Implementing A Next-Gen MES At A Fraction Of The Cost

A leading Medical Device Manufacturer faced a critical challenge: launching a new product introduction (NPI) for a novel medical device in a greenfield assembly facility. With just six months to begin scaled manufacturing, the team needed to implement robust Design for Assembly (DFA) and Design for Manufacturing (DFM) practices. Initially, only a few units were built monthly by engineers. To meet demand, production had to scale to hundreds of units per month, assembled by frontline workers. This required the engineering team to empower new staff with clear assembly instructions and ensure every step was documented via an electronic Device History Record (eDHR) for compliance.

Anticipating the complexity of onboarding a new workforce, the team recognized that paper-based SOPs and manual recordkeeping would be inefficient and error-prone. They needed a smarter, scalable solution to streamline training, ensure consistency, and maintain regulatory compliance.

Access the full case study to learn how digital solutions can accelerate your NPI success.