It’s been over two decades since the Agile Manifesto shook up the software development landscape, ushering in a new era of adaptability and flexibility. Agile development, with its iterative progress and real-time stakeholder input, stands in stark contrast to the rigidity of the waterfall model. However, in regulated industries such as medical device manufacturing and pharma, where adherence to strict standards is paramount, embracing this flexibility presents its own set of challenges.

I recently had an opportunity to delve into these challenges during my presentation at the Critical Manufacturing MESI 4.0 Summit. Implementing agile development in regulated environments is quite challenging. Changes that may impact product quality or data integrity undergo rigorous validation processes and are subject to regulatory audits, adding layers of complexity to the already intricate development landscape.

Setting the Scope

At B. Braun, where I am responsible for the implementation of Critical Manufacturing’s MES software in our newest factory, my focus is on the core manufacturing functionality. Ensuring accurate data transfer, like providing recipes to machines, is crucial. Changes in critical recipe parameters requires formal risk assessment and formal review and approval. Our strategy is clear – limit the MES scope to essential functions to control and document the manufacturing process. This approach enables faster deployment of these essential functions by keeping extraneous features like data analytics or plant maintenance separate.

Extending Agility

Clarity in functional scope isn’t just about streamlining operations; it’s also a key to standardizing validation across B. Braun’s expansive global network. With 65,000 employees and 80 production facilities acquired over time, deploying a standard MES to every site based on a clearly defined functional scope of MES, ERP, and production equipment becomes a complex but necessary part of our digitalization strategy.

Beyond Functionality

According to my experience, agile methodologies, typically aimed at meeting customer needs, must expand their definition. Requirements should encompass financial and timing needs, particularly in software development for investment projects. Clear time frames, budgets, and strict accountability are vital components of success. To meet these requirements, customer and supplier must strive to build a common view on the solution that will be built, both from a technical perspective and with respect to the actual business process to be supported. This requires investment into knowledge on both sides, setting our approach apart from traditional MES implementations where customers specify their needs without delving into the software intricacies.

Sharing Responsibility

At B. Braun, we have adopted a shared responsibility approach, blending agile flexibility with traditional accountability. This method uses templates to standardize product and process development, striking a balance between agile adaptability and waterfall rigidity. Working closely with Critical Manufacturing, we have shifted to a partnership model for MES development. Our focus is on creating templates that reflect universal needs while accommodating site-specific requirements, fostering a deep understanding of both B. Braun’s processes and Critical Manufacturing’s MES capabilities.

Agility in a Regulated World

Implementing pure agile development in regulated industries is challenging due to the complexities of testing and validating evolving customer requirements. Our hybrid approach at B. Braun incorporates several key strategies:

  • Focusing the MES on essential production and compliance needs.
  • Broadening the customer needs definition to include financial and delivery constraints.
  • Partnering with Critical Manufacturing for enterprise-wide software automation.
  • Adopting a template-driven approach, co-developing templates as products.
  • Investing in understanding the capabilities of the Critical Manufacturing MES platform in order to obtain maximum value from out of the box functionality.

While it may not be purely agile, our collaborative, our template-driven approach aligns with many agile objectives: prioritizing individuals and interactions, prioritizing working software, emphasizing customer collaboration, and responding to change. Most importantly, it represents a team-driven step forward in our digitalization journey at B. Braun.