Where a device writing role sits
The same device writing skills lead to different working lives depending on the organisation a writer works in and on whether they are employed or freelance. Device companies are mostly small, so a device writing job tends to cover more kinds of document than a pharmaceutical one. A small device company, a contract research organisation and an established employer put different amounts of support behind the writing, and employment and freelancing differ in the work, the pay, the flexibility and the clients.
The size of device companies
Medical device companies are generally smaller than pharmaceutical companies. Small to medium-sized enterprises predominate among device manufacturers, the exceptions being global players such as Medtronic, which had nearly 100,000 employees worldwide in 2017. Smaller device companies such as start-ups typically have fewer than 20 employees and may have nobody with the skills to clean, analyse and present data in the format regulatory approval or scientific publication requires, so that task may fall to the medical writer. Device companies are often smaller, which requires an all-rounder mentality. It helps a device writer to have that mentality, with a broad knowledge of clinical research, statistics and medical writing.
The range of documents in a device writing job
Because device companies' writing staffs tend to be smaller than pharmaceutical companies', device writers often multitask and prepare a variety of documents; a device company rarely has a department devoted exclusively to writing journal articles, for example.
Medical device writing falls into two major areas: regulatory or clinical writing, and publication writing. Regulatory or clinical writing analyses data comprehensively, in objective text with no word limit, while publication writing is detailed but must be concise because of strict word limits, and uses persuasive analyses.
The regulatory documents a device writer prepares include the study protocol, case report forms, informed consent, the investigator's brochure, the clinical study report, the Investigational Device Exemption, the premarket notification or 510(k), the premarket approval and product labelling. The same writer may also compose external presentations, including abstracts, posters, slide decks and web pages. The intended audience varies and can include study sites, internal staff and the sales force, customers, patients and health care professionals.
Device companies, contract research organisations and pharmaceutical companies
One writer suggests that a writer choosing between a device company, a contract research organisation and an established pharmaceutical company consider whether they will be working with many other medical writers. A small company the writer joins may have neither templates nor in-house expertise, in which case the writer guides it on both.
A contract research organisation that writes for medical devices may give a writer a group to support them, and an established group may give a good support network, with people who review and quality-control the writer's documents internally. A freelancer who joins such a group may still have that support, depending on the setup. Because a contract research organisation often works with clients and has to get the work right, many have infrastructure behind the scenes to ensure that advice is acted on and documents are reviewed adequately before they go back to the client. In one writer's experience, the pace of work in a contract research organisation probably makes its learning curve steep, and a writer there probably gains a lot of experience; her own time in such organisations was tense, but she learned a lot in a short period.
A writer who joins an established pharmaceutical company writes for pharmaceuticals. Very few companies, consumer goods companies such as Reckitt Benckiser perhaps among them, let a writer write for both pharmaceuticals and medical devices. A freelancer can work across device companies, contract research organisations and pharmaceutical companies alike, whereas an employed writer probably has to choose one of them to work for over a period.
Employment and freelancing compared
Writing about medical devices as an employee is not necessarily better or worse than writing as a freelancer; it is a matter of personal preference, skills and circumstances. The comparison below is a general one, from the perspective of two device writers, and another writer's experience may differ from it with the size and nature of the company or with the style of freelance work: several clients and projects at once, or a contract with one client at a time.
| Work characteristic | Employed | Freelance |
|---|---|---|
| Product or project | Involved in all aspects of a product's development and throughout its life cycle, such as working with engineers in the laboratory and on post-market surveillance, with opportunities to get back into the laboratory and do preclinical work | Involved only in writing the documents for a project, such as a clinical evaluation report |
| Variety of work | Limited to the company's products and therapeutic areas | A variety of products and therapeutic areas |
| Employer and clients | Works for one company at a time | May work for several companies or clients at the same time |
| Remuneration | A regular salary and benefits, such as a pension, health care, life insurance, discretionary bonuses, paid annual leave and sickness benefits, which may offset a lower salary than in a pharmaceutical company, especially after a move to a small company | May have neither regular income nor benefits; no paid annual leave |
| Flexibility over location | Depends on the employer and its culture | Usually more flexibility over when, where and how to work |
| Career development and training | May or may not be supported by the employer; may have in-house training; opportunities to attend other conferences; some employers support EMWA membership and training | Must pay for and organise their own training and career development, for which EMWA is particularly useful |
| Pharmaceutical projects | Moves away from pharmaceuticals | May continue working on both pharmaceutical and device projects |
| Business activities | Involved in corporate activities, especially in a large company | Must manage their own business as well as the projects |
| Transferable skills | Writing, IT, therapeutic-area knowledge, scientific and regulatory expertise | Writing, IT, therapeutic-area knowledge, scientific and regulatory expertise |
The transferable skills are mostly the same for an employed and a freelance device writer: good writing and IT skills, sound regulatory document expertise, scientific and medical knowledge, and the ability to adapt existing skills and knowledge to new situations. Even so, the range of projects and the level of expertise required may differ.
Freelance subjects and clients
A freelance writer might work across a range of therapy areas and types of device, and so has to be comfortable switching between subjects: spinal fixation devices one day, the coating materials of drug-eluting coronary stents the next and a glaucoma treatment the following week. With each new project the writer has to learn about the device and the disease it treats. That learning can be a useful exercise, particularly given the rigorous requirements of MEDDEV 2.7/1 and the MDR to present current knowledge and demonstrate that a device is state of the art. As with therapy areas, the needs of freelance clients vary.
There is always more than one way of writing a document, and a freelance writer sees many of them, which gives the writer an opportunity to see what works well and what does not, and to adapt and develop document templates and writing styles.