‘Poka-yoke’ packaging concept for medical device

Team Consulting is taking a novel approach to medical device packaging, which has the potential to minimise user error. The packaging concept applies the Japanese principles of ‘poka-yoke’ to pharmaceutical packaging.

Poka-yoke, which means ‘mistake-proofing’, is a design concept that originated in 1960s Japanese manufacturing and aims to prevent human error. Team came up with the packaging concept following a number of user studies, which showed that users make more mistakes if they are given all the components of a device at the same time with only paper instructions for guidance. Working with packaging manufacturer Burgopak, the concept was developed into a fully functioning prototype for the event.

Rather than relying on a paper IFU and user intuition, Team’s poka-yoke packaging presents users with each part of the device in order, with clear graphical instructions on how to construct and use the device at every stage. This ensures users cannot put the wrong pieces together or miss out key steps. By applying poka-yoke principals to packaging, medical device developer Team hopes to remove some of the fear and anxiety patients experience when using a medical device - and avoiding the need for time-consuming and costly design overhauls of the products themselves.

“Patients don’t get to grips with new drugs and delivery devices in an environment devoid of emotion and confusion. Their minds are clouded with feelings of anxiety or they are trying to take a lot of new information in,” said Team Consulting’s Director of Design Paul Greenhalgh. “At these important first touch points we need to provide them with a positive experience to help them get familiar with their new device.”

Greenhalgh continues: “Rather than giving the patient – or healthcare professional – all of the parts of the device and all of the instructions in one go, we think that the packaging could help avoid mistakes by taking them through the instructions and the product in easy to follow stages. That is why this poka-yoke principal was so interesting to us. We set ourselves the challenge of seeing whether you could apply something found in manufacturing and assembly and apply it to the pharmaceutical market."

Team also believes the principles can be applied to far more than patient-facing devices, reaching in to the clinician-facing world. Recent research from the US suggests that more than one in four hospital patients suffers some form of harm as a result of mistakes in the usage of medical equipment by professionals.

Greenhalgh continued: “If you look at a surgical environment, a poka-yoke approach to packaging may prevent staff mishandling equipment whilst setting up, not only to avoid errors, but also to help maintain the sterility of devices used in surgery. With human error continuing to account for such a high level of patient harm, even when experienced professionals are involved, the impact this could have is huge.”

For more information, visit www.team-consulting.com

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