Module 14: Design Development and Certification of Medical Devices

What are the future challenges of Human Factors and Usability Engineering?

Usability and Human Factors (Engineering) is changing rapidly in its application and methods. As such we have to enhance and improve the standardised methods:

❑ New medical devices are increasingly digital – the effect of battery life and living with these devices requires an understanding of user experience along with use safety.

❑ New medical devices are increasingly digital – the data that is gathered requires more security .

❑ New medical devices will require internet services and data storage.

❑ New medical devices will require more effort and time from the user (counter-intuitive) and therefore the benefits of the therapy will need to be increasingly obvious to the user.

❑ New medical devices for global use will require human factors from not just the USA, but soon also in China. The future may include other specific countries.

❑ New medical devices include Artificial Intelligence (AI, AGI) and Machine Learning (ML). How we evaluate users these devices will have to change.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development