Protocol for the clinical functionality assessment of a workstation for stereotactic neurosurgery

The objective of this study is to establish a protocol for the technical and clinical evaluation of a workstation for the planning of stereotactic neurosurgical interventions that has been developed in the framework of a joint European research project. Although several such workstations have been proposed before, they lacked the final and most important step, that of clinical validation. They failed to rigorously prove that their product was useful. The authors present a new method that is applicable to the evaluation of a wide range of medical technologies. Their protocol basically assesses the clinical relevance of the user requirements that are at the root of the development of the new technology. The evaluation consists of two stages. During functional specification, iterative prototyping is used to establish the clinical requirements and to assure the quality of the final product. A case study design is used in a second stage that assesses the clinical usability. A before-after study gives a first indication of cost effectiveness and improvement of health care quality.

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