The main aims of Human Factors Engineering (HFE) or usability are to create safe and effective medical devices and IVDs for human use. It is concerned with the design of devices that considers human capabilities, limitations, and characteristics.

HFE in medical devices has become more important since the introduction of the MDR and IVDR. To meet the General Safety Performance Requirements (GSPRs), manufacturers must document user interface for the intended user in the intended environment.

We interviewed our medical device and IVD trainer, Richard Young, to discuss human factors engineering to get some valuable insight. Richard provides answers to the following questions:

Why are we seeing an increase in training enquiries around human factors engineering (usability) for medical devices? What has happened and what has changed?

HFE has always been a discipline and there has been a greater interest in it as the state-of-the-art process has developed over the last 10 to 15 years. What we see in Europe with the MDR and IVDR, there is a greater emphasis on usability as it is seen as an important part to meet the GSPRs. As a result, the profile of HFE has increased.

There have been changes to the GSPRs, specifically looking at the intended use and intended environment of products. A lot of medical procedures have moved out of a clinical environment to the home, and this has driven more thinking around HFE.

How can manufacturers approach HFE? And what should they do about legacy products?

Yes, we need to include HFE as part of the development process. A lot of products on the market have a limited design history which needs updating. Part of the process of updating, the requirement of usability comes into play.

Europe is synchronising with the US. The absence of the state-of-the-art approach now results in a refusal to accept regulatory submissions. The main standard on usability is IEC 62366, released in 2015, which asks us to have a process at the early stages of development of the product which then runs throughout the lifecycle of the product. This is connected to risk management and tries to factor in human factors from the very beginning of the product and throughout the lifecycle. The standard then has various verification and validation steps to conduct to verify that human factors have been considered and addressed in the design. This is done through a series of experiments.

For legacy products, it can be both easier and more complicated. The standard gives us two approaches to take. The first, assuming nothing has changed with the product and there is a stable user interface, we are allowed to treat the user interface as an unknown pedigree. You would then document a review of the product, and this is often deemed sufficient so long as you can demonstrate continuity of the user interface in the environment it is used.

Where this goes wrong and the second approach needs to be applied, is when we discover the user environment, intended user or intended use has subtly changed over the lifetime of the product. If this has not been reflected in the data, it then needs to be updated and some elements of the design process may need to be repeated.

Is this only applicable to manufacturers selling in Europe or is this something that is required in countries globally

Globally, it is a growing requirement. It is certainly required for the European and US markets. The FDA have some very good guidance that is freely available which outlines what the FDA wants to see and the terminology they want you to use. The FDA have really increased the emphasis on usability to the point where they will refuse to accept a submission if human factors have not been considered in the application. This is where the FDA stop reviewing the application and send it back to you.

From a timeline perspective, the failure can be costly in terms of time and costs. If you want to get it right first time, we need to consider usability and have sufficient documentation to demonstrate compliance with the standard.

Is a usability study always required for device products?

As each device is unique, we must generate design verification data to meet regulatory requirements. In some cases, you may not need a study, IF you can show that the user interface has not changed and historically worked for many years. Manufacturers need some documentation to ensure they meet the GSPR. Either an assessment of historic pedigree or a study using clinical expertise or focus groups to qualify them for their use in the field. When thinking about a study make sure it is proportional to the risk classification of your product, is focused and brings you value for money.

 

Watch the interview on human factors below:

Learn more about the course: Understanding IEC 62366: Human Factors and Usability for Medical Devices

 

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