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The importance of Usability Engineering in medical devices

- by Seamus Kearney

When C isn’t for Covid-19 and other potential user errors.

Throughout the last few years, we have got very familiar with lateral flow tests, using them on an almost daily basis to ensure we weren’t carrying the dreaded virus to any gatherings we hoped to attend. Despite the frequency of their use and working as a marketer in the medical device sector, even I found myself re-reading the instructions to be doubly sure that the little red line next to the C definitely did not mean that cough was a C for Covid.

It turns out I am not the only one. A quick scan of social media showed several people in the UX community and beyond making their suggestions as to how this device could be more user friendly. When it’s something we all have to use, device manufacturers must be prepared for intense scrutiny. However, given the time constraints and need to work remotely in a pandemic, there is a fair chance that this device was created with limited or no usability testing. Everyone with a scientific background will be very familiar with the use of C for Control so may have become blind to its potential misinterpretation. What better example to explain the impact on society of the often overlooked, undervalued, but life saving discipline of usability engineering?

According to Gemma Anderson, ARC’s Senior Clinical Project Manager with extensive experience consulting on Usability Engineering, every year around 400 people in the UK die or are seriously injured in adverse events involving medical devices. Also, statistics show that by 1999, approximately 98,000 deaths in U.S. Hospitals were a result of medical device error. It was the 5th leading cause of death; exceeding auto accidents, breast cancer and AIDS and cost society $29 Billion. As a result, the FDA introduced regulation which places a greater share of the responsibility for use-related incidents on manufacturers by replacing the term user error with use error.

“Blaming injury or death on incompetent users of devices is no longer an option. Manufacturers seeking FDA approval for new devices must submit evidence of systematic human factors, analysis of use errors and how they will be controlled throughout the product development process"
— Gemma Anderson

Enter, Usability Engineering

Usability Engineering or Human Factors Analysis is intended to identify and minimise use errors and thereby reduce use-associated risks providing acceptable risk related to the usability of a medical device (related to the risk management process (ISO 14971)).

It should be used by manufacturers to analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety, permitting them to assess and mitigate risks associated with correct use and use errors i.e., normal use.

The principles of Usability Engineering should be addressed in the earliest designs of the medical device as intended to be placed on the market with continual improvements made throughout the lifecycle of the product, both during the initial development and the post-marketing phases. In short, a well-designed product that has been tested with the target customer will have much more chance of having a positive outcome.

Whilst mis-interpreting a Covid-19 lateral flow test as positive may not be life threatening, it has the potential to negatively impact the user’s day and beyond. A positive experience for the patient, customer or medical professional is more likely to have a successful outcome, support the mitigation of any risks of misuse and improve the commercial success of the product overall.

How we can help

ARC can support your Medical Device Development with a full usability engineering review and evaluation in relation to safety, task accuracy, completeness and efficiency and user satisfaction.

Working with an external partner like ARC provides an expert, non-biased assessment of a device Usability Engineering and risk management process; helping to spot any issues that you may have become blind to and providing other perspectives to ensure your risk mitigation is robust and your device is suitable for its intended use.

Get in touch to discuss your medical device usability needs and for advice on when to factor this process into your development plan.


Department of Health. An Organisation with a Memory: report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer. London: The Stationery Office, 2000.

Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000.

Usability for Medical Devices: A New International Standard: ISO/IEC 62366 (

Usability Engineering for Medical Devices: IEC 62366-1 (

Seamus Kearney
Article written by Seamus Kearney

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