Gap Analysis: what is and how to perform it

The Gap Analysis is to be understood as an investigation of the deviations that allows to compare the current condition (as-is) with the desired one (to-be) in reference to sector best practices, voluntary standards, legislative regulations, internal objectives, etc. Similarly, the gap analysis is to be considered as a necessary evaluation in all those cases in which it is regarded essential to search for the reasons for the same deviations, in particular the significant ones, between data and key variables of a project.

A gap analysis is applicable in different fields, such as:

A Gap Analysis, in any area it should be carried out, must be developed according to 4 precise steps:

  1. Analysis of the current condition (as-is)The goal of the first step is to analyze everything, documentation, data, processes, inspections, providing a clear picture of the current state.
  2. Identification of deviations and criticalitiesThe goal of this second step is to highlight the deviations and criticalities that emerged after the analysis of the current condition (as-is).
  3. Definition of the to-be modelThe goal of the third step is the description of how the condition should present itself, so that the defined goal can be achieved.
  4. Gap AnalysisThe goal of this last step is the identification and the global and schematic assessment of the gap, or the deviation between the current condition (as-is) and the expected model (to-be). This step generates the definition of actions aimed at reaching the desired state level.

It is good practice to define the priorities for implementing the necessary actions.

The above 4 steps give rise to a single document, perhaps tabular, in which to report the requirements identified in the as-is, the deviations and criticalities, the expected requirements as to-be, the activities needed to meet the expected requirements, the priority of the actions to be implemented. 
The document, with this information, can be considered the complete output of the gap analysis, as its objective is not only the identification of the gap, but also the global assessment of the gap to be filled, as well as the definition of activities and necessary resources to be put in place to comply with the reference standard.
Gap analysis is, therefore, an extremely effective and useful tool to ensure an objective and independent assessment of the actual condition, to provide strategic indications to close the gap, to optimise the resources to be deployed with a clear indication of expenses to be incurred and investments to be implemented.

Going into the regulatory framework in the medical device sector, gap analysis must be considered a fundamental tool to be used, especially in light of the entry into force of the European Regulation 2017/745 (MDR) which requires the adjustment of all CE marked medical devices according to European Directive 93/42 (MDD).
Conducting a gap analysis to assess gaps of documentation and process regarding of a medical device between MDD and MDR means performing a thorough, independent and timely analysis of the measures to be applied in order to ensure that the medical device is in compliance with the mandatory legislation.
The gap analysis therefore becomes the peculiarity of medical devices created so that, when completed the strategically useful actions to bridge the identified gaps, it can be modeled in full compliance with the European Regulation 2017/745 (MDR).