Usability/human factors engineering has become a critical part of new product development in the medical industry.
A robust and provable human factors engineering process is now essential to gain US FDA clearance for any new device. For many companies this can seem a daunting prospect, especially if the necessary expertise is not in-house.
Medical device design group Synecco provides this concise list of guidelines to help with the challenge of human factors engineering for medical devices.
1 - Make sure you are designing the right device. Asking some critical questions at the beginning of a project can save a huge amount of time and money. Is there a market for this new device? Will users accept it? Will people want to use it? Nail it down at the beginning.
2 - Identify and understand your users early. Once you have defined what you want your device to be, you need to fully understand how it will be used. Conduct ethnographic research to fully appreciate the context and environment of device usage. Observation will always deliver more usability-related insights than market research. Speak to your users, but never guide their feedback. By observing and speaking to users your device can deliver real benefits.
3 - Consider the entire product life cycle. How is the device packaged, transported and stored? Will the person preparing your device be the same person using your device? Will your device need regular maintenance? Whoever encounters your device is a user and their needs should be catered for.
4 - Identify usability-based risk early and monitor throughout development. The fundamental purpose of usability engineering is to mitigate risk during device usage and maximise device safety.
5 - Don’t ignore ergonomics and anthropometrics. The design interface you specify should be intuitive, should align with user expectations and prevent user errors. Ensure it’s comfortable to hold and actuate. Consult relevant anthropometric and strength data and identify the percentile range of your target user group.
6 - Don’t neglect device appeal and aesthetics. Realising your device to the highest possible level of design aesthetics will maximise appeal and engage users. People like using well considered, well designed products.
7 - Conduct usability testing and iteratively improve the design interface. No matter how good your team are they won’t get it right first time. Prototype your design interface and test it in worst case scenarios with real users. Identify the issues with your design interface, solve them, then repeat this process until your device is safe and easy to use.
8 - Document your HFE activities fully. To pass US FDA scrutiny your Human Factors engineering process will need to be documented fully in-line with relevant standards and guidelines. Everything from early stage evaluations with users to the final human factors validation report will need to be documented. These documents will then form your usability engineering file.
Synecco is ISO 13485 certified and as part of its product development offering the group provides a human factors and design engineering service.
