IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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IVD INSTRUMENTS 7. Th e instrument must be operable independent of a mains power supply (HW). 8. Th e PON instrument must operate in stand-alone mode, i.e. independently of a PC (FW). 9. Th e instrument should be portable and lightweight with a small footprint (HW). 10. Lot-specifi c confi guration should be introduced to the instrument at the user's site by applying bar code or RFID technologies (HW, SW, FW, GUI). 11. As the process owner, the PLM should have complete control over all aspects of the instrument (SW). 12. Th e PLM must have a smooth transfer of the instru- ment from small-series to high-volume production (production transfer). 14. Th e PLM requires reliable, long-term contracts as a basis for future business. A Modular PON Solution 13. Th e PLM must have high volume production potential at the OEM's manufacturing site. Qiagen's ESEQuant Lateral Flow system is described here as an example of an up-to-date customizing solution for IVD instruments based on a modular approach. In 2010, Qiagen Lake Constance (formerly ESE GmbH) introduced an innovative modular PON lateral fl ow system, which is based on the requirements listed above. Several companies that develop rapid tests were involved in the specifi cation of hardware and software and the subsequent validation of the various hardware and fi rmware prototypes. While the main hardware and fi rmware modules are generic and represent a consensus of customer needs, other features, such as corpo- Product Requirements (Customers' Needs) Product Requirements (Functional Specs) Development Processes Prototype No PLM OEM Usability Studies Yes Validation (Beta Side) Yes Verification Serial production Figure 2. Flowchart of project management for a modular OEM approach. 30 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 rate design elements, GUI, and the cassette holder, need to be customer-tailored during the design process.1 Th e rapid test manufacturer starts the customization pro- cess with a generic ESEQuant lateral fl ow reader and the corresponding software. Th e reader includes a generic GUI, which represents the consensus requirements of the rapid test manufacturers who were involved in designing the work- fl ow. Th e instrument is a fully functional device and includes important modules, such as a detector and mechanical parts taken from current serial production. Th e generic fi rmware is also fully developed. Use of components from serial produc- tion is the main benefi t for the rapid test manufacturer. Th e modular ESEQuant lateral fl ow system is an OEM business-to-business solution that enables rapid tests at the point of need. Th e system consists of the generic modules and customized components shown in Table I. Th e hardware of the main and basic component of the ESEQuant reader is strictly generic and enables immuno-chromatographic mea- surements at the PON. In addition to the reader, the system also comprises a software package for method development and data management and RFID/bar code technology. Th e miniaturized detector is available in two basic varia- tions, either for refl ectometric measurements or fl uorescence detection. While the refl ectometric detector is generic, the fl uorescence detector needs to be confi gured according to the fl uorescence dye(s) used in the assay of the PLM. However, a set of off -the-shelf fl uorescence detector confi gurations is available and allows R&D work to begin as early as possible. In addition, the fi rmware controlling the reader's basic functions is a generic module. As a starting point, the PLM starts the R&D work with a reader instrument containing a generic workfl ow. Th e GUI, which displays the workfl ow, provides features that represent the consensus require- ments of IVD manufacturers. During establishment of the ESEQuant lateral fl ow system, several IVD manufacturers contributed their ideas and needs regard- ing the generic GUI. However, prior to the customization phase, the workfl ow provided by the GUI must be defi ned by the PLM. Usability requirements, human factors engineering issues, and risk management aspects need to be con- sidered by the PLM for the design of an appropriate workfl ow. Th e ESEQuant systems' software module consists of Lateral Flow Studio software, which is strictly generic and serves as the reader development and management tool. On the other hand, end-user software solutions can be tai- lored to the specifi c requirements of the PLM, based on a standard version. Lateral Flow Studio software is a plug- No ivdtechnology.com

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