Location Location Location: Why Geography Matters in Human Factors Engineering

A good medical device fits seamlessly into the life/workflow of its user.  It doesn’t slow them down, it doesn’t need workarounds, it is simple, even effortless to use.  How many products though are really like that?  …and have you considered why that might be? 

One of the reasons could be that products are generally designed and developed in one geographical location, by people familiar with the users and their workplaces in that location and developed with a primary launch market in mind. 

Let's take an example – A UK based company is developing a product, it gives some consideration to the UK users and healthcare systems as the project team have experience in that, but their primary launch market is the US, so they carry out all of the research and final Human Factors validation study there, iterating the product to suit the users as they progress through the project.  The result – a product perfectly designed for US users and healthcare systems. 

But… 

That product isn’t only intended for the US – the company really want to sell into Europe and the UK and then into China.  How can they be certain that the product is safe and effective for use in those countries? 

The simple answer is that they can’t – there hasn’t been sufficient research to confirm that the product will be a good fit. 

…and the outcome could be disastrous – not only for the patients but also for the company – In the worst scenario: 

• Unforeseen use related issues could occur leading to adverse events, 

• Patients could be harmed, 

• Products could need to be recalled, 

• Users/Customers lose trust in the company.

More likely though, is that the product is just not a good fit for the user, it's even possible that the users might not be the same between geographical locations (e.g. Physicians are users in one location and Nurses in another). This can then result in inefficiencies of use, use related difficulties and general dissatisfaction, which may be enough to stop the product being used altogether and may result in important therapies and products not being widely adopted. 

How can we address this issue? 

Ideally, a good understanding of all potential launch markets should be gained before development starts – that means understanding the users, healthcare systems, existing products available, training etc. The differences in use and user characteristics, between geographies, needs to be clearly understood in order to ensure all needs are met. 

Then during development, as much as possible, carry out evaluations in different geographical locations to establish if the UI design is suitable. 

Building a plan for the location of research, formative evaluation and validation testing, including providing a justification for the validation testing location and why it’s appropriate to apply the study results in other locations, helps to ensure that all geographies are considered.   

A fully thought through user interface design and validation plan, alongside a detailed understanding of the users and their environments, will result in product user interfaces that are well designed for their differing launch markets. 

If you want to find out more on how to design a UI that is aligned with the needs of all your launch markets, the ClariMed team can help. We specialize in multi-geography human factors engineering strategies that ensure your medical device succeeds across all intended markets.

Our experienced team can:

• Conduct comprehensive user research across different geographical locations

• Identify critical differences in healthcare systems, user roles, and workflows

• Design validation studies that provide evidence for global market applications

• Help you build a robust justification for regulatory submissions across regions

Don't let geographical blind spots compromise your product's success. Contact ClariMed today to discuss how we can help you develop a truly global human factors strategy that keeps patients safe and users satisfied—wherever they are.

Ready to get started? Reach out to our team at info@clarimed.com or submit our contact form to schedule your consultation.