Withings CEO: People now trust companies with medical data

Withings boss talks hold ups with the FDA and more

After the disastrous period when it was bought by Nokia, Withings is back. Since its founder bought the company back from Nokia, it’s staged an unlikely comeback, setting its own direction as a medical devices company, with a big focus on consumer health wearables.

This year it’s launched the Withings ScanWatch, and the Sleep Analyzer – which join the Move ECG, its hybrid smartwatches, blood pressure devices and connected thermometer.

But it’s not all plain sailing. The company has struggled to get traction in the US, with multiple devices held up by lack of FDA approval.

We caught up with Withings CEO Mathieu Letombe, who explained why the consumer medical wearables has never been in such great health - and how it's getting its devices past the FDA.

Beyond the data fears

“Lots of things have changed in five years, not only in the medical space, but on the way we use data and share the data,” Letombe told Wareable.

“People are willing to have a company that they trust use their data for their own good. It's something we are constantly reassuring our users on that we don't share any data without consent – with anybody.”

When medical wearables first surfaced, privacy fears dominated the conversation. But those fears have dissipated – so much so we rarely hear the prophecies of data doom that used to accompany any wearable launch.

Letombe believes that it’s the big brands that have paved the way, through a mixture of good marketing, strong products, and crucially, not dropping the ball…yet.

“You have to be clear on the way you use data to reassure your consumer. And obviously, there has been a big push by Apple and Samsung.

“I think there is also lots of regulation that has been set up around the protection of private data and health data, so I think that structure is reassuring new consumers. Even though there is a large amount of health data being shared in the world, there has been no major breach. So I think the consumer has been reassured, and they also judge the value [of medical wearables].”

What’s coming next

So where are our wrist devices going next? Five years ago SpO2 and Afib detection seemed like far-off tech, and now they’re common place. And Letombe believes we’re still barely leveraging the data that wearables can already collect.

“The biggest change I see is not really in terms of technology. It's really in terms of how we use that technology. There is many, many things to see in those signals. The most important part is to make sure that's what you're looking for makes sense as a benefit for the consumer or the patient,” he said.

And he talked up the Withings Sleep Analyzer (below), which he says could do more than just track sleep quality – especially as we turn to look at our wellness in the post-Covid world.

“I think there’s something with the sleep mat. There are many things to see in the heart rate, in the respiration rate, temperature and heart rate. You could see a flu, maybe one or two days before you see the symptom. You could better understand the fertility cycle, drugs in take, you could see side effect of drugs intake, you could see alcohol intake.”

“It’s constantly connected to power outlet, meaning that you don't have to worry about the battery life. And that's something you spend six to eight hours on, which is more than the amount you spend at a physician. And we have that every night.”

Battery life essential to medical devices

But while Letombe believes that Apple’s dominance has enabled the medical tech market to grow, he believes that true medical wearables need to have longer battery lives than the Apple Watch can muster.

And he says that battery life is a cornerstone of Withings devices.

“I think this is one of our key differentiators is that if you want to take care of your health in the long term, you cannot really rely on something that you have to charge too often because it's a friction,” he said.

“The Apple Watch is a beautiful product, it does a lot of things that we will never do. We don't want to have an app store – we really want to focus on what's matter for health, activity, your sleep and sleep apnea, heart rate and ECG.”

The Apple Watch still doesn’t natively track sleep, and while that sounds easy to fix, doing that with the Apple Watch’s short battery life won’t be easy.

"We want to focus your focus on what matters. Providing people with long battery life so they don't have to think 'will I have enough battery to take an ECG tonight?' So, we just have a different positioning."

Battling the FDA

But Apple has managed to get its Afib, ECG and other heart rate features past the FDA in the US – but that’s been a sticking point for Withings.

Neither of its two ECG watches – Move ECG and ScanWatch (above) – have launched in the US, and its new Sleep Analyzer sleep mat is also MIA.

That’s because the FDA – the regulatory body that approves medical devices in the US – takes a hard line on wearable tech.

“The challenge comes when we innovate. We are adding ECG on top of a blood pressure monitor, and in that case, we lacked a bit of knowledge and organisation to be able to go beyond that,” Letombe explained.

“It's not the FDA – it's on our own shoulders. We’ve learned a lot. And we are working to being able to push all the devices in the US. It's kind of hard right now. Because of the Covid situation as it's not high priority.”

But is the FDA tougher than the CE in Europe, which has been quick to give medical markings to all of Withings’ devices?

Mathieu Letombe doesn’t think so – and points to the time consuming process of getting devices clinically evaluated.

“I think it's a difference of process. It's not tougher. It's that the process is different and you have to adapt to that. Sometimes the process is not very clear.

“It can easily take six months to have the clinical study, the protocol to collect feedback from the medical community, in order to proceed with those with those clinical trials.

“So, it takes a lot of time, even if you just have to change a small thing in the in the protocol you have been using. So this is where we are there is some back and forth it’s not just a simple response that you can get in one week, it's really building a new protocol and a new clinical study in order to demonstrate some specific kind of performances,” he said.

But for Letombe it’s a necessary part of becoming the company that Withings is trying to be.

“I think it's crucial to become a medical company. Clinical trials is also really expensive, but in our cases, it's not a choice anymore – and we know that this is what we want to do. We have basically all of our devices, being reviewed by the FDA right now.

“The US market is really important to us. I think our devices may make a lot of sense for the condition that are prevalent in the US population. So that's not something we are willing to stop, and we’re actually increasing our resources in order to compete.”

It’s clear that Withings isn’t letting up – and with the health tech revolution really hotting up, it could soon be a household name in the US.