Transcript:

Hi everyone, for this video I thought it would be helpful to talk about the importance of a gap analysis.

For anyone who is not familiar with the term, gap analysis or gap assessment, to put it simply, it’s a review of the current state of project or product materials against an end goal, and associated industry regulations. Essentially identifying the “gaps” or missing pieces to meet said goal and satisfy relevant regulatory regulations.

If you’re thinking that this sounds interesting, I’m here to tell you that really anyone can benefit from a gap analysis, especially if you have a clear end goal in mind. For example, within regulated medtech, most companies have the goal of achieving FDA clearance, whether that be through the 510(k) or DeNovo pathway, the goal is to ensure that the FDA clears the device for use and sale. With this goal in mind, there are many activities and milestones that need to be met to achieve this clearance.

At this point you may be thinking that a gap analysis is necessary for your product or project, but unsure about who should conduct this assessment. Most beneficial is for a 3rd party evaluation to come in and assess your product or project, so finding a trusted partner or consultant that is intimately familiar with the process of achieving your goal and meeting those important regulatory or industry regulations is crucial. They’ll be able to provide notes and tips based on successful experience to ensure you understand all of the activities you need to complete. This may include a list of product or software documentation essential for the project, a thorough review of software requirements, risk assessment, or even examining existing code to identify gaps in the design or missing safety and security components.

Typically, you should get some kind of thorough report that describes all of the areas in which gaps were identified, as well as areas that meet the expectation or standard of design or development for your specific goal. The areas where gaps have been identified should describe, in depth, how you can close that gap to appropriately execute the activity in question. This kind of information is invaluable as it takes out much of the guess work as to what needs to be done and really paints a picture of how to go about meeting a specific milestone or activity.

Aside from using the gap analysis as a guide throughout the product development process, you can take this analysis and present it to board members, investors, other project stakeholders to ensure everyone involved understands what activities and milestones are necessary to achieve your ultimate goal. Often, a gap analysis will be incredibly useful and beneficial during a fundraising round as it really does show investors that you are really taking your product or project seriously, having invested some money up front just to ensure it gets started on the right foot.

Investing in a gap analysis could be one of the smartest moves that you make and help your product get to market faster, with fewer surprises, and in the most efficient manner, reducing any unnecessary work that may have otherwise been completed.

If you’re not sure where to get started, feel free to give us a call or send us an email. We’re always happy to discuss your options and help you get moving in the right direction.