Medical Device Design

Medical Device Design, 1st Edition

Innovation from concept to market

Medical Device Design, 1st Edition,Peter Ogrodnik,ISBN9780123919427


Academic Press




235 X 191

Design, develop and bring medical devices to market successfully by following this integrated approach to designing recognized US and EU procedures.

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Key Features

      • The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how.
      • Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand.
      • Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.



      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.


      Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through to commercialization and FDA/regulatory approval.

      Peter Ogrodnik

      Affiliations and Expertise

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

      Medical Device Design, 1st Edition

        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


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