November 2004
Medical Device & Diagnostic Industry
Selected Contents
Editor's
Page:
Trials
without Errors
Cover Story
MD&DI’s
Medical Manufacturers of the Year
Erik Swain
What makes
for an outstanding medical device company? There are many ways to answer that
question, given the diversity of the industry and the wide array of accomplishments
by its member companies.
Out
from Under
Once
an underappreciated subsidiary of a drug company, Zimmer Holdings Inc. has become
one of the world’s top orthopedics manufacturers through strategic vision
and key acquisitions.
Aspect Medical Systems Inc. has made anesthetic delivery safer for millions of patients. But only after 18 years has it been able to reap the rewards of its efforts.
Outsourcing Trends
One-Stop
Shop versus Mom-and-Pop
William Leventon
Big
contract manufacturers seem to offer everything, but their small counterparts
still prosper.
WASHINGTON WRAP-UP
FDA
May Not Meet Its User Fee Goals
James G. Dickinson
Not
enough data are available to measure FDA’s performance in meeting the goals
set by MDUFMA.
NEWSTRENDS
- Abbott Joins Drug-Eluting Stent Fray
- Device Firms Embrace Bar Coding
- Puerto Rico Attracts Device-Industry Investment
- ArthroCare to Buy Opus Medical
- VAD Draws Varied Interest
- New Device to Treat Sleep Apnea
R&D DIGEST:
- Nanotube Fibers Emerge from a Tangled Skein
- Reconstruction
Relies on Computers and the Right Material
- Imaging Cavities in 3-D
- Thin
Film Could Become Drug-Delivery Device
Product Development
Insight
Virtual
Product Development Tools—Innovation and Risk Management: Part 1
Leslie Rickey
MSC.Software Corp.
Virtual processes
and tools enable medical device design engineers to innovate and cut costs while
they get products into the marketplace quickly.
Regulatory Outlook
Japan’s New Organization and Review ProcessMartin A. Yahiro and Kiyohito Nakai
Japan’s new Pharmaceutical and Medical Agency serves as a consolidated organization that regulates pharmaceuticals, biologicals, and medical devices.
