The key steps in the evolution of your new knee replacement system are:

• assemble surgical design team
• review key design parameter options, competitor offerings, relevant patents
• define a comprehensive set of design team preferences
• generate surgical implant solid models and manufacturing drawings
• confirm implant assembly and inter-connectivity via prototypes, if applicable
• identify implant regulatory testing requirements
• initiate manufacture of parts required for regulatory testing
• complete implant regulatory testing and polymeric material characterization
• submit for implant market clearance from regulatory body
• identify product packaging requirements and related testing requirements
• initiate necessary packaging tests
• produce or purchase prototype surgical instruments and sterilization trays
• confirm effectiveness of instruments with bone models and/or cadavers
• complete surgical instrument sterilization tray with definitive instruments
• validate sterilization protocols for loaded instrument trays, implants
• receive market clearance from applicable regulatory agency
• place production orders for implants, instruments, and instrument trays

This list can be resolved down to 3 key milestones:

    1) obtaining regulatory body clearance to use the implants

     2) generation and validation of implant system accoutrements (instruments, sterilization trays, packaging)

     3) production of sterile implants in side-size-thickness permutations and volumes sufficient to perform surgical cases on a limited or larger scale.