February 23, 2011 by Omnify Software
Pathway Medical Technologies, a Kirkland, Wash.-based innovator of endovascular treatments for peripheral arterial disease (PAD), is committed to bringing unique technology to the marketplace to treat severe PAD; however, the company was being held back by a paper-based system for managing all of its medical device documentation, part drawings and engineering changes. The company utilized a room that housed all of the paper procedures and hard drawings with a checkout system similar to how a library works.
“Since it was paper-based, you physically had to go to the vault to obtain any of Pathway’s product blueprints and drawings,” stated Ken Perino, senior director of Quality Assurance & Regulatory Compliance at Pathway Medical Technologies. “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.”
Perino spearheaded Pathway’s initiative to automate its product development process. He has worked in previous medical device start-ups and has become well versed in the benefits of a Product Lifecycle Management (PLM) system to support his efforts. Perino was interested in bringing in a PLM system to streamline the entire engineering change process, implement better security with document vaulting, improve Bill of Material (BOM) management, and make product information (drawings, blueprints, revisions and supporting materials) easily yet securely accessible to appropriate team members.
Pathway selected the Empower PLM solution from Omnify Software because of its ease of use, fast deployment time and low cost. Document control, engineering change, BOM and regulatory conformance processes are now managed via the Empower PLM system. All departments that have governing procedures are using the system, including: design engineering, quality, regulatory, manufacturing engineering, purchasing operations and facilities management. Any changes made to any procedures are performed and managed within Empower PLM.
“Gone are the days that a physical folder is being passed around and e-mails flying around in regards to where the folder is in terms of going through the different teams for an engineering change,” said Perino. “Because Omnify completely automates this process, when you submit your engineering change for review, the system sends it out to everyone who is a signer or observer in parallel, and the engineering team can view engineering changes in real time.”
Easing the ISO audit
Pathway Medical is required to meet ISO certification (ISO 13485:2003 international standard). ISO auditors will check to see how Pathway (or any company they are auditing) manages its product documentation, change orders/change management, and engineering processes. Prior to automating with PLM, Pathway used to have to show and explain its manual process and walk an auditor through their vault that housed all of the documentation. Now they can show the ISO auditors how it is accessed online and tracked. Custom reports can now be easily generated to show specific information as well.
For quality regulations and compliance, the company is implementing the Omnify Empower Quality Management module to document and track all non-conformances and customer complaints.
“There are some 15 to 30 non-conformances reported per week depending on Pathway’s product volume,” stated Perino. “These non-conformances typically occur on the production floor and during the inspection process; often due to a part failing a test or parts not matching up correctly. When parts come in, they are inspected, and if a part fails the inspection, it needs to be written up, documented and entered into the non-conformance database.”
ISO auditors also request to review the software validation and FDA requires it. Pathway Medical went through the proper channels and procedures to validate their software, proving that they applied security for authorized viewing and electronic signatures, and showing the audit trail of activity for documentation.
Another benefit of the Omnify Empower PLM system for medical device manufactures like Pathway Medical is the training management module. Pathway is using this module to manage all internal and external training events. It alerts trainees for training/re-training and can assign comprehension checkpoints to gauge understanding. Their training process is now fully automated. If training is needed, it is configured in the Omnify system as a task. Pathway has implemented an escalation process that automatically keeps reminding staff members that need to be trained.
“I particularly like the automated training setup on policy, product or document changes, and the fact that it easily identifies recurring training events,” said Perino.
Combined with the Quality Management module, this supports Pathway’s compliance with closed-loop CAPA system requirements.
Pathway has their Omnify Empower PLM system integrated with their ERP system, Exact MAX, via an API. Engineering Change Orders (ECOs) documented within Omnify automatically populate within MAX.
“Omnify combined with MAX are strong for regulated environments and successfully support Pathway Medical in addressing the reality of medical device regulatory requirements,” stated Perino. “With full lot and serial control, Pathway is able to maintain the level of traceability required by the FDA, and it provides customers with the assurance that Pathway’s processes are sound and effective.”
Within only a few months of deploying Omnify Empower PLM, Pathway has already seen major advantages and cost savings.
“Pathway now has the capability to engineer more products because the Omnify system has freed up Pathway’s resources and has more bandwidth to do more,” stated Perino. “Our engineering change processing time has been reduced from days to hours. We haven’t run the numbers on what that equates to in dollars, but I can say the less time our engineers spend processing engineering changes, the more time they can do actual engineering work. And that’s a very good thing.”