Medical Device Usability Evaluation
Human Factors & Usability Research for iRhythm's Zio Heart Monitoring Device
Project Overview
Led comprehensive human factors and usability research for iRhythm's Zio cardiac monitoring device to support FDA approval process and inform product development. The study combined summative usability testing with in-depth qualitative research to evaluate both clinical efficacy and user experience.
Strategic Challenge
iRhythm needed to:
Validate usability requirements for FDA submission
Identify potential use-related risks
Understand user behavior patterns across patient and healthcare professional populations
Generate insights to inform future product iterations
Ensure compliance with medical device regulatory requirements
My Role & Responsibilities
As Project Lead, I:
Designed and executed end-to-end research strategy
Managed relationships with stakeholders and healthcare facilities
Oversaw participant recruitment and screening
Led data collection and analysis
Presented findings to cross-functional teams
Research Methodology
Phase 1: Study Design
Developed comprehensive research protocol
Created detailed discussion guides for different user groups
Established metrics for summative evaluation
Designed data collection instruments
Set up recording and documentation systems
Phase 2: Participant Research
Conducted in-depth research with 30 participants:
15 Patients
Various age groups
Different medical conditions
Range of technology comfort levels
15 Healthcare Professionals
Cardiologists
Nurses
Medical technicians
Clinical staff
Phase 3: Data Collection
Conducted usability testing sessions
Gathered quantitative benchmarking data
Documented qualitative observations
Recorded user interaction patterns
Collected feedback on:
Device application and removal
Comfort and wearability
Data access and interpretation
Technical challenges
Emergency scenarios
Key Findings & Deliverables
Usability Assessment
Task completion rates
Error patterns and frequency
Time-on-task measurements
User satisfaction metrics
Risk assessment findings
Qualitative Insights
Patient experience journey
Healthcare workflow integration
Communication patterns
Pain points and barriers
Opportunity areas
Strategic Recommendations
Short-term improvements for immediate implementation
Long-term strategic opportunities
Risk mitigation strategies
Feature enhancement priorities
Service design opportunities
Impact & Results
Clinical Outcomes
Identified critical usability improvements for FDA submission
Documented use-related safety considerations
Validated device effectiveness across user groups
Established baseline metrics for future iterations
Business Impact
Informed product development roadmap
Identified new market opportunities
Enhanced value proposition for healthcare providers
Improved patient satisfaction metrics
Strengthened competitive positioning
Success Factors
Rigorous research methodology
Diverse participant pool
Comprehensive data collection
Clear documentation practices
Strong stakeholder engagement
Research Methods & Tools
Usability Testing Protocols
Task Analysis Frameworks
Risk Assessment Matrices
Interview Techniques
Behavioral Observation Methods
Data Analysis Tools
Key Insights
Patient Experience
Device wear comfort factors
Daily activity impact
Self-administration challenges
Emergency scenario readiness
Communication needs
Healthcare Professional Needs
Clinical workflow integration
Data accessibility requirements
Training and support needs
Patient communication tools
Technical requirements
Innovation Opportunities
Enhanced patient monitoring features
Improved data visualization
Streamlined healthcare workflows
Advanced analytics capabilities
Service design enhancements