A diversified orthopedic product company with 3 major divisions: Orthopedic: Bone growth stimulators, Mini fixators, Bone growth product containing MSC Spine: Spinal implants, Spine fusion, Spine bracing, Biologics Sports Medicine: Bracing products, Cold Therapy
Anterior cervical plating system Spinal fixation system Spacers Limbosacral Fixation system Courtesy: www.orthofix.com
Pull Out Strength Testing Custom Instrument Design Change For Hex Wrench Updating Screw Design from Double Lead to Triple Lead Mitigate Risks Engineering Change Order/Notice
Create Validation Protocol for the Mechanical Test. Research ASTM Standards Approval from other departments Designing Fixture Creating Drawings and rapid prototypes using 3D printer Evaluate the prototype and ordering metal version Carry Out the test on Instron Analyze stress-strain curves and compare results.
Product Development Phases Concept: Surgeon Idea Feasibility: Custom or Large Scale Production Design & Development: Napkin Design to Metal Prototypes Evaluation: Surgeon Review Scale Up User Preference Evaluation
Change request after UPE In-house evaluation Change in 3D Model Plastic Prototype Metal Prototype Design Freeze
Single lead: One thread profile Double lead: Two thread profiles Triple lead: Three thread profiles Triple lead screws get threaded three times faster than single lead screws
A-FMEA D-FMEA Review step of application Review Part of the Assembly Review Potential mode of failure Review Potential mode of failure Review Cause of Failure Review Cause of Failure Review Effects of Failure Review Effects of Failure Determine values for Occurrence, Determine values for Occurrence, Severity and Detection Severity and Detection RPN= O*S*D RPN= O*S*D Recommend Action if RPN higher Recommend Action if RPN higher than normal than normal