Integral Quality Monitoring (IQM) is an automated “final check” of the intensity and localization of radiation therapy beams. Radiation clinics perform exhaustive pre-treatment verification procedures to ensure that the correct dose is delivered to the correct part of the correct patient, but IQM is the only product that checks the dose distribution during treatment to enhance quality and safety. Real-time monitoring allows IQM to immediately notify the therapist if an error is detected.
Originally developed at Princess Margaret, IQM was licensed to iRT of Germany in 2013. This agreement was not the end of the story for TECHNA, as the deal involved a continued partnership to translate and refine the prototype technology into a commercial product used in clinics.
TECHNA helped engineer and refine the software and algorithms that power IQM and let the device interact with treatment planning and beam delivery systems to improve safety for patients, without needing any user interaction. Software testing and validation services were also provided by developers working for TECHNA, to ensure that the device met the quality needs of radiation therapy clinics.
As the technology moved from the lab to the first external sites (“beta sites”) for in-depth testing, TECHNA worked with iRT to manage and solve problems encountered—and improved the software and technology to ensure that the eventual global launch will be smooth.
For a medical device like IQM there are a number of regulatory requirements, and TECHNA assisted iRT in preparing the regulatory submissions and meeting these requirements, in particular when it came to achieving ISO 13485 certification and the process for receiving a CE mark.