The regulatory maze behind vaporware for health technology

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Every year at CES you see many fascinating health technology concepts and prototypes home urine scanners, smartwatches that can monitor blood sugar non-invasively, and a wearable patch to prevent sexual dysfunction. And then nothing ever seems to come to market. Or if it does, it doesn’t happen until years later, and often the final product isn’t nearly as capable as the first pitch.

There are three letters why: FDA.

The Food and Drug Administration is intended to protect public health. One of the many ways it does that is by regulating medical devices. This is a good thing. When human health is at stake, you want medical technology to be accurate, safe and reliable. You want these devices to have gone through the proper channels and tests. As a result, getting FDA approval is a rigorous process that can be tricky to navigate. It includes clinical trials and documentation. It’s not a process measured in weeks, but in months if you’re lucky, and years if you’re not. The tech world wants things fast, but the FDA doesn’t work around a company’s product timelines.

“It’s no small task to be a medical device company, to build this infrastructure, to build all the standard operating procedures that the FDA wants to see,” said Movano Health CEO John Mastrototaro, whose company is working to create an industry-leading FDA approved consumer smart ring.

If you’re an emerging health technology company, you essentially have two options: roll up your sleeves and dive straight into the complicated, time-consuming approval process; or nerf your gadget so the FDA doesn’t have to weigh in. You can guess which is the most popular option.

FDA approval is a long, difficult process

Movano Health is one of the companies at CES 2023 that invested heavily in the FDA approval process. Last year, the company showed up at CES with a bold plan for a women’s-first smart ring that would be able to monitor chronic diseases. At the time, Mastrototaro said The edge that a beta version of the ring would not be available until late 2022. It’s 2023 and there’s still no ring. The launch date is now slated for sometime later this year.

Renders of all three Evie Ring designs

If approved, the Evie Ring would retail for less than $300 and with no additional subscription.
Image: Movano

When I caught up with Mastrototaro at this year’s CES, he wasn’t overly impressed. Instead, he pointed to the fact that the ring — now called Evie, short for “proof” — successfully passed a hypoxia trial in October 2022, demonstrating clinical-level accuracy for heart rate and oxygen saturation measurements. The FDA, says Mastrototaro, requires accuracy across a wide range of oxygen levels with a 4 percent margin of error. That should be tested for women, men and people of all skin tones. The Evie Ring yielded a 2 percent margin of error. But the testing is not done. The next step is a test for pulse oximetry, or blood oxygen saturation, readings.

“As a medical company, we have to conduct clinical trials,” says Mastrototaro. To receive FDA approval, Movano must maintain documentation during the development and testing processes, and production must take place in a medical device manufacturing facility. Another thing medical device companies need to do is make sure their data practices are HIPAA compliant. Things like communications protocols, cloud infrastructure, and cybersecurity must be included as part of the FDA filing — and those protocols must be third-party tested. Mastrototaro says the clinical accuracy is “less than 1 percent” of anything submitted to the FDA.

But if successful, the Evie Ring would be one of the first consumer wearables to be fully approved as a medical device.

Clinical accuracy is “less than 1 percent” of anything submitted to the FDA

FDA approval may also be the only way a company can get new health technology into the hands of consumers. In recent years, Valencell — a wearable technology supplier to companies like LG, Jabra and Bose — has showcased its non-invasive blood pressure monitoring technology using photoplethysmography (PPG) sensors at CES. The surprise at this year’s CES was that Valencell’s decided to get into the consumer hardware game itself with a $99 cuffless, calibration-free fingertip blood pressure sensor.

The device looks like a fingertip pulse oximeter. It is worn on the middle finger, where a PPG sensor shines light into the skin. The device then measures the light that is reflected back and runs it through Valencell’s algorithm, which is based on a dataset of 7,000 people. That’s all it takes to get accurate diastolic and systolic readings.

Making it easier and more convenient to measure blood pressure could significantly improve the treatment of hypertension. After all, treatment depends very much on taking consistent measurements. While the CDC says one-third of American adults have high blood pressure, the Mayo Clinic estimates that 62 percent of Americans measure their blood pressure just a few times a month — far fewer than the recommended two times a day. And yet Valencell’s technology has been around for years without customers, despite its experience in the field.

Render of Valencell's fingertip sphygmomanometer

Valencell had to develop his fingertip blood pressure device for his technology to see the light of day. It is currently going through the FDA approval process.
Image: Valencell

“We tried to push [Valencell’s blood pressure tech] in the market in other people’s products, and we encountered resistance,” explained Valencell president and co-founder Steven LaBoeuf to The edge. Any company that wanted to make this kind of product or feature using Valencell’s blood pressure technology would have to go through the FDA — and no one wanted to take on that challenge. LaBoeuf said the FDA essentially told the company that in order to get approval, it had to have a commercial product with the technology in it.

“We realized the only way we could do that was to make our own product,” says LaBoeuf.

The other problem is that no one had previously submitted an over-the-counter, cuffless, calibration-free blood pressure monitor to the FDA. That meant the FDA had to come up with a test plan for Valencell’s device — a major reason why Valencell opted for a fingertip monitor design that would be more familiar to both the FDA and the medical community. A gadget worn on the wrist requires additional – more complicated – tests since it is a continuously worn device. (As in, you’d need to validate a smartwatch’s blood pressure accuracy while lying down, sitting, sleeping, and a slew of other scenarios.) The effort wouldn’t necessarily have made sense, as doctors still struggle with how best to use of portable data.

“We realized the only way we could do that was to make our own product.”

At the moment, Valencell says it wants to get FDA approval by the end of this year. But that’s an “if all goes well” timeline. You only have to look at Withings’ history of CES announcements to see that you can never predict when you’ll get FDA approval. Multiple Withings products never made it to the US market or took more than a year to arrive due to the regulatory process. For example, the Withings ScanWatch was introduced at CES 2020. It wasn’t until almost two years later that it got the green light to sell in the US.

It’s easier to hide behind the wellness label

Most consumer health gadgets focus on wellness features such as step count, activity tracking, and sleep monitoring because they don’t require an FDA review. For positions that straddle the line between wellness and medicine, companies will often side with wellness for the same reason. Take SpO2 monitoring, for example, where the vast majority of SpO2 features in smartwatches are currently limited to spot checks or are part of passive sleep monitoring. This form of SpO2 monitoring is effective for your “entertainment”. If the statistics are wrong, there is apparently no property damage because there is no claimed medical or diagnostic use.

But if you want to use SpO2 to detect a potential condition or simply ensure clinical-level accuracy for future features, you’ll need to commit to FDA approval — as Withings did with the ScanWatch and as Movano is currently doing with Evie. Meanwhile, Fitbit has been seeking FDA approval for sleep apnea detection using SpO2 for more than five years, but has released less ambitious SpO2 wellness features while it waits. When you see what’s involved in getting FDA approval — and how long it takes — it makes sense why most consumer tech companies want to avoid regulation altogether.

A person measuring SpO2 with both a finger pulse oximeter and the Withings ScanWatch.

The Withings ScanWatch is a rare smartwatch that has received FDA approval for an SpO2-related feature.
Photo by Amelia Holowaty Krales/Acutely

The main reason why Movano’s Evie Ring and Valencell’s fingertip blood pressure device could stand a chance is that the products were intended as medical devices from the start. It’s the opposite of companies that put consumers first and suddenly decide they want to become medical device manufacturers. It’s clearly easier for a company to learn the consumer side of the equation than the medical side.

The line between medical devices and consumer health technology is blurring every year as sensors, algorithms and wearables become more sophisticated. But if companies really want to convince us that we need their tools to live a healthy life, they cannot continue to hide behind the label ‘wellness’. Going forward, it’s hard to imagine that FDA approval won’t play a bigger role in consumer health technology. It’s that or we’ll have to make peace with the coolest health tech that never makes the jump from concept to reality.

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