Contents Page (MDDI archive, Feb 01)

January 2001
Medical Device & Diagnostic Industry
Selected Contents

EDITOR'S PAGE:
An Unceremonious Exit:
Does Henney Leave a Newly Politicized FDA?
by Jon Katz

Although the device industry and its advocacy groups have been largely silent, there is no lack of rhetoric as FDA awaits the next commissioner.

COVER STORY:
Current Design Trends in Medical Electronics
by Fernando Lynch
Electromedical manufacturers and component suppliers are taking steps to improve both performance and cost-effectiveness of increasingly miniaturized, high-precision, portable devices.

BIOMATERIALS:
Strategies for Evaluating and Validating Supplier Formulation and Process Changes
by Dale Steiner and Jerry Davis

Adopting a team or centralized approach enables medical manufacturers to respond to formulation changes rapidly and efficiently.

HUMAN FACTORS:
Human Factors Roundtable Part II: Standards Development and Implementation Issues
by Jon Katz

As materials designers confront the fundamental challenges of medical science, the discovery of new biocompatible polymers is creating unprecedented excitement.

STERILIZATION:
Continuous Monitoring of EtO Concentrations during Sterilization
by Patrick G. Smith

The ability to accurately monitor EtO levels throughout the sterilization process is expected to facilitate validation and result in more cost-efficient operation.

INSIDE MD&DI:
Keeping a Weather Eye on EtO Sterilization
by Gregg Nighswonger

Patrick G. Smith sees new opportunities for EtO sensing.

WASHINGTON WRAP-UP:
When FDA Doesn't Want Preemption
by James G. Dickinson

A fraud-based case has elicited a new FDA position on preemption.

Also:

Bleak Budget Outlook
Industry Protests Postmarket Rule

R&D HORIZONS:
Biometrics Technologies are Key Elements of Patient Security
by Gregg Nighswonger

Potential medical errors, the need for secure information systems integration, and HIPAA compliance are among the factors driving studies of security and identity authentication methods.

Previous Issues of MD&DI On-line:

2001
January

Medical Device Link.

The Online Information Source for the Medical Device Industry

January 2001
Medical Device & Diagnostic Industry
Selected Contents

Medical Device Link.

The Online Information Source for the Medical Device Industry

Medical Device & Diagnostic Industry

MD&DI Blogs

January 2001 Medical Device & Diagnostic IndustrySelected Contents

January 2001
Medical Device & Diagnostic Industry
Selected Contents