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Published: May 10, 2010
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IVD category winners in the MDEA competition

Leading designers and developers in the medical technology arena competed for top honors in the IVD category.

By: Christe S. Bruderlin-Nelson

Canon Communications LLC, publisher of IVD Technology magazine, received submissions from an assortment of worthy contenders for its annual Medical Design Excellence Awards (MDEA) competition. The awards, which recognize the best of the best in the medical technology field, focus on new products that are innovative, user-friendly, and cost-effective, and which enable quick and accurate detection. About a dozen experts in the medical technology community looked at these factors as well as at design and engineering achievement, end-user benefits, healthcare delivery, and manufacturing effectiveness.

This article profiles four winning innovators in the IVD category from this yearís competition. Additional information about the MDEA competition can be accessed at www.devicelink.com/expo/awards/home/.

PREVI Isola system
The PREVI Isola is a system for automating routine agar plate inoculation. It maximizes colony isolation, eliminates risks, and standardizes plate inoculation and results in a fully automated approach.

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The novel agar plate-streaking technology is called MicroStreak, invented by LVT Innovations Ltd. (Adelaide, Australia) with development assistance by Invetech (Melbourne, Australia). The two companies then collaborated with bioMÈrieux (Marcy l'Etoile, France) to manufacture and market the product as the PREVI Isola.

Invetech's director for biomedical instruments and devices, Andreas Knaack, said that he believes that what made the companyís entry stand out was that the instrument truly revolutionizes microbiology. "It hasn't been done before," Knaack said. "It's just incredibly clever."

One of the most basic, fundamental, and crucial tasks in diagnosis is streaking clinical samples on agar plates to see which bacteria, if any, grow, so that microbiologists can identify any offending bacteria to help provide a diagnosis. By automating the mundane parts of the process, skilled microbiologists can spend more time focusing on the analysis of the plates.

Knaack said that microbiologist John Glasson, the scientific director at LBT Innovations, grew tired of streaking plates and invented the core technology. "The challenge in microbiology so far was that very highly skilled microbiologists had to streak plate after plate with very unpleasant samples such as urine and stool," Knaack explained. "This is not good use of highly skilled operators."

According to Invetech, "Unlike other areas of clinical pathology, microbiology has not seen a wide-scale adoption of automated processing systems. Agar plate inoculation is a repetitive, manually intensive process that has not changed significantly in over 100 years." In addition to being a slow and laborious process, streaking plates by hand is costly and prone to human error and thus significant disparity among samples.

The new system helps automate specimen inoculation and other tasks, including plate selection, labeling, and barcoding for follow-up. Operators can run several tests per sample depending on what the ordering physician requests. The machine has a touch screen that the operator can use on the instrument, or microbiologists can work or plan from a separate server station.

The way it works is that the operator takes various tubes containing patient samples such as blood, urine, and stool, and places the tubes and agar plates in the instrument. The instrument takes the patient samples and dispenses them onto the agar plates using the novel streaking mechanism. The device then pulls the sample across the plates with a rotational motion for optimal growth. Finally, the plates come out of the instrument and go into an incubator.

The main component of the system, the MicroStreak applicator, is a flexible plastic cone with 17 tines. The machine controls the applicator and the plate rotation speed to achieve different levels of dilution for better control. Better streaking can mean more uniform results and less variation for better analysis overall. The system can process 180 plates per hour, "significantly more than an experienced human technician," who can prepare about 30 plates per hour under optimal circumstances.
About two years of development time and between 15 and 20 engineers worked on product development, all of which occurred at Invetech, which emphasized that removing the tedium of plate streaking can improve workforce retention, improve laboratory workflow, and reduce lab costs overall.

"It is also reasonably easy to use and, in my opinion, for an instrument of this size, it looks good," Knaack said. "What we've got here is true innovation."

Oragene-DNA self-collection kit
The Oragene-DNA self-collection kit provides DNA sampling technology that uses saliva, rather than more invasive methods. DW Product Development (Ontario, Canada) developed the delivery system for the Genotek-developed Oragene chemistry, which allows users to collect, stabilize, transport, and purify DNA taken from the saliva in almost any setting: hospital, clinic, physician's office, or even the patient's home.

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While technologically advanced, the product also has true ease of use. "The user experience is quite simple" according to the product entry. "Spit, flip the lid closed until you hear it snap. Reliable DNA sample collection can now be self-administered by the patient without supervision." Once secured inside the container, a proprietary solution stabilizes the sample, which can then withstand long-term storage at room temperature.

According to DW Product Development, the sample collection kitís proprietary chemistry is able to deliver high-quality and high-quantity DNA to meet a variety of analysis and testing needs. For now, researchers who would like a large number of participants for research studies will likely be the greatest users of the technology, as they can send out the kits to study participants simply. Other potential users include laboratories, clinicians, pharmaceutical companies, and direct-to-consumer companies that provide DNA testing.

For both patients and the healthcare system overall, this saves a clinic trip and is therefore more cost-effective and far less complicated than traditional blood sampling methods.

Rob Muir, senior designer at DW Product Development, said this productís strength is in its simplicity. "Simple to manufacture, simple to understand, simple to use, with no biohazards, no refrigeration required," Muir said. "The goal is to keep user error to a minimum. We simply want them to put something in a supplied container, close it, and send it back. Everything else, such as release and mixing of the preservation solution, should be transparent to them."

What this means for the patient is that there is no blood involved, and the patients do not even need to leave home to give the sample. "For children, the user can use a swab to collect the saliva, then squeeze the sample out in a pocket between the ribs used to open the film," Muir explained.

The other principal designers were Romeo Graham and Mike Sirois, who are also with DW Product Development, and Roy Sundstrum of DNA Genotek.

The key challenge was that the product needed to consist of a single part so that it would be cost-effective and easy to use in an unsupervised situation. "Getting a soft resin to perforate a tough film in a repeatable manner was the biggest challenge," Muir said. "Understanding how film behaves in tension, rate sensitivity, and tear propagation was key to optimizing the solution." The designers worked to develop details to puncture the tough plastic film and release the Oragene fluid. They accomplished this by using ribs to create tension on the film and to pull it sideways to ensure the film remains open so the Oragene fluid could come in.

"The OG-500 has removed the need to travel to a clinic to donate a DNA sample, and also the need to mate multiple parts as had been the case with previous DNA Genotek models," according to the entrants. In addition, the Oragene fluid is safe, but the at-home user will not have any exposure to the fluid if used properly. "Due to its ease-of use and intuitive nature, there are few instructions required and little potential for error."

Perhaps the best part is that patients can return their sample via standard mail.

ABL90 FLEX blood analyzer
The ABL90 FLEX portable blood analyzer measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry on whole blood at the point of care or in a laboratory. Nurses, physicians, therapists, and trained technologists are the intended users of the technology. Radiometer Medical (Copenhagen, Denmark) developed and designed the product.
Carsten Tessum, a product manager at Radiometer Medical, said one of the most important features is that the product is very fast. "The analyzer provides a full panel of acute care parameters in just 35 seconds, which is two to three times the industry standard," he said. "In addition, the extremely short one-minute cycle time boosts analyzer throughput, and quality control and calibrations are also done at high speed."

In addition, it requires less blood and is easy to use.

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One interesting feature of the design is the ability to operate on a small volume of blood: only 65 µL is necessary for a full panel of results. "Drawing less blood is always preferable, especially in neonatal and geriatric departments," Tessum said. The company is in the planning stages for a micro mode that requires even less blood.

"By introducing a small volume of blood from a sampler to the inlet, the analyzer provides 17 measured parmeters plus numerous calculated parameters," said Tessum. "The ABL90 FLEX has been designed for maximum ease of use through an intuitive color touch screen. Operation is guided by on-screen animations, and the inlet is designed for equally easy operation by both left- and right-handed users and requires only one hand for operation." The instrument is also quite compact and can be operational on a battery, making it completely mobile.

Safety was an important factor that went into the product design. Intuitive use of the analyzer combined with on-screen animated guides and ìdetails such as the inlet probe shield device that prevents the user from getting in contact with the probe and the built-in sample mixerî help to protect the users. In fact, the sample mixer ìensures that blood samples are homogenous and perfectly mixed with heparinî in just seven seconds.

"The overall software philosophy is that the analyzer must comply with the following three statements: ease of use, full connectivity, and high speed," Tessum said, explaining that the main design and engineering challenges of the product were "to minimize the maintenance of the product by developing a new generation of sensors and to minimize measuring time and the amount of blood used to measure the 17 parameters."

The ABL90 FLEX also connects with the Radiometer 1st Automatic workflow to automate many of the manual steps that were previously necessary. Users can scan their ID, the patient ID, and the sampler ID at the bedside, and then the result goes directly to the appropriate hospital system or the patient's bedside monitor.

The company incorporated several user tests, focus group interviews, and other interventions, and made design adjustments based on feedback to perfect the design. In addition, the analyzer is low-maintenance and only requires a monthly cassette change that takes a few minutes. Previous analyzers required maintenance and replacement procedures that were far more complicated.

"The short time to results and the first automatic process give a seamless blood gas workflow and free up caregiver time that can be used for what matters most: patient care," said Tessum. "The ABL90 FLEX gives healthcare professionals more time for patient care by providing the fastest blood gas results available on the market today."

Contour USB blood glucose meter
According to Tim Brown, the chief executive officer at IDEO, the key to great design is "design thinking," which brings us to another innovative design in the IVD market this year, Bayer's Contour USB blood glucose meter. The Contour USB meter plugs directly into a computer's USB port to help diabetes patients and their healthcare providers manage blood glucose levels better.

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"We refer to our overall approach as design thinking: a means of problem solving that uses design methodologies to tap into a deep reservoir of opportunity. These methods include observation, prototyping, building, and storytelling, and can be applied by a wide range of people to a breadth of organizational challenges."

One such challenge was the design of the Contour USB meter that IDEO helped develop for Bayer Diabetes Care, a division of Bayer Healthcare LLC. Specifically, IDEO aided in the development of the industrial design, the meter user interface, and the on-the-shelf packaging of the monitor.

The product is the first meter that plugs directly into a computer. Once connected, the monitor automatically launches "diabetes management software, providing diabetes patients and their healthcare professionals with instant access to blood sugar data and trends to help optimize diabetes management," according to a company press release.

The user applies blood to the test strip, at which point the meter prompts the user to input whether they took the measurement before or after a meal. The monitor comes with the Glucofacts Deluxe Diabetes Management Software, which is accessible on the monitor itself and on a computer. While patients can use only the monitor when testing blood glucose levels, once the patient plugs the monitor into a USB port, the software can track glucose levels over the long term. Patients can then print, e-mail, or save the data to share with a clinician during follow-up when appropriate.

The device has a color OLED display for better readability on a small screen with higher contrast. A pixel-based display allows for animation with text for a more interactive user experience, and clear instructions when errors occur.

Contour is also the first blood glucose meter on the market to come with a rechargeable battery. "Because the meter is designed for the patient on the go, it was imperative to have sufficient power to provide users with the confidence that they can carry Contour USB with them wherever they go," according to the designers. In fact, there is enough power for patients to test their blood 150 times, or enough to go about a month between charges, which take only two hours.

Bayer is promoting its new product with the help of paid company spokesperson and teen heartthrob, Nick Jonas, on a dedicated Website. "My simple win this month," Jonas says, "is using my new Contour USB meter during my hectic schedule. It makes it easy to keep track of all my levels by simply plugging it into my computer."

"With the Contour USB meter, patients are able to share their results with their healthcare professional during a clinic appointment, over the phone, or via e-mail, giving them the opportunity to make treatment adjustments, such as taking action to reduce their HbAIc levels, if necessary," said Dr. David Simmons, chief medical officer for Bayer Diabetes Care. "One of the main differences is that now this is a two-way conversation, and patients are better able to understand the logic behind such treatment adjustments, incorporating them into their daily routine with greater ease."

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