Automation development strategies offer IVD manufacturers creative ways to be more cost-efficient yet remain competitive.
By: Richard Park
Several trends in laboratory medicine have affected the development and implementation of automation in lab analyzers during the past few years. Such trends are related to reducing costs, running tests with fewer lab personnel, and maintaining quick turnaround times for test results. IVD manufacturers have been responding to such trends in automation and instrumentation in different ways.
One such trend is automating the preanalytical sample preparation steps, including registering samples in the laboratory information system, centrifuging blood tubes, and preparing them to be sampled. Seeing this trend, several major IVD manufacturers have developed and offer automated sample prep systems.
Taking into account these and other such trends, this issue discusses some of the latest technology developments in laboratory automation.
Authors Bruce Sargeant of Source Scientific LLC (Irvine, CA) and Alfred Lang of the BIT Group (Schwalbach, Germany) consider how IVD manufacturers must endure the rigors of field-testing and FDA certifications for their instruments, while at the same time fighting economic pressures for cost-efficiency. Their article, “Attaining Efficiency through Integration in Developing IVD Platforms” (page 35), examines how autonomous submodules allow IVD design engineers to concentrate on new features and better design in order to get ahead in today's marketplace.
Author Carl Herrgesell of RTEmd (Pittsford, NY) discusses how the use of open source software presents unique challenges in IVD devices. His article, “Applying Open Source Software to IVDs” (page 43), examines how an IVD manufacturer can assure its device's safety and efficacy with open source software inside, and protect its intellectual property in the free distribution licensing environment
This issue's In Person interview is a special one. IVD Technology had the honor and privilege of speaking with Leroy Hood, MD, PhD, cofounder and president of the Institute for Systems Biology (Seattle), and one of the leading experts in personalized medicine. In this interview (page 24), Hood explains what systems biology means and why he believes it holds great promise for the future of personalized medicine. Take this opportunity to read and learn about Hood's views on personalized medicine.
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Richard Park