The manufacturing world is currently dominated by buzzwords such as “digital transformation,” “industrial internet of things” and “Industry 4.0.” Not to be left behind, pharmaceutical companies have begun using the same terminology — including the discussion of “Pharma 4.0.” At the same time, however, critical business processes in pharma remain heavily dominated by a document-centric paradigm. Even worse, most manufacturing records are still paper-based. This dichotomy raises the question: Is the pharma industry truly ready for digital transformation?
The “Pharma 4.0” hype is largely being driven by the software industry that has served pharmaceutical manufacturers for the past three to four decades. Yet these same vendors have failed to meet a fundamental challenge facing the industry since the late 1980s: moving to a paperless, data-driven manufacturing environment. In other words, pharma has not yet achieved “Pharma 3.0 “objectives.
The stock explanation for this delay is to point the finger at the stringent regulatory environment surrounding pharmaceuticals. But shouldn’t the software industry shoulder some of the blame? Vendors could be driving innovation-based strategies, helping to automate compliance and empower agile business processes across the product lifecycle. Instead, they have simply facilitated labor-intensive, document-centric approaches.
This model has not been without its benefits for software providers. Leveraging Big Pharma’s substantial financial resources and desire to meet industry compliance requirements — sometimes at any cost — software providers have generated significant licensing and services revenues.
Meanwhile, technology stagnation has negatively impacted pharma in multiple ways. As ongoing innovation drives new technologies to evolve, they tend to become less expensive, easier to use, and, ultimately, accessible to everyone. Pharma manufacturers have not experienced this phenomenon, particularly on the shop floor, where process automation is still applied haphazardly. Few companies have achieved the promise of end-to-end, recipe-driven automation. As for adoption of manufacturing execution systems (MES), the continued prevalence of paper-based manufacturing records speaks volumes.
In fact, the use of information systems in pharma has not changed significantly since the 1980s. The typical technology stack consists of enterprise resource planning (ERP), MES, a process control system (PCS), a laboratory information management system (LIMS) and a process historian. Other solutions include warehouse management, corrective and preventative action (CAPA) and document management. This may sound like a reasonably complete package in terms of functionality. However, the reality is that these technologies don’t come close to delivering the integrated, data-driven business environment envisaged in a digitally transformed world. This same stack has existed for three decades. Digital transformation requires radically new thinking for pharmaceutical manufacturers, and a 30-year-old technology stack is unlikely to be up to the task.
So how much should we fault technology providers themselves? Genuine innovation is user-driven. If software companies don’t receive insightful customer feedback, it is unfair to assign them all the blame. However, poor user input alone doesn’t explain the lack of innovation. The fact remains that software vendors are not providing solutions that are progressively more functional, easier to use and less expensive.
On the contrary, the costs associated with deploying the conventional stack described above are generally growing. Again, this has been chalked up to increasing regulatory demands. As for availability to everyone, large segments of the pharma supply chain are still not using MES or PCS. They are simply too expensive to buy, deploy and support in a multi-product manufacturing environment. Innovation over the past 30 years should have made these technologies universally accessible — then the industry would be ready for true digital transformation
