Lean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without unnecessary detail. It promises efficiency, but the reality of implementing lean authoring within a cross-functional team often involves substantial negotiation. Lean authoring becomes not a black-or-white process but, rather, an exercise in grayscale methodology. This blog explores some of the challenges writers face when balancing team input and how staying anchored to the product label or Summary of Product Characteristics (SmPC) can help achieve a lean yet comprehensive final document.
Lean Authoring in Practice: A Balancing Act
One of the main hurdles in lean authoring is finding the right balance between providing enough detail and maintaining focus on essential messages. When the approach is taken too far, teams can realize they lack critical information needed for downstream documents, resulting in gaps that need to be filled later. Conversely, if lean authoring doesn’t go far enough, the final document can become too dense, and important messages might get lost.
This process can feel like constant negotiation, where writers must navigate the varying priorities of cross-functional team members. Regulatory leads, clinical experts, and other stakeholders often push for different levels of detail, leaving writers in the position of balancing those demands while striving to maintain clarity and purpose.
Preventing Over-Compromise
The back-and-forth of content negotiation can result in a final product that feels less cohesive than intended. As writers give and take to meet the needs of various teams, the document may lose its focus, making it harder for key messages to stand out. This is where lean authoring can face challenges, as the ultimate goal of clear, concise communication can be undermined by over-compromising on content.
To avoid this, it’s crucial for writers to not only be firm in advocating for a lean approach but also to understand the broader objectives of the document. Maintaining this focus helps ensure that the content remains lean and effective, even when adjustments are made.
Educating the Cross-Functional Team
One way to smooth the path of lean authoring is by investing time in educating the cross-functional team about its principles early in the process. A shared understanding of what good lean authoring looks like can help reduce friction when decisions about content arise. This education can take place before the writing begins, ensuring that all team members understand the importance of brevity and clarity. Ongoing education throughout the process can reinforce these principles and help guide negotiations when more detail is requested.
By helping team members understand the benefits of lean authoring—and what it aims to achieve—writers can build a stronger case for keeping the document streamlined, ensuring the content serves its purpose without unnecessary elaboration.
Anchoring the Message with the Product Label or SmPC
A key strategy for keeping lean authoring on track is to write with the product label or SmPC in mind. These documents serve as a roadmap for what the final submission or reports must convey. Aligning with the product label helps guide decisions on what content is truly necessary, reducing the chances of the document becoming overburdened with details that may not support the end goal.
This approach provides a helpful anchor during negotiations with cross-functional teams, allowing the writer to refocus discussions on what is most important for regulatory approval and patient safety.
Conclusion: Lean Authoring as a Collaborative Process
While lean authoring offers a path to clarity and efficiency, it also requires thoughtful navigation of cross-functional input. The process is not just about trimming words; it’s about striking a balance that ensures the document is both focused and comprehensive. Starting the process by educating the team on the principles of lean authoring and maintaining alignment with the product label or SmPC can help ensure the final document delivers the right messages effectively.
Lean authoring may be a challenging process, but the right strategies to applying it can reduce frustration and lead to stronger, focused regulatory submissions that communicate key messages clearly and efficiently.
