Medical
PLMsysteMheLPs MedicaL device start-uP streaMLine Product deveLoPMent Process
Omnify's Empower PLMsystemhelpsmedical device start-up PathwayMedical Technologies streamline its engineering change process, provide secure document vaulting, and improve BOMmanagement, while reducing resources, eliminating errors and speeding up the product development cycle By Gina Roos
PathwayMedical Technologies, a developer of endovascular devices for peripheral arterial disease (PAD), has selectedOmnify Software's Empower product lifecyclemanagement (PLM) solution to automate its product development processes and ease compliance audit requirementswith InternationalOrganization for Standardization (ISO), and the U.S. Food&Drug Administration (FDA).
Aftermeeting its first hurdle and receiving FDA approval for its
first revascularization systemin late 2008, PathwayMedical Technologies, headquartered in Kirkland,Wash., started to commercially ship the product in the United States. The privately- held company employs about 170 people.
Ken Perino, senior director of quality assurance and regulatory
compliance for PathwayMedical,who had experience implementing PLMsolutions at othermedical companies quickly realized the company needed to streamline and automate its product development processes that consisted of a paper-based system.
"When I first started here all we had was paper-based
document control, engineering changemanagement and employee training systems," said Perino.
Based on his experience at other companies, Perino knewthat
implementing a PLMsolutionwas a key requirement for anymedical manufacturer. PLMsystems helpmeet regulations, streamline processes, cut costs, and eliminate potential errors, he said.
At the time, themedical devicemanufacturer was housing all of
its paper documents and drawings in a roomwith a checkout systemsimilar to that of a library. This set-upmade accessing product information a time consuming task for both daily product development practices and annual compliance audits.
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Themodularity of the Empower PLMsystemallows the company to buy what it needs immediately and be able to add-on othermodules later, said Ken Perino, senior director of quality assurance and regulatory compliance for PathwayMedical
After evaluating four PLMsolutions in late 2009, Pathway
Medical selected Omnify's Empower solution, primarily due to its modularity, fast deployment time and low cost. Perino said the modularity allows the company to buy what it needs immediately and be able to add-on othermodules later as the company's requirements grow.
The initialmodules purchased targeted document control,
engineering change order (ECO)management, employee training and qualitymanagement.
Perino noted that the companymay look into the supplier
module at the end of this year, which would allow its key suppliers to get involved a bit earlier upstreamin the ECO process.
Since PathwayMedical's initial goals with the PLM
implementation were to improve processes formanaging product documentation, part drawings, and engineering changes, the company was first interested in the ECOManagement, Quality Management and TrainingManagementmodules.
ECOManagementmanages the change process and keeps all
players on product development teams, including designers, engineers, purchasers andmanufacturing, up-to-date on the latest product revisions.
QualityManagement is used for documenting and tracking all
non-conformances and customer complaints, and the Training Management module automates the management of all internal and external training, addressing the company's need to comply with quality management system requirements at both ISO and FDA.
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