Process Overview

Project Initiation

Project Initiation

  • Statement of Work
Product Definition

Product Definition

  • Field Studies
  • User Interviews
  • Usability Studies
  • Human Factors Assessment
  • Product Definition (Requirements) Document
Concept Generation

Concept Generation

  • Competitive Product Analysis
  • Structured Brainstorming
  • Concept Generation
  • Concept Selection
  • Establish Target Specifications
  • Final Project Schedule & Quote
Detailed Design

Detailed Design

  • Engineering Calculations
  • CAD Modeling & Drawings
  • Risk Analysis (FTA, FMEA)
  • Manufacturing Processes & Plan
  • Design Documentation
  • Final Prototype
Design Verification

Design Verification

  • Test Method Development
  • Test Method Validation
  • Verification Test Protocol(s)
  • Verification Testing
  • Verification Test Report(s)
Design Validation

Design Validation

  • Validation Test Protocol(s)
  • Product Validation (Field) Testing
  • Pre-clinical Testing Support
  • Clinical Trial Support
  • Validation Test Report(s)