Usability Engineering - Medical Device Design

Agenda

Usability engineering is considered in many areas of product design, but its importance is elevated in medical device product design because of issues of safety and effectiveness.

Medical devices are becoming more complex and smarter and the importance of usability engineering is increasing across the regulatory landscape.

Medical devices treat and diagnose an ever-widening range of conditions in the clinical field.

What does usability engineering  mean in the design process of your new medical device product.

The ability of users to interact easily with the device, i.e., using the device should be as intuitive as possible

The ability of users to interact and use the device error-free

The device should work the way the clinician or user expects it to work

When assessing the above points, medical device design engineers must account for a number of factors, including the intended use of the medical device, who will be using it, and where it will be used.

Also, it’s not about ideal world scenarios where you have well-trained and experienced users in perfect conditions. Instead, usability engineering is about real-world risks and real-world usability issues related to the design of the product. The objective is to resolve those risks and usability issues at the design stage.

Module  1: Introduction to Usability Engineering  

Module 2: History and Background to Usability Engineering 

Module 3: Current Legislative Requirements

Module 4: Usability in Medical Device Design

Module 5: User Centred design processes  

Module 6: Requirement/Task Analysis

Module 7: Cognitive issues  

Module 8: Conceptualization and Prototyping – Low Fidelity versus High Fidelity

Module 9: Usability Heuristics 

Learning Outcomes

When going through the usability engineering process, design engineers will consider multiple aspects of the device and how it is used, including:

The information that users get from the packaging, labels, and instructions

The information that users get from the device itself

How users interpret the information they have received and how they use the information to make decisions

How the user uses the device

How the device receives and reacts to the user’s actions