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Regulatory and Medical Writing, A Consultant’s Perspective - Part 2 – Audience

Audience, is by far the most important consideration in medical writing.  You must decide:

  • Who are your readers? – Are they professors, managers, engineers, scientists, clinicians, technicians, agency reviewers, patients, nurses – or are they a combination of several?

  • What does your audience know about the subject at hand and why are they reading the document in the first place? 

  • Is the document purposed to inform or to convince? 

  • How will the audience read the document?  - Will it be straight through like a novel or in bits and pieces? 

  • Will the reader discuss their reaction to the document with other readers?

Typing on keyboard

Consider this example from the world of regulatory writing.  Perhaps we are documenting the evidence available to allow marketing of an implantable electronic device that delivers insulin to the body.  We must describe the design of the device and its ultimate effectiveness in the intended use.  One audience may be electrical engineers who are very familiar with the electronics of the design yet have little or no understanding of diabetes.  Another audience could be medical doctors intimately aware of the disease and its clinical implications yet have no understanding of the electronics involved in the design of the device.  Given these different backgrounds we will need to define different terms and provide different background information to satisfy both audiences yet provide each, individually, with the tools and information they require to assess the product for market.

Not only are these audiences different in what they know about the subject but they also may have different purposes for reading about it.  The engineers are interested in the design of the device, its tolerances and controls while the medical reviewers are interested in whether they can safely use the device to treat diabetic patients.  This second audience must also have confidence and acceptance that the device can be safely implanted and so will rely upon the engineer’s opinion and vice versa.  The written reports for each need to be informative and convincing at a level that will be appreciated by the specific audience.

We also need to consider how each audience will read the report.  They will clearly seek different background information and be interested in different aspects of the research.  Most likely, neither audience will read the report straight through and so it behooves us to attempt to organize the material into sections with clearly descriptive headings allowing them to quickly and easily find the details most specific to their needs. 

Regulatory and medical writers are often put in situations where they know little if anything about the topic they have at hand.  Their readers, however, are intensely and personally interested in the report produced yet also may have little understanding of its data or its development.  It is the job of the writer to translate information and to look ahead at the implications of the research they are translating.  Certainly, the issues to be addressed are both personal and political as the greater topic of health and medicine has far reaching implications to the public in general.  This too adds a level of difficulty for the writer to mitigate an overall sense of urgency and importance with the unbiased and balanced nature of science itself.  Benefit versus Risk – that is the goal.


Let Regxia's team guide your Health Canada and FDA interactions. Learn more about our scientific and strategic consulting services here.

Betty Cory

Author: Betty Cory, President

Regxia Inc.


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