SERVICES & EXPERTISE

Human Factors & Design Research for Healthcare Product Development

Pulse HF partners with medical device and pharmaceutical teams to deliver rigorous human factors engineering and research that informs design, reduces risk, and supports regulatory compliance.

Clinician measuring a patient’s blood pressure during a medical examination.

INTRO

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.

  • Researcher interviewing participant during healthcare usability study.

    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

  • Hospital monitoring equipment and IV drip in a clinical care environment.

    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

  • Researcher working on a laptop with design notes during product research.

    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

  • Medical simulation mannequin used for clinical training and usability testing.

    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

  • Surgical team performing a procedure in a usability testing lab staged to look like a hospital operating room.

    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

  • At-home diagnostic testing kit for healthcare screening with all instructional materials and packaging.

    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

Healthcare professional examining a handheld medical device in a clinical setting.

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

Researcher reviewing mobile app wireframes during digital health design research.

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

Healthcare worker monitoring patient data on multiple hospital computer screens.
Healthcare professionals collaborating during a clinical team meeting.

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 Build Safer Healthcare Products

Whether you need targeted research support or end-to-end human factors expertise, Pulse HF is ready to partner with your team.

Contact PulseHF