Feature Articles

Published: May 1, 2009
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Winning IVD products share success stories

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

By: Christe S. Bruderlin-Nelson



Medical Design Excellence Awards





Photo by Roni Ramos
Each year, Canon Communications, publisher of IVD Technology magazine, sponsors the Medical Design Excellence Awards (MDEA), recognizing top innovators in the medical technology community. About a dozen jurors, each an expert in the medtech community, review the entries, focusing on product innovation, design and engineering achievement, end-user benefits, cost-effectiveness in manufacturing, and healthcare delivery.


“In the past, the entries have been consistently strong, and this year is no exception,” said juror Mark Vreeke, a partner at Rational Systems (Houston). Vreeke said that judging involves a three-phase process. Individuals first present each device before the group as a whole. Then the devices are separated by category so a smaller group can look at each device intently. Finally, the groups come back together to present their findings for award selection.


“I believe that this year the diagnostic arena was especially good,” Vreeke said. “The value of diagnostic tests, both perceived and actual, continues to grow. This has resulted in more design and development resources dedicated to diagnostics. We are seeing the results of the increased resources in the quality of submissions.”


This article profiles the top eight innovators in the IVD category that won top honors in the competition.


INRatio2: Innovative Blood Coagulation Monitor


INRatio2 blood coagulation monitor by Hemosense and Inverness.

IDEO (Palo Alto, CA) submitted the INRatio2 blood coagulation monitor, which Hemosense Inc. and Inverness Medical (Hayward, CA) manufactures. The device monitors coagulation parameters in patients taking blood thinners such as Coumadin and warfarin. Patients can use the monitor at home, which significantly can reduce their number of clinic visits, and it is useful in a clinical setting as well.


The monitor measures the international normalized ratio (INR) and prothrombin time, both indicators of blood coagulation, and gives results in just 1 minute. Speedy results mean patients can take immediate steps to keep their INR within the proper range. “It is so helpful for people who have active lives,” said Conan Li, vice president of R&D and clinical affairs at Hemosense. “They travel and work and don't have time to go to a clinic or doctor all the time. So this is a tremendous product in terms of convenience and lifestyle.”


Li told us about a 17-year-old with a hereditary disease that requires her to take a lifelong blood thinner. “She had to go give blood every two weeks,” he explained. “Once she got this meter, she was back to hanging out with her friends, having her own life, and she could monitor her coagulation and report it when she needed to.”


The monitor is modern, sleek, and compact with a large display that uses icons rather than words and fits in the hand. “I would have to give credit for much of that to IDEO,” Li said. “They worked with our team to come up with a very nice concept. It's really the design that makes it stand out.”


Following the design phase, manufacturing required several months, followed by clinical trials. “Once we submitted it to FDA, we received clearance in 28 days,” Li said.


Hemosense has launched the INRatio2 worldwide. Originally approved in select patients, Medicare now covers the device in patients with mechanical heart valves, venous thromboembolism, and atrial fibrillation.


“Our company's vision is that patients should be able to take care of their own health by doing testing at home and this is right in line with that vision,” Li said. “We are looking forward to doing great things with this.”


TearLab: A Pioneering Tear Osmolarity System


TearLab osmolarity system by TearLab Corp.
The TearLab osmolarity system, manufactured by TearLab Corp. (San Diego) measures biomarkers obtained from tear fluid to evaluate the severity of dry eye disease (DED). “The product basically is a point-of-care laboratory on a chip that measures biomarkers that correlate with a gene pathogenesis,” said Eric Donsky, TearLab's CEO. The system consists of a disposable microchip, a handheld computer, and a handheld base station reader.


Many conditions can lead to DED, which is multifactorial and complex, affecting approximately 40 million Americans, but there has never been an accurate way to evaluate the condition before the development of the TearLab device.


The handheld ergonomic computer has a place where a chip snaps in. The clinician places the device into the tear lake in the corner of the eye and collects the sample noninvasively. The device beeps when the correct volume is collected. It also helps to avoid reflex tearing, which changes the composition of the sample and leads to innacuracy.


Invetech (Mt. Waverley, Victoria, Australia) designed the product, which has a hydrophilic plastic chip with an inlet valve that collects 50 nanoliters from a tear film in less than a second. Collected tears go through a nanofluic channel to prevent evaporation, which is another major cause of diagnostic variability and inaccuracy. Impedance in the channel helps prevent evaporation to get the most accurate measurement of osmolarity. Software makes the quantitative measurement for the operator, and the results take only 20 seconds.


Donsky said that 30-50% of individuals who make an appointment for eye care come complaining of dry-eye symptoms. Because of the discomfort and lifestyle challenges, such as difficulty driving or problems with visual acuity, associated with dry eyes, patients with the symptoms tend to be fastidious about follow-up. But until now, there have not been diagnostics that measure osmolarity, and diagnosis was very difficult.


Donsky said the device is more than a test for dry eye: it represents a biomarker platform, since tears are derived from blood and are the cleanest sample that humans generate. “The tear proteome along with this technology has many potential applications.”


Benjamin Sullivan and Steven Zmina at TearLab designed the system in conjunction with Invetech and MiniFab, both in Melbourne, Australia.


Vitros 5600: An Integrated Clinical Lab System


Vitros 5600 Integrated system by Ortho Clinical Diagnostics.
Ortho Clinical Diagnostics (Rochester, NY) manufactures the Vitros 5600 Integrated system, a high-capacity clinical laboratory system. This device integrates clinical chemistry and immunoassay testing into one instrument, so that a laboratory can run multiple tests on patient samples without requiring multiple systems or splitting samples.


“The system features a unique sample-centered processing approach that allows up to 50 samples to be accessed and intelligently managed based on their status, without having to be moved or split between testing modules,” said Robert Geen, worldwide marketing manager at Ortho Clinical Diagnostics.


Geen explained that the device holds 150 reagents and has the potential to perform more than 100 different assays from a large test menu of over 120 tests, including tests for hepatitis and HIV. “This innovative design enables fast turnaround time for physicians and patients while verifying the quality of every test result to help minimize errors,” Geen said.


A team of approximately 150 individuals at Ortho Clinical worked on the mechanical, software, and electrical design engineers with the assistance of outside partners, including Priority Designs (Columbus, OH), to which the company gives supply and design credit.


Geen said the biggest challenge the teams faced was helping the slowest or busiest processing center from creating throughput bottlenecks and slowing down the entire analyzer. “The development of servo-controlled robotic metering arms solved that challenge by allowing the system to intelligently look ahead to pending test requests and create a list of 50 possible sample tubes to meter from,” he explained. “This allows smart scheduling software to build a test schedule that allows the analyzer to run near its maximum throughput all the time, regardless of the mix of test requests within each sample.”


“When a patient is waiting for a diagnosis, fast, accurate lab results mean everything,” he added. “The Vitros 5600 Integrated system reduces the time and number of steps it takes for the laboratory to deliver the quality test results physicians need to make important treatment decisions sooner, so patients have the best chance for a better quality of life.


eSensor XT-8: A Novel System for Warfarin Sensitivity Testing


The eSensor XT-8 tests for warfarin sensitivity using genomic data. Such diagnostics are a long-promised advance in the IVD market.

The eSensor XT-8 system for warfarin sensitivity testing is a device for detecting multiple genetic variations to identify patients at risk for warfarin sensitivity, said Robin Liu, one of the device's principal designers and the director of system development at Osmetech Molecular Diagnostics (Pasadena, CA). With this device, clinicians can better estimate the safest and most effective warfarin dosages.


The FDA-cleared device produces results in less than 30 minutes and can help identify patients at risk for warfarin sensitivity. Warfarin is the most commonly prescribed oral anticoagulant worldwide, and awareness about genetic variations in sensitivity can help reduce the risk of overdose, and help with initial dosing and future adjustments. Ultimately, tighter warfarin control means fewer adverse events and significant healthcare savings.


The device contains 72 gold-plated electrodes that each act as independent DNA microsensors. The microsensors are on a printed circuit board, Liu said, and the device can detect multiple genes in a clinical patient's sample. “The eSensor XT-8 system is one of a very few platforms cleared by FDA recently for genetic-based diagnostics and warfarin sensitivity testing,” he said.


Liu emphasized some key features of the device's design, including an easy-to-use graphical, touch screen interface; a small footprint; medium-to-high-throughput capacity with independent operation of each cartridge slot; a quick, simple, three-step work flow that requires limited training; a four-hour test turnaround time; and an embedded memory chip within each cartridge to track sample protocols and minimize errors. In addition, there is no need for user maintenance or test calibration, and its modular system design allows for independent operation of each cartridge slot.


True2go: An Inventive Portable Glucose Monitor


The True2go, which fits on the vial of test strips, is a reusable meter that twists on and off the vial with a quarter turn.

Home Diagnostics Inc. (Fort Lauderdale, FL) submitted its True2go portable glucose monitor for MDEA consideration. It stood out among the entries as the world's smallest glucose meter, which also gives results in 4 seconds from a 0.5-μl sample drawn from the fingertip or forearm. Its beveled tip, capillary fill strip makes it possible to use such a tiny sample of blood.


Brent Modzelewski, the director of engineering at Home Diagnostics said it is the only meter on the market that can operate in a stand-alone mode or attached to a vial of glucose test strips. “Its compact size and versatility makes it the perfect glucose meter for on-the-go testing by both type 1 and type 2 diabetics,” he said.


Ease-of-use makes the product particularly innovative. “The ability to twist-on and twist-off the meter to attach or detach from the test strip vial is the first of its kind and truly shifts the paradigm from the traditional large, stand-alone glucose meters,” Modzelewski said.


An auto-on feature and accurate strip lot autocalibration reduce the number of steps required for testing. This, combined with the True2go twist-on/twist-off concept, makes it easier for the patient by reducing the number of items needed to carry, Modzelewski explained. “These key features promote more-frequent testing, resulting in better blood sugar level compliance.”


In fact, the device performs an internal self-diagnostic step after a patient inserts a strip and before starting the blood test to make sure it is functioning properly. Modzelewski said the team put great effort toward the autocalibration codes embedded on the strip as well as the chip itself, which functions as the central intelligence of the system.


The team also evaluated several possible ways to attach the meter to the vial before finding a simple method that did not require training. “Style must not interfere with function or performance,” he said.


Supply and design credit for the product goes to Integrated Engineering Technologies (Tacoma, WA), Texas Instruments Inc. (Maitland, FL), and CSP Technologies (Amsterdam, NY).


BD Bactec FX: A Modern Blood Culture System


BD Bactec FX microbial detection system by Becton, Dickinson & Co.

The Bresslergroup Inc. (Philadelphia) submitted the BD Bactec FX blood culture system, which detects the growth of microorganisms in clinical specimens. Becton, Dickinson and Co. (BD; Sparks, MD) manufactures the device.


The automated system detects microbial growth in blood specimens specifically, to aid in the diagnosis of bloodstream infections.


Brad Spring, program manager and CTL at BD explained that the first step is to inoculate the Bactec culture media with a patient's blood specimen and then place the culture into the instrument. The Bactec FX then incubates and agitates the media to enhance organism growth. If bacteria are present, their metabolic activity will release CO2. The CO2 then will react with a fluorescent sensor in the bottle, which the instrument reads to detect bacterial growth.


Spring said that the product improves laboratory work flow, is easy to use, and saves space, thereby reducing the product footprint and lab employee time. “Because laboratory staff and space are at a premium these days, reducing the footprint and the lab's hands-on time was critical for customer acceptance of this product.” He also emphasized the product's data and result communication capabilities, which enable automatic physician notification when a culture is positive. “Positive results can be automatically transmitted to a PDA, so a physician can take immediate action.


“The aesthetics and ergonomics are key attributes that made our entry stand out,” Spring also said. “We partnered with Bresslergroup, an industrial design firm in Philadelphia, to create an attractive and functional design.” The entry also credited Crescent Industries Inc. (New Freedom, PA), and CW Thomas Inc. (Philadelphia) with supply and design.


The hope is that the product will improve medical outcomes, by increasing the speed and accuracy of detecting bloodstream infections. Ultimately, “rapid time to detection and enhanced organism recovery may lead to faster diagnosis and thus reduced hospital stays,” Spring said. “By improving medical outcomes and reducing hospital length of stay, the system helps reduce healthcare costs.”


BenchMark Ultra: A Breakthrough Slide Staining System


The BenchMark Ultra by Ventana Medical Systems Inc.

The aim of this product is to help pathologists in anatomic pathology and reference labs achieve reproducible and consistent results from tissue biopsies, regardless of technician, time, or day. The BenchMark Ultra, manufactured by Ventana Medical Systems Inc. (Tucson, AZ), aims to improve usability, streamline laboratory work flow, and allow for faster reporting of patient test results.


The company describes the device as “a random and continuous access slide staining system that processes immunochemistry (IHC), in situ hybridization (ISH), and fluorescein isothiocyanate (FITC) slides simultaneously with stat capabilities for expedited diagnosis.” According to Lisa Jensen-Long, senior marketing manager of development at Ventana, labs benefit from the flexibility and nimbleness of this system, and most importantly the quality of the results.


Pathologists rely on tissue biopsies to diagnose cancer and other diseases. They slice biopsy specimens into thin sections, which they place on microscope slides where they stain them for specific target molecules to assist in making diagnoses. The BenchMark Ultra fully automates this staining process.


“The BenchMark Ultra is the first true continuous access staining system that supports increased work flow efficiencies in pathology laboratories worldwide,” Jensen-Long explained. “It interfaces with most major laboratory information systems, and up to eight systems can be run from the same host, which can minimize human touch points and maximizes laboratory efficiency.”


The Ultra can process about 30% more slides in an eight-hour day than earlier platforms, while allowing random and continuous access to the slides. As a result, the lab does not have to batch slides.


Supply and design credits go to Flextronics Inc. (Jesús Maria, Aguascalientes, Mexico), SMC Corp. of America (Tempe, AZ), Baymar Solutions (Lutz, FL) and Intuition Design Inc. (Chesapeake City, MD).


“With the BenchMark Ultra, we provide clinicians with their patients' results faster, which allows them to begin treatment sooner,” Jensen-Long said. “Time saved in diagnosis is time gained in helping fight disease.”


Spectra MRSA: A New MRSA Detection Test


The Spectra MRSA plated medium helps caregivers quickly diagnose the hosptial-acquired infection, enabling aggressive treatment to prevent spreading.

Spectra MRSA, manufactured and submitted by Thermo Fisher Scientific (Lenexa, KS), is a chromogenic plated medium intended for the primary isolation of methicillin-resistant staphylococcus aureus (MRSA) from nasal swabs. It provides results in 24 hours.


The test has a positive predictive value (PPV) of 98.1%, which a spokesperson for Thermo Fisher said was higher than any MRSA test on the market. This provides physicians and others in the hospital setting with greater certainty about MRSA colonization.


“This outstanding performance also helps to avoid the unnecessary financial and social burdens associated with falsely reporting a patient as MRSA positive,” the spokesperson said, since a positive test can result in isolation and contact precautions.


There are two unique characteristics in the design of Spectra MRSA. First, the off-white medium incorporates a chromogenic substrate that changes to blue if MRSA is present, and the color contrast enhances interpretation.


The second is the choice of selective agent. Spectra MRSA uses an alternative cephalosporin antibiotic instead of Cefoxitin, which is the main selective agent used in several media currently on the market. “Cefoxitin can have drawbacks,” the spokesperson explained. “It is not very stable and is susceptible to hydrolysis. Also, there are some significant MRSA strains sensitive to Cefoxitin, which remain undetected when using this agent.” Drawbacks like those can result in false negatives.


Spectra developers carried out a series of experiments to optimize the performance of the raw materials. And after developing the right formulation for the medium, they challenged it with MRSA and non-MRSA isolates obtained from a variety of sources. “The medium was tested for stability under a range of different conditions,” the spokesperson explained. “The shelf life of the product was determined by a real-time storage trial carried out under normal (refrigerated) conditions at both the upper and lower limits of the recommended range (between 2° and 12°C).”


They call Spectra MRSA “diagnostics in a dish,” adding, “It is a practical, affordable solution to a formidable pathogen, which continues to reinvent itself and remain a public health concern.”



Copyright ©2009 IVD Technology


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