|Trends & Perspectives|
To be successful in the competitive IVD market, a diagnostic must produce reliable and sensitive test results while meeting a testing demand. As the winning products in the 2006 Medical Design Excellence Awards (MDEA) also demonstrate, careful consideration of user interaction is an essential component of good test design.
The MDEA competition is presented by Canon Communications llc (Los Angeles), publisher of IVD Technology as well as Medical Device & Diagnostic Industry, the program's sponsoring publication. The winners in the IVD category for this year include the following products:
• The Afinion AS100, a benchtop point-of-care (POC) analyzer by Axis-Shield PoC AS (Oslo, Norway).
• The CellTracks analyzer II, a semiautomated fluorescence microscope for counting and characterizing fluorescently labeled cells, by Immunicon Corp. (Huntingdon Valley, PA).
• The IDI-MRSA assay, a polymerase chain reaction–based test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA), by BD Diagnostics–GeneOhm (San Diego).
According to Gail D. Baura, PhD, vice president for research at CardioDynamics (San Diego) and one of the jurors for the awards, the winning products share a key design characteristic: optimization of assay preparation for ease of use. “Here, ease of use refers to the simultaneous testing of various chemistries in one cartridge in the Afinion analyzer, automation of what are typically manual steps with the CellTracks system, and minimization of wait time as with the MRSA assay,” says Baura.
Craig M. Jackson, PhD, president and cofounder of Hemosaga Diagnostics Corp. (San Diego) and another juror for the MDEA competition, believes that the purposeful integration of automation also helps differentiate the award-winning products from others on the market. “The Afinion was distinguished by its being a totally new platform for point-of-care testing. Its ease of use and user-friendliness were notable, but the thoroughness of the design and operation considerations were very evident. It was particularly pleasing to have a nomination folder filled with data that could substantiate their claims,” he says.
“The CellTracks analyzer was seen as the logical extension of Immunicon's automation program that focuses on low-prevalence cancer cells that can be trapped from a blood sample and then characterized with little human intervention. What I personally saw was the automation of necessary operations that are inherently boring to perform routinely—exactly the kinds of activities that should be automated,” he adds.
For Jackson, the IDI-MRSA assay is notable for its use of real-time PCR to drastically shorten the time between sample collection and test results. This enables laboratories not only to diagnose patients at the greatest risk sooner, but also to identify hospital employees who may be inadvertently carrying the infection. “The sooner the identification is made, the sooner appropriate action can be taken,” he says.
The awards ceremony will be held during the Medical Design & Manufacturing East 2006 Conference and Exposition, June 6–8, at the Jacob K. Javits Convention Center in New York City.
Corporate sponsors of the 2006 awards include ATS Automation Tooling Systems (Cambridge, ON, Canada), Avail Medical Products Inc. (Fort Worth, TX), DuPont Medical Packaging (Wilmington, DE), Dymax Corp. (Torrington, CT), The Electrolizing Corp. of Ohio (Cleveland), Ethox International (Buffalo, NY), The MedTech Group Inc. (South Plainfield, NJ), Norman Noble Inc. (Cleveland), and NuSil Technology LLC (Carpinteria, CA).
More information about the awards, including guidelines on entering the 2007 competition, can be accessed through the MDEA Web site at www.mdeawards.com.