from design and manufacturing to sales and service - which will lower costs over the long term.


Ref.: (
the_business_case_for_medical_device_quality.ashx )


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