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June 2008
Medical Device & Diagnostic Industry
Selected Contents





From the Editors

Good Ideas, Bad Execution

Erik Swain

A bill that’s supposed to fix problems with FDA inspections has some provisions that don’t make sense.

100 Notables

100 Notable People in the Medical Device Industry

There’s no way to honor everyone who has helped shape the medical device industry, but MD&DI celebrates the contributions of 100 of them.

Metals

Wired for Catheter Applications, Part 1

Brett Steen

Many catheter devices need conductive pathways to transport electrical energy. Microwires may be the answer.

Packaging

Sterile Packaging: Measuring Microbial Barriers, Part 2

Paul Herman and Curtis Larsen

An ASTM International standard test method ranks porous packaging materials in sterile applications by their ability to hold out bacteria.

Washington Wrap-Up

FDA Pressed on Device Appeals

James G. Dickinson

Two congressmen inquire about FDA’s ongoing saga with TMJ Implants.

Product Development Insight

Smoothing the Research Process

Rob Tannen

Device designers can use several techniques to improve user research.

Regulatory Outlook

Examining FDA’s Regulation of Diagnostics

Jane Baluss

Recent events signal a change in FDA’s oversight of diagnostics products and services.