Being Reactive, Not Proactive
In the majority of the nonconformity’s occurrences, there have been
reactions to resolve them rather than adopting any preventions to restrict
their occurrences by eliminating the possible causes. It is not the case
with medical device companies, it is, unfortunately, the case with every
other industry including automotive.
The reactive approach is not a long-term solution because organizations
are preparing for the nonconformities to happen while they should
identify the ways to prevent nonconformities from happening.
The medical device company doesn’t have easy access to all the data
sources, which keeps them at lagging position, not on leading.
There is a need for systems that can help identify issues before they
transform into bigger problems for end users as well as companies.