Services and expertise
Human factors and design research for healthcare product development
Focused, flexible, and built for healthcare
Pulse HF offers a comprehensive range of human factors and design research services tailored to the unique needs of each client. From early-stage exploration to validation testing (summative), we collaborate closely with your team to generate insights that are clear, actionable, and defensible.
Our mission is to help you make product development decisions with confidence and get to market faster.
01
Design Research
We translate real-world use and unmet needs into clear direction for product design.
- Qualitative VOC Research
- Quantitative Market Research
- Contextual Inquiry
- User Needs Identification, Screening, Prioritization
- Opportunity Definition
- Co-Creation
- Resonance Testing
- Time-in-Motion Studies
02
Usability Analysis
We analyze and document users, environments, interfaces, tasks, and training to inform and de-risk early design and support compliance.
- Anthropometric and physical capability assessments
- Cognitive and perceptual capability analysis
- Ergonomic and environmental analysis
- Heuristic analysis
- Expert review
- Usability benchmarking
03
Human Factors Documentation
We develop rigorous documentation needed to align with international standards and regulatory guidance.
- Gap Analysis
- HFE/UE Plan
- Use Specifications
- Known Use-Related Problems
- Task Analysis
- Use-Related Risk Analysis
- User Interface Specification
04
Formative Evaluations
We evaluate product use, identify usability issues, and highlight opportunities to mitigate risk and improve design.
- Study design and planning
- Recruitment and honoraria
- Research facilities and logistics
- Study moderation and notetaking
- Analysis, reporting and documentation
- Insight synthesis and recommendations
05
Validation Testing
We execute HF validation (summative) studies and generate clear reports and documentation for global regulatory authorities.
- End-to-end study design, execution, and reporting
- Human Factors validation (summative) testing
- Integrated design validation studies
- HFE/UE reporting for regulatory submissions
06
Instructional Design
We design labeling and instructional materials that effectively guide users and mitigate risk.
- Instructions for use
- Quick reference guide
- User Manual
- Packaging
- Labeling
- Training protocols
How we work
End-to-end or targeted support.
We can manage your project end-to-end or simply plug-in where needed.
- Study design and planning
- Recruitment and honoraria*
- Research facilities and logistics*
- Study moderation and notetaking
- Analysis, reporting and documentation
- Insight synthesis and recommendations
*Via specialized & qualified partners
An extension of your team.
We provide leadership when you need it and support when you don’t.
- In-depth product onboarding and knowledge transfer process
- Act as both a collaborative partner and subject matter expert
- Align with existing processes and templates – or bring our own
- Clear communication and accountability
Flexible ways to partner together.
We offer a variety of engagement models to fit your needs.
- Predictable fixed-fee projects
- Hourly time and materials
- Open-ended monthly support
- Staff augmentation
- Fractional HF leadership
Who we support
Supporting teams at every stage
Pulse HF works with organizations across the healthcare spectrum, including:
- Medical Device
- Pharmaceutical
- Diagnostics
- Digital Health & SaMD
- Consumer Health
From early exploration through regulatory submission, we support clients of every size at every stage of development.
Let’s work together
From early discovery through formative evaluations and summative testing, Pulse HF can support your team with human factors expertise at every stage of development.