The Medical Device R&D Handbook

The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time.

The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur.

Highlights Include…

An Introduction to Medical Plastics

Catheter Forming Equipment and Operations

Basics of Catheter Construction

Basics of Medical Needles

Rapid Prototyping for Medical Devices

Reverse Engineering for Medical Devices

Using Medical Illustration in Product Development

Introduction to Pre-Clinical Studies

Introduction to Regulatory Affairs

Assessing Biocompatibility

Exclusive Interviews with Key Industry Leaders

…And More

This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.

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