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Pathway Medical Technologies, a developer of endovascular treatments for peripheral arterial disease (PAD), is using Omnify’s product lifecycle management (PLM) software to engineer more products.

The company received US Food and Drug Administration (FDA) 510(k) clearance in 2009 to market its Jetstream G3 peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs (below the knee).

The Jetstream system is capable of treating a variety of diseases found in PAD patients, including hard and soft plaque, calcium, thrombus and fibrotic lesions.

Jetstream G3 SF allows physicians to treat a broader range of PVD patients, including the greater number of patients with critical limb ischemia and diabetes in the BTK population.

According to Ken Perino, Pathway’s senior director of quality assurance and regulatory compliance, the company was previously using a paper-based system for managing all of its documentation and part drawings.

Perino was interested in implementing a PLM system to streamline the whole engineering change process and to achieve a parallel process rather than a serial process.

The company also needed better security and some vaulting, basically putting it online.

It required better bill-of-materials (BOM) management tools and company-wide availability to the documentation online.

According to Periso, automating this process would enable the company to achieve certain efficiencies just by being able to access documents online.

By having all the drawings, blueprints and supporting materials available online allowed everyone to access Pathway’s data and it also provided better security in terms of access to valuable assets and product knowledge.

Certain levels of the company would only have access to certain revisions of drawings such as work construction for the production floor.

There would also be previous revisions of the documentation available to access.

Currently, Pathway has three active BOMs and plans to go to six BOMS by the end of the year.

There will be three different Jetstream products and various reiterations of those products.

It will be coming into three sizes that allow the device to go into different arteries in the legs.

The company will now be able to completely automate its BOMs, saving time and costs.

Pathway is implementing Omnify’s Quality module that will document all non-conformances.

There are some 15-30 non-conformances reported a week depending on the company’s product volume.

These non-conformances normally occur on the production floor and during the inspection process.

Often, non-conformances occur when a part fails a test or when parts do not match 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.

Pathway also provides customer support, tracking and addressing any customer complaints, which can range from two to six a week.

Currently, the company’s internal product/process non-conformances reside in a separate database than the customer-complaints database.

These two databases do not currently ‘talk’ to each other.

In terms of reporting requirements for the regulations, Pathway has to query the two databases for the information needed and then put that data into an Excel spreadsheet to bring to the meeting it holds in order to review all the data.

It is a manual method and very cumbersome.

The near-future plan is to have one database that contains both the non-conformances and complaints integrated into the reporting system so that Pathway will be able identify problems more quickly.

The company was scheduled to have an ISO audit in September 2010 and anticipates that it will have the Quality module up and running later in the year.

All document control, change management and regulation conformance will occur via the PLM system.

ISO auditors will check to see how Pathway manages it document controls and changes orders, change management and engineering processes such as ensuring it has the right signatures (electronic signature validations).

Prior to automating with the Omnify PLM software, Pathway had to show and explain its manual process and walk them through the vault that houses all of its documentation.

Now, the company will show the ISO auditors how it is accessed and tracked online and how reports can now be generated.

In terms of regulations and compliance regarding quality, Pathway will be putting the quality part of its processes into post-market surveillance and tracking any customer complaints regarding quality.

Production operators would not have the same level of access to the Omnify system.

There are multi-layers of security to get into the Omnify system; it is based on the latest work construction.

Users need an ID and a password to access the system.

Pathway has electronic signature requirements.

The views are configured specific to the department so that the user can only view what he or she is authorised to see.

An engineering change would have a different password.

Pathway deployed Omnify a few months ago and has already experienced advantages and cost savings.

Now, when a user submits an engineering change for review, the system sends it out to everyone who is a signer or an observer in parallel and, as such, the engineering team can view any engineering changes in real time.

The whole company is now using the Omnify system, including departments such as design engineering, quality, regulatory, manufacturing engineering and purchasing operations – basically every department except sales, accounting and finance.

All departments that have governing procedures are using Omnify.

Any changes made to procedures are done in Omnify.

Even facilities management has governing procedures within the system.

BOMs and all parts are brought into Omnify and automated.

Pathway now has the capability to engineer more products because the Omnify system has freed up resources and has more bandwidth to do more.

ISO auditors request to review the software validation and the FDA requires it.

The company went through the proper channels and procedures to validate its software.

Pathway had to prove that it applied unique users and had to show the audit trial of activity for documentation.

The company is currently evaluating using web services and determining how it might be able to give some of its suppliers limited access to the Omnify system to enable them see engineering changes that Pathway is planning.

Pathway is using the Training and Monitoring module, which manages all internal and external training events.

The module assists in the tracking and documenting of all internal and external training records, identifying affected users.

It alerts trainees for training/re-training and assigns comprehension checkpoints to gauge understanding.

Periso said he likes the automating training setup on policy, product and document changes and the fact that it easily identifies recurring training events.

If training is needed, it is configured in the Omnify system as a task.

Training is being tracked and Pathway has implemented an escalation process that provides reminders to staff members requiring training.

Training is put in as an alert and the process is fully automated.

Custom reports are configured and already available within the Omnify system.

The Omnify system is integrated with the company’s enterprise resource planning (ERP) system, called Max, via an API.

Max is ideal for medical device manufacturers because of its emphasis on part management, production planning and the ability to fulfil the needs of contract service providers.

ECOs documented within Omnify automatically populate within the ERP.

Omnify, combined with Max, is suitable for regulated environments and supports Pathway in addressing the reality of medical device regulatory requirements.

With full lot and serial control, the company is able to maintain the level of traceability required by the FDA.

It also provides customers with the assurance that its processes are sound and effective.

In the future, Pathway plans to use the Omnify system on the production floor and get monitors on the floor.

The company’s design engineers use Solidworks and the drawings are entered into the Omnify system.

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