IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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IVD INSTRUMENTS A Modular Approach to Customizing IVD Instruments By adopting a modular OEM approach, the rapid-test or private-label manufacturer can avoid investing in an R&D program that requires a time-to-market commitment. BERNHARD GERSTENECKER, MICHAEL DOUMANAS, AND KLAUS HABERSTROH R ecently developed rapid tests provide signifi - cant improvements that increase the scope and reliability of these tests. Th e trend toward rapid tests that enable quantitative interpreta- tion through an objective measurement creates market demand for the development of corresponding reader systems and accompanying software. At the same time, rapid test manufacturers usually have neither the expertise in developing instrumentation nor the time and resources to start such a development from scratch. However, original equipment manufacturers (OEMs) off er solutions that are easily customizable, cost-eff ective, and available quickly. Building a tailor-made instrument from scratch can be time consuming, expensive, and runs the risk of becoming an investment that fails to provide the highest return. It can easily take one to two years of work before a prototype instrument is available. Hardware and fi rmware, including the GUI and software, must be developed in accordance with the customer's specifi cations. Necessary documenta- tion must be prepared, which requires additional time and incurs additional costs. However, the time and costs prove to be worthwhile as the rapid test manufacturer receives a tailor-made instrument that's market ready and that meets the users' expectations. Modular Customizing Approach With a modular OEM approach, the rapid test manu- facturer or private label manufacturer (PLM) benefi ts from the customization of an existing basic—i.e., generic— version of an instrument without risking investment in an R&D program requiring a time-to-market commitment. Ideally, an instrument for processing rapid tests and its accompanying services should cover the following require- ments, which translate into specifi c hardware (HW), fi rm- ware (FW), software (SW), and graphical user interface specifi cations (GUI). 1. Flexible instrument programming by the PLM should ivdtechnology.com Lateral Flow Reader Hardware ESEQuant Lateral Flow Studio (LFS)-Software Firmware Workflow A-MF Assay-specific LFS-Method File (a-MF) LFT label 2D-Barcode RFID Figure 1. After an asay-specifi c method is completed, the accompanying fi le is downloaded to the reader. 2. Th e PLM should be able to purchase a tailor-made technological platform suitable for the many require- ments of the PLM's rapid tests (HW, SW, FW). be built in, enabling easy adaptation to various rapid tests (SW). 3. Key corporate identity elements, such as corporate col- ors or the PLM's corporate logo, must be visible on the instrument (HW). 4. Reliable processing of rapid test readings—scanning, interpretation, reporting, and storing of the required data—is a vital part of the OEM solution (SW, FW). 5. Connectivity is becoming an increasingly important requirement for a point-of-need (PON) instrument; corresponding interfaces must be included in the cus- tomized instrument (HW, FW). 6. Documentation for the hardware and software must be provided with the instrument and must conform to legal requirements, including the appropriate (harmonized) standards. IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 29

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