Systematic Literature Searches

A systematic, unbiased literature search is a mandatory source of clinical data. BioTop Medical has extensive experience in performing systematic literature searches: writing the protocol includes defining the search question using the PICO-method, establishing objective criteria for the selection and appraisal of the literature, setting-up a plan for the extraction of the data from the selected publications and the analysis of that data. We deliver the expertise in the search methodology, ensuring compliance with the requirements of the regulations.

Clients often ask: “How are you able to perform a literature search without being an expert on the subject of a specific medical device”.

In essence, a systematic literature search is a method of data collection. We determine and follow the protocol for a systematic and unbiased method, extracting the precise information we need which depends on the purpose of the literature search. The first step is the client training us in the medical application of the device, including principles of operation, mode of action, known alternative technologies. With this information we are able to draft the literature search protocol which the client reviews and approves before we can start the search.

Our (medical) scientific background and experience with a large diversity of medical devices and expertise in the search method, enables us to quickly acquire the specific knowledge we need to perform the search.

We use the guidance provided by MEDDEV 2.7/1 and follow the PRISMA method to perform literature searches for different objectives.  For example, the objective of the literature search can be to

• Determine if a device to be developed is state-of-the-art, early in the device development: clinical literature / incidents reported about similar and alternative device technologies.
• Be used as clinical data set in the device clinical / performance evaluation when equivalence to another device in the market is claimed: published pre- and clinical studies / incidents reported about the equivalent device(s).
• Be used as part of post-marketing surveillance plan, throughout the device life-cycle.
• Be the subject of the post-market clinical follow-up (PMCF).