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

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

4. 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

5. 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”

6. 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

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 • 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