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Summary:

Beam Technologies got FDA approval for its connected toothbrush today — approval it never thought it needed. But its story shows how the FDA is paying attention to startups seeking to add connectivity to medical devices and maybe even medical apps to regular smartphones.

BeamLitUp

Alex Frommeyer, the CEO of a company making connected toothbrushes, ended February thinking he was about to launch his Bluetooth-enabled brush in the following month. But the Food and Drug Administration had different plans. In March, the month the brush was supposed to launch, the FDA called him up and said that it needed to approve the product.

Today, roughly four months after the FDA intervened, Beam Technologies scored the FDA’s approval to market its Beam Toothbrush, and Frommeyer is happy to report that the brush should now arrive in retail stores and online in October. But the backstory of this approval is one that many startups seeking to add connectivity to medical devices — or maybe even medical apps to regular smartphones — should read.

As more startups seek to enter the medical IT space with connected devices, apps or new services, the looming threat of the FDA’s famously lengthy approval process is something most want to avoid. Corey Ackerman, president of Happtique, once shared an anecdote with me about a doctor who got approval for a medical app that was certified on an early version of the Android operating system only to realize that technically upgrading the app to later OSes would void the approval. But the FDA is aware of the ecosystem that’s seeking to connect medicine and tech and last year even pulled together a report trying to figure out how it should be regulated.

But the agency is not waiting around to figure out its strategy, based on Frommeyer’s experience. The FDA is aggressively arguing that adding connectivity and/or sensors to a medical device changes into a new class of device that needs FDA approval.

In February Frommeyer went public with his plans to build and market a toothbrush that used a Bluetooth radio and sensors to connect the toothbrush to a smartphone app that would track how long someone brushed and also offer music and entertainment while brushing. At the time, he told me one of the reasons he chose to build a connected toothbrush was that he didn’t need FDA approval, he only needed to submit the brush’s design. He told me:

On a practical side, dentistry is an easier entry point into the medical field because the Food and Drug Administration has more lenient rules for approving toothbrushes. They are medical devices, but as long as someone submits the design to the FDA, he can sell it. That means Beam can sell its toothbrush without spending millions and waiting for FDA approval.

However, the FDA disagreed and in March, called Frommeyer up and argued that because the connected toothbrush was essentially a new class of toothbrush (which the FDA classifies as a medical device) it would require the agency’s approval. Frommeyer didn’t like it, but he didn’t have much choice in the matter. “I thought their argument was weak, but what could I do,” he said. Thankfully the FDA worked quickly, got the documentation around connected toothbrushes that it needed and today Frommeyer got his approval.

That means the Beam toothbrush will hit the market in October with a retail price of $50 for the base and $4 for the replacement head. Folks who want a discount can visit the web site and pre-oder the base for $35 if they’re so inclined.

So perhaps the next frontier in the quantified self will involve dental data. Although personally I’m more excited about using it to help my five-year-old daughter get excited about spending the full two minutes brushing her teeth and seeing that she’s doing so using the data, instead of standing over her shoulder and nagging her.

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  1. antonwahlman Friday, June 29, 2012

    A government large enough to….

  2. Dear FDA – perhaps when you’ve done something to: prevent multiple E.Coli outbreaks/year, fast-track approvals on life/death oncology drugs, address the growing problem of shortages on approved drugs, and perhaps encourage some innovation on devices like insulin pumps/meters – then you could worry about……toothbrushes.

  3. another government agency stifling innovation because they haven’t figured out a way to make $ from it.

  4. This is not really a problem of mHealth, per se – remember even a tongue depressor is a Class I 510(k) device. http://www.accessdata.fda.gov/cdrh_docs/pdf/k992995.pdf

    Could the process be improved? Certainly, unquestionably – but the idea that the FDA is holding back innovation is a little overstated. Getting a 510(k) is just not that hard.

    I’ve talked to Alex a few times, and I am sure he will be a great entrepreneur, either with this or something else, but the FDA is not going to make or break his business.

    I am no FDA apologist – after more than 7 510(k)’s and many on-site audits (including a 510(k) where no good predicate existed), I have lots of beefs with the FDA.

    At the same time, I’m not sure our market is served well by a total lack of regulation, either – the downside is AppStores full of ineffective, unsafe products (if it’s not already that way) that turn people away from mHealth.

    There’s a balence, and that’s what we should be striving for.

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