Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices.

Features:

• Provides practical insight into the pitfalls and methods for success involved with developing new medical devices
• Includes several useful glossaries, extensive historical footnotes, and valuable lists of vendor resources
• Contains interviews with industry leaders and pioneers who offer practical advice based on actual experience
• Focuses on mechanical medical devices, a topic not covered in detail in other books
• Considers total product development, including technical, legal, regulatory, medical, and business details

Contents

Invention, Innovation, and Creativity

• Science and Discovery
• Art and Design

Introduction to Medical Plastics

• Biocompatibility
• Biomaterials Availability
• Materials Performance
• Processablility
• What Is a Polymer
• Basics: Thermoplastic and Thermosets
• Cross-Linked Thermoplastic
• What Is a Medical-Grade Plastic
• Finding Plastics
• Plastics for Machining
• Plastics for Processing by Machining
• High-Performance Engineering Plastics for Machining
• Commodity Plastics
• Elastomers
• Thermosets
• High-Performance Engineering Plastics for Molding
• Useful Specialty Plastic Material Forms
• Sheet and Film and Foam Plastics
• Tyvek
• PVC and Polyethelene Film
• Polyester Film (Mylar®)
• Polyimide
• Styrene Butadiene Rubber (SBR) Foam and Elastic Fabric (Wetsuit Material)
• Foam Sheet Material

Catheter-Forming Equipment and Operations

• Basic Forming Operations
• The Hot-Air Station
• Hot-Air Station Setup
• Types of Compressors
• Particle Filters
• Moisture Filters
• Safety
• Features and User Controls
• Basic Forming Operations
• A History of the Development of Glass Catheter Molds
• Hole Punching
• Slug Ejection
• Automated Hole Punching
• Balloon Dip Molds

Basics of Catheter Assembly

• How This Catheter Is Built
• Forming the Distal Tip Assembly
• Other Ways to Tip a Catheter
• Joining the Distal Tip Assembly and the Proximal Shaft
• Punching the Air Hole for Balloon Inflation
• Attaching the Proximal Luer Fitting
• Attaching the Balloon to the Catheter Shaft Assembly
• Assembling the Proximal Steering Hub
• Glossary of Catheter Terms

Introduction to Needles and Cannulae

• Needle Gauges and Sizes
• Metric and English
• Working with Hypodermic Tube
• Common Hypodermic Tubing Materials
• R&D Needle Grinding
• Simple Compound Needle Grinding Fixture
• Suture Needles
• Basic Types of Suture Needle Tips
• Suturing Methods
• Suture Sizes
• Suture Types
• Glossary of Needles and Related Terms

Rapid Prototyping for Medical Devices

• Rapid Prototype Technology
• In-House RP vs. Service Bureaus
• Types of Available RP Technologies
• Stereolithography Materials
• Sony SCS™
• 3D Systems: SLS™
• Stratasys: FDM
• Resolution and Surface Finish
• Solidscape
• LOM™
• Z Corp.: Three-Dimensional Printing
• Polyjet Objet™ Printer
• DLP: Envisiontec® Perfactory™
• Sintering and Direct Metal
• RP Applications in Product Design
• CNC
• Full-Size VMC CNC Machines
• Machinable Prototype Materials
• Rapid Tooling and Molding
• Which Technology Is Best
• File Preparation
• Other File Formats
• RP Cost-Saving Tips
• Secondary Processes to RP Parts
• UV Cure Sealing of Foam Parts
• RP Casting Patterns
• Reverse Engineering
• Innovative Applications of RP

Reverse Engineering in Medical Device Design

• The Value of Reverse Engineering in Patient Care
• Reverse Engineering Methods
• Case Study: Building on an Existing Product for Higher Performance
• Case Example: Making Your Own Stent
• Where to Find Used Medical Devices and Equipment
• Three-Dimensional Reconstruction
• Continuity
• Reverse Engineering and Inspection
• Destructive Reverse Engineering
• Reverse Modeling, Radiology, and Surgical Planning

Using Medical Illustration in Medical Device

• The Value of Medical Illustration to Medical Device R&D
• A Short History of Medical Illustration
• Types of Medical Illustration
• Device Development
• Intellectual Property Development (Utility and Method)
• Regulatory
• Investor Presentations
• Marketing, Physician Training, and Patient Information
• Medical-Legal
• Medical Teaching and Training Models
• Three-Dimensional Animation
• The Medical Illustration Bookshelf
• Finding and Using Medical Illustration

Brief Introduction to Preclinical Research

• In Vitro Testing
• The In Vivo Study

Regulatory Affairs: Medical Devices

• FDA Overview and Authority
• The Basics: Short Discussion of Establishment Registration, Standard Device Submissions, Device Listing, and Device Classification
• Special Considerations
• Good Quality and Procedural Practices
• Summary of Title 21 of the Code of Federal Regulations, Parts 800 to 1299, for Medical Devices

Introduction to Biocompatibility Testing

• What Is Device Biocompatibility
• What Are the FDA and EU/ISO Requirements for Biocompatibility Testing
• Do I Need Biocompatibility Data
• How Do I Determine Which Tests I Need
• Should I Test Device Materials, or Only a Composite of the Finished Device
• Is GLP Treatment Required for Biocompatibility Testing
• Designing Your Biocompatibility Program
• All About Extracts
• Sample Preparation
• Noncontact Devices
• Biological Tests Methods
• Analytical Testing of Biomaterials o Material Characterization

Index

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