Another successful summative study carried out in US

23rd August 2016

A team sent out to the US to perform a summative study for a major pharmaceutical company has just returned after two weeks of testing. The device being tested delivers medication for the treatment of an uncommon neurological condition in childhood. See the blog posted by Ruth on the 29th July 2016. (http://medical-device-usability.com/blog/busy-summer-at-mdu/). This device […]

Usability Testing: Environmental Factors in Hospital Settings

16th August 2016

Usability testing requires those involved to consider various factors that could affect the use of the device in question. One of the primary factors is the setting in which the device is used (or ‘Use Environment’). Under some circumstances, a device may be used in more than one setting, which would usually require the testing […]

Human factors studies and IRB (ethical) approval

11th August 2016

We often get asked by clients whether a human factors study needs to be approved by an IRB (or ethics committee in the UK). The answer is ‘it depends’. It depends on the risk that you are exposing participants to. As with any study involving human subjects, you will need to perform your own risk […]

MHRA guidance on human factors – feedback deadline looms

2nd August 2016

A quick reminder to everyone that the deadline for submitting comments to MHRA on their draft human factors guidance is Friday this week (i.e. the 5th). Feedback (and the draft guidance) is requested via an online form, available at https://www.gov.uk/government/news/human-factors-and-usability-engineering-guidance-for-medical-devices-including-drug-device-combination-products