Health Technology Assessment (HTA) methods have become a standard part of decision-making processes in healthcare service. Although it is routinely applied in drugs and surgery, HTA in medical devices is still quite challenging. The reason is that the main objective of HTA studies for devices is not optimization of the cost-effectiveness ratio, but rather decisions about procurement and/or incorporation of the device. The clinical benefit is not expressed in terms of quality of life, but in the rate of diagnostic yield, and in the extent to which the technology makes the therapy shorter and/or more patient-friendly. Utilization of multiple-criteria decision-making methods for evaluation of the aggregated clinical, technical and user´s effect (outcome) is recommended as the input to cost-effectiveness analyses. Different methods are derived for strategic and/or operational assessment of new technology. Other studied problems are identification of requirements for medical device selection and purchase, composition of expert panels, and assessment of medical device maintenance demandingness.

Faculty of Biomedical Engineering Czech Technical University Kladno Czech Republic

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