The diversity of medical devices, their increasing complexity, as well as the development of devices for personal use have increased the risk associated with misuse. The use made by "operators", by health professionals as well as patient himself must also be carefully evaluated to reduce the risk of incidents. Finally, the global environment (care structure, nursing home, home etc.) must also be taken into account. The concept of user experience indeed takes on its full meaning by aggregating the factors linked to the end-user, the device and their environment.
The design of clinical studies on the drug focuses on the pharmacological action of the product, trying to eliminate all biases related to the user, the context and the patient through randomization. But is this what should be done for the clinical evaluation of a new medical device, or should we imagine methodologies that, unlike drugs, would take into account users and their environment?
I'm not sure I fully understand the question.
Human factors (aka, usability engineering) evaluation does indeed take this into account and is increasingly an important aspect for many new product approvals, especially where the lay person is the primary user.
See:
o EN 62366:2008 Medical devices - Application of usability engineering to medical devices IEC 62366:2007
o IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
o EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010
o EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
o AAMI/ANSI HE75:2009 Human factors engineering—Design of medical devices
o https://www.fda.gov/media/84709/download
The clinical evaluation should not simply "rely, in principle, on clinical data" but "on clinical data that provide clinical evidence enough", the level of which must be "motivated" by the manufacturer and "appropriate" in consideration of the characteristics of the device and its intended use.
Demonstration of conformity with the general safety and performance requirements not based on clinical data must have appropriate justification, based on the results of risk management performed by the manufacturer, as well as on the results of non-clinical testing methods, including performance evaluation , bench tests and pre-clinical evaluation.
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