Peter J. Ogrodnik

Medical Device Design

Innovation from concept to market

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Academic Press
• Artikelnr. des Verlages: C2011-0-04144-3
• Erscheinungstermin: November 2012
• Englisch
• Abmessung: 20mm x 191mm x 235mm
• Gewicht: 898g
• ISBN-13: 9780123919427
• ISBN-10: 0123919428
• Artikelnr.: 36270171

Autorenporträt

Ogrodnik, Peter J.
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.

Inhaltsangabe

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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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 Chapter 10. Manufacturing Supply Chain
11. Labelling and Instructions for Use
12. Postmarket Surveillance Chapter 13 Sustainability and Resilient systems
14. Protecting Your IP
15. Exploiting IP
16. Obtaining Regulatory Approval to Market
16. Active medical devices
17. Software in Medical Devices
18 AI in Medical Devices
Appendix
A. Useful Websites FDA Medical Devices
B. Tables
C. ISO 14971 Annex C Pre-Risk Analysis Questionnaire Appendix
D. Generic Codes for Class I Medical Devices (MHRA)FDA Class I and II
Exempt Devices
E. Basic Materials Properties for Materials Selection E.1 Density E.2
Stress and Strain