Adjusting design methodology to meet the medical software regulations: Insights from Service and UX Designers

Abstract

The digitalisation of healthcare is seen as one possible way to reduce the overload in healthcare services. As a result, the need to develop better quality medical software more efficiently is also growing. Software is classified as a medical device when it is used either alone or as part of a medical device for medical purposes, such as analysing or monitoring medical information. In the European Union, medical devices are strictly regulated by the Medical Device Regulation (MDR). Additionally, standards play an important role in the field. In particular, compliance with the harmonised standards should be a means for manufacturers to demonstrate that their device meets the legal requirements determined in the MDR. However, the MDR applies to many different types of medical devices, which means that it is rather general and does not contain many software-specific requirements. Moreover, it does not specifically address the role of the designer in regulatory compliance or the methodology they should use. From the designer’s perspective, the information is scattered and leaves room for interpretation. This can be problematic from the quality point of view, as designers usually play a major role in improving it.

The main objectives of this thesis are to clarify the role of medical software designers in complying with regulations and the ways in which this translates into practice in their work. Based on these objectives, the following research question was formed: How can medical software designers ensure compliance with regulations and standards? To answer this question, data was collected directly from the designers of medical software with a data-driven qualitative approach combining a questionnaire and interviews. The questionnaire was conducted first to gather a general understanding of medical software design and how the regulations impact the work. This revealed that the impact of regulations expands to multiple areas of design, including the design process and expertise required. These were further investigated in the interviews. The questionnaire was answered by ten designers, mostly service and user experience designers from Solita, who have participated in designing medical software. From these designers, four were chosen for the interviews based on their expertise and the insightfulness of their answers. Additionally, one medical software design expert was recruited from another company to extend the perspective beyond Solita.

The results show that the designer’s ways to ensure regulatory compliance in their work focus on following IEC 62366-1, but a variety of other design practices are also found valuable. Based on the collected data, a set of guidelines was formed to summarise the main ways in which regulatory compliance should be considered in the designer’s work. These guidelines are divided into nine areas of application that are designer's expertise, designer's collaboration, design process, design methods, regulatory strategies, risk management, formative and summative evaluation, design reviews, and documentation. Additionally, a generic process model for designing medical software was formed based on the results. The model indicates similarities with the Double Diamond, Human-Centred Design, and Design Thinking design process models. Further research is needed to evaluate how the guidelines and process model function in practic