The Human Factor
Article by Kay Sinclair & Iain Simpson in May's edition of PMPS. Pharmaceutical companies face the challenge of adhering to new human factors standards for drug delivery devices, but should seize the opportunity to use enhanced usability as a point of market differentiation.
Pharmaceutical companies are increasingly using delivery devices as a primary differentiator in a market that is becoming more and more competitive. At the same time, regulators have adopted new human standards, introduced over the past few years, which means that all devices now need to undergo rigorous usability evaluation at every stage of development. This is increasingly important as it is becoming more common for devices to be used by a patient population that has less experience and training than healthcare professionals.
In recent years, several new standards covering human factors engineering have been developed, notably HE74, HE75 and IEC62366. In the last two years the FDA first adopted IEC62366, which focuses on the human factors process employed in device development (this standard essentially replaces HE74 and may well replace ISO60601-1-6 in the longer term). More recently, the FDA has also adopted HE75, which provides a reference on key human factors topics, such as visual displays, packaging design and general design principles.
The FDA now expects companies developing drug delivery devices to follow these standards, or at least demonstrate an equivalent approach. Furthermore, their uptake will have a significant effect on the design and engineering process, hopefully bringing benefits in terms of reduction of use errors for a wide range of medical devices.
Read the full article on the PMPS website (free registration required).