|Apple's headquarters in Cupertino, CA--Courtesy of Joe Ravi, CC BY-SA 3.0|
We've got an app for that. So drugmakers say in press releases we receive daily. But recasting the pharma business into a digital image? That could take an intervention. By Apple. And that intervention is reportedly on its way.
A slew of hiring reports from Apple-watching bloggers and reporters at Reuters show that the company is cherry-picking top talent in the world of biosensor technology. Engineers from companies that make pulse oximetry devices, heart-rate sensors, body-temperature detectors, glucose monitors--even an MIT researcher who's been working on an ear monitor that can check vital signs.
Add to this the expectation that Apple is planning to create an App Store-like platform specifically for health- and fitness-related offerings, and that creates a huge opportunity for drugmakers to mingle new sensory hardware with their own software. That's because the health initiative would open Apple's health-oriented gadgets and operating systems to outside developers.
If Apple indeed builds it, those developers will come. If pharma companies are smart, their own teams will join up--and those teams won't come on tiptoe, tentatively, too worried about FDA regulation to develop anything useful.
Apple has already thought of the regulatory pitfalls; company execs met with FDA officials last year, reportedly to help draft the agency's guidance for mobile health. That guidance turned out to be less onerous than drugmakers might have expected. FDA plans to focus on apps that turn a smartphone into a medical device, or are used as accessories to regulated devices.
In some cases, drugmakers may decide it's worth the trouble to win FDA approval for apps like that. Consider Merck ($MRK) and its recent investment in WellDoc, which recently won agency approval for BlueStar, its prescription-only diabetes management app.
In others, apps may need to skirt those requirements; Eli Lilly ($LLY), Merck and Sanofi ($SNY) have all developed mobile apps to help diabetes patients track their exercise and diet, and cheerlead healthy behavior. AstraZeneca ($AZN) and Sanofi recently signed up mobile providers to offer patient-monitoring services.
The sure thing is that, if Apple does follow through with its health software hub and a few of those biometric sensors, we can expect a tsunami of apps--and if drugmakers want to be part of that wave, they'll have to move quickly. Merck has its new digital group. Sanofi has been hunting for digital-health partners. Other Big Pharmas may want to step things up, too. The Apple effort could create a level playing field for smaller drugmakers eager to beat them to the punch.
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