Economic analysis is an important component that should be implemented when evaluating a new medical device. A new medical device should be both effective in improving patient outcomes as well as cost effective before it is implemented into clinical practice. This paper begins with an overview on the different methods of economic analysis including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. The second section provides a description of key design issues in cost-effectiveness analyses that are relevant to medical device trials including the perspective of the economic evaluation, the collection of cost data, how to establish clinical effectiveness in an economic analysis, how to conduct a sensitivity analysis, and when it is necessary to discount costs. It is important and necessary to consult with a health economist to ensure that the appropriate methodology is followed when conducting an economic evaluation. In conclusion, since most jurisdictions have limited funding available for health care, money definitely matters. If the cost of a medical device is unreasonable or if funding is not available, it will likely not be able to be implemented, regardless of its effectiveness. A well-conducted economic analysis will be able to answer questions on the medical device's efficacy and cost effectiveness.
