The Medical Device R&D Handbook

INVENTION, INNOVATION, AND CREATIVITY; Ted Kucklick
Science and Discovery o Art and Design
INTRODUCTION TO MEDICAL PLASTICS; Ted Kucklick
Biocompatibility 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 Acknowledgments
CATHETER-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 Acknowledgments
BASICS OF CATHETER ASSEMBLY; Ted Kucklick
How 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 Acknowledgments
INTRODUCTION TO NEEDLES AND CANNULAE; Ted Kucklick
Needle 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 Acknowledgments
RAPID PROTOTYPING FOR MEDICAL DEVICES; Ted Kucklick
Overview 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 Acknowledgments
REVERSE ENGINEERING IN MEDICAL DEVICE DESIGN; Ted Kucklick
The 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 Resources
USING MEDICAL ILLUSTRATION IN MEDICAL DEVICE R&D; Ted Kucklick
The 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 Illustrators
BRIEF INTRODUCTION TO PRECLINICAL RESEARCH; James Swick, Ph.D.
Overview o In Vitro Testing o The In Vivo Study o Summary
REGULATORY 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 Abbreviations
INTRODUCTION TO BIOCOMPATIBILITY TESTING; Northview Laboratories
What 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 Acknowledgments
INTERVIEW WITH THOMAS J. FOGARTY, M.D.
INTERVIEW WITH PAUL YOCK, M.D.
INTERVIEW WITH DANE MILLER, PH.D.
INTERVIEW WITH INGEMAR LUNDQUIST
INTERVIEW WITH J. CASEY MCGLYNN
INDEX