This document summarizes the activities of an orthopedic product company with three divisions: orthopedic, spine, and sports medicine. It describes new product development phases from initial concept to user preference evaluation. It also outlines engineering projects including custom instrumentation, screw design changes, and pull out strength testing. Regulatory documents and quality systems like risk analysis and FMEAs are referenced. Recommended skills for medical device engineering interns are listed.

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)