The Process Is Not the Job: A Technical Writer's Journey in a Regulated Industry - Improving Technical Writing in Regulated Industries
Insights from Gianni Angelini
A summary of the IUNTC Talk on June, 12, 2024, by Gianni Angelini
In this presentation, Gianni Angelini shared his personal experiences and insights gained as a technical writer in the medical device industry, focusing on the challenges and lessons learned. His journey illustrates significant professional growth and the evolution of technical writing practices within a highly regulated environment.
The presentation opened with a thought-provoking question: "What do we see?" This question sparked a discussion of Gianni's journey into the realm of medical device technical writing. Gianni entered this field in 2018, specializing in infusion pumps. These devices demand meticulous documentation due to their complexity and their critical role in healthcare settings.
Gianni Angelini is an Italian senior technical writer with 14 years of experience in various industries (machinery, software, fire systems, and lately medical devices).
He lives in Ireland, where he earned a master's degree in Technical Communication from University Limerick.
Gianni has published a beginner's guide on the knowledge and skills required by modern technical writing for the Italian audience. He is currently working on his second book on technical communication, for an international audience.
In the meantime, he is enjoying a 1-year career break.
June 2024 - written by Yvonne Cleary & Daniela Straub
Read full article
Challenges in Documentation
Initially, the manuals he encountered, and was required to update, lacked comprehensive instructions, especially concerning program changes within the pumps. A key challenge Gianni faced was insufficient detail in existing manuals regarding program switching. This gap hindered users' ability to operate the pumps effectively, prompting Gianni to rethink the documentation strategy.
Methodological Improvements
To address these issues, Gianni implemented a task-oriented approach. This involved enhancing the manuals with detailed instructions and reorganizing content for clarity and user-friendliness. His efforts not only improved current documentation but also, together with colleageus, he established a framework for future manuals.
Process vs. Job-Oriented Approach
Gianni recognized the prevalent cautious approach in regulated industries, which often leads to a mechanical, reactive mentality among technical writers. The risk of causing harm to users results in a very conservative approach to writing instructions, where technical writers tend to use the exact language of updates from SMEs, even if that language is unclear. They are more concerned with compliance than usability. Advocating for a user-oriented perspective, he emphasized the need for critical thinking and thoroughness in documentation practices.
Despite initial resistance, significant change occurred when a new system engineer introduced a requirements-based approach. This collaborative method enhanced accuracy and comprehensiveness in documentation, bridging the gap between engineers and technical writers.
Industry-Wide Trends
Gianni highlighted industry trends such as agile methodologies and a growing emphasis on critical thinking. These developments are reshaping technical writing practices in regulated environments, striving to balance regulatory compliance with innovation and usability.
Conclusion
Gianni's journey underscores the importance of technical writers engaging deeply with their roles, beyond mere procedural compliance. By adopting a job-oriented approach and prioritizing clarity and usability, technical writers can significantly enhance the quality of documentation, ultimately contributing to the safety and effectiveness of medical devices.