The first rule of FDA regulation of mHealth: You don’t talk about FDA regulation of mHealth



An interesting Gigaom article by Stacey Higginbotham on how “The FDA wants to regulate your connected toothbrush” gave me some thoughts:

Bluetooth Toothbrush

In my book mobile connected toothbrushes are in the cool category up there with “sharks with frickin lazer beams” as I see it as a small jump from a connected tooth brush to many other medical devices (and no doubt an important part of the move beyond the handset) and it’s remarkable that tech like this will be available from October 2012 from only $35 (for the base + $4 for the replaceable heads).

I also have a few reservations that will probably stop me becoming the worlds biggest fan of bluetooth toothbrushes:

1) I’m not sure it’s going to make a big difference as there are simpler ways of timing yourself brushing
2) As with those WiFi CCTV baby monitors I’m cautious of any unnecessary use of any radio devices by children (and from checking out the companies website it’s quite clear this is going to be the targeted end user)
3) I’m concerned that tech like this is part of a trend that’s making children increasingly reliant on tech. Educating a child about dental hygiene is itself a great opportunity to open parental dialogue, create good habits and reinforce health messages. Lots could be lost if we just try to substitute iPhone apps for such important parent/child experiences.
4) It’s quite easy to see ways to game this device so it’s never going to be a way of ensuring a child is brushing their teeth anyway (they might brush their dolls hair etc)

The FDA Deterrent

I’ve mentioned before how Tech R&D giants like Qualcomm are chasing dead ends as a result of FDA requirements but this article also highlights the problem that clearly exists at the other end of the spectrum with garage developers:

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… …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

Here we have a classic case of yet another talented mHealth innovator deliberately spending their energy and talents trying to work on the periphery rather than get stuck into real problems simply because of the FDA.

Whilst I know most people would probably think it weird but everytime I see something like a smartphone mounted on a golf club or the rear headrests in a car with no back seats I fail to see anything more than an innovator that has the talent and insight to connect anything but who has applied themselves to an unregulated market rather than tackle a more involving challenge like those associated with healthcare.

The cost of this deterrent to innovation is anyone’s guess but I’d say today the healthcare industry is missing out on billions of dollars worth of innovation as healthcare regulation encourages the best mobile minds to think of cool mobile money, gaming or gambling services first.

Regulators should be careful not to make the healthcare industry even less appealing than it already is to outsiders as there are massive new opportunities to create value from connecting healthcare.

Is the FDA playing it by ear?

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

Will Communities bring openess to the FDA?

in March, (the FDA) 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

From the comments: “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

I think it’s going to get increasingly difficult for the FDA to operate in the healthcare space as it becomes much more consumer focused without much greater openness in the way that it operates.

Communities Dominate Brands is a great book that highlights the challenges and opportunities in this new world and so that this post isn’t seen as the response of an armchair critic I’m happy to buy you a copy if you work for the FDA in regulating mHealth (just say hi in the comments).

Why isn’t mHealth business as usual for the FDA?

Unique from the medical device and pharma markets that the FDA already attempts to regulate the mHealth market is up against large countermarkets that the FDA has no influence over eg. mobile advertising is being used to draw associations between sport and fructose syrup soft drinks and sugary sweets, sell adult rated content to minors, promote 2 for 1 offers on fast food, etc, etc.

If you’re unfamiliar with these issues please read “Another 500 million reasons why I think the FDA has got it all wrong about mHealth regulation

A sign that the FDA has no intention of impacting on this critically important counter market can be seen in the definition given for a “mobile medical app manufacturer” that lets mobile app store’s (the gatekeepers for in-app and app-store ads) completely off the hook:

is defined as any person or entity that manufactures mobile medical apps in accordance with 21 CFR Parts 803, 806, and 807.7 This term does not include entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions; examples of such distributors may include owners and operators of “android market”, “iTunes store”, and “BlackBerry App World”

To begin to appreciate this consider that this definition essentially enables a situation to exist in which you can develop a healthy eating app that Doctors could prescribe to patients, jump through all the necessary hoops with the FDA and then patients using your app can be bombarded by the app store ad networks with location based ads everytime they’re in the proximity of a fast food store.

Next step for the FDA

There is an undisputed need for regulators and for an appreciation of the views of mHealth critics but a regulator needs to get subject matter experts in first so they can lead rather than follow and take a much more open approach so that they are seen to play fair with large and small firms eg. while we’ve now read about the FDA’s interest in Beam’s BT Toothbrush we’ve not heard anything about their conversations with the various mHealth devices that are already being retailed in Apple stores even though these seem to present a much higher risk profile eg. a timer for a child brushing their teeth Vs that same child getting lost.

Innovators need the opportunity to build on the work of one another and in my opinion it’s the brave innovators like Alex Frommeyer who are best placed to contribute most to the creation and development of the FDAs guidelines in this new area.

In 2012 the expectation we have for access to information and the recognised value of patient contributions are inconsistent with the FDA Approval process and there is an abundance of evidence to support this. The market should be under no uncertainty about what patient safety issues the FDA was concerned about relating to this toothbrush and to assure patient safety and reduce bureaucratic processes going forward it needs to be a simple process to view, add to and comment on the reservations and concerns the FDA has/had about any such regulated product/service.

Would a read/write approach really make a difference?

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10 Responses to The first rule of FDA regulation of mHealth: You don’t talk about FDA regulation of mHealth

  1. Pingback: The first rule of FDA regulation of mHealth: You don’t talk about FDA regulation of mHealth | healthcare technology | Scoop.it

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  3. geoffclapp says:

    The FDA has a lot of problems, but you left out the quote where the article said “Thankfully the FDA worked quickly” – getting a Class I is super, super easy. Getting a Class II is super easy. 510(k)s are not hard. 90% of mHealth today falls into this category of very simple “document and show” processes.

    Remember even a tongue depressor is a Class I 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.

    The biggest thing holding back mhealth is business model innovation, which you correctly point out in the start of the article.
    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 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.

  4. Hi Geoff, thanks for not taking my advice and talking about the FDA!

    Maybe I haven’t made it clear, I’m not actually calling for the FDA approval process to be made “easy” or “simple” but more transparent.

    The FDA has the opportunity to protect and promote public health by lending it’s weight to the mHealth market. Consumers would benefit if they could look to it as an arbitrator of what is safe but I’m not sure that’s what it’s doing eg. I’m sure I’m not the only one who would love to know why the FDA thinks it’s safe for children to rub their teeth with a radio.

    The fact that there are “AppStores full of ineffective, unsafe products” is itself creating a wild west that is regulating mHealth. The presence of ANY quality assurances will clearly tip the balance that the app review/rating processes have created and may create unwarranted trust in these apps by patients and medics.

    I think in the hyper connected world in which we live we need providers of any assurances to be as open as possible about how and why they make decisions. Without this approach I’m sure the market will quickly self correct and the regulators themselves will quickly be caught out of their depth…

    • geoffclapp says:

      I’m not sure how to take that first sentence, but it seems like I we might be agreeing but moving past each other.

      I totally agreed with your first section (about safety), and I’m all for more transparency on safety and the FDA (insert long conversation I’m not qualified to talk about on GMOs here) – never mind efficacy (which is outside the scope of a 510(k) Class I).

      I will admit I got a mixed message in your blog, about should the FDA be regulating this or not (I’m reacting to terms like “reduce bureaucratic processes”) – maybe it’s just me, as the reader, not clear exactly which position it’s taking. I think we agree on a lot of it, but maybe I’m misunderstanding.

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