Integrating human factors and health economics to inform the design of medical device: a conceptual framework

The reliability and clinical utility of a medical device are required to demonstrate its impact and to enhance its success in the market. To fully establish these attributes it is necessary to investigate the context of use and the needs of the users. In healthcare, there is a growing use of human factors and health economics methods to generate evidence of the potential success of a new device. This requires investigating not only the device itself but also the elements surrounding the technology - e.g., end-users, environment of use, other operators and technologies, etc. Acquiring this information in the early stages of device development is essential. This enables designers to appreciate the operational challenges and barriers that the device will face in real life settings and may enable improved design to better fit with the environment in terms of ease of use, safety and cost effectiveness. Human factors and health economics experts have not traditionally worked together to achieve this. However, both health economists and human factors experts need to understand and map the context of use to develop realistic scenarios for the costeffectiveness analysis and for usability testing of a new device. This paper presents a new conceptual framework for the integration of human factors and health economics to evaluate new diagnostics devices. The framework is currently under test, and its full implementation represents an ongoing aim of the National Institute for Health Research Diagnostic Evidence Co-operative of London.