Medical Device Book from C.H.I.P.S.

Medical Device R&D Handbook
by Theodore R. Kucklick

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


  • 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


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


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Medical Device R&D Handbook
by Theodore R. Kucklick
2005 • 376 pages • $138.95 + shipping
Texas residents please add 6.75 % sales tax

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