October 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
High
Hopes for High-Risk Stroke Patients
Packaging
Sterile
Packaging: Sample Sizes and Statistics
Dennis Gilliland, Laura Bix,
Hugh Lockhart, and Nick Fotis
Determining
appropriate sample sizes for operational qualifications can help manufacturers
ensure sterility of medical device packaging.
Software
Booting
Up: Trends and Technologies that Drive Software-Based Management Systems
MES:
A Look Back, a Look Forward
Brendan Gill
Regulations
and higher-quality standards have made manufacturing execution systems a necessity
for staying competitive in the 21st century.
Getting
the Most Out of Quality Software
Heather Thompson
Competition
is heating up among software companies; meanwhile, customers are increasing
their demands for intuitive features and flexibility.
ERP/MRP
Presents Unique Challenges
Christina
Elston
The spirit
of innovation in medical devices may be limited when it comes to choosing management
software.
Design Strategies
Nursing
Shortages and Device Design: A Hidden Connection
Erik Swain
The U.S.
nursing-shortage problem isn’t going away. It may be up to the medical
device industry to provide solutions.
WASHINGTON WRAP-UP
CDRH’s
Schultz Seeks More Postmarket Reports
James G. Dickinson
The
center’s director prioritizes his effort to crack down on companies that
fail to follow through with their postmarket reports.
NEWSTRENDS
- Manufacturing Presents Complications for Drug-Eluting Stents
- New Legislation Could Alter GPO Payments
- MD&DI 25th Anniversary Trivia Contest Results
- Getting What We Pay For: the Value of Healthcare
- FDA Allows OTC Defibrillators
- Survey Shows Strong Demand for Artificial Discs
R&D DIGEST:
- Heart Devices May Be Safe for MRI Scan
- Kinder,
Gentler ICDs
- Plastic Magnets Show Some Mettle
- Lumbar
Fusion Procedure Made Simpler
Healthcare Trends
Hospital
Defect Reduction: Will Device Makers Be Affected?
David
Warburton
As
hospitals increasingly stress procedures such as inventory and data management,
device makers will be called upon to provide new features and services with
their products.
Product Development
Insight
Beyond
Brainstorming
Bill Evans and Jonathan M. Wyler
A sound understanding of product value and the fertile areas for potential solutions positions product developers for effective idea generation and innovative concept refinement.
Regulatory Outlook
Japan’s New Regulatory SystemMartin A. Yahiro and Kiyohito Nakai
To keep abreast of the constantly changing medical device industry in Japan, the Japanese government has significantly revised its pharmaceutical affairs laws.
Q&A
Taking
the Reins
Erik Swain
CDRH’s
new director assumes control of a center facing numerous challenges. From implementing
user fees to regulating combination products, Daniel Schultz has his work cut
out for him.
U.S. Commercial Service: Helping Exporters Find Markets
The Healthcare
Technology Team provides assistance to companies
looking to begin exporting their products.
