Unjamming the Logs

When hired by Cochlear more than two years ago, Barnes brought with him experience with electronic product lifecycle management, or PLM. It didn't take him long to see that PLM might provide a solution to the company's paper-based log-jam.

"PLM is not just a document management system, it manages all product data — everything from CAD designs, part information and documentation, and controls this data through clear workflows, passing required product information to the manufacturing system," he says. "We get to the stage in the product maturity with requirements concreted down and have a product with 3-D models and design documents."

Cochlear's PLM project began 18 months ago with a pilot. To ensure the choice of technology was congruous with other existing systems, Cochlear's CIO, Leo Port, was involved in the early project phase from the strategic perspective. The Windchill product from software vendor PTC was used to pilot electronic document review for about four months.

"The pilot went reasonably well and resulted in a few changes to the document review process," Barnes says. "We needed to modify the workflow to get more efficiency. There were too many steps within the workflow system itself so we decided to get the key activities we needed. Now it's a simple process and well understood."

Absolute compliance with US Food and Drug Administration (FDA) regulations was also necessary, so external consultants were summoned to help validate and configure" the Windchill system as it was not compliant out of the box.

Cochlear's new information process involves using its engineering resources to build prototypes and then using Windchill to control this information in its early stages. When Cochlear is satisfied with the prototype, the product goes through a clinical trial study and then into a pilot production stage before it reaches manufacturing. The change control for all products, across the entire product lifecycle, is now done using Windchill. The system, which went live in April, houses some 12,000 documents and 5000 parts and has replaced the paper system.

The PLM system also alleviates problems associated with new item introduction. Previously, staff would enter new product information into various systems — manufacturing, ERP and a global complaint handling system — and it was often not systematically. With Windchill, item introduction is documented through defined workflow processes and, because it is driven by workflows, "you can't cut any corners", Barnes says.

Cochlear also saw the PLM roll-out as an opportunity for process improvement. "We looked at how [our processes] could be made more efficient," Barnes says. "We didn't get it right the first time but when we got people using the system we realized further efficiencies."

As at April 30, 27 projects have been started in the new PLM system, in addition to all of the existing products, Barnes says. However he believes it is too early to speculate any ROI figures that will come in three to six months. "Regarding the business benefits, we are not there yet," he says. "Immediately there is the visibility of product information, but we are going to see improvements in process efficiencies. We were in a situation where we couldn't support a paper system three years down the road, whereas now we have enterprise-class software. It will take time for the business to realize the full benefits. Going from paper to electronic is a big culture change." (For a look at how Cochlear managed its cultural change efforts, see "Out with the Old, In with the New".)