Case Study

Medical device complaint handling for global diabetes care manufacturer

Find out how Acolad automated medical device complaint handling, translation and regulatory reporting for a Fortune 100 diabetes care manufacturer.


About the client

Acolad has been working with this Fortune 100 Medical Device company for 24 years meeting their language needs across more than 31 languages. 

Time-sensitive, complex medical translations for a diabetes care product line

Our client’s diabetes care business unit was receiving hundreds of complaints a day related to the quality, safety and effectiveness of their diabetes care products. The complaints, both incident-driven and review-driven, need to be processed and analyzed to enable a timely response and ensure any serious issues are rapidly reported.   

The complaints were coming in from all over the world, in all languages. To add to the complexity, the issues were being reported in a variety of formats – from emails, PDFs, scanned messages and faxed messages. All of this feedback had to be translated into English in four hours or less to meet reporting requirements.  

Medical device complaint translation combining technology, automation and human expertise

To help deal with these unique challenges in the most efficient way possible, Acolad deployed a solution that combined technology the client was already using (Acolad portal) with the innovative integration of new technology. A workflow was added through the Acolad portal that allowed for auto-detection of a complaint’s source language. It was then integrated with machine translation to allow for the quick and automated translation processing of most complaints without the need for human intervention. 

Any documents that contained handwritten or scanned text are now handled through a “human in the loop” process, meaning that the whole workflow can provide that quality human touch where needed. For human–in–the–loop translations, Acolad set up teams that specialized in the 10 most common languages. The teams were recruited and trained to be able to work efficiently within the workflow process and tight turnaround time requirements. Acolad’s global reach meant project management teams could be set up around the world to make sure that someone was always available to handle real-time requests.

Finally, Acolad also set up an unlimited usage fee, to keep costs down even when the volumes of translation work might fluctuate.

The result

Fully-compliant medical device complaint handling across regions

Complaint reporting deadlines are now consistently met, thanks to the new approach. Machine-translated complaints are delivered immediately while human-in –the-loop-requests are turned around within the 4 hour regulatory requirement. Zero language quality issues have been reported. 

The new process put in place ensures that all complaints are properly handled, which is critical to making sure the client meets and exceeds its obligations for addressing complaints within the regulatory timeframe. It also helps with maintaining brand value, accurate monitoring of products and quality control, and ultimately with the reduction of labor costs.

No matter the language or format, Acolad has implemented an innovative workflow platform to enable the client to stay compliant with regulations and ensure patient safety.

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