Human Factors & Design Controls
Human Factors is a “hot topic” in Medical Device Development regulations and is a recognised discipline with clearly, defined methodology. It makes sense therefore to build this methodology into your development process. If you are struggling to get to grips with incorporating Human Factors processes into your Design Controls system or in your development plan, then we can help.
What Human Factors isn’t is a magic wand that fixes all of your device problems. What it does tell you is whether your customers will encounter problems with the current design configuration. It will give you a heads up advantage whilst you can still fix any problems and if incorporated into your design process, it will help smooth your path through development and provide you with an all-important compliance audit trail.
When developing new products understanding user needs is essential to device design. Meeting those needs with an elegant solution requires the involvement of Human Factors methods, which is the science of understanding human capabilities and behaviour and translating this knowledge into design solutions for products and systems.
Combining the requirements of both the FDA (HE74 & HE75) and European MDD (ISO 62366) we have created a Human Factors Engineering process based on a Six Sigma DMAIC process.
The DMAIC cycle illustrates the iterative nature of development and can be easily applied to the Human Factors / Usability Engineering Process required for device development.
How we can help you
Three Circles provides Human Factors consultancy and development support across the entire device development process. We can help you in several ways;
- We can integrate Human Factors Engineering into the design process, ensuring important user insights inform each stage of design and development or we provide bespoke tests and plans to support development programmes,
- If you are new to Human Factors and the concept of Usability Testing we can help integrate the Usability Engineering Process into your Design Controls System,
- Alternatively if you have any gaps that appear within the DMAIC cycle (e.g. you need a Usability FMEA generating, a formative usability test, or you need to track your design and risk requirements to you user needs), then we can help you there too.
Usability Engineering Process
We can help you integrate the Usability Engineering Process as defined in ISO 62366 into your design controls and development project, by creating your Usability Verification & Validation Plan and defining the most suitable Human Factors methodologies for your project.
We can also create key process documents; detailing who your users are; creating your usability plan; generating you product usability task analysis; identifying potential use errors; and show you how task analysis forms the basis for planning human factors efforts and creating a test plan.
Plugging the Human Factors gap
We provide consultancy or support with bespoke tests and plans to support your development programmes typically covering areas such as:
- Usability Evaluation and Validation plans
- Interviews & focus groups
- Task analysis
- Contextual enquiry and Cognitive walkthrough
- Usability testing and analysis
- Heuristic evaluation
- Comparative product analysis
We test your device with real users (appropriate for the Intended User profile), providing you with insight into the effectiveness of your device design and supportive data for your project risk analysis.
Benefits of Applying Human Factors
The typical benefits our clients gain are;
- Demonstrable risk mitigations, tested effectively
- Data-based design decisions
- Increased user satisfaction and reduced use error
- Market advantage features included in the design
- Increased market uptake
- Evidence based marketing claims
Get in touch today
Either contact us directly by clicking on the orange “Get In Touch” tab to the right, or alternatively at hello(Replace this parenthesis with the @ sign)threecircles.eu or by phone;
If you’re based in the EU, you can speak with our team on +44 (0)1782 955 255
If you’re based in the US or Canada, you can speak with our team on 312 239 8849