Save time and money by focusing on Usability Engineering

For some, it might seem obvious that for a product to be successful, the User Interface needs to be easy, safe and effective for the users to use, which requires a dedicated focus on designing and evaluating the interface. For others, it might seem excessive to spend a lot of resources involving users – “we know how the users will interact with the product” – seems to be the opinion.

However, our experience is that there is great value and potential savings in both time and money in focusing on Usability Engineering when developing products, and Medical Devices in particular.

Three levels play important roles in the use of a product: Utility, Usability and User Experience.





  • Utility – does the product fulfill the users need by having the right features for the users to obtain their goals?
  • Usability – is the product safe, effective, easy and efficient to learn and use? In medical devices, the focus is on safety and effectiveness.
  • User Experience – does the user have a good experience when using the product? This includes the users’ satisfaction and aspects surrounding the product itself.



Usability Engineering in Medical devices

For medical devices, product safety and effectiveness can be a matter of life and death and is the focus of the Usability Engineering activities. It is also a regulatory requirement to follow the Usability Engineering process defined in IEC 62366-1:2015 and FDA Guidance on Human Factors and Usability (2016).

When device User Interfaces are flawed, examples have shown that people can get hurt or die. This can happen if risks are not mitigated by design, ex. it is possible to insert a plug into the wrong connection port, resulting in electrical shock. It can happen if the user cannot hear a device alarm because the noisy use environment is not sufficiently taken into consideration when designing the interface. Another example is if the device buttons are not designed in a way that the users are able to differentiate between them.


The value of Usability Engineering

Focusing on and prioritizing Usability Engineering activities will generate numerous cascading benefits:

  • Medical devices that can be used safely and effectively
  • Fewer late-stage changes in the development, ultimately leading to faster time-to-market
  • Regulatory compliance – Even though not always submitted, documentation is still required and can be requested by authorities
  • Simpler and more intuitive product user interfaces
  • Minimized need for training and support
  • Improved user satisfaction leading to improved sales
  • Improved market life and customer loyalty
  • Minimized risk of liability claims and product market withdrawals

This list clearly illustrates that even though Usability Engineering activities takes time and resources, it is definitely an investment worth making.


Inspired to develop and evaluate great interfaces?

We hope this article has given you some insights into the importance and value potential in Usability Engineering. Please don’t hesitate to contact our expert team at Technolution for questions or inquiries.



Kasper Friis

Jon Storm Madsen

Partner / Head of Usability Engineering

Technolution A/S

Telefon: +45 45 26 10 00
E-mail: jsm@technolution.dk

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