The Exchange, March 2009

the Exchange

Issue 16(1), March 2009

In this issue:

The rewards of writing for the medical device industry

by Deborah Hemstreet (dvora@tech-challenged.com)

I will never forget how I officially entered the profession of technical writing. I had been working at a local university, and one of the students in the department where I worked (Biomedical Engineering) began a start-up company and was looking for a technical writer. To make a long story short, he asked me if I was interested. My own background was nursing, so when I learned about his product, needless to say, I was quite excited. It would be a new device that would enable three-dimensional imaging of the heart and its electrical current during a catheterization procedure. Under certain circumstances, treatment could be applied and then verified with this new device. To me it sounded like a miracle. I told him, “I’ve never done this kind of writing before. Here’s the deal, I’d love to do it, but please be honest with me. If you don’t like my work I’ll understand.”

I was hired and remained with the company long after he had sold it and moved on to new discoveries. Thus began my adventures in technical writing for the medical device industry.

Lesson one: Passion

If you want to write for the medical device industry, it helps to be passionate about what you are doing. When writing for your target audience, never forget who is going to ultimately benefit—not the end-user per se, but rather, the patient who benefits from the physician’s proper use of the device.

You do not need to have a medical background to write for medical devices, but it certainly helped me. As a nurse, I had specialized in critical care of heart patients; that knowledge contributed to my quickly grasping the concepts behind the device. Truth be told, I consider myself a highly non-technical person. I recall taking an aptitude test for technology and could not match a picture of a screw driver up with a screw. Suddenly I was documenting the software aspects of high-tech for physicians, the mechanical aspects for hospital technicians, and the installation and service manual for our own technicians. I loved it!

Lesson two: Regulatory authorities guard the passion

Some people view the regulatory authorities as a necessary evil. However, I can assure you, because of the passion many companies have regarding their devices, the regulations imposed by regulatory authorities are an important safeguard that prevents the release of new medical products before they are ready.

When documenting medical devices, the patient is paramount. This may not be apparent to technical writers trained to focus on the user of a product, but that is what the regulatory agencies are for. One of the primary considerations of agencies such as the U.S. Food and Drug Administration (FDA) and other regulatory authorities is the safety and effectiveness of new medical devices for patients.

Regulatory requirements have a direct impact on the documentation of medical devices. Research supporting the device, product development, service and support, the content of instructions for use (IFUs), and requirements for translation are all performed according to strict guidelines that are audited. If a company does not meet the regulatory requirements, they may have limitations placed on their ability to sell their products—and possibly even forbidden to sell them.

Good documentation is one of the keys to meeting regulatory requirements. Some of the things I learned early on included:

This means that you will want to have good connections with the regulatory people in your company. By establishing mutually respectful working relationships, they will begin to depend on you as much as you depend on them. You need the information that only they can provide, but they need a technical writer to help them get the information across in a clear manner that will not lead to difficulties later on.

Don’t ever forget that regulatory requirements affect the entire product, from concept to release. This is something that many employees find it hard to understand or accept.

Lesson three: The technical writer becomes a guardian

As I gained a deeper knowledge of our product and the requirements that affected its development, I found myself in the unusual position of learning of critical impact changes before other managers did. As the technical writer, I worked with software testing, software development, engineering, service and support, regulatory, quality, and product development.

The amount of information a technical writer needs in order to document a medical device can be huge. Because that information is presented from many different perspectives, you can find yourself in the unusual position of seeing how a piece of the puzzle affects the whole, long before others do.

For example, when a software developer implements a minor change in the software that impacts the GUI, you set out to document it. But to do that, the change must appear in the product's technical requirements document. You check, and find that the change does not appear in the requirements. You ask the software developer why they implemented the change. They explain that it was the only way they could make a separate and completely different requirement function properly. But there's a problem: The change affects an option that is specifically called out in the FDA Approval document as being handled by the device in a certain way.

This scenario actually happened to me. Because I was familiar with the aspects of the documentation that could not be changed without the approval of a regulatory person, I was able to take this issue to the regulatory manager. Needless to say, though he did not have a heart attack, the change had to go. The cost to the company would have been too great.

Technical writing for medical devices is closely scrutinized: every feature, every explanation, every claim, and every "how to" must be thought out carefully. This is writing where the “you cannot” takes precedence. For example:

If a regulatory or auditing agency requires a particular warning to be presented in a certain way in the documentation, you will have little say into the matter, even if the statement is poorly worded and ambiguous. The best you can hope for is that the Director of Regulatory Affairs will care enough to get involved and fight for you to get the text changed. A real-life example? I was ordered to place this warning in our manuals:

“All cooper signals input/output must be connected to the defibrillated approved connectors of approved medical equipment only.”

That text remained in the manuals for two or three years, until the Director of Regulatory Affairs took responsibility to change it. Here is the change, on his authority:

“All signal inputs/outputs must be connected to defibrillator-proof connectors of approved medical equipment only.”

I had known that the original text was wrong, but could not get anyone in the regulatory department to take the responsibility to change the text for nearly three years, all because an approval authority had said that the original text must appear in the warnings!

Lesson four: The lawyers get the last word

Perhaps one of the most difficult things for me to get used to was the input required from lawyers. Where I worked, all medical device documentation underwent strict approvals, both internally, on the product development side, and externally, by stakeholders including marketing, sales, regulatory, quality, and legal staff. Some companies may not require quite as much input, but legal approval is a given.

Lawyers will look at trademark usage, regulatory issues from a legal perspective, copyrights, and intellectual property. We are all familiar with those little “About” boxes that present all the sundry things we never wanted to know about a company’s patents and all of the copyright issues related to the product. Well, it’s the lawyers who provide that input! If you are fortunate (as I was), the lawyer will go through your manual with a fine-tooth comb, changing all of the punctuation, and making sure that a TM symbol appears with every occurrence of the product name in the table of contents, index, and screen captures. In documenting one product, I managed to get a special waiver for the screen captures. The lawyer was home sick…

Conclusion: It takes patience and perseverance

These are just a few thoughts from my experience while writing for the medical device industry. As you can see, writing for this industry requires a great deal of patience, the ability to communicate well with many different groups, the desire to learn, and the ability to yield to those above you—even when you are right. However, the rewards are great. You have the opportunity to document a device that improves the quality of life for many people. Perhaps the only people who will read your documentation will be the technical support group and the FDA, but without your documentation, the product cannot be released. Documentation in the medical device industry is not an option. Thus, you become a crucial contributor to a device that will literally change lives. Who could ask for more?

Deborah Hemstreet (dvora@tech-challenged.com) has been writing for more than 20 years, most recently for the medical device industry. Starting out as an licensed practical nurse, she found herself in technical writing, without even knowing it, when she was hired as an “English Typist” for an Israeli institute of higher learning. Once Deborah discovered that technical writing was a profession, she decided to learn more about it. In 2002 she received her MA with Distinction from Sheffield Hallam University for her thesis, Technical Communicators—Who are We? A Preliminary International Internet-Based Study of the Personality Characteristics of Technical Communicators. Deborah is now an independent contractor residing in Michigan, one of the states hardest hit by our current economic problems but seemingly ignored by global warming (recent highs being -2°F). In her free time she enjoys working on her Web site (http://www.tech-challenged.com), reading, playing the piano, cooking, and finding creative ways to stay warm.

Resources

FDA guidelines:

Quality assurance:

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Editorial: Selling the problem (or: 43.3% of the message)

by Geoff Hart (ghart@videotron.ca)

In his essay Godot for it (Harper's, July 2006), Stephen Brown joined the long series of writers purporting to teach business managers something from the works of a historical figure, in this case the author Samuel Beckett. Unlike many of the charlatans in this line of work (for example, anything related to "management according to Shakespeare"), Brown had some important points to make. But what stuck with me was a brief quotation from the end of the article. In writing about marketing, he had this to say:

"There's more to marketing than selling solutions: the problems for which we have solutions have to be sold as well."

The subtitle of this essay was inspired a few facts and figures published in the same issue in Harper's Index, the magazine's monthly collection of intriguing and infuriating and ironic statistics. Take, for instance, the fact that Hummer sales had increased three-fold over the past year, during a period when gas prices climbed more than 80%. Take, for instance, the fact that an estimated 90% of Americans believed that most Americans are too fat, but only 39% believed that they, personally, were too fat. (In short, 39/90 = 43.3%.)

What do these two statistics, pulled from the bewildering sea of data that tries to drown us each day, have in common? The common thread is that only part of the message is getting through. Sure, everyone's heard of greenhouse warming and everyone believes it's a bad thing, yet few of us believe that it's such a bad thing we should buy a Toyota Prius instead of a Hummer—even though the ongoing cost of that choice is 80% more painful than it was a year ago, and may be another 80% more painful next year. Sure, everyone (well... 90% of everyone) knows that being too fat is a bad thing, but only 4 in 10 believe that they themselves have a problem they should work on.

Why are these people so confident that the problem is someone else's, not theirs?

There are many possible explanations, but I believe that it comes back to Brown's insights into marketing. As scientific communicators, we've done a great job of selling solutions: Everyone knows about hybrid vehicles and public transit, and everyone knows that they're better for the environment. Similarly, everyone knows that eating more fruits and vegetables, eating less meat and highly processed food, and increasing their daily exercise time is good for them. For those who aren't prepared to go quite this far in adopting a solution, there are less drastic solutions: buying a car that is more fuel-efficient, but not so efficient that it's radical, or eating specially prepared "diet" foods. There's no shortage of solutions. What's in short supply seems to be a clear understanding of the problems.

The origins of rhetoric lie in the art of persuasion, and one powerful rhetorical technique relies on making an argument personally meaningful to the reader. This is clearly something we're familiar with as technical communicators, since we've all been repeatedly exposed to the concept that we need to think carefully about our audience's needs before we ever set finger to keyboard. That's something we're far less familiar with as scientific communicators, since our training—I'm tempted to say our conditioning—is that science is objective, and that facts speak for themselves. We have all been trained in some aspects of rhetoric, such as the need to muster facts in a certain way to bolster an argument, and in extreme cases, maybe even to descend to the level of using ad hominem attacks on discredited scientists or their science. What we're lacking is a clear sense of how to add what marketers know so well to our rhetorical toolkit: the knowledge that solutions alone are not enough, because it is only a keen awareness of problems that motivates someone to seek out a solution.

The vast majority of journal articles in the sciences begin with a clear statement of the problem the authors set out to solve, preceded by a lengthy discussion of the context in which that problem arises. Yet journal authors are writing for an audience that already understands that problem and is keenly interested in learning a solution. That's not the case in many other forms of scientific communication, and particularly not the case in those forms that target the general public. As the statistics on Hummer sales and obesity indicate, the general public may have grown tired of hearing about the problems because the problems are not personally meaningful to them—or perhaps are sufficiently scary that it's easier to pretend the problem doesn't exist. As a certain melancholy Dane once noted, it's not easy to "take arms against a sea of problems, and by opposing, end them".

How can we overcome these problems? There is no easy solution. It's human nature to wait until a problem becomes so apparent that we have no choice but to confront it. Were our species name (the sapiens part of Homo sapiens) truly justified, the word "proactive" would not be a necessary addition to our vocabulary; instead, we must be repeatedly told to think ahead and act before it becomes both necessary and too late. A partial solution lies in what we've learned as technical communicators: that we must focus on our audience. We must start our communications efforts with a clear understanding of their needs, and must build on that understanding by clearly explaining the problems in ways that are meaningful to that audience, without scaring them so much they become paralyzed and incapable of action. Rather than fear-mongering or distorting the truth to make it more palatable, we must present problems in a way that inspires our audience to take action. Then, using all the skills at our command, we must present reasonable and effective solutions in such a way that it seems easier to adopt the solutions than it is to ignore the problems.

A powerful example lies in the statistics being promoted by BP—formerly "British Petroleum", but now using this acronym to stand for "Beyond Petroleum". Many economists have argued that we cannot adopt energy conservation measures because the cost to the North American economy would be so excessive that it would throw the economy into recession. (As famous economist Fred Pryor wryly observes, "An economist is someone who sees something working in practice, and asks whether it would work in theory.") Yet BP claims they'll be saving US$650 million over 10 years while simultaneously reducing their emissions of greenhouse-effect gases. The North American automobile industry claims that it's not economically practical to improve the fuel efficiency of its fleet of vehicles, yet the same manufacturers produce cars with roughly double the fuel efficiency of the North American fleet for sale in the European market. Want proof? Have a look at the statistics on the following Web page: <www.vcacarfueldata.org.uk/search/fuelConSearch.asp>. In case you use the miles per gallon calculator instead of litres, note that the Canadian and European gallon is 4 L, not the ca. 3.8 L used for U.S. gallons. That alters the numbers upward by an additional 5% or so in favor of the European vehicles.

As I hope I've demonstrated in this essay, we scientific communicators need to think beyond our standard mantra of "the facts speak for themselves", and begin learning from other forms of communication so that we can add persuasion to our toolkit. In some cases, that means we must skillfully sell the problems: they must be clear without becoming scary, and the solutions must be both obvious and desirable.

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Book review: How to Write for a General Audience: A Guide for Academics Who Want to Share Their Knowledge with the World and Have Fun Doing It

[Kendall-Tackett, K.A. 2007. American Psychological Association, Washington, DC. ISBN 978-0- 9792125-3-6. 286 p., including index. $19.95 USD (softcover).]

Previously published in Technical Communication 55(3):290-291, August 2008.

by Nancy Berger (njb627@cfl.rr.com)

Reading Dr. Kendall-Tackett is not for the faint of heart. Before even making it out of the Introduction, she makes a “bold promise” to the reader: “Improving your writing will allow you to have fun, make money, and change the world” (p. 6). Still not sure you’re interested? Try this intriguing statement on for size: “A surprising number of authors compare writing to sex.” Kendall-Tackett then goes on to quote author Paul Dickson, who said that writing is “possibly the most fun you can have with your clothes on”. After accurately musing that she’d “be willing to bet that you don’t feel that way about journal articles” (p. 7), Kendall-Tackett spends the rest of the volume taking the reader by the hand, showing exactly how an academic writer can feel that way about professional articles they either have to—or want to—write.

Following the writing process of invention, first draft, revising, editing, and publication, the beginning chapters focus on nurturing the writer along with the idea. The chapter “Getting started: From idea to first draft” segues beautifully into the chapter “Finding time to write: Time management for writers”, before moving on to “Why we bore: The seven deadly sins of academic writers” and “The art of the story: How narrative nonfiction can add interest to your writing”. Revising and editing are addressed in three chapters.

At this point the book progresses from a mere feel-good, you-can-do-it, how-to instruction manual by offering “knowledge about how publications work” (p. 13). Emphasizing the importance of getting published in magazines and trade publications to build a portfolio that can be shown to book publishers, Kendall-Tackett provides the tools necessary to become what she terms a “crossover writer” (p. 15).

Covering the publication phase of the writing process in depth in her closing chapters, Kendall-Tackett writes about book proposals, contracts, and even book promotion with the use of a publicist, the media, seminars, and Web marketing. The ground covered regarding book promotion ranges from “Be careful with portable microphones” at conferences (p. 247) to “Increasing sales on Amazon.com” (p. 255). When she writes, “See you in print” (p. 15), she is serious!

Through the use of personal experiences and tricks of the trade, Kendall-Tackett has written a comprehensive book that addresses the romanticism of putting one’s own words into print, the realities of book promotion, and all of the steps necessary in between.

Nancy Berger (njb627@cfl.rr.com) has a BS in English language arts education and an MA in rhetoric and composition from the University of Central Florida. She teaches English at DeLand High School in DeLand, Florida, in addition to being both a certified College Board consultant and a National Writing Project teacher consultant.

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Book review: Microsoft Word for Medical and Technical Writers

[Aitken, P.G.; Okazaki, M.M. 2007. Piedmont Medical Writers, Chapel Hill, NC. ISBN 978- 1-60402-445-6. 158 p., including index. $39.95 USD (spiral-bound).]

Previously published in Technical Communication 55(2):217, May 2008.

by Ginny Hudak-David (hudakdav@uillinois.edu)

Authors Peter Aitken and Maxine Okazaki have, through the selection of their title, likely limited the audience for their gem of a reference book. In easy-to-understand language, they expose the many quirks and inconsistencies of Microsoft Word that you need to know and understand, whether or not you work with long documents or with medical text.

The book deals specifically with the popular Microsoft Word 2003, which is far more widely used than Word 2007. The authors are generous when they say that “the problems we speak of are not for the most part flaws or bugs in Word. Rather they are features of Word that have unintended or undesired consequences” (p. ix). The bug-versus-feature argument will likely never be resolved.

From templates and tables to styles, fields, and document sections, Aitken and Okazaki cover it all. If you have ever wondered about the impact of some of the settings in Word or the interrelationships between and among the myriad options in this popular software program, this is the book for you. Not only do the authors explain the settings, they offer recommendations about what you ought to do (or not do) to minimize problems. Take, for example, this text on linking to data being maintained in an external source (such as Excel), which is supposed to update automatically in your Word document: “Yes, it works sometimes, but we do not believe that the risk is worth it” (p. 133).

Recommendations, sprinkled throughout the nine chapters, are set off in boxes, easily distinguished from the tips that are also included in shaded paragraphs. A light touch makes the text easy to read and memorable. Take this sentence on working with fields and tables of contents:

"Repeat after us: fields do not update automatically, fields do not update automatically, fields do not update automatically. Perhaps they should, at least in some cases, but they don’t." (p. 56)

They then go on to tell you how to update fields, and they repeat an admonition from an earlier chapter reminding you of what does not work.

The text is straightforward and clear, matched by the functional presentation of the information using a spiral binding, which makes the book easy to handle and convenient on your desk. The contents and index are both well done and will quickly get you to the information you need.

If you go beyond the most basic features of Word, this reference volume is a must-have.

Ginny Hudak-David (hudakdav@uillinois.edu) is the associate director in the Office for University Relations for the communications unit of the three-campus University of Illinois system.

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Fun on the Web

We can build anything...

But should we? For example, most of us will really have little use for a wormhole generator, other than to impress our more impressionable friends. But most of us have some spare computer equipment lying around the attic or office that could be recycled. For these and other "yes, we can!" ideas, visit the Instructables site. But be warned: some of these projects aren't necessarily safe.

For a bewildering array of more practical tips, check out LifeHacker. Guaranteed to repay the hours you waste browsing with dramatically increased productivity and efficiency. Well... maybe.

Scientists can't dance?

You might be surprised. The American Association for the Advancement of Science wondered what might happen if they asked scientists to interpret their own research by tripping the light fantastic. You'll be amazed at the results. Visit the "Science in Motion" page to learn more.

Metric for imperialists

Never managed to master the metric system? That's okay: xkcd to the rescue, with the handy xkcd metric guide. Hint: Hold your mouse cursor over the daily cartoon. You'll see a popup balloon with a secret message, which is always worth a read.

The world in a minute

What would the entire history of the development of life on Earth—all 4.6 billion years—look like if you condensed it down into 60 seconds? Visit The Evolution of Life in 60 Seconds to find out.

Entertain your colleagues

Got any suggestions for the next issue? Send 'em along!

—Geoff (ghart@videotron.ca)

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Parting thoughts

"Myth: we have to save the earth. Frankly, the earth doesn't need to be saved. Nature doesn't give a hoot if human beings are here or not. The planet has survived cataclysmic and catastrophic changes for millions upon millions of years. Over that time, it is widely believed, 99 percent of all species have come and gone while the planet has remained. Saving the environment is really about saving our environment—making it safe for ourselves, our children, and the world as we know it. If more people saw the issue as one of saving themselves, we would probably see increased motivation and commitment to actually do so."—Robert M. Lilienfeld, management consultant and author, and William L. Rathje, archaeologist and author

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"We are generally the better persuaded by the reasons we discover ourselves than by those given to us by others."—Blaise Pascal

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"The important thing in science is not so much to obtain new facts as to discover new ways of thinking about them."—Sir William Bragg

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"Science matters, friends, although it pains me to say so. The attack on science is an attack on reason, and it cannot be ignored, or excused, or allowed to go uncontested.—Robert Wilson, Reason in the Sun

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"It is almost impossible to carry the torch of truth through a crowd without singeing somebody's beard."—George Christopher Lichtenberg, scientist and philosopher (1742-1799)

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"People who lean on logic and philosophy and rational exposition end by starving the best part of the mind."—William Butler Yeats, writer, Nobel laureate (1865-1939)

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"Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened."—Sir Winston Churchill

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"Intellectuals must be constantly clever and industrious. We know that we are peripheral to society's main thrust, and we must be constantly vigilant in seeking opportunities to piggyback on larger enterprises—to find something so big and so expensive that prevailing powers will grant us a bit of space and attention at the edges."—Stephen Jay Gould, The Immaculate Pigeon

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“Nothing is more frightening than ignorance in action.”—Goethe

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“First there is a time when we believe everything, then for a little while we believe with discrimination, then we believe nothing whatever, and then we believe everything again—and, moreover, give reasons why we believe.”—Georg Christoph Lichtenberg

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“In mathematics, you don’t understand things. You just get used to them.”—John von Neumann

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Contact and copyright information

The Exchange is published four times per year on behalf of the Scientific Communication special interest group of the Society for Technical Communication (www.stcsig.org/sc/).

Copyright for material published in the Exchange belongs to the author. For permission to reprint an article, please contact the author. We welcome comments and letters to the editor.

Submissions: To submit an article, please contact the editor. By submitting an article, you grant a license to this newsletter to publish the article in print and online. In your cover letter, please indicate whether the article has been published elsewhere, and confirm that you hold copyright to the text.

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Geoff Hart (ghart@videotron.ca)

Scientific Communication SIG Manager:

Kathie Gorski (kgorski@execpc.com)

SciCom SIG Webmasters:

Matt Hunt (matthew.hunt@acm.org) and Scott Hughes (RaySHughes@Eaton.com)

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STC's vision and mission

STC's vision: Technical communication is recognized as an essential part of every organization's competitive strategy.

STC's mission: STC advances the theory and practice of technical communication across all user abilities and media so that both businesses and customers benefit from safe, appropriate, and effective use of products, information, and services.

© 2009, Society for Technical Communication (901 North Stuart St., Suite 904, Arlington, Virginia 22203-1822 U.S.A., 703-522-4114, 703-522-2075 fax, www.stc.org.