July 2006
Medical Device & Diagnostic Industry
Selected Contents
From the Editors:
To Regulate or Facilitate?
Andrew von Eschenbach will have his work cut out for him when he tries to make the rank and file share his view of the agency as an active participant in industry.
Cover Story: Nanotechnology
Nanotechnology: Little Things Mean a Lot
Sherrie Conroy
Because nano-based developments are gaining ground in the device industry, it is critical to understand the challenges, potential applications, and regulatory issues posed by this emerging field.
Sidebar:
Pores, Tubes, Dots, and More
Coatings
The Future of Drug-Eluting Stents: A Coatings Perspective
Brian L. Robey and John S. Buan
The next generation of drug-eluting stents will have to capitalize on improvements to drugs, designs, materials, and coatings. Here's what coming in the coatings arena.
Molding
Reshaping Devices with Microfeatures
Dana E. Schramm and Raghu Vadlamudi
Manufacturers must understand the mold building, processing, handling, and packaging of medical devices as they become microsized.
Software
The Goldilocks Principle: Approaches to Software Validation
Mark Allen and Steve Gitelis
How much software validation do companies really need to do to satisfy FDA requirements and not waste valuable resources?
Washington Wrap-Up
Device Stocks Bring Criminal Probe on Crawford
James G. Dickinson
The former FDA commissioner faces investigation into his stock holdings. Also, a contact lens cleaner is removed from the market, and Larry Pilot reflects on the Utah Medical case.
Product Development Insight
Defining and Designing for Worst-Case Users
Michael Wiklund
Potential device users can have myriad limitations in using devices. Device designers need to take such limitations into account during product design. Here's how.
Regulatory Outlook
Building Quality into Device Clinical Trials
Michael E. Marcarelli, Marian J. Serge, Jean Toth-Allen, Cynthia A. Harris, and Barbara K. Immel
Human-subject protection and good sponsor-IRB relationships are critical parts to any device clinical trial. Implementing best practices can help achieve them.
NewsTrends
R&D Digest
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