unit-clean-delivery-kitUser engagement throughout the design and subsequent validation process are crucial to the success of all medical technologies, whether high-tech or low-tech.  The smallest details count when designing a medical device: colour, shape, feel, and language – the list goes on.  Technology should be developed with a close understanding of user needs, and consideration of their financial, environmental, cultural and educational requirements.

Free UE FRAMEWORKCultural considerations in the developing world make the design and development process even more challenging.  A report from Engineering World Health found that only about 5% of medical devices used in developing countries are locally produced.  This means that almost all devices are developed by out-of country engineers and designers who might not understand local intricacies and usability considerations. Thorough user engagement is not optional, but a vital component of appropriate medical technology design.

I’d like to cover three important  Medical Device Usability Engineering activities that are involved in designing medical devices for any application or region.

  • Developing appropriate technology involves user experience design to understand how people will interact with a device.  The design process seeks to make this interaction as simple, and straightforward as possible.  It does not mean dumbing down technology, or cutting out important features, rather it means making devices more intuitive to use.  The goal is to ensure devices are designed to minimize any opportunity for error.

 

  • Appropriate technology takes into account user needs, and aims to set medical practitioners up for success, not potential liabilities or failures.  It is vital to visit user sites and document user requirements and work flows, and observe delicate considerations that might be missed through user interviews.  Throughout the design process, re-engage with users and review product requirement documents to ensure the design is headed in the right direction, covering the appropriate use-cases and user needs.

 

  • Finally, set up a formalized validation process in order to catch any potential design flaws that were missed along the way.  This interactive and detailed approach aids in the design of technologies for a variety of contexts and helps keep the user at the heart of the design.

 

To bring to life the importance of  medical device usability engineering, I’d like to share a case study that demonstrates how usability engineering and testing saved a developing world project from a near catastrophic failure.  While visiting PATH (Program for Appropriate Technology in Health) in Seattle, I learned how usability engineering unearthed and addressed a significant design flaw for a Nepalese birthing kit.

Seeing a need for the provision of clean-delivery supplies, PATH developed a birthing kit originally intended for women in Nepal.  The kit contained “a small bar of soap for washing hands, a plastic sheet to serve as the delivery surface, clean string for tying the umbilical cord, a new razor blade for cutting the cord, a small plastic disc to cut the cord on (mimics traditional practice of cutting the cord on a coin to bring prosperity to the newborn and family) and pictorial instructions that illustrated the sequence of delivery events and hand-washing”.

Instead of readily accepting and embracing this life-saving kit, the user validation for the kit was met with immense apprehension.  The PATH team discovered when showing a kit to Nepalese women that the act of wrapping a baby in a white blanket (which was depicted in the last image of the pictorial instructions) indicated the baby had died and was being wrapped in a shroud for burial. The women were shocked and feared this birthing kit as a result – they could not see past the white blanket or accept any other meaning for this image.

PATH designers went back to the drawing board and returned with a creative and simple solution of adding a flower pattern on the blanket in this image.  Results changed dramatically.  With an improved understanding of the cultural sensitivities, and a minor change to a drawing, instantly the message of wrapping your baby in a blanket to keep them warm was clearly understood.

The PATH team discovered a substantial design flaw through user validation and were able to catch and fix the oversight before the product was launched into the market.  By incorporating the Usability Engineering activities I’ve covered in this blog, you can greatly improve success in designing medical devices for any application or region, and for any type of user.

Annelies is a Biomedical Engineer at StarFish Medical. She uses our Medical Device Usability Engineering Framework to guide design and development of Medical Devices for clients worldwide.


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