3 Challenges to Overcome When Implementing the Unified Namespace in the Life Sciences Sector

Significant benefits can be gained from implementing a Unified Namespace (UNS) architecture within the operational technology (OT) environment of life sciences sector manufacturing facilities.

A UNS architecture also facilitates new modernization opportunities while reducing future production process improvement costs. 

There are challenges to overcome, however, including challenges unique to the highly regulated production environments that exist in the life sciences sector. 

We'll explore three of the main challenges in this blog, outlining the reasons they exist and the steps that should be taken to overcome them. 

Overcoming the challenges is important as a UNS architecture will standardize the integration of equipment and systems in your facility. You will also optimize DataOps contextualisation through the implementation of a UNS architecture, in addition to creating a common approach to edge DataOps – a crucial step in production process optimization. Streamlining validation and ensuring scalability are other advantages that a UNS architecture will bring. 

Challenge 1: IT Alignment 

Both IT and OT environments in life sciences sector manufacturing organizations have communication and data integration challenges to overcome. Various systems need to be integrated using a common data exchange protocol, data needs to be standardized and contextualized, and solutions need to be optimized for network efficiency, scalability, and engineering complexity. 

The structure of communication and data integration solutions is often broadly similar in both IT and OT environments. There are, however, crucial differences. For example, the data exchange protocol MQTT is common in OT systems, equipment, and technologies, but less so in some IT systems (for example, ERP systems). 

In simple terms, communication and data integration solutions that work in IT environments are not ideal for OT environments. The reverse is true too, i.e., OT-optimized communication and data integration solutions may not suit fully IT-centric environments.  

This means IT and OT communication and data exchange solutions must be distinct and unique to that environment, but they can't be separate or siloed. Alignment between IT and OT is essential to ensure solutions co-exist and work together. 

Challenge 2: Company Culture 

The company culture challenge is common in the life sciences sector as the margins for error are slim. Deviations in product quality, for example, can result in considerable regulatory, commercial relationship, and corporate reputation challenges, in addition to enhancing risks to patient safety. Another example is the risk of unplanned downtime caused by the introduction of new technologies and changes to production processes. Even small disruptions in pharmaceutical or medical device supply and distribution chains can have significant consequences. 

One of the impacts of these small margins for error is the prevalence of company cultures that are averse to risk profile adjustments, alongside an extremely cautious approach to change. 

When planning the implementation of a UNS architecture, the concerns of leaders in the organization should be addressed with risks mitigated, contingencies planned, and project milestones organized to minimize disruption as close to zero as possible. All stakeholders should be involved in this process, including executives and both OT and IT leaders. 

Challenge 3: Complex IT System Data Integrations 

IT-centric systems commonly offer API integration as the option for communication and data exchange with other systems. This presents challenges when developing a UNS architecture where it is necessary to include these IT-level systems. 

There are workarounds that can be implemented individually for each system where these challenges arise, but that can increase the complexity of the architecture both in terms of its development and ongoing maintenance. 

The more scalable and effective solution is to utilize the API integration solution that is likely to already be in place within the IT environment of the organization. This API integration solution will probably be based on a hub-and-spoke model similar to UNS, creating a structure that can be viewed as two wheels on a single axle. The UNS architecture would feature on one of the wheels, the API integration solution on the other, with both co-existing and working together. 

Achieving a Successful UNS Implementation in the Life Sciences Sector 

The three UNS implementation challenges outlined in this article (IT alignment, company culture, and complex data integrations) are significant but can be overcome with proper planning and an understanding of the realities of manufacturing in life sciences sector organizations. 

By tailoring the Unified Namespace to these life sciences sector realities, you can achieve the benefits that are only possible when systems are integrated, and data is both usable and available. 

We have explained how to tailor a UNS architecture to the life sciences sector in our whitepaper: Unified Namespace: Optimized System Connectivity and Data Exchange in Your Smart Factory. Download the whitepaper today.