Reassessing Risk in the Design Process
The recent change in ISO 14971:2012 Application of risk management to medical devices, requires a change to the way risk is assessed during the design process. Where user risk was once mitigated by the Instructions for Use (IFU), the IFU can no longer be part of the equation. The change presents fresh challenges for medical product designers in 2014.
Arguably, the change may bring about greater designs; but a product cannot always be completely intuitive. In the medical field, there are many product-dependent user risks to consider; for example the sharp point of an insulin injector pen right through to products enabling electric shock therapy.
A greater emphasis on training as well as intuitive design is inevitable. The award-winning Video Laryngoscope by Venner, a recent project completed by IDC, offers a good example. The hand-held device helps medics obtain a view of the glottis to aid tracheal intubation, and can be used to facilitate endotracheal intubation as part of general anaesthesia or CPR during cardiac arrest. As a product design, it is intuitive; a clinician can use it immediately for intubation based on past experience and training, but may need instruction on how to use the video capability. In the absence of the IFU, training will become a solid solution for designs in 2014.