A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims not meant to be taken literally. Instead, I got the following nugget of awesome: So it would be like saying I ate a whale, when I really ate a cupcake? I think my response was laughter and "Sure, something like that..."

Which brings me to the point today about the use of hyperbole with regard to changes in medical device regulation. The mobile medical applications development industry is a perfect example. When the FDA's guidance came out regarding medical apps, the industry spun themselves into a tizzy. After further examination of the guidance, though, it was somewhat high-level in its content and, essentially, made the statement that mobile software could be classified as a device based on its intended use.

But, despite the hope that cooler heads would prevail, developers roared that innovation would be stunted and that patients would suffer. They exclaimed that it is very costly and overly lengthy to seek 510(k) submission and substantial equivalency ruling. It would set back the industry. I think we've had our first whale sighting, Captain Ahab.

On the contrary, our succulent cupcake example is the first software to receive substantial equivalency ruling by the FDA - the MIM Software MobileMIM application. The software is intended for viewing radiological images on mobile devices. It's a fantastic idea that makes image viewing more convenient for the physician. But the regulations caused them undue delay, cost an exorbitant amount of money,and destroyed their innovation, right? Not so much...

The 510(k) summary, which can be found in the public domain within FDA's databases, shows that the FDA received the submission on December 27, 2010. The substantial equivalency ruling was granted on February 4, 2011. That equates to 38 days (minus federal holidays, so even shorter!). The 510(k) was submitted as a traditional 510(k), which is given a 90 day review clock by law. By my standards, that is a reasonable-if-not-excellent time-frame for a SE decision.

Then, of course, is the cost (time and money) to submit a 510(k). The submission fee itself isn't outrageous - a mere $2,480.00 for small businesses. The expensive part is time and money required to create the records and conduct the testing required for a successful 510(k) submission. The costs can be high, but for good reason. Other than damage to a gamer's ego or patience, there is little consequence to glitches or issues experienced when playing Angry Birds. Oh no... you didn't kill your piggie? Try again. Restart the device. Close the game. But a glitch in a medical image used for diagnosis or determining the need for surgery? Not as trivial as a piggie, I assure you.

From a perspective outside of medical devices (or a strictly regulated industry in general), I certainly understand calling a cupcake a whale. But the process of finding the correct ingredients, being diligent at mixing the batter properly, and keeping a close eye while it bakes will taste much better than Ahab's prey. MobileMIM has found their german chococolate cake with chocolate icing ring, filled with ganache and topped with coconut shavings.


Image Credit: D. Fletcher on Flikr

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