In a much talked-about post at his blog Creative Connectivity, British wireless technology guru Nick Hunn warned the industry that its "crying wolf" over coming FDA regulations will create more problems than it will solve.

"That degree of fear of the FDA regulations is putting established companies off from coming into that market," he told DOTmed. "It's causing concern for startups, and perhaps most worrying of all, it's making investors wary of putting money in a company if they have to go through a protracted approval process."

"[Investors] don't like things with a five-year approval cycle," he said.

Hunn worries that eventually U.S. companies, fearing FDA oversight, might stick to sports and fitness applications - largely unregulated by the agency - which means the United States will suffer as "most of the disruptive medical innovation will happen outside the United States," to the benefit of foreign startup companies.

This is bad not just for the bottomlines of would-be medical app entrepreneurs, but, Hunn thinks, for the system as a whole.

"There's a lot of concern that we're not going to see change in health care costs if we do it the way the medical community wants to do it. They do very well, thank you, out of the current system. We need something more disruptive," he said.

And, in fact, Hunn calls for a more decentralized approach to health care technology in the States as he hopes an alliance of software companies and patient advocacy groups can fight back against what he sees as the FDA's perhaps overweening authority.

"The FDA has really quite amazing powers. It can regulate almost anything to do with the health of anybody living in the U.S. and any pets and farm animals," he said. "But like most regulators, they move at an amazingly slow pace."

This slow pace, Hunn thinks, is applauded by traditional medical device manufacturers who benefit in some ways from the medical device regulatory environment that makes it hard for competitors to emerge.

"GE, Medtronic, are more than happy for regulation to stay the way it is," he said. "The best way to change it is to have network operators, consumer group manufacturers, coming in and sitting down as a body with the FDA to tell them, 'Look, the world is changing, technology is changing. You need to change so you can reflect and safely regulate the industry in the new form.'"

Hunn acknowledges that the FDA's main problem is that, as he puts it, "if they get something wrong, people will probably die. That's the risk and that's why they exist."

But he says its feeling that if it regulates strongly enough, it's not going to happen, might be short-sighted.

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