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People. Processes. Performance.
Strategies for Clinical Studies & Strategies for Clinical Studies & Human Factors ResearchHuman Factors Research
Ginger Clasby, MSGinger Clasby, MSEVP, Business DevelopmentEVP, Business Development
Promedica InternationalPromedica Internationalwww.promedica-intl.com
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Product Development PrioritiesMinimize Medical Device Hazards
• Understand user requirements
• Design/engineer for consistent performance
• Minimize likelihood of user-related errors
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Importance of HFEWhy Products Don’t Sell
• Not easy to use
• Significant service requirements
• Price disproportionate to benefit
• Difficult to manufacture
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Field Test Case StudyCordguard™ Umbilical Cord Management System
• Used in delivery room Used in delivery room
• Unified system for umbilical cord Unified system for umbilical cord clamping, cutting and blood clamping, cutting and blood collection collection
• Collects neonatal blood samples Collects neonatal blood samples while minimizing chance of while minimizing chance of clinician exposure to bloodclinician exposure to blood
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Clinical StudiesWhat Do You Want to Accomplish?
• Device failure modes and rates
• User error types and rates
• Device efficacy
• Cost – benefit analysis
• Comparison vs. “gold standard”
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Clinical StudiesWhat Did We Want to Accomplish?
• Determine device failure modes & rates
• Determine user error types & rates
• Gather subjective feedback regarding device use
• Target sample – 100 births
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Who Are Product Users?Considerations.
• General health and mental state• Physical size and strength• Sensory capabilities• Coordination• Cognitive ability and memory• Knowledge about device operation/associated medical
condition• Previous experience with similar devices/expectations
about device operation• Motivation and ability to adapt to adversity
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Who Were Cordguard™ Users?Considerations.
• Midwives (low-risk deliveries)
• Residents (teaching hospitals)
• Obstetricians
• Neonatologists (high-risk deliveries)
• Labs
• Fathers/family members (may know nothing)
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What Do We Want to Accomplish?Considerations.
• Written protocol• Study objective(s)• User population• Methodology• Data capture
• Product development team and clinician review
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Where to Evaluate?Considerations.
• Convenience• Cost• Regulatory considerations• Medical center requirements
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Where Was Cordguard™ Evaluated?Considerations.
• Hospitals with large birthing population
• Appropriate “mix” of users• Physician-supporters on-staff
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When & How to Implement?Considerations.
• Patient consent
• Institutional Review Board approval
• Patient availability
• User training
• Data capture
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When & How to Implement?Cordguard™ Considerations.
• Randomly occurring patient availability 24/7
• In-service required for a large, frequently changing user pool
• Presence required at time of use
• Data collection done by company personnel
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Evaluating Study Results Objective and Subjective Data.
• Compare results to investigational plan success parameters
• Utilize clinician advisors for interpretation
• Assess needs for additional design modifications and impact on total program
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Evaluating Cordguard™ Study Results Objective and Subjective Data.
• Failure rate too high
• Cumbersome design
• Unacceptable design limitations re: blood collection
• Cost concerns
• Philosophical objections from users
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Evaluating Cordguard™ Study Results Next Steps.
• Initial product premise was flawed
• Significant engineering work remained
Product development activities cancelled
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Human Factors Engineering Guidance References.
• Do It by Design: An Introduction to Human Factors, FDA Do It by Design: An Introduction to Human Factors, FDA Office of Communication, Education & Radiation ProgramsOffice of Communication, Education & Radiation Programs
• Guidance for Industry & FDA Premarket and Design Guidance for Industry & FDA Premarket and Design Control Reviewers – Medical Device Use-Safety: Control Reviewers – Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Incorporating Human Factors Engineering into Risk Management, 7/18/2000Management, 7/18/2000
• Human Factors Design Process for Medical Devices: Human Factors Design Process for Medical Devices: ANSI/AAMI HE74:2001ANSI/AAMI HE74:2001