January 2002
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S PAGE
Medical
Devices: A Nickel a Name
TUBING
Medical
Tubing Offers More (and Less) to Device Makers
William Leventon
Modern tubing boasts more properties with less bulk than ever before. But the improvements will cost you.
PACKAGING
Flexibility
and Customization Expand Packaging Options
Wil Caraballo
Thermoform-fill-seal technology incorporates a wide range of variables that offer manufacturers flexibility in the design and modification of every area in the packaging process.
USER MANUALS
Medical
Device User Manuals: Shifting toward Computerization
Michael E. Wiklund
VALIDATION
A
Systems Engineering Approach to Requirements Validation
Trace
Baker
Product
development risks can be reduced by validating project requirements before the
design process begins.
ASSEMBLY
Reaping
the Benefits of Continuous-Motion Assembly
John Giacopelli
Continuous-motion
assembly engineering can be performed concurrently with new product design or
to make existing manufacturing systems more efficient.
TEST SYSTEMS
Test
System Engineering for Medical Devices: A Guide
Tore
Johnsen
Developing
test systems for R&D through production requires a combination of preparedness
and ongoing evaluation.
DEVELOPMENT TEAMS
Working
Together at a Distance
William
Leventon
Dispersed
product development teams may have limitations, but there are ways to maximize
their advantages.
WASHINGTON
WRAP-UP
Feigal
Sees Threats to Device Standards
James G. Dickinson
The CDRH director recently expressed doubts about the viability
of device standards as a regulatory tool for ensuring safety and effectiveness.
R&D DIGEST:
- Artificial Joint Cartilage Mimics Structure and Function of Natural Tissue
- Polymer Glass Coating Creates Germ-Free Surfaces
- Device Simulates Functions of Medical Leeches
- Low-Dose Radiation Used to Prevent Restenosis in Leg Arteries
- "Sonic Flashlight" Makes Human Body Appear Translucent
- Achieving Greater Precision in New Polymer Materials
- POPS Device Keeps Heart Alive for Nearly 12 Hours
- 3-D
Digital Imaging System Provides Microrange Resolution
BOTTOM LINE
In
the Know: Professional Development Offers a Wealth of Benefits
Stacey
L. Bell
Savvy
executives and their employers are discovering that membership in trade associations
delivers both a strong return on investment and invaluable personal growth.
NEWS & ANALYSIS
