V38 N4 / 2023 

©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

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ABSTRACT
Medical device development requires regulatory documen-
tation, but what constitutes good writing in those docu-
ments 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 sto-
rytelling can help hone your regulatory writing. It uses the 
literary components of setting, plot, and character to show 
how selecting contextual details, tightening causal con-
nections, and keeping the focus improve document qual-
ity. 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 con-
tribute to good storytelling. Key transitional phrases, syn-
tactical constructions, and relevant contextual data make all 
the difference.

Successful medical device development involves truckloads 
of documentation, from design control records to clinical 
literature to post-market surveillance. Yet none of these 
documents are accompanied by as much handwringing 
as the device’s regulatory submissions. Years and years of 
work hang suspended by the thread of a single submission 
packet. Will the FDA approve it? Will it be CE marked?
 Curiously, little training is associated with the spe-
cific writing skills that such vital regulatory documentation 
demands. The early twentieth-century boom in engineer-
ing birthed an entire profession of technical writers. Medical 
writers can attend specialized graduate programs at a 
number of universities. Yet outside a smattering of individu-
alized courses or certificate programs, the regulatory field has 
no commensurate area of professionalized writing expertise, 
even though degrees in medical device regulation abound.
 Is document quality inconsequential to regulatory agen-
cies? In 2014, Medical Writing devoted 2 different issues to 

argue the contrary.1,2 More recently, survey results published 
by the AMWA Journal in 2021 demonstrate the value of good 
regulatory writing: 87% of the regulatory reviewers surveyed 
claimed that poor writing impedes their assessment.3

 This lack of a distinct professionally adjacent writing 
field may be due to the strict stipulations regulatory agen-
cies provide. Major medical device manufacturers have 
company templates for what to write. Technical under-
standing of the product and its relationship to the clinical 
field and current state of the art is likely more important 
than the quality of a submission’s prose. Yet the AMWA’s 
2021 survey demurs. Moreover, when you talk to longtime 
regulatory insiders who have worked for the FDA or notified 
bodies, they tend to stress the writing. In my experience, 
when you ask these experts what makes for successful regu-
latory submissions, they answer with some version of, “It all 
depends on how you tell your device’s story.”
 Regulatory experts frequently stress the importance of 
storytelling, which I soon realized as I collaborated with 
them. (A benefit of working at a clinical research organiza-
tion is the exposure you get—not only to multiple devices 
but high levels of expertise.) The first time I heard it was 
from a senior colleague who had worked at the FDA for 
decades. I was helping to draft part of a pre-submission 
letter to the FDA. “Remember,” I was counseled, “it’s all 
about the story we’re telling.” A few days later, it popped up 
from another ex-FDA employee in a similar circumstance. 
 Then, in the middle of a large meeting, I heard a consul-
tant who used to work with a notified body insist, “We must 
help our clients to tell their device’s story well—that is cru-
cial!” Medical device regulation is a highly technical field—
it demands familiarity with the precise terminologies used 
in medicine, engineering, and law. Why were these techni-
cally proficient industry insiders talking about stories?
 It struck me as strange. Story is, after all, a catchall type of 
term. It’s amorphous, applying as much to a novel as a paint-
ing, as much to an advertisement as a lie. Storytelling belongs 
in the dusty corners of coffee shops, not brightly lit biomed-
ical engineering labs. Yet it was near ubiquitous advice: tell 
your device’s story, they said, over and over again.

Scott Dill, PhD / NAMSA, Minneapolis, MN

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

TOPICAL FEATURE

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AMWAJournal.org     28The Key to Better Regulatory Writing: Tell Your Device’s Story

 Many universities offer courses in “medical humanities,” 
a field that harnesses the power of narrative to explore how 
humans experience medicine. Story is essential for how that 
field understands medical practice and can overlap with the 
concerns of technical communicators.4 Yet these regulatory 
experts didn’t mean anything close to the medical human-
ities. They meant story as an organizing principle, not an 
encounter with the humanities.
 I began interviewing 12 senior regulatory experts to 
understand what they meant by storytelling, asking them 
pointed questions to draw it out as exactly as possible. What 
follows in this article uses their terminology’s literary sen-
sibility, only amplified with particulars extrapolated from 
their generalities. Setting, plot, and character encompass 
the practices necessary for good medical device storytelling. 

ESTABLISH THE CONTEXT: SETTING
You’ll often hear novelists say they long to provide a dis-
tinct sense of place. Near the beginning of her essay “Place 
in Fiction,” Eudora Welty claims that a novel’s sense of place 
determines its quality.5 Beyond a lofty goal, however, she 
notes that fiction is structurally “all bound up in the local.” 
Place, or the setting of a story, is crucial to how it works. The 
setting gives a story its feel, its sense of completion. Setting 
makes a story believable.
 Good storytelling means providing the appropriate 
amount of context. This was usually the first thing a person 
said when I asked them how to tell a device’s story: “Provide 
enough context—but not too much!” Too many details over-
whelm; strive for the right ones. Although the reviewers who 
read regulatory submissions often have impressive tech-
nical backgrounds, they will likely know little about your 
device. They won’t know how your device was developed 
or how it fits into a specific medical field. Prejudices from 
previous experiences might incline them to make unhelp-
ful assumptions about your device. It’s your job to preempt 
such misunderstandings. Your ability to put the device in 
the appropriate setting makes your submission believable.
 A couple of practices can help make this happen. First, 
do not make the mistake of assuming executive summaries 
and conclusions are unimportant textual padding. Make 
use of these sections. If you’re using boilerplate language 
instead of crafting these key passages to convey the appro-
priate context, you’ve thrown away a vital chance to com-
municate with your reviewer.
 Second, pay attention to phrasing. Adding helpful con-
textual details to frame your claims and data will create the 
right setting. Below is a paragraph taken from a pre-sub-
mission letter to the FDA (altered, with data and references 
removed). It is meant to provide an example of how atten-
tion to phrasing establishes helpful context. The underlined 

phrases below provide background to situate the data in the 
device manufacturer’s deliberately selected setting. In brief, 
the goal was to clarify how an off-label procedure (in the US) 
was safe and had clinical data, although from elsewhere.

Other US surgeons are employing off-label pro-
cedures to address the need for a more unified 
approach to heavily calcified disease extending into 
the aorta. In a special issue for Endovascular Now, 
the New York-based vascular surgeon John Smith 
explains his preference for “advanced treatment of 
lengthy aortic disease with a covered endovascu-
lar reconstruction of the aortic bifurcation (CERAB) 
technique for complex aortic disease.” Dr Smith’s 
preference is rooted in data now familiar to vascular  
surgeons. Published studies comparing standard 
endovascular treatment, CERAB, and open sur-
gery found higher 30-day mortality rates, but better 
medium-term patency with open surgery compared 
to the endovascular techniques [hard data here.] 
Due to its recent development, long-term data is not 
yet available for CERAB techniques.

 Note how the writer contextualizes the opening sen-
tence with what came before—we can infer that the pre-
vious paragraph discussed the views of US surgeons. 
Beginning with “Other US surgeons” establishes the critical 
context for the paragraph: we’re still talking about the US 
and its surgeons. That’s what’s often called a “signal term.” 
The surgeon quoted in the second sentence is placed in a 
US city. Does the city in which this doctor practices matter? 
Not really. But US practices and the US population matter 
for the FDA, and we want to remind the readers that this 
comes from US-based surgeons’ opinions. This provides a 
meaningful context to interpret the safety and performance 
data that closes the paragraph.
 Finally, note the last underlined phrase. “Due to its 
recent development” puts the finishing touch on the setting. 
Setting is about place; yes, certainly. It’s also about time. 
We want to know when something took place. The timing 
matters, too. The data are put into a chronological history 
of medical developments. Taken together, these small addi-
tions create an interpretive framework for the reviewer.

KEEP THE THREAD: PLOT
The British novelist E. M. Forster once said, “‘The king died 
and then the queen died’ is a story. ‘The king died and then 
the queen died of grief’ is a plot.”6 Plot, in Forster’s famous 
formulation, provides the causal relationship between 
events in a story. The king’s death and the queen’s death 
are simple events. We can tell the story of when, where, 
and how they happened. But for that story to have a plot 

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AMWAJournal.org     29The Key to Better Regulatory Writing: Tell Your Device’s Story

we must answer why. The king’s death causes the queen’s 
death—she died “of grief.” See how the event now takes on a 
causal relationship? Something made her death happen: the 
queen died of grief. That’s what we want in a plot—we want 
clear causal connections.
 Regulatory documentation keeps its plot thread by 
drawing out causal connections. Almost everyone I inter-
viewed emphasized keeping a sense of connection at var-
ious levels: between claims and data, between arguments, 
and between sections. This even applies to long documents, 
such as the Clinical Evaluation Reports required as part of 
marketing submission to the European Union. 
 If explicit connections are missing and the reviewer 
struggles to follow your case, you’ve opened the door to 
doubt. An auditor or reviewer could give up in frustration 
and write you off as unprepared. Or they might begin to 
wonder—how does this relate to such and such? Soon they 
will start to wonder what you’re not saying. Are you over-
looking something or—worse—hiding something? A lack 
of clear causal connections can erode your authority and 
invite counterarguments that might never have arisen with 
tight transitions between points.
 One straightforward way to think of this is, don’t skip 
the rationales! Robust rationales are critical to communi-
cating the logic behind design changes to the concerned 
regulatory agency. The basic principle of providing robust 
rationales—explaining why something changed instead 
of simply glossing over how it changed—can be broadly 
applied to all the claims you make in your documentation. 
 Other strategies can help you keep your causal con-
nections clear. First, signal the beginning, middle, and end 
with signal terms such as first, second; after, before; etc. 
This provides a sense of order. Second, use transition words 
that make the causal relationship between sentences clear. 
Keep the plot going with words like another, yet, while, fur-
thermore, etc. Third, remind the reader of the overall arc of 
the document and how this particular point relates to the 
overall point. For example, the State of the Art section in a 
Clinical Evaluation Report, which often feels forced and out 
of place, should be linked back to the rest of the document. 
That section places your device in the context of relevant 
treatments. Do so!
 Fourth, we were all taught to use topic sentences, but 
how consciously do we do so when using a template for reg-
ulatory documents? Yet those topic sentences provide the 
logical connections between your main points. They pro-
vide roadmaps to what is coming and how that point con-
nects to what came before. Topic sentences keep the reader 
engaged—on the writer’s terms.
 Additionally, the logical connections in your prose 
should go even deeper than topic sentences and transition 

terms. The way each sentence links up with the following 
sentence is a simple way to keep your logical connections 
tight. Think in terms of the grammatical logic of subjects 
and predicates. Usually, the predicate presents the informa-
tion that needs to be communicated about the sentence’s 
subject. If you consider your sentences as proceeding from 
a familiar subject to a new predicate, your prose will keep its 
logical connections rooted in its grammar. 
 The example below is from a clinical literature review 
on a device used during high-risk percutaneous interven-
tions. This short paragraph explains how the indication 
of high risk has a unique history that matters for under-
standing how the device in question works. Although this 
paragraph does not reference the device, it connects each 
sentence to the following through the logic of its grammar. 
The paragraph opens with a historical claim and ends with 
a justification for the increased vulnerability of the relevant 
population. As you read through it, note how the subject in 
bold font links back to the underlined predicate preceding it. 

Percutaneous coronary interventions (PCIs) now 
carry less risk than they did nearly half a century 
ago, when the procedure was first introduced. All 
PCI patients who were considered “high risk” (HR) 
patients early in the procedure’s development. Back 
then, procedural success was <60% and a cardio-
thoracic surgeon was required to be in the operating 
room. Procedural success is now nearly 100% and 
the definition of HR-PCI has now focused on a  
specific subset population. Specifically, patients 
who are HR-PCI typically present with unprotected 
left main coronary artery, multivessel, and bifurca-
tion lesions, as well as those with chronic total occlu-
sions. Such conditions are indeed “high risk.”

 English usually begins sentences with the subject of the 
sentence and then introduces some new information about 
that subject in the predicate, the second part of the sentence, 
which is often a verb or verb phrase. Regulatory documents 
should be written in what is called Plain English (or some-
times, Global English), whether they’re for a notified body or 
the FDA. Plain English is simplified and strives to be nonidi-
omatic. Thinking about the basic subject-predicate structure 
of your sentences can help produce the clarity associated 
with this style. More to the point, it will help you keep the 
plot by tightening your writing’s causal connections.

MAINTAIN FOCUS: CHARACTER
Another way to tell your story well is to develop key charac-
ters. Who’s at the center of your story? How will you keep the 
reader’s focus on that main character? In the data dump of 
technical specifications and clinical findings, it can be easy 

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AMWAJournal.org     30The Key to Better Regulatory Writing: Tell Your Device’s Story

to lose focus. The true protagonist in every regulatory docu-
ment is the patient. Remember, each piece of data you pull 
into your writing represents an actual human being. Real 
people hide behind your statistics. The point behind devel-
oping new medical devices is, after all, to help people! The 
reviewers at regulatory agencies are there because they want 
to help people—both by keeping them safe and enabling 
new developments. Don’t become careless in your tone or 
terminology such that your writing loses that human focus.
 Other types of character inhabit regulatory documents. 
The device in question may be your focus, but related alter-
native treatments are key to how readers perceive its value. 
Take the following review of the current state of the art for 
stenting. Example #3 below is taken from the State of the 
Art section of a Clinical Evaluation Report on a guidewire 
device. Stenting, not any specific stent, is the character 
being developed here. As you read through it, note that we 
are told why stents are employed over other procedures and 
why new stents have developed over time. A meaningful 
pattern has been presented here: a pattern that creates the 
story of stenting. Note how the information is being inter-
preted for us so that we keep the focus on the stenting.
 Finally, notice how the underlined text explains the 
value of the nearby claim (in bold text). Sometimes the 
claim in bold text comes first, as in the first sentence, and 
sometimes it follows the explanation. But the sentences are 
built to focus on stenting while developing and enlarging 
what that entails.

Stenting: Today, two main types of bare-metal stents 
are available: self-expanding stents and balloon-ex-
pandable stents. Because of the technical limita-
tions of self-expanding stents, and their tendency 
to provoke greater neointimal hyperplasia,  
balloon-expandable stents are now used for nearly 
all coronary stent procedures. Covered stents are 
most frequently used to treat emergent coronary 
perforations. As restenosis is a significant problem 
with bare-metal stents, drug-eluting stents were 
designed with immunosuppressant or cytotoxic 
drugs to inhibit neointimal hyperplasia. The risk of 
very late events associated with the implantation 
of permanent metallic stents (eg, stent thrombo-
sis and restenosis, fracture) led to the develop-
ment of fully bioresorbable stents, more commonly 
known as bioresorbable scaffolds.

 This is only an example, one way of thinking about how 
to keep your focus. Nevertheless, it demonstrates the value 
of explaining your claims and how this simple rhetorical 
practice helps clarify the paragraph’s focus. Paying attention 
to sentence construction, as this writer has done, gives the 
reader a clear sense of how stenting has developed.

CONCLUSION
The goal of this article has been to distill insights gleaned 
from a group of experienced regulatory experts on why they 
value good storytelling so highly. Although they often used 
literary terminology, it was unclear what that meant for them 
in practice. However, if you establish the context or setting 
for the device, keep the causal connections clear, and main-
tain focus on key characters, you’ll be off to a good start.

Author declaration and disclosures: The author notes no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact: scottddill@gmail.com

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