SERVICES
From front-end innovation to validation, discover how We Are Human, a ClariMed Company, can support your product development process.
STRATEGY & PLANNING
We combine our expertise in creative Human Centred Design with technical Human Factors Engineering principles to create a tailored approach to suit your needs.
From bigger-picture strategy facilitation to product-specific activity planning, we can support you.
We deliver:
- Human Factors Engineering Plans and processes
- Human Centered Design Plans and processes
- Agile Design and Test Sprint Plans
- Design and Innovation Roadmaps
- Human Factors standard operating procedures
Helping you focus and deliver
EXPLORATORY RESEARCH
We are passionate about conducting research to discover unmet needs, innovation opportunities and powerful insights. By immersing ourselves into real-world environments, listening to people’s stories, observing their behaviours and asking the right questions, we help you create genuine solutions that make an impact.
Example methods we use at this stage include:
- Contextual Inquiry
- Design Ethnography
- Diary Studies
- User Journey Mapping
- Persona Creation
- In-Depth Interviews
- Empathy Mapping
We are passionate about conducting research to discover unmet needs, innovation opportunities and powerful insights. By immersing ourselves in real-world environments, listening to people’s stories, observing their behaviours and asking the right questions, we help you create genuine solutions that make an impact.
Example methods we use at this stage include:
- Contextual Inquiry
- Design Ethnography
- Diary Studies
- User Journey Mapping
- Persona Creation
- In-Depth Interviews
- Empathy Mapping
- Heuristic Analysis
Helping you design the right thing
INSTRUCTIONAL MATERIALS DESIGN
We design and develop effective instructional materials including:
- Instructions for Use (IFU)
- User manuals (UMs)
- Quick Reference Guides (QRGs)
- Training Manuals
We work closely with our clients to provide:
- Styling and layout options
- Initial “wireframe” IFU concepts
- First & revised drafts
- Final printed designs
- Traceability to applicable standards
We utilize our combined experience in design, human factors, and regulatory compliance, backed by ClariMed’s broader capabilities, to create clear and concise instructions to support safe and effective device use.
Helping you prioritise the human experience at every step
USABILITY TESTING
From Formative to Summative/Validation testing, we have extensive experience conducting usability studies across the UK, USA and EU.
We provide end-to-end study support with:
- Test protocol writing
- Ethical/IRB approvals
- Participant recruitment
- Study logistics
- Expert moderating
- Data capture
- Rigorous analysis
- Reporting
Helping you design the thing right
USE RELATED RISK MANAGEMENT
We support comprehensive use-related risk management using our systematic approach to use-related risk identification and documentation
Our expert team can assist you with workshops and desk based activities on:
- Known Problems Analysis (KPA)
- Hierarchical Task Analysis (HTA)
- Perception Cognition Action (PCA)
- Use Related Risk Analysis (URRA) including (uFMEA)
- Hazards & Hazardous Situations Analysis
- Critical Task Identification
Helping you manage use related risk throughout the life cycle
TRAINING WORKSHOPS
Looking to empower students or team members in Human Centred Design or Human Factors Engineering? Our expert team has developed a series of interactive training workshops which incorporate engaging activities in:
- Design Thinking & Human Centred Design in Healthcare
- Human Factors Engineering in Medical Device Development
Each course can be customised to go as broad or deep in particular topics depending on your specific needs.
Our workshops are suitable for students and businesses and we can deliver both in person and remotely.
Helping your team develop
HF REGULATORY DOCUMENTATION
We have an expert understanding of HF regulatory requirements for the USA, UK and EU including IEC62366, FDA HF guidance and MHRA HF guidance.
We have expert understanding of Human Factors (HF) regulatory requirements for the USA, UK, and EU, including IEC62366, FDA HF guidance, and MHRA HF guidance.
We provide support in preparing HF documentation from HFE plans and protocols to HFE reports for regulatory submissions, leveraging ClariMed’s extensive regulatory experience.
Helping you meet regulatory expectations
