Maturity Assessment – The First Step Of The Pharma 4.0 Journey

By Davide Smaldone

Part 2

As more pharmaceutical and biopharmaceutical companies start their Pharma 4.0 journey, many are struggling to find an effective approach that could both suit the needs of the organization and bring value to the final users. There are several alternatives for shaping a Pharma 4.0 program, and choosing among them is usually a very complex exercise. There is no one-size-fits-all solution. In fact, the answer to the question, “Where can my company start a Pharma 4.0 initiative?” depends upon a company’s size, culture, system landscape, level of integration, propensity for risk, management attitude toward innovation, and much more.

When starting a Pharma 4.0 plan, the first step should be an assessment of the current status of the organization. This will help you understand the best course of action and help you monitor improvements as the program progresses. A few methodologies have been developed by universities, associations, and vendors that provide approaches on how to evaluate the digital maturity of a company. Most of them focus on system landscape, integration, and automation to determine the actual gap between industry 4.0 technologies and the company’s status quo, thereby indicating where attention should be focused. This approach provides a good starting point but doesn’t consider several elements that are as meaningful in a Pharma 4.0 journey as technology itself and that could significantly change the way in which 4.0 innovations are implemented and perceived.

NAKED TECHNOLOGY

In an article published in 2002 and based on 3,500 companies monitored over 20 years, Forrester’s CEO George Colony introduced the concept of “naked technology” that highlighted how adopting new technologies without corresponding organizational and process changes generated confusion and inefficiencies instead of improving a company’s ability to compete in the market.

This clearly demonstrates how organizations should assess and improve not only their digital and technological maturity but also their processes and supporting models. In doing so, they will promptly identify areas that need to change and subsequently evolve to support future business. In addition to this, when the Industry 4.0 paradigm is declined in the pharma and biopharma industry, there are several additional constraints that should be considered to effectively assess an organization’s readiness.

MAIN ELEMENTS OF A PHARMA 4.0 MATURITY ASSESSMENT

The following are the main elements that should be evaluated as part of a Pharma 4.0 readiness assessment:

1. STRATEGY AND DECISION MAKING: A well-designed maturity model should consider how a company strategizes for the future. Having clear strategic objectives with C-level sponsorship and commitment is a substantial advantage. Some of the nine Industry 4.0 technology elements (augmented reality, Internet of Things, cybersecurity, autonomous robots, Big Data, simulation, system integration, cloud computing, and 3D printing) will require a multi-year investment and will impact various areas of the organization. Being able to plan ahead and model the growth of the company from technological and business points of view is fundamental. Agility in the decision-making process is equally important, considering that the strategic plan will have to be adapted based on the actual outcomes of the new technologies as well the evolution of available technologies.
2. ORGANIZATION: The term “organization” is often identified with the formal structure adopted by a company for its governance. “Organization” is actually a much broader concept and encompasses all of the actions the company can take to obtain the resources it needs to compete in the market. The organization then drives elements such as the ability to react to external challenges, the propensity to change, and a value-added mentality. A flexible and reactive organization will be more suited to face the challenges posed by a Pharma 4.0 program, while more mechanistic companies could be slower to adapt and generally will pose a greater challenge for projects designed to deliver 4.0 innovation.
3. WORKFORCE: This is often an underestimated aspect, even though it’s one of the key success factors of any Pharma 4.0 program. The ability of a company to make “participated decisions” (i.e., involving employees at different levels in the corporate hierarchy), provide continuous training, and involve its employees in its core processes is key to determining the digital maturity of a company. Companies that have invested in an involved and committed workforce will have a substantial advantage when promoting innovation and change. Operators who feel empowered by new technologies will be able to make the most of the new tools, help the company fine tune the solutions that have been implemented, and help find new improvement opportunities.
4. INFORMATION TECHNOLOGY: Finally, the organization’s technological maturity needs must be evaluated. Elements such as system harmonization, integration, and compliance level should be tracked to understand whether there are any gaps that need filled before moving to a 4.0 implementation. Pay attention to data management in general and on master data management in particular. The more uniform and reliable the data, the easier it will be for the company to gather the information needed to enable 4.0 systems. This is especially true when looking at the current daily data generated by an organization that hasn’t carried out any 4.0 projects. That data already has value and can allow a company to gain significant advantage if it could be harvested and analyzed in a systematic way.

AVAILABLE MATURITY MODELS

As stated previously, there are multiple maturity models that can be used to assess an organization’s maturity level. Here are some of the most notable:

• The Digital Operation Self-Assessment Model: Developed by PWC, this classifies a company based on four maturity levels.
• The Connected-Enterprise Maturity Model: Developed by Rockwell Automation, this classifies companies based on technologies that support the management of information and operational flows.
• The ACATECH-Maturity Index: Developed by the German National Academy of Science and Engineering, this allows an evaluation based on four dimensions: resources, information systems, organization, and culture.

Most of the models are based on questionnaires divided into sections to which closed (usually graded from 1 through 5) or open answers must be provided. The assessment usually provides a final digital maturity score that is then detailed in sub-scores for each one of the analysis dimensions.

The models presented above are all general and mostly considered for highly automated industries. Thus, in some cases, these will have significant gaps if applied to a highly regulated industry such as pharma. For this reason, the ISPE Pharma 4.0 Special Interest Group has been working on the definition of a maturity model specific to the pharmaceutical and biopharmaceutical industry that is based on the framework defined by the ACATECH-Maturity Index.

PHASED APPROACH

A well-structured maturity assessment is instrumental when designing a Pharma 4.0 program and is an efficient and effective means for identifying the program’s main priorities. Depending on the assessment’s outcomes, it will be possible to determine even a multiwaved approach in which a first set of solutions is implemented as the basis for reaching the final program target. This allows the organization to manage change effectively and to progressively increase its maturity level. A phased approach could be useful for allowing a company the time necessary to adapt and develop (or acquire from outside) those capabilities needed to reach the next target maturity level.

DAVIDE SMALDONE is corporate demand manager at Italian pharma The Menarini Group.