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.