Lean Writing
A COMPREHENSIVE GUIDE WITH TIPS & TRICKS TO IMPROVE YOUR WRITING SKILLS.
Astract
In the highly regulated pharmaceutical and biotech sector, the regulatory authorities spend time and resources reviewing numerous documents prepared by companies. These documents often describe highly complex information and huge amounts of data. It is therefore important to develop documents that clearly and concisely convey the intended key messages to facilitate the regulatory authorities’ review.
Borrowed from the manufacturing industry and slightly adapted, the lean principle is an excellent method for writing clear and concise documents. Taking a lean approach increases customer value by optimizing the process and eliminating or reducing waste.
This whitepaper explains how to apply ‘lean’ in writing; summarizes the benefits and challenges of lean writing; and provides an overview of the lean writing approach with some tips and tricks. Tools and strategies to help implement lean writing are also discussed.
Problem Statement
In the pharmaceutical and biotech industry, there is a lot of competition to bring new medicines to the market. When requesting marketing authorization, a substantial number of documents need to be reviewed by the regulatory authorities. In 2022, the European Medicines Agency (EMA) received 100 initial-evaluation marketing authorization applications and the United States Food and Drug Administration. (US FDA) received 134 original applications (New Drug Applications [NDAs] and Biologics License Applications [BLAs]). In this race to market, the authors deal with several challenges during the development of these documents (eg, short timelines, insufficient budget and resources, ineffective internal feedback). If not managed appropriately, these challenges can result in poor document quality.
To gain insight into the regulatory authority’s perspective on document quality and value of medical writing, the American Medical Writers Association started a working group. Several regulatory agency reviewers (eg, US FDA, Health Canada, EMA, Australian Therapeutic Goods Administration) were invited to participate in an anonymized online survey (open April to August 2021) with questions targeted towards their experience with document quality. The results showed that these regulatory reviewers regularly received poor quality documents. The most frequently encountered document quality issue was ‘excessive length/repetition/verbosity’. Issues such as data errors, incomplete content, broken links, and poor tables/graphs were ranked low, suggesting that the authors implemented processes to catch these issues.
Since ‘excessive length/repetition/verbosity’ is also an easily avoidable document quality issue, it is strange to still encounter it in documents submitted to the regulatory authorities. The only plausible explanation for this phenomenon is the lack of or insufficient experience in the development of those documents. Consequently, there is no efficient document development strategy and all data are just being ‘dumped’ without selecting the most important information or making an interpretation or argument. However, major improvements in document quality, more specifically in trimming down and focusing content, can be achieved with minimal effort during the document development process.
Background & Solution
The most evident and best way to overcome ‘excessive length/repetition/verbosity’ is to get rid of the excess. The elimination of non-value-added elements is an integral part of the ‘lean’ approach, which is in fact not a new concept. The history of lean goes all the way back to the Arsenal in Venice in the 1450s. It was Henry Ford who brought the lean concept into the manufacturing system in the 20th century. Several years later, Kiichiro Toyoda, Taiichi Ohno, and others at Toyota invented the Toyota Production System with the aim to eliminate waste and achieve the best possible efficiency.
James P. Womack and Daniel T. Jones described the 5 core principles of lean (based on their research and observations at Toyota) as follows: 1) identify value, 2) map the value stream, 3) create flow, 4) establish pull, and 5) seek perfection. In other words, work with the customer’s needs in mind and focus on elements that add value; eliminate all elements that do not add value (waste); optimize flow to reduce time required to create
value; deliver the value as the customer needs; and strive for perfection through continuous improvement. In short, lean is about ‘achieving more with less’.
Meanwhile, these lean principles, initially applied to manufacturing environments, have been adopted by businesses across many different industries all over the world. It should come as no surprise that lean has also found its way into writing. The ability to clearly communicate ideas through writing is in high demand in any industry. Well-written documents, emails, and (blog)posts can persuade customers to purchase a product or convince investors to partner with a company.
In the pharmaceutical and biotech world, a wealth of documents (such as abstracts, clinical study reports, and submission files) is produced to transfer information to various audiences. Some of these documents, especially those submitted to the regulatory authorities, have large file sizes as they contain vast amounts of data and overly complex information, which demands higher storage requirements. Lean may also solve this problem by reducing the file sizes of these documents.
What is ‘Lean’ in Writing?
Lean writing is a clear and concise writing style that eliminates all unnecessary elements (‘waste’) for the audience and keeps the message to the point. It may also be referred to as ‘lean authoring’. The goal of lean writing is to make the document or communication for the audience as efficient and effective as possible. Clarity and conciseness are always desirable in any written text. No one has time to read pages of documents or likes to search for the key messages in an abundance of information.
Note that lean writing is not a synonym for ‘thin’ writing. When using a lean writing style, the text should still be complete to serve its purpose and audience and at the same time be easy to read and comprehend. It should also not be confused with ‘easy language’, which is used for people who have difficulties with reading comprehension that may be caused by health conditions, not being fluent in the given language, or other reasons.
Writing clearly and concisely is not easy and takes both time and effort. It was Blaise Pascal (1623-1662), who said “Je n’ai fait cette lettre–ci plus longue que parce que je n’ai pas eu le loisir de la faire plus courte”. (The present letter is a very long one, simply because I had no leisure to make it shorter.) There subsequently have been many variants commenting on the inverse relationship between brevity and ease of writing (eg, Mark Twain).
Words and phrases need to be carefully selected to express the idea clearly and succinctly and to avoid ambiguities or misunderstandings. The word choice, sentence structure, and the length of sentences and paragraphs are of crucial importance to hold the reader’s attention and to effectively convey the message. For example, long sentences force readers to slow down and work harder to understand what they are reading.
In addition to writing clearly and succinctly, it is vital to summarize the overly complex information and large amounts of data in an easy-to-digest way. If everything is provided without making any selection of the key messages or any interpretations or arguments based on the data, the reader will be overwhelmed by the ‘infobesity’ of the document (ie, an information overload).
Summarizing helps to sort the important information from the details or irrelevant information so that the large quantity of information will be reduced to the most important main messages. Summaries leave out the details or irrelevant information that may distract the reader from the key messages. The effort of reducing the complexity and volume of data by extracting the most relevant and meaningful points is time well spent.
Another crucial aspect in lean writing is to design the document. Like every building needs a well-designed architecture with designated rooms that can be filled with furniture later, documents also need good architecture (ie, a document structure or hierarchy). Instead of rooms, documents are divided into sections that can be filled with specific information.
It is essential to put enough thought into this structure before and during the writing process. This thinking exercise on how to present the information and data will ensure that the most relevant and meaningful information is put in the right sections where it can be referred to when needed instead of having to repeat it in several places.
By using a table of contents – the counterpart of a floor plan for a building – or other navigational aids, the reader can easily find the information they need or are looking for. Headings and subheadings create a visual hierarchy on the page and organize content to guide the reader. These headings briefly describe the content that follows and help
readers find content quickly.
Benefits & Challenges
The benefits of lean writing, when applied strictly and systematically, are numerous. In the first place, it offers many advantages to the readers. Keeping the content short and focused will improve readability, enhance comprehension, and save time. Readers appreciate getting what they need quickly and easily and will remain engaged and attentive when content is well written and to the point.
Lean writing will also streamline the document development process. The speed or efficient flow of the process and constant improvement is the essence of the lean approach. When ‘waste’ is reduced to an achievable optimum, the resulting lean documents will take less time to write but also to review and to check during quality control. The lower risk for inconsistencies that often coincide with frequent use of repetition or duplication will also facilitate the quality control check.
Additionally, the shorter delivery time (for writing, reviewing, and checking) and the decreased number of resources needed will save time and costs. All these elements together will strengthen the overall quality of the document. Saving time and money in combination with better quality in turn will positively affect the customers’ satisfaction, which drives repeat business.
The loss of ‘weight’ or volume of the electronic document by eliminating the waste should not be neglected. In an era where everything is made available online, one should think about the consequences regarding data storage and archival. Storing huge amounts of data requires a lot of energy, which contributes negatively to the ecological footprint. Hence, lean writing is already a step in the right direction.
There may be some drawbacks related to the lean approach, but these can be easily overcome. For instance, it may take some time to convince all stakeholders of this beneficial new way of working. There may be some resistance to change from those who are used to traditional ways of writing or who have insufficient expertise for a successful transfer of lean knowledge and implementation.
As always, clear communication to explain the need for this new approach, supplemented with effective training sessions and streamlined processes are key factors to success.
Lean Writing Approach
What is the lean writing approach? In lean writing, the focus should be on your audience. Keep in mind that it is not only about what you write but also about how you write and how you present it (visual style and overall readability). Ensure that what you read is focused because you want to grab and hold your audience’s attention. Eliminate everything that is not necessary for your audience. The lean writing approach is summarized in the graph below.
It is important to understand that lean writing is a process. People should not be worried about writing it right (right away). The best approach is to write and then rewrite, and when done writing, to go back and cut down further. It can also be beneficial to engage a colleague in this process. A different set of eyes and a mind that is detached from the writing can provide valuable input and identify issues that you may have overlooked.
TIPS & TRICKS: FOCUS ON YOUR AUDIENCE
Is the text needed?
Who is your audience? What do they need?
- Consider carefully what to include.
- Write for the narrowest audience possible.*
- Provide an interpretation of the results/ compelling arguments (story not storage).
- Delete everything that is important to you (or anyone else) but not to your audience.
- Remove everything that is not relevant for your audience.
* For the selective regulatory professional: ask yourself ‘does the regulatory reviewer need
this piece of information?’.
Is the message clear?
What is your point or argument? How can you make it clear(er)?
- Write straightforward and precise. Use a data-driven not data-centered approach.
- Choose a main message. Mixed or unclear messages leave readers unsure.
- Concise is better. Use short paragraphs, sentences, and words.
- Use the best word for the situation.
- Use consistent terminology and consistent order throughout the document.
Is the presentation effective?
How can you make it easy to understand and find? How can you improve ‘scan-ability’?
- Use top-down writing: start with the most important information and then go into more detail.*
- Use bulleted lists, tables, and figures (instead of text, where possible).
- Use one idea per paragraph. (Limit number of sentences.)
- Highlight key phrases and words to draw the reader’s attention.
- Facilitate navigation: use links for more information, create meaningful and informative (sub)headings.
* The principle of the reverse pyramid.
TIPS & TRICKS: INVERTED PYRAMID WRITING STYLE
The inverted (or upside-down) pyramid is a writing model commonly used in journalism but can be applied to many kinds of writing. The inverted pyramid writing style presents the information in descending order of importance. The most critical or key information is provided first, followed by less important information (eg, supporting details to understand the main ideas) and nice-to-have information (eg, background).
In contrast to the usual writing style, it ensures that the reader knows the key facts and conclusion after having read the first paragraph. In case the reader wants to know more, it can be found in the details that follow in the next paragraphs or by clicking on a link.
This writing style improves comprehension and helps to structure the content more logically as it starts with the key facts and sets the stage for what follows (namely the smaller details). It also allows users to scan the text to find specific information or to skim the information to get a general overview.
TIPS & TRICKS: FIND & REMOVE ‘WASTE’
Is the text focused? How can you improve what you have written? What can be reworded, shortened, or even deleted?
Avoid repetitions
Take out repetitions such as duplicated words or phrases within sentences, and numbers in tables repeated in the text. Only repeat information when necessary. Place information at the most logical place in the document and then refer to it in other places. Use these cross-references only when needed, do not overdo them!
Example 1 shows how to handle repetition in parallel constructions. The word ‘improved’ is repeated twice and can be removed. Example 2 presents a common redundancy; ‘each’ and ‘every’ are synonyms.
Remove unnecessary words or phrases
Ensure that all words deserve to be in the sentence. Challenge every word – do you need it? Is there a shorter alternative for wordy phrases? Look for unnecessary intensifiers (eg, very, much, quite); vague (all-purpose) nouns (eg, area, field, degree); empty fillers (eg, as such); tautologies (eg, past history); …
In Example 1, the unnecessary intensifier ‘very’ and the vague noun ‘area’ have been removed. In Example 2, the phrase ‘due to the fact that’ has been replaced with the single word ‘because’.
Avoid weak adjectives
Weak adjectives do not stand on their own (because they are ‘gradable’) and are used with ‘modifiers’ such as very, extremely, and quite. Swap weak adjectives for strong, descriptive adjectives to shorten your sentences.
In both examples, the weak adjective is replaced with a stronger adjective.
Avoid hidden verbs
A hidden verb (or nominalization) is a verb converted into a noun. Turning verbs into nouns will make your writing more verbose. Hidden verbs often need an extra verb to make sense. Look for endings such as –tion, -sion, and -ment and put the action in the verb.
In both examples, the sentence is rephrased to replace the hidden verb with the direct form of the verb.
Avoid negative phrasing
Try to use positive language whenever possible. Negative phrasing requires extra words and is harder to understand. Do not use double negatives or exceptions to exceptions. Look for negatives and change them to affirmatives.
These examples show the advantages of speaking positively. In the second example, the sentence really says ‘I have issues’; the only correct way to talk about the lack of issues is to use only one of the negatives.
Avoid passive voice
Avoid the passive voice as these sentence structures tend to be wordier. Keep most of your sentences in active voice which makes your writing more direct and engaging. However, the passive voice can be useful in certain cases (eg, to remove the emphasis on the subject).
These examples demonstrate that the active voice helps to eliminate excess words.
Lean Writing Tools
There are a couple of simple tools used in lean manufacturing that – slightly adapted – can be of help to the lean writer, namely the A3 model and 5S tool.
A3 Model
The A3 is a problem-solving framework that can be used as a storytelling device. The different sections of this format offer a template that can be used to structure the
writing and tell the story in the most complete and effective way:
‘Background – Current Situation – Goal – Countermeasures – Implementation Plan – Follow up’.
5S Tool
The 5S is a workplace organization tool that can be adapted to writing when you consider the writer’s page to be the workplace:
- Sort – What information adds value for the reader and what does not?
- Set in order – In what order should this information appear in the text?
- Shine – How can I simplify the text?
- Standardize – Does the text meet the requirements?
- Sustain – Does the text flow? If yes, does a proofreader reach the same conclusion or are other adjustments necessary?
In addition, there are many software tools that help writers to communicate more clearly and effectively and improve the quality of their work (eg, the Writer’s Diet tool). Over the last few decades, artificial intelligence (AI) technology for writing has made incredible strides. The list of current AI writing tools & apps for content creation and editing is enormous. It is beyond the scope of this whitepaper to provide an overview of these numerous tools and apps.
Implement Lean Writing
To successfully implement lean writing in the document development process, it is crucial to get everyone on board right from the start. Here are some simple steps to effectively roll out a new process that implements a lean writing approach.
One of the most important steps is to explain the need for and the benefits of a lean writing approach as well as its impact on the organization or team. Clear communication of this context is essential for a smooth adoption of the new process. It may also be helpful to select a process champion who will provide support when rolling out the new process.
Another important step is to design training that effectively addresses the needs of the organization or team. As with most processes, everyone involved needs sufficient training to adjust. For instance, writers need to learn how to apply lean authoring in their documents and reviewers need to understand what it entails so they can provide useful comments.
An efficient way to transfer knowledge and ensure all stakeholders are aligned within an organization is to create a shared library of documentation (such as guidelines and document templates) as a reference point. The company style guide is an essential part of this reference material. In simple words, a style guide is a set of guidelines that writers must follow when they are writing their documents. The style guide facilitates writing and saves time by not having to think each time ‘do I write 2 or two?’.
Finally, acknowledge that there will be a learning curve and that mistakes will happen. Learning from these mistakes will help to streamline the process and will set the stage for continuous improvement.
Conclusion
To limit the burden on the regulatory authority reviewers, it is essential to describe the data clearly and concisely. Repetition and other unnecessary elements make the text lengthy, difficult to read and understand, and prone to errors and inconsistencies. Text that is longer than needed also dilutes the key message and can distract the reader.
The lean authoring approach is an excellent solution to solve the problem. The author should focus on what is really needed from the reader’s point of view, choose words
deliberately, construct sentences and paragraphs carefully, and present the data in the most effective way. Everything that is not needed should be eliminated: avoid repetitive
text, use cross-references rather than a repeat of information within or across documents, and try to cut down as much as possible.
Additionally, this approach in regulatory writing may reduce turnaround time, fasten market approval, and bring new drugs to the patients sooner.
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