A Medical Device Manufacturer needed to complete a new product introduction (NPI) of a novel medical device in a new greenfield assembly facility. They had a 6-month timeline to start manufacturing the new devices at scale and needed to plan and implement DFA/DMA practices. The team needed to increase production from a few units a month built by engineers to hundreds of units a month by frontline workers. The engineering team needed to enable the frontline workers to assemble the units and record their activities at each step of the way via an eDHR for compliance purposes. In setting up the processes for building the product at scale, the team foresaw challenges around overwhelming new staff with changing instructions and recording information.

The frozen food supplier relied on paper-based processes to record machine downtime and audits, resulting in a lack of visibility and inaccurate information.