Lost in Translation: Why Speaking Both Technical and Business Languages is Critical to Digital Transformation Success

“Digital transformation is not about technology deployment. It’s about a new way of doing business that allows you to make jumps which were not possible before, like reducing launch time from 70 weeks to 7 weeks.” – Dr. Franziskus Kath

Dr. Franziskus Kath, former J&J executive and now independent consultant, brings over 26 years of healthcare industry experience spanning API manufacturing, pharmaceuticals, consumer health, and digital transformation. He most recently orchestrated J&J’s quality digital transformation strategy across all sectors.

Ahead of CDMO Live 2025, Franziskus explains why becoming “bilingual” in both business and technology languages is the key to successful digital transformation in pharmaceutical manufacturing and quality operations.

Breaking Down Functional Silos

Digital transformation fails when limited to individual departments. According to Franziskus, the approach must be holistic and business-focused.

“Digital transformation is specific because it’s not limited to one function. You start from business objectives – what do you want to accomplish? – but then you must integrate with other functions,” Franziskus explains. “Limited transformation to just one function isn’t wise because you all fall back on the same data, product data, supplier data.”

He advises companies to adopt a “digital core model” that brings together all key functions: “The typical functions you have at the table are supply chain, planning, R&D, sourcing, quality, operations, customer service. All of these need to come together because at a certain moment, customer service may need information from R&D or quality or procurement.”

This integration extends to data management: “If one function starts cleansing the data just for their own function, it cannot be reused with another group. For example, procurement and quality may have different information about suppliers – supplier location, supplier names, address, all these kinds of things. Everyone needs to fall back on the same data because otherwise you get very awkward outcomes.”

Developing ‘Bilingual’ Talent

Finding and nurturing professionals who understand both business and technology is crucial for digital transformation success.

“From a talent perspective, three categories are important. Of course, a good basis of technical skills for the area – that’s a no-brainer. But the two most important aspects of the change team are first, good business acumen, which clearly looks beyond your function. And then the other attribute is the hunger to change the status quo. You need to question the way we work,” says Franziskus.

He notes that this talent can be found on both sides: “You find IT people who step over into business functions because they want to do business but look at work differently. And QA people who step into data science roles because they’re passionate about technology but still think like a QA engineer.”

“That’s where you see the biggest progress,” Franziskus emphasizes. “People who made that switch looked at classical problems in a very different way, and that brought results to surface which were unthinkable before.”

Building a Digital Transformation Roadmap

Successful digital transformation requires a structured approach that balances business vision with technical foundation. Franziskus outlines critical steps for pharmaceutical organisations:

1. Define clear business outcomes: “Start from a business outcome, what do I want to accomplish in my business? What is the objective? Eventually, what do I want to take the business for?”
2. Design centrally, execute locally: “I strongly advise a model which is also known in the industry – the digital core, digital operating model. It’s important to have the design control at the centre, but then allow the deployment in the functions. Execution can be decentralised, but design needs to be central.”
3. Harmonise data governance: “You need to be very well organised around the data coming from the different systems. It needs to be the same – site names is a good example. How is a site called? You find in reality that the name of one of your sites can have six or seven different versions depending on whether you ask a QA person, procurement person, or supply chain person.”
4. Build the right technology foundation: “The backbone is the ERP where the business runs on, but then you have all the functional major applications – in manufacturing it’s the manufacturing execution system, in quality it’s the quality management system. These all need to be synced very well.”
5. Develop bilingual talent: “We had a large training programme, a self-service programme. Whoever had passion could join, get certificates, and it made them ready to run projects. We also had people joining our team to conduct a project for their department under the guidance of the central team.”
6. Measure success through business metrics: “I would not say that you should put out KPIs which are specifically to your progress in digital transformation. It should be business targets, and digital should deliver on the business targets.”

Creating Digital Integration with Manufacturing Partners

In an industry increasingly reliant on external manufacturing, digital integration must extend beyond company borders.

“If you look from the longer-term value for the patient who eventually gets your medicine, why should it be different?” Franziskus asks. “Supply chains today need to be integrated. In the past, you had total vertical integration, but now you outsource basically every piece. That creates interfaces and hurdles, handovers which introduce complexity.”

He believes CDMOs should prioritise integration with their customers through:

1. Standardising data exchange formats: Establish common data structures and taxonomies that both your organisation and manufacturing partners can use consistently.
2. Pursuing systems integration: “You can have LIMS to LIMS integration for the lab system of your vendor to your customer. You can integrate on the ERP platforms, like inventory management.”
3. Sharing technology roadmaps: Align your digital transformation strategy with key manufacturing partners to avoid incompatible investments.
4. Starting with critical processes: Begin integration with high-value processes like inventory management, quality investigations, or batch release.
5. Leveraging cloud solutions: “It’s easier if you go probably cloud-based and standardised data. The more you integrate, the more value you eventually will create for the patient.”

“I would strongly think that the biggest value for the customer in terms of time and speed and cost is if CDMOs also aim to push and integrate with their customers,” Franziskus emphasizes. “The more you are integrated, the more you can prevent supply disruptions.”

Implementing AI in Quality Operations

While pharmaceutical companies may lag behind other industries in digital adoption, Franziskus sees enormous potential for artificial intelligence to transform quality processes:

“Let’s take the example of an investigation. You have a deviation in manufacturing, so you have 30 or 60 days to investigate. Why does it take so long? Because people need to go back and review documents manually. With large language models and AI tools, you can analyse huge amounts of data in a very short time. What a normal person is doing today to collect information manually can be done in minutes.”

This acceleration brings significant business value: “Think from this perspective – if you find a mistake in operation with product on the market which may not be in good shape, think how many people you can prevent from getting harmed by reacting faster.”

As pharmaceutical companies continue their digital transformation journeys, Franziskus offers one final piece of advice: “Get out of your silo. Get bilingual, expose yourself, but keep the business in mind as the start. Ideally, you have a partnership where, if you work on a problem, you cannot tell who is the customer and who is the vendor. If you work this way, then you are fully integrated.”

Dr. Franziskus Kath will be speaking about digital transformation at CDMO Live in Rotterdam on May 7-8, 2025.