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Apple execs met with head of FDA to discuss 'mobile medical applications'

post #1 of 24
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A report on Friday reveals high-ranking Apple executives met with FDA Commissioner Margaret A. Hamburg and others in December over "mobile medical applications," strongly hinting that a so-called iWatch with health-centric features is well into development.

FDA
Source: FDA


As noted by The New York Times, senior Apple executives discussed medical electronics with Food and Drug Administration officials on Dec. 13 of last year, though the details and outcome of the meeting are unknown.

According to the FDA's public calendar listing, Apple was represented by SVP of Operations Jeff Williams, VP of Software and Technology Bud Tribble, Michael O'Reilly and government affairs counsel Tim Powderly.

It was reported on Thursday that O'Reilly was hired some time last year in an undisclosed role, though the executive's pedigree is in medical devices. Before moving to Apple, O'Reilly held the position of chief medical officer and executive vice president of medical affairs at pulse oximeter firm Masimo Corporation. He currently currently teaches anesthesiology at the University of Michigan and the University of California, Irvine.

Attending the meeting for the FDA was Jeff Shuren, director of the body's Center for Devices and Radiological Health, and Bakul Patel. The publication described Patel as a "staunch advocate" for patient safety, noting that he drafted the agency's mobile medical app guidelines.

While the reason for the meeting is unknown, Mark A. McAndrew, who spotted the meeting and is a partner at law firm Taft Stettinius & Hollister which handles health and science issues, said the high-level meet-up was anything but ordinary. McAndrew speculates Apple may either be looking for ways to clear regulatory hurdles ahead of a medical device or app launch, or is trying to push something through the FDA after seeing setbacks.

Most interesting is O'Reilly's presence at the meeting. Being a fairly recent hire, his attendance suggests at least one topic of discussion was a device capable of reading a user's pulse rate. Alternatively, Apple may have selected O'Reilly to head up the iWatch team.

Apple is widely rumored to be developing a smartwatch that some expect will have built-in health monitoring capabilities, along with other on-the-go applications. Most wearable devices on the market act as an accessory and connect with a smartphone or other device. Apple's solution is thought to work in much the same way; gathering information for specific iPhone or iPad apps, while serving as a remote screen for viewing of emails, messages and other correspondence.
post #2 of 24
The Apple way, not just a watch but something much more.

Whatever it is, it has been in development for years, the medical aspect may come from an idea Steve Jobs had while sitting in the hospital when he initally got sick.
Edited by Danox - 1/31/14 at 8:04pm
post #3 of 24

That's one disadvantage of developing a medical device: so much regulatory approval is required that Apple won't be able to maintain their usual secrecy. 

 

But yeah the evidence is stacking so high now for *something* medical to come from Apple, I am really curious to see what it is.

 

I wonder if there's a way, through monitoring of pulse etc, to "optimise" an amount of exercise?

post #4 of 24
Quote:
Originally Posted by AppleInsider View Post

McAndrew speculates Apple may either be looking for ways to clear regulatory hurdles ahead of a medical device or app launch, or is trying to push something through the FDA after seeing setbacks.

I have some experience in preparing documents needed to gain FDA approval regarding medical diagnostic equipment and it has always been pretty smooth. I suppose it gets easier once you have received approvals for similar products in the past. Now we just send them a nice glossy brochure with some forms and filings. The equipment does not have to be evaluated physically or even exist in a production version. FDA is a piece of cake compared to Canada. 

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post #5 of 24
Quote:
Originally Posted by ascii View Post
 

That's one disadvantage of developing a medical device: so much regulatory approval is required that Apple won't be able to maintain their usual secrecy. 

 

But yeah the evidence is stacking so high now for *something* medical to come from Apple, I am really curious to see what it is.

 

I wonder if there's a way, through monitoring of pulse etc, to "optimise" an amount of exercise?

 

Well the whole objective of CrossFit is to keep your heart rate at a certain level, which is supposed to burn fat and be a better overall workout, so I'm assuming through pulse, you can find the 'right' heart rate to be working out at. 

post #6 of 24
Quote:
Originally Posted by justp1ayin View Post
 

 

Well the whole objective of CrossFit is to keep your heart rate at a certain level, which is supposed to burn fat and be a better overall workout, so I'm assuming through pulse, you can find the 'right' heart rate to be working out at. 

I have never done CrossFit but it sounds like a CrossFit app could make good use of these new sensors.

post #7 of 24

I can see it:

 

It is a Watch

It is a Communication Device

It is a Medical/Vital sign monitoring device.

post #8 of 24

Does the FDA require years of testing for medical devices like it does drugs to ensure that it is safe for the public? I don't see how a medical iWatch can be released this year.

 

Any experts here on how the FDA approval process works ?

post #9 of 24
Quote:
Originally Posted by RalphMouth View Post
 

Does the FDA require years of testing for medical devices like it does drugs to ensure that it is safe for the public? I don't see how a medical iWatch can be released this year.

 

Any experts here on how the FDA approval process works ?

Im in no way an expert, but I would assume this is all so they can say the FDA agrees with its heart monitoring... Otherwise I'm sure they can release it, with no FDA backing. 

 

I think only drugs go through the extensive testing.

post #10 of 24
Quote:
Originally Posted by ascii View Post
 

I have never done CrossFit but it sounds like a CrossFit app could make good use of these new sensors.

 

They should, or if you already do CrossFit, I could look down and see what it tells me to either motivate me, or slow me down... 

 

I think the health area of this will be huge, but even better that its just one thing that this will do... I never cared about an 'iWatch' but more and more I'm getting curious as to what the final result will be.

post #11 of 24

post #12 of 24
Quote:
Originally Posted by winstein2010 View Post
 

I can see it:

 

It is a Watch

It is a Communication Device

It is a Medical/Vital sign monitoring device.

 

Add:

 

It is a mobile payment device

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post #13 of 24
Quote:
Originally Posted by justp1ayin View Post

Im in no way an expert, but I would assume this is all so they can say the FDA agrees with its heart monitoring... Otherwise I'm sure they can release it, with no FDA backing. 

I think only drugs go through the extensive testing.

The FDA has ordered simple urine and acne testing apps removed from the appstore. If a company is claiming medical benefits or usage I'm pretty sure they have to pass FDA testing.
http://www.popsci.com/technology/article/2013-05/fda-checks-urine-test-app
http://mobihealthnews.com/13123/us-regulators-remove-two-acne-medical-apps/
http://www.geekosystem.com/fda-urine-app/

Webpage here discussing who needs FDA approval and how to go about getting it.
http://www.dawnbreaker.com/about/phase3_spr10/fda.php

EDIT: 9to5 has a much more informative article, with details of the upcoming iOS8/iWatch/iPhone features that Apple may have been meeting with the FDA about. .
Edited by Gatorguy - 1/31/14 at 4:14pm
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post #14 of 24
Quote:
Originally Posted by RalphMouth View Post

Does the FDA require years of testing for medical devices like it does drugs to ensure that it is safe for the public? I don't see how a medical iWatch can be released this year.

Any experts here on how the FDA approval process works ?

Quote:
Originally Posted by justp1ayin View Post

Im in no way an expert, but I would assume this is all so they can say the FDA agrees with its heart monitoring... Otherwise I'm sure they can release it, with no FDA backing. 

I think only drugs go through the extensive testing.

No, anything that is listed as a "medical device" is highly regulated by the FDA. For example, a bed used in a nursing home is considered a "medical device" and must meet a large number of requirements set by the FDA.

Apple may want to avoid their unannounced product being considered a "medical device" thus avoiding a long process of meeting FDA specs that haven't even yet been proposed. The nature of Apple's product and even how it may be advertised is highly regulated, or may be highly regulated, by the FDA, depending on what words are used to promote the product. If Apple pitches the product for use by the fitness industry it may have more leeway in advertising and speed to market. If the FDA insists that the new product is a medical device, then it's a whole new ball game. Perhaps, Apple is planning for a group of products, some of which may blur the lines between consumer and medical use.

Here's another example: If a cosmetic company develops an anti-aging cosmetic, they can do so without encountering the FDA as long as they make "cosmetic" claims, if they use words that describe the improvements in medical terms, the FDA will fly up their butts like a swarm of bees.
"That (the) world is moving so quickly that iOS is already amongst the older mobile operating systems in active development today." — The Verge
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post #15 of 24
Quote:
Originally Posted by winstein2010 View Post
 

I can see it:

 

It is a Watch

It is a Communication Device

It is a Medical/Vital sign monitoring device.

 

are you getting it? These are not three separate devices, this is one device, and we are calling it... iWatch

 

http://news.rapgenius.com/Steve-jobs-iphone-keynote-2007-annotated

post #16 of 24
Quote:
Originally Posted by Gatorguy View Post


The FDA has ordered simple urine and acne testing apps removed from the appstore. If a company is claiming medical benefits or usage I'm pretty sure they have to pass FDA testing.
http://www.popsci.com/technology/article/2013-05/fda-checks-urine-test-app
http://mobihealthnews.com/13123/us-regulators-remove-two-acne-medical-apps/
http://www.geekosystem.com/fda-urine-app/

Webpage here discussing who needs FDA approval and how to go about getting it.
http://www.dawnbreaker.com/about/phase3_spr10/fda.php

EDIT: 9to5 has a much more informative article, with details of the upcoming iOS8/iWatch/iPhone features that Apple may have been meeting with the FDA about. .

First time post, after watching this forum (the good, the bad, the ugly) for many years.

Thanks for the links.

The FDA has, in two of your links, requested information from the developers as to why they have not sought FDA approval. They have not demanded removal of the app at this point in time, & it is still available. It is highly likely that the app will remain in the App Store, with subsequent FDA approval.

 

The link concerning acne treatments is about apps that have been removed from Android Marketplace & the App Store in 2011, not by the FDA, but by request from the FTC (based on lack of scientifically verifiable studies of efficacy).

 

Unrelated to your post, but posted for interest - a few years ago, Steve Jobs specifically commented on the medical device field (I think it was at an All Things D conference - still searching for the link). Basically the gist of his comment was that existing medical devices have very complex user interfaces, & that Apple could probably contribute to this field. Specifically, Steve stated "as it turns out, user interface is something that Apple is REALLY good at." Steve did that all the time. Tiny, offhand comments about where Apple was spending time & development, that were easy to miss if you weren't paying attention.

 

There is no rush to market strategy for Apple, ever - there is instead, a quite long, well-researched & well-considered approach to development of what will become breakthrough combinations of existing technologies.

post #17 of 24
Quote:
Originally Posted by Macky the Macky View Post
 
 For example, a bed used in a nursing home is considered a "medical device" and must meet a large number of requirements set by the FDA.

Sorry this is incorrect. 

 

Sec. 880.5100 AC-powered adjustable hospital bed.

 

The device is a Class II device but is exempt from the premarket notification procedures.

 

It is exempt because it is a standard device which is extremely similar to all other hospital beds which have previously been approved. The electric parts need to be approved by other government agencies but not the FDA so long as the bed is typical of all other hospital beds. This relaxation of the regulations of standard devices was adopted to allow FDA resources to be allocated to new and unique medical devices under review.

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post #18 of 24
Quote:
Originally Posted by aussienorm View Post
 

First time post, after watching this forum (the good, the bad, the ugly) for many years...

 

Unrelated to your post, but posted for interest - a few years ago, Steve Jobs specifically commented on the medical device field (I think it was at an All Things D conference - still searching for the link). Basically the gist of his comment was that existing medical devices have very complex user interfaces, & that Apple could probably contribute to this field. Specifically, Steve stated "as it turns out, user interface is something that Apple is REALLY good at." Steve did that all the time. Tiny, offhand comments about where Apple was spending time & development, that were easy to miss if you weren't paying attention.

 

There is no rush to market strategy for Apple, ever - there is instead, a quite long, well-researched & well-considered approach to development of what will become breakthrough combinations of existing technologies.

Welcome to A.I. as a member.

 

Steve was prescient. I believe that we will see products yet that he foreshaddowed with both off the cuff remarks and very, very considered commentary.

 

All the best.

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post #19 of 24
I agree, great and medically valuable health care wearables will soon rock the medical world. With apple leading the pack, once again.
post #20 of 24
Quote:
Originally Posted by island hermit View Post

Add:

It is a mobile payment device
Sounds like one more thing.
post #21 of 24
Quote:
Originally Posted by aussienorm View Post

First time post, after watching this forum (the good, the bad, the ugly) for many years.
Thanks for the links.
The FDA has, in two of your links, requested information from the developers as to why they have not sought FDA approval. They have not demanded removal of the app at this point in time, & it is still available. It is highly likely that the app will remain in the App Store, with subsequent FDA approval.

The link concerning acne treatments is about apps that have been removed from Android Marketplace & the App Store in 2011, not by the FDA, but by request from the FTC (based on lack of scientifically verifiable studies of efficacy).

Thanks for pointing out the specific actions taken with regard to medical apps. I misread them as banned and appreciate the correction, so welcome to the forum from another long-time member. 1smoking.gif

Regarding the FDA's authority over mobile devices and apps, they apparently drafted new rules that apply to them following the "acne app" incident. I've linked a pertinent article here:
http://mobihealthnews.com/11980/types-of-medical-apps-the-fda-will-regulate/
The draft regs cover a lot of area. It looks as tho the FDA would have broad authority over any attachment, accessory or app that Apple might be considering related to healthcare.
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post #22 of 24
I just had a revelation, I think we are all on the wrong track on what this will be. I don't think it has anything to do with the casual consumer. What if they made a diagnostic device that sends vitals to an iPad or iphone of the attending doctor and sends notifications to everyone hooked into the app when something goes critical and can not only track vitals but through the epidermis, sweat and body excrements like oils on the skin test for disease or toxicity. Instead of taking blood for sampling they slap on this wristband/watch and it sends all that chemical info to the lab for further analysis. This would speed up the diagnostic process and also make patient care "live" where your doctor gets your stats and knows your condition just by looking at his iPad.

This makes complete sense in context of Steve Jobs sickness in his last years...
post #23 of 24
Quote:
Originally Posted by Moneoa View Post

I just had a revelation, I think we are all on the wrong track on what this will be. I don't think it has anything to do with the casual consumer. What if they made a diagnostic device that sends vitals to an iPad or iphone of the attending doctor and sends notifications to everyone hooked into the app when something goes critical and can not only track vitals but through the epidermis, sweat and body excrements like oils on the skin test for disease or toxicity. Instead of taking blood for sampling they slap on this wristband/watch and it sends all that chemical info to the lab for further analysis. This would speed up the diagnostic process and also make patient care "live" where your doctor gets your stats and knows your condition just by looking at his iPad.

This makes complete sense in context of Steve Jobs sickness in his last years...

This sounds great! Earlier today I revisited the Prime Sense Web site to review medical/robotic information that had been on the site. All of the information had been removed. Oh well.

 

I remembered iRobot was one of Prime Sense's partners focused on building robots in the manufacturing and medical fields. The robots are named as follows...

 

iRobot Ava 500 Video Collaboration Robot -- iRobot Ava 500 brings together iRobot’s autonomous robotic mobility platform with the Cisco TelePresence EX Series personal system to deliver a new level of collaboration for office environments and other facilities. http://www.irobot.com/us/learn/commercial/ava500.aspx

 

RP-VITA Remote Presence Robot -- RP-VITA is the first remote presence solution for patient care that combines the latest in autonomous navigation and mobility from iRobot with the latest in telemedicine technology from InTouch Health.  http://www.irobot.com/us/learn/commercial/rpvita.aspx

post #24 of 24
Quote:
Originally Posted by RalphMouth View Post

Does the FDA require years of testing for medical devices like it does drugs to ensure that it is safe for the public? I don't see how a medical iWatch can be released this year.

Any experts here on how the FDA approval process works ?

The Food & Drug Administration does not require any testing for Class II medical devices which is the likely classification of the supposed iWatch based on the various rumors of offering integrated glucose, oxygen saturation and pulse monitoring. However, Class II medical devices must typically have a 510k Premarket Approval (PMA) submission prior to release of the device. A 510k PMA may require six months or more dependent upon many factors although the purpose of the 510k is to establish substantial equivalency with existing products.
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