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Published: May 4, 2011
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2011 MDEA winners in the IVD category

Industry leaders share what made their products winning entries in this year’s Medical Design Excellence Award competition.

By: Christe Bruderlin-Nelson

Each year, UBM Canon searches the globe for leading innovators in the IVD category for the Medical Design Excellence Awards (MDEA) competition. Once the winners have been selected, IVD Technology magazine, published by UBM Canon, profiles each company for its readers. The judges (all industry experts in the IVD field) evaluate entrants for design and engineering excellence, manufacturing effectiveness, and innovation. They determine which products are the most user-friendly and cost-effective, and enable efficient, accurate detection to improve healthcare with an eye toward swift, accurate detection. What follows is a look at this year’s winning entries.
Cobas b 123
Veteran designers of blood gas analyzers, the product developers at Roche Diagnostics put significant resources toward market evaluations before coming up with the company’s latest analyzer, the cobas b 123 blood POC system. Multiple focus groups with end users revealed that the greatest pain points were with the consumables in blood gas analyzers. Users wanted greater ease of use, and packs that were stable and consistent, and did not require refrigeration. Premature pack failure was the biggest problem. Likewise, they wanted the ability to transfer reagent packs from one analyzer to another.
The focus groups consisted primarily of healthcare professionals in the ICU, NICU, OR, ER, and labs, all of which needed an analyzer that would analyze 17 specific parameters. They wanted to avoid complex setup processes, and they did not want to waste valuable time dealing with mechanical failures to get accurate results.
Euan Cameron, International Product Manager for Blood Gas and Electrolytes at Roche Professional Diagnostics, noted the importance of the market shift from the laboratory to the point of care. “The biggest thing was that in the past, blood gas analyzers were more suitable for the laboratory setting, but we needed to address ease of use, because more and more testing is done outside the lab, at the point of care,” he said. The new system is thus suitable for use both in the laboratory and at the patient bedside.
In response to the request for 17 specific parameters, the new system analyzes at least that many, focusing on blood gases, electrolytes, metabolites, and co-oximetry as standards with additional derived parameters available using consumables that are far less prone to premature pack failure.
“There are many reasons for premature pack failure, which wastes valuable time for the healthcare provider,” explained Eric Zalas, Segment Marketing Manager at Roche. “The design of the fluid pack in the cobas b 123 really eliminated a lot of those issues and made the maintenance extraordinarily low.” In addition, the system has a full-color graphic interface that guides users through the process of working with the consumable reagent fluid packs.
Stephan Stoiser, International Product Manager for Roche Professional Diagnostics, added, “This is the first truly point-of-care analyzer. It offers the elements of time savings and usability, which differentiates it from the b 221 model. Everything about managing the system is so much easier. You don’t have to have a huge level of expertise to operate the system.”
Stoiser also said that there is absolutely no preventative maintenance. “All of the components are in the fluid pack itself. Users don’t ever have to get into the nitty gritty of the mechanics.”
Indeed, from a design standpoint, the beauty is in the reagent pack. The AutoQC pack and sensor are the key inner components. The fluid pack has a very long, 42-day stability. “You just open the door and slip the pack in,” Zalas said. “The pack has the sample port right in it, and the associated tubing and waste collection are all in one piece.” In other words, after a package is used, it’s easy to dispose of, with no leaking or exposure to biohazardous materials. Users can transfer any of the three consumables between analyzers, thanks to Smart-chip technology on each of the consumables.
The Roche team explained how simple changes also made a big difference. “It is lighted, so it is usable on a cart pulled into a patient room. The port is central, so it is as easy for a left-handed person to use as it is for a right-handed person,” they said. In addition, the unit has a smaller footprint, and can be connected wirelessly or via a network port to the hospital network so that laboratory staff can monitor the analyzers remotely.
Berndt Ebner and Wolfgang Sprengers, both Project Managers at Roche Diagnostics, were the principal designers of the cobas b 123 POC system. The total development time was five years and involved approximately 80 people during the R&D process. The award-winning cobas b 123 POC system is currently approved and commercially available in Europe and Asia. The cobas b 123 is currently in development and not available in the United States.
Leica Bond-III
On the forefront of technology in histopathology, the Leica BOND-III instrument, which Invetech designed for manufacturer Leica Microsystems, is a fully automated immunohistochemistry and in situ hybridization staining system that can diagnose a selection of infectious diseases and cancers from human tissue samples. When developing the product, the goals of the designers were speed, efficiency, and quality.
With two advanced staining techniques, the automated system targets proteins and molecular segments using state-of-the-art robotics and preconfigured reagents. According to Michael Zanker, Invetech Program Manager, and Andreas Knaack, Director of Biomedical Instruments and Devices, the instrument can provide diagnoses up to 50% faster than previous-generation strainers.
The Leica Bond-III stands on the floor and has more than 1500 component parts, including more than 200 custom parts in a modular design. Each unit has four independent robots: three double-axis robots dispense reagents, and one triple-axis overhead gantry robot manages the small-volume reagents.
“The instrument mimics the manual staining process by applying reagents, in a specific order, to the patient tissue,” explained Chris Rhoades, Global Product Manager of Bond Instrumentation at Leica Microsystems, the instrument manufacturer. “Utilizing dedicated robots within the instrument for each reagent type means that the Leica Bond-III is very efficient and demonstrates significant run-time improvements when compared to its predecessors and competitor systems,” Rhoades said.
The robots used are bulk fluid robots, and there is one for each staining platform, which transports the fluids to ten slides on each rack. After delivering bulk fluids, the robot arms deliver the primary reagents to the slides. The instrument can handle a maximum of 30 slides at one time and relies on complex control software to schedule each robot efficiently.
Current automated systems are not capable of performing more than one task at a time, resulting in run times that can be more than eight hours, since one arm dispenses the bulk and primary reagents. “The decreased run times allow for additional runs to be performed each day,” Rhoades said. “By enabling laboratories to meet increasing workloads using existing resources, the laboratory saves time and, ultimately, reduces costs.”
“The design allows for much higher throughput and a shorter turnaround time,” said Knaack and Zanker. “Complex control software allows the robots to work in parallel with the main robot, with their operations coordinated to avoid interference and maintain protocol integrity.” They also explained that it is possible to place the bulk fluid robots into the rear of the instrument to get them out of the work area as needed.
The designers paid attention to hazardous waste handling and maintenance. The tubing and fluidics system minimize the lengths the fluids must travel and reduce the need to purge, wash, and prime the line. It is the lowest producer of hazardous waste of its kind on the market and has high-capacity containers, which contribute to efficient reagent management. It also separates hazardous waste from non-hazardous waste to reduce the chance of human exposure to biohazardous materials.
The design of the product was complex, with substantial software development underlying the robot mechanisms. It was important to coordinate the robots so that they would not crash into each other during operations. The designers spent many hours working on ensuring the instrument operated efficiently and with very high throughput.
Lastly, the instrument uses barcoding on the reagents and patient slides to ensure that there is no mix-up between the reagents and the designated slides. Barcoding significantly reduces the possibility of errors, including those of wrong diagnoses. The system is also able to connect to a hospital’s laboratory information system to reduce transcription and other documentation errors.
Magpix multiplexing bioassay platform
With a backdrop consisting of a current generation of successful multiplexing devices, the developers at Luminex examined how the company could most effectively address the needs of their customers. Focusing on price, ease of use, uncomplicated setup, reliability, and geographical expansion into less resourced areas, the team went to work designing the Magpix versatile multiplexing bioassay platform.
The result is a compact analyzer designed for research and clinical laboratories that detects and measures up to 50 different proteins or nucleic acids at the same time from a single sample volume. It is compact and portable so it is suitable for use everywhere from academic research labs to mobile testing laboratories to areas with limited resources in emerging and developing international markets.
Luminex product developers had lofty goals. They wanted to maintain all of the benefits of high-end laser technology (e.g., sensitive, accurate, and reproducible results), but they wanted to design an even more robust detection system that required less technical service and calibration.
“The current generation products use lasers to illuminate the beads and then categorize the beads to determine what was biologically available. But lasers are costly and subject to significant variability since they get out of alignment during shipping,” explained Tim Dehne, Vice President of Systems Research and Development, who manages the group.
Magpix addressed this issue by designing a system that relied on low-cost, high performing, off-the-shelf light-emitting diodes (LEDs) rather than lasers. “These are the same LEDs we find in brake lights, Christmas lights, and traffic lights,” said technical lead Chuck Collins, Senior Director of Systems Research and Development. “They are common, less expensive, and they are not subject to the same variability upon shipment,” he said.
On the backside, they also needed to come up with a way to image and measure the fluorescence of the beads with greater efficiency than previous-generation analyzers. To do this, they employed a CCD imaging system and technologically advanced software. “We converted from flow cytometry technology that went single file to placing all of the beads in a chamber,” explained Collins. The beads are held in place in the chamber with magnets. Each bead has magnetite in it so that the imaging system can take a picture of it. The platform then uses a camera to photograph the beads to view and analyze the results.
Addressing the push toward automation in the market, magnetizing the beads meant that they could be held in place and not lost through a manual washing process. This reduced human error while increasing cost effectiveness, and lower costs means the platform is practical to use closer to the patient, away from a centralized diagnostic lab if necessary.
The team also went to work on ease of use and setup. “We had to think about how it would be for an end user to install it themselves and how the software would work,” explained Dehne. “It’s different than sending a trained Luminex employee in there, so we had to reconsider ease of use to make that happen.”
One requirement that developers had was that the beads should continue to be useful in current assays that Luminex built as well as in the assays of their extensive partner network. In other words, the beads needed to be fully functional with the previous technologies and get the same results. “We worked with our partners well in advance to make sure these beads would work,” they said.
Collins and Dehne said that space continues to be a premium in labs so technicians have to get creative with where monitors and equipment can go. “There is often room to go deeper, but not wider,” they explained, “so we took that into account with the design.” The result is a product that is about the size of a desktop computer that weighs less than 40 pounds.
Integrated Cycler real-time PCR thermocycler
Manufactured and submitted by 3M (St. Paul, MN) and Focus Diagnostics Inc. (Cypress, CA), the Integrated Cycler runs real-time polymerase chain reaction (PCR) and multi-analyte detection. Coupled with accompanying Studio Software, the Cycler works with Focus Diagnostics’ Simplexa reagent kits and assay protocols for IVD use. Focus is a subsidiary of Quest Diagnostics.
The FDA-cleared product performs amplification of nucleic acids for gene testing and has broad applicability to many types of analyses. It has a current menu of more than 25 molecular tests and reagents, with additional tests in the pipeline. The medical-grade instrument processes patient samples in disposable consumables for detection of infectious diseases. An external personal computer with associated software controls the operation parameters and can be used by trained laboratory professionals in a laboratory.
“A lot of people have been trying to accomplish what we have, but the trouble has been in holding it all together,” explained David Whitman, Director of Product Development in 3M’s Infection Prevention Division. “We have an adhesive that allows spinning at 2000 RPM. Other companies don’t have a commercially viable way to make a consumable like this,” he said, referring to 3M’s long history of adhesive technology. “Focus Diagnostics is a premier diagnostics company that brought their expertise to leverage what we have in the consumable diagnostics format,” Whitman added.
Centrifugation and non-contact heating are the keys to the design, which was the result of more than a decade of R&D that leveraged a wide variety of core technologies within the 3M company. The greatest technical challenge that Focus and 3M faced was maintaining accuracy and precision, while controlling the temperature of the consumable and optically scanning samples that were spinning rapidly. On top of that, the team had to determine which adhesives and laminates could tolerate high centrifugal forces and heat without compromising the reaction chemistries.
Whitman explained that one of the greatest features of the product is its complete scalability. On a single format, users can perform both high-throughput assays and fully integrated assays, simply by changing the disk format. He said that while competitors with sample-to-answer solutions are very good, conducting 96 assays at a time could take up an entire wall, whereas the Integrated Cycler takes less than a square foot.  “It’s about the size of a coffee maker,” Whitman said.
With less bench space and the scalability to perform multiple jobs on a single instrument, the product is quite cost effective. “We set out to make this as compact as possible with the layout,” Whitman said.  
The Integrated Cycler has an extremely easy setup. While similar products take a half-day to set up and require technical support, this product is literally out of the box. “You open the box, plug it in, and hook up a USB cord,” Whitman said. “Within five minutes, you can be running assays.”
Designing such a technologically advanced product that was easy to use and yet compact was no small feat, however. “We had a very large team,” Whitman said. “Bill Beddingham is a biomedical engineer and electrophysiologist by training. He was the godfather and principal architect. Pete Ludowise was the optics designer, and Curt Morgan led software development.” The companies give supply and design credit to WynEdge (Minnetonka, MN) and Benchmark Electronics Inc. (Winona, MN).
The partnership between 3M and Focus Diagnostics meant that molecular infectious disease diagnostics testing can happen on a smaller platform, more rapidly, and with greater ease in any laboratory, including hospital laboratories, closer to the point of care.
 


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