Thursday 20 April 2017

Fortune: Prepare for the Digital Health Revolution

Digital Health
 
Prepare for the Digital Health Revolution

Sy Mukherjee
6:30 AM ET

The business of medicine is inefficient, expensive, and ripe for disruption. Here are 21 companies that are using technology to reinvent it—and to change our lives in the process.

There are many choices we make over the course of our lives. Some are fairly insignificant, like the clothes we put on in the morning; others, such as the vocations we settle on, have life-changing consequences. But there’s one critical decision we don’t get to make: the choice of being born into a human body—and all the arbitrary ailments and inevitable biological breakdowns that follow.

This is what sets health care apart from other industries. The ­business of medicine is quite literally one of life and death. And throughout much of the world, it remains a messy, inefficient, ­expensive sector in need of radical reform.

Just consider some of the heart-wrenching numbers. Nearly one in four non-elderly American adults had past-due medical debt in 2015. That’s actually an improvement from 2012, when the figure was closer to 30% (insurance coverage gains under the Affordable Care Act are one likely reason for the decline). In Mississippi, more than 37% of the population owed money to care providers in 2015. Medical expenses are the top driver of personal bankruptcies. And last year the federal government projected that the nation’s health care bill would top $10,000 per person for the first time in history.

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So what do we get for these extravagant private and public costs? A system where it takes weeks to see a doctor face-to-face, where more than 6,500 locales are officially deemed to have too few medical professionals to meet patients’ needs, and where U.S. health outcomes are consistently mediocre compared with those of many of our developed-nation peers (and even some of the less developed ones).

This status quo is ripe for disruption. And while true reform will require all the relevant parties—government, industry, and health care consumers themselves—to make major adjustments, an insurgent group of digital health companies is doing its best to drag American medicine into the 21st century kicking and screaming.

That means superseding physical constraints like having an actual hospital by harnessing the power of mobile technology, making the act of taking your medicine less of a hassle, and peering into our very biological building blocks to wage war on the most intractable maladies.

To offer a preview of what this tech-optimized future might look like, we identified 21 innovative companies in five categories—each of which is challenging the conventional approach to medicine.

Welcome to the digital health revolution.

How health care is transcending physical walls.

At the turn of the 20th century, getting a checkup in America frequently meant your doctor came to you. Armed with a modest black bag of tools and old-fashioned medical know-how, physicians of yore would often take care of you right at your bedside.

As quaint as that image may seem today, it’s in some ways a vision of the future. New technologies are bringing back the house call—or a digital version of it, anyway.

The Companies

A slew of telehealth companies, from the Boston-based ­American Well to San Francisco startup ­Doctor On Demand, are again bringing health care to your doorstep—or more commonly, to your workplace. The National Business Group on Health last year surveyed 133 large companies employing 15 million Americans about their benefit practices: An astounding 90% said they expect to make at least some telemedicine services available to their workers this year. By 2019, nearly all of them will.

So what does that brave new world look like? Say you’ve been working after hours and suddenly feel feverish and woozy. You would walk down the hall to your company’s on-site digital health station—that’s a fancy word for “kiosk” (which, in turn, is a fancy word for “booth”)—where you would consult with a physician immediately by phone or video. That same doctor can take your vital signs—temperature, pulse, blood pressure—and if needed, send a prescription to the nearest pharmacy. Or maybe just tell you to go home and get some rest.

In December, American Well partnered with Concentra, which has more than 300 medical centers in 40 states, to provide some of those on-call physicians.

One obvious advantage of telemedicine is that the doctor can be anywhere—which is not the case for our traditional health care system. At hospitals across the country, in fact, there is an entrenched doctor shortage, which has grown only more acute as millions of Americans have gained health coverage in recent years.

New digital platforms are helping to solve that problem too. One New York startup, Nomad Health, pairs doctors with hospitals in need of physicians in three specialties—internal medicine, emergency medicine, and psychiatry. Nomad cofounder and CEO Dr. Alexi Nazem, in an interview with Fortune, likens the system to an Airbnb model for medical staffing. The professional matchmaking process lets health systems find doctors with specific credentials (say, an internal medicine specialist with five years’ experience who is free to work at a New York–area hospital in July) and vice-versa. The platform then automatically takes care of tasks like providing malpractice insurance if the hospital and doctor strike a contract.

This isn’t just convenient from a medical resource perspective; it also plays into a nascent “gig economy” in health care that’s become increasingly popular among younger, tech-savvy physicians. “With very little effort we’ve been able to tap into a huge flow of doctors who want to do short-term, freelance, flexible work,” says Nazem. “And I think that trend will continue [among millennials] not only because of the attitudinal shift [on freelance medical work] but also because the existence of technology actually makes it possible to do this kind of work.” Last summer the company raised $4 million in an early funding round led by First Round Capital and RRE Ventures.

And it’s not just medical startups driving this mobile health surge. Ride-sharing giants Uber and Lyft have started new programs to provide non-emergency medical transport for patients who struggle to get to a hospital. One platform that launched last fall, called Circulation, integrates medical records into Uber’s API so that nurses, caregivers, and hospital transportation coordinators can more easily schedule rides for patients and accommodate their needs (such as if they have a wheelchair or trouble seeing).

The Future

These technologies may one day fundamentally shift the way that health care is delivered and consumed. But before that transformation takes hold, some other changes will have to happen—including new reimbursement rules from insurance companies and policy shifts that make it easier for physicians to practice across state lines without gaining extra licenses or accreditation. There’s also the matter of whether mobile medical care will ultimately reduce national health spending: At least one recent report suggests that the technology may well cause people to pursue care they don’t need precisely because it makes it so convenient to get.

Still, don’t bet against the trend. For consumers, after all, convenience has always been king—and convenient and cheap? Well, there’s no beating that.
Illustration by molistudio
Algorithmic Medicine

Big data and AI push learning.

The term “big data” gets tossed around so casually that it’s easy to forget just how big “big” really is. Consider that 2.5 quintillion bytes of data are created every day, according to IBM (ibm, -0.46%). In health care, this amounts to an hourly avalanche of new research papers, clinical trials, scientific studies, and patient health information. And it’s impossible for doctors and medical researchers to keep up with even a tiny fraction of it.

Enter machine learning and artificial intelligence. Shorn of human weaknesses like the need to eat or sleep, computers are now speed-­reading through not only the vast academic literature but also CT scans, electronic medical records, and mountains of data from clinical trials and genomic studies. AI is also giving drugmakers critical insights into who benefits most from their treatments and changing the way hospitals manage their administrative operations.

The Companies

With IBM, the metamorphosis seems to have happened overnight: The starched-shirt centenarian went from a stolid mainframe and consulting giant to an upstart digital health pioneer—all in the blink of an AI. Big Blue can thank Watson—its Jeopardy!-winning, cognitive computing superstar—for that. And the company’s ravenous dealmaking business unit, IBM Watson Health, seems to be redefining daily what AI applications can be used for.

In the two years since Watson Health launched, it has struck partnerships with an impressive array of academic institutions, such as the Memorial Sloan Kettering Cancer Center and prominent biopharma companies like Pfizer (pfe, +0.19%), Medtronic (mdt, -0.05%), and Johnson & Johnson (jnj, +0.38%). In each case, Watson is given roughly the same task: Feast on reams of data and find hidden patterns—and hopefully new knowledge—within them. Watson can do this with electronic medical records as well as with so-called unstructured data (like that found in the image of an X-ray or brain scan).

Chart shows number of registered clinical studies

And as with telemedicine, its insights can be made mobile. Earlier this year, for instance, Watson’s oncology-focused unit struck its first deal with a community hospital, a 327-bed outfit in Jupiter, Fla., that can now harness the supercomputer’s power to match cancer patients with the treatments most likely to help them (thanks to a clinical data set expertly reviewed by Memorial Sloan Kettering).

But what if AI and deep learning could help doctors figure out a patient’s disease simply by analyzing a face—no scans or testing required? That’s precisely what Boston-based startup FDNA is trying achieve with its Face2Gene platform. The firm has put together a photo database of people with more than 2,000 rare genetic diseases. Doctors can snap pictures of their patients and upload them to FDNA’s mobile app, which then spits out a list of disorders they might have by analyzing telltale facial features associated with those conditions (the tech is not a diagnostic tool, but rather a way to narrow down the list of possible genetic suspects). And the company hopes the system can drastically improve the “diagnostic journeys” that those with rare diseases typically face: Such patients, on average, are seen by seven doctors before the correct diagnosis is made.

Cutting costs and catching on to illnesses as early as possible are major goals for this type of tech. But it can also be used to combat administrative headaches like long hospital wait times. Last October, GE Healthcare and the Johns Hopkins Hospital launched a fully digital hub to better manage everyday operations. The Judy Reitz Capacity Command Center gets a constant influx of data about important events at the hospital; it receives about 500 messages every minute from more than a dozen different Hopkins IT systems and with the help of predictive analytics turns this swamp of data into suggestions for action that prevent bottlenecks and get patients both into and out of the hospital faster.

And, according to Johns Hopkins at least, it’s showing impressive early results. The hospital says the command center has shaved more than an hour off the time it takes to dispatch an ambulance to another facility and that emergency room patients are assigned a bed 30% faster than before.

The Future

Now for a sobering fact: All the whiz-bang computing power in the world can’t find knowledge in the data if the data isn’t shared to begin with. And surprising as it may seem, says Greg Simon, former executive director of the White House Cancer Moonshot, we “still live in an information-scarce medical world.”

The federal government and private organizations have tried to encourage sharing in recent years through initiatives like the Genomic Data Commons, a “unified data repository” intended to hasten cancer cures by making research public. But real progress on this front will take more than a handful of public-private initiatives: It will require a change in mind-set—a radical new willingness to share and share alike.

Next-Generation Capsules
The evolution of drug delivery.

The hypodermic needle made a splash on the medical stage in the 1850s by combining two key inventions: the conventional syringe (eventually converted from metal to glass so that users could better measure doses) and sharp, hollow needles. While the innovation was initially used for ­purposes such as injecting pain sufferers with powerful opioids, it became a true game changer once insulin came on the scene in 1921. Unlike painkillers, insulin can’t be ingested—it has to be administered via an injection or a pump in order for the body to absorb it and control blood sugar.

The way that we take our drugs has continued to evolve in the decades since then—syringes became disposable, for example—and the progress is far from over.

The Companies

In the past few years companies like Braeburn Pharmaceuticals, Intarcia Therapeutics, and Proteus Digital Health have set out to create better medical mousetraps through devices that make existing drugs more effective. That means peace of mind for diabetes patients, who no longer have to constantly prick their fingers to measure blood sugar and manually adjust insulin doses, and hope for recovering opioid addicts, who might face a relapse if they don’t adhere to a strict treatment protocol.

Last May, Braeburn and partner Titan Pharmaceuticals became the first companies to win Food and Drug Administration (FDA) approval for an implant to treat opioid addiction. Their product, Probuphine, is made up of matchstick-size implants placed into patients’ upper arms in a simple outpatient procedure. These devices dispense a drug called buprenorphine—itself an opioid, but one that doesn’t produce the sort of euphoric and addictive high that more powerful painkillers such as OxyContin and morphine do.

But rather than have patients take buprenorphine manually, Probuphine dispenses small amounts of the drug continually into the bloodstream, ensuring that people actually stick to their prescribed regimen. The device can be used for up to six months.

This type of automated, long-term delivery system could make it easier to treat everything from brain diseases to diabetes. Indeed, diabetes is one affliction that Intarcia has in its crosshairs. The Boston company is seeking FDA approval for an under-the-skin pump system that it says can dispense a steady stream of diabetes drugs for a period of six months or longer. But ­notably—even before it has won marketing approval—some think the technology could be an effective weapon against another deadly scourge: HIV. The Bill & Melinda Gates Foundation said it will invest up to $140 million in Intarcia, in the hopes that its device can deliver prophylactic medicine—and help shield patients at high risk of infection from HIV.

The common theme of these innovations is that medicine itself is necessary but not sufficient: Patients actually have to take it as directed for it to work. Nonadherence to prescribed regimens is also costly, resulting in nearly $300 billion a year in wasted spending, according to some studies.

Automating the process is one way to tackle this problem; Proteus Digital Health, however, is taking a different approach. The Silicon Valley startup’s “smart pill” platform, Discover, helps doctors track patients’ biometrics—and whether or not they’re sticking to a drug protocol—with the help of ingestible (and on-the-body) sensors that communicate with a smartphone app. This way, patients with chronic diseases like hypertension and diabetes (and their physicians) can figure out the most effective dosing regimens.

The Future

Improving the way we take drugs could save those in the developed world many billions of dollars in annual health care expenses. It could also transform how the world’s poorest nations prevent and treat disease—whether through patches that administer vaccines or through long-acting implants that dispense HIV/AIDS drugs. Even in medicine, it seems, the delivery business is in the throes of revolution.
Illustration by molistudio
Genomic Revolution

Precision-editing the code of life.

Adenine. Thymine. Guanine. Cytosine. These four tiny compounds provide the basis of life. They are the “letters” that make up DNA’s code, and their various permutations can determine everything from our physical appearances to our risk of being born with a devastating disease.

So it’s not surprising that being able to manipulate these chemical building blocks is one of the most exciting prospects in medicine. And thanks to a gene-editing technology known as Crispr-Cas9, it’s become a whole lot easier to do just that.

The Companies

Crispr has been widely celebrated as one of the most (if not the most) groundbreaking biotech discoveries of the 21st century. That’s not to say gene editing is new (it isn’t), but Crispr simplifies the process by using molecular scissors that can be precisely targeted to snip out aberrant regions of genetic code, which can then be replaced with the correct sequences.

The technology’s possibilities are staggering—in theory, allowing medical scientists to do everything from cure genetic disorders like sickle cell disease to identify gene targets for combating HIV. Silicon Valley billionaire and cancer immunotherapy patron Sean Parker is funding the first U.S. Crispr trials in humans, which are expected to begin this year at the University of Pennsylvania and allied institutions; in March, pharma giant Allergan (agn, +0.17%) struck a $90 million deal with Crispr specialist Editas Medicine (edit, +0.83%) for access to the biotech’s experimental therapies to treat rare and serious eye diseases.

And Crispr-Cas9 isn’t even the only type of Crispr out there: On April 12, researchers at the University of Texas Southwestern Medical Center announced they had successfully paired the gene-editing tool with a different kind of enzyme, called Cpf1, to correct mutations associated with the devastating muscle-wasting disorder Duchenne muscular dystrophy. Crispr-Cpf1 could potentially prove even more promising than the Cas9 variety because the Cpf1 enzyme is smaller and can target certain genomic regions that Cas9 can’t reach.

What makes Crispr so exciting is that, thanks to its precision, the tool has opened up a world of innovation to research facilities that previously wouldn’t have been able to handle the expenses or complexities of genome editing. The possibility that different Crispr-associated enzymes may be more effective than others is fueling the scientific competition. So is the fact that Chinese scientists at Sichuan University in Chengdu launched the first-ever human Crispr trial, in a lung cancer patient last October—a milestone that American scientist Dr. Carl June predicted would “trigger Sputnik 2.0” and a “biomedical duel” in the field between China and the U.S.

The genomic revolution isn’t just a scientific one, though. It’s also regulatory. Gene-related tech has a way of putting the fear of God—or the fear of man playing God—in people. And regulators have been cautious when it comes to the field.

That’s partly what makes 23andMe’s landmark FDA victory in early April so notable. The Alphabet-backed Silicon Valley startup, valued at $1.1 billion, became the first company allowed to sell genetic tests (and accompanying health-risk reports) for 10 different diseases directly to consumers without a prescription. That includes conditions like Parkinson’s, Alzheimer’s, and celiac disease.

Victory wasn’t always assured. In November 2013, the FDA sent 23andMe cofounder and CEO Anne Wojcicki a stern warning saying that the company’s tests and health reports, which it was already selling straight to customers, were unapproved medical devices that hadn’t been cleared by the agency. The firm had to shelve many of its services as it worked to convince regulators that its genetic tests were accurate and the accompanying medical risk reports clear enough that they wouldn’t confuse or harm customers.

Now 23andMe has pulled off the kind of comeback that’s rare to see in biopharma. “The FDA has embraced innovation and has empowered people by authorizing direct access to this information,” said Wojcicki in a statement following the clearance.

The Future

Genomic technology has evolved from the stuff of science fiction to a tangible reality, with massive medical and financial implications. Just how high are the stakes? Enough that the brilliant minds behind Crispr-Cas9—University of California at Berkeley’s Jennifer Doudna, her academic partner Emmanuelle Charpentier of the Max Planck Institute for Infection Biology in Germany, and rival Broad Institute of MIT and Harvard scientist Feng Zhang—and the various biotechs affiliated with them are embroiled in an ugly, global patent spat over the rights to the tech. (Zhang and the Broad won a key intellectual-property ruling in the U.S. earlier this year, but the matter is far from settled in markets like Europe and Asia.)

And ethical concerns will continue to dog this space. The technology isn’t quite advanced enough to birth a world of “designer babies.” But even in the case of 23andMe’s home DNA kits, some question the morality of telling a customer he is at high risk for Alzheimer’s when there’s little the person can currently do about it.

The radical new models for drug discovery.

The lines between Big Pharma and small biotech are eroding. Traditional drug giants have caught on to the not-so-dirty little secret that outsourcing drug research (and in-licensing) may be a more effective strategy than trying to create groundbreaking new molecules within the confines of a single lab.

“No one company can corner in or create a monopoly on the best thinking that’s out there. And so if we’ve built the lab and we invested a billion dollars in discovering medicines, we can only do what we could in the four walls of our village,” as Allergan CEO Brent Saunders, a licensing-and-acquisition maven, put it during an interview with Fortune earlier this year. “But if we walk outside of that, we’re fishing in an ocean vs. a pond for innovation.”

But shifting collaborative models aren’t the only forces changing the face of drug development. Some companies are thinking not just outside the box but outside the planet when it comes to improving medicine.

The Companies

Elon Musk’s groundbreaking private space outfit, SpaceX, flew its 10th mission under a NASA commercial resupply contract in February. The Dragon spacecraft delivered payloads to the International Space Station (ISS), including some high-profile biopharma cargo from Merck (mrk, -0.45%) and others.

Merck has been collaborating with the Center for the Advancement of Science in Space (CASIS), which has been tasked by NASA to oversee the ISS’s U.S. National Lab since 2012. CASIS’s mission is to encourage “use of this unparalleled platform for innovation”—and Merck is taking this to heart by experimenting with drug development in the realm of microgravity.

Such an environment, it turns out, presents all sorts of opportunities that aren’t available down here on Earth, as Merck structural chemistry scientist Paul Reichert explained to Fortune in an interview.

For instance, you don’t get the kind of gravity-driven diffusion that makes molecules scatter to a specific destination based on their density (think of excess sugar falling to the bottom of an oversaturated glass). One of Merck’s main interests involves growing protein crystals, which form as larger and more organized structures in microgravity.

On the ISS, Merck has been doing experiments on its next-gen cancer medicine Keytruda. The mission, says Reichert, is “to understand the impact of the microgravity environment on the structure, delivery method, and purification” of these types of compounds. The lack of gravity-induced molecular changes on the U.S. National Lab could help Merck researchers improve drug delivery and manufacturing methods on Earth.

The Future

From tech incubators to world-class research facilities, from tweaks to biological machinery to computers that can unlock its secrets, and from research conducted on our pale blue dot to the cosmos themselves, the health care revolution is within our grasp. But ultimately realizing it will require collective changes in policy and scientific culture—and recognizing that technology, like humans, has its own limits.

A version of this article appears in the May 1, 2017 issue of Fortune as part of the "Future of Health" package. See the rest of the package here.

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