The Key to Better Regulatory Writing: Tell Your Device’s Story

Abstract

Medical device development requires regulatory documentation, but what constitutes good writing in those documents has no well-established pedagogy. Senior regulatory experts often use the language of storytelling when asked what makes for good regulatory writing. Twelve such senior experts interviewed for this article responded with some version of, “It all depends on how you tell your device’s story.” But what does this claim really mean? Regulatory documents are long and technical; they are not usually considered in literary terms. This article explains how storytelling can help hone your regulatory writing. It uses the literary components of setting, plot, and character to show how selecting contextual details, tightening causal connections, and keeping the focus improve document quality. Furthermore, it employs real life examples taken from the FDA and notified body submissions to illustrate exactly where and how those details, connections, and focuses contribute to good storytelling. Key transitional phrases, syntactical constructions, and relevant contextual data make all the difference.