GxP Lifeline

Innovation and Compliance Harmonize Perfectly at Cochlear


When employees of Cochlear, the world’s leading provider of cochlear implants, witness firsthand the way their products transform the lives of recipients, they can’t help being moved by the power of the company’s life-redefining devices.

“We're all a bunch of criers here,” said Tony Manna, president of Cochlear Americas, in a recent interview with MasterControl. “It’s just part of working at Cochlear that you have to be able to cry.”

Emotions run high when Cochlear employees see how an implant fulfills the company’s mission of helping people hear and be heard.  

“When people get one, their lives are changed and they want to thank you for it,” Manna said. “They want to tell you their story, and that's incredibly rewarding.”

More Than Just a Medical Device

For Justin Piraino, Cochlear’s senior manager of data strategy and analytics for North America, working for a company that develops miraculous medical devices offers more than just a sense of purpose and a paycheck. Having been implanted with a cochlear implant himself in 2007, Piraino sees the implants as a way people with hearing loss like him can connect with the world.

“It’s a device, but it’s given me back so much more,” Piraino said. “And to help other people get the same thing has been great because it allows us to do the mundane, day-to-day stuff. You’ve given something back that somebody lost.”

Founded on the motivation to help more people like Piraino, Cochlear was established in Australia in 1981 in support of a single professional clinic. Backed by a life-changing product and a desire to help those in need, the company hoped the clinic’s cochlear implant surgeon would find patients for them.

“That’s how the company evolved, but about 15 years ago the business came to the conclusion that that wasn’t enough to make people aware of what was available,” Manna said. “We started to shift our focus toward the candidate and the recipient.”

That shift had a direct impact on business success, as Cochlear’s market share is now over 50% globally and over 60% in the U.S., according to Manna.

The company’s impressive growth notwithstanding, Cochlear recognizes that the treatment rate for the entire cochlear implant industry is far exceeded by the number of potential candidates who are eligible for implants.

“Our potential market gets bigger every year, but awareness is our biggest challenge,” Manna said. “People are just not aware that this is an option for them.”

Cutting Through the Noise to Deliver Sound Innovations

Cochlear’s leadership believes that the key to raising awareness is a focus on quality that facilitates the development of the most feature-packed and user-appealing devices the market has to offer.

“We innovate so that [implant recipients] can connect,” said Manna. “That fits with who we are, what we do and who our people are that work here.”

Tom Pavlik, Cochlear Americas’ director of quality systems, said the company’s emphasis on quality is a primary driver behind the development of implants that boast a 99.6% reliability rating after 10 years of operation.

“Product quality is something that everybody in this organization is responsible for,” said Manna. “No matter what you do at this company, our whole quality management system is important.”

This year the quality-minded company unveiled its pioneering Nucleus® 7 sound processor that can be controlled from a compatible Apple or Android device.

“The N7 processor has SmartSound iQ, which is a cool feature that allows you to stream your phone or wireless device to your processor directly,” Ed Wertepny, Cochlear Americas quality systems manager, announced to attendees at MasterControl’s 2019 Masters Summit in Salt Lake City. In addition to providing greater controls via the user’s device, the SmartSound iQ enhancement is designed to replicate natural hearing by automatically adapting captured sound to the implant recipient’s environment.

One of the keynote speakers at the 2019 Masters Summit, filmmaker Irene Taylor Brodsky, has a deaf teenage son with a cochlear implant who reportedly takes full advantage of the new wireless functionalities.

“He can listen to a little bit of mom and a little bit of iTunes,” Brodsky said. “But usually anything coming out of the phone wins for his attention.”

A device-connected processor offers far more upsides than just entertainment, however. Piraino, who is an audiologist by training, said the wireless functionality helps implant wearers focus more attention on aural stimuli.

“A lot of times when I’m talking to somebody, I can read their lips and I’m not just using my ears,” Piraino said. “There’s a benefit to streaming sound directly with no visual reinforcement because you’re reinforcing the use of auditory.”  

Accelerating Compliance to Meet Clients’ Needs Faster

Cochlear’s devices are designed to be backwards compatible, which means they can be updated without replacing the implanted device or requiring a recipient to undergo additional surgeries.

“It's a key core belief of ours that we will not leave our recipients behind,” Manna said. “If you received an implant from us 25 years ago, you will still have access to the latest external processor technology without having to need a new implant.”

With the release of each new generation of processor, most recipients are typically eager to take advantage of the latest functionality enhancements. One of Cochlear’s preeminent concerns is responding faster to customers’ demands for retrofits, so the company implemented MasterControl quality and compliance management solutions in 2007 to help accelerate its business processes. In addition to facilitating faster responses to customer demands, eliminating paper-based processes and ensuring quality system regulation (QSR) compliance were other primary motivators behind Cochlear’s investment in MasterControl.

While accelerated processes have dramatically improved Cochlear’s efficiencies and compliance efforts, there are still obstacles to helping customers upgrade to the latest functionality. Making an update to an implant’s processor means the recipient’s device must be taken “off the air,” as the Cochlear team refers to it, in order to configure the new processor to each client’s individual specifications.

“Every person is going to be mapped a little differently, depending on what their hearing capabilities are,” said Pavlik.

The remapping process can be disruptive for clients, so the company makes every effort to get implants reconfigured and returned as quickly as possible so recipients can resume their normal lives with minimal delays.

“They’re not hearing, so their life changes,” said Manna. “So every issue that keeps them from hearing — keeps them from being connected — is a significant issue for us.”

To minimize “off air” downtime, Cochlear aims to update and return the processors the same day they are received from recipients, which is a primary reason why the company depends on MasterControl.

“Now that we are in an electronic system rather than a paper system, that’s all happening much more efficiently,” Pavlik said.

Gaining Greater Efficiencies

The various Cochlear business units in different global regions use an assortment of systems to manage quality and compliance processes, which led Pavlik to invite the company’s global head of quality to the U.S. so he could demonstrate how Cochlear Americas has been able to leverage MasterControl’s many uses.

“Now he’s thinking that MasterControl is a much better product for the company,” Pavlik said. “We’re gradually providing MasterControl licenses to our fellow members in Sydney so they become used to it and see some of the advantages of it.”

Cochlear Americas continues to discover an increasing number of novel uses for electronic forms, Pavlik said. As they do so, they’re making the company’s other business units aware of the benefits MasterControl provides in terms of effectiveness, efficiency and good documentation practices (GDP) compliance.

“I think we’re going to see more and more application [of MasterControl] in other areas because it’s just better,” Pavlik said.

Pavlik said his team’s creative use of electronic form functionality has expanded the benefits of MasterControl beyond Cochlear’s quality department. What’s more, the use of electronic forms has substantially diminished the organization’s GDP compliance pains.

“We’ve really enjoyed the ability to have e-forms here to get rid of paper,” Pavlik said. “What we’ve noticed is, not only does it make things more efficient, but the whole good documentation practices issue just disappears.”

Business benefits aside, Pavlik and his co-workers also appreciate the peace of mind that MasterControl provides during audits since it is the same system used by leading regulatory agencies like the U.S. Food and Drug Administration (FDA). He recalled Cochlear’s recent experience with an FDA audit during which the inspectors were impressed that requested training records were provided in minutes, if not seconds.

When Pavlik told the auditors that the quick access to documents was enabled by Cochlear’s MasterControl system, they reputedly replied, “Yeah, we use MasterControl, too!”

To learn how MasterControl’s cloud-based platform can help your company accelerate quality, compliance and other critical business processes, contact a MasterControl representative.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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