Design versus compliance
In 2011, the FDA in the US issued draft guidance which outlined the human factors activities that should be conducted during product development. While many manufacturers know that human factors activities need to be conducted, some still do not perform such activities early enough or do not perform enough of them.
I have often worked on projects where human factors has not been sufficiently considered during the product development process. This means that we, as device designers, come across critical usability issues late in the process where users cannot use the product as the manufacturer intended.
The main issue is that making changes this late during medical device development can potentially cost a lot of money and delay the overall project programme. But if safety is compromised, the manufacturer will have to make those changes if the regulators agree that it can lead to the product being used safely and effectively by its intended users, for its intended uses and that it can be marketed.
Therefore, human factors should be a design activity and not just a compliance one. It’s a discipline that needs to be embedded in the design process as early as possible just like other disciplines within the overall project management. Only then can the real value of human factors be unlocked and the benefits in terms of patient safety and usability be realised.