Point-of-care and home use diagnostic instrument -- MEDICA - World Forum for Medicine


DCA Design International

Point-of-care and home use diagnostic instrument

- Compact instrument for the measurement of HbA1c levels for diabetics
- Delivers critical data to allow diabetic users to improve their diabetes management
- Easy to use, disposable cartridge based system design giving fully automated assays
- Software structured to achieve extremely high levels of reliability and robustness.
- Sourcing of Far Eastern manufacturers
- Electronic hardware configured to match manufacturer’s processes and cost structures

The in2it™ instrument is a fully automated, cartridge based, diagnostic tool that allows users to monitor their HbA1c levels at home or at the point-of-care. By interrogating the historic data stored on board, diabetic users can manage their long-term HbA1c levels to achieve significant improvements in their condition.

DCA was responsible for all aspects of the instrument design up to the delivery of representative injection moulded pre-production prototypes to the client, Provalis Diagnostics. From this point in the development process, design responsibility was transferred to an in-house team at Provalis to allow refinement in parallel with the assay chemistry and protocols.

Building on DCA’s earlier work, Provalis successfully achieved 510k approval as a major step towards full product release which took place in the last quarter of 2004, with the formal product launch taking place at the medical trade show and congress, MEDICA 2004, in Germany.

DCA’s contribution to the design of the injection-moulded pre-production prototype included the styling of the instrument and the user ergonomics, including the design of the user interface logic and its graphical implementation.

The mechanical design was developed by DCA in parallel with the styling and DCA also provided the electronic hardware design for the pre-production prototypes. The instrument was specifically tailored to match the requirements of the Far Eastern manufacturer recommended by DCA to produce and assemble the in2it™. As a result, each subassembly is produced with its own dedicated PCB, allowing it to be assembled and tested in isolation before integration into the final unit.

The software used on the pre-production prototypes was authored by DCA. This allowed Provalis to undertake representative work with the assay and formed the basis of the production software developed by Provalis. Controlling the motors to achieve the necessary high cartridge torques and positional accuracies was one of the key functional challenges. It was also critical that at no time was the user put at risk, either by the operation of the instrument, or by the data displayed during, or after, an HbA1c test.

Throughout the development process, Provalis and DCA worked closely together so that the instrument, cartridge and assay were developed and optimised in parallel. The result is a compact, reliable system that is attractive and easy to use and which offers diabetic users the best available method for long term control of their condition.

John Curtis, Provalis Diagnostic’s Managing Director, said,

‘The product’s many advantages, including its lab accuracy, small size, operability via battery and general flexibility, answer the markets needs. Its effects on Provalis’ diagnostics sales will be fundamental’

Clinica, August 2004