Beatrix Doerr, DVM, PhD, Coriuvar Consulting; Gillian Pritchard, MSc, MRCP, MFPM, MBA, Sylexis Ltd
The medical device industry is similar, and yet different, to the pharmaceutical industry with regards to medical writing. While publications and presentations follow the same guidelines as the pharmaceutical industry, the position of a medical writer is not well known because medical device companies are often smaller with medical writing tasks performed by clinical project managers or other positions. But, this is about to change.
A hip replacement scandal in Europe detected safety and durability concerns about metal-on-metal hip replacement. Furthermore, a breast implant scandal in 2010 detected not only a high rupture rate of implants, but also the use of industrial-grade silicone, which had more contaminants than medical-grade silicone. From these scandals, new medical device regulations were developed to better protect patients and increase the scrutiny of product approval (“CE-certification”).
New Medical Device Regulations
As a first step, the European MEDDEV 2.7/1 Rev. 4 guidance on Clinical Evaluation Reports (CER), which is an integral part of the submission for product approval, was published in June 2016. The CER summarizes the clinical data for a product, compares it to the current state-of-the-art treatment, and demonstrates that general safety and performance requirements have been met. Key changes most relevant to medical writers are:
- Increased need for data from clinical studies;
- Systematic literature review on the state-of-the-art and subject device;
- Pre-determined frequency of CER updates in order to maintain product approval;
- Greater emphasis on risk:benefit analysis; and
- Requirement for authors to be experienced in medical writing.
Two key regulations followed in May 2017:
The MDR 2017/745 is in a three-year transition period that will end in May 2020. The IVDR 2017/746 has a five-year transition period ending May 2022, because its changes are even more substantial. In general, both regulations provide the regulatory framework for clinical studies, product approval, and post-market surveillance (PMS). In contrast to their precursor documents, the MDR and IVDR add a level of scrutiny to existing clinical study documents and require new documents to be created, such as lay summaries for clinical study reports. Ultimately, they will also lead to more clinical studies being conducted, with the associated need for clinical study documents and publications.
Notably, these new regulations do not only affect Europe. Based on the increased scrutiny (and, at the same time, a tempering in US Food and Drug Administration [FDA] requirements), several companies are now considering conducting clinical studies for medical devices in the US rather than Europe, whereas it was vice versa in the past.
In summary, there is an increasing need for, and rising awareness of, medical writers in the world of medical devices, making it a sweet spot to work for medical writing professionals.
What Are Medical Devices?
Medical devices are used in the diagnosis, monitoring, and treatment of diseases, injuries, and disabilities. Importantly, medical devices do not achieve their principal intended action by pharmacological or immunological means but may be assisted by such means. As an example, drug-eluting stents are regarded as medical devices because their primary mode of action is to open the vessel mechanically, whereas the drug has an important but ancillary function.
Examples of medical devices include:
- Wound dressings to sophisticated implants and materials
- Surgical instruments to surgical robots
- Simple shoe insoles to elaborate artificial limbs
- Blood glucose meters to imaging equipment
The list is endless! So are the writing opportunities!
Recently, digital health, including telemonitoring and digital health apps, has become important. Particularly in the case of apps, it is not always easy to distinguish between a “life-style app” (eg, a fitness tracker) and an app that is classified as a medical device. The latter has to clearly fit into the defined purpose of a medical device – that is diagnosis, prevention, monitoring, treatment or alleviation of disease, alleviation or compensation for injuries and disabilities, investigation, replacement or modification of the anatomy or of a physiological process, and control of conception.
In terms of their development programs, key differences exist between medical device and pharmaceutical development, as follows:
Key Differences Between Medical Devices and Pharmaceuticals
|Developed by engineers||Developed by chemists, pharmacists, pharmacologists, life scientists|
|Short development time (eg, 2-3 years)||Long development time (eg, 10 years)|
|Categorized by level of risk posed: class I being the lowest risk to class III being the highest risk||Licensed as prescription only medicines (POM) unless there are data to support use without prescription|
|If required, clinical studies are usually small with few patients||Usually require several clinical studies with large numbers of patients|
|Operator and implant method can influence outcomes – training and learning curve are important||Influenced by drug interactions and patient factors (eg, compliance, genetics); little prescriber training required|
|Modifications may be made during device development||Formulation established by early clinical development and not changed thereafter|
Medical Writing and Transferable Skills to Medical Devices
Having medical devices or technical experience is not essential to work in the medical devices industry; many of those currently writing about medical devices started out in pharmaceutical and scientific roles. The experience gained in developing good writing skills, objectively evaluating data, and building awareness of guidelines and regulations provides skills that are equally relevant to medical device and pharmaceutical writing.
Medical devices require similar documents to pharmaceuticals (eg, patient informed consent forms, clinical study protocols, and clinical study reports with lay summaries), albeit there are different content requirements. A document solely used for medical devices is the CER mentioned above. Periodic Safety Update Reports are also new documents according to the MDR, while they have been required in pharma for many years.
As with the pharmaceutical industry, medical device trials need to be registered and published. The same publication guidelines apply as for pharmaceuticals (eg, the ICMJE Recommendations, GPP3 Guidelines, and CONSORT Statement). There are a few specialized medical device journals, but mostly, the journals for medical device research are targeted to certain disease areas or specialities (eg, cardiac surgery, interventional cardiology). General medicine journals, like The Lancet or the New England Journal of Medicine, are also targeted, if warranted by the novelty and importance of the publication.
The process of preparing abstracts and presentations for major conferences is also the same as in the pharmaceutical industry. Taking the cardiovascular disease area as an example, there are major conferences with a focus on cardiovascular devices, particularly the Transcatheter Cardiovascular Therapeutics (TCT) conference in the US and EuroPCR in Europe, but there are also mixed conferences, like the conferences of the American College of Cardiology (ACC) or the European Society of Cardiology (ESC).
To summarize, it would not take much to transfer medical writing skills from the pharmaceutical industry to medical devices. In contrast, expertise gained in pharmaceuticals may be used to advise medical device companies (eg, publication planning, experience gained from European Medicines Agency [EMA] Policy 0070 in writing lay summaries).
Types of Medical Writing Positions
With the requirement for more clinical data by the new regulations and the increasing awareness of medical writers, an expansion in medical writing needs is anticipated, and the publication area will also need to become more sophisticated. Currently, only a few medical device companies have dedicated medical writing departments and a sound publication strategy, and many are not even aware of the upcoming requirements for data sharing. This means that writing positions may generally be less specialized, spanning both regulatory (eg, clinical study documents and CERs) and medical communications writing (eg, presentations, publications support), thus offering a broader range of writing tasks and opportunities. Also, increasing demand for experienced medical publication professionals is anticipated at both medical writer and, in time, writing manager and more senior levels.
Currently, there is a demand for employee medical writers and freelance medical writers alike, mainly from medical device companies. With an increasing awareness of medical writers, clinical research organizations and even universities are also looking for medical writers. Once aware of the benefits of a medical writer, there are physicians who will no longer work without one!
In general, the medical device writing field is evolving. Employed medical writers might work in clinical research departments, clinical science departments, medical writing departments, safety departments, or others. Medical writers are unlikely to find well-established positions and structures, but this ambiguity provides the opportunity for writers to create their own positions and structures. Good luck with your new endeavour!
1. MHRA Updates Alert on Metal-on-Metal Hip Implants. https://www.raps.org/regulatory-focus™/news-articles/2017/6/mhra-updates-alert-on-metal-on-metal-hip-implants, accessed on March 07, 2018
2. Silicone gel breast implants from Poly Implant Prothèse Company – Information. https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/EN/silicone_breast_implants_PIP_info.html, accessed on March 07, 2018
3. Dörr B. The new European medical device regulation and guidance document on clinical evaluation: An interview with Dr. Bassil Akra. Medical Writing 2017;26:76-77.
4. Pritchard G. 2017 Medical Writing 26;2:14-19 Clinical evaluation reports from the medical writer’s perspective.
5. European Commission 2017 Official Journal of the European Union. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2017:117:FULL&from=EN
6. MDR2017/745. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745, accessed on March 06, 2018
7. Guidance on Medical Apps. https://www.bfarm.de/EN/MedicalDevices/Differentiation/MedicalApps/_node.html, accessed on March 17, 2018
8. Dörr B, Whitmann S, Walker S. Writing for medical devices compared to pharmaceuticals: An introduction. Medical Writing 2017;26:8-13.