Smart medical devices can empower elderly to live independently in their familiar surroundings. To enhance their dissemination, they have to be shown to be cost-effective. Economic studies evaluating such technologies are missing or are criticized for their low quality. There are several challenges in the evaluation of smart medical devices, including their complex nature and innovative character. The question arises: how can evaluations elicit the benefits and cost-effectiveness of smart medical devices. This research has the aim of outlining challenges and demands on the evaluation of smart medical devices.

The embedding of the technology in existing structures can influence the effectiveness of the technology. By comparing such a technology with a regular intervention, learning effects have to be considered. Regular modifications and further developments of these technologies can complicate the traceability of the effects. Complex cause-effect relationships with possible interactions arise that are difficult to quantify and express in standardized endpoints, utilities or monetary values. Demands on the evaluation of smart medical devices have been explored with literature reviews and scenario techniques using the example of intelligent rollators.

It is important to apply mixed-method approaches not only in the clinical but also practical setting and conduct observational as well as qualitative studies. Potential users, their relatives and care personnel should be involved in the evaluation of intelligent rollators and attention should be payed to subjects with disabilities. Prospective studies should be conducted at different stages along the lifecycle of the technology. A conceptual model should be developed and evaluated as well as adapted on a regular basis.

The research shows the need to adapt common methods used in economic evaluation to the characteristics of smart medical devices. As a next step, a framework for the economic evaluation of such technologies within the scope of Health Technology Assessment is developed based on these demands.