One issue that came up last week with a client was how to conduct a literature review and how important literature reviews were. I have experienced in some cases, companies that have a lot of man power behind the reviews but these companies do not have solid criteria for focusing their searches. I have experience with other companies that do not necessarily have enough people or time to solely focus on conducting a literature review, yet they have created great search acceptance criteria. So which is better?

Let’s start from the beginning. Why conduct a literature review at all? In the medical device world, conducting literature reviews generally happens early on in a new device’s life. (However they can also be conducted with significant changes to an older device, such as a new intended use). The importance of literature reviews is to scan the market of current technology looking for similarities in devices. Literature reviews can be conducted to compare the safety and effectiveness of competitors. Literature reviews can also be conducted to try to find adverse effects of competitor devices. The end result is basically to compare and contrast the device your company is trying to develop, with current or similar technologies and competitors that are out there.

How can literature reviews be performed effectively? Simple! Start off broad and work your way down. This means, perform broad keyword searches first using important key words. Being able to justify why certain keywords were used, as well as why articles are chosen is extremely important to having an effective literature review.

Take a look at this article by Barb Danson who goes into seven steps to performing a literature review. Her seven steps include:

1. Write a detailed plan that outlines the purpose, objectives and methods to define the literature review
2. Perform the search using a methodical approach
3. Select and obtain articles
4. Summarize highlights from the selected articles
5. Prepare a data analysis spreadsheet to consolidate information
6. Create report tables
7. Write the report text

So rather than just generally searching and hoping to quickly find the most important articles right away, have a filtered approach. That way the governing bodies can see the methodology behind your approach. This in the end creates a more validated approach.

--Jillian F. Walker

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