JUNO-Checked - Technical Developments

Purpose and goal:

The aims and objectives of the project were partially fulfilled, with technical improvements being made to the JUNO-Checked System in relation to sensor performance and assay time. However, the product is still under development and further improvements must still be made before the final product can be validated as an IVD.

Expected results and effects:

The result and expected effect of the project was implement technical improvements leading to future generations of the JUNO-Checked System. The stability and reliability of the sensor has been improved and the assay time has been shortened since Carolin joined, with development of the final product still ongoing. In addition, Carolin has made significant contributions to quality and regulatory related product development activities including establishing the performance evaluation plan, performing risk assessment and risk control activities, design reviews, etc.

Approach and implementation:

WP1 was implemented utilising Carolin´s expertise in surface chemistry and biosensors, the performance of the sensor and assay were improved. Verification testing of the sensors was performed at RMC Malmö as intended. With respect to WP2, various medias and alternative electrochemical methods have been tested, resulting in an improved choice of media, however no improved electrochemical method was identified during the project.

For WP3, Carolin was trained in key medical device quality and regulatory topics and contributed significantly to generating important documentation.