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, […]
Numerous usability evaluation methods exist in which you do not need to perform in-person usability testing. When designing the user interface for a medical device, the US FDA and other authorities expect you to use these methods in addition to in-person usability evaluations. Desk analysis methods are complementary to actual in-person usability evaluations. Often, […]
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 […]
How design changes impact usability A lot of medical device manufacturers often wish to update their devices through the product life cycle. This can be software updates or minor aesthetical or functional modifications to the design. However, regardless of the update to be implemented, all changes must undergo an impact assessment in terms of their […]
Why plan your Usability Engineering activities? What is User Interface Evaluation planning and why should you make an evaluation plan in the beginning of your project? Most larger projects begin with a detailed plan, which is then updated as the project progresses. This is an important tool to ensure progress and movement in the […]
Getting your device faster on the market by integrating separate processes In many projects Usability Engineering, Risk Management and Design Control are three separate processes. Though this is partly true, there are also lots of overlap and dependencies between them. This article briefly describes how you can integrate these activities to increase the chance of […]
The need for a better tool. Planning a usability study – especially in medical device development – can be a cumbersome experience. Decisions need to be made on what to study and why, who to involve and why, and how to collect, treat, interpret and present data. Of course, all of this will be collected […]
Introducing the Usability Blueprint. Designing a usability study involves people from many different fields. Often, we see designers, anthropologists, UX professionals and QA specialists working together to cover all crucial aspects of the usability study. Based on experience from designing and planning multiple user-involving studies, we saw the need for a tool to easily facilitate […]
Morten Purup Andersen has a M.Sc. degree in Engineering Psychology from University of Aalborg, focusing on human interaction with User Interfaces. Morten is experienced in Usability Engineering and development of medical devices, software and IT, along with documentation and Design Control according to ISO 13485, IEC 62366-1:2015, ISO 14971, and FDA’s Human Factors Guidance. Morten […]
We often see medical devices that fail to launch at the expected date, fail to reach sales goals and thereby ROI, or even fail to reach market launch all together. When diving into the reasons for this, data reveals that project scope, execution, and expectations are key factors. Also, new studies confirm our belief: […]