The improvements made in the sound-processing systems enabled clinicians to be more engaged to tune or adjust the various settings to personalize device performance for each individual patient.
An Australia-based medical device company that designs, manufactures, and supplies cochlear implants to improve hearing for those with severe to profound deafness faced a business dilemma.
They needed to refresh their legacy sound-processing software, which clinicians used to tune each device and personalize it for each patient.
With limited access to software engineering talent, and their staff dedicated to maintaining the current software, there was little opportunity to develop new features and enhancements that would increase value for their end customers and implant recipients.
Stepping in as a strategic partner, the GlobalLogic engineering team, with 20+ years of experience in medical device software development, worked in tandem with the client’s software engineering team to review their issues list and improve the quality of the existing software system, all while providing assurance that the software developed adhered to compliance and other regulatory standards.
Building on this success, the client further requested that GlobalLogic develop, verify, and validate the next generation of their flagship sound-processing software product as per ISO 13485 / ISO 62304 / ISO 14971, CFR 21, and other regulatory standards.
To attain this approval, medical products need to be developed and tested in accordance with the harmonized standards that govern medical device software, namely ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
Partnering with GlobalLogic helped the client resolve backlogged critical software issues rapidly and improved their ability to bring their flagship product to market. With a systematic knowledge transfer approach, the client approached a steady state level within three months.
Now clinicians have updated, modernized software released with each new sound processor/implant, helping create improved clinician satisfaction and maintaining brand loyalty with their clinician base.