A study protocol to measure the variability of user testing methods in the medical device industry

Introduction
The success of a medical device is largely based on its ability to be employed as per
its use specification to safely achieve the intended outcome. Central to this is the
design of the device which, if poorly executed, contributes to ‘use error’ which affects
the efficacy, safety, and user experience of a medical device. Human factors
guidance provides recommendations to evaluate experience in a bid to improve
design efforts and ultimately the safety and usability of medical devices. The
heterogeneity of the industry means that the interpretation of these guidelines is
subjective and adapted differently to suit the use specification of the devices. There
is a lack of substantial evidence in literature to indicate which user experience testing
methods are favoured and widely used in practice.
Aim
The aim of this study is to explore the perceptions of industry professionals on
factors influencing the evaluation of user experience in the design of medical
devices. The primary objective is to explore the relationship between use
specification and human factors regulations in the selection of user testing methods.
The secondary objective is to investigate the role of the user in the design process
and the consequent influence on user experience evaluation.
Method
A bespoke survey approach was taken to achieve the objective of this structure by
crafting the questions and data collection strategy to interrogate the key issues. The
survey is to be distributed online on different platforms targeted at medical device
industry professionals. Snowball sampling is intended as a participant recruiting
strategy to reach a broad audience. The data is to be analysed using descriptive
analysis, using inferential statistics and thematic analysis of the open-ended
questions.
Anticipated Results
The data collected from the survey is to be analysed and is expected to highlight the
various user experience testing methods that are used and the gaps at different
medical device design phases within industry, throughout the product development
lifecycle. The association between use specification and the evaluation methods
applied will be identified and the medical device professional’s priority hierarchies for
user experience and usability of medical devices should be identifiable.
Conclusions
This study is designed to shed light on industry best practices, the gaps, and the
variability of user experience testing methods for various medical devices, as well as
the preferred methods, and the aspects of user experience considered in medical
device design. The results from this study will contribute to medical device user
experience knowledge base providing a best practice guide for when and how to
conduct effective usability testing. This will in turn improve the experience quality and
overall fit for purpose of each product.