If pharma execs ever doubt that the mobile-health revolution is well under way—if they hesitate for a moment to devote significant resources to the space, ignore patient and caregiver pleas for mobile-first communications or embrace mobile only to the extent that they responsively design their websites—they’d be well served to remember the story of one Jason Adams.

Adams doesn’t hew to stereotypes of the computer hacker. He’s a business exec schooled in molecular biology and the parent of a young daughter with Type 1 diabetes—and, as such, likely doesn’t fritter away his hours in his mother’s basement, his father’s attic or wherever hackers are said to ply their trade nowadays. But when he became frustrated with his daughter’s Dexcom G4 continuous glucose monitor—though it effectively monitored her blood-sugar levels, it wasn’t designed to beam the data to the Internet—Adams went the do-it-yourself route.

After some asking around, he happened upon the Nightscout Project, whose collective of engineers (many, like Adams, the parent of a diabetic child) birthed an open-source system that does exactly what the Dexcom monitor won’t: transmit the device’s readings into the cloud. Adams now monitors his daughter’s blood-sugar levels on a Pebble smart watch rather than on the non-Internet-enabled Dexcom-supplied receiver.

But for The Wall Street Journal, which reported Adams’s story a few months back and made him a mobile-wonk Internet idol, the glucose monitor hack would never have become newsworthy. And yet that’s not even the most interesting part of the tale. In the wake of the story’s publication, here’s what happened: nothing.

While FDA higher-ups and spokespeople admitted to some concern about the episode—particularly Adams’s admission that his jury-rigged solution isn’t 100% reliable—they dismissed it by saying, essentially, that they have bigger and more potentially hazardous app/device fish to fry. Dexcom, for its part, acknowledged its awareness of Nightscout but added little beyond that. Meanwhile, Nightscout’s website and Twitter feed remain largely what they were before all the attention.

(After the February issue of MM&M went to press, the FDA announced that it would allow marketing of the first set of apps that help people with diabetes or their caregivers share data from glucose monitors, like the Dexcom ones, via the Internet.)

So why is this episode relevant for pharma marketers, both those with a sizable mobile presence and those underinvested in the space? What can they learn from Adams and the other so-called Diabetes Dads that might have the slightest bearing on future mobile programming?

It is this: That patients and caregivers aren’t about to wait around for solutions. If their needs aren’t being met, they’re going to attempt to satisfy them on their own. 

“I don’t want to condone what the Diabetes dads did in any way, shape or form—let me make that clear,” says Will Falk, North and South America healthcare leader at PwC. “But if that’s not a clear indicator of consumer demand, I don’t know what is. These guys said, basically, ‘My child’s glucose is important to me. I’m going to have it on my phone, regardless of whether or not you give it to me.’ ”

Indeed, no longer is “if you’re not up on mobile, you risk missing out on opportunities” the de facto cautionary blanket statement for healthcare marketers. Rather, it’s “if you’re not up on mobile, you might get bypassed entirely.” The latter, one supposes, is a far more worrying prospect than the former.

“The drive to innovate within  mHealth is strong,” says John McCarthy, vice president of global commercial excellence at Astra-Zeneca. Matt Balogh, SVP, chief technology officer at Ogilvy CommonHealth Worldwide, agrees, joking that, “We say it every year—but this year is the year. I think there’s a broader understanding among everyone in healthcare that if you really want real behavior change, you have to be there.”

Chief among recent realizations is that the definition of what constitutes “mobile” continues to expand. McCarthy characterizes the current climate as “an inflection point,” noting that the industry is “moving beyond thinking about mobile as simply a marketing channel, and more as a means to help solve the real-world challenges that patients, healthcare providers, the business and the broader healthcare community are currently facing.”

Maybe that’s where to begin our State of the Mobile Union address: with a new, and broader, definition. The smartphone screen is the current ground zero for mobile efforts—which makes sense, given that even the most conservative estimates have smartphone penetration in the US at 60% (the mobile-space analysts Asymco pegged it at 70% last July). That said, any arms-wide-open definition should include wearables (intimately linked to the devices that capture the data they collect) and watches—even cars. “Think ‘mobility,’ not just ‘mobile,’ ” Larry Mickelberg, a partner at Havas Health and president of Havas Lynx US, suggests, adding a pun for good measure. “Thanks to Android Auto and Apple’s CarPlay and the rest of the connected-car revolution, mobile will really be, well, mobile.”

If not now, when?

While the pharma business has been accused of being slow to embrace anything marketing related with even the mildest tinge of newness, not everyone believes it’s behind the curve in mobile. Internal voices like McCarthy’s sound a voice of caution, especially vis-a-vis the do-it-now-fix-it-later approach of other consumer-facing businesses. “What we’ve found is that consumers have different expectations of the pharmaceutical industry than they do of other industries when it comes to mobile innovation,” he explains. “While pharma has generally kept pace with those expectations, there exists a tremendous opportunity to get ahead of emerging trends and create a new standard in mHealth.” In other words: The ambition and desire are there.

Are there doubters? Of course. “All too often pharmaceutical brands are limited by regulatory and technical infrastructures that delay innovation and progress,” Mickelberg says. “Add to this antiquated ‘outbound messaging’ strategies and audiences are left wanting for products and services with which they can truly engage.”

But in this instance, perhaps pharma’s reluctance to move quickly could work to its advantage. “I don’t think pharma is keeping pace, but that’s okay,” explains Geoff McCleary, VP, group director, mobile strategy and innovation at Digitas Health LifeBrands. “We live in a regulated industry. We can’t get around that. But the advantage is that the consumer space is spinning so quickly with iterations, maybe it’s a good thing for us to be able to sit back and look at trends—which ones are enduring and which ones are burning out.”

Balogh agrees. “In so many other places companies can get away with a mobile-first mentality, but in pharma we have to be more careful. We can’t make a mistake. Some people see that as handicap, but I see it as strategic. Since we don’t get to guess and check, we have to plan carefully. The work we do is better for it.”

Such thinking shines a light on a related benefit of the industry’s carefulness when it comes to relatively new channels like mobile: Namely, that it doesn’t lack for willing partners from which to choose. If it’s Wednesday, there must be five new health-tech start-ups hoping to connect with (or latch onto, depending on the cynicism with which one views such entities) supremely stable and well-funded healthcare mainstays. “You almost have to look at these companies with a bit of a VC eye, as opposed to, ‘Hey, that’s a great little widget they built there,’ ” says McCleary. 

More partners, more problems

On the flip side, with new partners come new headaches. They might know mobile and health-tech and be fluent in lingo-ese but many have yet to partner with a company of a comparable size and philosophy to one of the pharma giants. At the same time, companies from outside healthcare—hi, Google! nice to make your acquaintance, Apple!—see loads of profit potential in the space, particularly amid the current mobile and wearables hype.

“Out of the Fortune 50, there are 14 companies that are already healthcare companies. Of the remaining 36, 24 now have healthcare strategies,” Falk reports. “That’s going to drive a whole bunch of new behaviors. Those companies are going to drive change.” Will this nudge healthcare players and providers into faster action in mobile? After all, nothing motivates like existential fear, right? “Some people see the new competitive landscape as an opportunity. Most people see it as a threat,” Falk shrugs.

Expect, then, to see many more deals like the ongoing Novartis/Qualcomm partnership, in which the two companies are working together to mobilize clinical trials via Qualcomm Life’s 2net -secure and HIPAA-compliant connectivity platform. And don’t be surprised if the current Ford/WellDoc pilot program ends with glucose monitoring added to the in-dash display of Ford cars in order to warn drivers of plunges in blood-sugar levels.

The question of who’s doing mobile well today is not easily answered, due to the expected—and sort of remotely understandable, given concerns about maintenance of competitive advantages and whatnot—reluctance of pharma companies to discuss past and current mobile-centric campaigns. Still, it’s not a leap to say that the most effective programs have been the ones that leveraged the strength of the communities that mobile technology fosters.

Take the mobile component of Novartis’s campaign for MS drug Gilenya, created with FCB Health. “Hey MS, Take This!” was designed to amplify the defiant rallying cries of MS sufferers—and mobile devices proved the megaphone. “We wanted patients to feel like this was their experience, that Gilenya gave them a platform,” says Mike Devlin, executive VP, creative director at FCB Health. Adds FCB Health executive VP, group management direc-tor Sarah Hall, “Mobile is a crucial channel and is quickly becoming the info nerve center for people seeking information and engagement… At launch, we asked people to share their own ‘Hey MS, Take This!’ sentiment. We received dozens that first week and hundreds since. People really embraced the spirit of the campaign by sharing with us.”

So that’s lesson number one for healthcare marketers hoping to find their way in mobile: Embrace and unite your extended communities. The Gilenya campaign also touches on lesson number two, which is that potential audiences have the tools and are waiting for a good reason to use ’em. That holds equally for consumers as it does for mobile physicians—ones literally on the move from hospital to clinic to office and back again.

“Mobile devices are ideal for doctors and nurses because they’re always on the go,” Falk explains. “But until very recently, the industry’s message was, ‘Sit down, we bought you a perfectly good computer.’ Many doctors have better technology in their pockets than what they’ve been provided by the institutions
they work for.”

Predicting the unpredictable

Let’s face it: Even the savviest futurists haven’t had much luck foretelling mobile’s rocket-like surge during the past few years. MM&M ‘s own track record isn’t as sterling as anybody would like: The mobile trends identified in our June 2013 -Mobile Guide include “we are seeing an increase in mobile web usage as consumers search for answers to health questions on their smartphones on nights and weekends” (duh) and “we are seeing traction toward new capabilities provided, for instance, by Windows 8 tablets” (erp). So while recent history tells us to take everything that follows with a circa-1997-mobile-phone-size grain of salt, a few predictions are nonetheless offered for your clip-and-save pleasure.

Falk points to research conducted by the American Telemedicine Association, which anticipates that by the end of the decade 25% of all healthcare will be delivered virtually (“for the record, I think that figure is low,” he adds impishly). Should that come to pass, healthcare will be well on its way to joining other industries that have migrated to the virtual world. “In our lifetime we’ve seen banking go from 100% physical to 90% virtual. We’ve seen travel flip. We’re now, what, about two-thirds of the way through retail flipping?” he adds.

McCleary expects a twin push for meaning and cohesion. “When I’m tracking seven things with my wearables, what’s the bigger ecosystem that’s going to tie it all together?” he asks. “That’s the challenge for pharma this year and beyond—to answer the question, ‘What does it all mean?’ There’s a context that’s missing.”

Finally, McCarthy hopes that the business will reverse its historical course and fly in the face of its traditional fear of failure. “Mobile and today’s users demand constant iteration and product evolution to meet evolving expectations. This is a new way of thinking and operating within the naturally risk-averse pharma industry,” he says.

To that end, those in the throes of mobile mania would be wise not to let the healthcare business’s measured approach to the space discourage them. For all the fear that opportunities are slipping away by the minute, mobile marketing in general remains very much in its infancy. The iPad won’t celebrate its fifth birthday until April 3; wearables have only been a thing for 24 months or so. While consumers and health-tech companies are likely to demand of existing providers a swift rate of change and innovation, there remain many privacy, security and regulatory hurdles to be cleared.

“Let me make a point by analogy if I may. Do you remember the shift from in-patient to ambulatory care? Conceptually, that shift was easy to understand and easy to see by 1985—and it’s still not fully done,” Falk explains. “That shift involved a huge reorganization of people and processes, and I think mobile and the move to virtual care is similar in terms of transformation. It’ll be a 20-year journey—and we’re only five years into it.” 


A few years ago the go-to approach for lazy healthcare marketers was to scratch their chins as if immersed in deep thought, then say, “Yes, I believe the answer to our particular dilemma is an app. Let’s do an app.” Thus was born the Great App Rush of 2011, when even the most obscure conditions and products found themselves on the receiving end of app love.

It should come as little surprise that few of these apps-for-the-sake-of-having-an-app have survived to see 2015. But the industry has learned from its overzealousness and, in the wake of app-mania, evolved the scope and sophistication of apps they offer. In the process, it has shifted their form and function significantly; they’re now less smartphone tchotchke and more medical device.

“We’re moving toward being in the prescription app business,” says Matt Balogh, SVP, chief technology officer at Ogilvy CommonHealth Worldwide. Adds Will Falk, North and South American Healthcare Leader at PwC, “Before too long, we’re not going to be talking about the app store—we’re going to be talking about the app pharmacy.”

Falk and PwC have done their share of thinking about this. In PwC Health Research Institute’s report “Top Health Industry Issues of 2015,” the firm posits that healthcare apps will inevitably push further into the realm of medical device. In fact, that transformation is well under way. The report points to HRI research from its 2014 Clinician Workforce Survey, in which 86% of clinicians said they believe that mobile apps will be an important part of patient health management during the next five years. That’s not exactly a stunning conclusion (as, say, the opposite result would’ve been), but it underlines the velocity of change within mobile health as well as the desire of all interested parties to build on momentum within the space.

“Apps are going to be prescribed the same way that drugs are prescribed,” Falk says. “The challenge isn’t going to be getting physicians to prescribe them. It’s going to be getting good apps into provider systems.”

That’s not the only concern that boosters of prescribable apps have. Despite the FDA moving at, by its standards, a brisk clip (the “Top Health Industry Issues” reports it has approved some 100 products in the ten-plus years it has paid attention to them), it’s never easy to predict where or when a product, product category or organization might hit a regulatory pothole. This holds doubly true within fast-evolving mobile health, increasingly populated by tech firms unfamiliar with the world of Big Regulation.

For all the credibility that an FDA stamp of approval may convey, that stamp comes with a price. Let’s say you’re the creator of the Next Big App Thing. You’ve never dealt with the FDA approval process; heck, you’re not even sure that your app needs to go through the approval process. If not, you’re golden: You can get to market faster and more cheaply. If so, however, you face a whole new range of worries. How soon do you submit your app for approval? What happens if technology leaves your app behind while you’re awaiting approval? And what of the frequent app revisions/updates? Does each subsequent iteration have to be resubmitted for FDA approval?

Prior to January 20, the FDA had been monitoring apps that act as medical devices and “whose functionality could pose a risk to a patient’s safety if the mobile app were to not work as intended,” per the agency’s September 2013 note “Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications.” But the FDA then published a draft guidance meant to clarify what types of apps need to be approved, basically outlining differences between wellness apps and health apps.

“A general wellness product, for the -purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the agency wrote. As always, the industry and the public have 90 days to formally weigh in
on the new guidance.