A Digital-First Approach To Bio/Pharma Manufacturing Operations
By Srihari Rangarajan, EY
Given today’s rapidly changing pharmaceutical market, pharma manufacturers are leveraging the latest industry trends, from shifting from generic to personalized drugs to expanding into biosimilar markets to managing smaller commercial batch sizes. And amidst this rapid change, pharma manufacturing leaders should rethink their performance improvement strategy.
From supply chain inefficiencies to siloed functions and more, there are myriad opportunities to enhance pharma manufacturing operations. Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.
In this article, we’ll outline why and how a digital-first approach can support pharma operational transformation, enable operational visibility, and unlock value.
Benefits Of Digitalization
Traditionally, major pharmaceutical manufacturing networks have been segmented by business unit and global region. As such, customary local practices frequently became the norm, creating siloed operations that could not leverage the power of a global manufacturing network to drive success.
However, more recently, pharma companies have sought to standardize their supply chain processes across their network of sites through an operational excellence framework. Typically, they begin by determining a standard set of business practices, including structured meeting cadences, reporting strategies, operator care, and ways of working. Once defined, companies implement these standard processes across their network to build consistent culture and value throughout the organization.
Establishing a modern, fit-for-purpose operational excellence framework to address today’s supply chain and manufacturing challenges requires a more strategic approach — one that can deliver improved manufacturing reliability, reduced costs, and increased productivity. Achieving long-term operational resiliency today also involves a digital commitment, including investing in the right digital tools; storing, managing, and analyzing large amounts of data; navigating global labor shortages; and developing new strategic operating models for both today and the future.
By digitalizing this framework early, pharma manufacturers can achieve cross-functional collaboration for their sites and supply chain, driving efficiencies and delivering value. Other benefits of the digital framework include real-time feedback, cloud solutions, maturity progression monitoring, improved accessibility to the value chain, streamlined communication, process integration, the ability to leverage large volumes of data with a connected worker platform, and predictive analytics. Digitalization also enables plants and shop floors to be more proactive in solving problems and optimizing operations.
In addition, by adopting a digital manufacturing operational excellence approach, pharmaceutical companies can significantly accelerate their performance improvement efforts. This approach can enable enhanced productivity; fewer product recalls; less waste; reduced labor, maintenance, and energy and water costs; and several other operational benefits.
Using a smart management and coaching application enables consistent improvement of leading processes, capability development, and maturity progression monitoring across a distributed network of factories. As such, the application builds and sustains capability while also helping to empower people. For pharmaceutical manufacturers, these features enable an effective digital supply chain transformation that creates a more connected, predictive plant network.
Moreover, manufacturing plant networks that utilize real-time data monitoring are better suited to handle disruption. For example, advanced schedulers can allow for scenario planning and equip the organization to mitigate unplanned activities. In addition, comprehensive data drives predictive analytics. This allows the company’s system to guide its teams on where to focus cybersecurity and consumer engagement efforts.
A Three-part Approach: Design, Develop, Deploy
In the design phase of transforming manufacturing operations, leaders must focus on business objectives and results. A simple and proven set of analytics can help the organization derive value, identify top losses, and validate sustained improvements. Designing a daily management system can ease the transition from reactive to predictable; for example, line teams can set the plan for the day by leveraging line event data, operator input, and line observations to minimize stops and losses and plan ahead.
Pharma companies should consider two key approaches as they develop digital solutions: building platforms in-house or externally sourcing a platform through a reputable vendor. No matter how they are built, digital operational excellence modules should provide leading practices and journey maps that are customized down to the line level. These tools will allow the organization to advance along the digital maturity curve.
Operational platforms should also be able to determine performance issues, schedule work bundles to close capability gaps, focus on actions that lead to performance improvements, provide downloadable data for just-in-time usage, and track manufacturing capability improvement instead of production metrics improvement.
Both internal and external options bring their own advantages and trade-offs. On one hand, many pharma leaders choose external sourcing because fewer company resources are needed to stand up the solution. However, as this approach also requires more up-front investment, it may not be feasible for emerging organizations. On the other hand, an internally built tool may be a better fit for the company’s unique processes, but it will also require a more long-term investment to keep the tool current.
Pharma manufacturers have two ways to deploy their new platform. With a two-phased approach, the operational excellent production system is deployed first, followed by the digital application. With a direct to digital approach, the production system is deployed in parallel with the digital application.
With either approach, the deployment team should engage with the site stakeholders during the full life cycle of the project, focusing on solution scoping, master data setup, end-user training, and hypercare support. The right structured approach will provide systematic and disciplined line-level deployment methods, which rapidly improves manufacturing reliability.
Developing a structured deployment guide is another leading practice, often leveraged through a smart operational excellence deployment console. By integrating improvement methodologies with maturity-based road maps, organizations can establish a fully digital “plan, do, check and act” process cycle that conducts performance gap analysis; executes 90-day sprint action planning; supports teams’ ownership of the improvement journey; achieves rapid, scaled deployment of leading practices and methods; and enables real-time knowledge sharing across networks.
After the solution has been deployed, the team should focus on optimizing the site’s solution use and value realization, driven by usage adoption metrics. The deployment team would work with sites to determine value levers against which success is measured. Once these value levers have been determined, measurements should be taken at the time of deployment and at a set time after deployment (typically a few months later).
Today’s pharma leaders need to consider operational transformation with a robust digital component as a means of keeping pace with the competition. With several digital tools available to complement operational excellence implementation, taking a strategic approach from the outset will be key. Utilizing a smart management and coaching application is an effective option that enables consistent and phased improvement of leading practices and processes, capability development, and maturity progression monitoring across a distributed network of factories. Leaders who choose this path will enhance the organization’s capabilities and growth trajectory for the long term while also empowering its people.
About The Author:
Srihari Rangarajan is a partner, supply chain & operations, Ernst & Young LLP (EY). A seasoned supply chain executive with more than 20 years’ experience, Rangarajan develops solutions for clients across the pharma, medical device, and consumer product industries, leveraging artificial intelligence, machine learning, industrial internet of things, intelligent automation, AR/VR, and digital twin. Srihari holds a BE in chemical engineering from Annamalai University, an MS in chemical engineering from the University of Akron, and an MBA from the University of Chicago Booth School of Business.
The views reflected in this article are the views of the author and do not necessarily reflect the views of Ernst & Young LLP or other members of the global EY organization