   A diversified orthopedic product company with 3    major divisions:   Orthopedic: Bone growth stimulators, Mini fixat...
Anterior cervical plating system        Spinal fixation system             Spacers               Limbosacral Fixation syst...
   Pull Out Strength Testing   Custom Instrument   Design Change For Hex Wrench   Updating Screw Design from Double Le...
   Create Validation Protocol for the    Mechanical Test.   Research ASTM Standards   Approval from other departments ...
   Product Development Phases   Concept: Surgeon Idea   Feasibility: Custom or Large Scale Production   Design & Devel...
   Change request after UPE   In-house evaluation   Change in 3D Model   Plastic Prototype   Metal Prototype   Desig...
Courtesy: Othofix Spinal Implants
   Single lead: One thread    profile   Double lead: Two thread    profiles   Triple lead: Three thread    profiles   ...
A-FMEA                                  D-FMEA   Review step of application            Review Part of the Assembly   Re...
Courtesy: Othofix Spinal Implants
   Reports such as:   Sterilization Report   Biocompatibility Report   Verification Rationale/Protocols   Test Protoc...
   Medical Device Design   Orthopedic Device Design   Computational Biomechanics (Ansys)   Intro to Ortho Implants   ...
   3D designing software (Solidworks, ProE)   Drawing skills (Dimensioning & Tolerancing)   Manufacturing Knowledge (Mi...
   Daniel Greenberg, Staff Engineer OSI (Supervisor)   Dr. Max Roman (Academic Advisor)   Alexia Jones (Career Advisor ...
Internship Experience Li
Internship Experience Li
Internship Experience Li
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Internship Experience Li

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Internship Experience Li

  1. 1.  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
  2. 2. Anterior cervical plating system Spinal fixation system Spacers Limbosacral Fixation system Courtesy: www.orthofix.com
  3. 3.  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
  4. 4.  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.
  5. 5.  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
  6. 6.  Change request after UPE In-house evaluation Change in 3D Model Plastic Prototype Metal Prototype Design Freeze
  7. 7. Courtesy: Othofix Spinal Implants
  8. 8.  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
  9. 9. 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
  10. 10. Courtesy: Othofix Spinal Implants
  11. 11.  Reports such as: Sterilization Report Biocompatibility Report Verification Rationale/Protocols Test Protocols 510(k) approvals Risk Analysis
  12. 12.  Medical Device Design Orthopedic Device Design Computational Biomechanics (Ansys) Intro to Ortho Implants Biomaterials Bio-MEMS Total Quality Management
  13. 13.  3D designing software (Solidworks, ProE) Drawing skills (Dimensioning & Tolerancing) Manufacturing Knowledge (Mill, Lathe, Wire EDM) Understand the language Quick Learning Be assertive!!!
  14. 14.  Daniel Greenberg, Staff Engineer OSI (Supervisor) Dr. Max Roman (Academic Advisor) Alexia Jones (Career Advisor CDS)

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