By Dionne Crafford
Word economy contributes to streamlined documents. Yet the process of “lean” embodies so much more.
In 1913 Henry Ford created “flow production”, but the process allowed only limited variety. Toyota birthed the process of lean by revisiting Ford’s way of thinking. The process was distilled into five principles: identify value (customer perspective), map the value stream, create flow, establish pull (client needs “pull” services), and seek perfection (evaluate and adjust). Lean promotes the elimination of futility, cultivation of innovative improvement, and implementation of best practices.
Growing competition within the pharmaceutical industry translates into more studies and large regulatory submissions. Key messages get buried when data are presented (“storage” mentality) without accompanying compelling arguments (“story” mentality). Retaining only the essentials increases efficiency, utility, and practicality in writing, quality checking, managing, accessing, and archiving submissions. Key messaging (objective- and endpoint-orientated) improves readability, ease of interpretation, and overall reader experience (the “customer value” that “pulls” writing services). Adapting a lean authoring approach can reduce document length by 50% to 75%. However, should this be the only goal for “lean” medical writing?
Drees (2021) defined only getting rid of “storage” (reduction of data and words) as “thin” medical writing, and points out that in comparison “lean” medical writing (in addition to brevity) also focuses on “story” (key messaging using the most relevant content). Effectiveness is derived from goal orientation (reducing volume) and then doing the right thing (using fewer words). Efficiency is doing the right thing in an economical process-orientated fashion; key messaging must guide the reduction of information. Lean medical writing is effective and efficient. It is less about “stripping” and more about “honing”, about achieving more with less. The aim is to prepare fully developed documents that are complete and readable, with a “story” that makes the data-supported scientific rationale clear.
Lean writing was slow to be adopted by the pharmaceutical world. Historically, large volumes of information were often considered desirable, especially by companies and individuals used to authoring academic manuscripts and grant applications. Challenges to establishing a lean authoring approach on an organizational level pertain to implementation (templates, guidance, and training), communication (establishing a comprehensive platform across the organization to facilitate understanding), and alignment (management structure to ensure functional alignment with lean principles).
Factors that may hamper lean authoring on an individual level include the desire to write “elegant prose” (often not befitting technical scientific documents), time pressure (it is faster to spew “storage” than it is to craft “story”), “defensive writing” (avoiding messaging in fear of making a mistake), mental laziness (often compounded by fatigue), not having access to end-user feedback (to better grasp “client value”), and lack of adequate lean authoring skills, strategy, and insufficient training.
In the second and final post in this installment on lean medical writing, we will investigate specific concepts and strategies that we as medical writers can apply to make the lean process our own.
References:
Brown E, Jochman K. 2021. Calling all medical writers: Focus your writing with lean authoring. Regulatory matters section (section editor Jennifer Clemens). Medical Writing 30(1):70-71. https://journal.emwa.org/social-media/regulatory-matters/. Accessed 17 May 2023.
Bhardwaj P, Sinha S, Yadav RK. 2017. Medical and scientific writing: Time to go lean and mean. Perspectives in Clinical Research 8(3):113-117. https://pubmed.ncbi.nlm.nih.gov/28828305/. Accessed 17 May 2023.
Cuppan G. 2019. Some thoughts on lean writing. https://www.linkedin.com/pulse/some-thoughts-lean-writing-gregory-cuppan/. Accessed 17 May 2023.
Doris & Bertie. 2012. 36 tips for lean writing. https://www.dorisandbertie.com/goodcopybadcopy/2012/10/11/36-tips-for-lean-writing/. Accessed 17 May 2023.
Drees B. 2021. Lean medical writing: Story not storage. Trilogy Writing and Consulting. https://trilogywriting.com/document/lean-medical-writing-story-not-storage/. Accessed 17 May 2023.
Gurudiwan A. No date provided. Lean medical writing. https://coatbe.com/blog/lean-medical-writing/. Accessed 17 May 2023.
Harris D, James LC, Klapproth JF, Bass B, Winnier AR (on behalf of AMWA Value of Medical Writing Working Group). Optimizing the value of regulatory medical writers. AMWA Journal 36(4):138-144. https://cdn.ymaws.com/www.amwa.org/resource/resmgr/journal/spotlight/Optimize_Value_Regulatory_MW.pdf. Accessed 17 May 2023.
Lean Enterprise Institute. A brief history of lean. https://www.lean.org/explore-lean/a-brief-history-of-lean/. Accessed 17 May 2023.
Proharma. 2020. Lean principles: a life sciences overview. https://www.propharmagroup.com/thought-leadership/lean-principles-a-life-sciences-overview. Accessed 17 May 2023.