How much device experience an entry actually needs
Whether a writer without device experience can move into device work turns on four questions: whether the move can be reversed later, whether a writer with few years or none in medical writing can make it, which work does require prior device experience, and what to ask before accepting a device post.
Crossing in both directions
A writer can cross from pharmaceuticals to devices and from devices back to pharmaceuticals, and can write for both. In an employed post a writer would probably do the two one after the other, while a writer who wants to write for devices and pharmaceuticals in parallel is probably better served by the freelance route, which still offers work with pharmaceutical products. A writer who tries device work and does not like it need not worry, because in 2019 the need for medical writers was growing across many areas.
One writer believes that moving between areas is perhaps no longer judged as harshly as it once was. Trying things out shows a writer what fits, what they like and where their strengths lie. A writer who never tries something new never has the opportunity to do it. At some point a writer needs to give the move a try and to believe in themselves.
Getting experience is important, even where a writer who went into devices as a freelancer gets it in pharmaceuticals. A writer who wants to get into devices has transferable skills. In one writer's view, device experience could be very helpful to a writer's career.
Entering with little or no experience
A writer only two or three years into medical writing, without the maturity that years of handling things bring, can also make the crossing, in the view of one writer who made it. The reason she gives is that entrants often come from a doctorate, laboratory work or another part of the industry. Two of the three elements known as the three Es are education and exposure, and exposure makes up a large share of the three. Reading supplies the education, and learning on the job supplies the exposure.
A writer whose first field of interest is devices starts as one writer started in the pharmaceutical industry, with no experience at all, and that writer judged that she did not do too badly. By 2019 EMWA had seen people secure device writing as their very first medical writing work.
In 2019 device writing was still very new, and everybody in it was still learning from one another, as the workshops, the special interest group and the talks showed. Employers will understand that everyone is learning together. An employed entrant typically has a six-month probationary period, and the company wants the entrant to succeed. An entrant is often given tools and support to become informed. Being in the environment gives access to resources. In 2005 not even half of the formalised resources available in 2019 existed.
In one writer's experience, a writer often has to convince their peer group, or the new industry, that their skills can be applied there, and can do so by using EMWA's support and workshops or other education and by being well informed. A writer has to reassure themselves that the crossing can be made, and may have to persuade an employer too, since an employer can naively expect a newcomer to arrive with device experience although many skills transfer.
A writer weighing a device post should not be put off, and can use networks such as EMWA and faith in their medical writing skills to take on the challenge confidently.
Clients that require device experience
Large companies and contract research organisations writing for devices may simply need resource: they have document templates and standard operating procedures and will supply the literature search outputs, but they do not have enough writers in-house to write up literature reviews and clinical evaluation reports. Such work can be a great way to learn how to write those documents.
Small companies may have neither in-house writers nor the expertise to conduct literature reviews or prepare clinical evaluation reports to the MEDDEV 2.7/1 or MDR standards current in 2019. They want an experienced writer who can help and advise them, conduct the literature searches and write the documents using the writer's own templates and software, such as EndNote for reference management. For these clients, prior medical device writing experience is essential.
Questions to ask before accepting a device post
Before moving into a device post, a writer should:
- Think about the type of role and department, and understand the job description, the career development and the promotion opportunities.
- Ask what the device's classification is and whether it is marketed, since the answers give an idea of the device's development, strategic and regulatory plan.
- Ask about the experience and qualifications of the project teams, since device companies are often small start-ups that employer-review websites cannot help with.
- Ask whether the post means being mentored or mentoring; a writer may delight in being the only, or the most experienced, medical writer.
- Where the clinical and medical team is newly formed and growing, ask about taking part in laboratory-based studies as well as writing.
- Consider whether working with external consultants, surgeons and clinical teams, with cadavers and animal preclinical models, and brushing up on physics would suit.
- Ask whether the role involves preparing data in the format regulatory approval or scientific publication requires, and whether it requires negotiating with and managing vendors and contractors.