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
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,
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.
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