A therapy device whose therapies the manufacturer defines itself

The task

OPED builds therapy devices whose effect depends on precisely controlled air pressure. The VADOplex was to be redeveloped from the ground up: high-quality, tailored to its application and repairable when it comes in for service. It had to stay in operation for more than ten years, and its connectivity had to last that long as well.

The scope ran from the electronics and the firmware to the PC tool and the ERP interface. Regulatory approval management was part of it too.

The solution

The effect of the therapy depends on pressure. It has to be measured and set in the air tank, in the cuffs and at the valves. We developed the embedded software for this, together with the control algorithms.

Alongside it runs a PC application that connects to the device over USB. OPED's medical engineers use it to parameterise their own algorithms for individual therapies and load them onto the device. This let them try out therapy improvements while development was still under way.

Every device is configured for the individual patient. We therefore added an interface to the ERP system: order data goes straight to the device. This speeds up initialisation and makes it a reliable, repeatable process.

On the hardware side we produced the schematics and the PCB design. We organised PCB manufacturing with a cooperation partner.

Regulatory approval

The VADOplex contains a substantial amount of software and therefore has to meet international safety standards. IEC 62304 sets minimum requirements for development, maintenance, risk management, configuration management and problem resolution.

We prepared the complete regulatory approval documentation for the device to this standard and supported the approval process on OPED's behalf.