How to Navigate Medical Device Radio RegulationsHow to Navigate Medical Device Radio Regulations

Medical device companies sometimes seem as though they're playing catch-up with high tech when it comes to using wireless communications tools. But there may be a pretty simple reason: "There's a lot more regulatory approvals required," says Nicholas Abbondante, chief engineer at Intertek.

Sure, medical device industry professionals are pretty used to regulations, and the way they vary from country to country. They need to be prepared for a different animal of a problem, however, when adding in networking, USB, Bluetooth, and wireless capabilities to their devices, Abbondante says. (See Abbondante discuss regulatory challenges around wireless medical devices on Wednesday, October 15, at MD&M Chicago.)

"Even using a module doesn't mitigate all of them. Modules are often only approved, say for the U.S., Canada, EU and Japan. If you have a list of 170 countries, suddenly you're finding out that your time to market is going astronomically high and your cost is going astronomically high," Abbondante said.

"You thought you had a solution you sourced in the form of a radio module, but now you find out that in every country you go to, you have to go through some kind of regulatory process for the radio itself to get it certified," Abbondante said. "Sometimes it requires in-country testing. Sometimes it requires documentation package. Regardless, that can add a lot of time to the process."

It can get even worse if you're designing your own radio. Then there is even more to prove with regulatory agencies such as the U.S. FDA.

"Usually with the radios, there's a higher level of certification required in most countries," Abbondante said. "Suddenly your lead time has gone up by months if not years."

Besides the various regulatory requirements, there's the issue that the frequencies are not always the same in different countries, Abbondante said. "You might source a radio and find it's only legal in particular countries. So you need to source a different radio for other countries."

Also add on all the regulations around cybersecurity and information privacy.

The situation goes a long way to explain why medical device companies aren't fast adopters of mobile health. High tech companies such as Apple and Google, which seem to be increasingly branching into health care, may soon have this regulatory world to deal with, too.

"There are medical apps or fitness apps to measure biometrics. A lot of times, those have skirted past the medical device rules because they were considered fitness devices or weren't considered medical devices. But the area is getting grayer and grayer," Abbondante said.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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