Leveraging on manufacturing digitalization to drive growth in Medical Device and Diagnostics | Opcenter
By Sergio Bellisario • February 26, 2020 • 3 MIN READ	
Add to this the growing complexity of medical technology itself. The Internet of Medical Things (IoMT), connected diagnostics, next-generation implants, customized orthopedics, personalized medicine – these complexities are creating new challenges for medical device manufacturers not only from the treatment itself, but from the data generated throughout. It is an increasingly Big Data conundrum.
This reality is changing the way medical device manufacturers are running their business. Today, best-in-class digitalized med-tech companies are 4 times more likely to monitor intelligent analytics. Most of med-tech executives perceive intelligent analytics as one of the major opportunities for growth and perceive consumer feedback as a vital benefit of operations within IoMT programs. In short – medical device companies must have an infrastructure to support the analysis and application of this big data, and use it to better meet patient expectations.
The FDA and other regulatory agencies are expecting medical device manufacturers to do this. They have shifted their regulatory paradigm from compliance to quality. They are rewarding manufacturing behavior that applies intelligence and best practices to improve product quality. The FDA reported that from 2009 to 2014, there was a 3x increase in adverse events and a 50% increase in product recalls. These numbers will rise without proper digital processes implemented across all business segments within a given medical device organization.”
Orchestration, or MOM as the digital brain of manufacturing and quality operations. MOM collects production orders from ERP and Bill of Material / Bill of Processes from PLM and – using its digital intelligence – orchestrates all the manufacturing activities based on the best schedule and real-time shop floor information.
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