1. People. Processes. Performance. Strategies for Clinical Studies & Human Factors Research Ginger Clasby, MS EVP, Business Development Promedica International www.promedica-intl.com

2. Product Development Priorities Minimize Medical Device Hazards Understand user requirements Design/engineer for consistent performance Minimize likelihood of user-related errors

3. Importance of HFE Why Products Don’t Sell Not easy to use Significant service requirements Price disproportionate to benefit Difficult to manufacture

4. Field Test Case Study Cordguard™ Umbilical Cord Management System Used in delivery room Used in delivery room Unified system for umbilical cord clamping, cutting and blood collection Unified system for umbilical cord clamping, cutting and blood collection Collects neonatal blood samples while minimizing chance of clinician exposure to blood Collects neonatal blood samples while minimizing chance of clinician exposure to blood

5. Clinical Studies What Do You Want to Accomplish? Device failure modes and rates User error types and rates Device efficacy Cost – benefit analysis Comparison vs. “gold standard”

6. Clinical Studies What 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

7. 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

8. Who Were Cordguard™ Users? Considerations. Midwives (low-risk deliveries) Residents (teaching hospitals) Obstetricians Neonatologists (high-risk deliveries) Labs Fathers/family members (may know nothing)

9. What Do We Want to Accomplish? Considerations. Written protocol Study objective(s) User population Methodology Data capture Product development team and clinician review

10. Where to Evaluate? Considerations. Convenience Cost Regulatory considerations Medical center requirements

11. Where Was Cordguard™ Evaluated? Considerations. Hospitals with large birthing population Appropriate “mix” of users Physician-supporters on-staff

12. When & How to Implement? Considerations. Patient consent Institutional Review Board approval Patient availability User training Data capture

13. 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

14. 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

15. 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

16. Evaluating Cordguard™ Study Results Next Steps. Initial product premise was flawed Significant engineering work remained Product development activities cancelled

17. Human Factors Engineering Guidance References. Do It by Design: An Introduction to Human Factors, FDA Office of Communication, Education & Radiation Programs 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 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 Human Factors Design Process for Medical Devices: ANSI/AAMI HE74:2001