Closing the Strategy-Operations Gap in Life Sciences Manufacturing

Digital transformation initiatives almost always underdeliver when the operational realities do not inform the strategy from the start. I’ve experienced that outcome twice in my career, and once was more than enough.

In both scenarios, we were working with customers whose end users were running clinical programs, rather than commercial programs as they initially anticipated. This shift resulted in business cases that required more agility to accommodate smaller batch sizes, a higher volume of tech transfers, and a high level of process variability.

When a business case is not fully articulated when digital design begins, or when the business case changes without a clear redirection of the entire team, the end result falls short of fully meeting user needs and operational targets.

At the time, our team was not technically built, scoped, or positioned to bridge the gap between desired business outcome and operational reality. But we felt the pain and recognized the challenge. I watched team members work 80 hours a week on these projects, fighting through problems that could have been prevented by design-phase conversations that included the operations and quality teams. Instead, I watched a client rip out an entire digital system, having concluded that the technology platform itself was the problem. The truth, as you can imagine, was far more complex.

I am now passionate that no digital implementation project should proceed without involving key operational stakeholders in the strategy and maintaining alignment among them to the very end. The risks are too great otherwise.

The Strategy-Operations Gap in the Life Sciences

The gap between high-level strategy and practical implementation on the manufacturing shop floor endures because historically, no market players have been positioned to bridge it.

Consider the options available to manufacturing leaders pursuing digital transformation. On one side are IT-focused consultancies that develop global digital and AI strategies. Enterprise digital strategy is a vital piece of the digital transformation puzzle, and determines capital allocation, site alignment, and the transition of AI initiatives from pilots to full-scale programs. But the expertise of a strategic consultancy lies in enterprise-level systems; they often lack experience applying strategies in a way that accounts for real-world operating conditions. The outcome of working with a firm like that is architectures that are theoretically perfect—complete with detailed diagrams and lists of technologies—but don’t include crucial operational considerations.

On the other side of the divide are system integrators, who design solutions according to the precise design requirements provided. If provided with a thoughtful design, there are plenty of SIs that perform excellent work. But in many cases, they receive specifications from SOPs or derived from batch records that rely on paper-based processes not optimized for digital operations. Their capabilities do not typically extend to strategic evaluation of the digital solutions, and even though they are well-versed in operating realities, their results do not always achieve the intended business objectives.

Here’s a question that’s typical in many of our client engagements: How will different systems work together to accelerate batch release times?

The system integrator is focused on individual system implementation. The strategic consultancy is focused on the digital architecture, technologies in the diagram, and the roadmap to deploy them. But neither one is providing a comprehensive answer to the question. Neither one is responsible for ensuring those individual digital workstreams get deployed as a cohesive operating system to deliver the outcome of accelerating batch release times.

Anyone accountable for operations within a manufacturing facility has felt the pain of the strategy-operations gap: an operator on the floor running a batch through the automation system who has to open up a separate laptop and sift through dozens of workflows to find the one currently in use. A supervisor who has to call, walk to another system, or wait for someone to pull together data that should already be available at the point of decision. A quality reviewer reconstructing what happened across multiple systems because there was never consideration in the system design as to how an exception would be investigated and resolved.

The disconnect between strategy and operations is at the heart of the “digital EPC” conversation: most facilities lack a counterpart to the EPC on the digital side. The gap will not close without deliberate intervention. Someone must stand in the middle of it.

Pulling Operations Forward into Strategy with OpsCore

Stellix focuses on enterprise digital strategy, but with the experience of having deployed digital systems on the shop floor. This dual capability set allows us to close the gap between digital strategy and operational reality. Operational teams must be actively involved early in the design process to help communicate operational realities and fully leverage digital capabilities.

This is the premise behind our team’s OpsCore framework. Every engagement starts with the business outcome—the batch-cost target, the throughput goal—rather than the technology. From there, the work is deliberately hands-on: our experts go deep into the operational complexity, getting into the physical and operational detail of how a facility must operate to achieve the business KPIs, so that we’re not designing operating models in the abstract.

We execute via a workshop methodology that pulls in the right operational and quality stakeholders so we can ensure cross-system design decisions are made before implementation begins. Planning is grounded in the client’s operational KPIs and married with our deep expertise of digital solutions, and hypotheses are vetted and validated as a team. Piece by piece, the results compound—how you make a batch informs how the data architecture gets designed—until they add up to a digital basis of design (BoD).

Ask This Question Before Your Next Project

Life sciences manufacturers that achieve the returns outlined in their business cases are those that treat operational input as an essential part of digital strategy from the outset. For leaders considering their next capital or digital initiative, the key question is this: Do we have the capability to translate our digital ambition into a working operating system that delivers the capacity, throughput, and release performance our business case requires?

At Stellix, the answer is yes, and we’ve seen exactly where these projects go wrong when that experience is missing. Our OpsCore framework was built on the premise that operational realities should inform digital strategy from the very first design conversation. Reach out if you’d like to talk about what that looks like on your next project.

Join our upcoming webinar at 11 AM EST on Wednesday, 9 December, to learn more about OpsCore and how Stellix can help you design for Operational Excellence.