Capabilities and Services
Comprehensive Concept to Production Services

• High and low volume plastic products
  
• High and low volume metal products
  
• Extensive nitinol experience/forming capabilities
  
• Biodegradable and permanent implants
  

Comprehensive Research, Development and Design Services

• Rapid prototype development
  
• 3D part modeling with technical drawings/analysis (SolidWorks)
  
• Finite element analysis
  
• Feasibility assessment and testing
  
• Tolerance analysis
  
• In-house 3D printing (Objet Alaris30)
  
• Experienced in the OR environment
  
• Established machine shop and EDM partners
• Material sourcing
  
• IP Facilitation
  
• Project leadership as required
• In-house 50 W, Nd:YAG laser welder
  

Feasibility, Verification and Validation

• Mechanical testing (including protocols, testing fixtures, method development)
• Shelf life studies
  
• Implant degradation studies
  
• Sterilization studies
  
• Lab studies (mechanical lab, cadaver lab, etc.)
  
• Field validation studies; physician preference testing
  
• Manufacturing support

Quality Systems Support

• Design History File development/support
  - Design input/output documentation
  - FMEA
  - Risk analysis
  - Technical drawings
  - Protocols; reports; other documentation
  
• Quality Systems awareness/compliance
• Technical file development