Human factors engineering and ergonomics

Identifying physical and interaction needs - optimising design and compliance 

Background

With 100+ combined years of practical application of ergonomics, psychology and communications in design, Lucid’s team knows how to make products and services a great fit for the people who use them.

Diverse expertise helps us evidence meeting the standards, guidance and regulation for medical device and wellness products - delivering product that is safe, intuitive, engaging and a pleasure to use.

Discovery

We help you understand user capabilities and needs.

In desk research, user groups and interviews and questionnaires, techniques include:

• Ethnographic research, investigating culture, behaviour, beliefs, and way people socially interact.

• Workflow mapping, to understand and optimise process steps.

• Anthropometric data analysis, determining body size and shape and it’s impact on design.

• Competitive analysis, using and mapping the benefits and issues with existing products and services.

•  The information contributes to an optimum design specification, identifying potential risks and opportunities to add value.   

Design

Our regulatory specialists will plan human evaluation of your design - mindful of legislative constraints that preclude the intended use of new medical devices outside the context of regulated clinical investigations (trials).

During the design process, we’ll use product and packaging models, user interaction simulation, and preliminary instructions to make the experience of product use in as real-world scenarios as possible.

In applications such as surgery, we’ll work with clinicians to collaborate in effective simulation or incorporate human factors into clinical investigation protocols.

In over-the-counter, home-use scenarios where direction could influence outputs we’ll develop remote protocols that minimise intervention.

Recruiting and talking to users, observing their interaction, we evidence potential hazards, benefits and issues, cumulatively evidencing:

• Formative human factors studies, from the early, light-touch interviews to formal usability evaluation. 

• Summative human factors studies.  Evidencing mitigation of potential harms identified in risk management in functional interactions and instructional or user-interface comprehension.

Delivery

As part of regulatory submissions for FDA clearance, CE and UKCA mark, Lucid has delivered compelling evidence that designs are safe and effective.