Useval-DM

The Useval-DM project refers primarily to challenge 4 “Life Health Wellbeing” and its chapter 13 “Health technologies”. It refers secondarily to the challenge 7 “Information and communication society” and its chapter 7 “Human-Machine Interaction “ (HMI). Chapter 13 TECSAN of challenge 4 explicitly mentions “hopes” and “promises” provided by innovative health technologies, but also highlights the “concerns” about “risks related to […] the effects on human performances”. These are exactly the risks that qualitative usability validation aims at preventing and this is the core of the Useval-DM project. This project targets (as mentioned in the call): the “implementation of a proof of concept that is sound from an industrial or medical point of view, and also the exchange of knowledge between industrial and academic partners[…] in order to strengthen the French competiveness in the biomedical sector.” Innovative health technologies and their extensive use of computerized data require a thorough analysis of their human-machine interface (challenge 7 chapter 7). The European regulation on medical devices (MD) imposes a usability engineering approach (in particular for high-tech devices) to handle this problem. This approach allows, as mentioned in the call “to integrate the user […] and take into account the interdisciplinary dimension of human-machine-interaction”. Despite the obligation to apply usability engineering for MDs since 2010, the method is little known and poorly applied. Standards harmonized to the ergonomics essential requirement impose a final usability evaluation of MD, namely "usability validation". Usability validation is difficult to implement because: • it requires multidisciplinary competencies and testing equipment, preferably installed in a health institution like a hospital • it requires to carry out usability tests in simulated environments based on “worst-case scenarios”. The principal benefit of this procedure is scientific reproducibility. Yet this comes with the downside of a poor ecological validity. • the number of participants to those tests is a key factor that may introduce large cost variances and may impact the validity of the results. Harmonized standards provide no guidance and there is no scientific evidence to that question. • the usability validation is costly for manufacturers. It becomes urgent to properly conduct an economic evaluation of these methods in order to better support and guide the manufacturers in its planning and application. The MAIN OBJECTIVE of the Useval-DM project is to establish scientifically, including from an economic perspective, the critical methodological choices for the usability validation of MDs, focusing on the added value of (i) the variations of ecological validity (laboratory, simulator, work context) and of the cultural specificities (France, Switzerland) (ii) the variations in numbers of participants in the test. On the basis of the gathered results, the project will deliver guidelines and illustrative protocols to the stakeholders (manufacturers, health authorities, certification bodies, standard committees) in order to carry out effectively usability validations of MDs. Two European usability centers for health technologies (CHU Lille and HU Genève) will be in charge of designing scientific protocols of usability validation and implement their methodological variations. Experts in statistics and health economy (CHU Lille) will assess those protocols. They will cooperate with three manufacturers of innovative medical devices. The three MDs that are included in the study differ in the targeted user group (health care professional or patient) and in the complexity of human-machine interaction. Thus, an estimation of a possible generalization of the results can be given. Subsequently, an extended body of scientific evidence for a wide range of medical technologies could be established, possibly on a European level.