Class 1 Devices

Class 1 Devices

Case Studies in Medical Devices Design

1st Edition - November 24, 2014

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  • Author: Peter Ogrodnik
  • Paperback ISBN: 9780128000281
  • eBook ISBN: 9780128007969

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The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.

Key Features

  • These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes.
  • Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products.
  • Joins up theory and practice in an accessible style.


Medical and Biomedical Engineers, plus medical and clinical professionals involved with medical device design.

Table of Contents

    • Dedication
    • Acknowledgements
    • Chapter 1: Introduction
      • Abstract
      • 1.1. Reminder concerning classification
      • 1.2. A reminder concerning the importance of design rigour (or design control)
      • 1.3. A reminder concerning understanding the problem
      • 1.4. A reminder concerning a team/holistic approach
      • 1.5. A reminder concerning costs
      • 1.6. Introduction to the case studies
      • 1.7. Hints to enable you to understand the text
    • Chapter 2: Classification
      • Abstract
      • 2.1. Introduction
      • 2.2. FDA classification
      • 2.3. EU MDD classification
      • 2.4. Your turn
    • Chapter 3: Taking the Design from Idea to PDS
      • Abstract
      • 3.1. Introduction
      • 3.2. Developing the specification
    • Chapter 4: Conceptual Phase
      • Abstract
      • 4.1. A reminder about space
      • 4.2. The relationship with your product design specification (PDS)
      • 4.3. Solution selection
      • 4.4. Summary
    • Chapter 5: Embodiment Phase
      • Abstract
      • 5.1. A reminder about this phase
      • 5.2. Initial embodiment – or first prototype phase
      • 5.3. Prototype to final design
      • 5.4. Summary
    • Chapter 6: The Home Run
      • Abstract
      • 6.1. A summary of activity
      • 6.2. The technical file
      • 6.3. A note about manufacturing
      • 6.4. A note about post market surveillance (PMS)
      • 6.5. The final furlong5
      • 6.6. Continual improvement
    • References
    • Annexure I: Essential Requirements

Product details

  • No. of pages: 114
  • Language: English
  • Copyright: © Academic Press 2014
  • Published: November 24, 2014
  • Imprint: Academic Press
  • Paperback ISBN: 9780128000281
  • eBook ISBN: 9780128007969

About the Author

Peter Ogrodnik

Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments. He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.

Affiliations and Expertise

Partner in Metaphysis LLP, Award Leader MSc Medical Engneering Design at Keele University, Honorary Professor Guangxi University of Science and Technology

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