August 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
Device
Development: Investing in the Long-Term
COVER STORY
Hemocompatible
Coatings for Blood-Contacting Devices
William Leventon
Coating
makers take many different paths to ensure the blood compatibility of medical
products.
R&D
Roundtable
Keys
to Growth of the Medical Device Market
Research
expenditures continue to grow steadily. But are the dynamics of medical device
development shifting?
WASHINGTON
WRAP-UP:
James G. Dickinson
FDA:
Superhighway or Speed Bump?
A recent poll suggests manufacturers are increasingly satisfied with FDA’s
communication with industry and review times. Respondents support the agency’s
use of outside experts as reviewers.
NEWSTRENDS
- Reducing Medical Errors with Benign Failures
- GMP Actions Could Affect Part 11 Enforcement
- HEI and Cerner to Collaborate
- FDA Approves First Cobalt-Chromium Stent
- New Name for B. Braun Unit
- Plastic Compounders Form International Alliance
R&D DIGEST:
- SARS Containment Aided by Computing Grid Technology
- Nanoscale Sensor Has Potential Medical Applications
PRODUCT DEVELOPMENT INSIGHT
Project
Management Equals Risk Management
Richard Rosen
Initial
risk assessment can benefit product development.
REGULATORY OUTLOOK
A Sensible Approach to Biocompatibility
Testing
Jeffrey
K. Shapiro and Randy J. Prebula
Hogan & Hartson LLP
Proving that medical products will remain biologically inert during use
doesn’t have to be complicated.
