MDDI January 2003 Table of Contents

January 2003
Medical Device & Diagnostic Industry
Selected Contents

EDITOR'S PAGE:
Out with the Old, In with the New: MD&DI's New Look for 2003

COVER STORY

Metal Tubing through Thick and Thin
Gregg Nighswonger

From precision device components to novel microtools for surgery, a number of new uses for metal tubing are being explored.

Sidebar: Making the Most of Composite Tubing

PACKAGING

Correlating Peel and Burst Tests for Sterile Medical Device Packages
Rosamari Feliú-Báez, Hugh E. Lockhart, and Gary Burgess

The ability to mathematically relate peel and burst test data could allow results to be taken more rapidly to production and quality control personnel.

Taking the Stress Out of Package Protection
Balakrishna Haridas and Clinton A. Haynes

An examination of coupled predictive simulations of thermoforming processes and drop-impact loading in package design.

SOFTWARE SAFETY

Developing Safety-Conscious Software for Medical Devices
Timothy Cuff and Steven Nelson

To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial.

Sidebar: Safe Software: A Sample Application

MEDICAL DEVICE REGULATION

MDUFMA Spells Change for Manufacturers
Edward C. Wilson Jr.

The newest medical device legislation will provide FDA with increased revenue and resources, but how will the changes affect industry?

HUMAN FACTORS

Is Your Human Factors Program Ready for FDA Scrutiny?
Michael E. Wiklund

For the agency, human factors is more than a buzzword. Manufacturers lacking a comprehensive approach to user-centered design are likely to find this out firsthand.

DEVICE DESIGN

Applying Universal Design to Medical Devices
Stephen B. Wilcox, PhD

As more and more complex medical devices are being operated at home, manufacturers need to develop them with disabled users in mind.

WASHINGTON WRAP-UP:

FDA Aims to Eliminate the "Pre-1976" Stigma
A new CDRH office will be the showcase for director David Feigal's concept of the total product life cycle.