Fundamentals of a Literature Review: A Beginner’s Guide

By Published On: December 19th, 2023Categories: EU MDR, Literature Search and Literature Review

The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance a little more to better human health. Thousands of people worldwide work on thousands of devices each day to ensure this forward momentum is maintained.

Part of the research and development process is to ensure we are aware of and are actively building on the current knowledge. When each device is designed, we research what has been done so far and gain an understanding of it. This process is called a literature review.

Literature review holds a pretty important role in the medical device development and regulatory world. And it’s not only for research purposes. Thorough market research is required before developing a product to meet a market need. This leads us to the principles of a literature review.

A literature review is a key step in device development and marketing because it lays the foundations for the device clinically and technically and helps manufacturers identify gaps in relevant studies and marketing prospects. This article discusses the fundamentals of literature review, its importance, stages, and strategies for generating an excellent literature review.

Why do you need a literature review?

Well, the reason is simple. Would you jump into the dark without knowing anything about where you are going, or would you rather be prepared, have the necessary supplies, and maybe have a headlight with you? A thorough literature review arms you with these and more.

The purpose of a literature review is, first and foremost, to understand the current state of the industry, including what devices/tech are already available, their strengths and weaknesses, and potential areas of improvement. This is key information that you will absolutely need down the road.

Knowing where the research is at the moment will guide your research. For example, if you knew doctors were trying to work with stem cells to create regenerative teeth cavity filling, you would know to focus your R&D efforts on stem cell tech rather than the regular kind of filling materials. These are the types of info literature reviews give you. It also gives you an idea of what not to do. Remember that you are working with research papers published by people working in the field. These scholarly articles will almost always critically evaluate what has worked based on previous research and what needs to go now.

The value of a literature review remains high as you go through the development process. If you already have a device, any relevant literature on your device technology will give inside data on where to improve the device, how to beat your competitors, or even how to use the same tech to build an entirely new medical device. Reviewing literature opens up far more opportunities than regular market research.

There is a good reason why they made literature review a regulatory requirement. It will help you with other regulatory stuff like post-market surveillance, risk management, clinical evaluation, etc. A thorough and well-written literature review makes your life easier.

What are the 5 Cs of a literature review?

Before we get into the steps of actually writing literature reviews, let’s get some of the basic stuff out of the way. One of the most famous techniques for literature review writing is maintaining the 5 Cs. So, what are these?

The 5 c’s stand for Clarity, Cogency, Conventionality, Completeness, and Concision. These are not only for literature review, but if you remember from your college days, these apply to any academic writing.

Clarity in writing means you should be clear while summarizing sources. When citing journal articles, make sure you present the key findings and results of the paper. Cogency refers to being logical and accurate. Don’t overstate or undersell any research findings. For us medical writers, it means not glossing over the risk factors of your device/equivalent devices or claiming higher efficacy than it really has. Conventionally means maintaining the standard writing style and practice. It helps notified bodies and authorities go over your literature review.

Completeness and concision require you to provide accurate and sufficient data. Just citing a research paper is not enough, you need to provide the background information, the result data, the methodological approach, and any significant confounding variable. So that the reader can construct an educated understanding of the paper. Your own opinions and interests should not take the focus.


The steps of a literature review are simple. You start by taking a research question or topic. For medical device literature reviews, the device or the tech in question is the topic. Next, you have to do some thorough research in databases, websites, and publications for scholarly sources. Since this literature search is for professional purposes, the thoroughness and accuracy of the search are paramount. Don’t hesitate to use any tools you find to broaden your search. There are plenty of websites and software like Endnote, Lens, Local Citation Network, and Scopus that can help.

As you find relevant articles, read through them and assess them based on credibility, reliability, and relevance. Try to find peer-reviewed articles as they are already vetted. Keep a detailed list while you go through the prior research so that you have notes on key findings and insights at the end of your reading. At citemed, we use a custom application for this step alone.

After you are done with the search, it’s time for the review process. Review the list of literature you have, their annotated bibliography, the data, patterns, themes, etc. Choose the ones to include in your literature review based on usefulness, relevance, research methods, sample, parameters, etc. As you write literature reviews, all this info from existing research should come together neatly and comprehensively.

So, there you have it! Keep these statements in mind, use multiple databases, see if you can draw connections, and you should have a well-constructed, thorough literature review!

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