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White paper

What digital transformation means for medical device manufacturers

Digitization vs. digital transformation are just two of the many buzzwords swirling around medical device manufacturing. Many use these terms interchangeably, but the truth is, they represent two distinct approaches to automation – one that works, one that doesn’t.


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Digital transformation is comprehensive, with an enterprise scope. It takes an end-to-end-and-back-again view of product lifecycle, an information loop that connects all the pieces of innovation, quality, and efficiency. Its vision is to gain true intelligence and deliver it to the point of action, where impactful decisions can be made that truly advance the value to the consumer, in a timely and high-quality manner. That means data must be collected in a way that makes it accessible and meaningful, captured at each dimension of the design, engineering, and manufacturing process.

Because it is so big, we call it a “journey.” It requires planning and anticipates change. There are 3 key areas that medical device manufacturers embarking on their digital transformation need to consider.

  • How do we create a proactive business rather than a reactive business?
  • How do we truly leverage advancements in technology and platforms?
  • How can we be the agile enterprise needed to handle a changing regulatory environment?

These questions are explored in depth in our white paper, “What Digital Transformation Means for Medical Device Manufacturers – The Shift from Paper to Knowledge.”