June 2009
IVD Technology
Selected Contents
Editor's Page
Cancer bill offers high potential for IVDs
Richard Park
Gaining access to repositories of banked tumor samples would benefit the development of cancer diagnostics.
Trends & Perspectives
Processing Technologies
The impact of water quality on IVD testing
Johanne Long and Stéphane Mabic
Water purification systems can control water quality, which decreases manufacturing downtime and increases accurate test results.
Applying polymer laminate technology to developing IVDs
Leanna Levine
Polymer laminate technology is an enabling platform for rapid prototyping of single-use, lab-on-a-chip devices that are revolutionizing IVDs.
Laboratory Automation
Optimizing automated liquid handlers
Wade Yandell and Dave Wexler
IVD companies can use longitudinal data to understand liquid handler performance and obtain guidance on optimization practices.
Regulations & Standards
The evolution of the 510(k) submission: Part 1 of 2
Marlene A. Hanna
Medical devices were originally unregulated, then regulated as drugs. FDA’s oversight of devices has changed and grown during the past four decades.
In Person
IVD Manufacturing and Processing
Companies that manufacture IVDs have a lot to think about these days: contamination, outsourcing, and domestic and international regulation and labeling, to name a few.
