With medical devices, user-friendliness and ergonomics are essential,

but sometimes a designer’s intention does not match up with the

user’s experience. IEC 62366, however, offers a comprehensive and proven

process for ensuring device usability, as Richard Poate, medical health services manager at TÜV SÜD Product Service, explains

A standard way to ensure device usability I

EC 62366-1 - Medical devices – Part 1: Application of usability engineering

to medical devices, is applicable to both manufacturers of complete medical devices, and manufacturers of accessories intended for medical devices. It is a state-of-the-art standard and is therefore required for certification under the Medical Device Directive (MDD), and is also mandatory for the CB (global market access) and NRTL (North America market access) schemes. IEC 62366 determines how usability

must be integrated into the product development process, and specifically differentiates between ‘formative evaluation’, which takes place in parallel to design and development, and ‘summative evaluation’ at the end of the process. The standard’s core goals are to:

• Minimise the risk of use error • Ensure safety through the specific development of suitable user interfaces. Furthermore, IEC 62366-1 outlines a

usability engineering process in order to identify and minimise errors by end- users, while ensuring that ergonomic methods are deployed during the product development phase in order to create a safe interface that is user-friendly optimised. This process must cover risk control as it relates to the user interface design, and this detail must be held within a Usability Engineering File. The usability engineering process

includes: • Preparing a use specification • Identifying user interface characteristics related to safety and potential use errors

• Identifying both known and foreseeable hazards and hazardous situations • Identifying and describing hazard related use scenarios • Establishing a user interface specification and evaluation plan.

‘Use scenarios’ are also given

prominence in IEC 62366-1, and must be specified in detail. The standard also requires that all measures relating to the use of the device are verified with regard to their implementation and effectiveness, placing a special focus on validation. Such a validation process must specify the procedures, operating and environmental scenarios, and test user groups that have been used as part of the interface assessment. The validation must be carried out in accordance with the specified plan, and any necessary measures taken subsequently to make the required improvements. As the core goal of IEC 62366-1 is to ensure the safety of the device by eradicating unacceptable hazards, the usability engineering process can be part of the risk management process, so that any risks to the end-user are identified and mitigated.

RISK MANAGEMENT ISO 14971, Medical devices – Application of risk management to medical devices, details the risk management principles and practices as referenced in a number of key medical device standards. Each aspect of a risk management system must be thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design. A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional


safety and usability with minimal impact to the product development schedule. In order to help tackle this process

correctly, IEC/TR 62366-2:2016 - Medical devices Part 2: Guidance on the application of usability engineering to medical devices, provides a useful guide on how to apply the standard. It outlines a logical three-step process to reducing use-related risk: 1. Inherent safety by design 2. Protective measures in the medical device itself, or in the manufacturing process

3. Information for safety. These must all be validated and recorded in the Usability Engineering File, which also forms part of the Risk Management File.

USABILITY FOCUS Very often, design engineers design from their perspective, focusing on functionality rather than usability. Indeed, IEC 62366 cites that: “As healthcare evolves, less skilled users including patients themselves are now using medical devices, and medical devices are becoming more complicated. The design of the user interface to achieve adequate usability requires a different process and skill set than that of the technical implementation of the user interface.” Usability should be from the perspective of the end user, who is very often less technical. It is therefore vital that the design and evaluation team includes someone that can deliver the end-user perspective, such as a medical professional. If your end-users can’t use a device, they won’t buy it, so IEC 62366 will help you to achieve market longevity and commercial success.

TÜV SÜD Product Service


Usability should be from the perspective of the end user, who is very often less technical. It is therefore vital that the design and evaluation team includes someone that can deliver the end-user perspective, such as a medical professional

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