The benefits of digitalization through smart manufacturing in medical devices

By Christina Rucinski

Trends in the medical device industry

The medical device industry trends of today are challenging manufacturers to keep pace and enhance flexibility while operating with efficiency. This is why smart manufacturing is needed. As demonstrated by the recent global pandemic, everchanging supply and demand forces manufacturers to be ready and agile for production surges and declines as needs are met. Quality must remain at the forefront as product complexity and a shift towards value-based healthcare increase. With this, regulatory bodies worldwide are updating regulations to ensure a focus on quality. Adding in the increase of data flow from design, production and product utilization from the field and the challenges are quite daunting.

Challenges to smart manufacturing

It’s amazing to think about and acknowledge how many medical device companies are working on decades-old processes and tools for their device production. There were literally rooms full of boxes of papers and/or the “paper on glass” equivalent. Manual processes are flooded with opportunities for errors, leading to increased production time, recalls or worse yet, injury or death. This old status quo just isn’t acceptable anymore.

Today’s medical device innovation leaders must go digital with smart manufacturing to keep up with the competition, global supply demands, regulations and increasing amounts of data. This brings another challenge. You cannot address these challenges separately and remain competitive. Companies must efficiently manufacture high-quality, fully compliant products through one integrated digital system. There’s really only one true system out there that can back the claims to do this.

Achieve operational excellence today

Our Operational Excellence for Medical Devices enables operational agility, with real-time visibility, control and speed throughout the manufacturing process. It leads to high-quality, efficient medical device production that is regulatory compliant and provides perfect eDHRs.

Read this ebook to learn how to empower global teams and go beyond simply meeting regulatory requirements, but enable a truly digital approach to manufacturing, using digital twins and digital threads for smarter, more efficient production.

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This article first appeared on the Siemens Digital Industries Software blog at