The topic of usability was only of interest to the world of software and electronics, but it has rapidly spread to the field of electromedical technologies and Medical Devices in general.

Always more and more Medical Devices are being used to treat and monitor patients, often by unqualified or partially qualified users who use equipment that is not intuitive, is challenging to understand and difficult to use. As a consequence, usability, not only aims at patients’ safety but it has become an essential element in the Medical Devices’ design process. Moreover, its application enables easy and appropriate product use in terms of user/device interface and confirms how effective is the labelling with regard to readability and comprehension.

The usability of Medical Devices is evaluated by a specific set of rules that defines their characteristics, their main fields of application and the test procedures. Considering the current state of the art, usability is governed by IEC 62366, a not-yet-harmonized MDR/IVDR standard, divided in two parts:

• IEC 62366-1:2015 – Application of usability engineering to Medical Devices
• IEC TR 62366-2:2016 – Guidance on the Application of usability to engineering to Medical Devices, containing basic information and application guidelines.

User-device interface

As stated in IEC/TR 62366-2:2016 Guidance on the Application of Usability Engineering to Medical Devices, Usability Engineering primarily refers to the user-device interface and it indicates the requirements that, if properly implemented, can increase the likelihood that users will achieve their usage goals without encountering obstacles.

The user interface includes all the components that users interact with when preparing to use the device, while using the device itself and while performing maintenance.

If there are multiple variants of a Medical Device with user interface characterized by local language and market-specific using the device may be a little more difficult. Therefore, it is necessary to strike a balance between overall design and intuitiveness of the user interface, which often includes graphic symbols instead of text, to make it simpler and improve usability.

Usability and Security

As already demonstrated, Medical Devices developed with an incomplete or inadequate application of Usability Engineering principles or without it can cause serious problems. On the contrary, an adequate investment in usability equals an increasement in safety because it ensures that Medical Devices have reduced risk and that design deficiencies are identified and eliminated from the user interface.

How important is the human factor?

When designing a Medical Device, it is always necessary to consider human factors since problems related to the product use are often one of the reasons why many Medical Devices are recalled from the market. In fact, the main usage-related anomalies can result from design flaws, packaging/labelling, difficulty of use, the user and the environment in which it is operationally used. Failing to carefully read the manual before use can result in making the device unsafe or unusable, as well as the presence of too much information in the instructions.

How to best manage the usability process

In promoting the development of safe and effective Medical Devices, many manufacturers are applying usability engineering principles more extensively to identify and minimize predictable errors.

Therefore, it is recommended that the manufacturer develops a project plan including usability engineering that describes all related activities planned during the device development, from its conception to its final implementation. This plan has to demonstrate that the risks associated with errors which occur while using a Medical Device are reduced to acceptable levels, and therefore that the device is safe, effective, and usable, must also define the timing of activities, roles, responsibilities of team members and costs.

It may be advantageous for a development team to include at least one usability specialist with relevant academic training and knowledge of the field. Usability engineering skills can also be acquired through training, supplemented by experience in applying the usability process to the Medical Devices development.

Usability engineering projects must be adequately funded and it is critical to execute them in a timely manner, as late execution of work increases the risk of a medical device not meeting user needs. The results of the process are recorded in the Usability Engineering File, which includes a documentary overview, usage specifications, risk analysis, and final evaluations.

Finally, it should be considered that usability engineering principles are difficult to standardize as they are considerably different depending on location, even within specific countries, and according to the different companies’ approaches. This characteristic is partially due to the diversity found among usability engineering Professionals and partly due to the wide variety of Medical Devices.

In conclusion, usability is an essential element in the design of a Medical Device, a very important feature of the operational device profile and a mandatory requirement for obtaining CE marking for the MDR and IVDR Regulations, as well as for obtaining ministerial authorization in most non-EU countries. Failure to consider the relevant inputs in design exposes Manufacturers not only to significant regulatory risks but also to having to manage adverse events on patient, user and third parties or corrective actions in the field of great social, economic and image impact.

For application of usability requirements to Technical Documentation and product dossier and in defining the related process in the quality management system, Thema’s experts are at your disposal and can provide you with the strategic-regulatory consulting services you need.

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