Medical Device Link.

October 1999
MD&DI
Selected Contents

COVER STORY:
Job Satisfaction Remains High In Device Industry
by Gregg Nighswonger

Results of MD&DI's 11th annual salary survey indicate that long hours at work are being compensated by a continuing increase in average salaries.

SPECIAL SECTION:
Pulsed UV Curing for Medical Devices
by Louis R. Panico

Efficient light penetration through opaque materials and the avoidance of heat-induced substrate damage are among the benefits of pulsed curing systems.

QUALITY:
QSIT: The New Quality System Inspection Technique
by Timothy R. Wells

Developed in concert with industry groups, FDA's new inspection process emphasizes management responsibility for establishing effective quality systems.

DESIGN:
Predictive Analysis at the Forefront of Medical Product Development
by Balakrishna Haridas and Clinton A. Haynes

Predictive analysis and simulation of medical device and implant performance using nonlinear finite element analysis can significantly accelerate product development cycles while helping manufacturers to avoid costly mistakes.

STERILIZATION:
The Effects of Radiation Sterilization on the Microbial Barrier Properties of Tyvek
by Michael Scholla, Earl Hackett, Wazir Nobbee, Stasys Rudys, and Claude Michels

A study showed that, for Tyvek, the microbial barrier properties follow filtration theory for the variables of basis weight, porosity, and charge.

FIRST PERSON:
Reprocessing Single-Use Devices: Why Does the Debate Continue?
by William B. Stoermer Jr.
When it can be validated that a device can be cleaned, tested, and reused without harm to the patient, the device should be reprocessed, a member of AMDR maintains.

R&D HORIZONS:
Clinical Needs and Technology Drive Medical Imaging to 4-D
by Greg Freiherr
Advances in computed tomography, magnetic resonance imaging, and ultrasound systems bring challenges as well as benefits.

WASHINGTON WRAP-UP:
Novel Devices Won't Suffer, but the Others?
by James G. Dickinson

Also:

• Lab-Test Labeling Guidelines Stir Controversy
• Judge Curbs FDA Marketing Rules
• Group Seeks Action Against Reprocessors >
• HIMA Critiques Dispute Policy

BOTTOM LINE:
Developing a Successful Translation Strategy
by Marc H. Miller
Companies that adopt a broad perspective on the translation process can gain a competitive advantage in foreign markets.

SNAPSHOT:
Recognizing Opportunity
by Robert Drummond

EDITOR'S PAGE:
An Excellence Adventure: MDEAs Honor Development Vision, Innovation
by John Katz

Sponsored by MD&DI, the third annual Medical Design Excellence Awards will once again recognize outstanding achievements in medical device design and manufacturing.