Medical Devices and Usability (Human Factors) Engineering

USABILITY “a characteristic of the USER INTERFACE that facilitates use and thereby establishes EFFECTIVENESS, EFFICIENCY and USER satisfaction in the intended USE ENVIRONMENT” (ANSI/AAMI/IEC 62366)

Use errors caused by inadequate usability of medical devices has become an area of increasing concern.

Many manufacturers are responding by applying Usability Engineering (Human Factors Engineering) processes such as ANSI/AAMI/IEC 62366 to optimise the design of their devices.

These link to an overall risk management process, typically using ISO14971 for guidance.

Human factors testing must be focused on the use-related risk, and typically we will write a use-related risk assessment (URRA) for your device that enables you to link the study testing plan and test outcomes straight back into your Risk Management Plan.

We can help you to define the intended users, the intended uses, the primary use environments, the use scenarios, Primary Operating Functions and the User Interface. With our help you can also define ‘normal use’ and within that definition, to distinguish between ‘correct use’ and ‘use error’.

Experienced, trusted and innovative

  • Our HF studies are ANSI/AAMI/IEC 62366 compliant
  • Specialists in simulated environments such as ICU, Emergency Rooms and Operating Rooms
  • High fidelity testing for device prototypes
  • Gather rapid feedback with small-scale early prototype testing
  • Our Usability documents fit seamlessly into your design history file.

Simulation centre video showcasing the testing procedures in Cambridge, UK.

Generally, the process we follow for testing medical devices is:

  • What high risk tasks must be tested?
  • What is ‘correct use’ and ‘use error’?
  • Who are your intended users?
  • What use scenarios need to be simulated?
  • What are all the elements of the device’s user interface?
  • What use environments must be simulated?

We specialise in early formative evaluations of prototype medical devices that explore the design of the user interface, preferences, suggestions for improvements and uncovering any unanticipated use errors. When the time is right we then take your medical device in its final production level version through the summative evaluation phase that obtains objective evidence that your device user interface is safe.

Human Factors Reports

On completion of your summative testing you will have objective evidence to determine whether the safety of your device user interface is acceptable.

Our study outputs and reports form an important part of your Usability Engineering File; we write them in a format that is compatible with either ANSI/AAMI/IEC 62366 or the FDA Human Factors Engineering Report format, depending on which format is appropriate for your chosen markets.

We have the know-how to test your device