putilov_denis - stock.adobe.com

Answer

New Medical Device Seeks FDA Clearance and New Target Population

A California-based company’s new smart ring, curated especially for older female consumers, is shaking up the medical device industry and the traditional product design approach to seeking FDA clearance.

By
  • Alivia Kaylor, MSc
Published: 19 Sep 2022

From mobile devices to medical devices, digital technology is far too often tailored to the male body. However, one life sciences company is making medical technology history by developing a smart ring device specifically curated for female use.

“Historically, the market builds products for men first, leaving women as an afterthought. Movano is doing the opposite — making men the afterthought by focusing on women at first,” Movano CEO John Mastrototaro, PhD, told LifeSciencesIntelligence.

The Movano Ring provides its users with a holistic view of their overall health while delivering medical-grade data. The smart device gathers information about sleep, heart rate, heart rate variability, oxygen saturation, body temperature, respiration, activity levels, steps, calories burned, and menstrual cycles.

The new medical device is specially developed for women 30 years and older. This is especially important considering that “many women experiencing menopause do not receive adequate care,” said Mastrototaro.

“There's a lack of information, maybe more than misinformation, about what happens to a woman's body,” he continued. "Women's bodies change through the childbearing years and beyond, more so than men's. Because of that, a solution needs to be made available specifically for them. More data needs to be collected during the premenopausal, menopause, and postmenopause years to help advance treatment.”

Although the California-based life sciences company has plans to develop a smart ring designed for all genders, its primary focus currently is perfecting the female version with accurate data collection technology. “The device is solely focused, initially, on women, and the company is putting a lot of energy into getting the product right specifically for the female audience,” explained Mastrototaro.

The company interviewed more than a thousand women to understand their health desires and needs more deeply. “There are a lot of pearls of wisdom that have come from that research, which are being taken to heart and incorporated into the development of this device,” Mastrototaro noted.

In addition to surveying women’s health needs, Movano has made strides to include more women on the development team by hiring more female advisors and team members.

In an attempt to connect with more female consumers, Movano’s website also includes a comment section intended for women to speak their minds, which has been instrumental in guiding the process of product development.

The feedback has proved meaningful in understanding the challenges facing certain populations of consumers. “It's interesting — the more our team delved into this issue, the more we learned about the lack of resources for and the shame associated with women living through different life stages as well as the lack of responsiveness from the healthcare system surrounding women’s issues, where they are often dismissed,” Mastrototaro added.

A Yale University review of insurance claims from more than 500,000 women in different stages of menopause indicates that while 60% of females with significant menopausal symptoms seek medical attention, roughly 75% of them are left untreated. 

Because menopause affects every person differently, women’s health practitioners aren’t always certain how to best treat the myriad of symptoms accompanying this transition. And unfortunately, a New England Journal of Medicine report suggests that the newest generation of medical graduates and primary care providers lack the training to manage menopausal symptoms, ultimately leading to a widening gap in clinical care.

Seeking FDA Clearance

In the coming months, Movano’s smart device is expected to be available through a beta release for formal testing. Assuming the researchers obtain the same level of data accuracy as in the pilot study, the company will pursue filing with the FDA shortly after.

“The early beta evaluations will be more geared toward the accuracy of the metrics and the overall form, hardware, functionality, Bluetooth communication, and cloud delivery, which are gender-independent,” the company stated.

As the development progresses into the last stages and the accompanying app is in its final form, the company plans to test the product on women only. However, Mastrototaro clarified that all genders and skin colors were included in the pilot study.

With the recent news surrounding clinical care inequities among Black patients and medical devices such as pulse oximeters and thermometers, Mastrototaro confirmed to LifeSciencesIntelligence that “the FDA standards for pulse oximetry require a range of skin tones in the pilot evaluation.” Out of the seven participants, two were African American.

“The pilot study of seven included different ethnicities and spanned the gamut of skin tones, obtaining every bit as accurate data in all populations,” noting that the exact same procedure will be used in the formal trial. “It's a very important aspect to have a product that serves everybody well.”

During the beta release, Stanford’s Applied Sports Science Department will evaluate the smart rings on elite athletes to help model peak health and physical performance.

“Stanford has a lot of elite athletes at the university,” Mastrototaro highlighted. Stanford University affiliates alone have captured 296 Olympic medals (150 gold, 79 silver, and 67 bronze) from 177 medalists.

Although the company announced that its new smart ring will launch in the first half of 2023, the product will be launched without FDA clearance if waiting will cause a delay in release but Mastrototaro hopes to launch the device right out the gate with FDA clearance for heart rate and oxygen saturation.

“A typical FDA review cycle for products like this might be somewhere between three and five months to obtain clearance if things go according to plan,” he clarified.

Securing Data Privacy

The Supreme Court’s decision to overturn Roe v. Wade has caused providers, patients, and tech companies to rethink patient privacy. Although patient privacy has long been a priority for the healthcare sector, people are becoming increasingly aware of gaps in patient privacy efforts and new risks associated with patient health information.

“Another thing that's been on top of mind, especially for women, is Roe v. Wade and data security,” Mastrototaro noted. “Important elements that are built-in fundamentally to a medical device company are the security and protection of someone's health-related information.”

As a result, Movano will treat all obtained data as health-related information through encryption. Third parties will only be able to access the data if authorized by the appropriate user, meaning the reported health metrics will only be shared with healthcare providers upon request.

The Movano smart device “will have period tracking and related metrics, and naturally, that data will be managed the same way all other medical data is handled, giving women peace of mind knowing that their data is protected and is being treated as protected health information in the platform,” he emphasized.

Future Developments and Impacts

According to Mastrototaro, noninvasive glucose monitoring and cuff-less blood pressure monitoring are the next big FDA-cleared innovations to bring to market, which are both being developed and evaluated using proprietary radio frequency technology. However, containing numerous noninvasive health monitoring capabilities in a single ring proves challenging and is forcing Movano developers to expand its line of wearable devices as they look to include these metrics in a wrist-worn prototype.

In the meantime, the Movano Ring will “help people understand what they can do to maintain their health situation in a particular space and improve it just subtly along the way without unrealistic goals.”

Mastrototaro is confident that his company’s female-forward vision will help provide a comprehensive support system for a historically underserved community, bringing innovative treatment options to those experiencing “the change.”

“When the men in the room first made the decision to give up half the market and focus on women, we all said, ‘You know what? This is the right thing to do,’” Mastrototaro concluded.

Next Steps

Dig Deeper on Medical devices and imaging technology