Paper Cuts

Ever since its flagship bionic ear first materialized in the late 1970s, Cochlear has become synonymous with Australian innovation and manufacturing success on a global scale.

Despite being in its 25th year, Cochlear's high-tech medical devices had inconspicuously cloaked the method used to manage the product information — plain old paper — to the extent that it was restraining international collaboration, and more specifically, could potentially jeopardize its billion-dollar business vision.

Tasked with making the complete product design and manufacturing information globally visible from one system, Cochlear's documentation team set about transforming the archaic paper-based processes. After the transformation project was approved by the board, Cochlear pledged up to $2.5 million dollars over three years to catapult itself into the electronic document age. The transformation also ushered in a new thirst for unified content systems and collaborative editing platforms even the most tech-savvy business would hold its head high to.

Rapid growth over the past years led most senior people in Cochlear to realize electronic documentation would be fundamental to going forward, according to documentation systems manager Brent Barnes. To cope with its bullish expansion plans, Cochlear needed to lessen the time for documents to be approved, which in itself was a catalyst and original motivation for the transformation project.

Cochlear's vice president of quality and regulatory, Bronwyn Evans, says the company's rapid growth from a small engineering firm to a multinational is one of the reasons why this transformation was not attempted at least a decade ago. "In the 1990s, [the room] where we did all our manufacturing is now a meeting room," Evans says. "You could have sat around the lunch room and passed notes."

Evans says there is a certain irony about an advanced product manufacturer being bound to paper processes, but Cochlear had to be certain any new information management system would "really work" and meet the requirements of regulators. Medical device manufacturers are heavily regulated and scrutinized by government departments all over the world. Any change to a product has regulatory implications.

"That's why we have kept paper," says Barnes.

When regulatory approval for a product has been granted it may stay in production for many years. The life of the documentation for Cochlear implants is 75 years, so Cochlear's design is "fairly mature" from a paper perspective. Furthermore, when a product enters formal change control, where it goes through a much more rigorous process because it involves stock and manufacturing, Cochlear needs to make sure the scope of changes are "for the right reasons".

"The [document] reviews were not sequential and people would be updating the same document at the same time," Barnes says. "The other issue was lost reviews — they would just go into the ether. With paper you can't get any hard and fast metrics on the performance of document reviews."

Cochlear's paper processes were also hindering its burgeoning international engineering collaboration efforts. "We have 180 staff in Europe and an engineering facility in Belgium, with approximately 40 engineers working with people in Sydney," Barnes says. "Paper has its limitations as it involved scanning, e-mailing, printing, re-scanning and e-mailing back documents."

"People were doing changes and didn't realize the scope of what they were changing," Barnes says. "They weren't checking if all the parts were available and paper reviews were done independently."

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