Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Flexi-Q DV Auto-injector Case Study - DALI Medical Devices Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Initial Development Phase• Developed with a major pharmaceutical company• Drug in vial (expensive)• Generally elderly patient population (50-75 years)• Frequent or infrequent injections• Market transition from injection by healthcareproviders to self-injection at home• Design Concept: a Plunger Rod is used to fill thedrug from the vial into the injector8
- Page 1: Visit us @ Booth 320Flexi-Q DV Auto
- Page 7: Project History -General Top Level
- Page 11 and 12: Chosen Solution1. Implementing a De
- Page 13 and 14: Needle Shield Protection under Side
- Page 15 and 16: Study Methodology - Brief1. Devices
- Page 17 and 18: Pre-IDE• FDA review: Main issue w
- Page 19 and 20: Usability Study• Question to CDRH
- Page 23: Study Participants• Procrit ® -
- Page 26 and 27: Study Results• Observed Practice
- Page 28 and 29: FDA 510(k) Clearance• SE letter (
- Page 30 and 31: Flexi-Q DV Design Characteristics -
- Page 32 and 33: Lessons learned• Formative Study
- Page 34 and 35: Acknowledgments• P/L Biomedical,
- Page 36: Visit us @ Booth 320Thank You
Initial Development Phase• Developed with a major pharmaceutical company• Drug in vial (expensive)• Generally elderly patient population (50-75 years)• Frequent or infrequent injections• Market transition from injection by healthcareproviders to self-injection at home• Design Concept: a Plunger Rod is used to fill thedrug from the vial into the <strong>injector</strong>8
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