Addressing Key Obstacles to Adopting Operational Excellence in Biopharma

The success of operational excellence (OE) in many industries over the past few decades provides a solid rationale for the biopharma industry to adopt the same principles to streamline processes and improve productivity. However, it is important to understand some of the history and uniqueness in biopharma which has inhibited the growth of OE, along with some measures to address these challenges.

Overall, there are at least a few factors hindering OE adoption, including:

  • Biopharma organizations are typically functionally focused, often hindering cross-functional process improvement. In these organizations, excellence is measured by content knowledge depth, not by how well work is performed across the organization.
  • Focus has typically been on the science and technology, not on effective and efficient business processes.
  • OE has traditionally been a successful tool in predictable, high volume and low mix environments. This is not the case with most drug companies that are characterized by long, complex and variable environments.
  • Focus has been on ensuring regulatory compliance, with little concern for process efficiency. Organizations frequently “hide” behind regulatory compliance as a reason for not improving key business processes, even in cases where compliance isn’t a concern.

First and foremost, recognizing and understanding these hindering factors goes a long way to be able to address them.  Beyond that, a few strategies that we’ve found helpful include:

  • Demonstrate some OE successes early by targeting some intra-functional improvements.  This gives people some confidence and comfort in OE and its application.  Then begin the use of OE principles and tools to address some cross-functional process issues, which is typically more challenging.
  • Focus, at least initially, on the OE methods/tools that apply most universally, such as value stream mapping and workplace organization – 5S.  Help the organization recognize that the tools/methods can and should be tailored to fit the biopharma environment.
  • Work with the organization to help it view itself not as a set of functional silos, but rather as a series of cross-functional processes which reflect the way work is actually performed.

These approaches have been helpful in improving the overall efficiency, revenue, customer satisfaction and reducing cost of these biopharma organizations.

I am very interested in your feedback; please feel free to share your experience or thoughts on these or other methods to address the challenges presented.

Vedant Lahoty

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