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People. Processes. Performance. Strategies for Clinical Studies & Human Factors Research Ginger Clasby, MS EVP, Business Development Promedica International Product Development Priorities Minimize Medical Device Hazards . Understand user requirements

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People. Processes. Performance.

Strategies for Clinical Studies & Human Factors Research

Ginger Clasby, MS

EVP, Business Development

Promedica International


Product Development PrioritiesMinimize Medical Device Hazards

  • Understand user requirements
  • Design/engineer for consistent performance
  • Minimize likelihood of user-related errors

Importance of HFEWhy Products Don’t Sell

  • Not easy to use
  • Significant service requirements
  • Price disproportionate to benefit
  • Difficult to manufacture

Field Test Case StudyCordguard™ Umbilical Cord Management System

  • Used in delivery room
  • Unified system for umbilical cord clamping, cutting and blood collection
  • Collects neonatal blood samples while minimizing chance of clinician exposure to blood

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”

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

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

Who Were Cordguard™ Users?Considerations.

  • Midwives (low-risk deliveries)
  • Residents (teaching hospitals)
  • Obstetricians
  • Neonatologists (high-risk deliveries)
  • Labs
  • Fathers/family members (may know nothing)

What Do We Want to Accomplish?Considerations.

  • Written protocol
    • Study objective(s)
    • User population
    • Methodology
    • Data capture
  • Product development team and clinician review

Where to Evaluate?Considerations.

  • Convenience
  • Cost
  • Regulatory considerations
  • Medical center requirements

Where Was Cordguard™ Evaluated?Considerations.

  • Hospitals with large birthing population
  • Appropriate “mix” of users
  • Physician-supporters on-staff

When & How to Implement?Considerations.

  • Patient consent
  • Institutional Review Board approval
  • Patient availability
  • User training
  • Data capture

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

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

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

Evaluating Cordguard™ Study Results Next Steps.

  • Initial product premise was flawed
  • Significant engineering work remained

Product development activities cancelled


Human Factors Engineering Guidance References.

  • Do It by Design: An Introduction to Human Factors, FDA Office of Communication, Education & Radiation Programs
  • Guidance for Industry & FDA Premarket and Design Control Reviewers – Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, 7/18/2000
  • Human Factors Design Process for Medical Devices: ANSI/AAMI HE74:2001