WORK / Healthcare Human Factors in Healthcare

 

Human factors

Human factorssometimes referred to as ergonomics or usability engineering can often be misunderstood as being about ease of use, user friendliness or something that can be taken care of with good labelling or instructions. Human factors engineering is none of these things.

What is Human Factors?

Human factors – The scientific discipline concerning understanding of interactions where the user is a vital component of a system, and applying theory, principles, data and other methods to design in order to optimise human well-being and overall system performance.

Human Factors Engineering (HFE) is about converging evidence. It is not about numbers or hard facts, it is about due diligence of looking at user interaction and eliminating risk or hazard. It is a tool to create better solutions.

Human Factors and Medical Devices

HFE applied to the Medical industry – The unique aspect of HFE, when applied to the medical industry, is maintaining a delicate balance between device usability and device safety. The most usable solution may not be the safest solution; while a solution that is too focused on safety may become overly complex. Complexity in the mind of the user can lead to device failure. The ultimate goal is to create solutions that deliver great usability while being safe for users and patients.

FDA Perspective

Human factors linked to risk – Healthcare is a worldwide regulated industry. Medical solutions have a direct impact on health and welfare of millions daily. One of the world’s foremost regulatory bodies the Federal Drug Administration (FDA) has reassessed the importance of HFE relating to device success, risk and safety. Of the world’s leading medical device providers, over 30% have experienced device recalls due to human factors problems in recent years. With this in mind, the FDA has issued a HFE guidance document incorporating human factors into risk management. All products for FY13 onward will require a full HFE report as part of FDA submissions.

HFE and product development

Applying HFE – HFE should be applied during the early stages of the product development life cycle. Applying HFE early reduces the risk of problems surfacing during the latter project stages when corrections are costly and often extend time-to-market. In Design Partners’ experience, early application increases the likelihood of meeting user needs with innovative solutions and affords our clients commercial advantage with unique IP and better performing systems.

Interesting healthcare trends

HFE and current trends – In modern healthcare, patient education and independence are being recognised as critically important in returning patients to full health. It is also recognised to improve general well-being and quality of life . HFE is an important tool in enabling patient empowerment, breaking down barriers such as complexity and risk, opening up the possibility of accessing a wider range of treatments and healthcare solutions. As an example of this, the home use environment is a rapidly increasing healthcare sector and is set to continue on this trend for a number of years. This is just one example of HFE being an important component of successful solution delivery and ultimately commercial success.

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