Medical Device Link.

October 2000
MD&DI
Selected Contents

EDITOR'S PAGE:
Windows on the Heart
by Jon Katz

Advances in both imagining and diagnostic technologies are giving researchers a more objective picture of the present and future risks of heart disease.

COVER STORY:
Compensation for a Job Well Done Often Involves More Than Salary
by Gregg Nighswonger

In addition to comprehensive insurance packages, more medical device companies are now offering stock options, education benefits, performance bonuses, and pension programs to employees.

QUALITY:
Is the U.S. Meeting the Global Harmonization Guidelines for Auditing Quality Systems
by Tim Wells

A comparison of the guidelines and FDA practices reveals the agency is in compliance with most requirements.

MARKET RESEARCH:
Measuring the Impact of Cultural Variances on Product Design
by Bryce Rutter and Tammy Humm Donelson

For manufacturing attempting to market a new product internationally, the failure to perform in-depth cross-cultural research can be a costly mistake.

WASHINGTON WRAP-UP:
New FDA review chief brings industry background
by James G. Dickinson

With experience in academia, hospital administration, and industry consulting, new director of device evaluation Bernard statland vows to keep his focus on patients.

Also:

• Record $3.8 Million Fine for Fresenius
• Sponsors to Share PMA Data

DESIGN:
Developing Safe, Reliable, Medical Devices
by Ronald E. Giuntini

Reliability engineering tasks should be performed at each step of the product development process.

MEDICAL PLASTICS & BIOMATERIALS:
Customizing Filtration and Separation Materials
by Thomas S. Phillips

Product developers are usng polymers with customization capabilities for a widerange of medical and laboratory applications.

R&D HORIZONS:
New imaging techniques detect diminutive danger signs
by William Leventon

The latest radiology systems help recognize disease indicators during their early stages—when treatment may be most beneficial.