Technology + Method: The Transformative Productivity Equation

We spend a lot of energy talking about change, and even more talking about how to apply technology to it. The speed of AI innovation itself is no longer in question — it is happening, and it is happening fast. Executives and practitioners are largely aligned on that point, and aligned that the imperative is to adopt, use, test, and deploy. The question left standing is how.

That "how" is the familiar pattern we are observing: pilots are failing, POCs don’t scale, digital initiatives stall, etc. This is real, and it isn’t surprising that organizations reach for technology instead of method to answer it. The tool is always the easier lever to pull — it’s not a new behavior, and it’s a familiar failure mode. Something similar happened when Lean first arrived in manufacturing in the West. The tools got the attention — the focus was on the Kanban boards, the 5S audits, the Supermarkets, Andons, Poka-Yoke, Kamishibai, and so on — while the harder, genuinely transformative process behind them, the organizational adoption of Lean and the change in operational behavior, got skipped. That pattern resurfaces with every new paradigm, and we are clearly watching it happen again.

It’s disheartening that the prescription, once again, is entirely about the technology: data structure, infrastructure, context, integration, connectivity. Every one of those is correct and necessary. None of them will do much on their own, without a strategic process of transformation — one backed by leadership strong enough to actually drive the organization toward an order-of-magnitude productivity improvement.

Deploying transformational technology into an organization that hasn’t changed how it behaves, thinks, designs, engineers, and of course operates isn’t transformation. Transformation is genuinely hard, which is exactly why organizations keep reaching for the tool instead. It’s easier to issue a purchase order for tech; trying to change the way you operate is a challenging, conflict-ridden process that is uncomfortable and very risky.

So what is the best approach here? It really is not new, like in Lean and in CIM (Computer Integrated Manufacturing, yes, remember that?), the answer is the combination of a technology that is truly digital, and an effective method to guide how it’s adopted in a continuous transformative motion. A new way of working, designing, operating, and engineering, not just a new technology capability bolted onto the existing operational model. You will know it’s working when it produces a transformative, order-of-magnitude productivity gain. That is what leadership should be expecting, not an incremental improvement.

The Productivity Equation

The Productivity Equation

Let’s start by stating the obvious. The observation and discussion on digital adoption failure rates are real. I need to start with this background to ground reality and satisfy the skeptics — if there are any left.

MIT’s NANDA initiative found that 95% of enterprise generative AI pilots deliver no measurable return despite tens of billions in enterprise spend — not because the models are weak, but because the organizations never integrated them into how work actually happens. That’s consistent with what BCG found well before generative AI showed up: 70% of digital transformations fall short of their objectives. McKinsey’s own research on why transformations fail lands on the same conclusion from a different angle — the constraint is almost never the technology’s capability, it’s the organization’s ability to change how it works around it.

In the last three decades I have watched this unfold countless times, where companies attempt to absorb new technology without changing their approach or how they work, and then wonder why the improvements do not stick. The technology becomes the thing they tried. Not the operating model they run on.

This is the same digital divide I’ve been writing about for years — not embracing the required change is really just digital theatrics. Naming the problem is half the battle; solving it to produce a sustainable productivity gain is victory. This can only be achieved by executing on the equation — the two specific, concrete components, applied together.

The Technology

You have to use technology that is genuinely digital and AI-native. This critically means composable — not just connected, modular, AI-enabled, digital, IIoT, and, of course, not monolithic. Composable technologies are built to change at the pace of the business and operations rather than the pace of an IT project, and to absorb new capability, including AI, in hours-to-days iteration cycles rather than months-to-years projects.

That distinction sounds like a technical footnote until you sit with what it actually means operationally. In a traditional, monolithic system, a change — a new product introduction, an equipment upgrade, a new process step, a new quality procedure, a technology upgrade, etc. — will trigger a change request, a design review, configuration, a validation cycle, and a deployment window measured in months. This is due to the monolithic nature of the solution: architected around a single, centrally-owned data model, it cannot change locally without touching everything connected to it. That’s not a flaw a vendor fixes with a software update — it’s the architecture.

A composable platform inverts that. Each solution is scoped to one operator doing one job, apps share data through common structures but are independent of one another, and a local change stays local. That’s the concrete, measurable expression of "technology built for transformation": speed-of-change, hours-to-days instead of months-to-years. It’s also the precondition for AI to be useful in operations at all — a model can only iterate as fast as the system around it lets it, and a platform that requires a quarter to reflect a floor-level change will require a quarter to reflect what an agent just learned, too.

Notice that the method, composability, is already embedded in the technology. Technology alone — even genuinely composable technology — produces pilots, not transformation. This is the half of the equation; it is necessary but it is not sufficient.

The Method

You have to use a method that defines the underlying transformative theory and its mechanics — the concepts and the strategic guidance, together. Lean is the clearest example. Its concept is a specific definition of what a Lean operation looks like when it’s actually working, and it rules out what doesn’t count: Lean, at its core, defines a small set of principles for an operation — identify value, make value flow, execute pull, and enable perfection. A cost-cutting exercise with no customer-defined value isn’t Lean, no matter how many Kanban boards it has. The tools — Kanban, 5S, Andon, Poka-Yoke, Kamishibai — are what make that concept usable on the floor, not just legible to a consultant. Concept plus tools is the playbook, and the playbook is what makes a transformation widely usable and easy to adopt at scale.

So, a method that actually drives transformation has two specific components: a concept — the foundational idea, strategic model, and guiding vision that redefines how operations use technology, expressed as a framework that defines the outcome you should expect and, just as precisely, what falls outside it — and a set of tools and best practices that show people how to apply that concept correctly, in daily work.

A concept with no tools stays a slide in a training deck nobody can act on. Tools with no concept behind them turn into techniques people run without knowing what they’re supposed to add up to — which is exactly what happened when Lean arrived in the West, as I noted above.

The method here is called Composability, and I’ve explained it in a number of previous posts. It includes a concept, a framework, tools, and best practices. Composability is defined by five pillars, resting on two foundational, supporting conditions. Each pillar has its own supporting tools and best practices, all bound by the same framework. Here is the framework:

Bottom-up. Solutions are built from the operational level up — not imposed through top-down hierarchies — tailored to the specific process, with the people closest to the problem contributing directly to what gets built. This produces emergent design: solutions evolve in real time as operational needs evolve, deployed incrementally and iterated on immediately, rather than routed through an IT change-request queue against a predefined architecture.

Agility — Augmented Lean. Composability is the reunion of Lean and Agile: rapid test-fail-learn cycles and on-demand process changes, in place of the predefined processes a monolithic system locks an organization into. This isn’t a development methodology; it’s an operational property — the ability of the floor to respond to a process change, a quality event, or a new product introduction in hours-to-days instead of weeks-to-months. I call this Augmented Lean because it is, structurally, the Toyota Production System’s logic of standardize-then-improve, run inside a digital architecture that can actually keep pace with how often the standard needs to change.

Democratization. The people who know the process — engineers, technicians, operators — build and maintain the digital solutions themselves, using no-code and low-code tools, without waiting on centralized IT. This is also the organizational mechanism that lets change scale past the first pilot: people get trained to build, and the organization accumulates a growing portfolio of focused, continuously maintained apps instead of a single archived experiment. Generative and agentic AI are amplifying this pillar further — describe a process in natural language and get a working scaffold back, and the barrier to entry drops for people who would never otherwise touch a no-code tool.

Human-centric. Technology serves the operator, not the reverse. Traditional enterprise interfaces make the person on the floor into a data-entry function for the system — locate the right transaction, navigate the rigid form. A method that inverts this, designing around the operator’s actual workflow rather than the data model, puts the operator at the center: productivity gains come from augmenting human capability, not from forcing people to adapt to system constraints. This is also still fundamentally about people, not software.

Compliance. In regulated environments — life sciences, aerospace and defense, and others — this pillar is less about the baseline technical requirements every platform has to meet (audit trails, e-signatures, data-integrity standards — prerequisites, not differentiators) and more about a mindset shift: the belief that a digital solution can be continuously improved while remaining in a validated state, instead of locked down between full re-validation cycles. Changes get scoped, risk-assessed, and evidenced automatically, which is what makes agility and democratization survivable in a GxP context rather than a liability.

Underneath all five pillars, two more concepts have to be true, or the playbook doesn’t hold. The first is digital maturity — an organization’s actual, demonstrated capability to run composable architectures, not just its enthusiasm for them. Culture, skills, and governance have to advance in step with the technology; an organization can deploy a composable platform and still fail to capture the gain if its people and processes haven’t caught up to what the platform enables. The second is connectivity and data integrity — accurate, consistent, trustworthy operational data, available at the point of work. Without it, none of the five pillars actually function: an operator can’t be human-centric about a decision built on data they know is stale, and an agent can’t augment what it can’t see clearly. Digital maturity and connectivity are the two bases the five pillars stand on — not an afterthought to them, but the ground underneath.

None of this is a modularity story. Composability is not "interchangeable pieces." It’s an operating discipline that determines whether an organization can sustain the rate of change its business actually requires — and every one of Lean’s real tools, including standard work, lives inside it rather than outside it.

The Outcome is Always the Measure of Success

Technology without method produces pilots with marginal productivity increases. Method without technology is a theoretical exercise that fails on execution. Technology with a method drives transformation that results in order-of-magnitude productivity improvements.

My simple equation uses addition, but there’s a scenario where it actually becomes multiplication. A brilliant composable platform deployed with no method for what to build first, on which line, with which team, or toward which measurable outcome doesn’t stay composable for long — it degrades, most detrimentally, into just another monolithic JAM (Just Another Manufacturing System). That isn’t a smaller version of transformation. It’s a sure way to keep doing what you were already doing, which is exactly where the marginal outcomes come from. A beautifully designed operating philosophy with no platform capable of executing it for rapid time-to-value doesn’t drive transformation either. It’s a sure way to build distrust and skepticism.

Technology + Method = Productivity. Not one or the other.

A Composable Agentic Framework for Frontline Operations

Over the last year, “agentic AI” has shifted from emerging concept to practical conversation. Everyone is now talking about agents, and with today’s tools, building one has become every person’s business. But that raises a much bigger question: what agents should we build, and how do we organize them into something meaningful?

This is a topic that is not new and I have reflected on it through a number of lenses, e.g. Why IIoT is Transformative - its not the technology! and The Genius of the Toyota Production System Explained. This post however offers my first reflections on what a Composable Agentic Framework could look like for operations in general and manufacturing specifically. It’s an attempt to give industry an initial perspective, a concept and maybe some guidance for applying agentic AI to frontline operations in ways that improve both productivity and adaptability. Notice I say "initial", there is clearly much more to this topic that needs to be explored, discussed and debated - in addition the technology is nascent and we can expect much more sophistication and depth as it evolves.

Why Agents? Why Now?

For decades my peers and I, as manufacturing thinkers, have dreamed of holonic systems and fractal factories—production environments that adapt in real time, scale seamlessly, and continuously self-optimize. But until recently, that vision stayed in the realm of theory. The technology just wasn’t ready.

Now it is. Today’s digital platforms, IIoT connectivity, cloud infrastructure, and AI capabilities make it possible to realize this vision in practice. Instead of rigid, monolithic systems, we can now compose operations out of, and with, autonomous, collaborative agents that interact dynamically.

And this matters because composability is built on the idea that continuous, incremental improvements add up to transformation. What’s new is that agentic AI can accelerate these improvements beyond what we can imagine. Large language models and agentic frameworks have already proven their ability to supercharge productivity in domains like software development, research, and customer interaction. The challenge—and opportunity—before us now is to understand and define how to bring that same acceleration into composability and frontline operations.

Agents make this possible. Each agent is discrete, goal-oriented, and autonomous, yet designed to collaborate with other agents. When composed together, they create systems that flex, adapt, and continuously optimize.

In earlier posts, I’ve argued that digital transformation is not about IT and OT learning to coexist, but about creating a new whole where the distinction ceases to matter. That’s the essence of composability. Agents are the next step: a way to make that vision practical, modular, and scalable.

An Agent Framework for Composable Digital Solutions

The starting point is simple: in new digital operations platforms like Tulip, apps already behave like agents.

• They have a clear goal (guide an operator, track a unit, log a machine event).
• They operate autonomously within their context.
• They collaborate with other apps and systems through shared data, triggers, and transitions.

Add AI into the mix, and these apps become agentic apps—supercharged digital teammates. And when multiple apps are composed together, they form a multi-agent system that mirrors the complexity of real operations, in other words they become digital twins in the true sense of the concept.

But in order for this "mirroring" to become a digital twin we need to define some rules and this is where the framework comes in. To move from scattered apps and automations to composable digital solutions, we need a structured way to think about agents.

Add AI into the mix, and apps evolve into agentic apps—supercharged digital teammates. Composed together, they form multi-agent systems that can mirror the complexity of real operations—becoming digital twins in the truest sense. But achieving that requires more than simply building agents; it requires structure and guidance. Without it, the risk is a proliferation of scattered apps and agents with no cohesive purpose—at best delivering little value, and at worst creating more complexity, reduced productivity, and even unsafe outcomes. The goal of this suggest framework is to provide the rules and design principles that ensure agents align toward a shared purpose. This reflects the essence of holonic structures: their power comes not just from autonomy, but from working together toward a common goal. That shared purpose is what makes them optimal, and what turns a collection of agents into a true composable digital solution that delivers measurable benefits.

In my earlier blog post “To Data Model or Not to Data Model”, I described the Artefact Model as a key element in composability: a scalable, flexible, interpretable representation of the operational system. The Artefact Model gives us the common context in which agents can interact—products, orders, machines, deviations, and operators all represented digitally and consistently.

A Perspective on Agent Types

Before diving into the types themselves, it’s important to recognize that agents serve two distinct scenarios in manufacturing:

Authoring / Building – Here, agents augment the creation process. They help engineers, developers, and even citizen builders design solutions faster and smarter. Think of them as co-pilots that propose app templates, generate artefact structures, suggest best practices, and automate repetitive setup tasks. These agents accelerate innovation and democratize solution-building.

Operations – Once deployed, agents act within day-to-day execution. They monitor machines, guide operators, coordinate workflows, manage deviations, and connect enterprise systems. These operational agents are the ones “living” in production, continuously working toward defined goals while collaborating with other agents and humans.

The framework presented here is focused specifically on the operations scenario. That being said there are commonalities and some agent types apply to both scenarios, but the context differs: in building, agents amplify human creativity and speed; in operations, agents amplify execution and adaptability. 

Agentic AI in operations enables a powerful ecosystem where "teams of experts" (agents) work together, demonstrating "collective intelligence". Crucially, operational agents, empowered by AI, transform what were once innate objects like machines and materials into active, intelligent members of the dynamic work environment. We are giving them the ability to be agents—autonomous and collaborative participants within the dynamic manufacturing operation network.

With that lets take a look at a shared taxonomy for the different types of agents in a composable agent framework:

Physical Agents: These agents are defined by their direct representation of physical manufacturing objects within the digital twin. They continuously mirror the real-world status, attributes, and behaviors of their tangible counterparts, enabling real-time monitoring, analysis, and control. Here are some examples:

• Product Agent: Represents a specific product or unit throughout its manufacturing journey. Its goal is to track the product's individual status, quality parameters, and genealogy, providing a comprehensive digital record for each item produced.
• Machine Agent: Serves as the digital twin of a specific piece of equipment or machinery on the shop floor. Its purpose is to monitor machine health, performance metrics (e.g., OEE, availability, performance, quality ), and predict potential failures, enabling proactive maintenance and optimized utilization.
• Tote Agent: Represents a tote or device that carries and conveys product or material on the shop floor. This agent's role is to track the movement of the material or products it carrier in the operations and facilitates traceability and location with ease.

Operational Agents: These agents are defined by their focus on tangible operational entities and processes used in manufacturing management. They manage the flow of work, information, and events, ensuring that manufacturing processes adhere to plans and respond effectively to deviations. Here are some examples:

• Order Agent: Represents a specific production or work order. Its goal is to oversee the end-to-end execution of that order, tracking progress against the schedule, managing material consumption, and ensuring all required steps are completed.
• Deviation Agent: Activated when a process or quality deviation occurs. Its purpose is to identify, classify, and manage the deviation, potentially initiating corrective actions, alerts, or escalation workflows to relevant personnel or systems.
• Schedule Agent: Responsible for dynamically managing and optimizing production schedules. This agent works to ensure resources are efficiently allocated and production targets are met, adapting to real-time changes in machine status, material availability, or order priorities.

System Agents: These agents are defined by their role in facilitating integration and intelligent interaction with broader enterprise-level systems and data repositories. They ensure data consistency, enable seamless workflow orchestration across different platforms, and provide access to critical business context. Here are some examples:

• ERP Agent: Manages the flow of information between Tulip and the Enterprise Resource Planning system. Its function includes receiving work orders, reporting production updates, and managing material consumption and inventory levels in the ERP.
• UNS Agent: Represents the integration with a Unified Namespace. This agent enables seamless, real-time data exchange across the entire operational landscape, ensuring that all systems have access to consistent and up-to-date information.
• Data Lake Agent: Responsible for managing the ingestion of operational data from Tulip into a central data lake and enabling access to this data for advanced analytics and further AI model training. It ensures that the rich data captured by Tulip's composable applications is leveraged for broader insights.
• Device Agent: Corresponds to a specific connected device, such as a scale, barcode scanner, or sensor. This agent's role is to facilitate seamless data exchange between the physical device and the Tulip platform, ensuring accurate data collection and enabling device-triggered actions.

Staff or Companion Agents. These are a general type of agent that augment the human's ability to find information, research topics, suggest improvements, and perform tasks. They are used in a variety of scenarios and serve as utilities in both the operational environment as well as the engineering or builder environments. Here are some examples:

• Quality Research Agent: Quickly finds documentation, suggests troubleshooting steps to an operator, or summarizes a quality history for a supervisor.
• App Builder Agent: Generates app templates, proposes table structures in the Artefact Model, or scaffolds connectors based on device specs—accelerating citizen developers and engineers.

What unites these agent types in this framework is the three core properties: it has a goal, it operates autonomously within a bounded scope, and it is collaborative—able to exchange data, signals, and intent with other agents and humans.

Crucially, these agent types do more than align with the Artefact Model — they enhance it. By consistent real time representation of artefacts (products, resources, orders, deviations), agents enrich the shared digital twin with actionable state, decisions, and provenance. That enriched Artefact Model becomes the lingua franca that lets agents interoperate reliably, enables composition, and prevents the classic failure mode: a landscape of scattered apps and ad-hoc bots with no unifying purpose.

In short: agents must be designed to work as an integral part of  the Artefact Model so that autonomy and collaboration add up to a cohesive, safe, and value-driving digital twin.

Beyond Incrementalism: The Future of Multi-Agent Collaboration Frameworks

Much of what we know about manufacturing improvements has historically been driven by incrementalism—step-by-step gains in efficiency, quality, or throughput. This mindset is not wrong; in fact, it is the foundation of continuous improvement and the heart of lean thinking. But incrementalism alone can only take us so far. To thrive in today’s volatile and complex operating environments, we need systems that don’t just get gradually better but can adapt dynamically to new conditions.

This is where multi-agent collaboration becomes transformative. Agents, by design, are autonomous but collaborative, and when they interact at scale, they exhibit something greater than the sum of their parts: collective intelligence.

The result is emergence and self-organization: a system-level intelligence and adaptability that was not explicitly programmed into any single agent. Emergent behavior is what allows multi-agent systems to flex and reconfigure in response to disruptions, market changes, or unexpected events. This is not just automation—it’s a new layer of operational intelligence applied directly to the frontline.

But to realize this potential, we must also reconsider the frameworks that structure our digital manufacturing systems. Such a composable, agentic world—where apps act as agents and operations are orchestrated by multi-agent systems—doesn’t fit neatly into traditional manufacturing systems standards and hierarchies definitions (see my earlier post, OK, Let’s Talk ISA-95).

That doesn’t mean throwing standards away, but it does mean rethinking or adapting them to this new reality. If emergence is the key to adaptability, then our models and standards need to evolve to describe systems that are dynamic, distributed, and composable rather than hierarchical and rigid.

In short: incrementalism is still essential, but it is no longer sufficient. Collective intelligence, powered by agents and guided by frameworks like the Artefact Model, is what will enable manufacturing to achieve adaptability at scale—and truly fulfill the promise of digital transformation.

Final Reflections

Building, authoring, creating agents is within everyone’s reach. But without structure and guidance, we risk ending up with a fragmented landscape of apps and bots—scattered efforts that deliver little value, or worse, add complexity, reduce productivity, and even create unsafe outcomes.

My hope is that this initial framework presented here provides that needed guidance. It should help us define what kinds of agents to build, how to compose them into systems, and how to ensure they align with a unifying purpose. It grounds agentic design in Composability and its Artefact Model, ensuring that agents not only adhere to but actively enhance the shared digital twin. This alignment is what keeps autonomy and collaboration from drifting apart and turns them into something greater: collective intelligence with emergent adaptability.

This is why composability and agent frameworks matter. They give us the structure to channel autonomy toward common goals. They offer to guide us on the path to increased productivity with adaptability. And they point to the need for new thinking in our standards and models—beyond the rigid boundaries of monolithic approaches, toward a more dynamic and composable reality.

In the end, the promise of agentic AI in operations is a the newest step in the digital transformation journey: Continuous Transformation - reinvention at scale of manufacturing operations.

And this is just the beginning. There is so much more to explore, define, and refine. I invite you—industry peers, practitioners, and thinkers—to engage in this discussion and debate. Let’s shape together what a composable agentic framework should look like in practice. After all, it takes a village... 

Digital Maturity Embracing the Paradigm Shift with Composability

In my last post, The 5 Pillars of Composability, I broke down how composable systems have to be bottom-up, agile, democratized, human centric and compliant to enable a resilient digital  manufacturing environment. However, these pillars don't standalone and you may have noticed that the graphic drew the pillars within a structure, i.e. a house. Yeah a bit cliche but its a simple way to drive the point - the foundations is connectivity and data integrity while the roof is digital maturity. Without connectivity to reliable data and a high level of digital maturity, the benefits of composability can be diminished. 

• Data integrity ensures that the digital solutions operate on accurate, consistent, and trustworthy data, preventing breakdowns in decision-making or system performance. High-quality, accurate data is essential for making informed, evidence-based decisions
• Digital maturity enables organizations to effectively adopt composable architectures, ensuring they have the technical capabilities, culture, and processes in place to take full advantage of modular solutions. 

Together, data integrity and digital maturity complete the story of composability by ensuring that organizations can both build and sustain these flexible, adaptive systems in a reliable and future-proof manner. In this post I want to dive deeper into these concepts as they are foundational concept that propels us forward in the digital paradigm shift to reshape manufacturing operations.

Digital Maturity, Connectivity & Data Integrity complete the composability model

What is Digital Maturity?

Digital maturity represents an organization’s capacity to leverage digital tools and processes effectively based on their strategy with the objectives of significant increases in productivity. It's not a simple matter of capabilities related to adoption or implementation new technologies but rather about integrating them strategically to align with long-term goals. As companies mature digitally, they move beyond basic digital adoption to foster seamless connectivity across systems, data transparency, an empowered workforce and with that comes order of magnitude productivity improvements - the ultimate goal for transformation.

A digitally mature organization is one where digital tools support real-time decision-making, democratized technology access, and predictive insights - aligning perfectly with the benefits of composable principles. This is also what the Pharma 4.0 operational model prescribes, that manufacturers need to do more than automate - they need to integrate everything from operations to compliance in a way that’s seamless, agile, and deeply data-driven.

What is Connectivity & Data Integrity?

Its not news that data must be accurate, accessible, and trustworthy across all systems for true digital maturity. It must be connected, collected, contextualized and stored to ensure that data collected from production lines, suppliers, and product design all feed into a single, reliable source, creating actionable insights and reducing costly errors. Yet surprisingly it still is very much a challenge in many solutions that I encounter. Mostly in legacy situation, implementation of monolithic system, but also if not considered appropriately in newer digital technologies.

Connectivity in manufacturing is all about creating a seamless flow of data across systems, devices, and people. Imagine every machine, sensor, and workstation talking to each other and feeding data into a single network that anyone can access in real time. When systems are connected, it’s like moving from an isolated set of puzzle pieces to seeing the whole picture. Connectivity enables manufacturers to understand what’s happening on the production floor instantly, respond to issues faster, and improve coordination across departments. For example, in a highly connected factory, when a machine experiences a slowdown, that data can flow directly to maintenance teams and operators, letting them address the issue right away.

But connectivity is only as useful as the quality of data being shared, which brings us to data integrity. Data integrity is about making sure that information is accurate, reliable, and complete across its entire lifecycle. It’s not just about having data; it’s about having good data you can actually trust. In the Pharma 4.0 model, where data integrity is critical, maintaining high-quality data is a must, especially for meeting strict regulatory standards. This means putting practices in place to ensure that data isn’t duplicated, corrupted, or altered improperly, so everyone—from operators to auditors—can make decisions with confidence.

Together, connectivity and data integrity are the backbone of any digitally mature operation. They enable real-time visibility, reliable decision-making, and the flexibility to adapt to change. Without them, even the best technology can fall flat. So, as manufacturers embrace digital maturity and composability, focusing on solid connectivity and data integrity will be crucial for a smooth, resilient operation.

The journey from Technology Adoption to Strategic Transformation

Many manufacturers today are adopting digital tools, but there's a significant difference between early digitalization and achieving digital maturity. A mature digital approach emphasizes:

1. Strategic Data Utilization: Digital maturity involves a shift from collecting data in isolated pockets to having unified, actionable insights. For manufacturers, this means no longer relying on static, siloed data but leveraging real-time insights that span from the shop floor to the boardroom. Yes, this in a way nothing new and really dates to Industry 3.0 concepts - however with new digital tools this has become and achievable reality.

2. IIoT & Interoperability: Digitally mature systems don’t merely integrate; they interoperate, embodying the composable principle of Bottom Up where IIoT components are autonomous and collaborative. Composable architectures are inherently emergent in both design and control - the manufacturing solution is required to evolve with minimal friction.

3. Human-Centric Technology: In a departure from an automation focus, the current paradigm shift places people at the center of the digital equation. Technology becomes an enabler for employees, from line operators to managers, allowing them to respond dynamically to changes and resolve issues swiftly.

4. Resilient and Adaptive Workflows: A composable manufacturing ecosystem relies on digitally mature workflows that can adapt to disruptions, whether due to supply chain variances or unexpected equipment breakdowns. A digitally mature manufacturer leverages their digital capabilities to enable resilience, be predictive and adaptive.

The digital transformation journey towards order of magnitude productivity improvements

The path to digital maturity requires a tailored, strategic approach that elevates an organization from a technological upgrade to a business transformation—one that enables agility, resilience, and sustainable growth. The first step in this journey is to assess and align digital initiatives with overarching business goals. Defining what a mature digital state means for each organization—whether it's minimizing downtime, improving product traceability, or streamlining supply chain management—is critical. Aligning digital initiatives with operational excellence or lean initiatives by implementing data-driven approaches to cut down production waste and achieve near-real-time optimization are critical. Drive value by prioritizing areas where digital maturity will have the most impact on operational outcomes.

A characteristic of digitally maturity is how well your organization is equipped to handle the ever-evolving challenges and capitalize on new opportunities. Embracing composability allows your organization to not only keep pace with the current demands but to thrive in the future - thrive with the accelerated pace of digital innovation. Digital transformation should be more that mere adoption of new technology - it is embedding it deeply in your operational fabric, enabling sustainable growth and resilience in the face of change.

The 5 Pillars of Composability

I am seeing the industry converge on the term Composability to identify and explain the application of digital technologies that can effectively foster digital transformation. For digital transformation to happen, agility, flexibility, and human-centricity are a vital component that increase productivity in operations - the expected outcome. This is where the concept of composability emerges as the collective transformative paradigm. Let's also make it clear that the opposite of composable is monolithic and contrary to monolithic systems, Composable solutions empower manufacturers to adapt quickly, focus on the needs of their operators, and drive continuous improvement. 

Composable solutions are a critical ingredient in digital transformation because they empower manufacturers to enhance productivity by embracing flexibility, agility, and human-centric design. By focusing on the needs of operators and utilizing real-time data, digital tools enable rapid adaptation to changing conditions, boosting efficiency. This approach accelerates time-to-value, enhances collaboration, and supports sustained operational excellence, ultimately leading to higher productivity​.

The Composability Model for Digital Transformation

Let’s dive into the five key pillars that make composability such a powerful approach: Bottom-Up, Agility, Democratization, Human-Centric, and Compliance.

1. Bottom-Up: Building from the Ground Up

In contrast to the rigid, top-down structure of monolithic solutions, composable systems thrive on a bottom-up approach. This allows organizations to build solutions that are tailored to specific processes, activities, and operations. Composability starts at the operational level, focusing on solving problems at the frontline, rather than imposing broad, generic solutions from the top.

By empowering frontline operators and citizen developers to build apps that address their unique challenges, organizations can capture granular data about each activity. This leads to faster problem-solving, more efficient processes, and solutions that are adaptable to rapid changes​. The bottom-up approach is essential for increasing productivity and maintaining agility in a constantly evolving operational environment.

An interesting phenomena is that the bottom-up approach fosters an emergent design, where solutions are built iteratively, from the operational level up. This means frontline workers, who are closest to the challenges, contribute to the system’s development. By decentralizing control, emergent designs allows for rapid adjustments and iterations, ensuring that solutions evolve in real-time, in response to actual needs. This approach significantly reduces the time-to-value, as it enables immediate deployment and incremental improvements, accelerating innovation and aligning solutions with real-world demands​

2. Agility: Embracing Change through Lean and Continuous Improvement

Agility in composable solutions is crucial because it inherently supports Lean principles, which emphasize continuous improvement, waste reduction, and efficiency. Composability takes Lean further by bringing in adoption of digital technologies as a key enablers. Its the reunion of Lean and Agile, allowing for rapid cycles of innovation, quick iterations, and on-demand changes, which are essential for staying responsive in fast-paced environments.

In manufacturing, continuous improvement is key and agility is non-negotiable. Composable solutions, by design, are highly adaptable and enable organizations to iterate quickly. Unlike monolithic systems that lock you into predefined processes, composable systems allow for short test-fail-learn cycles that drive faster innovation. This agility extends to everything from software updates to operational adjustments, ensuring that you can stay ahead of challenges and capitalize on new opportunities. Agility also allows for faster implementation and a reduced time-to-value, meaning that benefits can be realized almost immediately after deployment​.

Augmented Lean represents this evolution of Lean, where digital tools and real-time data empower frontline workers to make immediate, informed decisions, maximizing efficiency and productivity in ways traditional Lean couldn’t achieve.

3. Democratization: Empowering Citizen Developers

The democratization of technology is another cornerstone of composability. This is where no-code and low-code platforms come in, they enable citizen developers - the people close to the operations, such as engineers, technicians, or operators - to create, modify, and maintain apps without needing deep IT or coding expertise.

This critically reduces dependency on a software skills, centralized IT and specialized OT departments - it speeds up the development of solutions that directly address operational challenges. As more people within the organization are empowered to contribute to solution development, it fosters a culture of innovation, encourages experimentation, and accelerates digital transformation​.

Democratization in composable solutions means empowering the people who know the process best, frontline workers and engineers, to create content. When those closest to the operations develop solutions, the results are more accurate, relevant, and effective. This drastically reduces development time because it eliminates communication gaps between IT and operations. With a no-code platform, these citizen developers can quickly build, test, and deploy apps that meet specific operational needs, accelerating time-to-value and promoting continuous innovation​

4. Human-Centric: Augmenting Human Capabilities

In a composable system, technology is designed to serve operators, rather than the other way around. In traditional monolithic systems, operators must conform to rigid workflows dictated by the system, limiting their ability to adapt and innovate. With composable solutions, however, operators are empowered by tools that assist them in performing tasks more efficiently, providing real-time insights, and reducing manual effort. This human-centric approach leverages the unique skills of workers, driving productivity increases by augmenting human decision-making and capabilities​

Therefore composability at its core is human-centric. It is built around augmenting human activity rather than replacing them, automating processes where it makes sense but still including them, ie "human in the loop". In a composable system, the technology is there to serve the operator, providing tools that digitize manual tasks, streamline workflows, and offer real-time data insights.

This focus on human-centric apps leads to more intuitive user experiences, reduced error rates, and improved operator efficiency. By connecting operators with their environment through digital tools, sensors, and IIoT devices, composable systems elevate the performance of the workforce, ensuring that technology acts as a productivity enabler.

5. Compliance: Built-In Validation

In the regulated industries, such as life sciences among others, compliance is a critical pillar and probably needs a deeper dive in a future blog post. Composable solutions, especially frontline operations platforms, must be designed with compliance in mind. They have to allow organizations to build and validate solutions iteratively while maintaining compliance. Digital data has to be captured and available to document all the required aspects such as: version control, audit trails, and automated validation processes.

With compliance built into the system from the ground up, organizations can ensure that their solutions are always aligned with regulatory requirements without stalling innovation. Continuous improvements and app iterations can be made seamlessly while keeping operations compliant​ with automatically captured digital data as evidence. 

Validation 4.0 is an essential component of composable solutions and is part of the Pharma 4.0 operational model. It applies a risk-based approach to testing, ensuring that apps are validated for their intended use without lengthy delays. This iterative process allows for continuous updates and improvements while maintaining compliance. Validation 4.0 integrates seamlessly into the digital transformation, supporting rapid deployment and constant change, enabling businesses to innovate faster without compromising regulatory standards. This agility is critical for modern operations to thrive in evolving environments​.

In Summary

Composable solutions represent a fundamental shift in how manufacturing operations are structured and executed. By embracing the principles of Bottom-Up, Agility, Democratization, Human-Centricity, and Compliance, organizations can achieve faster time-to-value, greater productivity, and enhanced operational flexibility. The future of manufacturing lies in building systems that are as dynamic and adaptable as the challenges they address.

Composability as defined here and if applied correctly can give your manufacturing operations a massive jump on your digital transformation. Interestingly it can also serve to sift through the hype and ambiguity in the different so called "digital" technologies. By simply asking the technology vendors how the implement and satisfy the 5 pillars you can effectively qualify any technology as being in or our of the new paradigm. Remember clear objectives and strategy are still the most crucial part of your digital strategy. These objectives have to clearly define how productivity is increased in your operation and clarity around the composability drivers is an excellent strategy.

Hour by Hour Boards in the Digital World

What does an Hour by Hour board look like in a digital world? This Lean visual management tool that is a common and useful method to drive performance in manufacturing. But what do they look like in the digital paradigm? I find that the go-to is to just digitize them, meaning replicate the whiteboard without much thought about what they can be and how we can impact outcomes, ie drive performance increase. 

If we are to really gain order of magnitude productivity increases when introducing digital technology we have to go past that "just digitize the board" mentality. Let's start by considering why its hour by hour (or some standard period). Its to provide a tangible target to aim performance at with a given frequency. Its also because the operators or person who is supposed to update the board does it at that frequency. 

However if we introduce digital tools then we also introduce means to capture the required data at higher frequencies and also varying frequencies. This can be done a simple screen to quickly quantities, to interactive capture of quantities through buttons, input devices and sensors and ultimately through advanced sensory devices such as vision.  With that in mind it becomes a bit trivial to just do it every hour! In addition we can also capture a lot of context about the data. From the obvious such as operators, stations, orders, etc. but also things like environmental data, events, materials used, stock levels, etc. 

Lets take an example of a digital solution that essentially is capturing good and bad quantities of parts produced with some context such as time stamp, operator, station, shift, product and optionally some comments. However unlike the manual boards the operators can enter data at any given frequency and much more frequent than hour by hour. The system can also prompt and even require that he enter data at a given frequency. This is of course, if we only we rely on manual entries, if we supplement with sensory devices we can get much more granular and frequent data.

Now that we have all this data we can of course display hour by hour board with total quantities. Great but let's think about what else we can derive from this data? First of all we can calculate throughput and output rates, for example:

• Throughputs: Good parts per hour, Good parts per shift, etc.
• Output: Total bad parts by day, total good parts by line

And then include simple predictions of performance, for example:

• Predicted good parts by end of shift, predicted total bad parts by line, etc.

But it doesn't end there! With this data you can also visualize trends of performance for example:

• Trend good parts by line by shift. 
• Daily performance trend 

We can also do comparison by a multitude of dimensions for example:

• Bad parts by vs good parts by operator, or by day 
• Good parts by product for different shifts or operators 

We can take actions on deviations and critical scenarios, for example:

• Send a text when Good parts per hour is below 10

With all this digital data there is just so much insight to gain from just a simple capture of quantities. We now have a continuous feed of information and the hour by hour transforms into a wealth of information and importantly insights. This information can be displayed in numerous, dare I say infinite, formats for use by the operator, supervisor, leadership and any function in the operation. 

And it doesn't end there. With enough volume of data we can start applying more advanced analytics (read AI/ML) and gain insights that we did not uncover. Then operationalize these insights by proactively doing something about the performance predictively and intelligently.

Remember we started by simply capturing good and bad quantities of parts produced in a digital form. This took us from just looking at quantities and performance against a target to the ability to look at performance trends, patterns historically, performance in the context of different dimensions. Then to insights based on human intelligence, taking proactive actions, then to predictive analytics with AI/ML ending with deep insights into our operation. This is where and how digital transformation offers order of magnitude productivity increases.  

Let me end with a favorite quote from Dr. Seuss:

"Think left and think right and think low and think high. Oh, the things you can think up if only you try!"

So do "think high", digital is much more than digitizing, re. the hour by hour board in this example. The "things that you can think" once you have digital data is where the value is.

Why Pharma is primed to capitalize on Digital

Digital and GxP compliance - a topic that is in high demand and interest these days. The general skepticism and misunderstanding of people in the quality functions of life sciences manufacturing companies is simply put; the biggest barrier currently in digital adoption. I spend so much time explaining and trying to convey the potential in digital technologies and why they are much more compliant than any paper based documentation method. The paper mindset is a shackle that all pharma and biotech companies have to cut off, now and fast otherwise the implications are dire! And, this is not news; regulators know it, executives know it, operations know it, even the quality leadership in most companies know it. That is why such concepts and guidances as Pharma 4.0, Control Strategy, CSA, Continuous Validation, etc. are being introduced and advocated.  

The industries dependency on paper as a mean of documented evidence for compliance is so engrained that it more than a solution it has become weaved into the culture. The selected attempts to introduce electronic solution for compliance such as eBR, LIMS, QMS, etc have been so painful, expensive and unwieldy that they have left us grasping and finding comfort in the paper based solutions. This has left the industry is in a constant dilemma where we know we need to step into the digital era (the unknown) but feel most comfortable staying in warmth of the paper world (known). While some opt for the compromise of traditional systems as an alternative (another known). 

Pharma and Biotech operations and processes are inherently dependent on data. Unlike other industries where the products are physical and you can see problems and defects, the processes can in most cases only be seen or observed through data. Yet we choose to observe by capturing this data mostly on paper and resist the adoption of digital means - why? Because of preconceived notions of compliance and painful experiences with other systems? This is mind boggling - its like someone with poor vision refusing to get a pair of glasses or contacts with obscure excuses that its "not allowed" (reference to regulatory guidance).

In other manufacturing industries operational excellence is the only way to stay profitable. In the life sciences industries the profit margins allow some leeway in productivity levels but of course have the additional burden of compliance. It means that the opportunity to gain significant productivity improvements are very high, e.g. in the CPG industry productivity increase of less than 1% are welcome. In life science not many will make an effort for such a again. With that in mind think about "the waste of documentation" in most processes - I would venture to say that there is more than 10% productivity increase potential by digitizing all paper records across most operations. 

With this I am making a plea to all my peers in the life sciences manufacturing industries. Adopt a "digital anything" mindset and start the transformation. If you see a piece of paper being used that is your opportunity to start digitizing. It does not have to be an intricate complicated "system" that needs IT and top down approvals. Start small and digitize a paper a day, one paper at a time and you will become digital faster than you have ever imagined. Yes there are regulatory implication but do no use that as an excuse, start the digitization process where the skepticism (or maybe fear) is greatest, e.g. the QA or documentation departments.

If one thing you should take aways from the changing paradigm is that transforming paper to digital is not only a must but also significantly easier than it was in the past. I have said this many times, there are no excuses not to start adopting digital technology, and that means the improvements can be incredibly rewarding.  Eliminate paper there are easier way to capture evidence in the digital world!

4 Questions As a Guide Towards True Digital Transformation

Most people that have heard me talk about digital transformation are probably sick of hearing me talk about the "order of magnitude" productivity gain that is promised by the ongoing digital industrial revolution. But here again it is a key principle that can be used to understand transformation and navigate through the existing maze of confusion of what is and is not digital technology. Simply put digital technology is a technology that can directly impact industrial or manufacturing operations to bring about an order of magnitude productivity increase. 

I have compiled 4 critical elements that can help you sort through the maze of different technologies that are touted as digital, Industry 4.0 or Smart Manufacturing technologies based on this principle. These 4 elements can be framed as question that guide evaluation and selection of technologies:

Is it adopted and implemented in a "Bottom Up" manner?

Adoption and implementation are performed in an agile method, starting small in an iterative manner and building on outcome of each iteration. Agile approaches are an inherent part of the digital transformation and advocate a way to learn faster by short and rapid test-fail-learn cycles. The overall manufacturing systems solution is built from the bottom up in an iterative manner. 

This is in stark contrast to the traditional system approaches, including MES, where top down hierarchical processes are used to provide a solution that fits within specific constraints that is hard to change. There should be no "gap assessments", the technology is adapted to the process in contrast to fitting the process to the solution. It also removes the difficulties associated with adhering to complicated standards and systems. It frees engineers to focus on building solutions rapidly that fit the process and increases the rate of implementation by an order of magnitude (here I go again...). There are some interesting implications to this approach one of which is that Industry 3.0 standards such as ISA-95 becomes less relevant in this context.

Does it inherently support and enable Continuous Improvement?

Lean principles are still the most effective way to achieve productivity increases in an industrial operation and therefore the technology should be a tool to implement these operational improvements. The adoption of the technology should be done in a methodical PDCA or DMAIC cycle with each improvement supporting the next. Changes and modifications to a solution are easy and support iterative and constant improvement. The technology solutions are targeted at improvement areas with clear and quantified goals.   

It should be no surprise that regardless of the paradigm shift that is going on Lean and the principles of TPS are still real and valid. There is a close connection between the continuous improvement process and agile (bottom up) development approach of using the technology/solution. Th technology should be a Lean tool that allows engineers to rapidly iterate thru solutions to problem building digital content to an effective solution. 

Does it offer a Democratized approach and how does it enable "Citizen Developers"?

Users and implementors of the technology do not need to have unique and specific skills that are common for software, IT or automation engineers. Engineers and SMEs can rapidly adopt the technology to develop solution for the operations. The technology is so easy to use and learn that it is effectively accessible to most people with a basic level of technical aptitude. This allows the people that are closest to the process to craft solutions that are focused on solving a problem or provide an improvement. The technology should be adopted by people from within the operation rather than implemented by external parties.

Democratization and the citizen developer is an important aspect of the digital transformation. With modern digital technology we all can become builders of digital content. We already do this when using office tools such as Word and Excel and now we can even easily program our IoT door to open automatically when we get within range so we don’t have to take our key out. This is a big change compared to the high level of skills and expertise needed to build even simple automation tasks in traditional systems. No-Code/Low-Code is a key enabler of Democratization, it allows people with no programming or IT skills to build content that automates manufacturing processes in a simple and intuitive way. 

I find that for bigger organizations citizen development may be alarming, i.e. they feel it is akin to "arming the rebels". However there is no way around it, the benefits far outweigh the risks in this case and democratization of technology is key element of the new digital age. At the same time most of the new platform technologies provide accessible and transparent control and management of content being created and consumed. 

Is the technology able to provide Human Centric solutions?

The use of the technology should result in solution that serve humans or specifically frontline operators. It has to be intuitive, simple, easy to understand and easy to use. It has to serve the frontline operator by making him more productive, the operator is the key to the productivity gains promised by digital technologies in I4.0  

Modern digital technologies and tools are built on the principle of supporting human activity, that is what makes them so effective and so widely adopted. People are the key to unlocking productivity gains from digital technologies, that therefore have to focus on supporting human activity. The premise is that in order to increase productivity technology needs to support the human operator. In the new digital age manufacturing needs to enable the connected worker whose tasks are monitored and supported by a larger network of digital tools. In addition the technology should be used to capture additional digital data streams such as instrumentation of the human activity, the data that human operators collect, input they can provide about the process, and more. 

In conclusion, if a technology is not able to impact your operations in this significant way then its not digital technology - simply drop it from the list. Let's take a simple example: SaaS MES that is purportedly in the cloud and requires experts with specific skills set to configure and use with a 6+ months implementation time frame. This is not and example of digital technology. You should be seeing quantifiable productivity increase results within weeks of adopting any technology.  Another example is if the technology implementation requires a waterfall/phased method that requires design of the substantial parts of the solution upfront then it is not a digital technology!  

You can watch me talk about these topics on the Manufacturing IT Podcast with Daniel Langley.

Maybe this will also nudge the skeptics out there since speed, effort and real world double and triple productivity gains are becoming real and undeniable. Charlie Chaplin once said "if you look down, you will not see the rainbow".

Are we seeing the return of the Custom MES, or is it something else? (Re-Posted)

The role of MES in the Industry 4.0 reality is a topic of debate and a source of critical misinformation. In general MES belongs to the era of automation and computer integrated manufacturing, i.e. Industry 3.0. MES or MoM came about in the 1990s to solve the challenges of coordinating and executing work on shop floors with the advent of computers. It really is a relic of the previous industrial era.

The challenge of coordinating and executing work on shop floors however has not changed. Manufacturing is increasing in complexity and the need to adapt to changing business requirements is accelerating. At the same time the advancement in computer technologies have ushered a new digital era that we now call Industry 4.0. How do we solve the shop floor operational challenge with these new technologies?

Are these new digital technologies making it attractive and maybe even necessary to develop custom manufacturing systems solutions, or custom MESs? For years we have advocated that companies focus on their core business competencies and leave the software development to expert best in class software companies. There are many horror stories of companies that are stuck supporting custom built software that is running their critical operations, why build and spend millions maintaining in house developed systems?

Yet the need to tailored solutions for shop floor operations is still valid and in fact even more critical as the rate of change to the business environment coupled with operational complexity increases. It seems like a case of history repeating itself since that is how MESs started in the 80s, however technologies have vastly evolved since. With the digital technologies that are now available we are going well past the simple ability to customize. We are taking a very different approach that is operations and human centric. It allows us to rapidly create tailored solutions that increase productivity by supporting frontline operators for each specific operation and activity.

This allows companies to once again opt to develop custom solutions to solve their manufacturing systems needs. Yet this time around they do not look like MES of the past, they are not custom solutions that are unique and require high cost and effort to manage and maintain. In the digital era solutions are built rapidly by the people that are closest to the operations, they are tailored to the frontline operator and help increase their productivity and all of this in a Cloud-Edge infrastructure that allows easy management and governance. There are a number of forces at play that are causing this to happen.

Emerging digital technologies, specifically no-code cloud based SaaS platforms provide user friendly ways to build tailored digital content with very quick ramp-up times. I.e. you don’t need software development skills. There is a real business need to get the promised productivity gains from these digital technologies. In other words organizations have allocated money and people to get things moving in their digital transformation.

The new generation of workforce comes from the digital age (i.e. digital natives) and are used to in simple words, just download an app for that. They are confronted with what they see as antiquated software systems that are not really user friendly and their reaction is to find another app. The new digital technologies aimed at the manufacturing operations space are in general human centered – they aim to solve (and support) what we as people do, whereas traditional MES is developed to automate a process.

Modern cloud and edge technologies provide a rich playing field for integration and capture of digital data to help bridge the digital divide. I.e. start capitalizing on productivity improvements while not having to decommission existing traditional systems.    

The transformational forces at play are unstoppable at this point. The high skill and expertise level required to implement and maintain the current IT/OT owned systems are becoming a thing of the past. The new tailored manufacturing solutions can be built at a unprecedented speeds by people that are closer to the actual manufacturing process. We will not have unique and specific monolithic systems for each department or business function. The future digital factory will be supported by a network of digital components, apps, edge devices and tools will have been composed in a iterative and agile process, ie bottom-up. Solutions will emerge and mature over time based on continuous improvement rather than a top-down design and development process. With that traditional hierarchical thinking and approaches such as ISA-95/88 will become less relevant unless they are adjusted to fit the new digital reality.

Are we then seeing a case of history repeating itself? Will we see a resurgence of home grown MES solutions that we will in a few years pay dearly to maintain or replace? The answer is yes but not what you might expect. There will be some level of custom software being built but at the same time what we will se are tailored solutions that do not carry the burden of the custom system of the past. Modern digital technologies such as no-code platforms are democratizing the manufacturing systems landscape. They are transforming manufacturing systems software development to a process of composing digital content for the shop floor. They are more of an engineering and operations toolset rather than an IT system. Again we might use the term MES but these new solution will really not look like anything that resembles current MESs, they will consist of digital content that support human operations and digitize all activities and process in the plant. They provide unprecedented levels of detail in the form digital data that is easy to use, analyze and interpret. They provide the foundation for digital maturity toward the predictive and adaptable states in Industry 4.0. Companies adopting these platforms will be able to accelerate their maturity and their digital transformation.

This is a reposting of an article in Engineers Outlook and is based on a previous post on this blog The return of custom built manufacturing software.