Medical Device Link.

EDITOR'S PAGE:

Sterling Silver

COVER STORY

And the Winners Are… 
Stacey L. Bell

Medical Design Excellence Awards 2003

PLASTICS

Advances in Medical Plastics
Gregg Nighswonger 

Device makers traditionally have had simple demands of the medical plastics they use. While clarity is foremost, durability and resistance to sterilization also remain key considerations. In addition to providing exceptional material properties, the current generation of advanced plastics and elastomers offers other benefits for medical manufacturers. Among these are improved hemocompatibility, enhanced radiation sterilization stability, and reduced allergy risks.

GLUCOSE MONITORING

Toward Continuous Blood Glucose Monitoring
Albert P. Kretz and Donald Styblo

For more-effective diabetes management, glucose monitoring should be minimally invasive, continuous, unobtrusive, and informative. Meeting this goal requires microminiature sensors and electronics. MEMS fabrication, new materials, and IC assembly techniques are now making it a practical reality.


Sidebar: Flip-Chip Processes Affect Size, Cost, and Reliability

WASHINGTON WRAP-UP:
James G. Dickinson

Adding Their ID to Devices Not Feasible, Makers Say
Last year’s medical device legislation mandates that all medical devices bear the names of their manufacturers. AdvaMed argues that this provision was intended to apply only to reprocessed devices. 

Plus:

• Are Illegal Imports OK for Diagnostics?
• AdvaMed Writes Ethics Code for Dealing with Doctors
• FDA Worries about Bone Cement Labeling
• Gynecare Intergel Withdrawn from Market
• New Guidance on Natural Rubber Latex
• FDA Explains Electronic Labeling Rule

NEWSTRENDS

• Europe Debates Device Definitions
• UTI Acquires Venusa Ltd.
• Americas Technical Center Focuses on Polymers R&D
• Using Remote Patient Monitoring to Support Home Healthcare
  
  
  

R&D DIGEST:

• Producing Fibers That Mimic Spider Silk
• Microgel Polymer Beads Provide Gene Therapy Vehicle
• Illuminating Nanoparticles Could Be Used for Imaging and Gene Detection

PRODUCT DEVELOPMENT INSIGHT

Eight Ways to Kill Innovation
Stephen B. Wilcox

Medical device manufacturers are supposed to thrive on change. Why, then, do so many of them make innovation difficult? 

REGULATORY OUTLOOK

When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel
Jeffrey K. Shapiro
Hogan & Hartson LLP

It is rarely used and carries risks. But for sponsors who disagree with the scientific basis on which their product was rejected by FDA reviewers, the dispute resolution panel may be an effective option.