healthcare Human Factors & Usability Testing

We offer a range of HFE research, design, and evaluation capabilities:

• Establishing HFE strategies for regulatory compliance
• HFE risk assessments
• Research based user need analysis
• Usability evaluations
• User centric product design inputs
• Formative and Summative test design, set up and execution
• Usability Reports

Usability errors are an increasingly common reported failure mode for medical devices. Each year, thousands of medical device incidents are reported, with severe harm to patients due to HFE problems in clinical procedures, which can result in device recalls.

The US FDA and European Medical Device Regulations require device manufactures to apply HFE principles during design and development of medical devices. In 2016 FDA HF/UE guidance and European IEC 62366 documents outlined a process, including activities throughout device development, culminating in validation testing with the final user interface design in simulated use environments with target user groups and intended use scenarios.

The ultimate purpose of these directives is to allow for early identification and mitigation of potential harm risks to both patient and healthcare users, however this is not without placing the burden of implementing a new process and addressing regulation on to the manufacturer.

The FDA recommends conducting a risk analysis on any medical device to determine if there is cause for potential harm to the end users. Likewise, the international regulatory community has incorporated IEC 62366, Medical devices – Application of usability engineering to medical devices, as a part of the approval process in the European Union and outside. The new European Medical Device Regulation and the latest revision of Quality Management System standard ISO 13485:2016 require a usability inspection explicitly for all medical devices as an essential requirement for device safety and clinical performance.