When you think of futuristic manufacturing facilities and processes, robots might come to mind in a science fiction setting where humans are absent and production lines are directed by computerized drones that perform tasks we can't even imagine today. As the pace of technology shuttles us swiftly into the real future, however, life-science manufacturers need to pause to examine the purpose of automation and how we can best steer its course.

In bioprocess manufacturing and other industries, technology is growing more powerful and sophisticated for solving problems. General users and implementers of new technologies, however, don't fully tap into available technology capabilities that exist. Sometimes the complexity overwhelms manufacturing teams and (because of layoffs and consolidation) information technology (IT) departments’ available time. So the options are outpacing the industry's ability to understand and correctly apply technological solutions to its manufacturing challenges.

Despite advancing technology, the same manufacturing quality problems persist and are being carried into the future while untapped information capabilities may sit idle on your server. To escape this fate, manufacturers need to ensure that future developments are implemented to solve the most critical problems rather than pursued simply for innovation's sake.

Both types of development are exemplified in everyday life by new smart-phone applications and consumer-based technologies. Ten years ago, people couldn't imagine the plethora of programs and services such as Yelp, Skype, or the innumerable “apps” for the Apple iPhone. Imagination is the only true limit of future technology evolution, so it is presumptuous to predict what will exist in another 10 years — much less how we will keep pace with future inventions.

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Steer the Course of Invention

Technology for process manufacturing grows exponentially. What prevents manufacturers from leveraging available technology for the right problems is threefold and boils down to communication, regulation, and education.

Communication: First, manufacturing industries are home to two kinds of people: manufacturing technology innovators/implementers and users. If users are not fully involved in prioritizing their needs, then innovators may continue down a path of developing and implementing technology that users do not necessarily want or have the time to understand and operationalize. Here are two components at work: need and understanding. Programmers should develop innovations that meet actual needs — rather than simply, “cool tech” looking for a problem to solve.

As Figure 1 shows, the gap widens between the rapid pace of technology and users’ ability to learn new applications in ways that make that technology useful. That gap can shrink when IT professionals and users collaborate to ensure that technology solutions address real-world manufacturing problems — and that adequate training is offered.

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Regulation: Second, life-science manufacturers operate under many regulatory requirements that ultimately drive the agenda for technology development. Over the past decade, quality by design (QbD) has been touted as a means to reach biomanufacturing's “desired state” of predictability and control. The FDA's Janet Woodcock has described this desired state: “Manufacturers have extensive knowledge about critical product and process parameters and quality attributes. … Manufacturers strive for continuous improvement” 1,. Some companies have put process analytical technology (PAT) solutions into place, but they may not fully understand them or use them to their full potential.

Education: Finally, the United States is struggling with an education system that may not be adequately preparing the next generation of scientists and manufacturing operators to understand and solve problems with advancing technology. Specialized training is required, as well as a shift to a problem-solving and collaborative type of organization.

In a 2010 article, Nyenrode Business University professor John Psarouthakis shared his perspective on how and why the United States has lost its manufacturing base to foreign nations. One thought-provoking point he made is that today's first-graders will be entering the workforce in 2020 underprepared as a generation, “which is now struggling with the basic skills of early grammar school” 2,. The article focuses on competitive threats to discreet manufacturing industries, but Psarouthakis wisely proposes, “Very simply, we need to solve three dilemmas: how to develop and deploy new technologies, how to more effectively manage our manufacturing organizations, and how to develop human resources for the future.” Those potential roadblocks to progress intersect for most biomanufacturing organizations and thus need to be considered by companies hoping to move rapidly toward the desired state of QbD and take full advantage of IT's potential.