Applying Usability Engineering to Medical Devices

Usability engineering for medical devices, or human factors engineering, is a concept of understanding interactions between the user and the system in use. The term ‘human factors’ is about studying how the user interacts with the system, technology, data or other ergonomics. This science-based discipline is a famous and well-adapted concept in psychology, engineering, defence, nuclear, petrochemicals and healthcare.

A large variety of medical devices are in use for monitoring, diagnosing and treating patients, and use errors leading to patient harm are an increasing cause of concern.

So, is it the user who is at fault every time? Do they lack competence or training to perform their job right? Maybe. But it cannot always be the case. Medical devices designed without applying usability engineering (human factors) are proven to be non-intuitive, difficult to learn and confusing to use in real settings.

Isn’t it true to state that usability engineering must be applied while designing the device, not while it is in use?

Usability Engineering or Human Factors Engineering is a process of applying knowledge about human behaviour, abilities, limitations, and other characteristics to design a medical device, software, systems and tasks to achieve adequate usability

Note: USFDA expands this term to also include mechanically-driven user interfaces, user documentation, and user training

Ok, understood. But what is achieving adequate usability? Well, it means achieving acceptable risks related to use.

Wait, what?! So, is usability engineering related to risk management? Absolutely true!

Usability evaluation is a method for exploring or evaluating user interfaces i.e., interactions between user and the device

Even though usability engineering focuses on improving user safety, the need to reduce design modifications and incurring costs after the market introduction come as side (yet competitive) benefits. Usability engineering encourages manufacturers to consider user perspective while designing their products to reap appealing rewards when the same users use their products with greater confidence.

Alceon Medtech Consulting can help you apply human factors concepts to your product portfolio. Reach us to evaluate existing status of your usability process and allow us to map the right directions for you. We can also help you train your resources or prepare relevant documentation. Inquire today at contact@alceonconsulting.com.

Alceon MedTech Consulting
Author: Alceon MedTech Consulting

Alceon MedTech Consulting (AMC) is founded with a mission to help our clients in the medical device and invitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market. We offer a range of services to our clients, including regulatory strategy development, risk management, clinical trial design and management, post-market surveillance, trainings and more.

Alceon MedTech Consulting

Alceon MedTech Consulting (AMC) is founded with a mission to help our clients in the medical device and invitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market. We offer a range of services to our clients, including regulatory strategy development, risk management, clinical trial design and management, post-market surveillance, trainings and more.