Design Partners have an integrated Human Factors Engineering and Usability Testing process designed to create significantly better products that are safer, de-risked and measurably easier to use.
Human Factors Engineering (HFE) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system. It is the process that applies theory, principles, data and methods to design to optimise both human well-being and overall system performance.
Our approach is research based and focused on delivering the best solutions to answer user needs. We combine human factors engineering expertise with industrial design creativity and engineering excellence to deliver user centred designs that surpass expectations.
HFE activities are conducted throughout all phases of device design and development, from preliminary analysis and usability inspection to formative evaluations and final summative validation testing in simulated use.
We offer a range of HFE research, design, and evaluation capabilities:
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.
We believe that HFE is a strategic product development tool to deliver competitive advantage, as well as meeting the regulatory perspective of design optimisation for safety and risk reduction.
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.
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