The importance of the USABILITY ENGINEERING (standard EN 62366-1:2015) for the MEDICAL DEVICE CE Marking

You might think that every procedure that the CE marking requires, is restrictive and only serves this certification. Let us change your mind.

When you want to sell a Medical Device in the European Union, you have to follow several standards including the EN 62366-1. This one requires to apply USABILITY ENGINEERING (also called HUMAN FACTORS ENGINEERING).

Actually, as it is said in the technical report IEC/TR 62366-2:2016, USABILITY ENGINEERING “can increase the likelihood that USERS are able to perform such actions correctly and without hindrance”. In fact, the aim is to reduce as much as possible USABILITY RISKS at the same time as to create an intuitive and efficient product.  Improvement of the MEDICAL DEVICE can be applied to a large scope of actions from “pressing a physical button” to “selecting items on a software menu”.

Even if this standard is more and more considered by MEDICAL DEVICE’s manufacturers, most of them apply it at the end of the MEDICAL DEVICE development process. Julien ALDEGHERI (CEO of USECONCEPT, the single French company specialized in USABILITY ENGINEERING) says: “Most of the time, we are getting in the end of the process to complete a quick USABILITY ENGINEERING. Those companies come back to us later with a new MEDICAL DEVICE project and this time, want us to start from the beginning… . We want to raise manufacturer’s awareness about USABILITY ENGINEERING, when it is launched during the earliest step, it always improves the RETURN ON INVESTMENT”.

USABILITY ENGINEERING is not only a needful process during the CE marking. It can also give major business-related benefits :

1)      Reducing time to market by anticipating the most possible shortcomings which could require time-consuming correction.

2)      Reducing time to market thanks to a whole USABILITY ENGINEERING package which reduces regulatory review times.

3)      Improving sales because USERS perceive the manufacturer as more “USER friendly” than other manufacturers.

4)      Training of USERS is easier and quicker because of an intuitive MEDICAL DEVICE. It is also time saving because USERS appropriate the product and master the procedure more quickly and more efficiently.

5)      Reducing demand for customer support because USERS are better able to fix a problem themselves without outside support.

6)      Decreasing number of returned products which seem “defective” when there is no technical failure.

7)      Increasing treatment compliance rates. Patients are not abandoning the treatment.

8)      Increasing the using of every available features (more visible), features which could be unknown on similar products without a USABILITY ENGINEERING procedure.

This listing shows a great number of benefits of USABILITY ENGINEERING especially when it has been started at the right time.

If you need any details and if you are interested, feel free to contact USECONCEPT.


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