The Medical Device R D Handbook (no chap 3)

Content: INVENTION, INNOVATION, AND CREATIVITY
 Ted KucklickScience and Discovery  o  Art and DesignINTRODUCTION TO MEDICAL PLASTICS
 Ted KucklickBiocompatibility  o  Biomaterials Availability  o  Materials Performance  o  Processablility  o  What Is a Polymer?  o  Basics: Thermoplastic and Thermosets  o  Cross-Linked Thermoplastics  o  What Is a Medical-Grade Plastic?  o  Finding Plastics  o  Plastics for Machining  o  Plastics for Processing by Machining  o  High-Performance Engineering Plastics for Machining  o  Commodity Plastics  o  Elastomers  o  Thermosets  o  High-Performance Engineering Plastics for Molding  o  Useful Specialty Plastic Material Forms  o  Sheet and Film and Foam Plastics  o  Tyvek  o  PVC and Polyethelene Film  o  Polyester Film (Mylar????)  o  Polyimide  o  Styrene Butadiene Rubber (SBR) Foam and Elastic Fabric (Wetsuit Material)  o  Foam Sheet Material  o  Resources  o  AcknowledgmentsCATHETER-FORMING EQUIPMENT AND OPERATIONS
 Ted Kucklick  o  Basic Forming Operations  o  The Hot-Air Station  o  Hot-Air Station Setup  o  Types of Compressors  o  Particle Filters  o  Moisture Filters  o  Safety  o  Features and User Controls  o  Basic Forming Operations  o  A History of the Development of Glass Catheter Molds  o  Hole Punching  o  Slug Ejection  o  Automated Hole Punching  o  Balloon Dip Molds  o  Conclusion  o  Resources  o  AcknowledgmentsBASICS OF CATHETER ASSEMBLY
 Ted KucklickHow This Catheter Is Built  o  Forming the Distal Tip Assembly  o  Other Ways to Tip a Catheter  o  Joining the Distal Tip Assembly and the Proximal Shaft  o  Punching the Air Hole for Balloon Inflation  o  Attaching the Proximal Luer Fitting  o  Attaching the Balloon to the Catheter Shaft Assembly  o  Assembling the Proximal Steering Hub  o  Glossary of Catheter Terms  o  Resources  o  AcknowledgmentsINTRODUCTION TO NEEDLES AND CANNULAE
 Ted KucklickNeedle Gauges and Sizes  o  Metric and English  o  Working with Hypodermic Tube  o  Common Hypodermic Tubing Materials  o  R&D Needle Grinding  o  Simple Compound Needle Grinding Fixture  o  Suture Needles  o  Basic Types of Suture Needle Tips  o  Suturing Methods  o  Suture Sizes  o  Suture Types  o  Glossary of Needles and Related Terms  o  Resources  o  AcknowledgmentsRAPID PROTOTYPING FOR MEDICAL DEVICES
 Ted KucklickOverview  o  Rapid Prototype Technology  o  In-House RP vs. Service Bureaus  o  Types of Available RP Technologies  o  Stereolithography Materials  o  Sony SCS?? ??  o  3D Systems: SLS?? ??  o  Stratasys: FDM  o  Resolution and Surface Finish  o  Solidscape  o  LOM?? ??  o  Z Corp.: Three-Dimensional Printing  o  Polyjet Objet?? ?? Printer  o  DLP: Envisiontec???? Perfactory?? ??  o  Sintering and Direct Metal  o  RP Applications in Product Design  o  CNC  o  Full-Size VMC CNC Machines  o  Machinable Prototype Materials  o  Rapid Tooling and Molding  o  Which Technology Is Best?  o  File Preparation  o  Other File Formats  o  RP Cost-Saving Tips  o  Secondary Processes to RP Parts  o  UV Cure Sealing of Foam Parts  o  RP Casting Patterns  o  Reverse Engineering  o  Innovative Applications of RP  o  Conclusion  o  Resources  o  AcknowledgmentsREVERSE ENGINEERING IN MEDICAL DEVICE DESIGN
 Ted KucklickThe Value of Reverse Engineering in Patient Care  o  Reverse Engineering Methods  o  Case Study: Building on an Existing Product for Higher Performance  o  Case Example: Making Your Own Stent  o  Where to Find Used Medical Devices and Equipment  o  Three-Dimensional Reconstruction  o  Continuity  o  Reverse Engineering and Inspection  o  Destructive Reverse Engineering  o  Reverse Modeling, Radiology, and Surgical Planning  o  ResourcesUSING MEDICAL ILLUSTRATION IN MEDICAL DEVICE R  Ted KucklickThe Value of Medical Illustration to Medical Device R&D  o  A Short History of Medical Illustration  o  Types of Medical Illustration  o  Device Development  o  Intellectual Property Development (Utility and Method)  o  Regulatory  o  Investor Presentations  o  Marketing, Physician Training, and Patient Information  o  Medical-Legal  o  Medical Teaching and Training Models  o  Three-Dimensional Animation  o  The Medical Illustration Bookshelf  o  Finding and Using Medical Illustration  o  Commercially Available Resources to Find Medical IllustratorsBRIEF INTRODUCTION TO PRECLINICAL RESEARCH
 James Swick, Ph.D.Overview  o  In Vitro Testing  o  The In Vivo Study  o  SummaryREGULATORY AFFAIRS: MEDICAL DEVICES
 Thom Wehman, Ph.D.Introduction  o  FDA Overview and Authority  o  The Basics: Short Discussion of Establishment Registration, Standard Device Submissions, Device Listing, and Device Classification  o  Special Considerations  o  Good Quality and Procedural Practices  o  Summary of Title 21 of the Code of Federal Regulations, Parts 800 to 1299, for Medical Devices  o  AbbreviationsINTRODUCTION TO BIOCOMPATIBILITY TESTING
 Northview LaboratoriesWhat Is Device Biocompatibility?  o  What Are the FDA and EU/ISO Requirements for Biocompatibility Testing?  o  Do I Need Biocompatibility Data?  o  How Do I Determine Which Tests I Need?  o  Should I Test Device Materials, or Only a Composite of the Finished Device?  o  Is GLP Treatment Required for Biocompatibility Testing?  o  Designing Your Biocompatibility Program  o  All About Extracts  o  Sample Preparation  o  Noncontact Devices  o  Biological Tests Methods  o  Analytical Testing of Biomaterials  o  Material Characterization  o  References  o  About This Chapter  o  AcknowledgmentsINTERVIEW WITH THOMAS J. FOGARTY, M.D.INTERVIEW WITH PAUL YOCK, M.D.INTERVIEW WITH DANE MILLER, PH.D.INTERVIEW WITH INGEMAR LUNDQUISTINTERVIEW WITH J. CASEY MCGLYNNINDEX