Conclusion
Case study methodology facilitated understanding of optimal technique, design and clinical parameters for use of the Odon Device. Systematic triangulation of data from varying data sources provided a comprehensive, contextual overview of device use and rapid understanding of amendments required. It also facilitated enhanced operator communication and consensus building, which was key in understanding and developing the iterative adaptations to the technique, device and parameters for device use. This methodology should be considered whenever innovative devices are introduced to clinical trials and settings. It allows for rapid assessment of device use and can support timely iterative adaptions to ensure there are minimal delays between device use in research and adoption in clinical practice.