The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all the while improving the clinical functionality.
The demand for medical devices is on the rise. A market report issued by statists estimated that the European medical technology market is estimated at roughly €140 billion in 2020.
There are over 500 000 types of medical devices and IVDs on the EU market and hundreds of companies producing medical devices, ranging from large multinational corporations to small businesses. These companies are responsible for creating a wide range of products, including diagnostic imaging equipment, implantable devices, and surgical tools.
The Medical Device Manufacturing Industry is driven by several factors, including an aging population and increasing health care spending globally. In addition, technological advancements have led to new types of devices being manufactured, such as minimally invasive therapies and regenerative medicine products — both areas experiencing rapid growth.
In the face of this growth, device manufacturers are increasingly seeking information technology solutions that can help them keep pace with the expanding volume of data generated during development, manufacturing, and post market surveillance activities. This is particularly true for small- to mid-sized manufacturers who lack the budget or resources to do their own research.
Research is the key to not only developing new technology but also to seeing how the current device will do in the market. There are several challenges that a literature review can overcome. The first major challenge is determining the actual need for a particular medical device. This includes both the overall potential market size and the device’s specific clinical problem to be solved. Market segmentation is also needed to determine what part of the total market should be targeted for the launch of a new product.
The clinical evaluation report (CER) for medical devices is a critical part of demonstrating the safety and efficacy of your device. Therefore, an important section of the CER is your literature search and review.
The literature review sets out to do two things; review the current knowledge /state of the art, and review the literature pertinent to your specific device.
Searching for and reviewing literature related to current knowledge/state of the art is done to identify which safety and performance features are the current states of the art within the industry and device category, i.e., to identify which performance features your device should comply with be considered current.
Let us take a look at why the literature review is such a cornerstone of the CER.
A literature review is essential for the CER.
For many medical device manufacturers, the literature review represents the majority, if not all, of the clinical data they collect on their device. Without it, it would be impossible to demonstrate the safety and efficacy of their device during the clinical evaluation.
Even for companies who have performed clinical trials, a literature search still provides valuable clinical data regarding the device and its performance. Lastly, the literature search is mandatory for the clinical evaluation report under the MDR.
Future Clinical Updates.
A good literature review provides context for the problem being solved and the solution being proposed. A thorough search can provide the manufacturer with critical information on who else has attempted to solve this problem, what approaches were taken, and how they were received in the marketplace.
It can also reveal whether other products are already available that may be better suited than the proposed solution.
Having an understanding of how other devices have been received can help to ensure that the new solution will be well received.
For example, if a device is designed to address a specific concern shared by many physicians but few patients, then it might not be as attractive as a similar device that addresses concerns held by both patient groups and doctors.
A thorough literature review will also help you create a good systematic process that will set you up for all repeat/updates for future documents, reducing future workload.
Flows into your PMS documents
Although literature review is more about Pre-market surveillance, it can essentially design your device’s PMS.
A literature review can help convince regulatory bodies that the risk/benefit ratio of a new device is beneficial enough to approve it for use.
It also helps support claims made by manufacturers about their products, including their intended use, safety and effectiveness. A literature review can also be used as part of marketing materials, such as brochures and videos.
This is particularly important when introducing an innovative product to the marketplace, because it can help healthcare professionals understand how it differs from existing devices.
The marketer’s dream document
Having a document that shows exactly how the theoretical device will work in the market or exactly which deficiencies the current designs need and which the new device are covering is immensely helpful.
A literature review serves many purposes in the medical device development process, from informing the R&D team about what has been done before to understanding how a new device fits into the market and helping determine whether a project is worth pursuing.
Example of a good literature review is the one that also helps manufacturers communicate their ideas to partners, investors and other stakeholders.
Reading a good literature review can provide a better understanding of a device’s purpose and value than other methods like reading articles describing the device or watching a video.
Tricks to great literature reviews
But what makes a good literature review?
How can medical device manufacturers ensure that their literature review will help them identify the need for their device and the market space it occupies?
The way you conduct your literature review depends on your research questions, but here are some tried-and-true strategies that can help you write a great literature review:
- Define your research question
- Determine what type of information you need to answer your research question (primary sources, secondary sources, etc.)
- Identify potential databases/indexes that might be useful
- Search major databases/indexes using relevant keywords