Klienditugi: 7440010 (E-R 10-18)

Medical Device Design: Innovation from Concept to Market 2nd edition [Pehme köide]

Peter J. Ogrodnik (Partner in Metaphysis LLP, Award Leader MSc Medical Engineering Design, Keele University, and Honorary Professor Guangxi University of Science and Technology)

Formaat: Paperback / softback, 538 pages, kõrgus x laius: 235x191 mm, kaal: 880 g
Ilmumisaeg: 26-Oct-2019
Kirjastus: Academic Press Inc
ISBN-10: 0128149620
ISBN-13: 9780128149621

Teised raamatud teemal:

Biomedical engineering

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Formaat: Paperback / softback, 538 pages, kõrgus x laius: 235x191 mm, kaal: 880 g
Ilmumisaeg: 26-Oct-2019
Kirjastus: Academic Press Inc
ISBN-10: 0128149620
ISBN-13: 9780128149621

Teised raamatud teemal:

Biomedical engineering

Püsilink: https://www.kriso.ee/db/9780128149621.html

Märksõnad:

Medical instruments and apparatus - Design and construction

Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.

This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.

Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
Presents additional content around software and biocompatibility concerns

Preface

xvii

Acknowledgements

xix

Chapter 1 Introduction

(16)

1.1 The medical devices world since 2012

(10)

1.1.1 What has changed since Edition 1

(1)

1.1.2 The internet of things and big data

(1)

1.1.3 The medical devices "police"

(1)

1.1.4 Essential definitions and how they have changed

(8)

1.2 What is design?

(4)

1.2.1 The design life cycle

(1)

1.3 Summary

(1)

References

(1)

Chapter 2 Classifying medical devices

(34)

2.1 Why classify?

(1)

2.2 Classification rules

(5)

2.2.1 Custom made devices

(2)

2.3 Classification case studies

(9)

2.3.1 EU classification

(4)

2.3.2 USA classification case study

(2)

2.3.3 Special cases

(2)

2.4 Further case studies

(5)

2.4.1 OTC joint support device

(3)

2.4.2 A device that can jump classification!

(1)

2.4.3 An In-vitro diagnostic device

(1)

2.5 Classification models

(2)

2.6 Classification and the design process

(2)

2.7 Classifying software

(6)

2.7.1 Software safety classification

(1)

2.7.2 Case Study

(3)

2.8 Impact of classification on conformity assessment

(1)

2.9 Summary

(1)

2.9.1 Homework

(1)

References

(1)

Websites for further information

(2)

Chapter 3 The design process

(28)

3.1 Design process v design control

(3)

3.2 Changes since the last edition

(1)

3.3 Design models

(9)

3.3.1 Pahl and Beitz, and Pugh

(4)

3.3.2 Divergent-convergent model

(5)

3.4 Managing design

(10)

3.4.1 Common design management models

(10)

3.5 Cross-reference with regulatory requirements

(2)

3.6 Summary

(1)

3.7 Tasks

(1)

References

(1)

Further reading

392

(1)

Chapter 12 Labeling and instructions for use

393

(24)

12.1 Introduction

393

(1)

12.1.1 The rules

393

(1)

12.2 Standard symbols and texts

394

(6)

12.2.1 CE 1 mark

394

(2)

12.2.2 Non-sterile device

396

(1)

12.2.3 Single use item

396

(1)

12.2.4 Sterility

396

(1)

12.2.5 Use by date

397

(1)

12.2.6 Lot number/batch number

397

(1)

12.2.7 Catalog number r/part number

398

(1)

12.2.8 Consult instructions for use

398

(1)

12.2.9 Prescription only

399

(1)

12.2.10 Manufacturer details

399

(1)

12.2.11 Date of packing/manufacture date

399

(1)

12.2.12 EC representative

400

(1)

12.3 Labeling

400

(6)

12.3.1 Outer packaging labels

401

(1)

12.3.2 Patient labels

401

(1)

12.3.3 Barcodes

401

(4)

12.3.4 Security labels

405

(1)

12.3.5 Cross-over of symbols between USA and EC

405

(1)

12.3.6 Translation

406

(1)

12.3.7 Position of labels

406

(1)

12.4 Marking

406

(2)

12.4.1 Company identification mark

406

(1)

12.4.2 CE mark

406

(1)

12.4.3 Part number and lot number

407

(1)

12.4.4 Size

407

(1)

12.5 IFUs and surgical techniques

408

(1)

12.5.1 Instructions for use leaflet

408

(1)

12.6 Surgical technique

409

(2)

12.6.1 Assembly and disassembly instructions

409

(1)

12.6.2 Warnings and contraindications

410

(1)

12.6.3 Production of the surgical technique

411

(1)

12.6.4 Document control

411

(1)

12.7 Declarations

411

(2)

12.7.1 Declaration of conformity

411

(1)

12.7.2 Declaration of classification

412

(1)

12.7.3 Declaration (or certificate) of cleaning and sterilisation

413

(1)

12.8 Translation

413

(1)

12.9 Software and items with electrical power

414

(2)

12.10 Summary

416

(1)

References

416

(1)

Chapter 13 Post market surveillance

417

(16)

13.1 Introduction

417

(1)

13.2 PMS and its role in design

418

(2)

13.3 Tools

420

(7)

13.3.1 Process control chart

420

(1)

13.3.2 Reliability --- bath tub curve

421

(2)

13.3.3 Weibull plot

423

(2)

13.3.4 Kaplan-meyer plots

425

(1)

13.3.5 Measles chart

426

(1)

13.3.6 Pareto analysis

427

(1)

13.4 Using your existing contacts

427

(3)

13.4.1 Early adopters and key opinion leaders

428

(1)

13.4.2 Focus groups

429

(1)

13.4.3 Courses and conferences

429

(1)

13.5 Vigilance

430

(1)

13.6 The good, the bad, and the ugly

430

(1)

13.7 Summary

431

(1)

References

431

(2)

Chapter 14 Protecting your IP

433

(10)

14.1 Introduction

433

(1)

14.2 Types of IP protection

434

(5)

14.2.1 Patent

434

(5)

14.2.2 Registered design (design patent)

439

(1)

14.3 Keeping mum

439

(2)

14.4 Talking with partners

441

(1)

14.5 Summary

441

(1)

References

442

(1)

Chapter 15 Obtaining regulatory approval to market

443

(68)

15.1 Introduction

443

(1)

15.2 Class I devices

443

(6)

15.2.1 EU application

443

(4)

15.2.2 FDA registration

447

(2)

15.3 Higher classifications

449

(1)

15.4 FDA process

449

(6)

15.4.1 Substantial equivalence (SE)

453

(1)

15.4.2 Other sections

454

(1)

15.4.3 Process

454

(1)

15.4.4 Effect on IP

455

(1)

15.5 EU process

455

(5)

15.5.1 Advice

455

(1)

15.5.2 Documentation

456

(1)

15.5.3 Technical files (DHF)

457

(2)

15.5.4 Standards

459

(1)

15.5.5 Stock control

460

(1)

15.5.6 Advice

460

(1)

15.5.7 The outcome

460

(1)

15.6 Getting to market

460

(2)

15.6.1 Unique selling points (USP)

461

(1)

15.6.2 Key opinion leaders (KOLs)

461

(1)

15.6.3 Independent studies

461

(1)

15.6.4 Health economics

461

(1)

15.6.5 Insurance

462

(1)

15.7 Summary

462

(1)

References

463

(2)

Appendix A Useful websites

465

(4)

Appendix B Tables

469

(2)

Appendix C ISO 14971 Annex C pre-risk analysis questionnaire

471

(16)

Appendix D Generic codes for class I medical devices (MHRA)

487

(6)

Appendix E

493

(4)

E.1 Basic materials properties for materials selection

493

(1)

E.1.1 Density

493

(1)

E.1.2 Stress and strain

493

(4)

Appendix F Further worked examples of a PDS

497

(14)

Index

511

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.

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