With the upcoming transition to the Medical Device Regulation (MDR) 2017/745 in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation Report (CER) is critical to obtaining the initial CE-marking and it must be updated continuously throughout the lifetime of the device.
What is a literature search?
The literature search for a clinical evaluation report is a search of existing literature to establish current knowledge on the safety and efficiency and safety of your medical device. The literature search can be a time-consuming and complex experience, but there are a few simple steps you can take to help you plan, document, and execute your literature search.
Formulating your hypothesis or research question
The most important step you can take to execute your literature search well is to come up with a strong research question or hypothesis. Your hypothesis should be interesting and relevant to clinical research, and, most importantly, it must reflect the intended use of your device.
If your research question or hypothesis is unfocused and unclear you will end up with results that are too broad or too narrow in scope, too much or too little literature, and literature that is not relevant to the research question.
It can be helpful to formulate the research question using the PICO methodology (P- Population, I- Intervention, C- Control or Comparison, O- Outcome). The PICO method is also one of the most common methodologies applied to the literature search. Choosing your research question with the PICO method in mind lets you directly transfer your question to your literature search strategy.
Other examples of Literature Search and review methods are PRISMA statement, MOOSE proposal, SPICE, PEO, and ECLIPSE, which are also available.
Fundamental for the success of your CER, the literature review is a critical step in demonstrating the safety and compliance of your device. For Smaller and Medium Enterprises (SMEs) who do not manufacture devices with equivalents on the market, the literature search can comprise a large part, if not all, of the clinical data included in the CER. Furthermore, Class I and Class II CERs rely heavily on clinical data from literature reviews and require emphasized focus on the literature search planning and execution.
Why should I hire a literature search writer when I already have a regulatory team?
Even in companies that already have a well-established regulatory and quality department, hiring an external literature search writer might be worth the expense.
In smaller companies, the regulatory and quality department frequently comprises a single person or teams of one to three people. In larger companies with global reach, ensuring regulatory and quality compliance over several markets and product lines is complicated and time-consuming, even in larger teams. In either scenario, internal staff might simply not have the time required for a well-planned and well-executed literature search.
Even if your employees have the time and willingness to take on the literature search, they might not be the best fit for the job. The literature search and review is a complicated process at best and each stage must be planned and executed correctly and systematically. Most regulatory people have scientific backgrounds and are well-versed in science and medicine, but might be lacking in analytical reading and writing skills.
For manufacturers in non-English speaking countries, requirements to avoid translation costs and write and submit the CER in English adds a second layer of difficulties for staff who are not 100% comfortable with or qualified for writing in English.
What should I look for in a literature search writer?
The most enticing part of hiring an external literature search writer is finding someone who is well-versed in the latest regulations, has a good grasp on the process required to conduct a good literature search, and know-how to analyze the results and communicate them in an effective and precise manner. In short, you need a literature search writer with experience.
Most professional literature search writers are well-established industry insiders, who have worked within the regulatory and clinical sphere for years and are specialists within their field. While professional literature search writers typically come from a scientific background, they also have significant experience writing scientific, medical, and technical content, making them perfect for the task.
A structured and systematic literature search lays the foundation for a strong CER and strengthens every stage of the clinical data. Literature search protocols must be well-planned and robust and it is important that the literature search can be replicated during subsequent updates.
Process flow during the literature search planning and execution stage is vital, which is why it is important to choose a literature search writer who has a defined process (and can follow it), as well as someone who understands the applied methodology and can analyze results accordingly.
Organization / Attention to details
The ultimate goal of the literature search is to be submitted to the notified body as part of the CER. Ideally, you want your CER to be precise, organized, thorough, and easily understandable, and you want your CER to be approved the first time it is submitted. By hiring an organized writer with attention to detail, you will receive a beautifully crafted literature search that does not require additional edits and can be submitted directly to the notified body (and will not receive a long list of corrections from the notified body in return).
A professional literature search writer should be up to date on the latest regulations and requirements, be knowledgeable about medical devices and their therapeutic indications, and be strong on clinical knowledge. Typically medical writers will have broad experience within the general therapeutic area of your device, if not the device type’s specific intended use.
The knowledge base of the medical writer depends on what type of CER you need. If your device is Class I or Class II and relies heavily on clinical data from the literature and post-market surveillance data, you need a writer with general clinical and therapeutic knowledge, but you might not need someone who is a specialist in clinical trials data and processes. If your CER is for a Class III or a novel device, you will need someone with a good understanding of pre-clinical data and clinical trials.
Lastly, you need to consider the timeframes and deadlines involved in your clinical evaluation. If you have to submit the clinical data within a short timeframe, hiring a literature search writer who can commit to the deadline becomes vital. Most professional literature search writers can offer different time frames at different prices, so you can choose the solution that works best for your company.
How to find and hire a literature search writer
First, you need to define the deadlines for your project.
Next, you want to define the estimated number of hours required for the project. This will depend on the novelty of your device, risk classification, and whether you want a partial or full solution.
Most medical writers today are either freelancers or part of a medical writing company. Freelancers can be hired directly through freelance sites online or through local networks and social media. They are usually flexible in terms of what can be provided and when. Most freelancers can be hired on a project basis, i.e. for a fixed fee.
Medical writing companies can be found online or in your local community. They typically have specialized staff and can provide package solutions for performing various services at once. The safety of being backed by a company structure is preferable to some and most medical writing companies provide continuous high-quality and professional service.
By hiring an external literature search writer, manufacturers can produce high-quality CERs in short time frames without damaging internal regulatory processes and compliance for their existing approvals. Training internal staff can be expensive and time-consuming and hiring an external literature search writer can be the best way to a beautiful CER in your required timeframe.