About Human Factors Engineering & User Research

THAY Medical focus on the human elements of how medical devices are used. We only focus on medical devices, medical technologies and healthcare systems. We can offer expertise in one specialist area and be good at it. We offer the service of fully providing documentation and evidence of safe use of a medical device using a human factors and usability engineering methodology. We are able to perform all aspects required for regulatory compliance, from user research through to formative and summative human factors studies.

Performing human factors engineering, also known as ‘usability engineering’, is essential if a product is to be easy to use, safe to use, intuitive, effective, efficient, profitable and able to produce a positive user experience in use. These key elements are the focus of the application of the process, and can then become the outputs of the process. Human factors engineering is a process that is slightly different to usability engineering – it covers extra elements such as profitability, sociality and culture; whereas usability engineering is focused upon use performance.


The Human Factors and Usability Process 

The human factors and usability engineering processes follow the same route during product development. A large portion of the process is the first stage – user research. This is the time to investigate the intended users, their capabilities and disabilities; the intended use environments and the use scenarios that the product will be used in and other unknowns. The process then moves into a design input and output stage where the user interfaces of the product are defined and initially tested out. Following this stage, the user interfaces are tested out (called ‘formative testing’) and verified, before the final user interfaces are tested out (called ‘summative testing’) and validated. Entry of the research and test data into a risk management process occurs throughout – to determine the use safety of the product.


Understanding device users requires:

  • Ethnographic Research
  • Conditions Research
  • Heuristic Evaluations
  • Task Analysis
  • One-to-one Interview & Contextual Enquiry
  • Clinical Practice Research

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User research can be vital to understand the human factors surrounding medical device use.

It is often performed in the conceptual phases of product development or post-launch once the device is being used in real clinical environments. In product development, it can form a source of credible data to base device requirements upon, and can produce data that can indicate the business return of the device once launched.

There are different types of user research which THAY Medical can perform. The most commonly requested are ethnographic research, heuristic evaluation, task analysis, contextual enquiry and research into global clinical practices. All are able to generate data that can determine use-based requirements and design inputs for medical product development.

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Observing what happens in real life

Ethnography is a social science where the researchers become one of the community of people which they are researching. This puts the researcher in the same level of human factors as the research subject, or enables the researcher to see what really happens in the life of a subject.

It is often performed to quantify “a day in the life of” or to understand product requirements, but here at THAY Medical, we mainly use it to quantify the occurrence of a task actually happening – something that feeds into a risk assessment for a medical device (to put fact behind the risk scoring). An example of this would be to spend a day in the life of a paramedic – to see how many call-outs typically occur, where most accidents take place, what injuries are most frequent. In summary, data is generated and collected by the research team, which is very powerful when making design decisions later in a medical product development.

More on Conditions Research

Understanding patients who have conditions, diseases and injuries

When developing a medical device where the intended user is not a clinically trained individual – a patient; it is vital to understand the human factors surrounding the condition, disease or injury they possess that requires them to interact with a medical device.

THAY Medical often have to research the patient perspective and immerse ourselves in the lives of patients with a variety of conditions, diseases and injuries. Some of recent projects involve the understanding of leukaemia, Parkinson’s disease and diabetes. We are able to research and quantify the effect of the patients condition on the medical device – through user research initially (to determine limitations, restrictions and ergonomics) before evaluating patients in human factors studies.

More on Heuristic Evaluations

Expert reviews on your medical device

In some cases, the user is the expert. With specific medical equipment, this can often be the case, since the medical device can only be operated safely by people trained in its use, and who use it frequently. When developing a new medical device, having an expert review your device is one method to gain an opinion on whether the device is generating the expected outcomes, at least from an expert perspective.

It is not user research per se, but it is when the expert is the intended user, which is often the case. In an heuristic evaluation, the medical device is evaluated in a specific manner, against a set of heuristics, and then scored. This can, when compared against related medical device, create useful data to see product gaps and enhancements your device requires, or result in an expert opinion that the medical product development is generating the intended outcomes and specifications.

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Understanding the sequence of use of a medical device

Task Analysis is a very useful tool to understand how the intended users of a medical device will potentially use and misuse it. It is a prediction tool. The intended use of the medical device can be broken down into specific tasks and sub-tasks and the perceptual, cognitive and physical attributes of each task or sub-tasks analysed.

This tool is essential for when developing a user (usability) risk assessment, since the failure to complete the task or sub-task can be predictable to a degree. Also, abnormal use and misuse can be predicted and analysed to form the worst case scenarios of the product use – such that if they result in harm, so the use based risks can be potentially mitigated during the product development. This is the most frequently requested tool in user research we perform, and with it being the precursor to a risk assessment, it is worth the effort in performing one.

More on One-to-One Interviews and Contextual Enquiry

Understanding user experiences

One-to-one interviews using the method of contextual enquiry is one suitable method for determining the real life use of a medical device or healthcare system. It enables the collection of use experiences in a manner that is friendly, focused on the participant and is low in bias. It is often performed as part of medical market research, but is on an individual basis rather than in focus groups or similar methods. The data gathered is often more reliable and truthful. It must be performed though, independently to reduce as far as possible any bias between interviewer and interviewee (participant). This is where THAY Medical can assist – by being independent and unbiased.

More on Clinical Practice Research

Understanding global clinical procedures

When developing a medical device, it is all too easy to focus on your local, intermediate users and design it according to their needs. With most medical devices requiring some level of clinical input, a clinical practice often determines the sequence of order, or the quality of the outcome of the medical device. Understanding global versus local variance in clinical practices is key if you plan to develop a medical device for global sale. If not it may become a local medical device and sales will not be powerful in other areas of the world as much as they should. THAY Medical believe that key to this is to research the variance in clinical practices worldwide and quantify them, so that sound judgement on the intended use of the medical device can be made.

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