MTU Library Catalogue

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Medical device design : innovation from concept to market / Peter J. Ogrodnik.

By: Ogrodnik, Peter J [author.].
Material type: materialTypeLabelBookPublisher: Amsterdam ; Boston : Elsevier/Academic Press, 2013Copyright date: ©2013Edition: First edition.Description: xvii, 350 pages. : illustrations ; 25 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9780123919427 (hardback); 0123919428.Subject(s): Medical instruments and apparatus -- Design and construction | Medical instruments and apparatus -- Standards | Medical instruments and apparatus -- Evaluation | Biomedical engineering | Engineering designDDC classification: 610.284
Contents:
Introduction -- Classifying medical devices -- The design process -- Implementing design procedures -- Developing your product design specification -- Generating ideas and concepts -- Quality in design -- Design realization/detailed design -- Evaluation (validation and verification) -- Manufacturing supply chain -- Labeling and instructions for use -- Postmarket surveillence -- Protecting your IP -- Obtaining regulatory approval to market.
Holdings
Item type Current library Call number Copy number Status Barcode
General lending MTU Bishopstown Library Lending 610.284 (Browse shelf(Opens below)) 1 Available 00161548
Total holds: 0

Enhanced descriptions from Syndetics:

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.

Includes bibliographical references and index.

Introduction -- Classifying medical devices -- The design process -- Implementing design procedures -- Developing your product design specification -- Generating ideas and concepts -- Quality in design -- Design realization/detailed design -- Evaluation (validation and verification) -- Manufacturing supply chain -- Labeling and instructions for use -- Postmarket surveillence -- Protecting your IP -- Obtaining regulatory approval to market.

CIT Module BIOE 8002 - Core reading.

Table of contents provided by Syndetics

  • Introduction
  • Medical devices: Definitions by FDA, MDD
  • The design process
  • Product development procedures
  • Developing a design specification
  • Ideas generation and selection
  • Implementing Quality in Design
  • FMEA Risk analysis 2k factorials
  • House of quality design optimization
  • Design for manufacture
  • Design for assembly
  • Design for disassembly
  • Life cycle analysis and environmental regulation