June
2008
Medical Device & Diagnostic Industry
Selected Contents
From the Editors
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.
Web Exclusive: Book Review
Reviewed by Vinny Sastri
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
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.
Industry News



