We hear a lot of buzzwords \u2013 Industry 4.0, Internet of Things, Industrial Internet of Things, Digital Enterprise, Digital Twin, Virtual Factory, and so many more. We are going to focus on two here: Digitization and Digital Transformation<\/STRONG>. Some people might use those synonymously, and that\u2019s ok. But we are going to highlight those two words to draw a distinction between two very different approaches to automation<\/STRONG>. Frankly, one works and one doesn\u2019t.<\/P> First, let\u2019s talk about the concept of \u201cpaving the cowpath.\u201d If you have not heard the expression before, it comes from a poem by Sam Walter Foss, \u201cThe Calf-Path,\u201d written in the late 1800s. The poem tells the story of a calf who meanders home, taking a very circuitous route through the woods. After him, a few other animals follow the same path, then flocks of animals, simply because it was there. Then men follow suit, then the path becomes a village\u2019s road, then the thoroughfare of a metropolis. And so it was that men followed this path a century later, \u201cand lost one hundred years a day.\u201d<\/P> The expression \u201cpaving the cow path\u201d uniquely describes what we mean by \u201cdigitization<\/STRONG>.\u201d Taking a current inefficient, cumbersome paper-based process, which people follow \u201cbecause we have always done it that way,\u201d and making the paper digital<\/STRONG>. That is not going be enough for today\u2019s medical device manufacturers<\/STRONG> to operate with competitive efficiency, produce high quality products, and stay compliant with FDA regulations. Those pieces of paper, now residing on a computer screen or handheld device, are still disconnected and unintelligent. They perpetuate siloes of information, stuck in documents that can\u2019t communicate.<\/P> When we talk about \u201cdigital transformation<\/STRONG>,\u201d think of this: Change. Digitization does not really change anything about a process, nor does it create efficiencies. It certainly does not connect the entire product lifecycle in order to gain transformational efficiencies, look at quality from a holistic perspective, nor garner intelligence that can only be achieved by analyzing data across functional disciplines and spanning multiple processes. Because it is so big, we call it a \u201cjourney.\u201d It requires planning and anticipates change. There are 3 key areas that medical device manufacturers embarking on their digital transformation need to consider.
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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<\/STRONG>. 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<\/STRONG>.<\/P>
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\u2022 How do we create a proactive business rather than a reactive business<\/STRONG>?
\u2022 How do we truly leverage advancements in technology and platforms<\/STRONG>?
\u2022 How can we be the agile enterprise<\/STRONG> needed to handle a changing regulatory environment<\/STRONG>?<\/P><\/p>\n