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Rebekah Cauthen has over 9 years experience in manufacturing IT, having worked with various manufacturing technology companies in both the United States and Europe. In 2019 Rebekah joined Critical Manufacturing as the Sales Manager DACH. Rebekah’s passion is supporting medical device manufacturers in their transition to manufacturing excellence and intelligence through state-of-the-art technology.
Medtech are not only in response to a temporary market shift, but reflect a fundamental change in the way supply chains and demand will perform in the future.
With a flawed traditional quality management system, not suitable for Industry 4.0, medical device manufacturers need to look towards the future. Predictive quality is a risk-based approach, where quality is embedded in the DNA of the process and product.
As the medical device industry grows despite the pandemic (current research shows a 7% market growth) the need for an MES for process oversight and guidance becomes an even stronger argument.
From an ideal Industry 4.0 perspective, the approach which is highly recommended is to have the QMS data reside within the MES itself, rather than as a siloed system. Since a MES contains both the master data and the process data which it captures in real time, it is the single source of truth feeding other IT applications, including the QMS.
The challenge with a QMS is that it is often a standalone system with a reactive approach to quality issues, whereas the manufacturing process requires a proactive approach to quality. Our argument is that a Manufacturing Execution System MES or MOM solution is a necessity for your holistic approach to quality, and we offer you ten reasons why MES should be the backbone of your quality operations.
