Forecasting for Success: The Power of Regulatory Gap Analysis

http://www.amarexcro.com/articles/docs/RAPS_Focus_Gap_Dec2008.pdf

This paper offers a broad plan for conducting a regulatory gap analysis for biomedical products, a definition of gap analysis, when and how to use gap analysis, and the benefits of conducting a gap analysis.

"Fewer than 1% of all biomedical products conceived move beyond preclinical testing, and fewer than 10% of those products make it onto the market." Thus biomedical product developers need to harness their time wisely to improve these statistics. Conducting a gap analysis is one way to cut down on both preclinical and clinical testing times.

The paper defines gap analysis as "the process of reviewing all available information for a candidate product to assess current development status, identify potential gaps in information required for subsequent steps, and develop a strategy to fill those holes."

According to the authors, the ideal time for performing a gap analysis is in the preclinical stages. This will allow for an understanding of the products unique nature. A particular focus of the information collection step needs to be on regulatory thresholds, precedents, and milestones. Once the developers know where their gaps are located, they can formulate a strategy for developing the product according to the standards set forth by regulatory bodies. The authors suggest sharing the action plan with the regulatory board to understand their concerns over the future developmental stages.

Aside from forming the basis for a developmental plan, their are other benefits to conducting gap analysis. First, it eliminates unnecessary developmental research and development testing. With the biomedical industry in particular, time is a precious commodity. Also, the gap analysis will aid in the speed in which regulatory agencies review and approve the product, since it knows the steps the developers are following. Troubleshooting these concerns will save a lot of headache later.