Module 14: Design Development and Certification of Medical Devices

Evaluating drug delivery devices in Human Factors and Usability Studies

Most studies and tests are performed in – ❑ Research facilities (with viewing capability) ❑ Actual real-life use environments ❑ Simulated-use environments

Many drug delivery devices are used where the patient needs or wants to use them. This is mainly with the Carer or Nurse or on their own – i.e. at home. Many drug delivery devices require management, and this is the new trend – self-management . This is not well understood!

Managing medication regimes at home is extremely variable and this is what human factors aims to understand.

IEC 60601-1-11:2015 focuses on home use medical devices that are electronic.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development