Introduction Economic evaluation of medical devices faces a number of challenges due to the issues involved in estimating the effectiveness and cost parameters. Estimation of effectiveness There are a number of challenges in estimating the effectiveness parameters. Randomized controlled trials are relatively rare in devices and data from observational studies may need to be used. Also, given short time cycle of medical devices, there may be multiple versions of the same device. Finally, effectiveness of a device is completely dependent on how it is used within the setting/pathway. Estimation of costs Costs of medical devices are dependent on organisational setting as the staff and other resource costs make up a significant proportion of the total costs. Furthermore, the costs also depend on diffusion of technology, lifetime of the medical device, redeployment and usage on multiple indications. Unit costs are also dependent on size of the patient population as the overall costs need to be divided by the number of patients. Economic evaluation Given the uncertainty in effectiveness estimates, modelling can help with the estimation of the cost-effectiveness of the medical devices. Modelling is useful in synthesising data from different sources which is useful as there may variations in the parameters between different settings. It is also useful to perform sensitivity and scenario analyses to identify which parameters are the key drivers of the cost-effectiveness. Value of information techniques can also be used to estimate the benefit of performing additional studies (e.g. randomised controlled trials) to reduce the uncertainty of the key parameters. Choosing the evaluation approaach There is no clear consensus on the methods to evaluate medical devices which may result in different devices being cost effective in different jurisdictions. For example, UK’s NICE Medical Technologies Evaluation Programme uses cost-minimization analysis to evaluate medical devices while CVZ in the Netherlands uses an MCDA approach.