Written by the MPA students Natalia Maj, Malla Tedroff, Jiehui Song, Jan Sassenberg and Gabriella Ezeani

Medical devices, artificial intelligence, robotics, software, Covid-19, the future of healthtech and… Zoom. On the 23rd of April, we presented our MPA research project on standardization and regulatory challenges of connected and intelligent medical devices at the first ever online BSI Conference, which attracted hundreds of participants from diverse industries and backgrounds. You can listen to the presentation here.

As part of the MPA at STEaPP, students work in groups together with a client on a real-world problem for their final master’s project. This year, we, a group of students comprising Natalia Maj, Malla Tedroff, Jiehui Song, Jan Sassenberg and Gabriella Ezeani, are collaborating with the British Standards Institution (BSI), the UK’s national standards body, on challenges related to the rise of intelligent and connected medical devices. Medical devices are becoming increasingly connected and technologically advanced, incorporating technologies such as artificial intelligence. These innovations disrupt the established regulatory frameworks, creating new regulatory and standardization challenges, especially relating to the protection of patient safety and device security. New, or complementary, standards are needed to address the regulatory gaps, and this is a very fascinating and challenging topic to research due to the complexity of software and connected devices.

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