MedTech
A therapy device whose therapies the manufacturer sets itself
The relaunch of a therapy device that works through precisely controlled air pressure. Electronics, firmware, a PC tool for parameterising the therapy algorithms, and the link to the manufacturer's ERP system.
The task
OPED builds therapy devices that work through precisely controlled air pressure. The VADOplex was to be rebuilt from the ground up: high in quality, shaped around how it is used, and easy to repair. The device had to stay in service for more than ten years, and its connectivity had to last that long as well.
The scope ran from the electronics through the firmware to the PC tool and the ERP interface. Approval management came on top.
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. That called for embedded software with the control algorithms to match.
Alongside it runs a PC application that connects to the device over USB. The medical engineers at OPED use it to parameterise their own algorithms for individual therapies and load them onto the device. Even during development they could try out therapy improvements this way.
Every device is configured for the individual patient. That is why an ERP interface came into the picture: order data goes straight to the device. Initialisation gets faster, and it stops depending on who does it.
On the hardware side we produced the schematics and the board layout. Board manufacturing was organised together with a partner.
Approval to IEC 62304
The VADOplex carries software in large measure 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 approval documentation to that standard and supported the procedure on behalf of OPED.