A methodology for design and appraisal of surgical robotic systems

Surgical robotics is a growing discipline, continuously expanding with an influx of new ideas and research. However, it is important that the development of new devices take account of past mistakes and successes. A structured approach is necessary, as with proliferation of such research, there is a danger that these lessons will be obscured, resulting in the repetition of mistakes and wasted effort and energy. There are several research paths for surgical robotics, each with different risks and opportunities and different methodologies to reach a profitable outcome. The main emphasis of this paper is on a methodology for ‘applied research’ in surgical robotics. The methodology sets out a hierarchy of criteria consisting of three tiers, with the most important being the bottom tier and the least being the top tier. It is argued that a robotic system must adhere to these criteria in order to achieve acceptability. Recent commercial systems are reviewed against these criteria, and are found to conform up to at least the bottom and intermediate tiers, the most important first two tiers, and thus gain some acceptability. However, the lack of conformity to the criteria in the top tier, and the inability to conclusively prove increased clinical benefit, is shown to be hampering their potential in gaining wide establishment.