@Risk

A recent survey by Sparta Systems found that nearly half (45%) of industry professional at top medical device organizations feel their current quality systems are insufficient to mitigate compliance, risk and safety issues associated with their complex supply chains.

I suppose that’s no surprise –considering both the recent globalization of manufacturing and supply of medical products and the multiplicity of supply chain threats today.

One thing is clear, though: As medical device supplier networks become more and more complicated, it’s becoming increasingly critical for manufacturers to identify and prioritize supplier relationships using a risk-based approach that focuses on quality, compliance, and security.

Here are a few more interesting findings from the survey:

• 56% of survey participants reported using more than seven overseas suppliers.

• 70% said that they worked with suppliers in more than four different countries.

• 80% of those in the survey prioritize supplier relationships based on the level of risk and safety they present to the greater manufacturing operation.

• Customer complaints, a common occurrence in the device industry, were handled mainly via quality management (QMS) applications (45%).  Others surveyed said they track, trace and report complaints using standard electronic databases (30%) and homegrown solutions or paper-based processes (12%).

• IT system deployments were evenly split between business unit-specific implementations (39%) and those that spanned the global enterprise (43%).

• Despite the FDA’s recently announced timetable for electronic submission of post-market adverse event reports (eMDR), 60% of companies in the survey reported that their companies had not yet begun preparing for electronic submission.