Medical device manufacturers are legally obliged to eliminate or at least minimize the risks arising from a lack of usability of their devices.
The IEC 62366-1 standard, entitled “Application of usability engineering to medical devices,” helps to proof that the legal requirements are met.
Content
The following articles will help you get started with the topic of usability and its implementation:
Understanding the term “usability” and how it differs from “user experience” is necessary to understand the regulatory requirements better.
The following article helps to distinguish between the terms “use scenario,” “user story,” and “user task.”
The FAQ on usability for medical devices answers further questions.
The laws and standards set requirements for proving the usability and safety of medical devices.
Manufacturers who wish to market their devices in the EU must meet the usability requirements of the MDR respectively IVDR as stated in Annex I.5.
Manufacturers should fulfill the requirements of IEC 62366-1 for proof of conformity. The IEC TR 62366-2 technical report, which provides the instructions for use for IEC 62366-1, assists in this regard.
The newer versions of these standards work with the User Interface of Unknown Provenance (UOUP) concept. This saves manufacturers of legacy devices, in particular, unnecessary work.
Some particular standards, in addition to IEC 60601-1, contain further requirements for usability, including those for the primary operating functions of medical devices.
IEC 60601-1-8 is also relevant for manufacturers of ME Equipment in the context of usability. IEC 60601-1-6, on the other hand, is no longer applicable.
The usability engineering process is part of the development process. An article describes the interaction between the usability engineering process and the development process in accordance with ISO 13485.
The FDA recognizes IEC 62366-1 as a “consensus standard” but formulates its usability requirements in its guidelines.
One article presents these FDA guidelines and how they interact, while another describes the human factors engineering process.
The article on FDA- and IEC 62366-1-compliant usability files is particularly relevant for manufacturers who want to market their devices in both markets.
These articles are also helpful:
One of the first steps in usability engineering (a part of requirements engineering) is to define and characterize the user groups. A distinction must be made between primary and secondary user groups.
Both types of user groups can be described using personas.
Once the stakeholders are known and described, stakeholder and thereby user requirements are elicited.
Manufacturers should not confuse user requests and user requirements. Another pitfall is working with requirement specifications and technical specifications.
Please also refer to the overview article on the systematic elicitation of requirements.
The focus of the legal requirements concerns the (safety) risks arising from use errors (not to be confused with user errors).
Manufacturers must consider foreseeable misuse and distinguish it from abnormal use.
The PCA (Perception, Cognition, Action) model is also helpful in risk analysis.
Both the stakeholder requirements and the risk analysis influence the legally compliant specification of the user interface. Depending on the user profile, manufacturers must also ensure and prove the accessibility of their devices.
The DiGAV requires proof of accessibility. It can be seamlessly integrated into the usability engineering process.
Several methods are used in the process leading up to the design of the user interface:
The linked articles present the methods and provide tips on how to apply them.
The instructions for use are considered to be part of the “user interface.” The standard explicitly requires that safety information is evaluated. Please, therefore note the following articles:
In the context of usability, the inspection or assessment is called “evaluation.” A distinction is made between
The article Formative evaluation: What the FDA and IEC 62366 require offers a good introduction. Details are described in the following articles:
The summative evaluation is carried out as part of a usability test. This article on summative evaluation describes the points you need to pay attention to.
The summative evaluation corresponds to a usability validation, which should be carried out in accordance with the requirements of IEC 62366-1 and FDA.
Please note that older versions of the standard differentiate between verification and validation of usability and not between formative and summative evaluation.
Further tips can be found in the following articles
The experts at the Johner Institute support you in all phases of your usability engineering process:
What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article 1. Verification a) Definition This definition does not explain what type of “requirements” need to be confirmed by verification. Limiting these requirements to product or component requirements is recommended to avoid…
DetailsThe term summative evaluation can be translated as “final evaluation.” A summative evaluation checks at the end of the development phase whether users can operate a device or a user interface safely. This article provides an overview of the regulatory requirements for the “summative evaluation” (sometimes also referred to as “summative assessment“) and gives you…
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article What the FDA calls “Human Factors Engineering” (HFE), IEC 62366-1 calls “Usability Engineering“. The FDA defines the term as follows: 1. How the FDA’s “Human Factors Guidances” interact In the introduction to the document “Content of Human Factors Information in Medical…
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development, one works with use cases and user stories. This diversity of terms makes a common understanding difficult. However, this is necessary to create consistent and legally compliant usability files and to avoid regulatory problems. This…
DetailsThe regulations relevant to usability engineering require formative evaluations. 1. Formative evaluation: Definition and differentiation a) Definitions In its guidance document, the FDA has published its own definition of the term: Thus, it replaces the old definition in the guideline Applying Human Factors and Usability Engineering to Medical Devices: „Process of assessing, at one or…
DetailsPoor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use. This article will…
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.