How costly is postponing a Human Factors and usability study?

PUBLISHED 1st September 2017

Whilst everyone is keen to get the latest medical devices out on the market as soon as they have been approved by the regulators, this enthusiasm can be costly if the device isn’t ready for usability testing and the study has to be delayed too close to the original date, thus incurring costs from venues such as cancellation fees if the space cannot be filled, as well as the more “standard” extras such as air fares.

Getting the balance right can be tricky – the launch of a new product means that the manufacturing company can start to recoup some of the development costs. However, underestimating the time to make changes following the findings of a formative study for example can then cause a rush and potentially small but vital usability points to be missed or indeed for the study to have to be postponed. Of course, it is better to postpone a study than push ahead with a product that is not ready or when a few extra weeks for some modifications would mean all the difference between a pass and fail at the validation study.

However, by planning human factors and usability studies (formative and validation) into the product development cycle from the start then it reduces the risk of these last minute glitches. As well as offering full-service formative and validation studies Medical Device Usability also offers “formative light” studies, which can allow testing of devices with a small group of participants for initial thoughts and feedback, and IFU-readability testing if small changes have been made to the IFU prior to the device going to the validation study.