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

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 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

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 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