"I just hope Apple is not doing what we're doing." †
Apple may face regulatory hurdles if it aims for devices which do more than monitor fitness. In January, the New York Times reported that Apple executives, including OíReilly, met with senior officials at the Food and Drug Administration, including Bakul Patel, who drafted the FDAís final guidance for mobile health.
In fall of 2013, the FDA announced that it would focus on regulating applications that attempt to turn a smartphone into a medical device, or that are intended to be used as an accessory to a regulated medical device. That might include apps and attachments to measure lung function or analyze urine, for instance, but not devices such as Nike's FuelBand, which tracks your steps but does not offer medical recommendations.
Apple also has witnessed rivals trying, and failing, to produce devices that reach a mass market. Samsung's Galaxy Gear smartwatch was panned by critics and consumer reviews have been tepid at best.
A report from Endeavour Partners found that one-third of American consumers who have owned a wearable ditched it within six months. Key challenges include battery life, style, usefulness, and medical relevance, it said. And this month, Nike confirmed to Re/code that it had laid off some of its FuelBand team.
Meanwhile, Google is taking a different approach. In March, it pre-empted Apple by unveiling Android Wear, a version of its Android software tailored for wearable devices. Like Apple, it's shown interest in medical technology: it is exploring contact lenses that can monitor glucose levels in tears.