Complex Medical Device Supply Chain Strategy

An innovative young medical device company asked our medical device consultants to help identify a new sub-contract manufacturer and component supplier for a second generation medical device.

A young medical device company had developed a novel device for the treatment of a chronic condition that is becoming increasingly prevalent in the developed world. The device was complex, incorporating high precision injection moulded parts, multi-layer extruded tubing, electronics and software. This led to a complex and geographically dispersed supply chain with vendors requiring quite unique expertise to manufacture the component and sub-assemblies of the device.  A consequence of this complexity was that the supply chain was difficult to manage and there were unacceptable delays in product supply. This prompted the company to develop a second generation device that was easier and less expensive to manufacture. This new device required a different set of manufacturing processes. At the same time the client made the decision to take more control over the supply chain and to contain it within relatively tight geographical boundaries. Our medical device consultants were asked to draw up a list of criteria that suppliers should meet and then use this to find new suppliers for the key stages in the manufacturing process.