Boca Raton : Taylor & Francis, 2006.
- xiv, 359 p. : ill. ; 25 cm.
- Title Variation:
Medical device R and 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(R)) 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 SCSa o 3D Systems: SLSa o Stratasys: FDM o Resolution and Surface Finish o Solidscape o LOMa o Z Corp.: Three-Dimensional Printing o Polyjet Objeta Printer o DLP: Envisiontec(R) Perfactorya 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 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.
- (source: Nielsen Book Data)
- Publisher's Summary:
"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.
(source: Nielsen Book Data)
Also available on the Internet.
- Kucklick, Theodore R.