Will Apple put Israel’s medical device industry out of business?

Along with the upcoming release of its new highly anticipated smartwatch, Apple CEO Tim Cook announced last week the launch of a platform that will enable iPhone owners to use their devices to measure, record, upload and analyze data about their health.

The ResearchKit will work with the Apple Watch, which has sensors that can determine pulse, gait and other physical characteristics.

That announcement could have a profound effect on Israel, a country that is one of the leaders in medical device technology. Although many of the medical devices produced by Israeli companies use imaging, lasers and other advanced technologies, which are not built into the iPhone (yet, at least), many others produce “simpler” devices that collect and analyze information about blood pressure, glucose levels, and Parkinson’s disease, among others.

With 700 million iPhones out there, does that mean Israel’s medical device industry is now in competition with a behemoth that has the money, marketing and moxie to take over the market?

Not necessarily, according to D. Todd Dollinger, CEO of The Trendlines Group and one of Israel’s leading experts on medical devices. The Trendlines Medical incubator, headed by Dollinger, was named Best Incubator by Israel’s Office of the Chief Scientist in 2010, and again in 2014.

“The new Apple platform looks like a great way to gather data – which may or may not turn out to be a good idea,” said Dollinger, “but I don’t see it taking on advanced characteristics of medical devices, at least in the near future.”

D. Todd Dollinger (photo credit: Courtesy)

According to Jeff Williams, Apple’s senior vice president of operations, iOS apps already help millions of customers track and improve their health, which means that the new ResearchKit is going to be an “upgrade” of what is available.

According to current rules of the Food and Drug Administration (FDA), the US agency that regulates medical devices, apps that are used for general information alone, such as a sports app that records heartbeats and calorie burn for activities, do not need any approval or oversight, but apps that provide medical advice do need to be reviewed by the agency.

Although the platform will only be available next month, Apple has already released five apps, at least one of which – GlucoSuccess, which will use an iPhone’s sensors and data collection capabilities to see how diet, physical activity and medications affect blood glucose levels — comes close to the description of a supervision-requiring app.

Tim Cook did not mention the FDA in his presentation, and an official Apple press release on ResearchKit does not discuss FDA approval either, leading Apple-watchers to conclude that the company has already begun talks with the federal agency to get approval for the use of the iPhone as a medical device.

ResearchKit is to be an open-source platform as well, and is likely to be offered for free, so it’s also likely that developers will use it to create not just apps, but hardware that connects to the iPhone and records information, or even diagnoses diseases.

If the iPhone does get those capabilities, it may have an impact on the lower end devices, said Dolliner, but “I have no fear for the future of the Israeli medical device industry.”

Most of the functionality in these devices is in the software anyway, he added, and for some developers, the ability to develop diagnostic and other software without the need to contract with a hardware manufacturer to build an actual device might be for the best, allowing them to concentrate on what they do best.

The iPhone is likely to have a very positive effect on many aspects of health care. “For example, I can see this replacing equipment in hospitals that is used to measure gait,” said Dollinger.

Over the past several years, researchers have begun looking at how people walk in order to understand a patient’s heart disease, cerebral palsy, Alzheimer’s and other diseases.

“Currently, hospitals use special walking pads to test for gait, and they are expensive and take up a lot of real estate. Using an iPhone to measure this will be a great advance in implementing gait measurement technology,” he said.

But the guts of that, and the many other apps that will emerge on the Apple platform, will be the advanced software that developers come up with – and that is a business Israel excels in, said Dollinger.

“I really see this as a platform to gather data. In the past it took years to build a body of data on patients with a specific medical condition. Now, in just a day you could have more data than you would have been able to collect in a year.”

Of course, more data that is more accessible to more people could mean bad statistics and worse conclusions, but I think a lot of good will come out of it,” he continued.

Despite that, Israel’s medical device business is safe. “The iPhone is a tool,” added Dollinger. “It is not going to replace the advanced medical devices we produce in Israel.”