Welcome to the October 2024 chapter newsletter.

CHAPTER NEWS

• Volunteer needed for Programming Committee Chair

• West Metro Medical Writers Social Hour

• Book Club Selections for 2025

• Join our AMWA North Central LinkedIn Community

FEATURE ARTICLES

• Four ways to be your own boss (and maybe someone else’s) as a biomedical communicator

• Book Review

• Grammar Talk: Hidden Verbs

• Book Club Notes: When Breath Becomes Air

CHAPTER NEWS

Volunteer needed for Programming Committee Chair

The AMWA North Central chapter is looking for a new Programming Committee Chair. The Programming Committee Chair is responsible for organizing AMWA events throughout the year, including identifying topics of interest and recruiting speakers. This is an important role in AMWA and is valuable for both member engagement and education. 

Please submit your interest or nominations to bod@list.amwanorthcentral.org. 

West Metro Medical Writers Social Hour

Please join us for an informal get-together on October 19, 2024, at 3:00 pm. We will meet at Big Stone Mini Golf at 7110 County Rd 110, Minnetrista, MN, 55364. Although this event is in the west metro of the Twin Cities, everyone is welcome. Please email Michael Franklin (franklin.editing@gmail.com) if you’d like to attend.

Book Club Selections for 2025

The book club selections for 2025 are a mix of factual texts and fiction. The books offer an eclectic mix with something for everyone. The selections are:

• January 27, 2025: In Shock: My Journey from Death to Recovery and the Redemptive Power of Hope by Rana Awdish, MD. The author presents a first-person account of being a patient and a physician. She encounters the same problems many patients do when they face a serious illness and offers a roadmap for anyone dealing with it. She also presents physicians with a plan and rationale for improving the doctor-patient relationship.

• April 28, 2025: Lessons in Chemistry by Bonnie Garmus (fiction). The book was a best seller. The narrator navigates being a woman on an all-male research team and the affections of one member of the team. In the course of the story, she becomes the unlikely star of a TV cooking show. The book was made into a miniseries in 2023.

• September 22, 2025: Gut: An Owner’s Guide by Austin Chiang. The author is chief medical officer for Medtronic’s Endoscopy division, and the book is part of “The Body Literacy Library.” The book presents a practical introduction to a part of the body we seldom think about until something goes wrong. In addition to myth-busting, it provides advice for making your gut healthier.

We are always looking for titles for the book club, so feel free to send us selections you think are noteworthy. We try to include a rotating schedule of writing or editing, biomedical, and fiction books, but we don’t always adhere to that order and often juggle titles to accommodate those that make the news. In 2026, the North Central Chapter will celebrate our book club’s 20th year! Congratulations to our first organizer, Mary Knatterud, PhD, for her steady guidance and active participation. As always, we hope to see you at one of our meetings! 

FEATURES

Four ways to be your own boss (and maybe someone else's) as a biomedical communicator

by Naomi L. Ruff, PhD, ELS, and Joy Frestedt, PhD, RAC, CPI, FRAPS, FACRP 

Single-member freelance business

Being a solitary freelance is the simplest way to be your own boss. The beauty—and the drawback—of this setup is that you are truly working on your own. You are responsible for every aspect of the business, from paying the bills to ordering supplies, as well as obtaining and performing 100% of the work; however, you also have a tremendous amount of flexibility. You are accountable only to yourself and your clients; you can choose how much work you wish to take on, which jobs to accept or refuse, and which clients to keep or “fire.” You can even set your own work schedule on the fly, as long as you do good work and send the deliverables on time. 

However, there are limits to how much work one person can take on without sacrificing quality or a reasonably balanced life, which can limit total income. Furthermore, because the work is confidential, discussing projects with others is not possible, and no one is around to suggest alternate ways around problems.

Because you are working alone, meeting other qualified and competent freelances is crucial. A good network can provide general support and advice. Moreover, when you have to turn a project down, you can refer a client to another freelance. This keeps the client happy (they just want their project completed), gives a colleague paying work, and eventually may lead to referrals coming your way as well.

Freelance business with subcontractors

Taking on subcontractors may have benefits for both you and your clients. Although your business technically still has only a single member, by hiring others, you can take on additional jobs, including larger, more lucrative, or more fulfilling projects. The company may even be generating income when you aren’t working. Furthermore, subcontractors with skills and expertise complementary to your own enable your company to provide clients with a broader range of services, while still giving them a single contract and point of contact because you are coordinating the subcontractor group and managing the project details.

However, for the freelance business to make a profit, the subcontractor(s) must be paid less for the work than the client is billed, which may mean hiring people who are less experienced and who may require training or supervision to meet your standards. Although training and supervising others can be rewarding, as the boss you are responsible for the subcontractors’ work and will need, at a minimum, to review all the documents they produce. The freelance writer who brings in subcontractors must also deal with the administrative tasks of recruiting, contracting, payments, and accounting relating to the subcontracting, as well as managing and coordinating the work done by the subcontractors. Together, these tasks can increase rather than reduce your workload.

Brick-and-mortar business

One key way in which owning a brick-and-mortar business focused on medical and technical writing differs from freelance medical writing is that your balance of activity shifts to constantly “drumming up” business for your workers rather than doing the work yourself. Another is the need to complete business-related tasks like the following:

• Hiring lawyers who can handle human relations and other employer/employee issues

• Incorporating the business (create and issue the certificate of incorporation, articles of incorporation, bylaws, officers/shareholders meetings, stock certificates)

• Insuring the company, the building, and the people (e.g., against liability)

• Hiring and training employees to meet customer expectations

• Setting up payroll (to pay salaries, taxes, insurance, social security, etc.)

• Setting up the information technology (IT) infrastructure (servers and communications)

• Bidding projects for overlapping timelines to keep your workers fully engaged and paid

• Ensuring staff meet the timelines and stay on budget

• Creating a quality management system and appropriate standard operating procedures

• Nurturing the company culture

• Anticipating competition and change in the industry

Learning to do all these tasks in 5-minute increments is a great strategy for a business owner because things just keep popping up! As the business grows, the company gains a reputation, and staff will come and go and sometimes come back again. This is healthy, even though the continual training can be tiresome, especially when fully trained individuals leave to go to the competition or to bigger firms. Staying flexible has a high value because this ability to change and grow may mean the difference between failure and success.

Virtual business

Another medical and technical writing business model is the entirely virtual company. This comes with equal shares of benefit and risk. Staff may love the independence and trust bestowed on them to “work from home”; however, the company often loses a fair amount of business autonomy, collaboration, and innovation. When working only with “remote” independent consultants (whose income is reported on 1099-NEC tax forms) and no on-site W2 employees, decisions can be more time consuming, and the number of “formal” meetings typically increases since no one bumps into anyone at the water cooler any more. The time to set up these meetings also increases when remote consultants are difficult to reach in real time.

Although the virtual business will not have the building and materials needed in the company office, it may now need to ship laptops and office equipment out to virtual employees and may need to deal with tax complications in multiple states if working virtually across state lines.

Common requirements for all businesses

Some business tasks are the same regardless of the type of business model described here:

• Hiring appropriate lawyers for incorporation and business contracts

• Hiring an accountant and tax expert

• Setting up the business as a Limited Liability Company (LLC), Sole Proprietorship, Partnership, S Corporation, or C Corporation

• Getting an employer identification number (EIN) from the IRS

• Insuring the company, the building, and the people (e.g., against liability)

• Renting or buying office space (although many freelances work out of their homes), computers, light bulbs, printers, paper, and other supplies

• Managing the project lifecycle and keeping the business profitable

• Attempting to collect payments when your clients fail to pay their bills

• Sales and marketing to get work in the door

Some of these tasks apply more to one business model than the others. For example, most freelance writers do not choose to set up a C or an S Corporation. These choices impact the tax rules the company must follow. For example, a C corporation is owned by shareholders and has unlimited growth potential; however, “double” taxation applies. The C Corp is taxed at the 21% federal corporate tax rate, AND individual shareholders have to pay personal income tax on any dividends or profits they receive from the company. S Corporations and LLCs are not taxed at the federal level, and the revenue is allowed to “pass through” directly to the owners and shareholders while still offering some protection for personal property.

What are the benefits to having a business?

Of course, having a business is not for everyone. Many people like the security of getting a regular employee paycheck—with benefits!—and the support of working closely with colleagues and peers.

Even among business owners, preferences vary. Many individuals love working as solitary freelance writers; however, others love to create a business entity with a larger footprint in the community to provide a broader range of services and products than one document at a time. Having an excellent team and a close physical proximity to team members working on the same or similar projects can contribute to a different written work product than writing done in isolation or in pieces by disconnected individuals. To quote Aristotle: sometimes “the whole is more than the sum of its parts.” 

With either the brick-and-mortar business or the virtual business, having a large number of employees or consultants will allow the company to do a larger number of projects than a freelance writer even when working with subcontractors. This can be quite exciting, and staff can be instrumental in helping a great many companies succeed when they deliver high-quality written documents to meet customer needs. On the other hand, being a solitary freelance writer or a freelance writer with subcontractors may be exactly the career of choice for those who want the freedom and autonomy of a career in biomedical communications without the responsibility for a cadre of employees and the extra work that entails.

Book Review

By Kendra Hyland, PhD

Long-time AMWA chapter member Joy Frestedt, PhD, recently wrote a book titled “Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs): A Practical Guide for the European Union and Other Countries.” Published by Elsevier, the book offers practical guidance for clinical evaluation scientists and experts involved in reviewing CERs/PERs.

Dr. Frestedt is an experienced regulatory writer and president and CEO of Frestedt Incorporated, a contract research organization founded in 2008 and based in the Twin Cities. The company provides comprehensive solutions in clinical, regulatory, quality, and engineering system solutions, focusing on the entire product development life cycle for pharmaceuticals, biologics, medical devices, in vitro diagnostics, foods, ingredients, dietary supplements, and natural products. Dr. Frestedt has written and constructed hundreds of CERs and has educated thousands of learners on how to conduct clinical data evaluations.

The book begins with an introduction to clinical evaluation reports and provides an in-depth history of the regulations and guidance documents. CERs and PERs are clinical documents required for compliance of devices with the European Union’s (EU) medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), respectively. CERs/PERs are part of a group of regulatory, technical, and clinical documents required for approval and maintenance of the CE Mark (conformité européenne, which is French for European conformity) for sale of devices in the EU. CERs/PERs summarize the available clinical data for a particular device, determine the clinical benefit to risk ratio of the device, and demonstrate compliance to the clinical and performance regulatory requirements. Because there are many similarities between the regulatory requirements, the book describes these requirements and guidance for the clinical evaluation/performance evaluation (CE/PE) process in parallel, while also highlighting differences. 

In chapters 2-5, the book provides a detailed description of the five-step data analysis process of planning, identifying, appraising, analyzing, and reporting (i.e., writing). 

1. Plan: Establishing the framework for the clinical evaluation.

2. Identify: Gathering relevant clinical data.

3. Appraise: Assessing the quality and relevance of the data.

4. Analyze: Interpreting and synthesizing the data to form conclusions.

5. Report: Documenting the findings in a comprehensive report.

This five-step process is iterative and repeated on a regular cadence, depending on the device’s risk level (annually for high-risk devices and every 2-5 years for low-risk devices). 

In addition to the chapter with tips on writing CERs/PERs, chapter 6 is dedicated to the methods and requirements for establishing clinical benefit-risk ratios, a key component of both CERs and PERs. Another chapter discusses how to develop a summary of safety and clinical performance (SSCP) and summary of safety and performance (SSP) documents, which are required for compliance to MDR and IVDR regulations and summarize relevant clinical data from the CER/PER. These public-facing documents will be available to health care practitioners, device users, and patients through a European Commission or manufacturer website. In addition, yet another chapter covers the review process, including the roles of the quality, regulatory, clinical, engineering, post-market surveillance, and external medical reviewers. It also explains the role of the notified body and expert panels in the review and approval process, providing examples of notified body questions and manufacturer responses.

The final chapters of the book describe the integration of the CE/PE process with post market surveillance and global perspectives. One chapter emphasizes the integration of clinical evaluation, performance evaluation, post-market surveillance, and risk management systems. It highlights the importance of continued monitoring during the device life cycle, post-market surveillance complaint data reporting, and the specific need for post-market clinical studies in situations where insufficient clinical data are available to the clinical evaluator. The final two chapters cover clinical and performance evaluation regulations in countries outside of the EU and offer a forecast of future directions for CERs and PERs.

In summary, Dr. Frestedt’s book is a helpful resource and teaching tool for both new and experienced medical device regulatory writers. For the novice, the appendices of the book contain helpful checklists, example templates, and definitions of terms and abbreviations used throughout. The many case studies and examples throughout the book highlight the points made in each chapter and demonstrate best practices. Most chapters have review questions and answers at the end as the book to further enhance learning. For experienced CER/PER writers, the book may be used as a reference guide, especially when authoring more unusual types of CERs/PERs, such as when devices are in development or have reached the end of their life cycle. Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs): A Practical Guide for the European Union and Other Countries is a comprehensive and practical resource for clinical evaluation scientists and other experts involved in the clinical evaluation process.

Where you can purchase the book:

• Elsevier: https://shop.elsevier.com/books/planning-writing-and-reviewing-medical-device-clinical-and-performance-evaluation-reports-cers-pers/frestedt/978-0-443-22063-0 

• Amazon: https://www.amazon.com/Practical-Reviewing-Performance-Evaluation-Countries/dp/0443220638

• Thriftbooks.com: https://www.thriftbooks.com/w/a-practical-guide-to-planning-writing-and-reviewing-medical-device-clinical-evaluation-reports_joy-frestedt/38815321/#edition=66723149&idiq=56644668 

Grammar Talk: Hidden Verbs

With fall and trick-or-treating right around the corner, something masquerading as another thing feels like a fitting topic. Here, we’ll cover how to spot hidden verbs in your writing and avoid the consequences of relying too heavily on these imposters.   

Hidden verbs are verbs used as nouns in a sentence. This phenomenon, known as nominalization, can clutter sentences and cloud their meaning.1 Here’s an example: 

“While I worked on my analysis of the data, I took notes on new research possibilities.”

This sentence has two hidden verbs: “analysis” and “notes.” They are used as nouns in the sentence, with support from the verbs “worked” and “took.” Unveil the verbs, and the sentence transforms: 

“While analyzing the data, I noted new research possibilities.”

Putting the key verbs to work instead of hiding them shortens the word count, enlivens the sentence, and helps the meaning shine. Instead of reading like a list of tasks, the new sentence highlights how the writer found inspiration in their data.   

Hidden verbs are tricky to find, especially in your own writing. One giveaway is words ending in -ment, -tion, -sion, or -ance.2 These suffixes are commonly used to turn verbs into nouns, for example: 

• -ment: achieve (verb), achievement (noun)

• -tion: inform (verb), information (noun) 

• -sion: decide (verb), decision (noun)

• -ance: attend (verb), attendance (noun) 

While reviewing your work, consider searching for these suffixes to spot nominalizations. Two other nominalization red flags include unnecessary supporting verbs (e.g., provide, achieve, give, have, or make) and “the” and “of” noun phrases.2 The following examples show sentences before and after removing the nominalizations: 

Before: “This figure provides an illustration of how participants’ blood pressure levels changed over time.”  

After: “This figure illustrates how participants’ blood pressure levels changed over time.” 

Before: “The reduction of anxiety has physical implications.”     

After: “Reducing anxiety has physical implications.” 

While researching this topic, I found many articles arguing that nominalization is important because it makes medical writing more formal. The underlying assumption is that formal means authoritative. My counterargument is that medical writing should derive its authority (i.e., trustworthiness) from its substance, not style. 

Excessive nominalization forces readers to do mental gymnastics to find important medical information—something most readers will not enjoy or even attempt. In contrast, reworking nominalizations creates engaging, easily understandable writing that captures the reader’s interest. By using fewer nominalizations, we can make the reader’s job — understanding complicated scientific subjects — easier and even enjoyable. 

References

1. Arduengo M. Finding the action in your writing: Avoiding nominalisation. Medical Writing. 2017;26:12-13. Accessed August 28, 2024. https://journal.emwa.org/writing-better/finding-the-action-in-your-writing-avoiding-nominalisation/ 

2. Plainlanguage.gov. Avoid hidden verbs. Accessed August 28, 2024. https://www.plainlanguage.gov/guidelines/words/avoid-hidden-verbs/  

Book Club Notes: When Breath Becomes Air

By Paul W. Mamula, PhD

Our book club met for its first in-person meeting since the pandemic shutdown. Kendra Hyland, Paul Mamula, and Mary Knatterud enjoyed a beautiful breezy but sunny day at the Como Lake Pavilion on September 23, 2024, and discussed When Breath Becomes Air by Paul Kalanithi.

The Book

Paul Kalanithi, a young neurosurgeon, wrote the book as he was dying of metastatic stage IV non-small cell lung cancer. The book is a short one—only 227 pages—and is easily read in one sitting. It has a wonderful prologue by Abraham Verghese, a fellow physician, who briefly met the author when their paths crossed at Stanford University Medical School. The book has 2 main sections: the first recounts the author’s early life and career choices, and the second covers his medical training, cancer diagnosis, and treatment. Kalanithi was able to return to work for about a year while being treated for cancer but succumbed after his final therapy failed. His wife, Lucy Goddard Kalanithi, an internist, completed and edited the manuscript after his death. Her epilogue provides details about the author’s final days and offers an upbeat ending. 

Our Thoughts

We all liked the book, which is available in multiple forms. Kendra Hyland enjoyed the audiobook format, while the others read it as a physical book. Mary Knatterud said, “I was blown away by this achingly honest, achingly sad memoir—often weeping during the brief time it took to get through it.”  I would add that although the book is sad, it is also a hopeful take on life and family. Kalanithi relied heavily on his family during his last days and savored the time he spent with his newborn daughter. 

I was struck by the literary references liberally sprinkled throughout the book. The author earned a B.A. in English literature from Amherst College and an M.A. in English from Harvard University before deciding on a medical career. A humanities background for physicians is not unusual, though. I met 2 such physicians during my time in science—Fredrick Hecht, MD, a prominent medical geneticist, majored in French, and Harold Varmus, MD, professor of microbiology and immunology and former director of the NIH, earned his undergraduate degree in English literature. The humanities background provided Kalanithi with a sound philosophical framework for his medical career.

The literary tidbits and philosophical insights made the book a thoughtful read and helped ease some of the darkness of Kalanithi’s impending death. Knatterud said, “I was delighted, despite all the sadness of Kalanithi’s narrative, to learn this etymological tidbit: ‘The root of disaster means a star coming apart…‘ ’’ (page 90). She added, “I was moved by his profound and poignant take on the supposed truth of faith versus the supposed truth of science, as evidenced by this statement: ‘No system of thought can contain the fullness of human experience.’ ” (page 170).

Knatterud noted, “I was struck by the utterly disparate notions of personal priorities held by Kalanithi as a 10-year-old, then by him as a graduating medical student, and finally by him as baby Cady’s dying father, all epitomizing understandable evolutions in his thinking: page 21 describes him as a boy who rarely saw his cardiologist father (‘All I knew was, if that was the price of medicine, it was simply too high’); in contrast, page 68 details his adamant opposition to some of his medical school classmates’ ‘focus on ‘lifestyle’ specialties’ and their ‘egotism’ in wanting to delete from their graduation oath ‘language insisting that we place our patients’ interests above our own.’ Yet he is of course comforted by one of the main bittersweet gifts of his tragic disease: intense time with his daughter during the first eight months of her life.”

Kalanithi’s Cancer and Diagnosis

The diagnosis of lung cancer came as a shock to Kalanithi who diagnosed the disease himself, based on the symptoms that were unusual for a 30-something physician. Lung cancer (small cell [SCLC] and non-small cell [NSCLC]) is the leading cause of death from cancer in the United States, with 234,580 cases estimated for 2024.1  Smoking is the top risk factor but about 10% to 20% of patients with NSCLC have never smoked.2  They may have other risk factors, but none were apparent for Kalanithi. 

Also interesting was Kalanithi‘s interaction with his physician. When Kalanithi first suspected cancer, he lobbied for an MRI, but his physician decided on x-rays based on Kalanithi’s age, the low likelihood of cancer (nonsmoker), and the initial diagnostic test (x-rays). She thought symptoms might be related to longer hours in surgery and to stress. The initial x-rays showed nothing remarkable, but follow-up films a few months later revealed many lesions in his lungs. One might wonder if an MRI at an early stage might have bought him a little more life. On the other hand, as Jerome Groopman, MD, noted, “When you hear hoofbeats, think horses, not zebras.”3 So perhaps his physician’s initial choice of tests might not seem unusual.

In sum, we enjoyed the book and recommend it. 

What’s in Store for 2025

As is tradition for our September book club meetings, we selected the books for 2025. We will announce the list in a separate article in the newsletter and on our website. Our next book club will be on January 27, 2025, when we will discuss In Shock: My Journey from Death to Recovery and the Redemptive Power of Hope by Rana Awdish, MD. Currently, we have not decided whether to meet in person or via Zoom, but save the date and please join us, even if you have not read the book. Our discussions are always lively, and they also offer a chance to meet fellow AMWA members.

References

1. American Cancer Society: Cancer Facts and Figures 2024. American Cancer Society, 2024. Cancer Facts Figures 2024 - 2024-cancer-facts-and-figures-acs.pdf [Accessed June 24, 2024].

2. Samet JM, Avila-Tang E, Boffetta P, et al.: Lung cancer in never smokers: clinical epidemiology and environmental risk factors. Clin Cancer Res 15 (18): 5626-45, 2009. [PUBMED Abstract] [Accessed June 24, 2024].

3. Groopman J. How Doctors Think. Boston: Houghton Mifflin, 2007