In this article, we look at the regulatory framework, the relationship between risk management and usability, and the key question: how can you, as the manufacturer, combine both processes to the best of your knowledge?
The European Union's Medical Device Regulation (EU) 2017/745 (MDR) places increased requirements on risk management for manufacturers of medical devices. Risk management is a crucial part of the conformity assessment process for medical devices and must be carried out in accordance with the provisions of the MDR. The manufacturer must implement and maintain a risk management process throughout the entire product life cycle. This includes creating a risk management plan and identifying, assessing, and minimizing potential risks.
The harmonized standard EN ISO 14971 (currently EN ISO 14971:2019+A11:2021 ) defines a structured risk management process in accordance with the MDR requirements to identify, assess, and mitigate potential risks arising from the technical and clinical performance of the medical device. The standard requires a series of systematic processes that assess the safety and performance of the device to prevent harm to patients, users and even the environment throughout its life cycle.
The MDR also lays down extensive requirements for the usability and ergonomics of medical devices to reduce the risks to patients, users, and third parties due to incorrect use. These include Article 5 and Annex I.
Article 5 of the MDR focuses on taking into account the intended purpose of the device when fulfilling the requirements in Annex I. This leads to the definition of the intended purpose and the aspects to be considered in its description, in particular in relation to the intended user groups and the intended environment of use.
Annex I also contains usability requirements in paragraphs 3, 5, 14, 21, and 22 with regard to
In accordance with the MDR requirements, IEC 62366-1 (currently IEC 62366-1:2015+COR1:2016+A1:2020 ) provides a structured methodology for the usability engineering of medical devices and specifies a process for the analysis, specification, development, and evaluation of usability in relation to safety. This process is concerned here with the human factor, that is, how smoothly and efficiently a user can interact with a device to fulfill its intended purpose.
But how do risk management and usability interact?
The usability engineering process enables the manufacturer to assess and reduce the risks associated with normal use. This includes both the correct use of the medical device and the errors that may occur during the use of the medical device and that could lead to a different result than intended by the manufacturer or expected by the user, the so-called "use errors".
As far as abnormal use is concerned, the usability engineering process can be used to identify risks - but not to assess or minimize them.
Risk management, on the other hand, considers both normal use and abnormal use. Here, the hazards and hazardous situations are identified, the risks are assessed, and they are minimized as far as possible.
IEC 62366-1:2020 describes how risk management and usability are interlinked (see Figure 1):
In addition, the usability process defines the use environment and the user groups or so-called user profiles, which can help to define the associated risks in the context of risk management.
Or to summarize: the usability process is one of the most important resources to adequately supplement the risk management process.
Similarly, the risk management process ensures that all risks, including those related to usability, are minimized. This is done by identifying appropriate measures in the form of design measures, protective measures, or information for safety and, where appropriate, training to users. These measures can have a direct impact on usability. For example, simplifying a complex operating element can improve usability and at the same time reduce the risk of operating errors.
In a further point, usability testing in the form of a summative evaluation under certain conditions can serve as proof of acceptance of the overall residual risk and be used as an argument in the risk-benefit analysis.
It is clear from the above how closely the two processes are linked. However, the question now arises as to how this interaction can be managed in order to develop a safe and efficient medical device.
To develop a safe and effective device, appropriate risk management must be practiced - but in order to sell the product, its ease of use must also be guaranteed. To this end, it is advisable to consider the following points to the best of one's knowledge:
Risk management and usability are closely linked with patient safety at the center. Effective risk management is about identifying and eliminating potential risks, while usability ensures that the device can be used safely and effectively in clinical practice.
Ensuring that the medical device is not only safe and effective, but also easy to use for healthcare professionals or laypersons is essential for regulatory compliance and market success.
What do your risk management and usability processes look like? What are the biggest challenges for your company? Let's talk about your current situation. We are happy to support you with our comprehensive expertise.