IVD Industry Overview
Examining IVD-related election year issues
The primary election issue for IVD companies is the evolution of the clearance and approval system. My belief is that the rules and regulations are fine, and OIVD management needs to make improvements to clarify, standardize, and speed up the clearance and approval processes. Compliance issues need to be dealt with outside of the clearance/approval system, and the IVD industry needs to lobby on that. However, since legislators like to legislate, there is a threat of new laws that will require...
Designing Medical Device Software for the Millennial
2010 was a catalyst year for computing. When Apple launched the iPad tablet computer in April, it brought the keyboard and mouse one step closer to extinction. Similarly, with Windows 7, Microsoft added true touch-screen support to desktops, tablet PCs, and smartphones. Google made an entrance as well, with Android, an operating system for smart phones and slates. Touch screen will be the dominant user interface for years to come, according to DisplaySearch.com, which monitors and reports on...
The Year in IVDs
Allegra X-30 Series Benchtop Centrifuge by Beckman Coulter The underlying themes and questions in the IVD industry during the past couple of years have been, How will the global economic downturn affect the industry, and how will IVD manufacturers overcome challenges as a result of the recession? Industry analysts continue to believe that the IVD market will not be stalled by difficult economic conditions. Nonetheless, it remains to be seen how the fallout from the recession will...
Consulting Services
In vitro diagnostics is a global business. IVD manufacturers are looking not only at the United States but also to growing economies like China and India as their future markets. Bringing a new IVD product from laboratory to market has never been easy; it involves development and implementation of good manufacturing practices and sometimes multiple regulatory submissions. These efforts are often complicated by delays in the development process, high costs, errors in design, and delays in timely...
Contract manufacturing
Contract manufacturers are described on FDA’s Web site as companies that “manufacture a finished device to another establishment’s specifications.”1 More than 1500 companies at more than 14,000 locations are currently registered with FDA as contract manufacturers.2 In addition to these companies, many other unregistered firms are also contract manufacturing nonregulated products and offering contract sterilization, repackaging, relabeling, remanufacturing, and...
Manufacturing equipment and supplies
The good news is that in a stagnant economy, the $37 billion global IVD market continues to grow at a compound rate, which is expected to approach 9% through 2012. The challenging news is that IVD manufacturers encounter a myriad of obstacles when considering their manufacturing solutions. IVD testing devices are much more sensitive and complex than in the past. Not only is the technology more complex, stringent per-piece pricing adds to that complexity. There is an ever-constant need to reduce...
Packaging and Labeling Materials and Components
IVD devices are an important part of healthcare. These devices typically contain a sample collection area on which chemical reagents or biologically active proteins react, sometimes electrochemically, with the sample to produce something that can be measured optically or photometrically. By virtue of their critical function in analyzing samples ranging from urine, saliva, and blood to swabs of cellular matter at home or in a laboratory, their reliability must remain intact. This integrity must...
Electronic and mechanical components and software
When designing an IVD or other medical instrument, most engineers look at the requirements as a group of mechanical, fluidic, electrical and software systems interacting to produce a desired result. Often, these engineers see only part of the picture. Quite a few factors come into play both during design and manufacturing and after the instrument is deployed. Following the design phase is integrating systems, performing validation, gaining approvals, manufacturing, and servicing in the field....
Assay system components
The enzyme-linked immunosorbent assay (ELISA) is one of the most widely used techniques in both basic immunology research and diagnostic analyses. Because ELISA enables peptides, proteins, antibodies, and hormones to be selectively detected in small concentrations among a multitude of other substances with relatively low cost and high simplicity, the method provides an important and useful tool for disease monitoring, diagnostics, doping tests, and environmental and food analytics. ELISA...
Filters, membranes, and bioseparation equipment for today’s IVDs
IVDs in the twenty-first century have evolved far beyond traditional immunochromatographic, colorimetric, or cell-counting technologies used for disease detection and characterization. Recent advances in the identification of novel biomarkers indicative of disease, and movement of highly sensitive genomic/proteomic amplifications toward near-patient testing, have spurred expansion of the IVD industry beyond core technologies and procedures. The modern landscape of clinical and point-of-care or...