There are quite a few steps you need to keep in mind as a medical device manufacturer before you launch your product into the market. However, one process that keeps on going is the clinical evaluation of the device. The process conventionally starts during the preliminary or development phase of the device. This helps the manufacturer gather data that shows the risk factors involved with using the device and makes it okay for market use.
What tests are necessary?
In every European Union, the CE marking and later the Clinical Evaluation Report or CER is absolutely important, and it needs to be continuously updated. On the other hand, the United States of America requires a PMA or Pre-market Approval from the Food and Drug Administration (FDA) for regulatory and scientific review. It helps evaluate the effectiveness and safety of any medical device so that the consumer is satisfied with the product. Most times, it also uses a proof-based review that allows for the scientific evaluation of the devices.
What is the use of such data?
This data is calculated throughout the lifetime of a particular medical device and is integral. It further helps ensure the performance and safety of the device based on hordes of clinical evidence. In addition to that, it also allows Notified Bodies and other relevant authorities to display the conformity of the device along with necessary evidence. This process is not just important for the initial marketing of the product but is required throughout its lifespan.
Literature reviews for a medical device
Systematic Literature Review is a highly important part of the manufacturing process of medical devices. It ensures the success of PMA and CER. In other words, an effective systematic literature research strategy will further strengthen every stage of the medical device’s tenure in the development stage as well as the market, starting from the design to the concept of the device.
More than being just a thoughtful investment for better effectiveness of your product, screening its literature becomes important as it helps comply with the rules and medical device regulations set by the regulatory authorities while the approval process is going on. Along with that, as it helps with post-market surveillance, it also is integral for the global success of your product.
For the majority of small and medium-sized companies, this literature represents most, if not all, of the data collected. For instance, this search recognises the sources of clinical data that helps establish the current knowledge. This further helps manufacturers understand
- The clinical background in the relevant medical field
- The clinical data corresponding to other similar devices of the same device under evaluation
- Recognise potential threats, risks and hazards.
This is what makes it very important to have a literature search strategy that is strong and effective and can also be copied in the future for subsequent updates of the same.
With the information present in this article, by now, you have understood how important it is to formulate a robust literature research strategy. It helps the manufacturer make the device a lot more able and minimise risks if any. Without one, there is a lot of information about the device that is absent and cannot be understood.
That being said, forming one can be quite confusing for a new company. This is when it is best to hire a professional and capable service that can help you with the same. Rest assured, with more data about your new device, you will surely be able to attract more customers to the market.