04 Syllabus

01 Objectives     02 Practical Experience     03 Workload     05 Syllabus 

  1. Background of Clinical Problem
    1. What is the clinical problem?
    2. Surgical Anatomy
    3. Current treatment options
    4. Expected outcome of current treatment options
    5. Deficiencies of current treatment options

  2. Defining the Unmet Need based on the following:
    1. A detail understanding of clinical problem
    2. Focus group study with local surgeons
    3. Literature review of the current state of art
    4. An understanding of the views of key opinion leaders in the field based on:
      1. literature review
      2.  focus group discussions with local surgeons and
      3. trade publications
  1. Observations at surgery or surgical video review

  2. Generation of Design Specifications
    1. Introduction of Design Theory and Methodology (Ulrich/Eppinger)
    2. Conversion of verbalised need to design specifications
    3. Generation of need-metric matrix and metrics bench marking

  3. Industrial Benchmarking including Adverse Event Report (MUADE)
    1. Analysis of product brochures
    2. Literature review
    3. Detail review and analysis of adverse event reports

  4. Intellectual Property Strategies
    1. How to conduct a thorough patent search
    2. Patent Filings
    3. Claim Analysis
    4. Determination of freedom to operate
    5. Determination of proprietary position
    6. Licensing issues

  5. FDA Medical Device Regulatory Strategy (+CE Marking)
    1. Device Classification
    2. Regulatory Pathways
    3. 510(k), PMA, IDE, HDE

  6. Quality System in accordance to CRF Title2 1
    1. Design History File
    2. Design Qualification
    3. Design Verification
    4. Design Validation
    5. FDA Guidance Documents

  7. GLP, GCP, GMP and Sterility Requirement

  8. ASTM Standards
    1. Overview of ASTM standards and introduction to other standards
    2. The 12 basic ASTM standards for medical device certification
    3. How ASTM standards relates to design verifications and FDA regulatory pathways

  9. Bioethics covers Helsinki Declaration, Belmont Report, IRB, Conflict of Interest