Medical Device Design : Innovation From Concept to Market

__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. Medical Device Design Copyright Dedication Preface Acknowledgements 1 - Introduction 1.1 The medical devices world since 2012 1.1.1 What has changed since Edition 1 1.1.2 The internet of things and big data 1.1.3 The medical devices “police” 1.1.4 Essential definitions and how they have changed 1.2 What is design? 1.2.1 The design life cycle 1.3 Summary References 2 - Classifying medical devices 2.1 Why classify? 2.2 Classification rules 2.2.1 Custom made devices 2.3 Classification case studies 2.3.1 EU classification 2.3.2 USA classification case study 2.3.3 Special cases 2.4 Further case studies 2.4.1 OTC joint support device 2.4.1.1 Exemption? 2.4.1.2 Classification? 2.4.2 A device that can jump classification! 2.4.3 An In-vitro diagnostic device 2.5 Classification models 2.6 Classification and the design process 2.7 Classifying software 2.7.1 Software safety classification 2.7.2 Case Study 2.8 Impact of classification on conformity assessment 2.9 Summary 2.9.1 Homework References Websites for further information 3 - The design process 3.1 Design process v design control 3.2 Changes since the last edition 3.3 Design models 3.3.1 Pahl and Beitz, and Pugh 3.3.2 Divergent-convergent model 3.4 Managing design10 3.4.1 Common design management models 3.4.1.1 An essential task 3.4.1.2 Serial design 3.4.1.3 Ad-hoc1212Ad hoc (Latin). It generally signifies a solution designed for a specific problem or task, it is not general, and ... 3.4.1.4 Concurrent design/concurrent engineering 3.4.1.5 Collaborative models 3.4.1.6 Holistic1616Holistic is from the Greek and means whole – or in our case include everyone. A search of holistic design on th ... 3.4.1.7 Which model is best for me? 3.5 Cross-reference with regulatory requirements 3.6 Summary 3.7 Tasks References Further reading 4 - Implementing design procedures 4.1 Introduction 4.2 Review of guidelines 4.3 Overall procedure 4.4 Audit/Review procedure 4.5 The design process 4.5.1 New product procedure 4.5.2 Clarification/product specification procedure 4.5.2.1 An initial literature review is important 4.5.3 Detailed design procedure 4.5.4 Design verification/validation/evaluation procedure 4.5.5 Design changes 4.5.6 Control of documents 4.5.7 Risk assessment procedure 4.6 Implementing a procedure 4.7 Summary References 5 - Developing your product design specification 5.1 Introduction 5.1.1 Lining up the PDS with the new “risk” focused requirements 5.2 Developing the statement of need (or brief) 5.2.1 Identifying the ‘one thing’ 5.2.2 Formalising the statement of need 5.3 The product design specification (PDS) 5.3.1 Essential elements of a PDS 5.3.2 Customer 5.3.3 Regulatory and statutory 5.3.4 Technical 5.3.5 Performance 5.3.5.1 Biomechanics 5.3.6 Sales 5.3.7 Manufacturing 5.3.8 Packaging and transportation 5.3.9 Environmental 5.3.10 Summary 5.4 Finding, extracting and analysing the content 5.4.1 Focus groups 5.4.2 Regulatory bodies 5.4.3 Immersion 5.4.4 Libraries 5.4.4.1 Standards 5.4.4.2 Journals and learned publications 5.4.4.3 Books 5.4.4.4 Librarians 5.4.5 Technical literature 5.4.5.1 General trade magazines 5.4.5.2 Catalogs, fliers and trade literature 5.4.6 The internet 5.4.7 Conferences and symposia 5.4.8 Others 5.5 Devices containing electronics or electrical power 5.6 Software 5.6.1 A word about mobile/cell phones and apps 5.6.2 Platforms 5.6.3 Operating systems 5.6.4 Embedded software 5.7 Summary 5.8 Homework References Further reading 6 - Generating ideas and concepts 6.1 Introduction 6.1.1 The ‘engineer's notebook’ ? 6.1.2 A number of phases 6.1.2.1 Initial PDS for an overall concept 6.1.2.2 Risk analysis, PDS and ideas generation 6.1.2.3 Latter phases 6.1.3 Creative space ? ? 6.1.3.1 The white room ? 6.1.3.2 Personal space ? 6.1.4 Generating concepts/ideas 6.1.4.1 Radial thinking ? ? 6.1.4.2 Inversion (or word association) ? ? 6.1.4.3 Analogue ? ? 6.1.4.4 Brainstorming ? 6.1.4.5 Discretizing ? ? 6.1.4.6 Morphological analysis ? ? 6.1.4.7 Research ? 6.1.4.8 “Post-it-notes” method ? ? 6.1.4.9 Mood boards ? 6.1.4.10 Simply thinking 6.1.4.11 We have ideas! 6.1.5 Selecting concepts and ideas 6.1.5.1 Morphological analysis 6.1.5.2 Criteria assessment 6.1.5.3 Weighted criteria assessment 6.1.5.4 Selection in Stages 6.1.6 Risk Analysis 6.1.7 Summary References 7 - Enhancing quality in design 7.1 Introduction 7.2 Why quality in design? 7.3 Optimization 7.4 2k Factorial experiments/design of experiments 7.5 House of quality 7.6 Failure mode and effect analysis (FMEA) 7.7 Fault tree analysis 7.8 Ishikawa diagram 7.9 D - 4 –X 7.10 Six sigma 7.11 End user input 7.12 Talk to your suppliers 7.13 A word about software development 7.14 Summary References 8 - Design realisation/detailed design 8.1 Introduction 8.2 The process to design realization 8.2.1 Macro project plan 8.2.2 Assemble design team 8.2.3 Micro-plan 8.2.4 Delivery of sub-projects 8.2.5 Delivery of overall design 8.2.6 How? 8.3 Assemble your detailed design team 8.3.1 DHF considerations for the “lead designer” 8.3.2 Phases of a team 8.3.3 Design meetings/design reviews 8.4 Design calculations 8.4.1 Computer aided analysis 8.4.2 Computer aided analysis disciplines 8.5 Materials selection 8.5.1 Formalising the selection process 8.5.2 PDS 8.5.3 Precedent 8.5.4 Research 8.5.5 Regulatory bodies 8.5.6 Standards 8.5.7 Materials search engines 8.5.8 Advisory bodies 8.5.9 Consultancies 8.5.10 Animal products 8.5.11 Biocompatibility 8.5.11.1 Scope 8.5.11.2 Definition(s) and standards 8.6 Computer aided design 8.6.1 Cloud computing 8.6.2 Document and revision management 8.6.3 Collaboration 8.6.4 Reverse engineering 8.6.5 Engineering drawings 8.6.6 Part numbering 8.6.7 Tolerances 8.6.8 Sign off 8.6.9 Rapid prototyping (RP) 8.6.10 3D visualization 8.6.10.1 3D data visualization to the extreme 8.6.10.2 Help with assembly and disassembly 8.7 Component selection 8.8 D-4-X 8.8.1 Design for manufacture (DFM) 8.8.1.1 DFM: software 8.8.2 Design for assembly (DFA) 8.8.2.1 DFA: software 8.8.3 Design for disassembly (DFDA) 8.8.3.1 DFDA: software 8.8.4 Design for sterilzation (DFS) 8.8.4.1 DFS: software 8.8.5 Design for environment/sustainability (DFE) 8.8.5.1 DFE: software 8.8.5.2 Design for environment: where? 8.8.5.3 Design for environment: plastics 8.8.6 Design for usability (DFU) 8.8.6.1 DFU: Software 8.8.6.2 DFU: ergonomics 8.8.6.3 Man-machine-interface 8.8.7 Design for desirability 8.8.8 Design for connectivity 8.8.8.1 Big data 8.9 Summary References 9 - Risk management, risk analysis and ISO 14971 9.1 Introduction 9.2 Risk management 9.3 Risk analysis 9.4 Identifying risks/hazards 9.5 Assessing level of risk 9.5.1 Other ways of assessing risk 9.6 Risk management procedure document 9.7 Risk management folder in the technical file 9.8 Risk management and internal procedures 9.8.1 Risk management and the company's risk register 9.9 Software 9.10 Standards, courses and certification 9.10.1 A copy of the standard? 9.10.2 Courses and certification 9.11 Summary References 10 - Evaluation (validation and verification) 10.1 Introduction 10.2 Reporting of evaluations 10.2.1 Criteria based evaluation 10.2.2 Independence 10.2.3 Qualifications 10.2.4 Repeatability and reproducibility 10.2.5 Cross-correlation 10.2.6 Report format 10.3 In-Vitro evaluations 10.3.1 Accelerated life tests 10.3.1.1 Vibration 10.3.1.2 Cyclic loading 10.3.1.3 Static loading 10.3.1.4 Humidity and temperature 10.3.1.5 Normal use 10.3.1.5.1 Software in “normal” use 10.3.2 Cleaning and sterilisation 10.3.2.1 Supplied non-sterile 10.3.2.2 Gamma irradiation 10.3.2.3 Ethylene oxide 10.3.3 Calibration 10.3.3.1 Sensitivity 10.3.3.2 Range 10.3.3.3 Repeatability 10.3.3.4 Reproducibility 10.3.3.5 Resolution 10.3.3.6 Linearity 10.3.3.7 Summary of calibration 10.3.4 Surface/shape/dimension evaluation 10.3.4.1 USB microscopes 10.3.4.2 Commercial optical microscopes 10.3.4.3 Profile projectors 10.3.4.4 Hardness testing machines 10.3.4.5 Scanning electron microscopes (SEM) 10.3.4.6 Atomic force microscopy (AFM) 10.3.4.7 Beam profile reflectometry (BPR) 10.3.4.8 3D scanning 10.3.5 Tests associated with electrical safety 10.3.5.1 EMC testing 10.3.5.2 IP testing 10.3.5.3 Power source related 10.3.6 Literature review 10.3.6.1 Conducting the review 10.3.6.1.1 Keyword selection 10.3.6.1.2 Systematic review 10.3.6.1.3 Reviewing your findings 10.4 In silico 10.4.1 Animation and virtual reality 10.4.2 Dynamic simulation 10.4.3 Finite element analysis (FEA) 10.4.4 Computational fluid dynamics (CFD) 10.4.5 Software error checking 10.4.6 Caveat 10.5 In-vivo 10.5.1 Clinical study, clinical trial or clinical evaluation: what is the difference? 10.5.2 Why conduct a clinical study? 10.5.2.1 A regulatory requirement 10.5.2.2 Comparative studies 10.5.3 Structure of clinical studies 10.5.3.1 The hypothesis 10.5.3.2 Investigation specification 10.5.3.3 Study types 10.5.3.3.1 Retrospective studies 10.5.3.3.2 Prospective studies 10.5.3.4 Relationship with ethical committees 10.5.3.5 Informed consent 10.5.3.6 Relationship with regulatory bodies 10.5.3.7 ISO 14155 and EC-FDA Guidelines 10.5.4 Analysis of data 10.5.4.1 Outliers and missing values 10.5.4.2 Correlation 10.5.4.3 Averages and confidence limits 10.5.4.4 The student T-test 10.5.4.5 Multi-variant analysis 10.6 Presenting the outcomes of your evaluation 10.7 Value to ‘healthcare’ analysis 10.7.1 Distinct health benefits 10.7.2 Length of service/life 10.7.3 Having the ability to state clinical benefits 10.8 Summary References 11 - Manufacturing supply chain 11.1 Introduction 11.2 Identifying potential suppliers 11.2.1 Samples 11.2.2 Initial audit 11.2.3 Contractual arrangements 11.2.3.1 Preparation for an unannounced audit 11.2.4 Approved supplier register 11.2.4.1 Critical suppliers 11.2.5 Suggested procedure for supplier approval 11.3 Packaging 11.3.1 Sterile packaging 11.3.2 Non-sterile packaging 11.3.3 Packaging testing 11.3.4 Storage considerations 11.4 Procurement 11.4.1 Supply chain glossary 11.4.2 Costing 11.4.3 Manufacturing changes 11.5 Summary Further reading 12 - Labeling and instructions for use 12.1 Introduction 12.1.1 The rules 12.2 Standard symbols and texts 12.2.1 CE 1 mark 12.2.2 Non-sterile device 12.2.3 Single use item 12.2.4 Sterility 12.2.5 Use by date 12.2.6 Lot number/batch number 12.2.7 Catalog number r/part number 12.2.8 Consult instructions for use 12.2.9 Prescription only 12.2.10 Manufacturer details 12.2.11 Date of packing/manufacture date 12.2.12 EC representative 12.3 Labeling 12.3.1 Outer packaging labels 12.3.2 Patient labels 12.3.3 Bar codes 12.3.3.1 UDI and GUDID 12.3.4 Security labels 12.3.5 Cross-over of symbols between USA and EC 12.3.6 Translation 12.3.7 Position of labels 12.4 Marking 12.4.1 Company identification mark 12.4.2 CE mark 12.4.3 Part number and lot number 12.4.3.1 Effects of laser marking 12.4.4 Size 12.5 IFUs and surgical techniques 12.5.1 Instructions for use leaflet 12.5.1.1 Non-sterile items 12.6 Surgical technique 12.6.1 Assembly and disassembly instructions 12.6.2 Warnings and contraindications 12.6.3 Production of the surgical technique 12.6.4 Document control 12.7 Declarations 12.7.1 Declaration of conformity 12.7.2 Declaration of classification. 12.7.3 Declaration (or certificate) of cleaning and sterilisation 12.8 Translation 12.9 Software and items with electrical power 12.10 Summary References 13 - Post market surveillance 13.1 Introduction 13.2 PMS and its role in design 13.3 Tools 13.3.1 Process control chart 13.3.2 Reliability – bath tub curve 13.3.3 Weibull plot 13.3.4 Kaplan-meyer plots 13.3.5 Measles chart 13.3.6 Pareto analysis 13.4 Using your existing contacts 13.4.1 Early adopters and key opinion leaders 13.4.2 Focus groups 13.4.3 Courses and conferences 13.5 Vigilance 13.6 The good, the bad, and the ugly 13.7 Summary References 14 - Protecting your IP 14.1 Introduction 14.2 Types of IP protection 14.2.1 Patent 14.2.1.1 Filing 14.2.1.2 Examination 14.2.1.3 Withdrawing a patent 14.2.1.4 Freedom to operate 14.2.1.5 Other countries 14.2.2 Registered design (design patent) 14.3 Keeping mum 14.4 Talking with partners 14.5 Summary References 15 - Obtaining regulatory approval to market 15.1 Introduction 15.2 Class I devices 15.2.1 EU application 15.2.2 FDA registration 15.3 Higher classifications 15.4 FDA process 15.4.1 Substantial equivalence (SE) 15.4.2 Other sections 15.4.3 Process 15.4.4 Effect on IP 15.5 EU process 15.5.1 Advice 15.5.2 Documentation 15.5.3 Technical files (DHF) 15.5.4 Standards 15.5.5 Stock control 15.5.6 Advice 15.5.7 The outcome 15.6 Getting to market 15.6.1 Unique selling points (USP) 15.6.2 Key opinion leaders (KOLs) 15.6.3 Independent studies 15.6.4 Health economics 15.6.5 Insurance 15.7 Summary References Appendix A - Useful websites Appendix B Appendix C C.1 ISO 14971 annex C pre-risk analysis questionnaire Appendix D D.1 Generic codes for class I medical devices (MHRA) D.2 FDA class I and II exempt devices Appendix E E.1 Basic materials properties for materials selection E.1.1 Density E.1.2 Stress and strain F - Further worked examples of a PDS F.1 Introduction F.2 Knee brace case study: the need F.3 Knee support case study: the PDS F.3.1 Customer section F.3.2 Regulatory and statutory section F.3.3 Technical section and performance section F.3.4 Sales section F.3.5 Manufacturing section F.3.6 Packaging and transportation section F.3.7 Environmental section Index A B C D E F G H I K L M N O P Q R S T U V W 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