The Apple Watch – Tipping Point Time for Healthcare

Posted on September 26, 2018 by steve blank

I don’t own an Apple Watch. I do have a Fitbit. But the Apple Watch 4 announcement intrigued me in a way no other product has since the original IPhone. This wasn’t just another product announcement from Apple. It heralded the U.S. Food and Drug Administration’s (FDA) entrance into the 21stcentury. It is a harbinger of the future of healthcare and how the FDA approaches innovation.

Sooner than people think, virtually all home and outpatient diagnostics will be performed by consumer devices such as the Apple Watch, mobile phones, fitness trackers, etc. that have either become FDA cleared as medical devices or have apps that have received FDA clearance. Consumer devices will morph into medical grade devices, with some painful and well publicized mistakes along the way.

Let’s see how it turns out for Apple.

Smartwatches are the apex of the most sophisticated electronics on the planet. And the Apple Watch is the most complex of them all. Packed inside a 40mm wide, 10 mm deep package is a 64-bit computer, 16gbytes of memory, Wi-Fi, NFC, cellular, Bluetooth, GPS, accelerometer, altimeter, gyroscope, heart rate sensor, and an ECG sensor – displaying it all on a 448 by 368 OLED display.
When I was a kid, this was science fiction.  Heck, up until its first shipment in 2015, it was science fiction.

But as impressive as its technology is, the Apple’s smartwatch has been a product looking for a solution. At first, positioned as a fashion statement, it seemed like the watch was actually an excuse to sell expensive wristbands. Subsequent versions focused on fitness and sports – the watch was like a Fitbit– plus the ability to be annoyed by interruptions from your work. But now the fourth version of the Watch might have just found the beginnings of “gotta have it” killer applications – healthcare – specifically medical diagnostics and screening.

Healthcare on Your Wrist
Large tech companies like Google, Amazon, Apple recognize that the  multi-trillion dollar health care market is ripe for disruption and have poured billions of dollars into the space. Google has been investing in a broad healthcare portfolio, Amazon has been investing in pharmacy distribution and Apple…? Apple has been focused on turning the Apple Watch into the future of health screening and diagnostics.

Apples latest Watch – with three new healthcare diagnostics and screening apps – gives us a glimpse into what the future of healthcare diagnostics and screening could look like.

The first new healthcare app on the Watch is Fall Detection. Perhaps you’ve seen the old commercials where someone falls and can’t get up, and has a device that calls for help. Well this is it – built into the watch. The watch’s built-in accelerometer and gyroscope analyze your wrist trajectory and impact acceleration to figure out if you’ve taken a hard fall. You can dismiss the alert, or have it call 911. Or, if you haven’t moved after a minute, it can call emergency services, and send a message along with your location.

If you’re in Apple’s current demographic you might think, “Who cares?” But if you have an aged parent, you might start thinking, “How can I get them to wear this watch?”

The second new healthcare app also uses the existing optical sensor in the watch and running in the background, gathers heart data and has an algorithm that can detect irregular heart rhythms. If it senses something is not right, up pops up an alert. A serious and common type of irregular heart rhythm is atrial fibrillation (AFib). AFib happens when the atria—the top two chambers of the heart get out of sync, and instead of beating at a normal 60 beats a minute it may quiver at 300 beats per minute.

This rapid heartbeat allows blood to pool in the heart, which can cause clots to form and travel to the brain, causing a stroke. Between 2.7 and 6.1 million people in the US have AFib (2% of people under 65 have it, while 9% of people over 65 years have it.) It puts ~750,000 people a year in the hospital and contributes to ~130,000 deaths each year. But if you catch atrial fibrillation early, there’s an effective treatment — blood thinners.

If your watch gives you an irregular heart rhythm alert you can run the third new healthcare app – the Electrocardiogram.

The Electrocardiogram (ECG or EKG) is a visual presentation of whether your heart is working correctly. It records the electrical activity of the heart and shows doctors the rhythm of heartbeats, the size and position of the chambers of the heart, and any damage to the heart’s muscle. Today, ECGs are done in a doctor’s office by having you lie down, and sticking 10 electrodes to your arms, legs and chest. The heart’s electrical signals are then measured from twelve angles (called “leads”).

With the Apple Watch, you can take an ECG by just putting your finger on the crown for 30 seconds. To make this work Apple has added two electrodes (the equivalent of a single lead), one on the back of the watch and another on the crown. The ECG can tell you that you may have atrial fibrillation (AFib) and suggest you see a doctor. As the ECG is saved in a PDF file (surprisingly it’s not also in the HL7’s FHIR Format), you can send it to your doctor, who may decide no visit is necessary.

These two apps, the Electrocardiogram and the irregular heart rhythms, are serious health screening tools. They are supposed to ship in the U.S. by the end of 2018. By the end of next year, they can be on the wrists of tens of millions of people.

The question is are they are going to create millions of unnecessary doctors’ visits from unnecessarily concerned users or are they going to save thousands of lives?  My bet is both – until traditional healthcare catches up with the fact that in the next decade screening devices will be in everyone’s hands (or wrists.)

Apple and The FDA – Clinical Trials
In the U.S. medical devices, drugs and diagnostics are regulated by the Food and Drug Administration – the FDA. What’s unique about the Apple Watch is that both the Electrocardiogram and the irregular heart rhythms apps required Apple to get clearance from the FDA. This is a very big deal.

The FDA requires evidence that medical devices do what they claim. To gather that evidence companies enroll volunteers in a study – called a clinical trial – to see if the device does what the company thinks it will.

Stanford University has been running a clinical trial on irregular heart rhythms for Apple since 2017 with a completion date in 2019. The goal is to see if an irregular pulse notification is really atrial fibrillation, and how many of those notified contacted a doctor within 90 days. (The Stanford study appears to be using previous versions of the Apple Watch with just the optical sensor and not the new ECG sensors. They used someone else’s wearable heart monitor to detect the Afib.)

Nov 1 2018 Update – the design of the Stanford Apple Watch study published here

To get FDA clearance, Apple reportedly submitted two studies to the FDA (so far none of the data has been published or peer reviewed). In one trial with 588 people, half of whom were known to have AFib and the other half of whom were healthy, the app couldn’t read 10% of the recordings. But for the other 90%, it was able to identify over 98% of the patients who had AFib, and over 99% of patients that had healthy heart rates.

The second data set Apple sent the FDA was part of Stanford’s Apple Heart Study. The app first identified 226 people with an irregular heart rhythm. The goal was to see how well the Apple Watch could pick up an event that looked like atrial fibrillation compared to a wearable heart monitor. The traditional monitors identified that 41 percent of people had an atrial fibrillation event. In 79 percent of those cases, the Apple app also picked something up.

This was good enough for the FDA.

The FDA – Running Hard to Keep Up With Disruption
And “good enough” is a big idea for the FDA. In the past the FDA was viewed as inflexible and dogmatic by new companies while viewed as insufficiently protective by watchdog organizations.

For the FDA this announcement was as important for them as it was for Apple.

The FDA has to adjudicate between a whole host of conflicting constituents and priorities. Its purpose is to make sure that drugs, devices, diagnostics, and software products don’t harm thousands or even millions of people so the FDA wants a process to make sure they get it right. This is a continual trade-off between patient safety, good enough data and decision making, and complete clinical proof. On the other hand, for a company, a FDA clearance can be worth hundreds of millions or even billions of dollars. And a disapproval or delayed clearance can put a startup out of business. Finally, the rate of change of innovation for medical devices, diagnostics and digital health has moved faster than the FDA’s ability to adapt its regulatory processes. Frustrated by the FDA’s 20th century processes for 21st century technology, companies hired lobbyists to force a change in the laws that guide the FDA regulations.

So, the Apple announcement is a visible signal in Washington that the FDA is encouraging innovation. In the last two years the FDA has been trying to prove it could keep up with the rapid advancements in digital health, devices and diagnostics- while trying to prevent another Theranos.

Since the appointment of the new head of the FDA, there has been very substantial progress in speeding up mobile and digital device clearances with new guidelines and policies. For example, in the last year the FDA announced its Pre-Cert pilot program which allows companies making software as a medical device to build products without each new device undergoing the FDA clearance process. The pilot program allowed nine companies, including Apple, to begin developing products (like the Watch) using this regulatory shortcut. (The FDA has also proposed new rules for clinical support software that say if doctors can review and understand the basis of the software’s decision, the tool does not have to be regulated by the FDA.)

This rapid clearance process as the standard – rather than the exception – is a sea-change for the FDA. It’s close to de-facto adopting a Lean decision-making process and rapid clearances for things that minimally affect health. It’s how China approaches approvals and will allow U.S. companies to remain competitive in an area (medical devices) where China has declared the intent to dominate.

Did Apple Cut in Front of the Line?
Some have complained that the FDA has been too cozy with Apple over this announcement.

Apple got its two FDA Class II clearances through what’s called a “de novo” pathway, meaning Apple claimed these features were the first of its kind. (It may be the first one built into the watch, but it’s not the first Apple Watch ECG app cleared by the FDA – AliveCor, got over-the-counter-clearance in 2014 and Cardiac Designs in 2013.) Critics said that the De Novo process should only be used where there is no predicate (substantial equivalence to an already cleared device.) But Apple cited at least one predicate, so if they followed the conventional 510k approval process, that should have taken at least 100 days. Yet Apple got two software clearances in under 30 days, which uncannily appeared the day before their product announcement.

To be fair to Apple, they were likely holding pre-submission meetings with the FDA for quite some time, perhaps years. One could speculate that using the FDA Pre-Cert pilot program they consulted on the design of the clinical trial, trial endpoints, conduct, inclusion and exclusion criteria, etc. This is all proper medical device company thinking and exactly how consumer device companies need to approach and work with the FDA to get devices or software cleared. And it’s exactly how the FDA should be envisioning its future.

Given Apple sells ~15 million Apple Watches a year, the company is about to embark on a public trial at massive scale of these features – with its initial patient population at the least risk for these conditions. It will be interesting to see what happens. Will overly concerned 20- and 30-year-olds flood doctors with false positives? Or will we be reading about lives saved?

Why most consumer hardware companies aren’t medical device and diagnostic companies
Historically consumer electronics companies and medical device and diagnostic companies were very different companies. In the U.S. medical device and diagnostic products require both regulatory clearance from the FDA and reimbursement approval by different private and public insurers to get paid for the products.

These regulatory and reimbursement agencies have very different timelines and priorities than for-profit companies. Therefore, to get FDA clearance a critical part of a medical device company is spent building a staff and hiring consultants such as clinical research organizations who can master and navigate FDA regulations and clinical trials.

And just because a company gets the FDA to clear their device/diagnostic/software doesn’t mean they’ll get paid for it. In the U.S. medical devices are reimbursed by private insurance companies (Blue Cross/Blue Shield, etc.) and/or the U.S. government via Centers for Medicare & Medicaid Services (CMS). Getting these clearances to get the product covered, coded and paid is as hard as getting the FDA clearance, often taking another 2-3 years. Mastering the reimbursement path requires a company to have yet another group of specialists conduct expensive clinical cost outcomes studies.

The Watch announcement telegraphed something interesting about Apple – they’re one of the few consumer products company to crack the FDA clearance process (Philips being the other). And going forward, unless these new apps are a disaster, it opens the door for them to add additional FDA-cleared screening and diagnostic tools to the watch (and by extension a host of AI-driven imaging diagnostics (melanoma detection, etc.) to the iPhone.) This by itself is a key differentiator for the Watch as a healthcare device.

The other interesting observation: Unlike other medical device companies, Apple’s current Watch business model is not dependent on getting insurers to pay for the watch. Today consumers pay directly for the Watch. However, if the Apple Watch becomes a device eligible for reimbursement, there’s a huge revenue upside for Apple. When and if that happens, your insurance would pay for all or part of an Apple Watch as a diagnostic tool.

(After running cost outcome studies, insurers believe that preventative measures like staying fit brings down their overall expense for a variety of conditions. So today some life insurance companies are mandating the use of an activity tracker like Apple Watch.)

The Future of SmartWatches in Healthcare
Very few companies (probably less than five) have the prowess to integrate sensors, silicon and software with FDA regulatory clearance into a small package like the Apple Watch.

So what else can/will Apple offer on the next versions of the Watch? After looking through Apple’s patents, here’s my take on the list of medical diagnostics and screening apps Apple may add.

Sleep Tracking and Sleep Apnea Detection
Compared to the Fitbit, the lack of a sleep tracking app on the Apple Watch is a mystery (though third-party sleep apps are available.) Its absence is surprising as the Watch can theoretically do much more than just sleep tracking – it can potentially detect Sleep Apnea. Sleep apnea happens when you’re sleeping, and your upper airway becomes blocked, reducing or completely stopping air to your lungs. This can cause a host of complications including Type 2 diabetes, high blood pressure, liver problems, snoring, daytime fatigue. Today diagnosing sleep apnea often requires an overnight stay in a sleep study clinic. Sleep apnea screening doesn’t appear to require any new sensors and would be a great app for the Watch. Perhaps the app is missing because you have to take the watch off and recharge it every night?

Pulse oximetry
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood. The current Apple Watch can already determine how much oxygen is contained in your blood based on the amount of infrared light it absorbs. But for some reason Apple hasn’t released this feature – FDA regulations? Inconsistent readings?  Another essential Watch health app that may or may not require any new sensors.

Respiration rate
Respiration rate (the number of breaths a person takes per minute) along with blood pressure, heart rate and temperature make up a person’s vital signs. Apple has a patent for this watch feature but for some reason hasn’t released it – FDA regulations?  Inconsistent readings?  Another essential Watch health app that doesn’t appear to require any new sensors.

Blood Pressure
About 1/3rd of Americans have high blood pressure. High blood pressure increases the risk of heart disease and stroke. It often has no warning signs or symptoms. Many people do not know they have it and only half of those have it under control. Traditionally measuring blood pressure requires a cuff on the arm and produces a single measurement at a single point in time. We’ve never had the ability to continually monitor a person’s blood pressure under stress or sleep. Apple filed two patents in 2017 to measure blood pressure by holding the watch against your chest. This is tough to do, but it would be another great health app for the Watch that may or may not require any new sensors.

Sunburn/UV Detector
Apple has patented a new type of sensor – a sunscreen detector to let you know what exposed areas of the skin of may be at elevated UV exposure risk. I’m not big on this, but the use of ever more powerful sunscreens has quadrupled, while at the same time, the incidence of skin cancers has also quadrupled, so there may be a market here.

Parkinson’s Disease Diagnosis and Monitoring
Parkinson’s Disease is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination. It affects 1/% of people over 60. Today, there is no diagnostic test for the disease (i.e. blood test, brain scan or EEG). Instead, doctors look for four signs: tremor, rigidity, Bradykinesia/akinesia and Postural instability. Today patients have to go to a doctor for tests to rate the severity of their symptoms and keep a diary of their symptoms.

Apple added a new “Movement Disorder API” to its ResearchKit framework that supports movement and tremor detection. It allows an Apple Watch to continuously monitor for Parkinson’s disease symptoms; tremors and Dyskinesia, a side-effect of treatments for Parkinson’s that causes fidgeting and swaying motions in patients. Researchers have built a prototype Parkinson’s detection app on top of it. It appears that screening for Parkinson’s would not require any new sensors – but likely clinical trials and FDA clearance – and would be a great app for the Watch.

Glucose Monitoring
More than 100 million U.S. adults live with diabetes or prediabetes. If you’re a diabetic, monitoring your blood glucose level is essential to controlling the disease. However, it requires sticking your finger to draw blood multiple times a day. The holy grail of glucose monitoring has been a sensor that can detect glucose levels through the skin. This sensor has been the graveyard of tons of startups that have crashed and burned pursuing this. Apple has a patent application that looks suspiciously like a non-invasive glucose monitoring sensor for the Apple Watch. This is a really tough technical problem to solve, and even if the sensor works, there would be a long period of clinical trials for FDA clearance, but this app would be a game changer for diabetic patients – and Apple – if they can make it happen.

Sensor and Data Challenges
With many of these sensors just getting a signal is easy. Correlating that particular signal to an underlying condition and avoiding being confounded by other factors is what makes achieving medical device claims so hard.

As medical grade data acquisition becomes possible, continuous or real time transmission will store and report baseline data on tens of millions of “healthies” that will be vital in training the algorithms and eventually predicting disease earlier. This will eventually enable more accurate diagnostics on less data, and make the data itself – especially the transition from healthy to diseased – incredibly valuable.

However, this sucks electrons out of batteries and plays on the edge electrical design and the laws of physics, but Apple’s prowess in this area is close to making this possible.

What’s Not Working?
Apple has attempted to get medical researchers to create new health apps by developing ResearchKit, an open source framework for researchers. Great idea. However, given the huge potential for the Watch in diagnostics, ResearchKit and the recruitment of Principal Investigators feels dramatically under resourced. (It took three years to go from ResearchKit 1.0 to 2.0).  Currently, there are just 11 ResearchKit apps on the ITunes store. This effort – Apple software development and third-party app development – feels understaffed and underfunded. Given the potential size of the opportunity, the rhetoric doesn’t match the results and the results to date feel off by at least 10x.

Apple needs to act more proactively and directly fund some of these projects with grants to specific principal investigators and build a program of scale. (Much like the NIH SBIR program.) There should be as sustained commitment to at least several new FDA cleared screening/diagnostic apps every year for Watch and iPhone from Apple.

The Future
Although the current demographics of the Apple Watch skews young, the populations of the U.S., China, Europe and Japan continue to age, which in turn threatens to overwhelm healthcare systems. Having an always on, real-time streaming of medical data to clinicians, will change the current “diagnosis on a single data point and by appointment” paradigm. Wearable healthcare diagnostics and screening apps open an entirely new segment for Apple and will change the shape of healthcare forever.

Imagine a future when you get an Apple Watch (or equivalent) through your insurer to monitor your health for early warning signs of heart attack, stroke, Parkinson’s disease and to help you monitor and manage diabetes, as well as reminding you about medications and tracking your exercise. And when combined with an advanced iPhone with additional FDA cleared screening apps for early detection of skin cancer, glaucoma, cataracts, and other diseases, the future of your health will truly be in your own hands.

Outside the U.S., China is plowing into this with government support, private and public funding, and a China FDA (CFDA) approval process that favors local Chinese solutions. There are well over 100 companies in China alone focusing in this area, many with substantial financial and technical support.

Let’s hope Apple piles on the missing resources for diagnostics and screening apps and grabs the opportunity.

Lessons Learned

  • Apple’s new Watch has two heart diagnostic apps cleared by the FDA
    • This is a big deal
  • In a few years, home and outpatient diagnostics will be performed by wearable consumer devices – Apple Watch, mobile phones or fitness trackers
    • Collecting and sending health data to doctors as needed
    • Collecting baseline data on tens of millions of healthy people to train disease prediction algorithms
  • In the U.S. the FDA has changed their mobile and digital device guidelines and policies to make this happen
  • Insurers will ultimately will be paying for diagnostic wearables
  • Apple has a series of patents for additional Apple Watch sensors – glucose monitoring, blood pressure, UV detection, respiration
    • The watch is already capable of detecting blood oxygen level, sleep apnea, Parkinson’s disease
    • Getting a signal from a sensor is the easy part. Correlating that signal to an underlying condition is hard
    • They need to step up their game – money, software, people – with the medical research community
  • China has made building a local device and diagnostic industry one of their critical national initiatives

Filed under: Life Sciences (NIH), Technology | 11 Comments »

The End of More – The Death of Moore’s Law

Posted on September 12, 2018 by steve blank

 A version of this article first appeared in IEEE Spectrum.

For most of our lives the idea that computers and technology would get, better, faster, cheaper every year was as assured as the sun rising every morning. The story “GlobalFoundries Stops All 7nm Development“ doesn’t sound like the end of that era, but for anyone who uses an electronic device, it most certainly is.

Technology innovation is going to take a different direction.

GlobalFoundries was one of the three companies that made the most advanced silicon chips for other companies (AMD, IBM, Broadcom, Qualcomm, STM and the Department of Defense.) The other foundries are Samsung in South Korea and TSMC in Taiwan. Now there are only two pursuing the leading edge.

This is a big deal.

Since the invention of the integrated circuit ~60 years ago, computer chip manufacturers have been able to pack more transistors onto a single piece of silicon every year. In 1965, Gordon Moore, one of the founders of Intel, observed that the number of transistors was doubling every 24 months and would continue to do so. For 40 years the chip industry managed to live up to that prediction. The first integrated circuits in 1960 had ~10 transistors. Today the most complex silicon chips have 10 billion. Think about it. Silicon chips can now hold a billion times more transistors.

But Moore’s Law ended a decade ago. Consumers just didn’t get the memo.

No More Moore – The End of Process Technology Innovation
Chips are actually “printed,” not with a printing press but with lithography, using exotic chemicals and materials in a “fab” (a chip fabrication plant – the factory where chips are produced). Packing more transistors in each generation of chips requires the fab to “shrink” the size of the transistors. The first transistors were printed with lines 80 microns wide. Today Samsung and TSMC are pushing to produce chips with features few dozen nanometers across.That’s about a 2,000-to-1 reduction.

Each new generation of chips that shrinks the line widths requires fabs to invest enormous amounts of money in new chip-making equipment.  While the first fabs cost a few million dollars, current fabs – the ones that push the bleeding edge – are over $10 billion.

And the exploding cost of the fab is not the only issue with packing more transistors on chips. Each shrink of chip line widths requires more complexity. Features have to be precisely placed on exact locations on each layer of a device. At 7 nanometers this requires up to 80 separate mask layers.

Moore’s Law was an observation about process technology and economics. For half a century it drove the aspirations of the semiconductor industry. But the other limitation to packing more transistors onto to a chip is a physical limitation called Dennard scaling– as transistors get smaller, their power density stays constant, so that the power use stays in proportion with area. This basic law of physics has created a “Power Wall” – a barrier to clock speed – that has limited microprocessor frequency to around 4 GHz since 2005. It’s why clock speeds on your microprocessor stopped increasing with leaps and bounds 13 years ago.  And why memory density is not going to increase at the rate we saw a decade ago.

This problem of continuing to shrink transistors is so hard that even Intel, the leader in microprocessors and for decades the gold standard in leading fab technology, has had problems. Industry observers have suggested that Intel has hit several speed bumps on the way to their next generation push to 10- and 7-nanometer designs and now is trailing TSMC and Samsung.

This combination of spiraling fab cost, technology barriers, power density limits and diminishing returns is the reason GlobalFoundries threw in the towel on further shrinking line widths . It also means the future direction of innovation on silicon is no longer predictable.

It’s the End of the Beginning
The end of putting more transistors on a single chip doesn’t mean the end of innovation in computers or mobile devices. (To be clear, 1) the bleeding edge will advance, but almost imperceptibly year-to-year and 2) GlobalFoundaries isn’t shutting down, they’re just no longer going to be the ones pushing the edge 3) existing fabs can make current generation 14nm chips and their expensive tools have been paid for. Even older fabs at 28-, 45-, and 65nm can make a ton of money).

But what it does mean is that we’re at the end of guaranteed year-to-year growth in computing power. The result is the end of the type of innovation we’ve been used to for the last 60 years. Instead of just faster versions of what we’ve been used to seeing, device designers now need to get more creative with the 10 billion transistors they have to work with.

It’s worth remembering that human brains have had 100 billion neurons for at least the last 35,000 years. Yet we’ve learned to do a lot more with the same compute power. The same will hold true with semiconductors – we’re going to figure out radically new ways to use those 10 billion transistors.

For example, there are new chip architectures coming (multi-core CPUs, massively parallel CPUs and special purpose silicon for AI/machine learning and GPU’s like Nvidia), new ways to package the chips and to interconnect memory, and even new types of memory. And other designs are pushing for extreme low power usage and others for very low cost.

It’s a Whole New Game
So, what does this mean for consumers? First, high performance applications that needed very fast computing locally on your device will continue their move to the cloud (where data centers are measured in football field sizes) further enabled by new 5G networks. Second, while computing devices we buy will not be much faster on today’s off-the-shelf software, new features– facial recognition, augmented reality, autonomous navigation, and apps we haven’t even thought about –are going to come from new software using new technology like new displays and sensors.

The world of computing is moving into new and uncharted territory. For desktop and mobile devices, the need for a “must have” upgrade won’t be for speed, but because there’s a new capability or app.

For chip manufacturers, for the first time in half a century, all rules are off. There will be a new set of winners and losers in this transition. It will be exciting to watch and see what emerges from the fog.

Lessons Learned

  • Moore’s Law – the doubling of every two years of how many transistors can fit on a chip – has ended
  • Innovation will continue in new computer architectures, chip packaging, interconnects, and memory
  • 5G networks will move more high-performance consumer computing needs seamlessly to the cloud
  • New applications and hardware other than CPU speed (5G networks, displays, sensors) will now drive sales of consumer devices
  • New winners and losers will emerge in consumer devices and chip suppliers

Filed under: Technology | 5 Comments »

Is the Lean Startup Dead?

Posted on September 5, 2018 by steve blank

A version of this article first appeared in the Harvard Business Review

Reading the NY Times article “Jeffrey Katzenberg Raises $1 Billion for Short-Form Video Venture,” I realized it was time for a new startup heuristic: the amount of customer discovery and product-market fit you need to find is inversely proportional to the amount and availability of risk capital.

And while the “first mover advantage” was the rallying cry of the last bubble, today’s is: “Massive capital infusion can own the entire market.”

Fire, Ready, Aim
Jeff Katzenberg has a great track record – head of the studio at Paramount, chairman of Disney Studios, co-founder of DreamWorks and now chairman of NewTV. The billion dollars he just raised is on top of the $750 million NewTV’s parent company, WndrCo, has raised for the venture. He just hired Meg Whitman. the ex-CEO of HP and eBay, as CEO of NewTV. Their idea is that consumers will want a subscription service for short form entertainment (10-minute programs) for mobile rather than full length movies. (Think YouTube meets Netflix).

It’s an almost $2-billion-dollar bet based on a set of hypotheses. Will consumers want to watch short-form mobile entertainment? Since NewTV won’t be making the content, they will be licensing from and partnering with traditional entertainment producers. Will these third parties produce something people will watch? NewTV will depend on partners like telcos to distribute the content. (Given Verizon just shut down Go90, its short form content video service, it will be interesting to see if Verizon distributes Katzenberg’s offerings.)

But NewTV doesn’t plan on testing these hypotheses. With fewer than 10 employees but almost $2-billion dollars in the bank, they plan on jumping right in.

It’s the antithesis of the Lean Startup.  And it may work. Why?

Dot Com Boom to Bust
Most entrepreneurs today don’t remember the Dot-Com bubble of 1995 or the Dot-Com crash that followed in 2000. As a reminder, the Dot Com bubble was a five-year period from August 1995 (the Netscape IPO) when there was a massive wave of experiments on the then-new internet, in commerce, entertainment, nascent social media, and search. When Netscape went public, it unleashed a frenzy from the public markets for anything related to the internet and signaled to venture investors that there were massive returns to be made investing in anything internet related. Almost overnight the floodgates opened, and risk capital was available at scale from venture capital investors who rushed their startups toward public offerings. Tech IPO prices exploded and subsequent trading prices rose to dizzying heights as the stock prices became disconnected from the traditional metrics of revenue and profits. Some have labeled this period as irrational exuberance. But as Carlota Perez has so aptly described, all new technology industries go through an eruption and frenzy phase, followed by a crash, then a golden age and maturity. Then the cycle repeats with a new set of technologies.

Given the stock market was buying “the story and vision” of anything internet, inflated expectations were more important than traditional metrics like customers, growth, revenue, or heaven forbid, profits. Startups wrote business plans, generated expansive 5-year forecasts and executed (hired, spent and built) to the plan. The mantra of “first mover advantage,” the idea that winners are the ones who are the first entrants in their market, became the conventional wisdom of investors in Silicon Valley.“ First Movers” didn’t understand customer problems or the product features that solved those problems (what we now call product-market fit). These bubble startups were actually guessing at their business model and did premature and aggressive hype and early company launches and had extremely high burn rates – all predicated on an IPO to raise more cash. To be fair, in the 20th century, there really wasn’t a model for how to build startups other than write plan, raise money, and execute – the bubble was this method, on steroids. And to be honest, VC’s in this bubble really didn’t care. Massive liquidity awaited the first movers to the IPO’s, and that’s how they managed their portfolios.

When VC’s realized how eager the public markets were for anything related to the internet, they pushed startups with little revenue and no profits into IPOs as fast as they could. The unprecedented size and scale of VC returns transformed venture capital from a financial asset backwater into full-fledged player in the financial markets.

Then one day it was over. IPOs dried up. Startups with huge burn rates – building leases, staff, PR and advertising – ran out of money. Most startups born in the bubble died in the bubble.

The Rise of the Lean Startup
After the crash, venture capital was scarce to non-existent. (Most of the funds that started in the late part of the boom would be underwater). Angel investment, which was small to start with, disappeared, and most corporate VCs shut down. VC’s were no longer insisting that startups spend faster, and “swing for the fences”. In fact, they were screaming at them to dramatically reduce their burn rates. It was a nuclear winter for startup capital.

The idea of the Lean Startup was built on top of the rubble of the 2000 Dot-Com crash.

With risk capital at a premium and the public markets closed, startups and their investors now needed a methodology to preserve capital and survive long enough to generate revenue and profits. And to do that they needed a different method than just “build it and they will come.” They needed to be sure that what they were building was what customers wanted and needed. And if their initial guesses were wrong, they needed a process that would permit them to change early on in the product development process when the cost of changes was small – the famed “pivot”.

Lean started from the observation that you cannot ask a question that you have no words for. At the time we had no language to describe that startups were not smaller versions of large companies; the first insight was that large companies executed known business models, while startups searched for them. Yet while we had plenty of language and tools for execution, we had none for search.  So we (Blank, Ries, Osterwalder) built the tools and created a new language for innovation and modern entrepreneurship. It helped that in the nuclear winter that followed the crash, 2001 – 2004, startups and VCs were extremely risk averse and amenable to new ideas that reduced risk. (This same risk averse, conserve the cash, VC mindset would return after the 2008 meltdown of the housing market.)

As described in the HBR article “Why the Lean Startup Changes Everything,” we developed Lean as the business model / customer development / agile development solution stack where entrepreneurs first map their hypotheses about their business model and then test these hypotheses with customers in the field (customer development) and use an iterative and incremental development methodology (agile development) to build the product. This allowed startups to build Minimal Viable Products (MVPs) – incremental and iterative prototypes – and put them in front of a large number of customers to get immediate feedback. When founders discovered their assumptions were wrong, as they inevitably did, the result wasn’t a crisis; it was a learning event called a pivot— and an opportunity to change the business model.

Every startup is in a race against time. It has to find product-market fit before running out of cash. Lean makes sense when capital is scarce and when you need to keep burn rates low. Lean was designed to inform the founders’ vision while they operated frugally at speed. It was not built as a focus group for consensus for those without deep convictions.

The result? Startups now had tools that sped up the search for customers, ensured that what was being built met customer needs, reduced time to market and slashed the cost of development.

Carpe Diem – Seize the Cash
Today, memories of frugal VC’s and tight capital markets have faded, and the structure of risk capital is radically different. The explosion of seed funding means tens of thousands of companies that previously languished in their basement are getting funding, likely two orders of magnitude more than received Series A funding during the Dot-Com bubble. As mobile devices offer a platform of several billion eyeballs, potential customers which were previously small niche markets now include everyone on the planet. And enterprise customers in a race to reconfigure strategies, channels, and offerings to deal with disruption provide a willing market for startup tools and services.

All this is driven by corporate funds, sovereign funds and even VC funds with capital pools of tens of billions of dollars dwarfing any of the dollars in the first Dot Com bubble – and all looking for the next Tesla, Uber, Airbnb, or Alibaba. What matters to investors now is to drive startup valuations into unicorn territory (valued at $1 billion or more) via rapid growth – usually users, revenue, engagements but almost never profits. As valuations have long passed the peak of the 2000 Internet bubble, VC’s and founders who previously had to wait until they sold their company or took it public to make money no longer have to wait. They can now sell part of their investment when they raise the next round. And if the company does go public, the valuations are at least 10x of the last bubble.

With capital chasing the best deals, and hundreds of millions of dollars pouring into some startups, most funds now scoff at the idea of Lean. Rather than the “first mover advantage” of the last bubble, today’s theory is that “massive capital infusion owns the entire market.” And Lean for startups seems like some quaint notion of a bygone era.

And that explains why investors are willing to bet on someone with a successful track record like Katzenberg who has a vision of disrupting an entire industry.

In short, Lean was an answer to a specific startup problem at a specific time, one that most entrepreneurs still face and which ebbs and flows depending on capital markets. It’s a response to scarce capital, and when that constraint is loosened, it’s worth considering whether other approaches are superior. With enough cash in the bank, Katzenberg can afford to create content, sign distribution deals, and see if consumers watch. If not, he still has the option to pivot. And if he’s right, the payoff will be huge.

One More Thing…
Well-funded startups often have more capital for R&D than the incumbent companies they’re disrupting. Companies struggle to compete while reconfiguring legacy distribution channels, pricing models and supply chains. And government agencies find themselves being disrupted by adversaries unencumbered by legacy systems, policies and history.  Both companies and government agencies struggle with how to deliver innovation at speed. Ironically, for this new audience that makes the next generation of Lean – the Innovation Pipeline – more relevant than ever.

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Lessons Learned:

  • When capital for startups is readily available at scale, it makes more sense to go big, fast and make mistakes than it does to search for product/market fit.
  • The amount of customer discovery and product-market fit you need to do is inversely proportional to the amount and availability of risk capital.
  • Still, unless your startup has access to large pools of capital or have a brand name like Katzenberg, Lean still makes sense.
  • Lean is now essential for companies and government agencies to deliver innovation at speed
  • The Lean Startup isn’t dead. For companies and government the next generation of Lean – the Innovation Pipeline – is more relevant than ever.

Filed under: Corporate/Gov't Innovation, Customer Development, Harvard Business Review, Venture Capital | 27 Comments »