Delivering Comprehensive Literature Search and Review for Medical Devices
Although literature searches are commonly done as part of a device’s clinical evaluation, manufacturers should use them to obtain information throughout its entire life cycle. In agreement, the MDR mentions literature searches as a source of information in the pre-clinical evaluation, clinical evaluation, and post-market surveillance phases.
The output of the literature search and literature review are:
> Literature on the device in question and the equivalent device. Note: If the manufacturer holds own clinical data for the device in question (e.g. own premarket clinical investigations, PMCF Studies, other PMS data), the literature is considered together with those data for consistent appraisal and overall analysis.
> A review of the current knowledge/ the state of the art needed for the proper conduct of the appraisal and analysis of the clinical data of the device under evaluation and the equivalent device (i.e. applicable standards and guidance documents, information on the medical conditions that are relevant to the clinical evaluation, therapeutic/ management/ diagnostic options available for the intended patient population, etc.).
The literature collected may relate directly to the device in question (e.g. publications of clinical investigations of the device in question that have been performed by third parties, its side effects or complications, incidence reports) and/or to equivalent device, benchmark devices, other devices and medical alternatives available to the intended patient population.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
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Literature searching is used to identify data not held by the manufacturer that are needed for the clinical evaluation. Literature searching identifies potential sources of clinical data for establishing:
• Clinical data relevant to the device under evaluation, which are data that relate either to the device under evaluation or to the equivalent device (if equivalence is claimed).
• Current knowledge/ the state of the art. Includes applicable standards and guidance documents, data that relate to benchmark devices, other devices, critical components and medical alternatives or to the specific medical conditions and patient populations intended to be managed with the device.
• The searching strategy should be thorough and objective, i.e. it should identify all relevant favourable and unfavourable data. For some devices, clinical data generated through literature searching will represent the greater part (if not all) of the clinical evidence. Thus, when conducting a literature review a comprehensive search should be conducted. If a comprehensive search is not deemed necessary, reasons should be documented.
• Several searches with different search criteria or focus are usually necessary to obtain the necessary data.
• A literature search and other retrieval of data are carried out based on a search protocol. The search protocol documents the planning of the search before execution.
• Once the searches have been executed, the adequacy of the searches should be verified and a literature search report should be compiled to present details of the execution, any deviations from the literature search protocol, and the results of the search.
• It is important that the literature search is documented to such degree that the methods can be appraised critically, the results can be verified, and the search reproduced if necessary.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.