CIMdata PLM Industry Summary Online Archive
18 December 2008
Implementation Investments
Cochlear Sets Quality Standard with Dyadem
Dyadem has announced that Cochlear Limited, an industry leader in hearing implant innovation, is using software from Dyadem to enhance and standardize its quality assessments. Dyadem’s FMEA-Med, a software solution that helps automate compliance reporting, enables Cochlear to link risk and quality assessments, and to set a new standard in quality for its hearing implant solutions. Cochlear’s solutions enable thousands of hearing-impaired to improve their range of hearing and live fuller lives.
FMEA-Med is a software solution that delivers industry-standard Failure Mode and Effects Analysis (FMEA) reports for medical device and pharmaceutical manufacturers. The FMEA methodology improves quality and prevents potential flaws in hardware design and manufacturing processes in a variety of industries. Dyadem’s FMEA-Med helps manage Quality Lifecycle Management processes, and was built to reflect the unique standards and operating environments of the medical device industry. This is essential to an industry that is regulated heavily, and where poor product quality has unique consequences.
With sites in both Australia and Sweden now using FMEA-Med, Cochlear is able to standardize its risk assessments and risk rankings, allowing it to keep track of specific FMEA studies and compare the design and production processes for all implant components. “Previously, different terminology and risk rankings were used across various departments and components, making it difficult to accurately compare and link DFMEA (Design FMEA) and PFMEA (Process FMEA) studies,” said Anna Windevall, Manufacturing Operations Engineer, Cochlear Bone Anchored Solutions in Sweden. “With Dyadem’s FMEA-Med, Cochlear can now link and share studies across departments and sites, making it much easier to implement a company standard of quality based on comparable and accurate risk rankings.”
Previously using a basic spreadsheet for its studies, Cochlear quickly found that the cumbersome documentation and inability to link studies made for a frustrating assessment process. Since implementing FMEA-Med, Cochlear has been able to more easily show management where investment dollars should be allocated, allowing it to remain the market-leader in its industry and ensuring that its high standard of quality remains consistent.
“Cochlear’s commitment to quality is one of the reasons it has remained an industry leader,” said Kevin North, President and CEO of Dyadem. “Medical device companies have traditionally had challenges ensuring consistency and accuracy in their risk assessments, but with our Quality Lifecycle Management solutions, we have given the industry a legitimate opportunity to address this. Cochlear is proving how easy it is to create quality products, be on the cutting edge of technology, and improve competitiveness and productivity, all at the same time, and without compromise.”
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