Even if the product is regulated, not all regulations are equally tough.

If the medical app is substantially equivalent to one already out on the market (for example, two kinds of nearly identical image viewers), then the new product can go to market simply by proving substantial equivalence (strong similarities), Thompson explained. This is the 510 (k) process that the FDA rejected for Mobile MIM. But, as with Mobile MIM, if the FDA determines there is nothing already out there that's like it, the company will have to reclassify to create a designated category, or it'll need to navigate through a premarket approval application, which can be more difficult.


"The premarket approval application is a very resource-intensive process of doing clinical trials and proving the clinical safety effectiveness of their products," he said.

Culture clash
Software companies entering a regulated medical app field are also apt to face a culture clash. The Silicon Valley startup culture might be unaccustomed to the buttoned-up oversight culture of Bethesda.

"I think there's a cultural problem that the app makers are software companies unused to regulation," Thompson said. "They're using their old business model of quickly generating new software versions, trying to be first to the market, hoping that theirs will get all the brand recognition."

But for medical technologies, being first is sometimes a liability. The greater load of the regulatory burden often falls on the first one to make the product.

"The pioneer has a tougher row to hoe because they have to basically navigate where there's no map," Thompson said. "They have to figure the pathway through the agency and provide a certain amount of data and information to establish the right to market the product.

"Others can follow quickly on their heels, by proving they're just like the pioneer product. Oftentimes, that's an easier thing to do."

Since launching medical products requires deeper resource investment to address FDA regulations, the costs and effort involved do act as a barrier to entry. It can still pay to get to market first. It's likely competitors will still have to clear some hurdles, giving an opportunity for the pioneer to establish its product and be more likely to hold onto a top spot in that sector.

Crying wolf
However, not everyone thinks that the FDA's toughening stance is the problem. Regardless of what the FDA decides to do, some think the media's and industry's public panicking over the coming involvement could end up doing some of the greatest injury to the nascent business.

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