Our Process

Project Definition

Product Development Specifications, IP Review, Physician Feedback, Market Research & Competitive Analysis

phase%201%20ip phase%201%20market%20research Phase%201%20physician%20feedback

 

Phase 2 – Concept Development

Innovative Brainstorming, Concept Evaluation, Initial Breadboard Fabrication, Animal/Cadaver testing

phase%202%20%20brainstorming phase%202%20animal-cadaver%20testing phase%202%20breadboard%20fab. phase%202%20concept%20eval.

 

Phase 3 – Engineering Development

Detailed Design, Design FMEA, Bench Testing, Clinical Testing

phase%203%20clinical%20testing phase%203%20detail%20design phase%203%20FMEA

 

Phase 4 – DFM / DFA

Human Factors/Ergonomics, Design Verification, Manufacturing Fixture Development, DMF/DFA, Manufacturing Component Fabrication & Sourcing

phase%204%20design%20verification phase%204%20DFM.DFA phase%204%20human%20factors-ergonomics phase%204%20manufact.%20compon.%20fab%20&%20sourcing phase%204%20manufact.%20fixture%20develop.

 

Phase 5 – Design Validation

Sterilization Validations, Packaging Design & Validations, Process Validations, Transportation Testing, Biocompatibility, Quality & Process Documentation

phase%205%20packaging%20design%20&%20validat phase%205%20quality%20&%20process%20documents phase%205%20sterilization

 

Phase 6 – Contract Manufacturing

Manufacturing Line Support, Quality Line Support, class 10,000 clean rooms

phase%206%20clean%20rooms phase%206%20manufact.%20line%20support phase%206%20quality%20line%20support