As healthcare industry professionals, we often find ourselves searching for medical devices across the FDA databases. When working on a new product, for instance, Regulatory Affairs professionals might search for classification options, or similar devices to serve as predicates (in case of 510(k)). Alternatively, they may be on the lookout for newly cleared/approved devices, to be included in an annual Post Market Surveillance report.
Personally, as a Product Manager and Marketer, I often search through the FDA databases for existing cleared/approved devices, to map competitors or identify new players. And these are just a few examples of device searches per se (that is, I’m not even talking about Adverse Event or Recall searches, or searches for Warning Letters, etc.).
The FDA maze
Now, if you’ve ever searched for devices or classifications on the FDA website, you might have encountered, like me, the maze-like nature of this interface.
What I mean is that you need to go through different screens and tables until you finally find the info you’re looking for, be it the product code you’re looking for, or a list of devices that have the same indications for use. One of the biggest issues is that devices’ Indications for Use and/or Intended Use are not searchable. So, you end up having to open multiple 510(k) summary documents until you find what you’ve been looking for. This process is of course extremely time-consuming, and the chances of missing important information are high. Moreover, since the FDA keeps its data separate by device class (I,II, III)… you need to know at least the relevant device class before starting your search (and what if you don’t ?!).
Bottom line, the FDA maze is a significant time drainer!
Tracing device “lineage”
Another cumbersome task is understanding device predicate “lineage”. For instance, Regulatory Affairs specialists sometimes wish to find the original predicate device in a given product code, to track the evolution of FDA’s expectations from that code (which would be the topic of a whole separate article in and of itself). Alternatively, they may be searching for “descendant” devices, to find more recent predicates. Either way, tracing device lineages is a daunting, tedious task, as here too, you must dig into 510(k) summary documents to find the relevant details.
We need a new way of searching for medical devices on the FDA databases so that we can start spending less time searching and more time focusing on value generation.
A new way of searching across the FDA databases
Well, I’m happy to say that, with Kimi, we’ve taken initial steps to enable faster and easier ways of searching for medical devices across the FDA databases. Kimi allows you to search across class II and III devices in one go, and more importantly, to map predicates and descendant devices, over multiple generations, with just one click! Kimi also allows you to search for terms that are used inside 510(k) documents (like Indications for Use and Intended Use statements, or Device Description), and much more.
These are very early days for Kimi, we have a lot more time-saving functionality planned, and I’m eager to see where your feedback will guide us from here!
