As part of the development process of the smartphone enabled otoscope, we needed to produce short run batches of devices to complete both verification testing and in-use trials. Our client, TympaHealth, was a start-up company with limited manufacturing capability. With extensive experience at all stages of development, Team Consulting took on the responsibility to manage the production of short runs of the device that would meet the technical and regulatory requirements of a CE Marked Class I medical device.
For the batch manufacture of the Tympa System, we worked very closely with a contract manufacturing partner and several sub-suppliers for the provision of a range of components. These components included plastic injection moulding, aluminium casting, machined parts, optical elements and printed circuit board assemblies.
Secondary processes were needed to finish some component parts including anodising of aluminium parts, pad printing to provide branding and safety symbols on some plastic components and a clean room assembly. Team also managed the peripherals including secondary packaging, IFUs and associated literature.