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Product Designer
Product Manufacturer Product Description and Principal Function(s) SensiDx™ is a revolutionary critical care diagnostic instrument. It is a first of kind instrument that analyses whole blood samples in hospital critical care units and provides accurate and quantitative diagnostic results in less than five minutes. Most other testing systems require several hours for analysis. SensiDx™ requires minimal expertise to perform the tests, making it ideal for use in non-laboratory settings.The SensiDx™ System incorporates Ambri’s biosensor technology that has the potential to detect up to 40 drugs and disease markers in blood samples. The first test to be released to hospitals is a pregnancy test - hCG. Other tests to be released include cardiac markers (Troponin I, Myoglobin, CK- MB) for detection of heart attacks and the electrolytes sodium and potassium. This breadth of tests and speed will provide fast diagnosis in emergencies and potentially cut hospital costs by shortening length of stay or reducing admissions. The SensiDx™ development incorporates a world-first innovation in POC instruments. Its disposable cartridge applies unique “closed tube sampling” involving a double needle piercing process. This contributes to fast results and accurate diagnosis without removing the lid from the sample in the Vacutainer™ tube, avoiding handling of blood and eliminating the possibility of contamination and any hazardous spillage for operators. This also enables multiple testing from the same container, eliminating the need for additional patient samples. The design enables an equalising of pressure from the sample container to the disposable cartridge, avoiding bubbles and controlling the flow of blood evenly onto the six membranes within the cartridge, while the sample is controlled and held at a constant temperature. The analyser reads and processes an electrical signal from the biosensors (embedded technology) in the disposable cartridge and measures the speed of the reaction or rate of change in the electrical signal. It digitally records this data onto an easy-to-read screen and accomplishes all of this in less than five minutes. Its portable size means it will fit in any Emergency Department environment, is connected to the hospital’s laboratory and hospital information systems and is an attractive piece of equipment that is fast, accurate, easy to use and maintain. The development program is broken down into three areas, each with its individual requirements. 1. Development of the SensiDx™ Critical Care Analyser. Its key requirements are: · Be simple and easy to use. · Compatibility with the SensiDx™ test cartridge (see below). · Compatibility with standard sampling tubes (Vacutainers™). · Provide communication interface to laboratory information system (LIS). · Provide temperature regulation and control to sample under test. · Be fully self contained, i.e. no external PC’s or power supplies required. · Provide a high value, well engineered appearance, shall be transportable, and its footprint shall fit on a standard hospital trolley. 2. Development and design of the SensiDx™ disposable test cartridge. Key requirements are: · Allow for up to six biosensor membranes in a cartridge. · Distribute sample evenly to all membranes. · Minimum sample volume required. · Avoid bubbles. · Small size. · Low cost. 3. Design and commissioning of a manufacturing process for high volume manufacturing of test cartridges. · Uniform exposure to process to all membranes, i.e. low coefficient of variance in final product. · Minimise required volume of chemistries. Key Product Features and Benefits Healthcare systems are under enormous pressure worldwide to provide quality diagnostic care while minimising costs. Coupled with an aging population, a POC diagnostic instrument that produces fast and accurate results, significantly reducing patient treatment turnaround time will factor highly in any nation’s healthcare equation.SensiDx™ sets a very high benchmark for innovation in the emerging POCT segment. The accurate and rapid testing capability offers significant advantages to both, hospitals and patients. With the SensiDx™ System there is no need either to keep the patient waiting, or to send them away and recall them for a result. Since time to treatment is often critical, rapid testing aids better medical management as well as increasing patient satisfaction. The SensiDx™ represents ‘state of the art’ design, engineering and compliance with international market specifications in the dynamic and rapidly growing healthcare industry sector. Invetech has developed this unique instrument from a blank slate to manufactured product in only 13 months. Its market success will ensure important opportunities for promoting Australia’s world class skills in design and manufacture of medical equipment. The SensiDx™ is a truly revolutionary instrument and incorporates innovative world-first engineering solutions to achieve significant breakthroughs in this important healthcare market. The SensiDx™ has received an enthusiastic response from potential users at the prestigious AACC Clinical Lab Expo held in Orlando Florida, USA in August 2002 and the Australiasian College of Emergency Medicine held in Sydney in November 2002. The following environmental design considerations were made. · No sharp edges on the instrument to avoid operator injuries, and to allow for easy cleaning by wiping it down with a damp cloth. · Materials used in the instrument have no specific environmental issues, and include steel fabrications, moulded ABS polymers, and electric and electronic components. · The needles in the test cartridge are protected by a “sharps barrier”, which is only released after the cartridge is inserted into the Analyser. · Even though the materials used in the cartridge have no environmental issues, a used cartridge will have to be disposed of in biohazard waste, due to the blood contained in it after a test. SensiDx™ is designed for cost effective low volume manufacture. It uses a cast aluminium chassis, injection moulded cover panels, and investment cast stainless steel sample tube holder. The relatively high investment in injection moulding is justified by provision of an outstanding aesthetic result and product presentation, reduced number of components, and easy clean surfaces. |
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Design Award
