The regulatory maze behind health tech vaporware

Every year at CES we see many fascinating health tech concepts and prototypes. — Home urinalysis, smartwatches that can non-invasively monitor blood sugar levels, and wearable patches to prevent sexual dysfunction. And nothing seems to hit the market. Or, if so, it just happens years later, and often the final product isn’t as capable as the initial pitch.

The reason is the following three characters. FDA.

The Food and Drug Administration is intended to protect public health. One of the many ways to do that is by regulating medical devices. This is good. When human health is at stake, medical technology must be accurate, safe and reliable. We hope these devices go through the right channels and tests. As a result, obtaining FDA clearance is a rigorous process that is difficult to navigate. This includes clinical trials and documentation. It’s not a process measured in weeks, it’s a process measured in months, if you’re lucky, or years otherwise. The tech world wants a quick response, but the FDA doesn’t get around companies’ product timelines.

“As a medical device company, building this infrastructure and having all the standard operating procedures required by the FDA is no easy task,” said John Mastrototaro, CEO of Movano Health. for consumers.

For companies developing new health technologies, there are basically two options. Roll up your sleeves and dive into the complicated and time-consuming clearance process. Or weaken the gadget so the FDA doesn’t need to intervene. You can guess which one is the more popular option.

Movano Health is one of the companies to invest heavily in the FDA clearance process at CES 2023. Last year, the company exhibited at her CES and unveiled bold plans for her ring, the first smart woman to monitor chronic illness. At that time, Mastrotaro said. The Barge Ring Beta will not be available until late 2022. It’s 2023 and still no ring. The release date is currently scheduled for later this year.

When I met Mastrototaro at CES this year, he wasn’t too upset. Instead, he said the ring (now called her Evie, short for “evidence”) passed her hypoxic test in October 2022, and her heart rate and oxygen saturation measurements were clinically available. I pointed to the fact that it was shown to be level accuracy. According to Mastrototaro, the FDA requires accuracy over a wide range of oxygen levels with a margin of error of 4%. It should be tested on women, men, and people of all skin tones.Evie Ring provided her margin of error of 2%. But it hasn’t been tested. Next is a test of pulse oximetry, or an index of blood oxygen saturation.

“As a medical company, we have to conduct clinical trials,” says Mastrototaro. To obtain FDA approval, Movano must maintain documentation throughout the development and testing process, and manufacturing must occur in a medical device manufacturing facility. Another thing the medical device company must do is ensure that its data practices comply with his HIPAA. Communication protocols, cloud infrastructure, cybersecurity, etc. must be included as part of the FDA submission, and these protocols must be tested by a third party. Mastrototaro says clinical accuracy is “less than 1%” of all submissions to the FDA.

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

FDA clearance may be the only way companies can get new health technologies into the hands of consumers. Over the past few years, Valencell, a wearable technology provider to companies like LG, Jabra, and Bose, has showcased its non-invasive blood pressure monitoring technology using photoplethysmography (PPG) sensors at his CES. One surprise at his CES this year is that Valencell decided to get into the consumer hardware game itself with his $99 cuffless, calibration-free fingertip blood pressure sensor.

The device looks like a fingertip pulse oximeter. When worn on the middle finger, the PPG sensor shines light onto the skin. The device then measures the reflected light and runs Valencell’s algorithm based on a dataset of 7,000 people. That’s all you need to get accurate diastolic and systolic measurements.

Easier and more convenient blood pressure measurement could significantly improve hypertension treatment. Ultimately, treatment relies heavily on making consistent measurements. The CDC says one-third of American adults have high blood pressure, but the Mayo Clinic estimates that 62% of Americans measure their blood pressure only a few times a month. Still, Valencell’s technology has been around for years, despite its experience in the field.

“We tried to push [Valencell’s blood pressure tech] When we entered the market for other folk products, we met resistance,” explains Steven LaBoeuf, President and Co-Founder of Valencell. The BargeAny company wishing to create this type of product or feature using Valencell’s blood pressure technology will have to go through the FDA. The FDA basically told the company that it would have to have a commercial product incorporating the technology in order to get approval, LaBoeuf said.

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

Another problem is that no one has ever submitted a commercially available 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. That’s the main reason Valencell chose a fingertip monitor design that both the FDA and the medical community are more familiar with. Wrist-worn gadgets require additional (and more complex) testing as they are continuously worn devices. (For example, we need to validate the blood pressure accuracy of the smartwatch in different scenarios, such as lying down, sitting, sleeping, etc.). How to get the most out of wearable data.

Valencell now says it aims to obtain FDA clearance by the end of this year. But that’s the “if all goes well” timeline. Withings’ history of her CES announcements shows that you can’t predict when she’ll get FDA clearance. Multiple Withings products have never made it to the US market due to the regulatory process, or it took him over a year to arrive. For example, the Withings ScanWatch was announced at CES 2020. He was approved for sale in the United States nearly two years later.

Most consumer health devices don’t require FDA review, so they focus on health features like step counting, activity tracking, and sleep monitoring. For features that straddle the wellness-medical line, companies often err on the wellness side for the same reason. Currently, most of his SpO2 capabilities in smartwatches are limited to spot checks or are part of passive sleep monitoring. This form of his SpO2 monitoring is effective for ‘recreation’. Even if the metric is wrong, it ostensibly does no real harm, since no medical or diagnostic applications have been claimed.

But if you want to use SpO2 to detect underlying conditions, or simply want to ensure clinical-level accuracy for future functionality, you’ll need to commit to FDA clearance — just like Withings did with ScanWatch. Like Movano is currently doing with Evie. We just released our Wellness feature. Seeing all it takes to get FDA approval and how long it takes, we can see why most consumer tech companies want to avoid regulation entirely. can.

Movano’s Evie Ring and Valencell’s fingertip sphygmomanometers have potential in large part because they were originally envisioned as medical devices. This is the exact opposite of a consumer-first company suddenly deciding it wants to be a medical device manufacturer. The consumer side of the equation is clearly easier for businesses to learn than the medical side.

The lines between medical devices and consumer health technology are blurring with each passing year as sensors, algorithms and wearables become more sophisticated. But if companies really want to convince us, need I use my device to live a healthy life, but I can’t keep hiding behind the “wellness” label either. It is unlikely that FDA approval will cease to play a major role in consumer health technology in the future. Either you have to settle for the coolest health tech that never makes the leap from concept to reality.