The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry. On the other hand, getting too specific in the data and focusing on one particular product category can prevent a company from seeing the forest for the trees.
Recently, I was asked by companies interested in the field of digital medical devices used in the care of people with diabetes to help them assess trends in the regulatory environment. To do that, I decided to create an index that would capture the regulatory environment for medium risk digital diabetes devices, trying to avoid getting too specific but also avoiding global data on all medical devices. In this sense, the index is like any other index, such as the Standard & Poor 500, which is used to assess the economic performance of the largest companies in terms of capitalization. My plan was to first define an index of product codes for these medium risk digital diabetes products, then use that index to assess the regulatory environment in both premarket and postmarket regulatory requirements.
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