PLM Eases Compliance, Achieves 40% Savings

Pathway Medical Technologies is a Kirkland, WA-based innovator of endovascular treatments for Peripheral Arterial Disease (PAD), and maker of a device that clears out blockages in clogged leg arteries. In 2009 Pathway Medical received the U.S. Food & Drug Administration (FDA) 510(k) clearance to market its JETSTREAM G3 peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs (below the knee).

JETSTREAM G3 is Pathway’s latest technology innovation, capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus, and fibrotic lesions. This technology, combined with national screening initiatives, is increasing the options for patients suffering from PAD and helping them avoid long-term complications of the disease.

The Challenge
Pathway Medical was using 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,” states Ken Perino, senior director of quality assurance and regulatory compliance, 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 their product development process. Having worked in previous medical device start-ups, he 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. His goals were to 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.

Solution
Pathway selected the Empower PLM solution from Omnify Software for its ease of use, fast deployment time, and low cost. Managed via the Empower PLM system are document control, engineering change, BOM, and regulatory conformance processes. All departments that have governing procedures are using the system, including design engineering, quality, regulatory, manufacturing engineering, purchasing operations, and even 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 emails are flying around in regards to where the folder is in terms of going through the different teams for an engineering change,” Perino states. “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 13485:2003 certification. 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 their documentation. Now they can show the ISO auditors how it is accessed online, and tracked, while custom reports can 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,” Perino states. “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 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.

In addition, 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,” Perino explains.

Success
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,” Perino says. “Our engineering change processing time has been reduced from days to hours. We have not 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. That is a very good thing.”

Omnify Software
Andover, MA
omnifysoft.com