Supply chain complexity hampers medical device company operations, compliance
A survey of medical device industry professionals reveals insufficient systems for complying with industry mandates and maintaining supplier quality. Nearly 60 percent of respondents reported that they had not begun preparing for the electronic medical device reporting mandate (eMDR), which requires automated submission of post-market adverse events.
Despite the FDA's recently announced timetable, nearly 60 percent of medical device industry professionals report that they have not begun preparing for the electronic medical device reporting mandate (eMDR), which requires automated submission of post-market adverse events. Without adequate preparation for this mandate, companies not only remain exposed for potential fines and citations, but also for greater device safety issues if they don't report and resolve these issues quickly.
These are some of the findings of a survey released this month by Sparta Systems, maker of enterprise quality management and compliance software. Sparta conducted the survey of medical device industry professionals at AdvaMed's MedTech Conference in Washington D.C.
The survey found that although 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.
"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," said Mike Jovanis, vice president, product management at Sparta Systems.
Efficiency remains the chief concern of medical device company managers 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.
According to the survey report, 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 to ensuring the quality of finished products.
Fifty-six percent of respondents reported using more than seven overseas suppliers, and 70 percent indicated that they work with suppliers in more than four different countries. Eighty percent of professionals surveyed said they prioritize supplier relationships based on the level of risk and safety they present to the greater manufacturing operation.
Seisa Medical is an ISO 13485-2003 certified contract manufacturer of complex medical devices and components. It operates plants in Cd. Juarez, Mexico, and in Myjava, Slovakia. It is not known if Seisa participated in the survey.
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. The survey found that IT system deployments were evenly split between business unit-specific implementations (39 percent) and those that spanned the global enterprise (43 percent).
The survey also found that customer complaints, a common occurrence in the device industry, were handled mainly via quality management (QMS) applications (45 percent). Other ways to track, trace and report complaints included standard electronic databases (30 percent) and homegrown solutions or paper-based processes (12 percent).
Jovanis said, "While some organizations are making progress, many legacy IT solutions in the device industry are falling short of meeting global, enterprise-wide 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."
Click to get more information about the survey, Sparta Systems , and its TrackWise software for managing quality and compliance issues.
- Edited by Renee M. Robbins, managing editor, MBT www.mbtmag.com