Manufacturing & Processing Technologies
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...
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...
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...
IT Innovations Raise the Bar for IVDs
Healthcare is being reshaped by IT. Some of the most influential solutions transforming the healthcare industry involve the flow of data, be it life-saving information transmitted to hard-to-reach locations following a natural disaster, or the aggregation of patient results on a single screen to accelerate actionable decision-making. The clinical laboratory environment is a relative newcomer to the widespread adoption of more sophisticated IT solutions compared to other segments of the...
Process monitoring: reducing costs and improving quality
As with all manufactured goods, IVD products need to be tested for quality. With most consumer goods, defects result merely in unhappy users and broken, useless products. But with IVD equipment, it is a completely different story. Whether IVDs are used in a laboratory or a medical practice or by patients at home, faulty IVDs that go to market can injure patients or cause death and can destroy a company’s finances and reputation. Flawless quality in IVDs is imperative. The challenge...
Wireless Vacuum Pump System
The KNF SC920 Series vacuum pump system for laboratory processing applications is exclusively equipped for wireless remote control of all pump-operating modes and functions. The wireless technology maximizes pump system flexibility and saves valuable space by allowing the system to be located away from process equipment without requiring obstructive cabling. Users ultimately benefit from the system’s fast and precise processing, extremely quiet operation, and easy regulation of all...
Immobilized Trypsin
Immobilized Trypsin is TPCK-treated trypsin immobilized on 4% agarose. It helps to eliminate contamination of protein digests by the enzyme and is readily removed by separating the agarose from the digestion solution. The TPCK treatment inactivates the interfering chymotrypsin activity. A serine endopeptidase, trypsin cleaves peptide bonds on the carboxy side of s-aminoethyl cysteine, arginine, and lysine residues. After trypsin digestion, the peptides are readily identified by mass...