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Published: May 1, 2007
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Prizewinning IVDs optimize patient care

The winning products in the IVD category feature accuracy and ease of use, facilitate faster detection, and enable more-targeted therapies.

By: Beth W. Orenstein






Photo by Roni Ramos

Now in its 10th year, the Medical Design Excellence Awards (MDEA) presented by Canon Communications LLC has become the premier awards program for the medical technology community. Medical products chosen for recognition are changing the face of healthcare by excelling in product innovation, design and engineering, end-user benefit, and cost-effectiveness.

This year, a multidisciplinary panel of judges selected three products in the IVD category that fit the prestigious competition's stringent criteria.

The IVD winners are: a point-of-care blood chemistry analyzer for use in medical or veterinary applications; a measurement device that uses ultrasound technology to quickly and accurately quantify hematocrit levels in human whole blood for the purpose of screening blood donors; and a histology system that automates the preparation of hematoxylin- and eosin-stained slides.

The winning products in all 10 medical product categories will receive gold or silver recognition at a ceremony June 13 during the Medical Design & Manufacturing East 2007 Conference and Exposition at the Jacob K. Javits Convention Center in New York City.

Jurors say this year's IVD winners stood out for their ease-of-use and safety improvements.

In some cases, says Michael Schollmeyer, DVM, director of clinical research of CHF Solutions Inc. (Brooklyn Park, MN), similar devices had been commercially available but they were too complicated and cumbersome to be practical.

Two of the winners, he says, are notable because they are small and simple to operate with touch screen technology. Because they do not require skilled laboratory technicians and are small and portable, they are ideal for office-based or field testing.

“Simplifying devices helps to eliminate potential errors from the user, which is a great benefit to the patient as well,” adds Jerry McVicker, PhD, scientific director of Midland BioProducts Corp. (Boone, IA), another juror in this year's competition.

Juror Craig Jackson, PhD, president and chief technical officer of Hemosaga Diagnostics Corp. (San Diego), also points out that the winning devices are responding to the pressing need in healthcare today for faster turnaround for IVD measurement results. Indeed, two of the winning devices provide results in minutes, while the histology system significantly reduces preparation time. Faster turnarounds can translate into cost savings for busy physician practices, blood donation centers, and histology labs, Jackson says.

The histology slide preparation system also provides significant safety improvements, eliminating a neurotoxic chemical that is needed in the traditional process, and because it automates the process, it allows for consistent results of higher quality than ever before.

All of the winning devices are state-of-the-art and likely to have a significant impact on the quality of patient care that is provided today and tomorrow.

Blood Chemistry Analyzer

The vast majority of blood chemistry assays that physicians require when examining patients in their offices are routine—not specialized. Still, typically, physicians have to send their patients to a laboratory for testing and wait for the results— sometimes as much as a week.

“Even if the physician gets the results within the next day or two, typically he is looking at a chart, not a face, when he is discussing them with the patient,” says Kenneth Aron, vice president of product development for Abaxis Inc. (Union City, CA).

The Piccolo Xpress chemistry analyzer Abaxis Inc. (Union City, CA).

Abaxis' MDEA-winning chemistry analyzer, the Piccolo Xpress, which became available in September, offers a solution to the problem. The Piccolo Xpress can provide up to 14 different blood chemistry values from a 100-µl sample of whole blood, serum, or plasma in about 12 minutes. The device is capable of performing basic, comprehensive, and hepatic function tests. A minimum of four tests can be run at one time.

“We feel the Piccolo improves treatment because it means lab results can be an integral part of the doctor visit as opposed to being part of a follow-up conversation,” Aron says.

The Piccolo Xpress is a replacement for the Piccolo Analyzer, which was introduced in November 1995 with two reagent discs. “Audie Hickey and his engineering team took advantage of advances in electronics, optics, and chemistry to update our box,” Aron says.

The Piccolo Xpress has a much smaller footprint than its predecessor. It is about the size of shoebox, measuring 9.5 in. high, 6 in. wide, and 11.5 in. deep, and weighing only 15 lb.

Its small size makes it much more portable and therefore more practical for use in the field. “Saving surface space is extremely important in the hospital environment,” says James Toleman of James Toleman Industrial Design (Puget Ville, France), who takes the design credits.

Another design goal was ease of use. Abaxis did not want the users to need specialized training to be able to operate the analyzer.

“Indeed, once you insert the disc into the Piccolo drawer, you push the ‘on' button for the panel you wish to run, and you walk away,” Aron says. Anyone in the office can operate the analyzer, prompted by the instructions on the touch screen.

Toleman says FDA appreciated its simplicity because it has approved the instrument for use by nontrained hospital staff. “Nurses can use this type of instrument for the first time,” he says.

The analyzer also needed to produce results quickly because no one wanted patients sitting around for hours waiting for their tests; that would have defeated the purpose. Results take about 10 minutes for most panels — for a few, it's 12 minutes. Results are provided in a hard-copy report suitable for patients' files or transferred to laboratory information systems (LIS) or electronic medical records (EMR) in less than 15 minutes.

The costs of running the tests are all within reimbursement guidelines. “But ultimately it's a cost-saver for the physician's office because the results are there when the patient is,” Aron says.

The physician doesn't get paid for the time he spends tracking down patients to discuss their results or staying late to update charts, agrees Christopher Bernard, vice president of sales and marketing. “When you have a point-of-care device in your office, more time is spent with the patient and more of it is billable time. You have more control and expedited treatment pathways for the patients.”
For that reason, the device has found particular success in oncology centers, where patients are unable to proceed with their chemotherapy if they don't have the results of their kidney or other general-health functions by their scheduled appoint-ment. “If someone shows up and has not had their blood tested,” Aron says, “it can be a real disruption for the clinic and the patient.”

The Piccolo Xpress is also in physician's office labs, smaller hospitals, and emergency clinics.

The compact analyzer performs quality control checks on each sample; it has onboard QC monitoring to ensure chemistry and instrument integrity. Says Aron, “This assures you the highest quality and accuracy in results.”

Blood Bank Screening

Accuracy is important in any medical application, but especially so in the blood banking industry. Accuracy means improved safety for donors and a better supply of blood products for recipients, both of which are critical.

FDA requires that all blood donors have a hematocrit (or hemoglobin) of at least 38 — below that number, the donor is anemic and could pass out or have a serious reaction to donating blood. By the same token, if a qualified person's hematocrit is not measured accurately, he could be wrongly turned away. If such errors were to happen frequently, it could negatively impact the size of the nation's blood supply.

The UltraCrit hematocrit measurement device by Separation Technology Inc. (Altamonte Springs, FL).

The award-winning UltraCrit Hematocrit Measurement Device, which was developed by Key Technologies Inc. (Baltimore) and is owned by Separation Technology Inc. (Altamonte Springs, FL), was designed to improve the ability to screen blood donors with accuracy and speed.

“It is the first and only commercially available medical product that uses ultrasound for this application,” says Brian Lipford, vice president of engineering at Key Tech. The device became commercially available in August.

The device was designed so that it would be simple to use. A one-time-use cuvette is used to collect a single drop of blood via capillary action, usually from a fingerstick. The droplet is loaded into the device. Once loaded, the device automatically starts the measurement process, which takes all of about 30 seconds. “This is one of the fastest measurement times currently available,” Lipford says.

Screen prompts provide operating instructions for the device.

Lab and field data confirm the accuracy of the device, proving it to be comparable to large, expensive lab-based analyzers, Lipford says.

The design team, led by Scott Corey of Key Tech and Jami Meeks, president of Separation Technology, had two major challenges. The first was to develop the new technology and the second was to miniaturize it so the device so could fit in the palm of the operator's hand.

“Ultrasound has long had a track record of applications in the medical industry, but until our product it has never been used to interrogate and distinguish properties of blood,” Lipford says. “This was an entirely new application for ultrasound. Our design team really had no roadmaps or specifications to follow.”

It took several years and thousands of man-hours of testing and design iterations for the team to develop a device that uses less than a drop of blood and a custom miniaturized transducer to produce results in less than 30 seconds. “New algorithms, processing techniques, and blood collection and handling methods were developed,” Meeks says. The UltraCrit literally takes hundreds of millions of ultrasonic measurements per second, which are collected, filtered, and analyzed by signal processing algorithms.

The design team initially used workstation computers and custom data collection systems to perform the necessary operations. “Moving this to a handheld device meant taking $10,000 worth of computer power and packaging it into a credit-card-sized space envelope for a small fraction of the cost,” Lipford says.

Although initially developed for the blood banking industry, the device is slated for applications in other point-of-care settings such as emergency rooms, physician offices, natal care and the military, Meeks notes.

The company is most proud that its testing shows that the UltraCrit is as accurate as blood analyzers found in laboratories that cost hundreds of thousands of dollars.

Histology Slide Preparation

The hematoxylin-and-eosin (H&E) stain is the first step in preparing histology specimens. The manual technology used by most labs to stain H&E slides has remained virtually unchanged for the last century.

The Symphony one-touch histology slide preparation system by Ventana Medical Systems Inc. (Tucson, AZ).

That's what makes the MDEA-winning Symphony one-touch histology slide preparation system by Ventana Medical Systems Inc. (Tucson, AZ) so innovative. The Symphony system, which became available in May 2006, introduces true automation to the staining process and, in doing so, provides much-higher-quality slides for pathologists to read for abnormalities and infections.

“Pathologists have uniformly said ‘Wow' when they are looking at our slides for the first time,” says Mike Rivers, director of marketing for Ventana, which designed its new product in house.

The system automates every aspect of preparing slides: slide identification, drying, deparaffinization, hydration, staining, dehydration, coverslipping and curing.

Traditional preparation methods require dipping and dunking slides in successive vats of up to 15 different reagent baths. Because the slides share the same reagents, over time their quality deteriorates, especially toward the end of the batch, says Devon Campbell, engineering manager, primary staining, at Ventana. “If you talk to folks who work in the lab, they will say that the first slide of the day is better quality than the last one. The prevalence and impact of this problem is quite significant.”

The Symphony system eliminates cross-contamination by using fresh reagents to treat each slide. Aside from alcohol, which is supplied by the customer, all the reagents needed to prepare each slide with the Symphony are presented in prepackaged, ready-to-load engineered containers.

Without cross-contamination, the slides are of unprecedented quality and definition. A recent abstract for the United States and Canadian Academy of Pathology (USCAP) by six of the world's leading cancer institutions showed slides stained on the Symphony system were so significantly better for highlighting nucleoli in cancer that they increased the likelihood of making a diagnosis of limited adenocarcinoma of the prostate in challenging cases.

Another goal in designing the Symphony system was to eliminate the neurotoxic chemical xylene entirely from the staining process. “We set the bar high determining we needed to find a way to do it without xylene, and we succeeded,” Campbell says. The in-house design team developed a novel reagent, Symphony Clear, to take the place of xylene. As a result, the Symphony system is not only safer for the technicians who are preparing the slides but also for the laboratory environment.

Another value in automating the process is providing quality control. “Because slide preparation is historically a manual operation, there is a lot of variation in the way people do it,” Rivers says. Automating the process standardizes the amount of reagents used and the time each slide sits in a bath. The automation provides consistency and quality control, which means results of exceptional quality each and every time, Campbell says.

The system is designed to operate at a high volume. Each system has 25 trays that can each hold up to 20 slides. Up to 500 slides can be processed at any one time, Rivers says.

“What's unique about this system is that you don't have to do it in a mass process,” he adds. “You can add a tray, as long as you're not above the total of 25, at any time, and specify a unique protocol for each individual tray.”

The system is designed to operate continously. The advantage is that technicians can load up to 500 slides at night and return the next morning to find them ready. “The automation eliminates the need to have the lab staffed all night so that someone is there to take things out of one machine and put them in another,” Campbell says. The reduction in staff time could result in significant cost savings for the lab.

Also, Rivers says, “the technology affords the lab technicians the opportunity to do more value-added work rather than tending machines and carrying slides from one machine to another. It really allows them to focus on what it is they do best.”

The process from start to finish takes about 45 minutes for the first tray.

Patients also can expect to hear their results sooner from doctors who are associated with labs that use the Symphony as automation reduces turnaround time. When waiting to hear about a diagnosis of cancer, minutes can seem like an eternity.

The Symphony system's clients include some of the most prestigious cancer centers in the world.

Beth W. Orenstein is a freelance medical writer who works from her home in Northampton, PA.

The most important thing, Campbell says, is that the patients benefit because they can be assured that the pathologist reading their slides is seeing precisely what he needs to render a proper judgment. “Our slides give a level of detail that the pathologist finds great value in.”


This year's MDEA-winning diagnostics offer improvements in three critical areas: productivity, safety, and quality. While each product has different applications, each contributes to improving patient care. All three are easily operated, which reduces errors and improves safety for physicians and their patients. Saving

practices and blood banks time and money by being able to offer near-patient diagnostics is an added benefit. For the technology companies that brought these products to market, the true benefits are in knowing that they are helping to make patient care the best it can be.


Copyright ©2007 IVD Technology


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