This project was for the development of a medical device for use in operating theatres for a well known UK manufacturer of anaesthesiology equipment. The unit provides mechanical lung ventilation during surgical operations and is designated a critical care device by all medical standards bodies. The project was in fact an upgrade of a previous product which was expensive to manufacture and had a fixed feature set, the control system being ‘hard wired’.
Prior to any design work being performed a complete risk analysis was performed to evaluate all potential single points of failure. This allowed all involved to focus on any areas that needed special attention during the design and verification process.
The design work performed included development of a complete 16 bit processor board including all the I/O to control the ventilator, plus a separate user interface panel. This was done to schematic level with local contractors providing the PCB design & layout services.
Once the PCB’s were designed and bills of material produced, we put out the sub-contract manufacture of these assemblies to tender. Following a selection process, a supplier was chosen, and a close liaison formed to ensure that the requirements of the client were fully covered.
Software design for the project was performed to the module level and the code produced in the FORTH language. The rapid turn-round time of the FORTH development environment and the ability to interactively test the code enabled us to keep up with rapid changes to the performance specification made by the client.
Once produced, the software was formally verified and validated using an independent contractor. The use of the FORTH language came into its own here, with much of the potentially complex verification process being performed on the device interactively.
Using the data from the risk analysis and the verification process, a complete documentation package was produced to comply with the relevant medical standards (FDA & CE). This successfully underwent an extensive examination by the clients quality assurance assessors.
The finished product came in well underneath is production cost target and currently enjoys improving sales to delighted customers.