17 min. read

The AliveCor Report

In this article:

In this 4,400-word report, E&O digs into the strategic moves, challenges and lucky breaks that the AliveCor has team navigated since their original prototype went viral as the breakout device of the Consumer Electronics Show in 2011. How has its most formidable competitor, Apple, forced AliveCor to shift its strategy? What kind of traction does AliveCor have today? What is its path forward? Read on for all this and much, much more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

AliveCor might never have existed if the Speaker of the House during Watergate, Rep. Carl Albert (D-OK) hadn’t had heart issues. That inspired his son — years later — to pursue biomedical engineering coursework while in medical school at Duke. He took those courses so that he could figure out how to build a heart monitoring device for his dad. (Those weren’t so easy to find back in the 1970s.) Dr. David Albert, the co-founder of AliveCor, did end up getting his medical degree, and he has invented many medical devices for heart patients since he began tinkering at Duke.

It’s also almost a certainty that AliveCor would have been a footnote in the annals of digital health history if a certain venture-backed company hadn’t botched its chance to acquire it — for a song — before the rest of the world had even heard of the iPhoneECG.

There’s also a good chance that if Dr. Albert hadn’t uploaded his YouTube video of a demo featuring his pre-FDA, prototype device before heading to CES 2011, the iPhoneECG would not have gone viral; Albert would not have appeared on Good Morning America and countless other news programs; and investors would have continued to argue that there was no market for a direct-to-consumer medical device for heart patients.

But, through a mix of luck and grit, AliveCor does exist. And as these pages will make clear, it’s an important case study for digital health entrepreneurs and investors. Apple clearly agrees. Last year, at a time when it was considered the most valuable company in the world, Apple announced its very first FDA-cleared medical device: a stripped-down, knock-off version of AliveCor’s Kardia Band.

Without a doubt, the tale of AliveCor is a storied one. Despite the many tempting rabbit holes in AliveCor’s history, this report will focus on the strategic decisions AliveCor management made along the way. It’s broken into sections focused on AliveCor’s growth metrics, product portfolio, regulatory strategy, business models, hiring problems, and longterm strategic opportunities.

AliveCor by the numbers

AliveCor is a private company so it keeps quiet about most of its growth metrics. Here’s a quick summary of ones mentioned throughout this report as well as a few additional ones that have not been reported elsewhere:

  • 2018 revenue: $24,000,000.
  • 2019 expected revenue: $40,000,000.
  • 2018 Q4 revenue: $10,000,000 — largely attributed to increased media attention resulting from Apple’s announcement about adding its own ECG software to the Apple Watch.
  • Monthly active users: 200,000.
  • First-year revenues from the veterinary market, pre-FDA clearance for humans: $1,000,000.
  • Number of ECGs in AliveCor’s database: Nearly 50,000,000.
  • Number of ECGs captured each month: About 1,500,000.
  • Current employee headcount: About 70.

A few quick takeaways

  • This has yet to be reported elsewhere: As of this summer, AliveCor has stopped selling its Kardia Band device as a result of Apple’s ECG feature launch. AliveCor has also put its SmartRhythm feature on pause, but this may make a return for other smartwatches in the future.
  • The venture-backed company teased in the introduction of this report was eCardio. Before AliveCor had a prototype built, eCardio made a $250,000 investment in the venture with an option to acquire AliveCor in short order. However, eCardio ran into revenue problems soon after and forfeited its option to acquire AliveCor’s technology. The AliveCor founders got to keep the money and used it to fund the development of its prototype devices, including the one featured in Dr. Albert’s viral YouTube video.
  • The metrics above show a current headcount of 70 employees with $24 million in revenue for 2018. While the headcount was likely closer to 60 for most of last year, the numbers (and the existence of the company’s television advertisements) suggest AliveCor is spending a substantial portion of its revenues on customer acquisition. Perhaps it goes without saying, but particularly true in this case: The ideal analysis of AliveCor’s long-term prospects would hinge on its CAC, which this report does not manage to piece together.
  • As the conclusion below discusses, AliveCor is well-positioned for growth. It will both complement and compete with the likes of Apple — and other big consumer device makers working to commoditize ECG features in wearable fitness devices. In other words, rumors of AliveCor’s demise have been greatly exaggerated.

AliveCor’s products, past and present

AliveCor Veterinary iPhone ECG: Launched in August 2012, the first commercial product from AliveCor was for veterinary use only: dogs, cats, horses, and other animals veterinarians treat. It’s still available via resellers for $299.

iPhone ECG/Alive ECG/AliveCor Heart Monitor: First available for preorder December 2012, this FDA-cleared device was for physicians-only initially at a $199 price point. It was a single lead ECG embedded in a case that fit the iPhone 4 and iPhone 4s. The second iteration of the device wasn’t a case, but a smaller, companion device that could be adhered to the back of various Android and iOS smartphones via velcro stickers. Physicians had to prescribe the device to patients who would then pay for it out-of-pocket.


AliveInsights: AliveCor added a remote interpretation service for its device users in November 2013. Patients prescribed an AliveCor device from their doctors could use the new service by taking an ECG reading and then opting to send it to either a cardiac technician or cardiologist, right from their smartphone. It cost $12 for a cardiologist to interpret it and either $2 or $5 for a cardiac technician to do so in either 24-hours or 30 minutes, respectively. The service was a temporary pilot powered by partnerships with CompuMed and its one-time, almost acquirer eCardio.

AliveCor Heart Monitor (OTC): In February 2014 AliveCor announced a new FDA clearance that made its device available to patients direct-to-consumer the following month. Anyone could now buy the device from AliveCor’s website for $199. They could send their ECG to their own physician via email (if their physician allowed that) or send the ECG to a remote interpreter via AliveInsights, as noted above. The price for buying a device OTC eventually settled at $99.

Kardia Pro/Kardia Station: In March 2017 AliveCor launched a physician portal called KardiaPro. They renamed it to KardiaStation in mid-2018 on the AppStore but the old branding weirdly remains in place elsewhere. Patients pay $15 a month to connect to their physician’s KardiaPro account. Physicians use the portal to review ECGs sent in from their own patients and they get reimbursed for Medicare patients using CPT Codes, including the new remote patient monitoring CCM codes. Kardia Pro aims to make getting this reimbursement easier. AliveCor has also worked to interface Kardia Pro with some EHRs, including Epic installations at various hospitals.

Kardia Mobile Premium: Each AliveCor device comes with 30 days of free premium service, which allows users to store unlimited ECGs in AliveCor’s cloud, provides them with a monthly summary of their readings, unlocks the ability to track medications, and allows them to buy a replacement device for just $19.99 if something happens to their first one. This service runs $9.99/month or $99/year.

Kardia Band: The first FDA-cleared medical device for the Apple Watch actually launched first (pre-FDA) in the UK in October 2016 for £199 / €229. It cost $199 in the US initially and the price was dropped to $99 shortly after Apple announced plans for its own FDA-cleared ECG software in September 2018. Apple’s launch effectively made Kardia Band obsolete. AliveCor quietly discontinued its Watch band in the summer of 2019, and it can no longer be purchased on AliveCor’s site or via Amazon.

SmartRhythm: As part of its Kardia Band offering, AliveCor used the continuous heart rate monitoring function of the Apple Watch to create a new analysis feature called SmartRhythm in its Kardia app. The offering compared users’ heart rate data and activity data to what AliveCor’s neural network predicted the user’s heart data should look like. When it sensed something was off, SmartRhythm instructed the user to use Kardia Band to record their ECG. AliveCor discontinued SmartRhythm in mid-2019, but it is like to return on other platforms — possibly even Apple’s — in the future.

FDA cleared algorithms: While not individually priced products today, AliveCor has been a pioneer in submitting new algorithms to the FDA for clearance as medical devices. So far the company’s algorithms are cleared to indicate: normal ECG, bradycardia, tachycardia or possible atrial fibrillation. The FDA has also cleared AliveCor’s algorithm for detecting hyperkalemia via ECG analysis.

Kardia Mobile 6L: AliveCor’s newest product is its six-lead ECG device, which launched in May 2019 for $149. The 6L’s debut coincided with the winding down of the company’s Kardia Band offering and it marks a strategic shift for the company to stick with its smartphone-enabled peripheral devices and away from smartwatches — for now. The company has kept this device in its back pocket for years as it was originally invented in 2013. By collecting heart rhythms from six leads instead of one, Kardia Mobile 6L gives interpreters and its own algorithms five additional views of the rhythm data, which will lead to more accuracy and new opportunities for analyses.

Kardia Accessories: The company also sells carrying pods ($29) and clips ($15) to attach the Kardia Mobile to a smartphone.

How AliveCor brings in revenue

Direct-to-consumer medical devices: The core business model for AliveCor has remained consistent since the years before its flagship product got FDA clearance to go to market: Sell smartphone-enabled medical devices directly to Baby Boomers with heart conditions or concerns. AliveCor has also sold devices to medical professionals like veterinarians, cardiologists, and other physicians both from past offerings and current ones, but the large majority of their revenues have come directly from patients who pay for AliveCor devices out of pocket. Pre-launch, AliveCor pitched investors and potential partners an expected $99 price tag for its over-the-counter ECG device, which is where the price stands today for its single-lead ECG. For one iteration AliveCor tinkered with a $75 price point a few years ago. It has sold older models at clearance prices (as low as $40) to move inventory, but the $99 price has stuck. AliveCor’s new six-lead device, however, has a starting price of $149.

Price it like a co-pay: That original $99 is meant to be around the price of a co-pay for the average Medicare patient. AliveCor has long-received pushback on this strategy because medtech incumbents believe the only way to sell a medical device is to ensure the physician or hospitals could make money off of it. When the company first launched its product, the idea that a heart patient would willingly pay $99 out-of-pocket also struck many AliveCor detractors as a non-starter. And yet that’s where the vast majority of AliveCor’s revenue comes from today.

Major heart centers as sales catalysts: AliveCor has published research with PIs from most of the big name cardiac care facilities in the US. Most of these now suggest their patients buy an AliveCor device, and a few use AliveCor’s Kardia Pro software to analyze ECGs sent in from their patients. The advent of CCM billing codes for remote patient monitoring has opened up a new reimbursement stream for these care providers, and Kardia Pro aims to make it easier for them to get paid via that reimbursement pathway. AliveCor gets paid by patients who send ECGs to their providers Kardia Pro accounts as this requires a subscription fee to unlock. AliveCor also does integration work to make Kardia Pro interface with some EHRs, but it is unclear if they charge providers for this service or they consider it a cost of doing business with that provider’s patient population.

Unregulated veterinarian market first: Before AliveCor had FDA clearance to market to human patients, it began selling its original device and its companion app to veterinarians who use it on dogs, cats, horses, and even grizzly bears, monkeys, and eagles. In its first year on the market for veterinarians, AliveCor brought in close to $1 million in veterinarian revenues for the startups before they were cleared to market in the human health market. Beginning in this unregulated market was great for AliveCor’s cash flow, but it also helped them fine-tune the product, which was the same as the device undergoing the FDA clearance process at the same time.

Selling DTC medical devices is hard: AliveCor has long struggled with CEOs — it has had six in the past eight years, as discussed more in-depth below — but one of those interim CEOs, Ira Bahr, has been the brains behind the company’s direct-to-consumer marketing strategy. Bahr is a longtime marketing executive who is perhaps most famous for naming Sirius satellite radio. He is currently AliveCor’s COO and has helped develop a series of television commercials with major ad agencies to drive AliveCor sales. The company’s ads have run alongside game shows like Wheel of Fortune and a number of popular Fox News shows like Sean Hannity’s, which has garnered the ire of protesters seeking to block conservative talk shows of any ad revenue. While AliveCor makes use of less expensive ads on Facebook and other platforms, its core demographic — the average AliveCor patient is 61 and up — is more likely watching TV. This expensive acquisition channel may explain why the company continues to take on debt and hasn’t ramped up its hiring dramatically in recent years. Its headcount has grown modestly over the years from around 50 in 2016 to around 70 today.

Competition from Apple drove revenues in 2018: AliveCor says its revenues in Q4 2018 jumped thanks to Apple’s announcement that it would add an FDA-cleared ECG function to its latest version of the Apple Watch, a near clone of AliveCor’s Kardia Band. While industry watchers roundly concluded this spelled the end for AliveCor, the company said that the media mentions it received in every article that covered the Apple ECG watch led to that revenue spike. It helped, of course, that Apple announced the product and the FDA clearance but its ECG function wasn’t activated until months later.

As a result, AliveCor raked in about $10 million in Q4 revenues for a total of $24 million for 2018. The company aims to bring in $40 million in revenues for 2019.

AliveCor’s regulatory foibles, tactics, and firsts

AliveCor has both pioneered new categories of regulated medical devices and creatively found ways to legally market its products outside of the regulator’s purview.

First, sell into an unregulated market: As discussed briefly above, AliveCor’s decision to market its iPhone-enabled ECG device to veterinarians brought in about $1 million in revenues the year before AliveCor secured FDA clearance to market its device for use with humans. While the FDA regulates how a company markets its devices and the language it uses around the claims it makes, selling the AliveCor ECG device to veterinarians also opened up the door for e-patients (and maybe even a few doctors?) to buy one for themselves. AliveCor never encouraged this behavior, but it is hard to tell how much of that initial $1 million was from veterinarians. While it’s not a focus today, AliveCor does continue to sell into the veterinarian market through resellers.

Accidental pre-FDA clearance marketing: AliveCor’s founder Dr. David Albert rose to fame in 2011 after he uploaded a four-minute video demo of his heart monitor prototype to YouTube. He uploaded the video because a handful of potential partners and investors told him they would not be making it to the Consumer Electronics Show that year, but they would still be interested in learning more about the iPhone ECG device. Albert also absent-mindedly clicked an option on YouTube to share the video with his network on LinkedIn, which inadvertently sent the video into viral territory. The viral video ended up on countless local news networks around the country and the world. Before long Albert was on The Today Show and some talked about the not-yet-legal-to-market iPhone ECG being the break out device of CES 2011. The media attention led the FDA to call Albert who convinced them it was all a big accident, and he never intended the video to be so widely viewed.

Get prescription-only clearance first, then over-the-counter: While AliveCor always intended its ECG device to be sold direct-to-consumer, its first FDA clearance was a prescription-only device. That meant only physicians could buy them directly and patients could only buy them via their physicians. The company decided to start with an Rx-only clearance because it believed it to be the easiest path to market. It likely made the FDA more comfortable, but it also helped get an initial community of physicians familiar with the device before patients began bringing ECGs in with them on their own. AliveCor held back from revealing which predicate device it used in its initial clearance, but the FDA has since made a redacted version of AliveCor’s first 510(k) document public. The predicate was: HeartCheck Pen Handheld Heart Rhythm with GEMS Home (K121009).

Smartphones, algorithms, smartwatches: AliveCor’s original iPhone-connected ECG device was part of the first wave of FDA-cleared medical devices that worked as a companion to smartphones. While Apple claimed to create the first “direct-to-consumer” FDA-cleared medical device for the Apple Watch when they announced their own homegrown ECG software, AliveCor should be recognized as the true innovator with the first FDA-cleared Apple Watch peripheral. Apple claimed it was truly direct-to-consumer (and, therefore, the “first”), because AliveCor’s ECG device requires a physician to remotely interpret the user’s ECG before the device is unlocked for the patient to use on their own. Both Apple’s and AliveCor’s devices are cleared as over-the-counter (OTC) devices, however, and so neither require a prescription. Finally, AliveCor has been a pioneer in FDA-cleared algorithms, including ones for detecting AFib and hyperkalemia (dangerously high potassium levels in the blood). While there are dozens of FDA-cleared algorithms now, AliveCor’s AFib algorithm, which the FDA cleared in 2014, is widely considered to be the first to secure 510(k) clearance.

Evidence first: More on this below, but as part of its first 510(k) submission, AliveCor collected clinical data that it had published and presented at the American College of Cardiology and Heart Rhythm Society scientific sessions. The data focused on both AliveCor’s accuracy as well as its clinical value.

AliveCor is a clinically-validated company first and foremost

With more than 75 studies published to date and well over 100 poster sessions at leading cardiology scientific sessions, AliveCor rightly stresses the body of clinical data that supports its product offerings. The company put together this helpful PDF that covers many of its studies and breaks them down into various subcategories.

AliveCor’s CEO problem

While I don’t have the data to prove it, I suspect AliveCor has had more CEOs than any other digital health company. In its eight years of existence, the company has had six CEOs. AliveCor’s messaging on this has remained consistent since the beginning: Inasmuch as the company is inventing a new category, it is creating a new type of corporate leader. Since AliveCor is both a consumer electronics company that sells DTC as well as a medical device company regulated by the FDA and beholden to various international standards, it has hired high-profile CEOs with experience in one but not the other of both of those worlds. An ideal CEO would understand both, but the company argues no such person exists in the business world today.

Here’s a rundown of AliveCor’s six CEOs.

Judy Wade, AliveCor CEO June 2012-December 2012: AliveCor’s first CEO lasted less than a year. Wade had been CEO of a mobile games and apps company named Hands-On Entertainment. She was an executive at Linden Lab, makers of the online game SecondLife, prior to Hands-On, and she spent much of her career climbing the ranks at McKinsey. AliveCor touted her consumer technology background. In those early days, however, AliveCor was very much a medical device company focused on R&D, building an evidence base, and trying to get through the FDA. It was too soon to focus on the DTC strategy.

Dan Sullivan, AliveCor CEO April 2013-August 2013: AliveCor’s second CEO had an even shorter tenure and a markedly different background. Sullivan had most recently grown and sold a medical device business named SuperDimension to Covidien for $300 million. AliveCor highlighted his medtech and global commercialization capabilities when they announced the hire. Sullivan and Wade both likely felt uncomfortable navigating digital health’s uncharted waters.

Euan Thompson, AliveCor interim CEO August 2013-November 2015: Khosla Ventures investor and longtime medtech executive Euan Thompson took over as CEO on a part-time basis while still working as a VC for Khosla. At the time Khosla Ventures owned a majority stake in AliveCor (it no longer does). While it was an interim CEO position, the company noted early on it was likely to be a longterm situation. Thompson deserves a lot of credit for building the foundations for AliveCor that led to it growing into the company it is today.

Vic Gundotra, AliveCor CEO November 2015-January 2019: Thompson only stepped down as interim CEO once the company had recruited Gundotra, a high-profile executive at Google. Gundotra’s appointment was transformative for the company as he brought on other former Googlers to lead both software and hardware at AliveCor. His appointment also elevated AliveCor’s brand in tech circles since Gundotra is well-known among the tech and business press. After serving as AliveCor’s longest-running CEO for almost 3.5 years, Gundotra stepped down for personal reasons unrelated to the business.

Ira Bahr, AliveCor interim CEO January 2019-July 2019: AliveCor’s marketing lead Ira Bahr stepped in briefly as the company and its lead VC Vinod Khosla searched for Gundotra’s replacement. As noted above, Bahr has leveraged his formidable experience in the ad agency world to build AliveCor’s direct-to-consumer marketing machine. While Bahr stepped down as interim CEO, he remains with the company as COO.

Priya Abani, AliveCor CEO July 2019-present: Vinod Khosla personally recruited Abani from Amazon, where she was general manager and director of the company’s Alexa group. Before joining Amazon three years ago, Abani spent a decade at Intel, but AliveCor marks her first healthcare venture. Vinod Khosla is also now the chairman of AliveCor’s board, which shows how focused he is on this particular portfolio company now.

How AliveCor competes with Apple, others

In September 2018 when Apple announced that it had secured two FDA clearances for heart sensing software on its Apple Watch, many industry watchers assumed this was the beginning of the end for AliveCor. After all, Apple’s announcement more or less made AliveCor’s latest product, the $199 Kardia Band, obsolete. In the short term, however, Apple’s move buoyed sales of AliveCor’s devices leading to a massive $10 million spike in revenues that quarter, which was about how long it took Apple to go from announcement to market launch. Apple’s entrance into the ECG market has had an impact on AliveCor’s strategy, but the company is well-positioned to compete against Apple and other comers. Here’s why.

Apple drove AliveCor to shutter two products: As noted above, AliveCor has quietly discontinued sales of its Kardia Band device as of the summer of 2019. The sunsetting of its smartwatch product line was timed with the launch of its six-lead ECG device and marked the beginning of AliveCor’s new hardware strategy in the face of competition from Cupertino. An earlier casualty inflicted by Apple was AliveCor’s SmartRhythm feature, a premium analysis feature that crunched heart rate data from the Apple Watch and prompted Kardia Band wearers to take an ECG reading if something appeared off in their HR. AliveCor users noticed that SmartRhythm was interfering with the accuracy of their activity data tracking on the Apple Watch, and AliveCor decided to shut the offering down because it could not control the underlying platform that it was built on. (This mentality is also highlighted in AliveCor’s decision early on to use a high-frequency chirping technology to transmit data between its hardware and smartphones instead of a smartphone’s data port or Bluetooth. The chirping tech only required the smartphone to have a microphone, so this tactic helped AliveCor avoid having to update their hardware every time a new smartphone model came out.)

Biggish data and a 50M ECG moat: Apple’s brilliant privacy strategy has led the company to forgo storing user’s health data on any company servers. Instead, health data is stored locally on the user’s device. Meanwhile, AliveCor is collecting 1.5 million ECGs every month right now, and it already has close to 50 million ECGs in its database. Apple won’t compete with AliveCor on this front, it has already established that. Meanwhile, the PatientsLikeMe-iCarbonX forced divestment makes clear that the US government won’t let companies from China build a massive database of US patients’ health data, including ECGs. (It’s an open question if that policy might expand and extend to companies headquartered in other countries, like, say, South Korea?)

Do AliveCor’s demographics trump Apple Watch’s? AliveCor’s typical user is a 61-year-old with a known or suspected heart condition. According to the company, more than half of its users have said their physician recommended they buy an AliveCor device, which again reinforces the idea that AliveCor users are heart patients. Apple Watch users, meanwhile, are likely much younger: Overall, growth in the smartwatch market has been driven by people aged 18 to 34, according to the NPD Group. Given that atrial fibrillation is typically an issue for an older demographic, the majority of Apple users probably won’t need the feature. Still, at the scale Apple is operating on, with tens of millions sold, it is likely that Apple has more Baby Boomers and seniors than AliveCor’s 200,000 monthly active users using its built-in Apple Watch ECG.

Big data (from the right patients) is machine learning opportunity: Despite Apple possibly having a larger patient population using its ECG software, AliveCor is in a position to mine its datasets to create new clinical products. The best example of this is AliveCor’s hyperkalemia algorithm, which is FDA-cleared to detect dangerous levels of potassium in the blood right from the ECG. No actual blood is required for AliveCor’s analysis. AliveCor will continue to launch FDA-cleared algorithms and products and services based on them. Some will be prescription-only algorithms.

Better hardware, better data: AliveCor discontinued sales of its Kardia Band in the wake of Apple’s move into ECG, but it managed to swap out that smartwatch peripheral for a six-lead version of its single-lead ECG device instead. AliveCor had actually invented its six-lead device way back in 2013, it only brought it to market once Apple closed off its immediate hardware opportunity in wearables. The Kardia Mobile 6L offers better quality data, which will lead to new, regulated algorithms as AliveCor’s database of six-lead ECGs grows. In light of the super quick launch of the 6L, however, the company’s likely deep bench of hardware inventions shouldn’t be underestimated.

Beyond hardware: Longterm AliveCor has the opportunity to grow beyond its hardware business. As FDA-cleared ECG-sensing becomes commoditized, in part thanks to Apple’s unprecedented and odd FDA clearances, AliveCor’s ability to develop algorithms from its massive ECG dataset will allow it to sell analytical services to patients using any ECG-sensing device on the market. That means even if Fitbit, Garmin, Samsung, and other wearable companies follow Apple’s lead into FDA-cleared ECG offerings, AliveCor would still be well-positioned to dominate the analytics layer.

4 min. read

Express Scripts talks but CVS launches. India’s 4,800 health startups.

In this article:

This is the sixth edition of the E&O weekly newsletter for paying subscribers. Topics include CVS’ new quasi-formulary for digital health, Cleveland Clinic’s Propeller Health study, India’s 4,000+ health startups and more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 006. Express Scripts talks but CVS launches. India’s 4,800 health startups.

Get E&O weekly. | Subscribe | Digital health research from Brian Dolan.

Welcome to E&O.

Last week’s newsletter had a 77 percent open rate. Here’s what’s happening this week:

  • Your editor is in Helsinki courtesy of the Finnish government, which flew in a small contingent of healthcare reporters from the UK, Latvia, Japan, Germany, and the US to talk digital health in Santa’s homeland. More on Finland-based digital therapeutics, heavy metal bands, and “sisu” (Finnish grit) in the weeks to come.
  • Boston Consulting Group put together a brief overview of how digital technologies are beginning to change the six stages of clinical trials, including study design and protocol development, site selection and initiation, patient recruitment and enrollment, trial monitoring, and more.
  • A massive survey from Phillips concluded that China leads in digital health adoption. One data point: In China, 60% of healthcare professionals always or often suggest patients use digital technologies to monitor their blood pressure. The South China Morning Post also ran a feature on digital health’s opportunity in the country.
  • Bond Capital’s Mary Meeker presented her high-profile (and increasingly maligned) Internet Trends slide deck for 2019 (https://www.bondcap.com/report/itr19/), which included a few slides on digital health — but nothing you don’t already know.

Save those clicks for a rainy day and read on for more important studies, deals, insights, data, and news below.

Did this get forwarded to you? Not yet a paying subscriber? You can sign up right over here.

CVS sets up new digital health channel for payers

The big digital quasi-formulary story this week goes to CVS Health. The nation’s largest PBM just created a new acronym for healthcare types to commit to memory: VBM, or vendor benefit management, which CVS describes as a new service that helps payors “easily onboard and manage third-party vendors that provide digital and non-digital health and wellness solutions.”

VBM is available today with launch partner Big Health, makers of the insomnia digital therapeutics Sleepio. CVS explained that “the service was developed with client input and vendor selection will be based on clients’ goals for their plan and members.”

Makes one wonder if last month’s Express Scripts announcement about a future digital health formulary — set to launch no sooner than six months from now — was intended to take the wind out of CVS’s PR sails this week. Unlike CVS, Express Scripts referred to their future offering as a “formulary” and looks to be mirroring much of the same processes traditional pharmaceutical formularies use. (I’ve made inquiries as to how ESI plans to get the digital products into patients’ hands once they are prescribed and will update once more details are available.)

This helpful health data timeline comes from Microsoft-hosted HL7 FHIR DevDays event it held in Redmond, WA this week.

Cleveland Clinic shares Propeller-powered COPD study results

The Journal of Telemedicine and Telecare published the study this month. From the Cleveland Clinic:

“Between October 2016 and May 2017, 39 patients who have COPD and had at least one hospitalization or emergency room visit during the year prior to enrollment took part in the study…”

“Patients were provided with electronic monitoring devices for maintenance and rescue inhalers for one year. The monitoring platform, provided by Propeller Health, connects a small sensor to a patient’s existing inhaled COPD medication; the sensor then transmits data to the patient’s smartphone, or data hub, delivering alerts and insights on medication adherence and usage trends. Alerts were then emailed to the study team, giving researchers insights on patients’ rescue and controller medication use.”

“The results showed a significant reduction in COPD-related healthcare utilization compared to the year prior to enrollment, from an average of 3.4 trips to the hospital to 2.2. There was also a reduction in all-cause healthcare utilization, but that was not statistically significant.”

Garmin moves deeper into healthcare with sleep stage validation study

The fitness company’s health unit is working to get its sleep tracking software into the hands of clinical researchers. Last month the director of the University of Kansas Medical Center (KUMC) Sleep Medicine Clinic presented findings from the study that showed the Garmin software could identify sleep stages. The findings were presented at the Annual Meeting of the American Academy of Neurology. Garmin pointed out that, unlike Fitbit’s similar study from 2017, theirs was not conducted in a controlled sleep lab but under real-world conditions.

India has 4,892 health tech startups

That is according to a report in Inc42 that includes an overview of the Indian health tech market with examples of startups by category. Two examples mentioned in the diabetes space are Wellthy Therapeutics and Fitternity.

Wellthy just presented results with partner Roche India at ADA 2019 this week

“Mean first and last logged fasting blood sugar (FBS) (149.33 mg/dl vs 132.83 mg/dl, p = 0.0013) and random blood sugar (RBS) (202.20 mg/dl vs 169.79 mg/dl, p = 0.004) values.” Higher engagement with the program also correlated with a bigger drop.

One more ADA mention: The association has finally come around and begun suggesting that lower carb diets can be helpful to patients with diabetes. This news actually broke at the end of 2018 but it received much more attention at the event this week. The ADA’s reluctance to embrace this as part of their standards of care had been frustrating for many over the years.

Health Catalyst inks a deal with MedRhythms

The companies will team up to better target patients who could benefit from MedRhythms digital therapeutics products. The partnership also sees Health Catalyst helping with measuring clinical outcomes and integrating into providers’ clinical workflow. MedRhythms takes “a neuroscience-based approach to treatment, employing the principles of rhythmic auditory stimulation (RAS),” which has been shown to improve walking for patients with stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, and Parkinson’s Disease.

List of FDA/CE Mark medical apps

Health futurist Koen Kas put together a great list of medical apps that have registered with the FDA or gotten clearance — as well as apps that have a CE Mark. E&O is working on a similar database, but this one looks like a worthwhile resource in the meantime.

This tweet from Box CEO Aaron Levie crossed my Twitter stream a few minutes before I met with Finnish-based company Aiforia, which seems to check boxes 2, 3, and maybe 4 on here:

That’s a wrap on Issue 006: Hit reply to send me good luck catching my connecting flight in London tonight. No time for tea, it’s going to be tight.

6 min. read

Virta Health study. FDA-cleared algorithms. Arthritis DTx.

In this article:

This is the fifth edition of the E&O weekly newsletter for paying subscribers. Topics discussed include lessons from Theranos, Virta’s two-year study, FDA-cleared algorithms, DTx generics and more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 005. Virta Health study. FDA-cleared algorithms. Arthritis DTx.

Get E&O weekly. | Subscribe | Digital health research from Brian Dolan.

Welcome to E&O.

Last week’s newsletter had a 71 percent open rate. Here’s what’s happening this week:

Don’t click those, read on for more important studies, deals, insights, frameworks, and news below.

Did this get forwarded to you? Not yet a paying subscriber? You can sign up right over here.

Virta’s two-year study results

The big outcomes story this week goes to diabetes-focused Virta Health. Virta’s coaching program helps participants stick with a keto diet to put their diabetes into remission. The company’s most recent study, which was published in Frontiers in Endocrinology, is an impressive two-year look at its “digital-monitored continuous care intervention” that builds on a one-year study the company published in April 2018.

Virta’s summary of the study’s results is below.

The most common pushback Virta Health’s competitors and detractors point to when it comes to the company’s keto diet-based program is how difficult it is for the average person to complete. Virta’s recent study includes a topline metric of 74 percent retention, which is clearly intended to help bat down this objection. Click here to read the full Virta Health study.

As E&O noted in last month’s Approximating Livongo Health’s S-1 research note, Virta Health is the one competitor that Livongo sales reps seem to hear about most often during meetings. As we wrote last month:

Some of Livongo’s sales presentations even include a slide titled, “Debunking the Hype about ‘Diabetes Reversal.’” It’s not hard to imagine a self-insured employer wondering why they should buy a diabetes management program when there’s a diabetes reversal program on the market. Livongo stresses the difficulty of a ketogenic diet and shows potential customers a comparison chart that keto diets are only adopted by 4.2 percent of potential members, while Livongo’s average enrollment rate for its program is about 36 percent of people with diabetes at a given customer site. Livongo closes by arguing the keto diet program also costs employers more per member than it saves in its first year. Suffice to say, “diabetes reversal” comes up in Livongo’s sales conversations and it’s an objection the sales team has been trained to overcome.

STAT’s Rebecca Robbins has a great write-up of the Virta Health study here.

Lessons from Theranos

Theranos documentary star and Stanford University professor Phyllis Gardner gave a must-read interview to The Mercury News about the fallout from the Theranos debacle and her own fame for seeing through the entrepreneur early on. Best quotes:

“Look, in high tech, you can fake it til you make it. In medicine, you do not fake it. Ever. That is verboten, and that is why we have regulatory agencies. No. You don’t fake it ’til you make it. You don’t fail 10,000 times and get it right on the 10,001st. That is absolutely evil to say that, for me.”

“For example, (blood) clotting times. If you are under-coagulated, you bleed to death easily; if you are over-coagulated, you clot off. And it’s a very fine line, and it’s a very narrow therapeutic window. She was sending out wrong clotting times! People were changing their meds based on that. That is putting patients’ lives in imminent danger.”

Gaia to launch DTx for arthritis this summer

German digital therapeutics company Kaia Health now has more than 150,000 monthly active users for its back pain program. The company also has a COPD program and is planning to launch a third digital therapeutics for osteoarthritis this summer. In Germany the company has secured reimbursement for half that country’s population: 40 million out of the 80 million people in Germany could get reimbursement for Kaia’s back pain program today. The company plans to focus on the self-insured employer market in the US.

FDA cleared algorithms

Berci Meskó, MD, PhD, the director of The Medical Futurist Institute created the beautiful chart above that maps most of the AI-based algorithms that the FDA has cleared or approved over the years. Click here for a larger version.

Generics and digital therapeutics

The best Twitter content this week goes to Propeller Health’s COO Chris Hogg who built on something Sanofi’s Chief Digital Officer/Chief Medical Officer Dr. Ameet Nathwani said on-stage at BIO2019 in Philadelphia: What does a generic digital therapeutic look like?

Hogg on Twitter:

“We’ve been pondering this interesting question for a while. Then think about if you combine a drug + digital in the label. How would you create a therapeutic equivalent of that drug? Since it’s not possible to create a TE of the digital component… All of a sudden you have a new class of drugs (DTx) and combinations (drug + DTx) that change/evolve over time (versioned drugs!) and that cannot be replicated as a therapeutic equivalent. Very interesting times.”

Hogg also started a worthwhile discussion this week with this tweet:

“Prediction: We will see true clinical adoption and scaling of digital health and digital therapeutics products in Europe before the US.”

Pear Therapeutics CEO on DTx market maturity

Here’s how Pear Therapeutics CEO and President Corey McCann described the brief history of digital therapeutics on this week’s Rock Health podcast:

“We are in the very beginning of the adoption curve. We have seen a similar type of ‘warhead mentality’ around selling gene therapy.

If you look at the evolution of selling prescription digital therapeutics, we were in a world where — maybe three years ago — where no one in pharma had any idea what this was. In the last two years we have transitioned to a place where pharma thinks they know what this is, and they are very eager to learn more. We then transitioned to the scout phase where pharma diligenced everything that moved and did that without much of an intention to do deals. I think we are now into the deal phase where you see a good deal of collaboration with digital therapeutics companies to develop these things to fill a pharma pipeline.

We are just about at a tipping point. We’re not quite there yet, but we are transitioning to the phase in the conversation where digital therapeutics are a must-have as opposed to some sort of exotic modality.”

First customer goes live with Mount Sinai Health System spinoff’s prescribable app system

One of the companies working to bring a digital health formulary and prescription pathway to the market, Rx.Health, went live with its first clinical customer this week: a family medicine practice in New Jersey called GMed Healthcare led by Dr. Vikram Gupta. Rx.Health’s offering is called Rx.Universe — more on the offering here.

Amalgam Rx inks deal with Novo Nordisk

Digital therapeutics company Amalgam Rx subsidiary iSage Rx announced a deal with Novo Nordisk that sees the biopharma launching a white-labeled version of the company’s iSage app in Brazil using the brand DoseCheck. The program will include more than 80,000 physicians in Brazil. iSage is an FDA 510(K)-cleared, prescription-only mobile application for the automated titration of all brands of basal insulin.

John Oliver skewers the medical device industry, FDA

HBO star John Oliver spent the majority of his program last weekend lambasting the medical device industry and the FDA over lax regulation and public safety concerns. The YouTube clip of the segment already has a few million views after just a few days online. One of the framings that stood out to me was how he described the 510(K) process, which I’m used to hearing about as an expensive, time-intensive process that has hampered digital health innovation over the years. Here’s Oliver’s take:

“The way most products get cleared is through a loophole in the system called the 510(K) pathway. It wasn’t actually a bad idea when they came up with it. Basically, the FDA wouldn’t make companies go through a strenuous testing process if their device was one that was substantially similar to one that had come before. That way they wouldn’t stifle innovation. It was only supposed to apply narrowly. The problem is nowadays 80 percent of medical devices are cleared via the 510(K) loophole.”

Watch the full segment here.

That’s a wrap on Issue 005: Hit reply to send tips, news, and feedback my way.

6 min. read

Facebook Health. Apple Asthma. Blue Note.

In this article:

The fourth edition of the E&O weekly newsletter for paying subscribers included some digging into Facebook’s new health strategy lead, a VC fund that is spinning up DTx startups, our scoop on the Tueo founder joining Apple and more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 004. Facebook Health. Apple Asthma. Blue Note.

Get E&O weekly. | Subscribe | Digital health research from Brian Dolan.

Welcome to E&O.

Facebook hires Roni Zeiger

The big digital health hire this week goes to Facebook. Google’s former head of health strategy Roni Zeiger M.D., who has spent the past seven years on a labor-of-love startup, peer-to-peer health communities company, Smart Patients, announced his decision to join Facebook. He actually posted about it on his personal blog nearly a week before. It wasn’t until former HHS CTO Susannah Fox flagged it on Twitter that the media picked it up. Roni writes:

“As for what’s next, I’ll be joining Facebook as their new Head of Health Strategy, doubling down on my commitment to peer support. I can’t resist the opportunity to help improve Health Support Groups and the quality of health information across Facebook.”

Late last year Roni sat on a panel with Facebook’s Vaughn Hester, a strategic partner manager with a focus on health groups, to discuss how to create fruitful partnerships with medical researchers looking to use social media data. Given their mutual presence at the UCSF panel, it’s clear her work and Roni’s work at Smart Patients had some overlap. Roni’s focus at Smart Patients has been on unlocking the power of peer support — mostly for patients but for nurses, physicians and others on the care team too.

In a talk she gave last April, Hester explains that she joined the Community Partnerships team at Facebook about 18 months before, not too long after Facebook created it. She described her job as supporting community leaders working in health:

“Community leader for us has a pretty broad definition. We look at people who are building both online and offline. People who are building small, tiny communities of five people all the way up to people running communities of 4 or 5 or 6 million people… And we are really excited about communities creating what we call meaningfulness.”

To get a better sense of Facebook’s approach to this kind of community support, watch this 14-minute video of Hester’s talk, which includes a reference to a nurses group. The overview of her work suggests her purview is far wider than patient communities.

In July, just a few months after Hester’s talk, CNBC reported on a privacy breach that affected Facebook’s patient community groups:

“Facebook recently closed a privacy loophole that allowed third parties to discover the names of people in private, ‘closed’ Facebook groups. A Chrome extension that was made specifically for marketers to harvest this information en masse was also shut down prior to Facebook’s move, after the social media network issued a cease-and-desist letter to the application’s makers earlier this year, according to a spokesperson. Facebook’s decision came after members of a private group for women with a gene mutation associated with a higher risk breast cancer complained, concerned that their names might be exposed and open them to discrimination from insurers or other privacy violations. A spokesperson for Facebook said shutting down the ability to view members of closed groups was a recent decision based on ‘several factors,’ but was not related to this group’s outreach.”

The understandable outrage in the fallout of that report led to prominent patient leaders, including e-Patient Dave, to call for a mass exodus from Facebook groups to more responsible communities like PatientsLikeMe or Roni’s startup, Smart Patients.

But the future for those two companies is now uncertain.

While Roni’s blog post suggested Smart Patients will carry on, his departure has caused many to wonder how long it might last. Meanwhile, PatientsLikeMe’s majority owner, China-based healthcare AI company, iCarbonX, is being forced to divest by the Committee on Foreign Investment in the US (CFIUS). That ongoing firesale puts the future of PatientsLikeMe in doubt, too.

Enter Roni Zeiger, the new head of health strategy at Facebook.

One closing thought: While Roni is almost certainly going to try to help Facebook fix its approach to patient communities, his experience at Google might be instructive to his approach to his new job. In an October podcast interview, Roni mentioned that while at Google he helped create high-profile products like Google Flu Trends and Google Health, but the simplest thing he helped Google do probably had the biggest impact. After receiving an email from a frustrated mother who was trying (and failing) to find a poison control number via Google, Roni and his team added an “in case of emergency call this number” result for any Google search in the US that was related to poison control searches. It’s still there today. Roni: “That touched more people, by a couple of orders of magnitude, than I will see in my whole clinical career.”

Apple Health report follow-up: E&O’s recent report focused on the previous work experience of Apple’s Health team included a scoop: Respiratory-focused Tueo Health’s founder Dr. Bronwyn Harris now works at Apple. We highlighted Harris as one of the many digital health entrepreneurs now working at Apple who may one day help form the Apple Health Mafia should they leave to start a new venture. CNBC reported a week later that Harris was at Apple because the company had acquired her startup.

Redesigned E&O DataSheets

Based on your feedback we gave the prototype DataSheet, focused on DPP companies, a slight redesign. How’s it looking now? Check it out right here.

New digital therapeutics startup to watch: Blue Note Therapeutics.

Venture capital firm Jazz Venture Partners, which is an investor in both Akili and Pear Therapeutics, is launching a new digital therapeutics startup called Blue Note Therapeutics in San Francisco. So far the team consists of one person: former Amgen executive Geoffrey Eich, who most recently ran Denmark and Iceland for the pharmaceutical heavyweight. Eich also served as the digital health lead at Amgen for about 18 months among many other roles during his 12 years with the company. Blue Note is currently hiring a head of product and a head of technology.

The job postings describe the company as: “A fully integrated prescription digital therapeutics company to discover, develop, and commercialize software-based medicines targeting serious diseases. Prescription digital therapeutics are rigorously developed, scientifically validated, and FDA-cleared digital interventions prescribed by physicians to treat medical conditions as first-line or adjuvant therapies.”

Blue Note is starting up on the strength of the digital therapeutic category as a whole not because it had an idea for some therapeutic in particular.

18-year Eli Lilly vet joins Omada Health as Chief Commerical Officer

Wei-Li Shao, who most recently served as the VP of Lilly’s US-based neuroscience business unit, has joined Omada Health as its Chief Commercial Officer. Shao left Lilly at the beginning of the year to take his time exploring opportunities in digital health, which he has tracked closely for seven years. Shao writes:

“For the last 3 months, I’ve met with over 10 companies and venture capitalists. I have personally sat down with over 85 people I didn’t know 3 months ago. From my home in Indianapolis, I have traveled to and from Boston and San Francisco at least every other week.”

Shao also wrote a children’s book on diversity and inclusion call Anny the Tall Girl.

Omada’s last Chief Commercial Officer was Tom Schoenherr, who left to join Ambry Genetics as its COO in 2017. He remains an Omada advisor. Omada’s first CCO was Mike Payne, who left to join Virta Health in 2016 but is now at Ancestry.

Novartis VP breaks down digital-enabled clinical research

Jacob Laporte, Vice President and Global Head of Digital Development at Novartis, wrote a worthwhile column this week that tackles what he calls the four new archetypes of clinical research. Following headline-grabbing “remote” clinical trials like the first one Pfizer did years ago, Laporte acknowledges the impact digital and virtual technologies have had in his field. Here’s a quick rundown of his four archetypes:

  1. Augmented Site: Similar look and feel to traditional trial sites where participants physically travel to a location, but these visits might be supplemented by telemedicine, mobile nurses, or remote sensors, when appropriate to reduce the burden of frequent visits.
  2. Local Provider: Efforts to build a “trial-in-a-box”, shared infrastructure that could be deployed anywhere may increase local provider participation in clinical research, which requires significant investment to ensure compliance with industry standards and regulatory requirements.
  3. Central Site: A single location handles the administration while technologies or a mobile staff enable the participants to stay home. This is the classic “remote” trial archetype.
  4. Direct-to-patient: This type of study is what Apple’s ResearchKit has enabled. Laporte references the Apple Heart Study, which Apple did with Stanford. Laporte writes: “It’s harder to imagine how this concept would be applied in a clinical trial of an experimental medicine. But, these types of studies could have huge implications on our understanding of disease mechanisms and help us better characterize subpopulations of patients, which could ultimately lead to better informed clinical hypotheses, more streamlined clinical trials, and potentially more targeted medicines.”

That’s a wrap on Issue 004: Hit reply to send tips, news, and feedback my way.

3 min. read

FDA Pre-Cert Dropouts? NightWare for Nightmares. Amazon wearable.

In this article:

This is the third issue of the E&O weekly newsletter for paying subscribers. Topics include FDA Pre-cert, Amazon’s wearable plans, NightWare’s breakthrough FDA clearance and more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 003. FDA Pre-Cert Dropouts? Amazon wearable.

Get E&O weekly. | Subscribe | Digital health research from Brian Dolan.

FDA wants more Pre-Cert participants

In something of a surprise move, the FDA announced this week it would open its Pre-Cert program up to new participants who will be accepted on a rolling basis for what it’s calling the 2019 Test Plan. The first batch of Pre-Cert participants had to show they were planning to apply for a De Novo clearance, but this new call for volunteers seeks both De Novo and 510(K) applicants. One industry insider (and longtime Pre-Cert detractor) wondered whether the news means some of the original nine participants dropped out. As a reminder, those included: Apple, J&J, Fitbit, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily.

Rock Health follow-up analysis to its Q1 funding report

“Since Q1 2018, the top five deals each quarter account for about one-third of total digital health funding in that quarter.” For this most recent quarter, Rock Health found that $534M was invested in the ten largest funding deals or about 55 percent of funding dollars that quarter. Four deals accounted for one-third of the capital raised in the quarter, or about 6 percent of the 64 Q1 deals Rock Health tracked.

For your next slide deck

Juniper Research predicts the digital therapeutics market, which it describes as “software that augments or replaces traditional therapies”, will increase from $2.2 billion in revenues in 2019 to $32 billion in 2024. Diabetes and weight loss therapies will make up more than $19 billion of those future revenues, according to the firm.

CableCos to try home health again

CNBC reports that its parent company Comcast is developing a health-focused device that passively tracks people while they are at home. The cable company’s planned device will sit in the home in a fixed place like a smart home assistant (Google Home, Amazon’s Alexa-powered Echo), but won’t offer any smart speaker or assistant features. Somehow, Comcast’s device will track how often a person uses the bathroom as one signal about their health condition.

The reported device might be an offering from Comcast’s health joint venture with Philly-based Independence Blue Cross, Quil Health. Quil is currently testing an app-based service that is trying to help people better navigate their way through the health system. For now, the app is focused on helping people follow their care plan post knee surgery.

Like Big Tech companies, cable companies have a long history of joint ventures and false starts in healthcare. Cox and Cleveland Clinic announced one in 2015 called Vivre Health that intended to launch a home health service. In the same press release Cox announced an investment in kiosk-based telemedicine company, HealthSpot. Both Vivre and HealthSpot are now out of business.

FDA grants breakthrough status to Apple Watch-powered nightmare therapy

Here’s how NightWare described itself in a recent, 50-person interventional clinical trial it just wrapped up:

“NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares. Through the use of a smartwatch-based application that senses physiologic parameters, the participant is aroused from sleep (without awakening the participant) so that the nightmare is interrupted prior to reaching a threshold of severity in which the participant would awaken in distress. Seconds later the participant returns to sleep without having experienced a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of symptoms from image rehearsal therapy and allows for a simple method with easily achieved adherence compared to existing treatments.”

Big Health is now available to 12 million

This week mental health and sleep-focused digital therapeutics company, Big Health, announced that its Sleepio product is available to 12 million people around the globe. The company just inked a big deal with the NHS that grants 8 million people in London and another 2.3 million in the Thames Valley complimentary access to the digital therapeutic for poor sleep. The remaining 2 million make up the total covered lives at Big Health’s self-insured employer customers in the US. The company did not share how many of these potential users converted into actual ones.

Code-named Dylan, Amazon working on voice-activated, health-focused wearable: According to a report in Bloomberg, Amazon is working on a voice-activated wearable that recognizes human emotions and may advise the wearer how to better interact with those around them. The device attempts to discern emotional state based on an analysis of the wearer’s voice. Bloomberg is quick to point out this device appears to be early-stage and may never launch, but Amazon has launched some kind of beta program related to it.

That’s a wrap: Please hit reply to send feedback my way. — Brian

9 min. read

Apple’s healthcare work experience

In this article:

This report focuses on the prior healthcare experience of Apple’s health team. Apple has recruited talent from health systems, pharma companies, medical device makers, and more than two dozen digital health companies. E&O focused on the more than 100 named inventors on Apple’s health-related patents but included the work experiences of more than 200 Apple health employees in total.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Do big tech companies understand healthcare? It is a common refrain in healthcare circles that, no, they don’t. Usually, that’s followed by pointing out past failures like the go-to Google Health debacle.

CareMore CEO Sachin Jain, perhaps the most thoughtful healthcare executive writing today, just published a column in Forbes on this very subject. Here’s how it starts:

My mentor, Leeba Lessin, used to say, “You can’t change something unless you know something.” Amazon, Apple, Google, Uber and a host of startups are all trying to enter the health care market, promising products and systems to improve efficiencies and outcomes. When I read about their efforts, I think about Leeba’s wisdom.

History is filled with the stories of companies that have tried and failed to enter the health care market.

Why did they fail? In many cases, it’s because innovators and technologists alike thought of health care from one perspective – their own.

It’s easy to imagine a technologist designing a system based on her experience as a new parent in a maternity ward, or as an outpatient in a surgery clinic, or as a visitor tending to a sick parent in the hospital. Unfortunately, this perspective misses so much about health care that lies outside of those experiences.

Jain has almost certainly had direct experience to back up his thesis, but his column is focused on solutions to the problem, not exploring the problem itself. Jain moves quickly past the table setting because he knows his readers accept the premise that Big Tech companies like Apple just don’t get healthcare.

At the same time in pharma circles, executives are quick to point to big tech as competitors that they need to take seriously. Here’s what Alessandro De Luca, the CIO of Merck Healthcare at Merck Group, said in a keynote speech in Brighton, England this week:

I don’t know about my future competitors, but my present competitors are called Google, called Alibaba, called Facebook, Tencent, and Amazon. Those are the pharma competitors. These guys are entering the pharma space very strongly, and those are not small players. They have the data. They have the technology and when digital health [is commonplace] they will rule the world. And everybody will have to adapt.

Finally, here’s one more take from a pharma executive.

One of the speakers at the Yale Digital Medicine Symposium last month was the man who brokered the deal between Apple and J&J for the multi-year study the companies are collaborating on focused on patients with AFib. The speaker was Dr. John Whang, J&J’s head of integrated evidence in cardiovascular and metabolism. When asked how he managed to bring these two massive companies together, Whang said (emphasis mine):

Really, Apple had their own vision. It was not aligned with ours initially, but [I] sort of brought them to — because they are new to healthcare, they don’t really know the dynamics. You can hire people in, but unless you sort of have the DNA of operating in the healthcare environment, you don’t really know the issues you are going to face in implementation. I had to sort of walk them off their storyline to get us in line together and that was sort of the nut of it. And persistence. Probably more than anything else, there were so many times when this thing was going to go dead. And you just pick it back up and you try again. For innovation that is always a key part.

Whang wouldn’t say any more about the deal-making process, but his implication was clear. If you weren’t a healthcare company from the beginning — if it’s not in your DNA, to use his words — you can’t “hire in” healthcare expertise to make up for it. This report aims to put some data around how much healthcare expertise Apple has now, but it won’t answer the question Whang’s comments give rise to: Does it matter? Apple’s own successes or failures in healthcare will have to prove that out.

Methodology: Patents to inventors to colleagues to past work experience

Most analyses of Apple’s health team focus on a few big-name hires, but for this report, E&O went the other direction. By mining Apple’s nearly 25,000 patents and extracting the inventor names listed on about 150 health-related ones, E&O developed a list of 113 Apple employees who officially contributed to Apple’s health R&D. Of the 113 a little over 100 have LinkedIn profiles that listed their prior work experience and educational background.

One interesting finding: For Apple’s core health R&D team, or those named as inventors on health-related patents, the average number of years working at AppleMost of the employees in this group continue to work at Apple on health projects so that number is increasing. is about 5.5 years.

In addition to the patent holders, E&O found another 128 Apple employees on LinkedIn who disclosed that they worked at Apple on health projects.

The graphic below lists out the 27 digital health companies that current or recent Apple health employees worked at prior to joining Apple. Of course, Apple acquired both Gliimpse and Beddit so those startups perhaps contributed more to Apple’s health expertise than the others. The list of digital health companies is impressive — it reads almost like a who’s who of successful or, at least well-known (Theranos!), health tech companies.

Apple’s health team also hails from more traditional healthcare organizations, including health systems, life sciences companies, and big medical device makers. The image below lists the 25 healthcare companies and organizations that Apple’s health team worked at prior to Apple.

Take, for example, Erno Klaassen, Director of Health Technologies at Apple. Klaassen has worked at Apple since early 2013, which is the year Apple began aggressively hiring for health talent. Klaassen joined Apple after six years at medical device giant St. Jude Medical where he worked as a technical manager of teams working on sensors for implantable medical devices. Klaassen now leads R&D efforts for new health-related technologies, applications, and products, according to his LinkedIn page. His various teams shipped products include the hardware powering the ECG feature on Apple Watch Series 4 and the sensing, firmware, algorithms, software, and UX behind the Beddit Sleep Monitor.

Another Apple health R&D employee with prior medical device work experience is Divya Padmanabhan, a senior engineering manager at Apple. Padmanabhan worked at Medtronic for two years on software that connects with an implanted pacemaker/defibrillator. During her 9.5 years at Apple she has served as the lead software engineer for optical sensors on the first Apple Watch and worked her way up to managing multiple sensor software teams that deliver a range of software products that support Apple’s health initiatives. Her team also writes the software that powers the Apple Watch’s elevated heart rate alerts, irregular heart rhythm detection, and ECG.

There are many more: Olivier Humblet, formerly a data scientist at Propeller Health, has worked on Apple’s fitness products for the past three years and is named on a patent related to wearable devices and caloric expenditure. Thomas Sullivan, formerly of Proteus Digital Health, led the hardware team that built the ECG feature of the Apple Watch Series 4. Ueyn Block, who previously worked at C8 Medisensors like three of his other Apple health colleagues, has co-invented a number of patents, including one for a method that uses an optical heart rate monitor to identify physical activity.

What counts as health care experience?

When Jain wrote his Forbes column this week he probably wasn’t thinking about medical device R&D as relevant healthcare experience, but he does indicate that tech companies don’t have a broad enough view of healthcare. Whang also focused his criticism on inexperience in “implementing” healthcare. Given the lists of health companies in the images above, I’d argue Apple has pulled talent from almost every corner of healthcare.

If you take a generous approach, about half (49 percent) of the Apple health employees in this study have some kind of healthcare experience. That might mean they previously worked at one of the companies listed above or they might have a medical degree of some kind — including biomedical engineering degrees, which are common in this group. The percentage shrinks when you focus on the Apple health R&D team, or those named in Apple’s health-related patents. For that group, we have data on 103 out of 113 people, because 10 of them don’t have LinkedIn profiles. Some 38 percent of the 103 Apple health team employees named on patents have previous healthcare experience.

The beginnings of an Apple Health Mafia

Of the 103 Apple health employees listed on health-related patents, 23 — or 22 percent — have left Apple and now work elsewhere, went back to school or retired. E&O tracked another six Apple health employees in this study who have since moved on. Notably, of that wider group eight (8) now work at Google. Two went to Airbnb and one is at Amazon. Only a couple former Apple health employees have gone on to start their own companies, but given the concentration of digital health talent at Apple right now I predict that will change in the next few years. Here’s a quick rundown on a few Apple health employees who have either gone on to start their own companies after leaving Apple, or are likely to do so given their entrepreneurial past.

Brian Carlsen spent about nine months working on Apple’s health team before leaving to start Ciitizen Corp. While at Apple, Carlsen was named as an inventor on two patents related to Apple’s efforts to make it easier for people to access their medical records. As co-founder and director of clinical informatics at Ciitizen, Carlsen is taking a similar tack: The company’s initial focus is to make it easier for people with cancer to “have complete control of their health data”.

Marcelo Lamego left Apple’s health team in mid-2014 after a seven-month stint and founded his own wearables startup, called True Wearables. During his brief time at Apple, Lamego said he helped Apple define the current and future required resources needed for the Apple Watch’s bio-sensing capabilities, helped hire scientists and engineers to build the Apple Watch, and negotiated a contract with a local, large university “for data collection on human subjects to model the interaction between the subjects’ physiology and bio-sensing technology,” according to his LinkedIn page. Lamego’s new startup, True Wearables is focused on low-cost, fully disposable, wireless medical devices. Its first device is a single-use, 0.12 ounce pulse oximeter called Oxxiom.

Current Apple health employees who are likely second-time digital health entrepreneurs

Apple has publicly acknowledged two health acquisitions in recent years: Beddit and Gliimpse. Gliimpse co-founder Karthik Hariharan is still at Apple but is likely to start a new company or join his Gliimpse co-founder Anil Sethi at Ciitizen, the health startup he founded after leaving Apple. One of Beddit’s early employees, software lead Kim Dikert, who has continued on at Apple, was one of the founders of Rovio Entertainment, the company that created the popular Angry Birds game. Dikert and his former Beddit colleagues, Mikko Waris, Joonas Paalasmaa, and Lasse Leppäkorpi, all seem likely to start new ventures in the future.

Apple’s health team also includes a couple of well-known digital health founders whose companies it did not acquire. Mango Health’s founder Jason Oberfest recently joined Apple and while he isn’t likely to leave soon, he’s another one to watch. Like Oberfest, Tueo Health’s founder Dr. Bronwyn Harris joined Apple in the past year, so while she likely wouldn’t strike out on her own again soon, another startup might be next for her. Another interesting former entrepreneur on Apple’s health team is Evan Doll, the founder of Flipboard. He worked at Apple prior to founding Flipboard so leaving Apple’s health team to start a new health venture tracks with his prior moves.

Sara Kianian, a clinical research study lead at Apple, describes herself as: “passionate about exploring innovation and entrepreneurship with biological sciences and medicine in order to integrate technology with health care in an effective and positive way.” Kianian was previously the CEO and founder of Aera Devices, which aimed to develop non-invasive medical devices that detected COPD early on to prevent debilitating symptoms associated with the chronic disease. (Makes you wonder if she’s leading a COPD study for Apple.)

Ali Amin, a mechanical design R&D engineer with Apple’s health technologies group describes himself on LinkedIn as having a “strong entrepreneurial drive” since he previously started a medical device company and an electronics hardware store. The medical device was CareChair, which aimed to reduce the risks associated with moving a person in a wheelchair to a bed. He co-founded CareChair while still studying at university. Earlier in his studies, he worked at a startup called Medella Health that wanted to develop a wearable to help people better manage their diabetes.

There are at least another half dozen Apple health team members with some kind of entrepreneurial venture in their work history. Apple’s concentration of digital health talent is sure to produce a number of health startups in the future.

Conclusion: When does Apple become a healthcare company?

J&J’s Dr. John Whang’s implication that a tech company doesn’t have healthcare in its DNA and hiring in healthcare expertise won’t change that, captures a commonly held view in health circles about big tech as it tries to break in. About 38 percent of Apple’s health R&D team has prior healthcare experience. Overall, half of its health team may have prior healthcare experience from some of the largest healthcare incumbents across health systems, medtech, and pharma. Apple has also recruited talent from more than two dozen digital health companies.

Whang should think of this team as a group of former Dignity Health, St. Jude Medical, Cleveland Clinic, Quest Diagnostics, Medtronic, and Duke Health employees. Apple’s health team benefits from experiences forged working at digital health pioneers like Propeller Health, Alivecor, WellDoc, Proteus Digital Health, and AirStrip Technologies.

He might be right that none of those hires, nor the sum of those hires, changes Apple’s DNA. But he has to admit: This isn’t the iPod team trying to figure out healthcare.

4 min. read

Omada User Growth. Apple Work Experience. European DTx.

In this article:

This is the second edition of E&O’s weekly newsletter for paying subscribers. Topics included: Omada’s cumulative user growth, Apple employees with healthcare-related work experience, and Germany’s push into DTx.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 002. Omada User Growth. Apple Work Experience. European DTx.

Get E&O weekly. | Subscribe | Digital health research from Brian Dolan.

Apple’s healthcare work experience

This week E&O wrote a deep dive on the Apple health team’s prior work experience. Apple has recruited talent from health systems, pharma companies, medical device makers, and more than two dozen digital health companies. Paying subscribers can read the full 2,500-word report here. That link won’t work if you aren’t already a paying subscriber and this was forwarded your way, so consider signing up right over here.

This is Issue 002: Here we go.

JNJ-Apple AFib study deal-maker on Apple’s inexperience.

The Yale Digital Medicine Symposium, which took place a few weeks ago, included some great discussions. At one point, Dr. John Whang, J&J/Janssen’s head of integrated evidence in cardiovascular and metabolism, who is credited with brokering the big, multi-year AFib study Apple is doing with J&J, talked about how he got the two behemoths together:

“Really, Apple had their own vision. It was not aligned with ours initially, but [I] sort of brought them to — because they are new to healthcare, they don’t really know the dynamics. You can hire people in, but unless you sort of have the DNA of operating in the healthcare environment, you don’t really know the issues you are going to face in implementation. I had to sort of walk them off their storyline to get us in line together and that was sort of the nut of it. And persistence. Probably more than anything else, there were so many times when this thing was going to go dead. And you just pick it back up and you try again. For innovation that is always a key part.”

Whang’s assertion about Apple not having healthcare in its DNA led to this week’s deep dive about Apple’s healthcare work experience. After analyzing Apple’s nearly 25,000 patents for health-related ones, I dug into the backgrounds of the Apple employees listed on the health patents. Read the report if you haven’t already to learn more about where Apple recruits worked previously and where a few Apple health alums work now.

Germany’s health minister pushes for digitization

I’ve yet to find a good English translation of the news coming out of Germany, but Germany’s Health Minister Jens Spahn floated a draft bill this week that would, among other things, create a validation and reimbursement process for digital therapeutics. Germany-based digital therapeutics company Gaia’s CEO Dr. Mario Weiss cheered the news and summed the relevant portion up as follows: “In principle, the digital therapeutic reimbursement process will be similar to drugs. Evidence will be key. All payers in Germany will be obliged to reimburse after the decision by the BfArM (Federal Institute for Drugs and Medical Devices).”

While Sanofi suggests Brexit slows European DTx: Sanofi-Genzyme’s Chief Medical Officer Dr. Ameet Nathwani added the role of Chief Digital Officer earlier this year. In an interview with Bloomberg, Nathwani discussed Sanofi’s partnership with Happify for digital therapeutics focused on depression and multiple sclerosis. Nathwani said digital therapeutic adoption might move more slowly in Europe partially because of Brexit. The slowdown stems from the European Medicines Agency subsequent move from London to Amsterdam.

(Cigna’s) Express Scripts plans a Happtique

The past decade has seen the launch of many digital health formularies that have, at times, described themselves as an Express Scripts for digital health. Xealth, WebMD, Happtique, and RxUniverse are among those trying or have tried to create a digital health formulary.

This week, Express Scripts announced it would launch its own digital health formulary, complete with a validation process overseen by physicians, pharmacists, and other medical researchers. Express Scripts’ validation process will focus on safety, quality, usability, and affordability. When it launches in 2020, Express Scripts plans to have digital offerings focused on diabetes, cardiovascular, behavioral health and pulmonary conditions.

Cigna has tried this before with its GoYou Cigna Marketplace, which it launched in 2013 in partnership with SocialWellth, the company that bought Happtique’s assets.

Omada Health’s user growth

Omada Health announced that it had crossed 250,000 cumulative participants in its diabetes prevention program (DPP) and other offerings. Here’s a look at the company’s cumulative participant growth over time, starting in September 2015 when the company first reported its numbers and had just 20,000 participants.

Meet the new digital medicine association, DiME

New non-profit association Digital Medicine Society (DiME) launched in Cambridge, Massachusetts this week with funding from Arkitekt Ventures, Digitalis Commons, and TMCity. While no members are listed on the group’s website at launch, it does boast a lengthy list of strategic advisors and scientific advisors, including executives from digital therapeutics companies like Pear Therapeutics and Akili Interactive as well as advisors from pharmaceutical companies like Novartis and Genentech-Roche. DiME also seems to be working in tandem with the Digital Therapeutics Alliance as that group’s leader, Megan Coder, is on DiME’s advisory board too.

Akili suggests not to innovate an outcome

Akili’s CEO Eddie Martucci told the Yale Digital Medicine Symposium: “As a general philosophy, I don’t think we should be trying to bring things into clinical trials, at this stage, that are different or disparate from accepted known clinical endpoints. I think we want to be showing that this actually works… you can only innovate so many things, and I generally don’t recommend innovating an outcome for a pivotal trial. I absolutely recommend using digital to get better and better outcomes measures over time, but those, of course, have to be validated.”

Martucci also summed up pricing models for digital therapeutics: value-based pricing models, “potentially” drug pricing models, DC codes “even though these are pieces of software”, medical benefits and DMEs are “starting to emerge”.

Proteus paid when patients 80 percent adherent

Dr. Scooter Plowman, a senior medical director at Proteus Digital Health sat on the same panel as Martucci at the Yale event a few weeks ago. Plowman provided more detail on Proteus’ value-based contract with Palm Springs-based capitated provider group Desert Oasis Healthcare (DOH).

DOH “has about 80,000 senior lives and the average age with our study with them is 72,” Plowman said. “We have had really rapid enrollment, 150 patients in just the last several weeks. The beauty of it is, they are paying us our fees and for our services only when patients are 80 percent adherent and only then we get a bonus payment when they come under control.”

That’s a wrap on Issue 002: Please hit reply to send feedback my way.

5 min. read

Going Global. Khosla-AliveCor. Propeller Strategy.

In this article:

The first edition of the E&O Weekly newsletter for paying subscribers. Topics included: Going Global. Khosla-AliveCor. Propeller Strategy.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Issue 001. Going Global. Khosla-AliveCor. Propeller Strategy.

Get E&O weekly. | Subscribe
Digital health research from Brian Dolan.

Welcome to E&O.

** Wow. What a week. Thanks for the support. And, hey, if you aren’t already a paying subscriber and this was forwarded your way, sign up right over here.

This is Issue 001: Let’s get to it already.

Khosla owned AliveCor: This week I learned Khosla Ventures held a majority stake in AliveCor a few years back, but is now just the largest shareholder. Was that an open secret? How many other digital health companies (were at one time or) are currently mostly owned by a single investor?

Livongo S-1 research follow-up: E&O’s first report focused on Glen Tullman’s soon-to-IPO-company, Livongo. Readers have pointed out a few things in reaction to it: 1). Livongo seems to have sat on its acquisition of Diabeto, which could have enabled Livongo to potentially integrate with some 40+ glucose meters, but hasn’t. 2). The first peer-reviewed study I mentioned in the article last week is brand new. Livongo just announced it today. 3). Since Livongo does not put devices through the FDA, its diabetes management app — which the FDA has used enforcement discretion on — offers fewer capabilities than the competition.
All good comments, please keep them coming.

Introducing E&O DataSheets: In addition to weekly long-form articles and this here weekly newsletter, E&O is excited to add a new product as part of your subscription: DataSheets. Think of these as mini-databases or embedded spreadsheets (and like spreadsheets, they are fully searchable and sortable). The first one is focused on companies working on Digital Diabetes Prevention Programs. It’s up now and paying subscribers can check it out right here. WellDoc, Vida Health, OneDrop, and others are moving into digital DPP in the coming months, and it was surprising to me how many digital DPPs are using Fitbit devices. Noom, which just announced a $58 million venture round, is among those digital DPP providers with full recognition from the CDC.

E&O will update this DataSheet every week to help you track DPP companies. A few more DataSheets are in-progress so expect those soon. Any requests?

ResMed says Propeller in “pilot stage”

On its quarterly call this week with analysts, ResMed revealed a few things about its recent $225 million acquisition, Propeller Health. Michael Farrell, CEO, ResMed characterized Propeller as at the end of its pilot stage: “Propeller Health is at the beginning of converting from pilot to scale and commercialization. We will empower the team to grow and to scale and bring all our skills to the table. The opportunities are vast. There are more than 60 million diagnosed COPD and apnea patients in the United States and major markets in Europe alone.”

ResMed confirmed that Propeller currently costs it between $0.02 and $0.03 in diluted earnings per share (which works out to between $2.89M and $4.33M in earnings) each quarter, and ResMed said it expects that to continue for the next few quarters.

Farrell added that Propeller’s profitability could flip quickly: “It is public [knowledge] that Propeller is working with some very large pharmaceutical companies, and some of them don’t want us to talk about it. But if any one of these pilots starts to commercialize, and [our customer] is comfortable with us talking about it publicly, we will update you on that. And this would then move very quickly from dilutive to accretive in a heartbeat… It is a medium- to long-term play. We are not calling the date, the time or the hour or the quarter that, that happens, but that is what the investment is around.”

Propeller Health CEO and Co-founder David Van Sickle also mentioned on an investor call in April that “nearly 100,000 patients” have participated in a Propeller program over the years.

Haven recruits East Coasters

The JP Morgan-Berkshire Hathaway-Amazon joint venture is now up over 40 total hires at its Boston and NYC offices. So far the team includes alums from ZocDoc, Verily, Ariadne Labs, and other healthcare companies based (or with big offices) on the East Coast. Surprisingly, no San Francisco transplants yet. Maybe it’s just that the quick hires are the local ones, but geography seems to be playing a role in recruiting at Haven — despite its sky-high profile.

Related: Is Boston the center of the digital health world now? An old hand tried making the case to me earlier this week. San Diego gave up the title to Silicon Valley once VC interest ramped up in 2012-2013. Now Boston?

Details on Medtronic’s CGM app malfunction and FDA recall

News broke in July 2018 that the FDA declared a recall for Medtronic’s Guardian Connect App since the app could be shut down by the device’s operating system “without alerting the user it was no longer running or communicating with the CGM transmitter, resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.”

What’s new: This past week the FDA finally filed the recall documents and they reveal how many people are using Medtronic’s app-enabled CGM around the world: 9,238 registered users. None of those users are in the US.

The list of countries where people were using the app as of July 2018 was long and as follows: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa. Read the total recall filing here.

Trending up: Going global.

Medtronic’s list of countries got me thinking about internationalization in digital health. Giants like Medtronic are everywhere but smaller digital therapeutics companies have made moves to go global. This gets tricky since every country has its own regulatory requirements for software as a medical device. Here are a few recent global maneuvers:

  • ADHD-focused Akili Interactive inked a big deal with Shionogi & Co. that brings it to Japan and Taiwan.
  • WellDoc continues to roll out its diabetes-focused digital therapeutic Bluestar in Canada with its partner LifeScan.
  • French digital therapeutic company Voluntis, which has initial focus areas in diabetes and oncology, aims to take its diabetes offering to Canada, Germany, and the UK this year.
  • Livongo continues to dangle international opportunities ahead of its IPO, especially in India and China. It hasn’t made a move yet though.
  • As the image above shows, Propeller Health, however, might be the furthest along. The company has COPD and asthma-focused clinical trials and commercial pilots ongoing in more than 15 countries as of 2019. Its global footprint is attributable largely to its pharma partners. Propeller’s new parent company ResMed is in more than 100 countries. The map above shows Propeller Health’s global rollout strategy. Brazil, China, and South Africa are on the company’s shortlist for rollouts in the next year or two.

That’s a wrap on Issue 001: These are formative days for E&O and your feedback is most appreciated. Please hit reply to send anything my way. Next week will be better. Don’t miss it!

14 min. read

Approximating Livongo Health’s S-1

In this article:

Digital health company Livongo Health is expected to go public later this year. In anticipation of the company’s S-1 filing, E&O has put together this 3,600-word report, including annual revenue figures, quarterly adoption metrics, regulatory mishaps, acquisitions, growth strategies, predictions and much, much more.

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!

Less than five years ago, longtime healthcare IT executive Glen Tullman took the stage at TechCrunch Disrupt 2014 and announced the launch of his new startup, a diabetes-focused company called Livongo Health. Incredibly, Livongo launched with an FDA-cleared, cellular-enabled glucose meter, a clinical validation study already underway at the University of Massachusetts, and a handful of paying customers that included Office Depot. On the day it officially launched the company had already achieved milestones that prove elusive to many health startups.

2 min. read

Welcome to Exits & Outcomes

In this article:

Exits & Outcomes is a new subscription-only, weekly newsletter for digital health strategists, creatives, and operators. It’s a new service created and written by Brian Dolan, the founder of MobiHealthNews, which HIMSS acquired in 2015.

Digital health has matured considerably in the past 12 years since I first started writing about it, but most health tech journalism is still written for those just entering the discussion. Exits & Outcomes (E&O) is a subscription-only, weekly newsletter for digital health strategists, creatives, and operators. It’s for later-stage startups and big company innovation teams. E&O isn’t for newbies or tourists: its focus is on incumbent strategy shifts, challenger companies with traction (and how they achieved it), long-form teardowns, market maps, emergent trends, and other competitive intelligence data.

Above all else, E&O will move beyond the dominant sensationalism in health tech to re-focus and ground the discussion on what’s really working and what might happen next.

Powered by the E&O Database
E&O is one part curator and two parts data-backed journalism. Digital health has been noisy for years and finding the signal is increasingly difficult, especially for someone who already has a full-time job. I’ll spend my week doing that for you, but I’ll have help. For the past two years, I’ve been building a digital health database that tracks nearly 5,000 digital health startups. This data engine will power exclusive insights served up in the E&O weekly newsletter.

About me

Hi. I’m Brian Dolan, the founder and lead writer at Exits & Outcomes. You might know me from my last startup, MobiHealthNews, which we launched in 2008 and sold to HIMSS in 2015.

The New York Times, Washington Post, Wall Street Journal, BBC and more have quoted me or cited my digital health research, analysis, and reporting. I have spoken at conferences and private engagements in the US, Europe, and the Middle East. Over the years, big tech companies, health systems, medical device makers, pharmaceutical companies and others have subscribed to my digital health research to help forge their strategies.


If you have a tip or story idea, email me here: b@exitsandoutcomes.com

article end logo