Entering medical device writing

Medical device writing opened to medical writers as device regulation tightened. Writers have entered it from clinical research, from in vitro diagnostics, straight from clinical medicine and from pharmaceutical writing, whose skills carry across while the device regulations, vocabulary and documents have to be learned. In 2016 working life appeared to differ little between pharmaceutical and device writing, and writers who have crossed between them hold varied views of the move.

The size of the device industry

The medical device industry is large yet relatively unknown, although everyone uses its products. ¹ In 2017 and 2018 more than 500,000 types of device were on the EU market. ^{1, 2} The 2017 count includes in vitro diagnostic devices. ¹ In 2017, according to the European Commission, the European medical device industry employed over half a million people and had total sales of over €100 billion. ¹ In 2018 the devices registered on the European market had total annual sales of €110 billion. ²

Some regard the industry as quite niche, but one writer with over a decade in it holds that it should not be ignored. ¹ The research and marketing budgets of pharmaceutical conglomerates dwarf those of device companies, so big pharmaceutical companies command attention well beyond the scientific world, while people in the device industry sometimes feel they have to fight to be heard. ¹

Why the sector opened to writers

Ten years before 2023, device regulation was less strict than pharmaceutical regulation, and clinical study documents for devices were mostly written by project managers. ³ In 2014 the device industry was under greater regulatory scrutiny than in the past, with relatively new research requirements, especially in post-market surveillance. ⁴ These studies require writers in every domain: clinical writers for protocols and reports, regulatory writers for filings and safety monitoring, and publication writers for evidence. ⁴ In 2015 one device writer observed that devices were starting to follow the pharmaceutical industry, as regulation grew stricter and departments more specialised, and strongly believed that medical devices would be an emerging field for medical writing. ^{5, 6, 7, 8} The MEDDEV 2.7/1 revision 4 guidelines on clinical evaluation brought greater stringency, and device companies became increasingly aware of the medical writing profession. ³ In 2017 the Medical Device Directive was about to be replaced by the more stringent Medical Device Regulation (MDR), which would have repercussions of all kinds within the industry. ¹ In 2018 new EU regulations were raising the standards of scrutiny in the device field, tightening control over high-risk devices and adapting certification to higher standards of transparency, and their requirements for more clinical data and close monitoring of device use opened unique opportunities for medical writers. ^{9, 10}

The MDR (Regulation (EU) 2017/745) brought an exponential increase in demand for device writers, even if at first only for clinical evaluation reports. ³ By 2023 many device companies had understood the added value of professional medical writers and also enlisted them for clinical investigation plans and reports. ^{3, 11} In the couple of years before 2024 the MDR made medical devices an up-and-coming field for medical writers. ¹²

In 2026 the global device sector was growing as never before, driven by rapid innovation in biotechnology and personalised medicine. ¹³ As regulatory frameworks evolve and the demand for high-quality documentation intensifies, the need for skilled communicators who can handle complex scientific and clinical material has never been greater. ¹³ In 2019 the development of new technologies and an evolving regulatory environment meant that manufacturers would need knowledgeable writers. ¹⁴

At EMWA's 2018 symposium on medical devices, about a third of the audience had less than two years of medical writing experience and another third more than ten. ¹⁵ This most likely reflected newcomers' wish to enter a new field with good job opportunities, and experienced writers' wish to explore new horizons, perhaps after growing too comfortable in their own area. ¹⁵ Interest was strong in 2019: at EMWA's spring conference all three device workshops were fully booked and the expert seminar series on devices was well received, which reinforced one device writer's impression that medical devices belong on any list of trends in medical writing. ¹⁶

What the sector offers a writer

The breadth of the documentation a device requires gives writers an opportunity to find a niche, whether in standard regulatory writing, scientific publications or patient-oriented documents. ¹⁷ As manufacturers take up modern digital technologies, writers can also act as translators of complex science for a broad public. ¹⁷ Writers who join the device field will work with familiar scientific concepts while preparing new types of documentation and expanding their expertise into physics and engineering, and in 2018, with the new regulations taking effect, they would be working at the forefront of establishing new standards in the field. ¹⁷ The field also lets a writer add new types of document to their portfolio, such as systematic reviews, market approval documentation and post-market surveillance reports. ⁹ Devices go from development to market in three to seven years, so after three years in devices a writer has a good chance of seeing a device either reach the market or stay on it. ¹⁴

In 2018, with many of the EU's device policies still being established, writers could become involved in the legislation process and, working alongside the authorities, help shape the field and set future standards. ¹⁰

At EMWA's 2018 symposium on medical devices, one speaker counted among the pros of device writing, compared with writing for pharmaceuticals, business opportunities, longer-lasting relationships with device companies and the fast pace of constantly new devices, and among the cons the time pressure that pace brings. ¹⁵ Another speaker pointed to job opportunities at notified bodies. ¹⁵ In 2024 one freelance writer judged devices a field with a lot of potential and a great niche to work in. ¹²

Job titles to look for

A writer looking for a way in should look beyond the job title and also consider clinical scientist, clinical research scientist and clinical specialist roles. ^{18, 19} For a writer interested in specialising in a particular indication, such a role gives wider scope for scientific input into every step of preparing a preclinical or clinical study, from planning and set-up, interactions with key opinion leaders, surgeons and engineers and day-to-day study conduct to data cleaning and the study report. ¹⁸

The route in from research

One writer came to device writing from outside writing: she studied veterinary medicine, took a doctorate in parasitology and worked for a couple of years as a veterinarian, then moved into clinical research as a clinical research associate and later a project manager, and then held increasingly senior roles in the medical device industry, in the last of which she was responsible for pre- and post-market clinical studies, implant specialists, the safety department and department coordination. ²⁰ Her positions in clinical research rose to senior manager responsible for clinical research in Europe, and her first contact with medical writing came when she joined the medical device industry as a project leader. ⁵ Since 2011 she has been independent with her own company, focusing on clinical research and medical writing, and over the years the work has become more and more medical writing. ²⁰

With one company she began by writing publications, and she now does basically all of its medical writing, from the clinical study report through the clinical evaluation report to the publication. ²¹ Being deep in the topic makes her fast, which is good for everybody. ²¹

Another writer started in medical writing in 2004 with an engineering and orthopaedic research background, doubting whether the job suited someone with that background, and the training at her first EMWA conference was clearly focused on writing for pharmaceuticals. ¹⁶ By 2019 she had found device writing to be her perfect niche. ¹⁶

The route in through in vitro diagnostics

One writer came to in vitro diagnostic devices by grabbing an opportunity that a series of events presented, and found a big learning curve. ²² The in vitro diagnostic sector, which is classified under medical devices, is an industry in itself. ²² She saw first-hand the need for qualified writers to communicate product-related material in a precise and articulate way. ²² After a change in circumstances she moved into freelancing with a client already in hand, which let her work across a range of in vitro diagnostic devices instead of one product line, for clients from mid-sized to big companies. ²² The move came relatively early in her medical writing career. ²³

In 2018 the German in vitro diagnostic market was dominated by small and medium-sized companies that frequently lacked dedicated teams or departments to write medical communication or regulatory documents, so the work had to be outsourced, which provided opportunities for freelancers. ^{24, 25} A range of technical documents was then needed, especially because of a significant change in the EU regulations for in vitro diagnostic devices. ²⁵ Overall, the new in vitro diagnostic regulation was set to increase the number of regulatory documents to be completed. ^{22, 25}

The route in from clinical medicine

One writer came to device writing straight from clinical medicine: she studied medicine at RWTH Aachen University in Germany, did her thesis at the Institute of Physiology and worked as a physician in orthopaedic and trauma surgery for almost four years in Lörrach and Heidelberg, then started as a medical writer at a device manufacturer in 2018. ^{26, 27} In 2020, at the manufacturer's peripheral interventions business unit, she established the documentation the MDR requires for Class I to Class III devices and was the clinical affairs subject matter expert on the MDR remediation team. ²⁶ She wrote post-market clinical follow-up plans and reports while also supporting those activities on the practical side, established clinical development plans for new development products, and had begun supporting regulatory affairs with overseas data reports for international submissions focused on China. ^{26, 27}

The route in from pharmaceutical writing

Many regulatory medical writers start their careers in pharmaceuticals; some also work in medical devices, and in 2019 an increasing number were switching to device writing. ²⁸ MEDDEV 2.7/1 revision 4 on clinical evaluation, introduced in 2016, and then the MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) increased the need for and awareness of regulatory medical writing among device and diagnostics companies. ²⁹ So writers with pharmaceutical experience are well placed either to move to a device company or to take on device writing projects. ²⁹ With sound writing skills and broad experience, there is no reason a writer cannot move from pharmaceutical to device writing, work solely in devices, or work in both at once. ²⁸

One freelance writer became a regulatory writer in 2006, when she set up her own company, after working in a pharmaceutical and device consultancy, in clinical development at a global pharmaceutical company, in phase I–II research at a contract research organisation and in academic clinical medicine. ³⁰ Her research experience had been mostly pharmaceutical, but it included work with devices such as an ambulatory blood pressure monitor and an investigational device for administering insulin, phase III trials of a pharmaceutical delivered by a novel device, and the chance to learn how devices were approved and regulated in the United States and Europe. ³¹ She applied that experience to device development at a time when ISO 14155 contained guidance only on trial conduct and the clinical investigation plan and few device companies ran clinical trials. ³¹ So when she set up her company she simply continued working on both pharmaceutical and device projects. ³¹ Her device writing was adapted with each iteration of MEDDEV 2.7/1 and in 2019 continued under the MDR and IVDR. ³⁰

One writer came into devices in 2015, when the contract research organisation she worked for acquired another whose medical writing was done entirely by contract writers. ³² As medical writing lead she inherited a device project, at a time when manufacturers were bracing for the MDR, with a team meant to deliver several clinical evaluation reports on cardiovascular stents and catheters within a couple of months. ³² Rather than decline it as outside her expertise, she presented a proposal and a budget to build in-house capability in writing clinical evaluation reports. ³² Once it was approved, she hired the contract writers to train their in-house counterparts, shadowed several projects and then delivered several reports herself, learning the device vocabulary and discovering the joys of performing systematic literature reviews. ³² With the MDR looming, the client was only too happy to discuss more writing projects. ³² When she left for big pharma in 2019 the project was worth almost US$1 million. ³² Her device knowledge later proved useful in pharmaceutical projects involving drug delivery systems and in vitro diagnostics. ³²

Another writer wrote oncology trial documents for independent research groups and then went freelance, and a client asked her for a clinical evaluation report for a device moving from the Medical Device Directive to the MDR. ³³ She had never written one, but she saw the parallels in analytical rigour, evidence synthesis and regulatory alignment, and she made her case from her pharmaceutical oncology experience. ³³ For that first report she immersed herself in the MDR framework and learned its nuances. ³³ The project succeeded, and as word spread, requests followed for clinical evaluation reports and plans, state-of-the-art sections and summaries of safety and clinical performance across hardware, software, in vitro diagnostic and companion diagnostic devices of different risk classes. ³³ She describes her migration as built on transferable skills, strategic timing and a willingness to evolve. ³³

In summer 2017 one writer with a background in clinical, regulatory and pharmacovigilance writing at pharmaceutical companies and contract research organisations was looking for her next move. ¹⁸ Remote working had become her only option, she missed face-to-face interaction, and she wanted a new challenge and to get back into science and writing. ^{18, 34} She drew on her association with EMWA since 2006, the articles in its journal and her network of colleagues and friends to find out more about devices. ¹⁸ A LinkedIn advertisement led her to a med-tech startup in Cambridge, UK, that was turning an engineering prototype of a robotic surgery system into a medical device, and the post was advertised as clinical research scientist. ^{35, 34} What appealed to her was a smaller company, working closely with directors who were renowned innovators in their field, a more technical environment, a prototype close to its regulatory goals of a CE mark and then a US 510(k) submission, and a growing clinical and medical team she would be part of. ³⁵ She used the June 2017 device issue of EMWA's journal to make her pharmaceutical experience count in the move, and her transition point came at EMWA's 2018 spring conference in Barcelona, where she attended the device symposium and took her first device workshops, on literature reviews and clinical evaluation reports. ³⁵

At the robotic surgery company, unlike at large global device companies or even many pharmaceutical companies, the responsibility for producing and supporting a wide range of documents, and for other non-writing activities, fell to her, and she found herself back in a laboratory. ¹⁹ The role gave her opportunities to transfer project management skills and her clinical, regulatory and pharmacovigilance experience of working as part of a multidisciplinary team, to mentor, advise, innovate and deliver, and to benefit from the variety of the work. ¹⁹ She played a pivotal part in data collection and in authoring the study plan, completed a surgical theatre access training course, trained in good laboratory practice, refreshed her good clinical practice training, and gained new skills writing for validation studies showing proof of concept in preclinical models and for usability studies looking at the perspective of the user as well as the device. ³⁶ She produced slides for investigator meetings. ¹⁴ She expected the opportunity to write post-market surveillance and post-market clinical follow-up documents, which draw on the skills of writing safety narratives and development safety update reports. ¹⁴

The pharmaceutical skills that carry across

Pharmaceutical medical writers have expertise in clinical research and regulatory documentation that can be used in the device field: their understanding of clinical research, regulatory standards and scientific storytelling, and their experience of study reports, regulatory submission documents and patient-facing materials, place them uniquely to pivot into devices. ^{37, 38} Even without experience of writing about devices, a medical writer, particularly one with pharmaceutical experience, has significant expertise to offer. ³⁹ Speakers at EMWA's 2018 symposium on medical devices held that medical writers' transferable skills include knowledge and understanding of regulatory procedures and objective writing, and that thanks to them writers familiar with writing for the pharmaceutical industry will easily adapt to the device field. ⁹ Beginning writers and writers coming from the pharmaceutical industry find many transferable skills applicable to the device industry. ^{4, 15} They still need a working knowledge of the device regulations. ⁴

Pharmaceutical writers typically prepare a wide variety of documents, such as clinical study reports, pharmacovigilance documents, publications, lay summaries and consent forms. ¹⁰ One speaker at EMWA's 2018 symposium on medical devices pointed out that the skills this develops are highly relevant to device writing: knowledge of clinical study design, the ability to follow guidelines, language and communication skills, a systematic approach to writing projects, and the project management needed for working with multiple partners and managing client expectations. ¹⁰

The transferable skills fall into two groups, technical and scientific skills and soft skills. ^{40, 41}

• Technical and scientific skills:
  • scientific literacy and clinical understanding: interpreting clinical data, mechanisms of action and therapeutic context, and applying knowledge of anatomy, physiology and disease states
  • regulatory content expertise: experience of writing clinical and regulatory documents, and familiarity with GxP principles, such as good clinical practice and good documentation practice, and with quality systems
  • evidence synthesis and literature review: systematic literature searching and critical appraisal
  • document structuring and clarity: structured, readable, audience-targeted writing that translates complex science into clear, compliant documents
  • data presentation: tables, graphs and summaries for technical and regulatory audiences
• Soft skills:
  • cross-functional collaboration in multidisciplinary environments
  • detail orientation and a compliance mindset: precise terminology, traceability and audit-readiness
  • project management and agility with timelines, version control and stakeholder feedback

⁴¹

For one writer who crossed over, the transferable skills began with an all-rounder mentality, the willingness to wear several hats at once, project manager and writer together, and a sound scientific and clinical background with good scientific and analytical skills. ⁴² Two years in pharmacovigilance helped her with the safety sections of post-market clinical follow-up, although those differ a little because of the device effect and the question of whether a problem is operational or user error. ^{42, 43} She also counted following a template to the letter where the company has one, attention to detail, the inquisitiveness to decipher information and keep asking questions, project managing a group toward consensus, sound IT and Word formatting skills, and good written English with editing, proofreading and quality control. ⁴³

Being able to absorb and appraise new scientific information quickly and adapt to changing realities is a core medical writing skill, useful in both industries; for an agency writer, for example, it is not uncommon to start a project on an indication or medicine they know little about at first. ^{44, 45} Knowledge of regulations, templates and guidance also carries, since most pharmaceutical documents have device counterparts that, despite some differences, are similar in scope and even structure, so device documents may be less obscure than many pharmaceutical writers assume. ⁴⁶ The objective, precise, lean and unambiguous style of regulatory writing should also be applied to devices, adjusted for the device terminology, the ISO 14155:2020 document structure and applicable style guides. ⁴⁷

Project management and team leadership carry too: experienced pharmaceutical writers are used to running projects like a tight ship, developing trusting relationships with the team, establishing roles and communication routes and managing expectations. ⁴⁸ For a clinical investigation report, for example, a writer could propose to the team from the start a timeline, a data collection plan built from the source documents, and a meeting plan of kick-off, data interpretation and comment resolution meetings. ^{48, 47, 49}

The significant core differences between the industries require some adjustment, but medical writing is a profession used to fast change, and experienced pharmaceutical writers will always find some common ground. ⁴⁹ Writers may find themselves intimidated when asked to prepare the documentation for a device's approval and certification. ¹⁰ Yet venturing into a device project may not be as daunting as feared, since pharmaceutical regulatory writers already have the transferable skills that will get them through it more easily. ⁵⁰

What a pharmaceutical writer has to learn

There are many opportunities for pharmaceutical writers willing to leave their comfort zone. ⁵¹ Recognising the similarities and understanding the differences between the pharmaceutical and device landscapes lets them use their existing skills in devices. ⁵¹

In one freelance writer's view, device writing is more on the technical side, and it is a regulatory field with its own rules, so a writer with pharmaceutical regulatory experience cannot simply switch but has to read the MDR, the Medical Device Coordination Group's guidance and the rest to work in it. ¹² The regulatory and development landscapes of medicines and devices differ significantly, so a writer crossing over needs targeted upskilling. ⁴⁰ A writer must learn new terminology, grasp the device classification systems to understand the regulatory pathways, and learn usability engineering to ensure safe and effective interaction with the device. ⁴⁰ A writer dealing with in vitro diagnostics must understand the distinctions between precision, specificity and sensitivity. ⁴⁰ Fluency in these areas is essential for producing high-quality documentation aligned with device-specific standards. ⁴⁰

A pharmaceutical writer moving into devices should prioritise training in the key frameworks, including the relevant ISO standards, the Medical Device Coordination Group's guidance and the International Medical Device Regulators Forum's guidelines. ^{40, 33} Familiarity with these frameworks is essential for producing accurate, audit-ready content. ³³ EMWA, AMWA, RAPS and TOPRA offer specialised training, networking and certification in regulatory writing and clinical documentation. ³³ RAPS and TOPRA focus on regulatory affairs, with deep dives into global device regulation. ³³ Engaging with these communities helps writers stay current, build expertise and connect with peers making similar career shifts. ^{33, 52}

A pharmaceutical regulatory writer considering a first device project may want to research a few topics first. ^{53, 54} One is the device concepts, definitions and terminology, including the names of the regulatory documents. ⁵⁵ Another is how a device is developed, which differs from how a medicine is developed. ⁵⁶ A third is the regulations and guidance, among them the MDR, ISO 14155:2020 and MEDDEV 2.7/1 revision 4 for clinical evaluation. ^{45, 44}

Learning on the job and adapting existing skills are important. ¹⁹ Ways of acquiring new skills, whether employed or freelance, include working on a new type of document with a colleague or as part of a larger team, becoming familiar with the regulations, guidelines and new software, and attending EMWA workshops. ¹⁹ This is how the writer who set up her own company in 2006 learned to write clinical overviews and summaries, and then clinical evaluation reports and literature reviews. ^{19, 30}

EMWA's 2015 webinar archive holds webinars on patient informed consent forms for medical devices and on quality by design in clinical trial protocol writing. ^{7, 8} The quality-by-design webinar was made for pharmaceutical studies but can also be applied to device studies. ⁸ EMWA workshops such as introduction to writing for medical devices and writing clinical evaluations for medical devices go into more depth, and its workshops on protocol writing for pharmaceutical studies also help a writer write a better device protocol. ⁸

Working life in each industry

A survey of medical writers working predominantly in industry or for agencies in both industries ran from 8 to 14 March 2016 and received 112 responses. ^{57, 58, 59} About two thirds of the respondents worked in Europe and one third in the USA, and of the 108 who answered the question, 68% worked principally in pharmaceutical writing, 28% in medical devices and 5% as freelances or consultants. ⁵⁹ Of 96 respondents, only 5% worked fewer than 30 hours a week; most worked either 30 to 40 hours (50% of pharmaceutical against 14% of device respondents) or more than 40 to 50 hours (34% against 68%), and some worked more than 50 hours (9% against 11%). ⁶⁰ Paid holidays, excluding weekends and public holidays, were generally either 15 to 20 days a year (22% of pharmaceutical against 43% of device respondents) or more than 20 to 30 days (64% against 36%). ⁶⁰ On the survey's limited findings, the differences in development and markets between the two industries did not give many writers a different experience: quality of life appeared to differ little between them, with positive responses from both sides. ^{57, 61} A possible reason is that an increasing need to follow guidelines and regulatory edicts in both is blurring any previous distinction between them. ⁶¹ Taken as a whole, the data left the survey's authors with the impression that the device world may still just have the edge, possibly because of the supportive nature of its smaller teams compared with the more frenetic activity around bringing a new drug to a global market. ⁶¹

Guidelines, document types and clinical areas in each industry

The medical communication and regulatory guidelines that the survey's respondents in device and pharmaceutical companies followed were similar. ⁶⁰ Employees of both kinds of company reported following GPP3 and the ICMJE recommendations, CONSORT, STROBE and PRISMA as appropriate, plus all applicable regulatory guidance. ⁶⁰ Several pharmaceutical respondents also named ICH, the Association of the British Pharmaceutical Industry and FDA guidance, while device writers named STARD for reporting diagnostic accuracy and the European MEDDEV standards. ⁶⁰ The types of document and daily responsibilities appeared to overlap broadly between the two, but the clinical areas in which pharmaceutical and device writers reported working differed. ⁶⁰

Development, publication and communication in each industry

The issues facing writers in pharmaceutical work and in device work differed in 2016. ^{61, 62} On the device side, the survey reported:

• faster development and commercialisation
• frequent product updates, such as laboratory software
• regulatory requirements that differ by class of device and may be less stringent
• limited publications and fewer patients per study
• publications and congress presentations generally focused around regulatory approval and product launch, then tapering off
• an emphasis on accuracy and precision, ergonomics and patient preferences
• a need to consider outcomes from the user's perspective as well as the device's
• operator variability and training as big factors in performance, so that learning curves are often explored in publications
• less emphasis on publishing and more on commercial activities, such as building client relationships and educating physicians and payers
• limited publication around diagnostics

⁶²

On the pharmaceutical side, it reported:

• a slow development cycle
• multiple studies involving large patient numbers
• a push for publications and congress activity across the product lifespan
• study designs, outcomes, goals and messaging that tend to be predictable and consistent
• more direct-to-patient communication
• codes of practice and regulatory requirements that tend to limit medicinal products more than devices

⁶²

The survey also reported that the two differ in their audiences and communication needs, and in their therapeutic areas and the language that goes with them. ⁶²

Moving between pharmaceuticals and devices

In 2016, anecdotal evidence suggested that writers entering medical communications generally travelled down one of two paths, pharmaceuticals or devices, with limited crossover between them. ⁶³ Many skills are transferable between the two, but writers wishing to change focus from pharmaceuticals to devices or the other way may face challenges. ⁵⁷ The 26 respondents who had moved between the two areas and the eight who worked across both held varied opinions. ⁶⁴ Some found the unfamiliar regulations and types of analysis problematic, particularly in early clinical development. ⁶⁴ One who had moved from devices to pharmaceuticals did not find it challenging at all, and another who made the same move found that a focus on publications rather than regulatory writing, together with investigational device exemption experience, made the transition to new drug application and investigational new drug writing relatively easy. ⁶⁴ One who moved from pharmaceuticals to devices found devices a far more comfortable environment, where the employees are respected significantly more. ⁶⁴ Opinions were divided on whether publishing strategies differ between the two: eleven respondents thought them similar, nine different and two were unsure. ⁶⁴ Six preferred to work in pharmaceuticals, four in devices and five had no preference, so preference showed no clear difference between the two branches. ⁶⁴ Demonstrating efficacy, safety and affordability was important in both, and the two were also similar in authorship requirements, rules around honoraria and, in the respondents' words, "bizarre journal reviewer comments". ⁶⁴ The survey's authors concluded that changing from pharmaceutical to device writing or the other way is possible, but that it is likely to need time and effort to become familiar with new regulations, language and approaches. ⁶¹