The development of instrumentation systems for in-vitro diagnostic testing presents a more complicated challenge to the developer. In addition to the usual standards for laboratory instrumentation the design and manufacturing of diagnostic instrumentation must comply with the more rigorous requirements of the relevant EU directives for in-vitro diagnostics or medical devices.
Moreover, developing diagnostic tests instrumentation requires a sound understanding not just of the measurement principles being applied but also of the chemistry of the test samples and their interaction with the measurement process. Samples will often include blood, serum or urine usually combined with other reagents and / or antibodies. Sucess or failure of projects in this field will often depend on degree to which this interaction is undersstood.
Development teams for these products will be multi-disciplinary, composed of physicists, engineers, chemists, bio-chemists and mathematicians. The technologies involved will invariably also inlcude high volume, low cost disposable development. There will also be a strong focus on manufacturing process development to ensure reliable and repeatable production of devices and instrumentation.
Greg Davidson can bring his experience of several sucessful projects to bear on your project. These include:
- Luminescent immunoassay systems for sample processing and measurement.
- Automated colorometric immunassay systems.
- Fluorescent optical bio-sensor system.
- Automated 'point of care' diabetes monitoring system.