Apple Watch 4: New York Times Review

Here's an article reviewing the Apple Watch 4 that was published in the New York Times on 19 September 2018.

Here's the link: https://www.nytimes.com/2018/09/19/technology/personaltech/apple-watch-series-4-review-health.html?em_pos=large&emc=edit_ct_20180920&nl=technology&nlid=67594383edit_ct_20180920&ref=headline&te=1

As of the posting of this article, Apple has yet to release their ECG app -- the thing I guess that most of us have interest with regards to the Apple Watch 4. It's the one thing that moves the Apple Watch 4 from a consumer to a medical device and a hardware platform on which to base medical applications and services. So, until the ECG application is available, I'm holding off on reviewing the Apple Watch 4.

Apple Watch 4 -- FDA Announcement: Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health

The FDA just provided what amounts to a "shout-out" to companies that design and manufacture intelligent, wearable devices that include medically-related monitoring devices and specifically, the Apple Watch 4.

Here's the link to the FDA statement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm

And here's an interesting quote from the announcement:

... [There have come] a new swath of companies that are investing in these new opportunities [e.g., wearable, intelligent monitoring devices measuring medically-related, physiological characteristics with analysis capabilities.] These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.

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I find it interesting that Dr. Gottlieb states that the Apple Watch analyzes pulse rate data, not the ECG, to detect "rhythms suggestive of atrial fibrillation." Yeah, that's a way to do it, but analysis of the ECG is a much better way. When I do a deep dive on the Apple Watch 4, I'll look into this and questions like it.

Apple Watch 4: Will it be suitable as a remote medical monitoring device? Part 1

When I first commented about the Apple Watch as being a possible platform for a remote medical monitoring system in 2015, I was initially excited about the possibilities. Sadly, the technology in 2015 was not quite ready as a platform for remote medical monitoring systems. However, Apple may be turning a corner with the Apple Watch 4 due to be released in Fall 2018. 

To be an effective remote medical monitoring and remote patient management device, the Apple Watch will need to reach acceptable levels of performance in the following seven areas of concern:

1. Bio-sensors
• Built in: are there enough bio sensors with enough resolution?
• Extended: the capability to have additional bio sensors that communicate wirelessly with the watch?
2. Communications over the Internet: Is there a reliable and secure means of communication back to the patient's monitoring system? And the means to communicate with the patient over that same communications channel(s)? 
3. Processing capability, hardware and software: Does the watch have the processing capability to host medical applications?
4. User interface: Visual, touch screen - will patients be able to interact with medical application using the touch screen? Will the watch have an effective audio user interface in order to hear instructions and make requests of the application running on the watch?
5. Reliability: Will the hardware and software reliable enough for a remote medical monitoring and patient management application to run on it?
6. Battery life: When running a remote medical monitoring and patient management application(s) on the watch, will the battery life before needing to recharge be acceptable?
7. Rugged: Is the Apple Watch 4 rugged enough to be a remote medical monitoring and patient management device?

I'm going to touch on each of the areas of concern regarding the performance of the Apple Watch 4.

1. Bio-sensors: I'm not going to address this issue until the Apple Watch 4 has been released. Once it has been released, I'll write an article specifically discussing this topic.
2. Communications over the Internet: A model of the Apple Watch 3 does have the capability of communicating over 4G so reliable communication over the commercial wireless provider networks is possible. We can assume that this capability will continue to the next release. So communications capabilities are likely to be adequate. 
3. Processing capability, hardware and software: Improvements in both are promised over the Apple Watch 3. We can probably assume that hardware and software capabilities will be adequate.
4. User interface:
• Visual, touch screen: The Apple Watch screen has been targeted to those with good visual acuity (with or without glasses) and fine finger control to be able to use the touch screen effectively. Current reports say that the screen will be larger than the Apple Watch 3. Nevertheless it's still a small screen. 
• Auditory: The Apple Watch 3 has Siri, meaning it does have an auditory user interface. More on this after the release of Watch 4.
5. Reliability: Apple has made positive strides in reliability with each release of the Apple Watch. We can assume that this will continue and that the Apple Watch 4 will be reliable enough to serve as a platform for remote medical monitoring and remote patient management applications.
6. Battery life: The Apple Watch 3 has a reported battery life of up to 18 hours. Again Apple has continued its improvements in this area. Patient medical monitoring should be continuous and without long breaks. Even with one or more days of battery life, the watch will still need to be changed and that could take hours. However, having said that, the price of an Apple Watch (because of the ruggedness requirement) that would serve as a remote medical monitoring and patient management device would be around $600. As medical devices go, that's inexpensive and inexpensive enough so that the patient could or should have at least two Apple Watches that would enable the patient to switch watches when necessary. That would place a burden on application software developers to manage when patients change watches, however, this should be manageable.
7. Rugged: The Apple Watch 3 has a version in a stainless steel case. This should be adequate for most situations. Also the issue of reasonably low price and the ability to have redundant watches should effectively address this issue.

Adhesives: Part of the Future for the Remote Monitoring Sensors?

I just ran across this article a few minutes ago. It's a serious article published in Machine Design. Here's the link: http://www.machinedesign.com/mechanical/adhesives-enabling-future-wearable-medical-devices?NL=MD-005&Issue=MD-005_20180724_MD-005_524&sfvc4enews=42&cl=article_1_b&utm_rid=CPG05000003255032&utm_campaign=18775&utm_medium=email&elq2=5b76b40ea8f44d76b2b883c5c09f23fe

It's an extremely readable article and what's being described has in my opinion real applicability in the future of medical sensors. Adhesive, "band-aid" or strip sensors development applies to both the fitness set as well as to remotely monitored patients.

Transmitting data to monitoring systems and people will likely require an intermediate device such as a smart phone. I suspect that the real issues and hurdles will likely revolve around digital communications issues and standardization. Having worked most of my life in the communications domain, communications issues can be successfully overcome.

Here are a few quotes from the article:

Device manufacturers are taking steps to create medical devices that are smaller, lighter, and less invasive. Whether they’re adhering device components together or sticking a device to skin, adhesives are uniquely bonded to a device’s success.

Both consumers and patients want wearable devices to be smaller, lighter and less cumbersome to use for seamless integration into their everyday lives. The design process can get challenging when devices must maintain accurate sensing capabilities, but also reduce friction to ensure precise data collection. Adhesives can help to keep friction to a minimum by being breathable and maintaining a low profile. In addition, options with flex electronics, as well as addressing battery implications and electromagnetic interference, provide opportunities for advancement.

Adhesive wear time is a crucial consideration when designing a wearable device, impacting overall resilience and durability, as well as how often the user will need to change their device. 

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I should mention that by the looks of things, it appears to me that 3M maybe behind the article. Nevertheless, I think that considering adhesives in the research, design and development process of a bio-sensor is worth your time.