Apple job listing hints at work on Class II medical device

AppleInsiderAppleInsider
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Apple is looking to hire a regulatory project manager that will help the company develop a Class II medical device or feature likely related to the Apple Watch or iPhone.

Credit: Andrew O'Hara, AppleInsider
Credit: Andrew O'Hara, AppleInsider


In a recent job listing, the Cupertino company says it is seeking a project manager who will be responsible for regulatory support for product submissions, approvals, and launch readiness. The listing was first spotted by MyHealthyApple.

The project manager will work in the company's hardware division, which indicates a future Class II medical product or a health feature for one of Apple's existing devices, like the iPhone or Apple Watch.

Class II medical devices are those that have a moderate to high risk to the user. This includes the Apple Watch's electrocardiogram (ECG) and irregular heart rhythm features. About 43% of all medical devices and features fall under the Class II designation.

The person chosen for the job will "lead projects requiring regulatory approval to help launch ground breaking technologies for Apple." Additionally, Apple says the project manager will lead a broad team developing projects across engineering, regulatory, and clinical disciplines.

Apple has increasingly emphasized health features for its Apple Watch and iPhone devices. Current reports indicate that the company is developing some type of non-invasive glucose monitoring technology, likely for inclusion on its flagship wearable.

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Comments

  • Reply 1 of 3
    GeorgeBMacGeorgeBMac Posts: 11,421member
    Yes, glucose monitors can be deadly -- especially if it fails to report low glucose levels.
    Everybody worries about high glucose levels in diabetics -- but that usually takes a long time to have an effect.   But low glucose levels (pushed down by meds & exercise but not compensated for with food) can kill very quickly.  And worse, many diabetics lack sensitivity to the warning signs of low levels and fail to take the appropriate actions.

    Apple needs to get this one right.

    With A-Fib they can leave the responsibility with physicians and monitoring is a nice to have early warning system to check with a doctor.
    The same is not true of diabetic glucose levels.   Ongoing, reliable monitoring is the key.

    That said:  There are millions of people with pre-diabetes and even diabetes who are not aware of their condition.   So the glucose monitoring by the Apple Watch could alert them to see their doctor and be tested and save them from the devastating effects of untreated diabetes.
    caladanian
  • Reply 2 of 3
    tedz98tedz98 Posts: 80member
    The holy grail with Type 1 Diabetes is the development of a closed loop system that integrates glucose monitoring with a wearable insulin pump. The monitor instructs the pump to deliver doses of insulin based on blood glucose levels. Having blood glucose monitoring built into the Apple Watch is an interesting next step. But Apple would have to ultimately develop integration with insulin pumps which might not be possible. I’m guessing the pump manufacturers won’t want to have a third party integration.
  • Reply 3 of 3
    GeorgeBMacGeorgeBMac Posts: 11,421member
    tedz98 said:
    The holy grail with Type 1 Diabetes is the development of a closed loop system that integrates glucose monitoring with a wearable insulin pump. The monitor instructs the pump to deliver doses of insulin based on blood glucose levels. Having blood glucose monitoring built into the Apple Watch is an interesting next step. But Apple would have to ultimately develop integration with insulin pumps which might not be possible. I’m guessing the pump manufacturers won’t want to have a third party integration.
    That would have little value since those insulin pump systems, by their nature, already have access to body fluids to do the measurement.  It's unlikely that an external, non-invasive measurement could ever match that accuracy.  And, with that kind of automation, accuracy would be critical.

    But, I could see Apple introducing ai into the mix that could remember when the last meal was and predict when the next meal or exercise might be.   The scenario I'm thinking of is:  the person eats something before a run, the insulin pump sees an excess of glucose so it  pumps insulin into the person's system, then when the person is in the middle of their run they go hypoglycemic and do a face plant.

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