The market for chronic nausea relief runs the gamut from old-fashioned elastic wristbands with integral pressure-producing inserts to soothing over-the-counter potions to medications approved by regulatory agencies. But the origin of patients' symptoms are often hard to pinpoint and comfort can prove elusive.
Enter durable digital wearable developers. The developers of these technologies say they are convinced their products can safely relieve patients' symptoms without side effects, and are also stepping up preparations for the growth of the digital therapeutics market.
The digital nausea relief market has some anatomical commonalities such as electronic pulses of pressure or neuromodulation that target the median nerve's P6 acupressure point on the underside of the wrist, but the nascent market also shows some noticeable differences in vendor strategies. Some of these digital devices offer mature technology that has no way to quantify its benefit at scale, and some offer promising Internet of Things connections but are not yet fully defined in market strategy.
The developers of these devices are also discovering viral consumer-peer recommendations often carry greater weight than regulatory approval or clinician endorsement. Taken together, all these elements may serve as a microcosm of how the digital therapeutics ecosystem will emerge and mature.
"We have been surveying as many consumers as we can, trying to figure out how to market this, and 90 percent of the women we talked to thought they trusted things they saw on Facebook and mommy blogs more than the advice from their doctor," Matt Bucklin, co-founder of San Francisco-based Sense Relief, developer of a free acupressure app for the Apple Watch, said.
Sense Relief's smartwatch app in action.Sense Relief
Rich Ransom, CEO of Horsham, Pa.-based neuromodulation device manufacturer Reliefband, said his company also relies on paid social media, with 60 percent of its marketing dollars used that way to market its bands. Reliefband licenses user-generated content from influencers who are also customers.
"For a product like ours that is testimonial driven, you can't really demonstrate how Reliefband works," he said. "You really need someone to testify to the fact they had a problem and they used Reliefband and it worked. That's the only way our device sells."
To connect or not
Ransom and Reliefband, which introduced its new waterproof Sport version in August, are taking a calculated risk in not pursuing some sort of networked connection between their band and clinical researchers, wellness professionals, or clinicians. While the company plans to market a strap that will allow users to wear their Reliefband on the underside of the wrist with their smartwatch on the top side, with an estimated introduction date around the year-end holidays, there are no current plans to further develop communications capabilities.
"We do have the capability of putting Bluetooth into the circuitry," Ransom said. "We just made the strategic decision that at this point that is not who we are as a company. We want to make it as easy for everyday life as possible."
Ransom said many nausea sufferers may be looking for non-pharmaceutical alternatives to drugs such as the widely prescribed ondansetron; he said the Reliefband, which originally received FDA approval as a Class II (intermediate risk) device in 1998, and expanded approval to include nausea caused by migraines, hangovers, and anxiety in 2019, fills that slot.
Reliefband Sport How To Video youtu.be
Ransom is not ruling out adding connectivity capabilities, but also did not commit to saying that would be a definite direction for the technology, which uses transcutaneous pulses in the 8- to 40-milliamp range rather than pressure to stimulate the median nerve. He did say, though, the Reliefband Premier version, with a retail price of US$249.99, could be easily modified.
"We have a lot of opportunity within the display to do more things," he said. "I'm not going to say any more than that right now, but we are planning to come to CES 2022 with maybe a concept or two. The idea is to continue to evolve, to continue to make the device more user-friendly. In time it might make sense to put some Bluetooth integration in and connect it to apps. We need to figure that out still, but right now our focus is getting relief to people who need it, in a way that is not difficult for them."
More user data needed
Bucklin and the Sense Relief team, on the other hand, are going all-in on developing a networked digital therapeutic with their app, which provides pressure pulses via the Apple Watch's Taptic Engine. The company recently received a vote of confidence in that approach via an innovation grant from the UCSF-Stanford Pediatric Device Consortium.
The company will use the grant to integrate the open source Stanford Byers Center for Biodesign's CardinalKit iOS research platform into its own analytics of how, and how often, users with pregnancy-related nausea take advantage of the app, and then publish that data.
"Sense Relief's redesign will allow for better surveying of customers and data collection on a HIPAA-compliant platform," PDC spokeswoman Juliana Perl said. The PDC did not disclose the amount of the grant.
In order to build a market for the app, though, either through a direct-to-consumer approach in which additional services and information supplement the free app, or through emerging corporate wellness digital formularies, Bucklin said there needs to be plenty of that survey and usage data testifying to the app's utility.
"The data we have already on usage is pretty compelling," he said. "More than 50 percent of people who download it continue to use it. It's all anonymized, but we can see the users using it repeatedly. I can kind of assume if they downloaded a free app and use it more than once or twice they are probably getting some benefit out of it."
Sense Relief's progress may be a bellwether of the ambiguous way digital therapeutics wend their way into a market. Though the architecture of the app does not mandate the company seek FDA regulatory approval from a legal standpoint, Bucklin said they will still need to figure out how to offer compelling evidence it works and works well.
Sense Relief App Instructions For Fast and Safe Relief From Nausea and Morning Sickness youtu.be
"The most we can gather from talking with regulatory experts so far is that we are in this in-between discretionary space," he said. "The device is technically the Apple Watch, so we don't have a device. But we also aren't software as a medical device, because it's user activated, and we are not making health recommendations. So we just have to be careful with the claims we are making, but we do want to do the studies and eventually submit to the FDA and try to work with them to figure out where we fall."
Ultimately, Bucklin said the app's potential can go beyond early-term morning sickness to study symptoms that may lead to pre-term labor. And though he said Sense Relief is not the first entity to use wearables to study maternal anomalies – researchers at the University of California-San Diego and Columbia University have studied adhesive wearables and Fitbit data, for example – he does think the data the company hopes to gather can add significantly to the discipline's body of knowledge.
"The potential is there, but we're going to need a lot of data to get there," he said. "We're excited at Sense Relief because we already have lots of people who use it for morning sickness. They may continue to use it and we can collect more data, I would imagine, than through any other method."
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