Building the case against Apple developing a medical device

By Brian Dolan
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masimoWhile the most recent meeting made headlines, the first time Apple executives actually met with the FDA wasn't at the end of 2013, but rather three-and-a-half years ago. The Financial Times pointed this out earlier this month.

On June 11, 2010 Apple's Vice President of Software Technology Bud Tribble and the company's VP of Worldwide Government Affairs Cathy Novelli met with the FDA's Director of the Center for Devices and Radiological Health Dr. Jeffrey Shuren and his colleague at the agency Alberto Gutierrez. According to the FDA's public meeting log sheet the topic discussed was "medical devices".

At the time the FDA was formulating its draft guidance on mobile medical apps (MMAs), which would eventually publish about a year later. The number of FDA clearances for mobile medical apps was ramping up around then too. In 2010 the FDA cleared 12 mobile medical apps as medical devices, up from six the year before. By 2013 that number would jump to 24 MMA clearances for the year.

The December 2013 meeting between Apple and the FDA was focused on "mobile medical apps", according to the agency's public meeting log. It is likely both meetings were focused on this subject, but in mid-2010 the FDA hadn't yet coined the technical term for a regulated medical app, which are in effect medical devices.

Apple's 2013 meeting with the FDA included a larger contingent from Apple. Tribble and Novelli were present but three other Apple employees joined them. Jeff Williams, Apple's SVP of Operations was one. While he wears a lot of hats at Apple, 9to5Mac reports that Williams also leads special projects at the company and is believed to be running the rumored iWatch project. Another meeting attendee was Tim Powderly who works with Novelli in government affairs. Lastly, and perhaps most tellingly, was relatively new Apple employee Michael O'Reilly, the former CTO of medical device maker Masimo.

Masimo has been making traditional medical devices since the late 1980s, but it launched its first and only direct-to-consumer product at the end of 2012. The iSpO2 is an iPhone-enabled pulse oximeter intended for use by mountain climbers and airplane pilots -- two groups that worry about their blood oxygenation levels. While the company pitches the device as having a fairly niche and nontraditional use case, the marketing claims helped it to avoid FDA regulation of the device.

In addition to blood oxygenation, the device measures pulse rate and perfusion index (the strength of the arterial pulse), using the same pulse oximetry technology as Masimo’s medical products, according to the company. The companion iPhone app collects that data, charts it over time, and can help users email it to friends.

Consider why Apple might have brought Mike O'Reilly to that meeting -- the only member of the Apple team with hands-on medical device industry experience. His former company's only direct-to-consumer product was an iPhone-connected health device known for cleverly avoiding FDA regulation.

Wouldn't Apple recruit and bring along someone who had successfully navigated the FDA clearance process for smartphone-enabled medical devices, if they were looking to do the same? If Apple is working on a health tracking device and companion software, as has been widely rumored and as we have heard from our own sources, the company will be careful not to add any functionality or make any claims that would push it into FDA regulated territory.

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