Customer story

Oticon Medical Continues Striving for Clinical Excellence

How Greenlight Guru Clinical (formerly SMART-TRIAL) is helping Oticon Medical, industry-leading medical device manufacturer of hearing aids, and why they have remained loyal customers for years.

The Challenge

General purpose tools like paper-based forms and survey software had become frustrating and inefficient to manage, as too much time was being spent manually transcribing data.

The Solution

Greenlight Guru's EDC software makes it easy and fast to collect clinical data. All in compliance with industry regulations.

The Results

Oticon Medical has been our loyal customer since 2018. They have happily renewed with us recently for 3 more years. In addition, the company estimates that they now complete studies 130-140% faster.

Oticon Medical AB

Founded: 2007

Company Size: 200-500 employees

Headquarters: Askim, Sweden

Device Classification: Class IIa, IIb, III

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Since 2018, Oticon Medical, an industry-leading medical device developer of in bone anchored and cochlear implant hearing solutions, has relied on Greenlight Guru Clinical for all its clinical data collection needs. 

Today, we are excited to announce that Oticon Medical has extended its partnership with Greenlight Guru Clinical for another 3 years.

All celebration aside, we wanted to get a closer understanding of what’s inspired Oticon Medical to remain such a loyal client, the impact our clinical data solutions have had on their business, and the platform features they’ll be looking to in years to come on the road of continued clinical excellence.

Oticon Medical’s partnership with Greenlight Guru Clinical began

When Oticon first came to Greenlight Guru Clinical (formerly SMART-TRIAL) in 2018, they were looking to upgrade their methods of data collection. The general purpose tools like paper-based forms and survey software had become frustrating and inefficient to manage, as too much time was being spent manually transcribing data. As a result, the company was lacking in data transparency and the usage of internal resources on data management was high. 

Oticon selected Greenlight Guru's EDC software as the solution that could minimize and/or eliminate the use of paper, help improve compliance with industry standards and regulations and be easy to use. 

The first use of Greenlight Guru Clinical at Oticon Medical was for ongoing data management of their Ponto sound processor product—one which enables those with a partial hearing loss to understand what others are saying by protecting speech clarity and fading out background noise.

The effects of the switch included improved overview, internal communication, data security, and compliance rates. In addition to enabling better compliance with regulations, an estimated return on investment (ROI) was 136% in the first 24 months and more than 270% after four years. The company also estimates that they now complete studies 130-140% faster since switching to Greenlight Guru Clinical.

Additionally, the number of hours spent on printing and transcribing data was substantially reduced and over 199 days a year are saved on data management. Having implemented Greenlight Guru Clinical, Oticon has reported improved overview, internal communication, data security and compliance rates.

Why Oticon Medical keeps choosing Greenlight Guru Clinical

We wanted to get a deeper understanding of what aspects of Greenlight Guru Clinical had made our partnership with Oticon Medical so fruitful. So, we sat down with Maria Åberg Håkansson, Director Clinical Affairs at Oticon Medical, who told us the three major benefits that keep them coming back.

Greenlight Guru Clinical easy-to-use platform simplifies the clinical experience

When clinical teams are forced to use general purpose tools or ones created for pharmaceutical trials, the results can be less-than-ideal. Processes slow down, data collection becomes inefficient, and compliance becomes next to impossible. But why? It’s because clinical studies for medical devices are built differently, and require solutions that are purpose-built for MedTech. 

“There's such a big difference in how you work and conceptualize medical device studies compared to pharma. What you often see when you try to evaluate EDC systems for clinical devices or clinical studies, you see a lot of features that you really don't need from a medical device perspective. I think that the strongest asset you have with SMART-TRIAL is that- its MedTech specificity." Maria Håkansson, Director of Clinical Affairs at Oticon Medical

For Håkansson, one of the biggest benefits of using our clinical solution has been the way it works with their clinical processes, not against it.

“In the typical medical device setting, I would argue that you don't see specialized data managers or programmers handling data management or working with these kinds of systems. You really need easy to use systems because you have much broader roles in your clinical team. That is what I see in our team right now— every person has operational functionality without needing additional training.”

Greenlight Guru Clinical provides the ultimate clinical toolbox

Oticon Medical’s clinical testing needs have grown in complexity over the past four years. Its products require pre-market and post-market studies, whether in its class IIa surgical techniques, its class IIb implants, or its experimental Sentio system, which falls under the class III category. 

In order to keep up with the demands of medical device regulations on safety and performance across the entire product lifecycle, Håkansson told us that one of the biggest selling points in their contract extension has been the sheer number of platform features tailor made for medical device studies.

"The library of ready-to-use modules and templates has made things so much easier. Study build takes less time since we are able to store all our previous protocols and study designs to access or copy for new projects." Maria Håkansson, Director of Clinical Affairs at Oticon Medical
Håkansson also expressed appreciation for the way features like extract functionality and survey capabilities have impacted their high-level approach to study design.

“These features have allowed us to have a much broader mindset when it comes to the kind of data we’re collecting, and how we collect it.”

Greenlight Guru Clinical's customer support is best-in-class 

When you’re already drowning under a sea of paperwork, even the thought of implementing a new EDC software or eCRF solution can feel overwhelming. The onboarding process is so critical, and it’s exactly why our implementation has been developed with the conviction and commitment to ensure your success.

“I really have to highlight the customer service, because it’s been great,” Håkansson said. “It’s very smooth and fast customer support, and you help us continuously improve with training and on-demand answers if we ever get stuck.”

Håkansson told us that our hands-on approach to onboarding has actually improved the company’s internal processes for employee engagement and training. She also commended the platform for its help in lowering the work-load for her colleagues. But, most of all, Håkansson said she appreciates the relationship that comes with our team.

"It feels so inviting and personal working with the customer service team.. They have really been so helpful along the way." Maria Håkansson, Director of Clinical Affairs at Oticon Medical

What’s Next for Oticon Medical?

As Oticon Medical looks to the future of its life-changing solutions for hearing loss, Håkansson says they see Greenlight Guru Clinical right there beside them. “We have a clear plan for new studies in the pipeline and I am confident that your software will continue to fit our needs for them in the years to come.”


Are You Ready to Aim for Clinical Data Excellence?

Greenlight Guru Clinical has supported 500+ and counting medical device studies worldwide. We are made for MedTech. Let's talk today.

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