Michele C. D’Alessandro, VP & CIO, Manufacturing IT, Merck
The manufacturing world is undergoing its fourth industrial revolution, known as Industry 4.0, spurred by the proliferation of digital capabilities (Internet of Things), and the integration of these capabilities into existing production and supply systems. Although there are skeptics of the Industry 4.0 movement, one cannot ignore technology’s impact on the way manufacturers—including those in the pharmaceutical industry—conduct business.
"Smart devices in the manufacturing setting provide a revolutionary way to connect operators to their work, and to each other, in real time"
While the marriage of the physical world of pharmaceutical manufacturing and the cyber world is complex and challenging, it is also exciting for anybody fortunate enough to focus on it. A multitude of technology advances are being heralded at an increasing rate. Non-traditional firms are entering the manufacturing IT space, offering innovative and next generation options. Pharma manufacturing technology professionals are pressured to innovate and adopt in order to get a leg up on the competition, grow their industry positions, or, at the very least, ensure they don’t lag behind.
The following disruptive trends are a source of great opportunity—as well as challenge—for those in Pharma IT:
1. Additive manufacturing driving innovation
Additive manufacturing, also known as 3D printing, creates physical objects based on a digital model by “printing” (applying) materials in successive layers. This digital technology has produced the likes of airplane engine parts, medical/dental implants, custom prosthetics, and even innovative product designs not previously possible. It is already leveraged in manufacturing across consumer goods, art, fashion and the like. And with the advances in material science, alloys and composites, the revolutionary potential across the manufacturing spectrum is unlimited. For Pharma specifically, there are numerous possibilities from the printing of prototype machine and lab parts, to artwork and labels, to molecular models.
2. Advanced Analytics (Multi-Source and Multivariate) providing new insights
The information age has created mountains of data in every field. More data has been created in the past two years than in the entire history of the human race—and manufacturing generates more data than any other sector. That being said, the proliferation of data itself is not the disruption. The disruption is the way the data is processed, made available, and ultimately used to drive outcomes. This includes the ability to combine structured and unstructured data using modern in-memory data warehousing technology and advanced statistical modeling like multivariate analysis. With the advances in storage, memory and compute power at a significantly lower price point, this approach becomes viable for big and small manufacturers, providing data insights for optimization in product development, quality control, process analytics, and beyond.
3. Intelligent sensors and decision automation enabling the workforce
A fundamental basis of the digital manufacturing revolution is the use of sensors (IOT 4.0). In particular, intelligent sensors, which are comprised of both a sensor and microprocessor, are able to detect conditions and respond to them. They understand the environment they are placed in, apply learning algorithms and manage a wide range of decisions that were previously operator managed. As this capability expands, the disruption will be significant. Workforce requirements will change, and manufacturing and IT will need a different set of competencies. For example, IT groups will need to up skill part of their workforce so they can install, program and support this new technology.
4. Mobility revolutionizing the work
Smart devices in the manufacturing setting provide a revolutionary way to connect operators to their work, and to each other, in real time. Moreover, the workers’ adoption curve is rapid, given the proliferation of smart devices in their personal life and their comfort level with them. Manufacturing mobility applications span the spectrum from the removal of paper documents and the processing of routine transactions, all the way to innovative employee-crowdsourcing of problems, issues, and investigations, combining process execution and social collaboration.
5. Robotics changing the landscape of the shop floor
The new breed of robots is unlike those before; they are able to sense and learn, remember/recall and apply dexterity to their tasks. As they become smarter, cheaper, and safer, they are being applied for far more than the traditional automated jobs in manufacturing. Additionally, their precision is far beyond that of humans, and they are even capable of social “intelligence,”—working side by side with humans and learning to collaborate just as readily as they learn their tasks. This is known as “cobotics,” where operators and machines are teamed up. Cobotics is highly successful when used for specific ergonomically challenging tasks. And the range of applications will grow as automation providers introduce more sophisticated sensors, and higher functioning robotic equipment, expanding well beyond aerospace and automotive, where they have readily been deployed already.
6. Cyber Protection expanding beyond traditional systems
Industrial control systems are becoming an increasingly disparate, yet highly connected, set of technologies. They control and automate significant portions of manufacturing across many industry sectors. Industrial control systems, and the manufacturing businesses that rely on them, benefit from them being heavily networked and these connected operating environments have driven significant efficiency and effectiveness. Moreover, manufacturers have benefited from linking operations and associated data and knowledge horizontally, across a company, using networked control systems with integration to an enterprise IT backbone. On the flip side, there are significant, and increasingly evolving, challenges associated with a hyper connected manufacturing operating environment. It is becoming increasingly difficult to separate Information Technology (IT) and Operations Technology (OT) from each other. Both need to be adequately protected, and the threats in each need to be fully understood, especially as the OT systems become increasingly vulnerable to cyber threats. A cyber briefing issued in late 2016 finds that there were more incidents involving industrial control system operations in 2015 and 2016 than in any year prior. Manufacturing technology solutions, and the implementation strategies for them, will need to emphasize “secure by design” as a minimum must in order to protect manufacturers from operational continuity issues as well as cyber and information security breaches.
These trends are not the only ones that will become more widely deployed over the course of the coming year, but they will be some of the most significant. And there’s no guarantee exactly when or how these trends will play out. As an IT leader, I have learned that it can be self-defeating to focus on too many innovations at once, leading to a lack of sufficient progress on any. It is far better to choose a few and focus on them, guided by probability of success and key value to your business. Equally importantly, it’s worth picking a few and getting started, iterating and shifting as you go— the earlier you start, the more time you will have to make them a success before your competition does.