PDA Letter Article

Digital Transformation without the Transformation

by David Hubmayr, Takeda Pharmaceuticals

In March 2020, the COVID-19 pandemic forced us to rapidly change our familiar working models. “Digital Transformation” became the omnipresent buzzword and PowerPoint presentation on this topic followed PowerPoint presentation. The plans were huge, and they could not be implemented fast enough.

Many technical possibilities, which had often been delayed until then, suddenly had to be used to keep many areas of life and business running at all. We quickly converted many things to virtual and digital formats. In reflection, was all of this the postulated Digital Transformation?

The spectrum of what is understood by Digital Transformation is very broad. It ranges from switching the recording of measurements on paper to recording the measurements in a spreadsheet file up to nested neural networks.

So, what is Digital Transformation?

According to author Prof. Dr. Key Pousttchi,

The term Digital Transformation refers to significant changes in everyday life, business, and society through the use of digital technologies and techniques and their impact. Typically, the term is used in a narrower sense for the subset of corresponding changes to companies and industries, whereby a distinction can be made between the dimensions of service creation, service offering and customer interaction (1).

This definition uses two key terms: "digital" and "change,” and the term “Digital Transformation” also comprises two components (words): "digital" and "transformation.” To transform something means to change it; to change something means it is transformed.

The first component, digitization (execution of digital), is the translation of analog to digital. Digitization changes the shape or the mode in which something exists—the system to capture, record, evaluate and make something available. Giving a straightforward legacy example, the recording of a measurement value (during a process step) remains the recording of the measurement value (during aprocess step) but, in the course of digitization, the system of recording changes, from paper to a spreadsheet file.

The captured measurement values stay the same, independent of the system (paper or spreadsheet file) used to capture them; they do not automatically or magically become better or worse purely because they are captured in a spreadsheet file instead on paper. The standard deviation of an experiment or laboratory test does not automatically or magically become narrower or broader just because the statistical analysis is run with the help of specific software rather than on paper.

Digitization makes things easier and more efficient, but it does not change the underlying analog process. Digitizing a process that is inefficient does not make it operationally excellent—this is essential.

Is Digitization equal to Transformation?

If we look at Digital Transformation exclusively in terms of digitization, it has been largely successful. But what about the second part of Digital Transformation, the aspect of “transformation”?

As with any transformation or change, it must be wanted, initiated, implemented and followed up. The make-it-or-break-it criterion is an unblocked mindset that enables the willingness to change, to transform. In addition to the lack of availability of suitable digital solutions, the lack of an unblocked, adaptive mindset—what is called "thinking differently from the ground up"—surprisingly, still exists.

Ideally, change is initiated with foresight (proactive instead of reactive), avoiding as best possible sloppy implementations of immature solutions that do not fit the organization, solely to not fall back on the curve even more.

While the goal of digitization is to translate something, the claim of “Digital Transformation” goes beyond that. Pure digitization is a tool for a transformational process. Pure digitization assumes that what is being translated into digital is already considered "ideal" in its original state but is considered "impractical" in its current form of delivery and therefore needs to be digitized.

Storing large amounts of data (Big Data) in an office spreadsheet file is impractical. Wet-signing a document (by several people, especially if geographically dispersed) is impractical. During the pandemic, it was obviously impractical to meet in person; that is why we now use the cloud and electronic signatures and meet via video conferencing. All very practical.

Converting Analog to Digital

Before anything is converted from analog to digital, appropriate resources (human and time) must be made available to question what is to be converted and to think about it digitally, from the ground up.

In analog, a measurement value was recorded manually every 10 minutes because a shorter time interval was not feasible for the human operator. In digital, a datapoint (value) can be recorded every second or shorter. The new technical possibilities automatically raise follow-up questions, like:

  • How to deal with the newly acquired volume of data—where and how to record, process, secure, evaluate and make it available?

And even more basically:

  • Does the recording of this process parameter still make sense? Or should another parameter be recorded instead or additionally?

The new technical, digital possibilities—in combination with answers to these follow-up questions—open unique opportunities to question the status quo and implement the underlying (analog) system, not just digitized, but rethought from the ground up. This can unleash unrecognized potential and realize pent-up opportunities.

Through the essential process of questioning, a digital transformation emerges, based on digital technologies. We must honestly admit that the transformation part of the proclaimed Digital Transformation has taken place only inadequately. Overwhelmingly, Digital Transformation has been equated with digitization, and the transformation process has fallen by the wayside.

How successful has the Digital Transformation been so far, taking into account the "transformation" component? A lab protocol that looks the same on a monitor as it does on paper has been successfully digitized. When creating the lab protocol in digital form, one often moves away from the original on paper because, with the new technical possibilities, one can go new ways. However, this is not yet a successful Digital Transformation.

To deliver on the transformation part as well, it is necessary to determine what is the actual purpose of the object or system to be digitized. Recording the parameters of a process step aims to monitor the course of the process step as closely as possible to real time and, if necessary, to intervene in a timely manner to ensure the predefined quality of the process step is met. Far too seldom is the purpose of recording this process parameter questioned. Does the recording and evaluation of the recorded data contribute to the understanding of the process step? Or is the recording just a tick on a "compliance" checklist?

Ready-Made Solutions are a Misconception

The central misconception in Digital Transformation is the current standard practice of thinking that ready-made solutions can be bought.

An established example of this Digital Transformation misconception is the placement of a robot in a lab. With its arm motion controlled by an impedance controller, the robot takes a sample well plate from its tabletop work area and places it into a high-performance liquid chromatography autosampler. Celebrating the installation of this robot in the lab as Digital Transformation, in the framework of a lab-of-the-future Industry 5.0 initiative (yes, some folks are already at 5.0, acutely knotting their minds on how to define it), should be challenged.

Tools are bought and "agile working approaches" are rolled out. Questions about the user group, the user group's level of knowledge, the user group's goals, the requirements and needs in the transformation, what can be put on the user group and what it can be expected to do, are not negotiated in advance.

Speaking straightforwardly, Digital Transformation is primarily a negotiation process. Right now, we're not negotiating enough.

This matches the experience of anyone who has ever been involved in buzzword-heavy presentations involving artificial intelligence, machine learning, deep learning, blockchain, modeling and Industry 5.0. Each time, the message was and is that all of this is necessarily purposeful, urgent and forward-looking. Buzzwords and such phrases as "disruption," "innovation" and "big hairy goals" (which are allowed to be audacious) are revered, even if no one really understands what they mean. The result may be digital, but it is rarely a transformation. Significant amounts of energy and time are lost—along with the trust of many stakeholders.

A negotiation process is something different. A negotiation process is about understanding Digital Transformation in an open-ended way—not as a pure digitization of analog practices, but as a goal-blurred joint search process, gladly guided by a North Star.

What a digitally transformed solution will look like is not clear until it has been found. However, this is exactly the huge challenge we now face, because we have the tendency to control processes and find decisions through “offices,” plans, (steering) committees and boards. This is diametrically opposed to engaging in the discovery process of transformation.

Further, current procurement processes are designed to avoid exactly one thing: a blurred target. Anyone requesting a budget must explain, in advance, exactly on what it will be spent.

There is a sense that there has been a digitization push, which is precisely why we notice what is still not working. As the list of what needs to be done grows, stand-alone solution after stand-alone solution is seen to be rolled out, creating a rag rug. Significant efforts are made somehow to stitch solutions together afterwards.

This approach can lead to an actual situation where lab-instrument raw-data is picked up from the lab instrument by a lab-instrument-specific data agent, routed via processing levels into a dedicated lab-instrument cloud, further transferred into a corporate-wide electronic lab-notebook (ELN) cloud, picked up from the ELN cloud and put into an electronic platform that finally provides the collected lab-instrument data enriched with all metadata, offering it findable, accessible, interoperable and reusable to the end user. On its way from the lab instrument, the data has passed one data agent, multiple processing levels and two clouds to finally reach its final, third cloud.

Nevertheless, we are sticking to the unsuccessful approach of Digital Transformation according to plan, using the same strategies that, as yet, have not produced any solutions.

Let`s get some headspace and refocus on patients. The status quo is holding us back.


  1. Pousttchi, Key. “Digitale Transformation." In Enzyklopädie der Wirtschaftsinformatik – Online-Lexikon, 7th Edition, edited by W. Hugentobler, K. Schaufelbühl and M. Blattner, 819-826. Berlin: GITO Verlag, 2020.

About the Author

David HubmayrDavid Hubmayr holds responsibility for GMS/GQ Data, Digital and Technology at Takeda Pharmaceuticals and has over 10 years of experience in the biopharmaceutical industry. Stretching across functions from E2E quality assurance to R&D, he has a proven track record of conducting and managing global quality and digital innovation initiatives in green-field start-up and commercial-operations environments. Hubmayr is a member of the “CPV-of-the-Future” and chairs the “Synthetic Data Generation” working group for PDA. He recently spoke on “Synthetic Data Generation Utilising Artificial Intelligence—Proven Opportunities for Biopharma and Robotics” at the 2022 PDA Robotics and Automation Conference in Dublin, Ireland. Linkedin — David Hubmayr