For some, it might seem obvious that for a product to be successful, the User Interface needs to be easy, safe and effective for users to use, and that it requires dedicated focus in the development process. For others, it might seem excessive to spend a lot of resources on evaluating the product with users, because the belief sometimes is that the product team already knows how the users will use the product.


For medical devices, product safety and effectiveness can be a matter of life and death, which is why we, at Technolution, have employed such dedicated specialists in Usability Engineering. It is also a regulatory requirement to follow the Usability Engineering process defined in IEC 62366-1:2015 and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices (2016).


Three levels play important roles in the use of a product:

  • 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 how to 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.


Focusing on and prioritizing Usability Engineering activities will generate numerous cascading benefits. You ensure that Medical devices can be used safely and effectively. But you also avoid some late-stage changes in the development process, which could ultimately be leading to longer time-to-market and costly budget expansions. You ensure regulatory compliance – even though not always submitted, documentation is still required and can be requested by authorities. Your user will enjoy a simpler and more intuitive product user interface, which also means minimized need for training and support. Improved user satisfaction will also lead to improved sales, improved market life and customer loyalty. Finally, minimized risk of liability claims and product market withdrawals are also important benefits of a dedicated focus on usability right from the beginning.


Inspired to develop great user 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 specialist 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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