Is Medical Writing Really a Profession in Practice?

I’ve been reading a book by Donald Schön, The Reflective Practitioner: How Professionals Think in Action, that has got me thinking about the working definition of the term “profession” and whether this term is appropriately applied to the field of medical writing. I am not sure it is for the following reasons.

When considering medical writing as a profession then one must ask whether the knowledge base of medical writing has the requisite properties and whether it is regularly applied to everyday problems of practice. Many who work to define professions state that the systematic knowledge base of any profession is thought to have 4 essential properties:

1. Specialized
2. Firmly bounded
3. Scientific
4. Standardized

Some would suggest the above parameters make Medical Writing a good fit under the moniker of profession. However, I call into question how many medical writers really look closely at the disciplines of writing or knowledge management. Much output I see and many conversations I have with medical writers suggest many write to standards bounded by myths and personal preference and not driven by the evidence of science.
Edgar Schein suggests there are three well-defined components to professional knowledge:

1. Underlying discipline or basic science
2. Skills and attitudinal component
3. Applied science component (yields diagnostic problem-solving techniques to the actual delivery of the services)

I would find that Medical Writing fails to be a true profession as suggested by Schein’s criteria. I see the central gap being the failure to develop a general body of scientific knowledge bearing precisely on the problem of effective and efficient medical writing practices. I say this because of my McCulley/Cuppan work where I have many observations of how medical writing is considered and applied in the pharmaceutical and medical device industries.

For Schein, basic and applied sciences are convergent whereas practice is divergent. This suggests that the hallmark of the true practitioner is the ability to take the convergent knowledge base and convert it into skills and services that are tailored to the unique requirements of the client system—a process that demands divergent thinking skills. My observations suggest that many who operate under the aegis of medical writing are poorly placed to engage in effective, meaningful divergent thinking. The preferred thought pattern is at best the convergent model of “what did I/we do last time?” and at worst “just let me populate the tables and make sure this document is compliant with the template and ICH E3 guidance."

I think I am largely in the camp of those who would call Medical Writing something besides a profession. But I am certainly not with those who would suggest it is but an avocation. Frankly, such a description is quite derisive.

I find myself considering applicable to medical writing the Grady McGonagill position that those who rely on intuition and reflect on their work only episodically risk accumulating unintegrated clusters of habitual practice. They may develop to a level of competence but not beyond. I’d say this is a reasonable description that fits the largest cohort of those who work under the mantel of medical writing.

So what do you think—is Medical Writing truly a profession in practice?


Originally published on our Knowledge Management blog

The Expanded Roles of Professional Communicators in Other R&D-Intensive Organizations

In continuing our discussion on the role of professional communicators we will examine the changing roles of communicators in other research and development organizations to see what can be learned by those writing in the life science R&D arena.

In the aerospace proposal industry, for example, “best-in-class” billion dollar organizations rely heavily on seasoned writing professionals operating as communication specialists to direct the development of their high-stakes multi-million dollar proposal documentation.

New roles for communicators are also seen in the computer industry where document specialists work within cross-functional team structures. For example, document developers have increasingly assumed full and early membership on project development teams, so they contribute their expertise on an on-going basis as hardware, software, and networking products are developed (Kirsch 1989, Zimmerman 1989). Professional communicators play a role in making subject experts’ tacit knowledge into elements that are explicit, which then enables these knowledge elements to be codified into purpose-filled products like research reports and regulatory submission documents (Hughes 2002). This is in contrast to an older organization of work where the development science was completed and the product (hardware or software) along with the development knowledge was "tossed over the wall" to a waiting publications group who would develop the documentation for the existing product. The “toss over the wall” approach can force a publications group to work around flaws in the product, trying to hide poor design conceptualization and execution within the documentation. When the scientific development is assumed completed, and the writing takes over as a wholly separate task, there is no way to back-up the science when flaws are discovered in late-stage development.

The “toss over the wall” approach is still used in many pharmaceutical and medical device research organizations. The separation of research from writing, as suggested by Maura Taaffe in her paper “Issues in Medical Writing”, is, in fact, what we often see in our work with pharmaceutical and device companies. Such separation constrains those doing the writing from getting the full scientific perspective they need early in the document development process to enable them to write the strongest possible documents. Handing off the document development tasks at the end of the process puts documentation on the critical path and can cause difficulty if scientific issues are discovered at late stages by those doing the writing. Delayed document development, which in turn may delay initiation of additional research or submission for regulatory approval, is a major concern across the pharmaceutical and device industries. It is interesting to note Taaffe’s supposition that the clinical community suspects “that good writing is trying to cover up flawed thinking and can lead readers down the path of unreliable, unscientifically valid conclusions.” It is possible that such an attitude contributes to the compartmentalization of knowledge and the application of knowledge.

In response to these recognized problems of workflow organization, the computer industry, the aerospace proposal development industry, and, to some extent, engineering in general have been moving toward a cross-functional team model, with the professional communicator joining the project team early and developing the documentation simultaneously or in advance of the product development science. Writers on these teams contribute user-centered design perspective—they are the team members who tend to be most in tune with the needs of the end user and who understand the difficulties of creating truly helpful documentation. Since they are professional communicators, they also tend to play process roles in group facilitation. In many of the better organizations, they help prototype early document drafts, help manage document reviews, and coordinate various levels of edit over the final study reports, technical manuals, product monographs, and help systems. They also play a role in implementing principles of change and innovation. Thus, the “activity” of a professional communicator comprises many tasks and requires developed skills in several different areas.

Regardless of the industry in which they are employed, professional communicators often do considerably more than just write. In some R&D organizations where we have worked, the writers experience increased responsibilities and are integrally involved with projects and project teams. It is our position that any research enterprise that wants to get the most value from their investment in research should revisit how they are utilizing professional writers in the process of creating their business critical research reports and regulatory submission documents. In the next installment we will discuss ways to quantify the value added by integrating the professional communicator into a project team.

Works Referred and Cited

Hughes, Michael. 2002 “Moving from Information Transfer to Knowledge Creation: A New Value Proposition for Technical Communicators.” Technical Communication 49, No. 3:275-285

Kirsch, J. "Trends in the Emerging Profession of Technical Communication: New." In Barrett, E. (Ed.) The Society of Text: Hypertext, Hypermedia, and the Social Construction of Information. MIT Press, 1989. 209-234

Taaffe, Maura 1998 “Issues in Medical Writing.” Michigan Tech University
http://www.hu.mtu.edu/hu_dept/humanities/tc@mtu/papers/medical.htm

Zimmerman, M. "Reconstruction of a Profession: New Roles for Writers in the Computer Industry." In Barrett, E. (Ed.) The Society of Text: Hypertext, Hypermedia, and the Social Construction of Information. MIT Press, 1989. 235-249.


Originally published on our Knowledge Management blog