FDA nod to Apple Watch notable, but …

FDA nod to Apple Watch notable, but …

Apple Watch’s entry into the device world garnered a ton of attention and praise, but a good portion of observers have reservations about whether it will truly move the needle in healthcare.

Apple’s big news that it received FDA clearance for heart monitoring technology on its new Apple Watch device garnered its fair share of Twitter hype and media headlines heralding the announcement as the world’s most valuable company’s big splash into healthcare.

At its worldwide product launch event Wednesday, the company unveiled the new features of its device which includes the capability to take an ECG at any time, the ability to to detect irregular heart rhythms that could mean atrial fibrillation and fall detection which can contact emergency services if necessary.

Reaction was mixed with some deeming the entry into the medical device world as notable while others dismissing the FDA-clearance as a non-story.

“This update really establishes the company’s increasing efforts to push the Watch as a serious medical device. Apple seems to be diving into heart disease first, the most common cause of death around the world, making serious moves as a health company,” wrote Ross Muken, an analyst with investment advisory firm Evercore, in an investor note.

Meanwhile, most market observers are taking a wait-and-see attitude to the company’s strategy in overcoming the existing barriers and hurdles in entering the clinical space.

Longtime healthcare investor and advisor Lisa Suennen was bullish on the fact that the company decided to invest the time and energy to build a medically valid product and pointed to the investment as a “harbinger of future products.”

Still even with that potential, Suennen is a bit skeptical about whether the features announced by Apple has turned the trendy gizmo into a must-have medical device, especially at its high price point. She added that doctor recommendations will be key in the Watch’s early adoption as a health management tool and it is yet to be seen if Apple will shift its marketing and customer focus towards health systems.

“Since there are other medical devices that can perform the same measurement at lower cost, I believe consumers will want to see more from the Watch for it to be perceived as an essential medical device,” Suennen said in an email. “I think that it will also need the imprimatur of the patient’s physician for that to happen, at least in the short term.”

Raj Khandwalla, a practicing cardiologist and director of cardiovascular education at Cedars-Sinai Medical Care Foundation, said his initial response to the news was excitement, but also surprise that Apple decided to develop its own internal technology rather than work with existing companies like AliveKor, with which it already had a partnership.

The addition of the ECG and afib monitoring as a standard feature on the Apple Watch is a major technical achievement but could prove problematic, according to Khandwalla.

“It’s nearly unprecedented that you would deploy a medical grade diagnostic across the population irrespective of a person’s risk and clinical position of having a disease,” Khandwalla said in a phone interview. “Among young and healthy populations, the prevalence of atrial fibrillation is so low that even if the Watch says they have the condition, it’s unlikely that they do.”

He highlighted the potential issue of false positives for atrial fibrillation creating undue stress on both users and patients. He added though that the device’s ECG can be used in conjunction as more specific test to confirm a potential heart issue.

At its launch event, the company touted the ease with which people could send heart data to their doctor, but Khandwalla is concerned about adding another data pipeline in a clinical environment already inundated with information sources.

“Already we get information from patients using these wearables and that information isn’t integrated into our electronic medical records or our workflow,” Khandwalla said. “In many cases it’s just another flow of information coming out of left field.”

Which is not to say he wouldn’t recommend the device to his patients.

While he said he’s still waiting to see the results of the company’s upcoming heart study, Khandwalla could definitely see a role for the Apple Watch as a way monitor patients who are at high-risk for atrial fibrillation, especially if Apple is able to better incorporate clinical data into its monitoring and detection algorithms.

Brian Chapman, a principal with management consulting firm ZS Associates, who specializes in medical products and services, said major existing hurdles, especially in terms of clinical workflow and reimbursement, need to be addressed before the Apple Watch technology can move to being a true diagnostic device.

“Using the Watch to identify suspected atrial fibrillation is very different from an ironclad diagnosis that will lead to management and intervention,” he said in an email. “It is very consequential to see how the FDA is treating this development, but there is still some distance between a consumer device with the capability of finding a signal and a medicalized diagnostic solution that guides therapy.”

Of course there’s still the question of whether Apple wants to truly make a full-fledged effort to turn their consumer product into a medical device. Apple CEO Tim Cook has previously expressed that the FDA’s regulatory process would hold back the speed on innovation for the Watch.

It’s a sentiment that have given some observers confidence in the company’s more medically focused competitors, like iRhythm Technologies, whose ZioPatch device is widely used for cardiac monitoring.

“We don’t see Apple turning the iWatch into a regulated medical device approved for clinical diagnosis; to be clear, Apple Watch is approved for over-the-counter (OTC) use and is not a continuous monitor,” J.P. Morgan analyst Robbie Marcus wrote in an investor note. “Attaining an approval with a similar label to iRhythm’s Zio would significantly slow the rate of innovation and put the consumer device at the whim of the FDA.”

Daniel Kivatinos, the co-founder and COO of Sunnyvale, California-based startup DrChrono, which produces an EMR platform for Apple devices, countered by saying Apple’s relentless focus on the customer experience has already provided the pathway to wide scale usage in healthcare.

“I think when you have a company like Apple really thinking about healthcare in a really thoughtful way, it changes the medical community’s perception of what technology can be,” Kivatinos said in a phone interview.

“I look at the new Apple Watch in much the same way that I look at the iPhone, which is such a good device that it has pushed its way into the medical setting.”

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