CIMdata PLM Industry Summary Online Archive

31 January 2011

Implementation Investments

Pathway Medical Technologies Selects Omnify Empower Product Lifecycle Management

Omnify Software announced that Pathway Medical Technologies, an innovator of endovascular treatments for Peripheral Arterial Disease (PAD), selected the Omnify Empower PLM solution to automate product development processes and ease compliance with ISO (International Organization for Standardization) regulations.

Focused on developing, manufacturing and distributing innovative medical devices for millions of people affected by PAD, Pathway Medical implemented PLM technology in order to improve processes for managing product documentation, part drawings, and engineering changes. The company wanted to eliminate their old paper-based system which consisted of housing all of their paper procedures and hard drawings in a room with a checkout system similar to that of a library. This set up made accessing product information a tedious and time consuming task for both daily product development practices and annual compliance audits.

Pathway Medical searched for a solution that could meet the needs of a medical device start-up and selected Omnify Empower PLM because of its ease of use, fast deployment time and low cost. In addition, product features such as Quality Management, for documenting and tracking all non-conformances and customer complaints, and Training Management, to automate the management of all internal and external training, address the companies' need to comply with ISO quality management system requirements.

"We have streamlined our entire engineering change process, employed better security with document vaulting, improved Bill of Material Management, and can now make product information such as drawings, blueprints, revisions, and supporting materials, easily yet securely accessible to appropriate team members with Omnify Empower," stated Ken Perino, senior director quality assurance and regulatory compliance for Pathway Medical Technologies. "Within only a few months we have already seen major advantages and cost savings due to the fact that Pathway has the capability to engineer more products because the Omnify system has helped to free up resources and we have more bandwidth to do more."

Mr. Perino also added that, "Managing compliance data with Empower PLM has simplified our audit process, making it much easier to show auditors how product information is accessed and tracked online and prove the audit trail of activity for documentation as well as get requested documents much faster than through our previous paper-based vault system."

"A combination of highly complex product development and growing compliance requirements has made PLM technology a necessity for device manufacturers to deliver innovative, safe and compliant products," said Chuck Cimalore, chief technology officer for Omnify Software. "Omnify Software is seeing rapid adoption of Empower PLM by small to mid-size medical device manufacturers because it is a robust, yet easy to use solution that helps to validate and simplify their compliance requirements and audit processes."

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