Medical Device Design

Innovation from concept to market


  • Peter Ogrodnik, Professor of Engineering Design at Staffordshire University (UK) and co-founder of Intelligent Orthopaedics Ltd.

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
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Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through to commercialization and FDA/regulatory approval.


Book information

  • Published: November 2012
  • ISBN: 978-0-12-391942-7

Table of Contents

    1. Introduction
    2. Classifying medical devices
    3. The design process
    4. Implementing design procedures
    5. Developing your product design specification
    6. Generating ideas and concepts 
    7. Quality in design
    8. Design realization/Detailed design
    9. Evaluation (validation and verification)
    10. Manufacturing supply chain
    11. Labeling and instructions for use
    12. Postmarket surveilance
    13. Protecting your IP
    14. Obtaining regulatory approval to market