Advances in medical technology including computer aided and robotic surgery, digital health and increased use of portable devices have improved patient care in both hospital and home environments. These advancements have brought an increased level of complexity in patient care with new challenges to both patients and clinicians. The available performance data on medical devices (MD) is scarce and of variable quality despite work from regulatory bodies, with multiple associated challenges and lack of effective systems in place for its collection.

This research used human factor methods to address i) the current state of safety and performance data availability for MDs and ii) methods of capturing safety and usability data in hospital and home environments by using human factor methods.

Part A of this thesis concentrated on hospital based devices whilst Part B addressed home use MDs. End user experiences were utilised throughout to gain an understanding of the current system including its challenges and reasons leading to lack of data. Patients, clinicians, manufacturers, human factor specialists and MHRA were involved at all stages of this research.

The studies led to the developments of the pathway map to reporting and information transfer in operating theatres and furthermore the development and initial evaluation of the MD-PRS concept (Medical Device Performance Reporting System) as a single dedicated method of reporting all MD malfunctions/ failures. The My-VID usability tool (My Voice in Design) was developed and evaluated as a method for collecting usability data directly from patients on home use MDs.

In conclusion, this thesis used human factor methods to better understand the current system of data collection, available data sources on MDs and challenges faced prior to developing methods for improvement, based on end user experiences . Finally, methods of applying this research to clinical practice were addressed in the final chapter.