Overcoming the trials and tribulations of being a startup company, Pathway Medical Technologies (Kirkland, WA) received 510(k) clearance in 2010 for its Jetstream G3 peripheral atherectomy catheter, which is designed to treat peripheral arterial disease (PAD). Despite this achievement, however, the small company struggled with an inefficient product development process bogged down by paper-based systems. Looking to remedy the situation, it implemented product life cycle management (PLM) software to automate and streamline operations.

Prior to the PLM software, Pathway stored all of its paper-based medical device documentation, part drawings, and engineering changes in a room, ensuring traceability through a library-like checkout system. "Since it was paper-based, you physically had to go to the vault to obtain any of Pathway's product blueprints and drawings," explains Ken Perino, Sr., director of quality assurance and regulatory compliance. "If you found someone had checked out the documentation you were looking for, you had to go and find that person, which was a time-consuming effort."

In order to avoid such wasted time and promote real-time information sharing, the company selected the Empower PLM platform from Omnify Software (Andover, MA) to automate product development. Accessible by all departments that have governing procedures, the system enabled the company to efficiently manage document control, engineering changes, bill of materials, and regulatory conformance processes.

It also facilitated ISO audits. In the past, Pathway had to explain its manual processes and walk an auditor through the documentation vault. However, Omnify's PLM allowed Pathway to demonstrate to auditors how information is accessed online and tracked. "During ISO audits, companies are required to display how they manage specific business processes," explains Chuck Cimalore, president and CTO of Omnify Software. "Omnify Empower PLM enables companies to demonstrate structured, automated processes complete with full history tracking and electronic signatures. Additionally, auditors will ask companies to produce specific documents and procedures. Since all product data, documentation, and history information are available in a single Omnify environment, auditors' requests are handled immediately with a couple of mouse clicks."

To further ensure quality systems compliance, Pathway implemented the platform's quality management module for documenting and tracking all nonconformances. "There are some 80 to 100 nonconformances reported per week, depending on Pathway's product volume," Perino notes. "These nonconformances typically occur on the production floor and during the inspection process--often due to an assembly failing a test or parts not matching up correctly. When parts come in, they are inspected. If a part fails the inspection, it needs to be written up, documented, and entered into the nonconformance database."

Within a few months of deploying the PLM software, Pathway observed distinct improvements. "Our engineering change processing time has been reduced from days to hours," Perino says. "The less time our engineers spend processing engineering changes, the more time they can [spend doing] actual engineering work. And that's a very good thing."