September 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
It’s
All about the Money
Manufacturing
Manufacturers
Get Lean to Trim Waste
William Leventon
Those who
advocate lean strategies tout the savings in labor, space, and time on the plant
floor and beyond.
Extrusion
Extrusion
Firms Adapt to Demands for New Procedures and More
John Conroy
To meet
medical device industry demands, extrusion companies are producing tighter
tolerances and streamlining manufacturing processes.
Integrated
Circuits
Wireless
Medical Devices: Satisfying Radio Requirements
Carl Falcon
Understanding
radio protocols and requirements is the first step in successfully using
wireless communication in medical applications.
WASHINGTON WRAP-UP
Another Attack on FDA’s Troy, This Time with a StingJames G. Dickinson
Some worry that FDA’s chief counsel is too eager to involve the agency in legal proceedings dealing with product liability damages.
NEWSTRENDS
- Stent Recall May Raise Quality Expectations
- User-Fee Increases May Prompt MDUFMA Reassessment
- Schultz Takes the Reins at CDRH
- Chinese Market: Lucrative but Challenging
- Stryker to Acquire SpineCore
- Correction
R&D DIGEST:
- Probe Could Improve Breast-Cancer Detection
- Space Technology Now Used as Mobile Hospital Cleanroom
- Device Facilitates Dental-Screw Placement
- New
Indicator for Early-Stage Heart Disease
Product
Development Insight
Beyond
Brainstorming
Bill Evans and Jonathan M. Wyler
Implementing a
systematic approach to product definition can improve the efficacy of
idea-generating sessions.
Regulatory
Outlook
Jeffrey K. Shapiro
Promotional claims comparing one device with another are common and legal. But companies should carefully consider possible pitfalls before making such claims.
Q&A
Forging
New Regulatory Pathways at FDA
Erik Swain
FDA’s
Office of Combination Products is poised to determine how the agency will handle
the products resulting from the increasing convergence of the drug, device, and
biologics industries.
