New Intern (NI): Hello, Senior Medical Writer – today’s my first day! I’m really excited to know the skills one needs to acquire for writing related to medical devices!
Senior Medical Writer (SMW): That’s great, and welcome! We’re happy to have you, and I hope I can answer any questions you might have. But I want you to remember two important things about medical writing for medical devices. As medical writers, we always need to ensure that the medical device is safe for a patient. In addition, it must perform as intended. But to get started, I’d like to ask you a question.
SMW: What’s the first thing you think of when you hear – Medical writing for medical devices?
NI: Hmm – I think of an operation manual that comes with devices like a blood glucose monitor, a blood pressure monitor, and a sleep apnea machine. But beyond that, I’m not sure of the specifics.
SMW: Well, that falls under medical writing for medical devices, but there’s much more to it! Let’s start at the ground level to ensure we’re on the same page moving forward. Before we get to medical writing for medical devices, let’s cover medical writing in general.
NI: Sounds good! So, what is medical writing?
SMW: Medical writing is a science and art involving the writing of scientific documents of different types for regulatory submissions, scientific/technical presentations, medical communication, medical journalism, and medical editing, among other needs for drugs, devices, combination products, biologics, and more.
Examples of documents include literature reviews, clinical protocols, clinical investigation reports, clinical evaluation plans and reports, post-marketing surveillance plans and reports, periodic safety update reports, 510(k), and premarket approval applications. The writing projects are essential either to obtain regulatory approval for the device to be marketed or to maintain the device on the market in different countries. Once a medical device is approved for use, there is a periodic update of most of these technical documents throughout the device’s lifecycle.
NI: I see. Then what are the specifics around medical writing for medical devices?
SMW: Medical writing for medical devices usually requires help from experienced professionals who understand the complexities of technical writing in a highly regulated environment. Medical writers need a basic understanding of clinical research, statistics to interpret clinical and non-clinical studies, challenges faced by the medical device industry, and regulations that govern the marketing of a device in a particular geographic location. A writer should be able to understand the importance of each document and the impact of wrong interpretation of any referred data on medical devices and their regulations. Besides, writers ensure their documents are grammatically correct and free of spelling and formatting errors.
NI: Interesting. What’s the industry demand like for medical writers for medical devices currently?
SMW: The demand for medical writing for medical devices has increased significantly in recent years due to a few key factors.
Increased scrutiny from global regulators requiring additional or more detailed regulatory documentation requires
- a) Real-world evidence collection for all medical devices throughout their life cycle. It includes modern wearables, software as a medical device (SaMD), and other novel medical drug-device combination products
- b) Increased accessibility and channel-specific content for medical device documentation
- c) Clinical investigation for high-risk devices.
In addition, companies are expanding the range of medical devices. A few examples include combination products and artificial intelligence/machine learning (AI/ML) based software as a medical device, among others.
As the demand for medical writing continues to grow steadily in the medical device market, many skilled medical writers have become available to help train aspiring individuals who would like to choose this career path and create a roadmap for their future.
NI: Wow, that’s really interesting! I’m guessing there are different, even more, specialized types of medical writing for medical devices, too?
SMW: Oh, sure! Medical writing involves writing different types of documents for different purposes and audiences, like:
- Medical journalism for the general public, written in simple, non-technical language.
- Educational content for physicians, such as textbooks, continuing medical education programs, presentations, and e-learning tools.
- Educational content for patients.
- Marketing materials and literature targeted at healthcare professionals, such as manuals, brochures, and handouts.
- Publication and presentation content, including journal articles, manuscripts, abstracts, and posters.
- Research documentation, including the clinical trial protocol, investigator’s brochure, consent form, report, and proposal.
- Regulatory documents, including instructions for use, clinical evaluation plans, clinical evaluation reports, periodic safety update reports, 510(k)s, and premarket approval
NI: So, different types of medical writing for medical devices are intended for a unique audience, from physicians, patients, the general public, and medical device manufacturers to regulators. That must mean that the language and the level of technical content must be appropriate for the respective audience.
SMW: That’s exactly right. For example, documents for medical professionals and regulators are typically highly technical and include scientific data with detailed explanations. In contrast, documents intended for patients and the general public are written in layman’s terms.
NI: What about regulatory documents?
SMW: Documents for regulatory submission must fulfill a set format and structure with content guided by specific regulations or regulatory guidance documents.
Changes in regulatory requirements and device specifications often require creating new or updated regulatory documents. These updates can be critical to ensuring patient safety and obtaining optimal results from a device.
NI: This is enlightening! I had no idea there was so much complexity to medical writing and medical writing for medical devices specifically, but I’m here to learn. Couldn’t have asked for a better introduction!
SMW: So happy to help get you started! Remember, medical writing for medical devices is a science and an art. It demands a deep understanding from different perspectives and a genuine aptitude for quality writing. Thorough knowledge of specific documents and a deep understanding of the therapeutic area is required as it is extremely critical to create scientifically accurate documents that meet regulatory requirements.
Connect with Experienced Medical Writers for Medical Devices
Whether you’re just starting to develop a new medical device, ready to start clinical trials, need to update an existing device, or anywhere in between, our experienced medical writers can help eliminate all the headaches that come with developing clear and compliant documentation. Contact ClinChoice today to learn more.
ClinChoice is a leading global Contract Research Organization (CRO), with over 4000 clinical research professionals across North America, Asia, and Europe. For more than 27 years, ClinChoice has been providing high-quality contract research services to pharmaceutical, biotechnology, medical device, and consumer products clients, encompassing a broad range of services and therapeutic areas. ClinChoice offers cutting-edge, full-service solutions for Clinical Trials, Regulatory Affairs, Medical Device Safety, Toxicology, and Medical Affairs.