4. Additional aspects


Additional aspects 

One of the important domains in the HTA Core Model is the technical characteristics (TEC) of a Medical Device or IVD. The issues in this domain need to be described in sufficient detail to differentiate the technology from its comparators. 

Furthermore, some high-risk Medical Devices (HRMDs) have specific considerations such as long-term use and unknown interactions with the human body, the means of explanting and replacing implantable devices, the human-machine interface, the management of dataflow generated, etc. Although these issues are taken into account in usability standards, and many methods of Human Factor Engineering (HFE) have existed for years, they seem to be underused [2].


[1] Bob North. The growing role of human factors and usability engineering for medical devices. What’s required in the new regulatory landscape. BSI Group 2016. https://www.bsigroup.com/LocalFiles/de-de/Medizinprodukte/Growing-role-of-human-factors.pdf.