Growing Supply Chain Complexity Increasing Impact on Medical Device Operations

(Sparta Systems: Holmdel, NJ) -- A recent survey of industry professionals at top medical device organizations found that although the increasing complexity of global supply chains is changing how device companies manage suppliers, many (45 percent) feel their current quality systems are insufficient to mitigate compliance, risk, and safety issues associated with supply chain management. Among these and other key findings, the survey, conducted by Sparta Systems, indicated that efficiency remains device companies’ chief concern when managing overseas suppliers. Other priorities were evenly distributed among gaining insight into product sourcing, meeting differing regulatory standards, and managing regional supply quality issues. 

As device manufacturers continue to grow their supplier networks and source components from further corners of the globe, the need to identify and prioritize supplier relationships using a risk-based approach becomes critical in ensuring the quality of finished products. Of those device manufacturers surveyed by Sparta Systems, 56 percent reported using more than seven overseas suppliers, with 70 percent indicating that they worked with suppliers in more than four different countries. Eighty percent of those professionals surveyed purported to prioritize supplier relationships based on the level of risk and safety they present to the greater manufacturing operation. 

To manage supplier relationships and manage other quality and compliance processes, many companies have deployed sophisticated IT systems serving a range of additional functions in the global manufacturing operation. Among other key findings, Sparta Systems’ survey found that:

• Customer complaints, a common occurrence in the device industry, were handled mainly via quality management system (QMS) software applications (45 percent). Other ways those who were surveyed track, trace, and report complaints varied between standard electronic databases (30 percent) and homegrown solutions or paper-based processes (12 percent).

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

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

“Stringent standards in the medical device industry continue to drive the advancement of quality and compliance processes at manufacturers, yet much work remains to be done,” says Mike Jovanis, vice president of product management at Sparta Systems. “While some organizations are making progress, many legacy IT solutions in the device industry are falling short of meeting global, enterprisewide quality and compliance requirements. Medical device manufacturers will need to embrace the concept of consolidated quality systems and implement enterprise-class solutions that track and manage quality and compliance processes, while integrating with adjacent applications.”