Published on July 1, 2020 with data updated through Q1 of 2020

Smartphone Market Analysis for Connected Mobile Medical Devices (CMMD) & Software as a Medical Device (SaMD) White Paper Cover

The move towards a highly interconnected, IoT-driven healthcare industry has made the development of  Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) essential for companies looking to stay ahead of the curve.

Smartphone applications, in particular, are at the forefront of the shift in how care is being delivered. With more than four out of five American adults owning a smartphone, developing the right Bring Your Own Device (BYOD) strategy for smartphone apps that connect to devices and standalone mobile medical apps requires an acute understanding of the smartphone consumer, the smartphone market, and upcoming trends.

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Smartphone Market Analysis for Connected Mobile Medical Devices (CMMD) & Sofware as a Medical Device (SaMD) is the latest in a quarterly series of white papers that analyzes current and evolving smartphone market developments to help companies developing for CMMD or SaMD understand key trends and capture more market share for their products.

This white paper will help you answer questions (using data updated through Q1 of 2020) such as: 

  • What smartphones and operating systems are consumers using?
  • What are the demographics of smartphone users?
  • How quickly are users substituting new smartphones and operating system versions in place of old ones?
  • What are the trends for Bluetooth 5.0 adoption, and when should you target Bluetooth 5.0 for your connected device solution?
  • What are the BYOD strategies of major medical device companies?
  • Which recent developments may impact my smartphone strategy?

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Introduction

Since the introduction of the iPhone in 2007, iOS and Android smartphones have come to define and dominate the U.S. smartphone market, with approximately 81% of American adults owning a smartphone in 2019. 99% of these adults own either an iOS or Android phone.

Chart 1. Percentage of U.S. adults who own cellphones and smartphones

In response, medical device manufacturers have been building increasingly sophisticated mobile medical applications, ranging from standalone Software as a Medical Device (SaMD) such as digital therapeutics or insulin dosage recommendation applications, to applications for controlling Class III implanted medical devices.

Initially, many of these solutions included a smartphone paired with a specific medical device, or were offered on only one or two smartphone models. In recent years, however, mobile medical solutions have been increasingly offered for download on patients’ and clinicians’ own smartphones, otherwise known as BYOD (Bring Your Own Device).

But a BYOD environment places additional demands on medical device companies with regulated mobile medical applications, as well as regulators like the FDA and EU.

During development, applications and their integrations need to be verified on different smartphones and operating systems and, once in-market, manufacturers often need to certify new operating systems and smartphones for compatibility with their software. With thousands of potential variants in the hands of consumers, this can be a substantial effort.

In a BYOD environment, companies also need to determine which version of Bluetooth to target and test across smartphones and operating systems, and what trade-offs should be made between market coverage, verification, and platform compatibility testing discussed further in Appendix A of this white paper.

Companies developing a smartphone strategy for connected medical devices must consider a number of important variables.

Key considerations include:

  1. Will users be provided with a smartphone for their medical device, or will they use their own smartphone?
  2. If a user brings his or her own device, what are the best smartphones and operating systems to target as an overall business strategy?
  3. How will the smartphone application be updated over time?
  4. What will need to be tested, and how will it be tested?

For the last several years, Orthogonal has compiled and analyzed smartphone market information to help inform our software development customers on the best strategies for market coverage, verification, and platform compatibility testing.

This white paper updated on a quarterly basis. In each new edition, we cover:

  1. Smartphone subscriber base share across iOS & Android;
  2. Predominant hardware and operating system (OS) updates;
  3. Hardware and OS trends;
  4. Bluetooth trends;
  5. Smartphone strategies of major medical device companies; and
  6. Noteworthy smartphone developments over the last quarter.

Where available, we’ll be covering data up to approximately four years prior (currently Q2 2016). We primarily focus on active subscriber base data for smartphones rather than sales or shipments, because the former describes what devices are actually in use by consumers, rather than which ones are being sold or shipped to stores at the moment.

PART 1: iOS & Android Market Share and Demographic Analysis

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Overview

There are two operating systems that are on over 99% of smartphones currently in use: iOS and Android. At the most basic level, iOS is offered by Apple, while Android is a free and open platform (with some restrictions) developed and maintained by Google. iOS can only run on Apple devices, while Android is found on a variety of smartphones and tablets from other leading brands, including Samsung, Google, LG, HTC and Motorola, among others.

Over the last seven years, iOS and Android have gone from a combined 78% share of the smartphone market to over 99%. Both have a roughly equal share of the North American subscriber base (varying between 45% and 55%, depending on the data sets being used), with Android having a much larger subscriber base share in the rest of the world.

In order to determine which SaMD and/or connected medical device your company should support, it’s important to know the key market differences between iOS and Android.

Numerous data sets derived across varying analytics providers show fairly high variation between iOS and Android subscriber base share. Of these providers, Comscore has the largest data set and will be referenced most frequently.

We’ve compiled data from a number of sources and have noted these sources throughout the white paper. In many cases, there is no definitive data set or there are several different data sets that have different data collection methods that do not match (although most are relatively close). We’ve endeavored to compare these data sets and select the highest quality ones for our analysis.

iOS Versus Android Subscriber Base Share

As of February 2020, ComScore data shows that iOS subscriber base share covers approximately 48.8% of the U.S. market (other sources, such as StatCounter, cite up to 60%).iOS vs Android US Subscriber Market Share, 2020 Q1

Chart 2. iOS versus Android U.S. subscriber base share, 2020 Q1

The data also shows that iOS has steadily increased its subscriber base share by about half a percent per month over the last seven years. This past year has seen iOS subscriber base share grow slightly faster.

Up until Q1 of 2020, iOS growth has been primarily at the expense of Blackberry and Microsoft. However, with Blackberry and Microsoft currently commanding less than one percent of the overall subscriber base, its growth over the past year has been at the expense of Android. While this trend is also reflected in other data sets, it is too early to tell if the trend will continue.

Feature Comparison

For the most part, both iOS and Android smartphone and operating system features parallel each other: one platform adopts a new feature first, and the other follows suit with their OS version or hardware introduction (usually within a cycle or two).

One area with important functional differences between the two platforms relevant for medical device companies lies in the management of health and fitness data. Currently, Apple’s HealthKit and ResearchKit are much richer and more applicable to medical devices than Google Fit.

Closed Platform Versus Open Platform

Apple’s iOS platform is a closed platform with a forced upgrade path (i.e., Apple pushes its iPhone users to upgrade to the latest hardware model of an OS version via automatic updates).

On the other hand, the Android operating system is open-sourced. Consequently, multiple manufacturers offer the Android platform, with each manufacturer offering several different smartphone variations as well.

Moreover, almost all manufacturers (with the exception of Google) delay the implementation of OS updates by a number of months, and many do not “force” upgrades like Apple does. This results in significantly more versions of the Android OS in active use compared to Apple.

All the combinations of Android smartphones and OS versions add up quickly, creating thousands of variants. Therefore, the upgrade path for Android is much longer than that of iOS, due to all the variants which require support.

Android and iOS Subscriber Demographics

While Pew Research Center provides demographic information on smartphone users (summarized in Table 1), there is relatively little survey data on comparative demographics between iOS and Android. There is less data on iOS and Android subscribers by age, but what data there is tends to show roughly even distribution between iOS and Android for those over 55 years old.

We’ll discuss and break down more key differences between iOS and Android, focusing on subscriber base share differences, in the following sections.

% of U.S. Adults Who Own the Following Devices

 Any cellphoneSmartphoneCellphone, but not smartphone
Total96%81%15%
Men98%84%14%
Women95%79%16%
Age 18-1999%96%4%
30-4999%92%6%
50-6495%79%17%
65+91%53%39%
White96%82%14%
Black98%80%17%
Hispanic96%79%17%
Less than high school graduate92%66%25%
High school graduate96%72%24%
Some college96%85%11%
College graduate98%91%7%
Less than $30,00095%71%23%
$30,000-$49,99996%78%18%
$50,000-$74,99998%90%8%
$75,000+100%95%5%
Urban97%83%13%
Suburban96%83%13%
Rural95%71%24%

Table 1. Percentage of U.S. adults who own the following devices

Source: Pew Research Center survey, conducted Jan. 8 to Feb. 7, 2019

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Apple iOS

Overview

Headquartered in Cupertino, California, Apple is the world’s leader in smartphones. In the first quarter of 2020, Apple represented approximately 48.8% of the overall subscriber base in the United States (Chart 3), with Apple CEO Tim Cook reporting6 an active subscriber base of over 1.5 billion devices worldwide.

The company boasts both more affordable models, such as the iPhone SE, as well as higher-priced premium smartphones, such as the iPhone 11 Pro Max. The Apple operating system, iOS, runs on the company’s iPhone, iPad, and iPod touch devices — and, until recently, on Apple Watch, which now has a related OS, Watch OS.

Smartphone Vendor U.S. Subscriber Market Share, Q1 2020

Chart 3. Smartphone vendor subscriber base share in the U.S., Q1 2020

iPhone Models in Use

The Latest

In September of 2019, Apple released three versions of its newest model, the iPhone 11: iPhone 11, 11 Pro, and 11 Pro Max. In 2018, Apple also released three new phones — the iPhone 10 XR, XS, and XS Max — bringing the total number of hardware models released by the company to 24. These new phones join a diverse portfolio of recent Apple smartphone offerings, including the iPhone SE.

Additionally, Apple also sells certified refurbished models, including the iPhone 8, and X, and as of January 2020, the iPhones XS, and XS Max. Currently, the only third-party retailer selling certified refurbished iPhones is Back Market.

Chart 4. Number of iPhone models in production by quarter, Q1 2020

Chart 5. iPhone model subscriber base as a percentage of total North American smartphone market, Q1 2020.

Recent Trends

Over the past three years, Apple has been releasing about three new phones per year, typically in September. Many iPhone models (five specific models across both the iPhone 5 and iPhone 6 generations) were phased out in 2016. By contrast, fewer were pulled off the market in 2017 (just one — the 256GB iPhone 7) and four in 2018. On September 2019, Apple has discontinued four new models: the iPhone 7, iPhone 7 Plus, iPhone XS, and iPhone XS Max. On April 15, 2020, the iPhone 8 and 8 Plus were discontinued when Apple launch iPhone SE 2020, a successor to the iPhone SE launched in 2016.

# of iPhone Models Released By Year, 2020 Q1

Chart 6. Number of iPhone models released by year through Q1 2020

# of iPhone Models in Production by Quarter, 2020 Q1

Chart 7. Number of iPhones in production by quarter through Q1 2020

# of iPhones in Production and # of New iPhones Released, 2020 Q1

Chart 8. Number of iPhones in production and number of new iPhones released through Q1 2020

Discontinued iPhones & Length of Time in Production, 2020 Q1

Chart 9. Discontinued iPhones and the length of time in production through Q1 2020

Insights

The new iPhone 11 models have longer battery life and faster 4G service, along with multiple cameras. The 11 Pro and 11 Pro Max have a telephoto lens, wide-angle lens, and super wide-angle lens to autofocus pictures. For mobile medical apps utilizing the smartphone camera, these new lens capabilities may add additional functional possibilities, along with more complexity, software updates, and testing for existing applications.

One feature which bears watching in the future is the new U1 chip, included in all of the new iPhones. This new chip enables Ultra-Wideband (UWB), which

can pinpoint location with 30cm accuracy — much better than Bluetooth. It can also use “time of flight” to determine location, measuring how long it takes for a radio wave to pass between two objects (when compared to Bluetooth, this can improve security by preventing relay attacks). Additionally, UWB passes through walls and human bodies safely and easily, and can transfer data at up to 8mbps, which is up to four times faster than Bluetooth 5.0. BLE.

While clearly superior to Bluetooth, the U1 chips are also more expensive, and there are currently no UWB smartphone peripherals. However, Apple’s adoption of the feature may change this going forward.

Finally, Apple’s new trade-in service is a strategic move that should serve to remove older iPhones from circulation and incentivize the purchasing of its newest models.

iPhone Model Support: Devising Your Strategy

The Latest

In Q1 2020, 94% of the iPhone active subscriber base in North America was comprised of the following models: iPhone 6S, 7, 7 Plus, SE, 8, 8 Plus, X, XR, XS, XS Max, and 11. Together, these models also comprise 43.6% of the total North American subscriber base share among all smartphone manufacturers for Q1 2020.

Chart 10. iPhone model subscriber base as a percentage of total iPhone subscribers, Q1 2020

Insights

Apple has had a relatively consistent two- to three-year life cycle for its smartphones, with upgrades partially driven by the typical two-year mobile operator contract, as well as the OS upgrade cycle and its planned obsolescence. We don’t expect major changes to this dynamic.

As shown earlier in Chart 9, discontinued iPhones can spend anywhere from less than one year to up to three years in active use. While discontinued iPhones are no longer sold, in most cases they can still be used and upgraded to the newest iOS. However, this capability is ultimately phased out for discontinued iPhones due to planned obsolescence and the company’s forced upgrade path.

Other models, also shown in Chart 9, were either discontinued or rendered obsolete due to software upgrades from iOS 10 (the prevailing software in 2016) to the current software, iOS 12. The arrival of iOS 13 will cause the obsolescence of older iPhones not supported by the iOS 13 operating system.

If you currently have smartphone applications in the market with a user base that includes iPhone 7 or earlier versions, you’ll need to determine a strategy for managing this user base: either continue to support these phones and the older operating systems they run on, or force an upgrade to newer phones and operating systems.

The former potentially exposes you to additional cybersecurity risks and other maintenance and support issues, while the latter risks alienating certain users.

The higher the IEC 62304 software safety classification of the mobile application and level of concern of the connected device(s), the more we would recommend forcing smartphone and operating system upgrades. If you are planning to bring your connected device or SaMD to market in Q4 2020 or beyond, you should be safe targeting the new iPhone SE 2020 and later models.

iOS Version Product Life Cycle

The Latest

Apple offers increased functionality and bug fixes with each new iteration of its iOS software, which forms the operating system running on all iPhone smartphones. iOS 13, released last September, currently commands 91.3% of the subscriber base share.

At the moment, iOS 13 (released in September 2019) is the most popular version. iOS 12, which was released in 2018, holds 6.46% of the subscriber base share, iOS 11, which was released in 2017, holds 1.34% of the subscriber base share, and iOS 10 makes up 0.6% of the subscriber base share (Chart 11).

Recent Trends

Typically, the latest iOS version has the vast majority of the subscriber base share, both because it has the best functionality, and because many iPhones are set to auto-update to the newest iOS. For example, in 2016, the newest iOS was iOS 10, which boasted improved voice recognition capabilities and integration with apps, among other features. iOS 10 dominated the market until mid-2017 when iOS 11 was introduced.

We can expect that iOS 12 will eventually be phased out by iOS 13. Apple releases a new iOS each year, typically in conjunction with (or slightly thereafter) the release of its latest iPhone models. This matters for developers and product managers, who must stay up to date with the most recent iOS innovations.

Though the new iOS 13 will rapidly replace iOS 12 for most users, users of iPhones that cannot be upgraded to iOS 13 may choose to keep using iOS 12 on their phones, rather than upgrade to a new model. Therefore, it is difficult to predict precisely what the iOS share will be in the future — just that newer models will increasingly dominate the iOS market as older versions become obsolete.

Still, the tendency is for users to upgrade to the most recent iOS, and as of Q1 2020, older versions of the operating system — that is, iOS 6 through iOS 12 — comprise about 10% of the market.

Insights

One effect of Apple’s iOS update system is that some older devices are effectively phased out if they are not supported by a major OS release. For example, iOS 13 is not supported on the discontinued iPhone 7, essentially spelling the death of this particular model. Users may continue to use the iPhone 7 without updating it, but they may enjoy limited functionality.

Companies may wish to consider an iterative update format to complement the iOS update in order to provide compatibility for a wide range of devices, both old and new. As we highlighted earlier, a new iOS is typically launched each year, and Apple’s forced upgrade path means that every two- or three-years certain iPhone models are rendered obsolete, forcing users to upgrade or stay with their old phone.

iOS Version U.S Subscriber Market Share, Q1 2020

Chart 11. iOS version U.S. subscriber base share, Q1 2020

The iOS Beta Program

For each new full iOS version, iOS beta 1 is typically released in conjunction with a “first look” at the Apple Worldwide Developer Conference (WWDC) in early June; a beta 2 is launched for developers a few weeks later; a public beta often one or two weeks after that; and a series of developer and public betas thereafter — until a golden master is released to developers about two weeks before full public launch. While changes to the beta typically decrease significantly with later beta versions, it is possible to have UI changes in the beta until fairly late in the cycle.

As a medical device software developer, you should start doing initial analysis of the OS changes and a dry run test of your software as soon as the first beta comes out. Depending on your software’s associated patient risk, it is prudent to ensure that the software cannot run on the public beta in production, while providing sufficient labeling (i.e., warnings) to users of this fact.

iOS Version Point Upgrades

Apple typically releases several minor upgrades to each major iOS version, with an average of 12.5 updates annually in recent years. Minor upgrades are meant to address bugs, make minor system improvements, and occasionally add new features.

Chart 12 shows that iOS 13 has had 12 minor version upgrades, with the most recent one as 13.4.1, as of March 2020. iOS 12 has seen 19 minor updates. This version has the highest number of updates, compared to iOS 11 (which experienced 16 minor updates) and iOS 10 (which saw 12 minor updates).

Usually, the latest major iOS point version predominates the market, though some users may be slow to upgrade to the most current point update. As highlighted earlier, iOS 13 and the majority of its minor versions (13, 13.1, 13.2, 13.3, 13.4, 13.4.1 and 13.5) represent over 90% of the iOS subscriber base share as of Q1 2020.

iOS Version Update Count by Quarter, 2020 Q1

Chart 12. iOS version update count by quarter as of 2020 Q1

iOS 13 Point Version Upgrades Over Time, 2020 Q1

Chart 13. iOS 13-point version upgrades over time through Q1 2020

iOS 12 Point Version Upgrades Over Time, 2020 Q1

Chart 14. iOS 12-point version upgrades over time through Q1 2020

iOS 11 Point Version Upgrades Over Time, 2020 Q1

Chart 15. iOS 11-point version upgrades over time through Q1 2020

Average Days, Min and Max between Point Version Releases

Chart 16. Minimum, maximum, and average days between point version releases

The average time between point version releases is just under 30 days, with the shortest time between releases coming in at zero days (Apple released versions 10.0 and 10.0.1 on the same day).

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Android OS

Overview

Android is a smartphone operating system developed, operated, and maintained by Google. Based on a modified version of the Linux kernel, Android is an open-source operating system meant to run on touchscreen mobile devices such as smartphones and tablets.

As the primary competitor to Apple iOS, Android is used by 49.6% of smartphone subscribers in the U.S., according to ComScore. Globally, Android has a much larger subscriber base share, with over 2.5 billion global users (compared to approximately 900 million global iPhone users), or around 72.26% of the global smartphone market.

A defining difference between Android and iOS is that multiple manufacturers — including Google, Samsung, LG, Motorola and HTC in the U.S., and Huawei and Xiaomi in China — use the Android OS, giving consumers freedom and flexibility when choosing their device. iOS, on the other hand, is exclusive to Apple devices.

Android’s appeal lies in the fact that it can be used on a variety of devices and integrated with users’ Google platforms (such as Google Maps and Gmail) for a powerful, unified computing experience across smartphones, tablets, and personal computers.

Other Android features include affordability, long battery life, easy customization, voice assistance, and cloud backup storage via Google Cloud.

While the flexibility afforded by all the different Android smartphone manufacturers is great for consumers, it also makes the upgrade path for Android more complex: each Android manufacturer offers many different smartphones, most manufacturers lag behind Google when it comes to the availability of Android OS versions, and there is no forced upgrade path. As a result of these factors, there can be several thousand smartphone models to consider when deploying a BYOD strategy.

Subscriber Base Share by Major Android Manufacturers

The Latest

While a large number of smartphone manufacturers worldwide sell Android- based phones, four manufacturers sell the vast majority of Android phones in North America: Samsung, LG, Motorola, and Google (which all follow Apple in subscriber base share in Chart 18).

You’ll notice that Chart 17 and Chart 18 highlight roughly the same data. Chart 17, representative of ComScore data, shows that in February 2020, Apple held 48.8% subscriber base share, Samsung 27.9%, LG 7.6%, Motorola 4.4%, and HTC 0.4%. Since Samsung’s subscriber base share is about the same as LG, Motorola, HTC and others combined, we can say that Samsung is ahead of the rest of the Android manufacturers in subscriber base share in the United States.

Smartphone Vendor U.S. Subscriber Market Share, Q1 2020

Chart 17. Smartphone vendor subscriber base share in the U.S., Q1 2020 (ComScore)

While comprehensive, ComScore data does not include Google. However, because Google has become a larger player on the smartphone scene over the last few years, especially when compared to HTC, we’re also including data from StatCounter to reflect this growth (Chart 18).

Stat Counter’s data, based on web usage, shows that Google has slowly but steadily been increasing its subscriber base share, and as of Q1 2020, occupies 2.52% of the market.

Smartphone Vendor U.S Subscriber Market Share, 2020 Q1

Chart 18. Smartphone vendor subscriber base share in the U.S., Q1 2020 (StatCounter)

Recent Trends

Despite periodic fluctuations, both data sets show a relatively consistent trend in subscriber base share for the major Android brands. Google, as the originator of the Android OS, occupies a much smaller percentage of the market than one might expect.

Recent data also shows that both Apple and Google have gained more subscriber base share (Chart 18), and to a lesser extent, Motorola, chipping away at the competition offered by Samsung and LG.

Insights

Smartphone sales in the United States are primarily mobile operator driven. While it is possible to buy smartphones from vendors other than mobile operators, even Apple, which sells smartphones through its site and Apple stores, only sells about 10% of its phones this way (although this may change as a result of Apple’s aggressive trade-in program). This has resulted in a high level of stability in the market.

Still, there are a couple of ways in which this can shift. Currently, Google only sells through one mobile operator in the U.S. — Verizon. If this changes, Google’s share may well increase at the expense of other manufacturers. And if other vendors that have a high subscriber base share in Asia are able to strike deals with mobile operators in the U.S., there will likely be a shift as well (albeit a slow one).

Recently Introduced Smartphone Models

The Latest

Q4 2019 and Q1 2020 has been productive two quarters so far for the largest Android smartphone manufacturers:

  • In contrast to Apple, Samsung releases models throughout the year. This year has already seen the release of Samsung Galaxy S20, S20 Plus and S20 Ultra, and Z Flip in Q1. As of Q1 2020, Samsung currently has 25 phones in production, which run on a variety of Android OSes. Some of these latest models support Android 10, while others only support Android versions 6, 7, 8, or 9.
  • Google released the Pixel 4 and Pixel 4 XL in Q4 2019 and discontinued the Pixel 3 and Pixel 3 XL in Q1 2020. Including the 4 and 4 XL, Google currently
  • offers four phones on the commercial market. Its recent models only support Android 9 and Android 10.
  • LG released the G8X ThinQ in Q4 2019 and the V60 ThinQ, which arrived on the commercial market in Q1 2020. Including these newer models, LG currently offers a total of 13 phones, some of which support Android 10, and some of which only support Android 6, 7, or 8.
  • Motorola launched the Motorola One Hyper and Razr in Q4 2019, the Motorola G Power, G Stylus, Edge and Edge+ in April 2020. Including these models, Motorola currently has 16 smartphone models on the market supporting either Android 10 or Android versions 8 or 9.

Recent Trends

2019 was also a dynamic year for Android smartphone manufacturers, ushering in new products which run the Android 9 OS:

  • Samsung introduced the Galaxy S10 and S10e in February 2019, which are compatible with Android version 9. Samsung also launched the Note 10 and Note 10+ (which runs on both Android versions 9 and 10), and Tab S5e (which runs on Android 9) in Q3 2019, and A51 in Q4 2019 (which runs Android 10). Samsung stopped the production of the full line of Galaxy S7 phones (including S7, S7+,
  • S6 Active) in Q3 2019. The phones launched in 2019 all run either Android version 9 and/or 10.
  • Google introduced the Pixel 3a and Pixel 3a XL in May 2019, which both run Android 9. Google also discontinued the Pixel 2 and 2 XL in Q2 2019, which effectively phased out support for Android 8 in 2019.
  • LG introduced the G8 ThinQ, G8X ThinQ and V50 ThinQ in Q4 2019. These devices all support Android 9.
  • Motorola introduced the G7 in Q1 2019 and the Z4 in Q2 2019, the Motorola Zoom in Q3 2019, and the Motorola One in Q4 2019, which runs on Android 9.

Insights

In addition to ongoing trends such as the ever-increasing processing power of RAM and storage, a few new ones have emerged among the recent (and upcoming) releases: more cameras (including tri-camera and quad-camera phones), more AI (especially around image processing), and, despite some initial hiccups, foldable phones.

Foldable phones present a new form factor and potential new use cases, as they may end up being used by both tablets and smartphones alike.

For SaMD and Connected Mobile Medical Device (CMMD) manufacturers looking to utilize smartphone cameras, additional cameras and the use of AI for image processing can be a double-edged sword: they offer more power, but also rely more on OS level image processing, which may require additional testing and/or workarounds, should image processing play an important role in functionality with a higher safety classification.

The FDA is only in the exploratory stages of developing policies around updates to machine learning based algorithms, and while the outline of policy for continuous learning algorithms is starting to emerge, it is unlikely that this will apply to the use of third party algorithms in consumer smartphones. If you are using algorithms that take images from smartphone cameras as inputs, we recommend using raw images and implementing your own locked algorithms.

Android Smartphone Models in Use

The Latest

Currently, Samsung has 25 models in production for the U.S. market, Google has four models, and both LG has 13 models and Motorola has 16 models (Chart 19).

Looking at the number of new models released per year, Samsung averages around 6 models per year, LG about 8 models per year, Motorola around 8 models per year, and Google releases 2 new models per year (Chart 20).

# of Android Smartphones in Production, 2020 Q1

Chart 19. Android smartphone models in production through Q1 2020. Data taken from U.S. vendor websites.

Insights

Given the typical two- to three-year life cycle per phone, the number of Android smartphone models in use in the United States ranges somewhere between 120 and 180 models.

While subscriber data from different sources shows that certain models are more popular than others, and that new models have higher popularity overall, the market is still highly fragmented, with the top 10 models having a combined share of 18% of the total Android market and around 9% of the total smartphone market.

This makes getting to 90% of the market on the Android side much more difficult than on the iOS side.

# of Android Smartphone Models Released By Year

Chart 20. Number of Android smartphone models released by year through Q1 2020

Android Smartphone Models Subscriber Base, 2020 Q1

Chart 21. Android smartphone models subscriber base through Q1 2020

Android Version Product Life Cycle

Background

Android released its first commercial OS version, 1.0, on September 23, 2008. Since then, the OS has been continually developed by Google and the Open Handset Alliance.™ Each update has traditionally been named after a dessert except for the current OS which is the 10th version, known as Android 10.

Android 10 was released on September 3, 2019 and Android 9 or “Pie” on August 6, 2018. Android 8, or “Oreo,” was released on August 21, 2017.

As of Q1 2020, which began approximately twenty months after the release of Android Pie, the OS versions with the largest subscriber base share were: Android 9 “Pie” (42.23%), followed by Android 8 “Oreo” (28.28%) and Android 7 “Nougat,” (15.83%). Together, Pie, Oreo, Nougat, and Marshmallow (Android 6) represent well over 90% of the Android subscriber base share (Chart 22).

Android’s newest OS version, Android 10, was released last September and will be rolled out to Android phones in the upcoming months. As of Q1 2020, It currently has 24.6% of the subscriber base share. Android 10 also marks a shift in how Google names its OS versions. The company recently acknowledged that while fun, their current approach (i.e., naming OS versions after desserts) isn’t necessarily accessible to all users. They believe that “this change helps make release names simpler and more intuitive for [the] global community.”

As with iOS, Android continually makes minor updates to its OS in between versions, often released every few months. This means one can expect any given version of Android to undergo several point upgrades throughout its life cycle

Android OS Version U.S. Subscriber Market Share, 2020 Q1

Chart 22. Android OS version U.S. subscriber base share through Q1 2020

Trends

The OS version life cycle is longer for Android than for iOS, typically between two and three years. This pattern holds true for most Android smartphone brands. The only exception to this among the four major Android brands in the U.S. — Samsung, LG, Motorola, and Google — are the Google Pixel phones, which typically undergo planned obsolescence in terms of both hardware and software.

Because Google Pixel phones are owned by Android, as soon as Android releases a new OS version, Pixel is the first to adopt it. This means that its life cycle, at approximately two years, is the shortest among Android devices, and comparable to the product life cycle of Apple iPhones.

Insights: Manufacturer Android Updates Lag Behind Google

One of the challenges for manufacturers using Android is that in order to implement the latest version they need to modify the lower level hardware code that interacts with the higher level AOSP operating system code. Prior to Android 8 Oreo, no formal vendor interfaces existed, so manufacturers had to update large portions of the Android code base with each update, and often needed updates from the system on a chip (SoC) as well.

Google rearchitected Android for Oreo and later versions with Project Treble, establishing a modular base of hardware abstraction layers (HALs) that formalize the divisions between hardware subsystems and the client on the software side, with interfaces specified in hardware interface definition language (HIDL). This should make OS upgrades substantially easier for manufacturers going forward.

Unfortunately, the Oreo upgrade proved to be one of the worst performing upgrades to date by device makers, taking an average of 208 days for the upgrade to reach the flagship of non-Google phones (Chart 23). The Android 9 Pie upgrade performed even worse, with an average of 220 days for non-Google phones. However, international device makers including Nokia, OnePlus, Sony, Vivo and Essential saw better performance, averaging only 96 days. These makers were also able to enroll smartphones in the Android Beta Program, which allows users to test drive and provide feedback on pre-released versions of an Android OS before the official version is released to the public.

In Q4 2020, both Samsung and LG joined the international device makers in the Android 10 Beta Program. As a result, we saw significantly shorter upgrade time for Samsung and LG for Android 10 compared to Android Pie (Chart 23).

We hope Motorola will join the pack to enroll in the Android Beta Program going forward to reduce lag times in future versions.

Length of Time for Upgrade to Reach Current Flagship

Chart 23. Length of time for upgrades to reach current flagship. (Note: Motorola did not roll out Android 10 until March of 2020)

Form Factors & Screen Resolution

Form factors such as screen resolution, screen size, and pixel density should play a role in your development strategy. Especially for Android, the large variety of phones means that you will likely need to adapt your product to a multitude of screen parameters.

Apple

A picture containing monitor, cellphone, sitting, phone Description automatically generated

Apple continues to innovate in the design of their smartphones. The company launches larger-screen smartphones boasting more powerful features each year. In 2018, the most popular iPhone model was the iPhone 7, followed in second place by the larger-screen iPhone X (which has since been discontinued in favor of the similarly-sized XS), as well as the larger screen XR and XS Max models.

A bunch of different cell phones Description automatically generated

With the iPhone X, Apple introduced a fuller screen with a notch, which added additional design considerations. The notch has been continued in the iPhone XS, XR, and 11 models.

Android

The unfortunate truth is that not all Android hardware models’ form factors are extensively well-characterized in terms of subscriber base, due to the high level of competition within the Android space and numerous companies offering multiple hardware models.

However, you should be aware of screen size, screen resolution, and pixel density in order to ensure the best user experience possible. Incompatibility in visual parameters such as these can affect the usability of your SaMD product by making text and graphics harder to read or interact with on the smartphone screen.

And, similar to the most recent Apple models, Android manufacturers have also begun incorporating the (in)famous notch into the design of their new mobile operating systems.

By looking at the major players in the Android space, one can get an idea of significant parameters to anticipate. Despite the fact that there are a multitude of hardware models running Android, the smartphones leading in subscriber base all currently belong to the Samsung Galaxy line of smartphones (S8, S9 and S10).

Insights

More and more, consumers are opting for bigger screens with better visual display characteristics — and both iOS and Android smartphone manufacturers are taking note. Large-screen smartphones and phablets (such as Samsung’s Note series) are capturing more of the subscriber base, though not yet taking the top spot.

Still, consumers are not abandoning smaller smartphone screens and resolutions, but some of these are being phased out by hardware manufacturers in favor of larger screens with an improved visual experience.

While increasing in popularity, larger screens are not likely to replace the more conventionally sized screens of existing smartphones, which still remain popular — that is, unless manufacturers continue the trend of phasing out smaller-screen mobile devices in favor of more powerful large-screen smartphones.

Finally, it’s worth a second mention that foldable phones are gradually making their way onto the market. New OS versions like Android 10 have been developed with this trend in mind. While the data is insufficient, we’ll keep monitoring for important new developments.

Screen Size, Resolution, and Pixel Density by Vendor

iPhoneScreen SizeScreen ResolutionPixel Density
iPhone 84.7 in1334 x 750326 ppi
iPhone 8 Plus5.5 in1920 x 1080401 ppi
iPhone X5.5 in2436 x 1125458 ppi
iPhone XR6.1 in1792 x 828326 ppi
iPhone XS5.8 in2436 x 1125458 ppi
iPhone XS Max6.5 in2688 x 1242458 ppi
iPhone 116.1 in1792 x 828326 ppi
iPhone 11 Pro5.8 in2436 x 1125458 ppi
iPhone 11 Pro Max6.5 in2688 x 1242458 ppi

Table 2. Apple screen size, resolution, and pixel density

SamsungScreen SizeScreen ResolutionPixel Density
Samsung Galaxy S95.8 in2220 x 1080570 ppi
Samsung Galaxy S9+6.2 in2960 x 1440529 ppi
Samsung Galaxy S106.1 in3040 x 1440550 ppi
Samsung Galaxy S10+6.4 in3040 x 1440522 ppi
Samsung Galaxy S10e5.8 in2280 x 1080438 ppi
Samsung Galaxy S206.2 in3220 x 1440563 ppi
Samsung Galaxy S20+6.7 in3200 x 1440525 ppi

Table 3. Samsung screen size, resolution, and pixel density

MotorolaScreen SizeScreen ResolutionPixel Density
Motorola E55.7 in720 x 1440282 ppi
Motorola G65.7 in2160 x 1080424 ppi
Motorola G76.2 in2770 x 1080403 ppi
Motorola Z36.0 in2160 x 1080402 ppi
Motorola Z46.4 in2340 x 1080403 ppi

Table 4. Motorola screen size, resolution, and pixel density

LGScreen SizeScreen ResolutionPixel Density
LG G55.3 in2560 x 1440554 ppi
LG G65.7 in2880 x 1440565 ppi
LG G8 ThinQ6.1 in3120 x 1440564 ppi
LG V35 ThinQ6.0 in2880 x 1440537 ppi
LG V40 ThinQ6.4 in3120 x 1440537 ppi
LG V50 ThinQ6.4 in3120 x 1440538 ppi

Table 5. LG screen size, resolution, and pixel density

GoogleScreen SizeScreen ResolutionPixel Density
Google Pixel 35.5 in2280 x 1080443 ppi
Google Pixel 3 XL6.3 in2960 x 1440523 ppi
Google Pixel 3a5.6 in2220 x 1080441 ppi
Google Pixel 3a XL6.0 in2160 x 1080402 ppi

Table 6. Google screen size, resolution, and pixel density

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PART 2: Bluetooth Support

Bluetooth Support Across Apple & Android

Bluetooth logo PNG images free download

There are currently two Bluetooth versions available for Apple and iOS devices: Bluetooth 4.2 and Bluetooth 5.0.

The majority of devices with Bluetooth-connected mobile apps that have been developed over the last few years utilize Bluetooth 4.2.

Bluetooth 4.2

Launched in December 2014, Bluetooth 4.2 introduced the IPv6 protocol, the most recent version of the Internet Protocol, for direct internet connection.

Version 4.2 supports both Bluetooth Classic and Bluetooth Low Energy (BLE). Bluetooth Classic is used to connect mobile phones to Bluetooth headsets for phone calls and for streaming applications such as audio streaming and file transfers. By contrast, BLE is a low power version of Bluetooth, meant for power sensors and accessories where low power consumption is more important than fast throughput and continuous connections. Like Bluetooth Classic, BLE allows devices to communicate with one another and is meant for a range of internet-enabled devices.

BLE was not meant to replace Bluetooth Classic, but rather, to serve as a way for Bluetooth devices to communicate quickly and easily with connected devices in the ever-growing Internet of Things.

The main benefit of BLE is that, as a low-power technology, it can communicate with nearby devices that must, by design, consume less power. These devices include wearables such as heart rate monitors and fitness devices, which typically must run on batteries for long periods of time and therefore cannot use a lot of energy.

BLE achieves its ultra-low power consumption by “turning the radio off” as much as possible and sending small amounts of data at slower transfer speeds. Compared to Bluetooth Classic, BLE connections are also much faster, as discovery occurs on only three channels, whereas Bluetooth Classic has a time- and power-consuming 32-channel discovery process.

The efficient and low-power nature of BLE, along with its ubiquity in the smartphone market and low-cost BLE modules and chipsets, make it indispensable for connected medical device applications.

Bluetooth 5.0

Bluetooth 5.0 was introduced in July 2016 and is currently the latest version of the short-range wireless connectivity standard. Official specifications for Bluetooth 5.0 state that “Bluetooth 5 brings some major advances to [Bluetooth Low Energy] and makes it ideal for an even broader range of IoT scenarios … [Bluetooth 5.0] will have a substantial impact in many sectors and further position it as the low power wireless technology of choice in the Internet of Things.”

Bluetooth 5.0 offers a number of improvements on Bluetooth 4.2, and in particular, major updates to BLE (Table 7).

FeatureBluetooth 4.2Bluetooth 5.0
SpeedSupports up to 1 Mbps2x data rate, supports up to 2 Mbps
Range200 meters outdoors, 10 meters indoorsoutdoors, 40 meters indoors
Message Capacity31 bytes255 bytes
Robustness to Operate in Congested EnvironmentsLower - in 2.4 GHz spectrum with no code hopingHigher - uses code hopping in @.4 GHz spectrum
Power RequirementHigherLower

Table 7. Bluetooth 4.2 versus Bluetooth 5.0

Source: Amar InfoTech

Bluetooth 5.0 Support Across Devices

It’s important to highlight that not all smartphone models and OS variants that support Bluetooth 5.0 include all of the benefits of the new update, particularly on the Android side. These improvements are optional to varying degrees, so hardware manufacturers that support 5.0 may be missing one or more of these new features.

One important new feature in the Bluetooth 5.0 specification is a choice of three physical layers, or PHYs, which configures the physical parameters of the radiofrequency communications between devices; in essence, the PHY is the Bluetooth chipset. To run Bluetooth 5.0, the phone’s PHY must, at minimum, support LE 1M PHY, the chipset used in Bluetooth 4.0. However, there are two more advanced types of PHYs with better capabilities which do not have to be used in Bluetooth 5.0 smartphones.

The second type of PHY, the LE 2M PHY, is faster, and the LE Coded PHY provides about four times the range of Bluetooth 4.2 without increasing power usage. However, while most new smartphones on the market support either LE 2M PHY and LE Coded PHY, most do not support both.

A second new feature in Bluetooth 5.0 is the use of longer “advertising” packets. In this case, advertising refers to Bluetooth’s ability to broadcast its signal to identify itself to other Bluetooth devices. So-called Bluetooth “advertising” is essential so that the device can locate and link up with other devices. With a longer advertising packet, more information can be transmitted between the connecting devices, which serves to improve the user experience.

However, longer advertising is not required for all Bluetooth 5.0 devices, nor is it supported by devices that only run Bluetooth 4.2. This means that even if newer Bluetooth 5.0 smartphones support longer advertising lengths, older smartphones running Bluetooth 4.2 will not be able to communicate with them, causing compatibility problems between different generations and hardware models/variants of smartphones.

In short, three of the features available in Bluetooth 5 (LE 2M PHY, LE Coded PHY, and extended advertising) do not actually have to be supported for the device to be classified as Bluetooth 5.0.

Consequently, when a smartphone manufacturer says its hardware model supports Bluetooth 5.0, there may be limitations that prevent it from interfacing with other devices which have support for all of the new features of Bluetooth 5.0.

Unfortunately, this also means that many devices classified as Bluetooth 5.0 will not actually have all Bluetooth 5.0 features. For example, the Samsung Galaxy S9+ only supports the PHY 2M Layer, while Galaxy S10+ supports all three. This is why it is important to determine whether a device has support for the new Bluetooth 5.0 features before designing a Bluetooth-enabled SaMD product. As noted above, many flagship smartphone models are missing some of the new Bluetooth 5.0 features.

Bluetooth 5.0 and Apple Smartphones

Starting in Q1 2016, over 20% of iPhone hardware models supported Bluetooth 4.2. The iPhone 6 was the first Apple smartphone model to support Bluetooth 4.2, followed by the iPhone 7, 7 Plus, and SE. Q4 2017 saw the introduction of Bluetooth 5.0, which is supported by the newer iPhones, including the iPhone 8, 8 Plus, X, XR, XS, XS Max and the just-released iPhone 11 models.

In Q1 2020, 100% of Apple iPhone hardware among North America’s subscriber base supported Bluetooth 4.2 and up, while 71.44% of phones supported Bluetooth 5.0 or higher. This data indicates that the vast majority of iPhone models used in North America meet both Bluetooth 4.2 and 5.0 standards, and that over 70% of iPhones are Bluetooth 5.0 compatible.

iPhone Subscriber Base & Bluetooth Version Support, 2020 Q1

Chart 24. iPhone subscriber base and Bluetooth version support through Q1 2020

Bluetooth and Apple iOS

Apple’s iOS 13 launch this September offers new Bluetooth BLE functionality. The iOS 13 software introduces support for Bluetooth Basic Rate / Enhanced Data Rate (BR/EDR) devices. BR/EDR is generally used for short-range, continuous wireless connections, which is why it’s ideal for IoT devices, such as connected medical devices. iOS 13 also ushers in Apple’s emphasis on greater security and privacy. Furthermore, the changes in the new iOS make it easier for developers to use the Bluetooth Application Programming Interface (API).

Bluetooth 5.0 and Android Smartphones

Samsung Galaxy S7 was the first of Samsung’s flagship line of Galaxy smartphones to offer Bluetooth 4.2, while the S8 was the first of the company’s Galaxy line of smartphones (as well as one of the first phones on the market) to offer Bluetooth 5.0. As mentioned earlier, however, Samsung has been inconsistent in the implementation of Bluetooth 5.0 specification options across its hardware models.

Bluetooth 5.0 and the Android OS

In addition to lack of hardware support, several older versions of the Android operating system do not offer full software compatibility with Bluetooth 5.0. At the present moment, Android versions 8 and above currently support both Bluetooth 4.2 and Bluetooth 5.0 (although not necessarily across all three domains).

Bluetooth 5.0 For Your Connected Device

Given this information, when should you actually target Bluetooth 5.0 for your connected device?

There are two parts to answering this question:

  1. Do you actually need the features of Bluetooth 5.0?
  2. When will enough of your user base have Bluetooth 5.0-capable smartphones?

For the first part, it’s worth noting that many applications don’t need the higher bandwidth, range, advertising, or more robust coexistence in a congested environment. For example, if you’re only transferring a small amount of data between a device and your smartphone when the application is in foreground mode (and close to the device), then you likely don’t need Bluetooth 5.0.

If, on the other hand, you frequently transfer large amounts of data (like waveform or image data) when the smartphone application is in background mode and/or the smartphone is far from the device, or when you are controlling a medical device via BLE from your smartphone in a congested environment, then Bluetooth 5.0 improvements are much more useful — and in some cases necessary — to make your connected device system safe and feasible.

For the second part, a simplified answer is that it depends on when your next product release is scheduled and what level of market coverage you’re looking for.

As of Q1 2020, Bluetooth 5.0 covers approximately 75% of the iOS market (Chart 24) and is growing by about 10% per quarter. We expect Bluetooth 5.0 to comprise 90% of the iPhone market by the end of 2020 (Q4 2020).

On the Android side, the data is much less clear. While Android phones have a similar two- to three-year average upgrade cycle, and Bluetooth 5.0 support was rolled out across the flagship phones of the major Android vendors, there is much less data available. Our best guess is that full Bluetooth 5.0 is currently supported for between 40% and 50% of the Android subscriber base, with a similar 10% per quarter increase in Bluetooth 5.0 support as on the iOS side, as older models get replaced.

Ultimately, your strategy should take into account your need for Bluetooth 5.0 improvements as well as when, where, and how much subscriber base share you need for the product you’re releasing. Based on recent trends, it’s certainly safe to say that if your commercial release is in Q4 2020 or later, and your product can benefit from Bluetooth 5.0 features, you should pick Bluetooth 5.0.

Industry Trends for Smartphone Compatibility Certification

PART 3: Industry Trends for Smartphone Compatibility Certification

Smartphone Compatibility Certification Trends

The FDA has increasingly been requiring a platform (smartphone/OS) compatibility testing strategy from connected device vendors whose mobile apps have higher patient risk. A number of vendors with device solutions publish their smartphone/OS compatibility certifications on their website. We selected 12 leading connected medical device and SaMD products for our analysis of the overall competitive trends in the connected medical device space. The companies chosen had all made their device compatibility available publicly via their respective websites.

Of the 13 apps we considered in our analysis, all but four support Apple’s most recent smartphones (which run on Bluetooth 5.0).

Samsung is next, and is supported on a variety of connected device apps, followed by Google and LG. Only two versions of Motorola smartphones were supported by a single app, making the brand the least covered by connected device applications.

# of Smartphones Supported by Company, 2020 Q1

Chart 26. Number of smartphones supported by chosen companies in Q1 2020

iOS Subscriber Base Coverage by Company, 2020 Q1

Chart 27. iOS subscriber base coverage by company in Q1 2020

*Due to the limited amount of Android subscriber data (Google, LG, and Motorola data are missing), we’ve omitted similar chart for Android, as it would not adequately reflect true coverage

As seen in Chart 28, most companies cover around 90% of the total iOS subscriber base, but a much smaller percentage (somewhere between 5%-10%) of the total Android subscriber base.

# of Smartphones Supported By Company, 2020 Q1

Chart 28. Number of smartphones supported by chosen companies in Q1 2020

These patterns seem to reflect the smartphone brands’ prevalence on the market, indicating that software developers have done their research regarding subscriber base share and primarily target Apple devices, as well as various models of Samsung smartphone hardware, which runs the Android OS. Interestingly, it appears that some manufacturers, such as Abbott and Voluntis, have yet to update their software for newer Samsung models, potentially indicating that an app may have been, or is in the process of being, discontinued.

So, what determines which OSes and devices are supported?

In general, companies primarily support the most recent versions of the iOS, unless their product has been around long enough that they still have some users with older smartphone versions. This reflects the faster/semi-forced update path for iOS. Companies tend to go back further on versions of Android, due to greater fragmentation from reduced update availability/forced updates.

For smartphone hardware, most have fairly wide coverage on the iOS device side (iPhones, and where applicable, iPads), but have far less coverage on the Android side. The best coverage on the Android side is for Samsung phones (which still have far less coverage, on average, than iPhones), followed by Google and LG.

Finally, some developers of connected devices and SaMD products have a smartphone platform compatibility certification program (in some cases this is mandated by the FDA), the results of which they publish on their website. This typically includes both operating system versions and smartphone model numbers.

We recently initiated coverage of this area and expect to add more products and trend analysis to our coverage in subsequent reports.

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PART 4: Quarterly Development Insights

Summary

The first quarter of 2020 saw no major discontinuity for smartphone manufacturer trends — including Apple’s revenue which was driven by strong demand for their iPhone 11 and 11 Pro models and Google’s revenue fueled by Search and Cloud services. However, Samsung, Google, LG and Motorola saw a decrease in revenues in Q1 compared to previous years. The COVID-19 pandemic which came in the middle of the quarter has put a strain on global supply chains and sales channels for device makers who have manufacturing factories in China. It will be interesting to see how the next quarter will play out for all of the major smartphone vendors.

As of the time of this writing, the trade war between U.S. and China has temporarily been put “on hold.” While tariffs have been delayed (for now), both manufacturers and consumers will be paying close attention to new developments and their significant impact on smartphone manufacturing and prices.

Apple Q1 2020

Apple’s Q1 results showed that the services segment of the Apple brand (such as Apple Pay and the App Store), and not the smartphone segment, reaches a new all-time high of $13.3 Billion in total revenue despite COVID-19’s impact.

Apple’s earnings reported a user base of 1.5 billion users across all devices and quarterly revenue of $58.3 billion, a one percent increase from the previous year. International sales made up 62% of its Q2 revenue.

In this quarter, Apple hit its highest quarterly revenue, fueled by strong demand for their iPhone 11 and 11 Pro models as well as all-time records for Services and Wearables. Their strong business performance has driven a net income record of $22.2 billion and generated an operating cash flow of $30.5 billion.

Samsung Q1 2020

The world’s largest smartphone maker, in second place in terms of U.S. subscriber base share, saw its Q1 consolidated sales at approximately $44.65 billion USD (55 trillion Korean won), an increase of 5% from a year ago.

The COVID-19 outbreak has led to concerns over demand for smartphones and other consumer electronics. Some of Samsung factories and retail stores around the world had temporary closure and that might have impacted sales. The company did not break down the operating profit and consolidated sales numbers for each of its business units during the Q1 earnings call.

Due to more people working from home and making online purchases, the company saw a stronger demand for memory chips due to an increase in demand from data centers which supports a variety of internet services. The company is hopeful that the memory chips will continue to drive earnings in Q2 2020.

Google Q1 2020

As the maker of both the Android OS and Pixel, Google-owned between two and three percent of the subscriber base share of North America’s Android smartphones in Q1 2020. Google’s parent company, Alphabet reported revenue of $41.2 billion in the first quarter of 2020 which was mainly driven by Search, YouTube and Cloud business units.

Although the parent company’s Q1 2020 revenues were up 13% compared to last year, CFO Ruth Porat said that this quarter ended on a low note and that the company experienced a significant slowdown in ad revenues.

Google’s non-advertising revenue, which includes hardware such as its Pixel phones and Play Store reported revenue of $4.44 billion, a decrease compared to $3.62 billion the same quarter last year while Google Cloud products reported $2.78 billion.

LG Q1 2020

LG Mobile Communications division reported $843.9 million USD (KRW 998.6 billion) in sales in Q1 2020, a 34% decrease compared to Q1 2019. The reason for the decrease is due to supply disruptions from Chinese partners. Costs were further reigned in through production and marketing efficiencies, ongoing efforts to help reduce the effect of the pandemic. The company is optimistic that with the launch of the new LG Velvet 5G smartphone in Korea during the second quarter will boost sales in Q2 2020.

Motorola Q4 2019

In Q4 of 2019, Lenovo’s Intelligent Devices Group (IDG) which made up of two business units: the PC and Smart Devices Group (PCSD) and Mobile Business Group (MBG) continues to lead the company’s strong performance. PCSD group reported annual revenue of $40 Billion, up 3.6% year-on-year. On the other hand, the MBG group was impacted by the pandemic in the fourth quarter when the company had to close down their primary smartphone factory in Wuhan. Despite this, the business was able to leverage its global manufacturing footprint and produced 6 million phones during the quarter. The MBG group aims to maintain profitability by focusing on innovation and reentering the premium segment with the company’s iconic Motorola Razr smartphone.

*The latest available data at the time of this writing. Data from Lenovo-owned Motorola is limited to Q4 2019.

The U.S.-China Trade War Deescalates

The ongoing U.S.-China trade war continues to affect the smartphone market, with virtually all of the major smartphone manufacturers (and their subcontractors, such as Foxconn) operating at least some production facilities in China.

In fact, many U.S. tech companies, such as Apple, are considering moving approximately 15% – 30% of their hardware manufacturing operations out of China due to the steep tariffs imposed over the past couple of years, which do not appear to be subsiding anytime soon.

In Q3 2019, U.S. President Donald Trump announced a new list of duties. The tariffs would add an additional 10% tax to over $300 billion in consumer goods, including apparel, electronics, toys, and others.

The tariffs, originally scheduled to kick in on September 1, 2019 and then later delayed to December 15th, 2019, will likely include all assembled electronics (the Office of the USTR has yet to release a final list of all affected goods). They will be paid by U.S. importers, rather than China. Companies may decide to pass along the tariffs to consumers or absorb the added costs — though in the personal electronics space, it is expected that any price hikes will be passed along to consumers.

South Korea’s Samsung, the premier maker of Android-based smartphones worldwide, also operates two factories in China, although it is shifting its manufacturing to India and Vietnam due to the slowing Chinese smartphone market.

The tariffs will likely have wide-ranging effects on other known Android smartphone manufacturers like Google, Nokia, and Lenovo-owned Motorola, which also operate manufacturing facilities in China. This means that other smartphone models, including the Google Pixel 3, could also be subject to these duties.

Three days before the December 15th, 2019 deadline, President Trump delayed the new round of tariffs. On January 15th 2020, the US signed a ‘Phase 1’ trade deal with China where the countries agreed to delay some of the tariffs that had been imposed on $160 billion Chinese imports, including cellphones and laptops as part of the Phase 1 agreement. In exchange, China promised to provide more protection for American companies’ intellectual property and to stop requiring U.S. companies to share their technology as a cost of doing business in China. This agreement brings (at least) temporary relief to the smartphone manufacturers.

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Appendix A: Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) Products with Smartphone Compatibility Certifications

Company Mobile AppMobile App Description
Dexcom G6® AppThe Dexcom G6 is an FDA-permitted continuous glucose monitoring system that allows you to make diabetes treatment decisions without confirmatory fingersticks or calibration.
Dexcom G5® AppThe Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System provides real-time glucose readings for patients with type 1 or type 2 diabetes every five minutes. With Dexcom G5 Mobile, dynamic glucose data can be accessed and shared safely and conveniently anywhere, anytime to your compatible smart device.
Medtronic MyCareLink™ Heart AppThe Medtronic MyCareLink Heart App is used with Medtronic pacemakers and CRT-P devices with Bluetooth wireless telemetry. The app can be used to automatically send heart device information to your clinic on a scheduled basis or anytime your doctor requests device information from you. The information can be sent wherever you go.
Medtronic Guardian™ Connect AppThe Medtronic Guardian Connect App pairs with the Guardian Connect Continuous Glucose Monitoring system for people on insulin injections. The app displays sensor glucose data, trends, and alerts in a simple and easy-to-use design.
Roche Accu-Chek® Connect AppThe Roche Accu-Chek Connect app pairs with the Accu-Chek meter wirelessly via Bluetooth. You can then log results automatically, chart your data, send results to caregivers, and calculate insulin doses.
Abbott FreeStyle® LibreLink AppThe FreeStyle LibreLink app is used with the FDA-approved FreeStyle Libre 14-day sensors to instantly capture and view real-time glucose levels, assess 8-hour glucose history, and see a directional arrow indicating how glucose is changing. The app also includes a series of in-app reports that visualize trends and patterns to help people understand how well they’re controlling their glucose.
AliveCor® KardiaMobile AppThe AliveCor KardiaMobile app works with the FDA-cleared KardiaMobile, KardiaMobile 6L, or KardiaBand EKG devices. Touching the sensors on your Kardia EKG device for 30 seconds allows the data to be captured.
Senseonics Eversense® AppThe Senseonics Eversense app allows you to get your data in real time on your smartphone. The app receives and displays data in easy-to-read charts and graphs. You can discreetly check your info on an Android or iOS smartphone or Apple Watch. New readings are uploaded every five minutes.
Voluntis Insulia® AppThe Voluntis Insulia app is a prescription-only medical device that recommends basal insulin doses for adults with type 2 diabetes based on the treatment plan created by a healthcare provider.
Companion Medical InPen® AppThe InPen Mobile app is a diabetes management tool that tracks insulin doses from the InPen, calculates insulin doses, and shares therapy details with healthcare professionals and family members.
Philips Lumify AppThe Philips Lumify app is paired with the FDA-cleared Philips Lumify, a smart-device diagnostic ultrasound solution. Lumify operates on user-supplied compatible Android smart devices equipped with internet and email functionality. To use Lumify, users download the Lumify App from Google Play, connect their Philips transducer to their compatible smart device via USB, and launch the app to begin scanning.
ResMed® AirMini™ AppThe ResMed AirMini app enables you to use your AirMini machine right from the palm of your hand. The data is transferred via Bluetooth wireless technology. The app also provides you with a 30-day therapy history and a daily therapy score each morning.
Oticon Medical Ponto Trial Companion AppThe Oticon Medical Ponto Trial Companion App is an app that helps provide a way for patients to evaluate whether bone-anchored hearing and the Ponto Sound System are the right decision for them. The app guides patients to experience different listening situations and rate their hearing experience. Patients can email their ratings reports directly to their hearing care professional.

References

For further information on how we derived the charts and numbers highlighted in this article, please send an email to info@orthogonal.io.

Smartphone Vendor Market Share

Smartphone Introductions

Apple Devices Release Dates & Compatibility

Android Devices Release Dates & Compatibility

Android Manufacturer OS Release Dates

iOS Version Update Dates

Android Version Update Dates

Android Version Distribution Percentage

Android Screen Sizes & Resolution

Peer Analysis

**

About the Authors

Bernhard Kappe, Chief Executive Officer

A person looking at the camera Description automatically generated Bernhard Kappe is a software development leader, technologist, and pioneer who consistently provides his clients with an unfair advantage by introducing them to important new trends and techniques at the leading edge of the adoption bell curve (e.g., Agile software development, Lean User Experience, Software Product Management, DevOps, Lean Startup and open source software). For the last eight years, as founder and CEO of Orthogonal, Kappe has exclusively focused on adapting these approaches to the medical device and HealthTech industry. He has worked with clients including Novo Nordisk, Google, Tandem Diabetes, and Nanowear to connect medical devices to mobile apps and the cloud while shortening product development life cycles, improving delivery predictability, and creating engaging user experiences. By developing new diagnostic and treatment devices and business models, his clients have seen software-enabled market growth and improved patient outcomes and have contributed to bending the healthcare cost curve.

He can be reached via:

Email: bkappe@orthogonal.io
LinkedIn: https://www.linkedin.com/in/bernhardkappe/
Twitter: @bernhardkappe
Phone: 312-372-1058 x6002

Randy Horton, VP of Solutions & Partnerships

A person wearing a suit and tie smiling at the camera Description automatically generated Randy Horton is VP of Solutions and Partnerships at Orthogonal, a software development consulting firm that gives medical device manufacturers an unfair advantage by helping them rapidly design and develop new Software as a Medical Device (SaMD) and connected medical device solutions. Randy Horton is passionate about helping established organizations break through to their “what’s next” by building new capabilities and launching new products and services that are both innovative and successful. Much of his career has been centered on working with healthcare and life sciences organizations to tackle the problems summarized in the Quadruple Aims: Improving the individual experience of care, improving the health of populations, reducing the per capita costs of care, and improving the work life of those who deliver care. Randy credits much of his passion for creative business thinking and being a connector of people and ideas to the four years that he spent at a Montessori pre-school. Noting that he still seems to live in the open classroom of his childhood, one of Randy’s executives once observed, “It’s not that Randy thinks out of the box. It’s that he doesn’t even have a box.”

He can be reached via:

Email: rhorton@orthogonal.io
LinkedIn: https://www.linkedin.com/in/randyhorton/
Twitter: @randyhortonchi
Phone: 312-433-943

Ke Li Yew, Marketing Associate

A person wearing a purple shirt and smiling at the camera Description automatically generated As a Marketing Associate at Orthogonal, Ke Li Yew plays a key role at the intersection of Marketing and Sales. Her work involves conducting market research, analyzing key trends in the medical device and digital health industries, and managing Orthogonal’s online presence and communications.

Yew is currently pursuing her Master of Healthcare Informatics at Harrisburg University of Science & Technology. Previously, she graduated from University of Michigan with a degree in Biochemistry. In her spare time, Ke Li enjoys spending time outdoors. A few of her favorite activities are hiking and fishing.

She can be reached via:

Email: kyew@orthogonal.io
LinkedIn: https://www.linkedin.com/in/ke-li-yew/
Twitter: @keliyew
Phone: 734-834-2974

Who Is Orthogonal? And Why Do We Care About Digital Health?

Orthogonal is a software developer for connected mobile medical devices (CMMD) and Software as a Medical Device (SaMD).

We work with change agents who are responsible for digital transformation at medical device and diagnostics manufacturers. These leaders need to accelerate their pipeline of product innovation to modernize patient care and gain a competitive advantage.

Orthogonal applies deep experience in CMMD/SaMD and the power of fast feedback loops (FFLs) to rapidly develop, successfully launch, and continuously improve connected, compliant products—and we collaborate with our clients to build their own rapid CMMD/SAMD development engines.

Over the last eight years, we’ve helped a wide variety of firms develop and bring their regulated/connected devices to market.

Almost twenty years ago, we began our consulting work to create great software products in a range of industries, including financial services, education, research, and healthcare. We spent nearly a decade working with leading-edge FFL techniques that have now become recognized best practices such as Agile software development (with XP, Scrum, and Kanban), Lean User Experience (Lean UX), and Lean Startup.

Nearly a decade ago, we got a glimpse of digital healthcare and the enormous potential of the cloud, IoT, and smartphones, and the potential impact of medical device software. Realizing that’s what we wanted to focus our energies on exclusively, we narrowed our focus to the development of CMMD and SaMD.

We’ve never looked back. Our team gets up every day excited to help move the needle on healthcare. For almost ten years, we’ve helped a wide variety of firms develop and bring their regulated/connected devices to market. We’re even more excited about the next ten years and what we will help accomplish during The Great Acceleration of Digital Health.

If you need help building your next CMMD or SaMD, or to learn more,
send us a message or call us at (866) 882-7215.

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