A global medical device manufacturer worked on a project team with a leading OEM to launch the design and manufacture of an OEM infant medical device – second generation.

A project team with members from the medical device manufacturer and OEM was formed with defined goals and project plans. Product specifications were developed, equipment purchased, processes validated, SOPs written and training completed.

Product was successfully launched as planned. After the launch, continuous improvement efforts using Lean and Six Sigma methodologies were implemented to reduce manufacturing costs.