September 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
The Next Wave of Innovation
COVER STORY
Blazing New Paths for Product Introductions
Erik Swain
In getting its Cypher stent to market, Johnson & Johnson's Cordis subsidiary not only assumed leadership of the emerging combination product market, but also broke new ground in coordinated FDA-CMS approvals.
Sidebar: Three More Success Stories
Needle manufacturers may find that adhesives can help them create safer devices.
Sidebar: The Adhesive-Selection Process
NEWSTRENDS R&D DIGEST: REGULATORY OUTLOOK
Device manufacturers must get new products to market quickly and efficiently, all while controlling costs. A clear understanding of standards compliance issues provides a vital tool for success.
ASSEMBLY TECHNOLOGY
Light-Cure Adhesives for Needle Assembly
Christine M. Salerni and James A. Serenson
WASHINGTON
WRAP-UP:
FDA Enforcement: When Less Is More
A white paper issued by Mark McClellan attempts to defend FDA's enforcement activities under the Bush administration. But agency watchdogs and former officials declare it "a joke."
A Primer for IEC 60601-1
Leonard Eisner, Robert M. Brown, and Dan Modi
