2.  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

3. Anterior cervical plating system Spinal fixation system
Spacers Limbosacral Fixation system
Courtesy: www.orthofix.com

4.  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

5.  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.

6.  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

8.  Change request after UPE
 In-house evaluation
 Change in 3D Model
 Plastic Prototype
 Metal Prototype
 Design Freeze

9. Courtesy: Othofix Spinal Implants

10.  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

11. 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

12. Courtesy: Othofix Spinal Implants

13.  Reports such as:
 Sterilization Report
 Biocompatibility Report
 Verification Rationale/Protocols
 Test Protocols
 510(k) approvals
 Risk Analysis

14.  Medical Device Design
 Orthopedic Device Design
 Computational Biomechanics (Ansys)
 Intro to Ortho Implants
 Biomaterials
 Bio-MEMS
 Total Quality Management

15.  3D designing software (Solidworks, ProE)
 Drawing skills (Dimensioning & Tolerancing)
 Manufacturing Knowledge (Mill, Lathe, Wire
EDM)
 Understand the language
 Quick Learning
 Be assertive!!!

16.  Daniel Greenberg, Staff Engineer OSI (Supervisor)
 Dr. Max Roman (Academic Advisor)
 Alexia Jones (Career Advisor CDS)