How do med/surg distributors fit in a world of wearable, digital devices?
The names are new: AliveCor, Empatica, EnLiSense, Nemaura, VivaQuant.
The technologies are new: KardiaMobile, Embrace2, the SWEATSENSER and the sugarBEAT® continuous glucose monitor.
And so are the questions being raised about wearables:
- How accurate are they?
- Will they alter the way chronic disease is managed?
- Who will pay for them – insurers, patients, providers?
- How will they pay for them – e.g., outright purchase, rental/lease, subscription?
Investors, patients, payers and doctors are asking such questions. Med/surg distributors should probably do the same.
“As part of a subscription-based service, we do not see the role of traditional distributors,” Nemaura Medical CEO Faz Chowdhury told Repertoire in an email.
Following is a look at three companies developing wearables, and their plans on how to bring them to the U.S. market.
Nemaura Medical
In July, Nemaura Medical (Loughborough, England) submitted a De Novo 510(k) medical device application to the U.S. Food and Drug Administration for its sugarBEAT non-invasive continuous glucose monitor. Less than two months earlier, in May, the company had received CE Mark approval to market and sell the device throughout the European Union.
SugarBEAT consists of a daily, disposable adhesive skin patch connected to a small rechargeable transmitter, connected via Bluetooth to a mobile application, which displays glucose readings at five-minute intervals throughout the day. Passing a mild electric current across the skin, sugarBEAT draws a small amount of glucose molecules out of the interstitial fluid, which sits just below the top layer of skin, into a chamber within the patch. The transmitter measures the glucose levels in the chamber, then transmits the reading.
“We believe sugarBEAT is best positioned to conquer this market – of over 25 million diabetics in the U.S. – where we have a sensor that can be worn on intermittent days/periodic intervals, with a view to enhancing patient training/coaching to change lifestyle, diet, etc., says Chowdhury, who holds a masters degree in microsystems and nanotechnology, and a doctorate in nanomedicine and drug delivery.
“In the UK the NHS is currently funding ‘Apps’ with subscription-based services to help pre-diabetics avoid becoming diabetic and Type 2s to go into remission, in order to save on the long-term socioeconomic costs,” he says. “We believe governments and healthcare providers around the world will increasingly adopt this stance.
“We have already seen what Livongo is achieving with mainly coaching, and more recently with the use of a 14-day invasive sensor,” says Chowdhury. “SugarBEAT can provide a superior level of service at a significantly reduced price (since sensors will only be used infrequently), therefore penetrating a far deeper patient pool. We believe for these reasons, sugarBeat is positioned for the type 2 market.”
Questions remain as to how sugarBEAT will be marketed and sold. Will it be available only by prescription? Will people with diabetes buy the device directly from the company? Will they rent them? If so, from whom?
“Yet to be determined,” says Chowdhury. “But all of the above are anticipated options, as part of subscription-based services that offer much more than just the device.”
EnLiSense
EnLiSense’s SWEATSENSER Dx platform uses passively expressed sweat to detect biomarkers related to various diseases, CEO Sriram Muthukumar told Repertoire in an email. “It can report levels in real-time and at low levels and therefore can be applied for pre-symptomatic situations. We have to date been able to establish detection of biomarkers for diabetes, infections, and immunological diseases.” EnLiSense is located in Allen, Texas.
“Since our platform is 100% non-invasive and diagnostic, we expect it to be a Class II FDA device that can be made available OTC when we bring it to market,” said Muthukumar. The company intends to sell it to patients and users through healthcare providers, pharmacies and commercial channels, such as Amazon. The company would not share how it intends to price the device.
In late 2018, EnLiSense was one of three companies to receive research and development funding from DRIVe, that is, the Division of Research, Innovation and Ventures, which was established by BARDA (the Biomedical Advanced Research and Development Authority), part of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
(The other two companies receiving DRIVe funding were Petach Tikva, Israel-based Biobeat and San Francisco-based Spire. Biobeat’s wristwatch has been cleared by the FDA for monitoring blood pressure, heart rate, oxygen saturation, respiratory rate, stroke volume, cardiac output, sweat, skin temperature and other factors, under a technique known as reflective photoplethysmography. Spire Health is a developer of the Spire Health Tag, a wearable device that monitors real-time bio-signals, like breathing, heart rate, heart rate variability, activity and other changes in the health signatures of the user’s health data. A companion app sends notifications to the user’s cell phone that could potentially be used to alert users to impending illnesses before they strike.)
Bloomlife
The Smart Pregnancy Tracker from San Francisco-based Bloomlife is designed for simplified contraction tracking and is not intended for diagnostic purposes, Eric Dy, CEO and co-founder, told Repertoire in an email. “The technology combines a discrete wearable patch with data analytics to provide moms with a convenient and accurate way to automatically track and time contractions. This information provides reassurance to moms, helps them more easily communicate with their care team, and make more informed decisions toward the end of pregnancy.”
The device is available for rental from the Bloomlife website for $20 a week.
Bloomlife intends to submit an enhanced product – Bloomlife Plus – for FDA consideration later this year. Bloomlife Plus would identify labor onset.
“Once the clinical and healthcare economic value is substantiated, medical distributors can help drive widespread adoption through their extensive networks and sales teams,” says Dy. “Bloomlife is bringing long overdue innovation to prenatal care, and we’re excited to find partners to help bring our vision to the market.”
Editor’s note: This is the first in a periodic series on wearables. Future articles will address such questions as: How is the FDA dealing with them? How are Medicare and other payers reimbursing physicians for remote monitoring of patients? Who will be buying and selling these devices and systems? What do Repertoire readers need to know?
For members only
Technology companies aim to tie patients and consumers tightly to them, disrupting conventional relationships.
For example, in the world of subscription-based services, “patients” are considered “members” by companies such as Mountain View, California-based Livongo. The company develops technology to help people – members – manage hypertension, diabetes, weight management and behavioral health.
“Livongo’s team of data scientists aggregate and interpret substantial amounts of health data and information to create actionable, personalized, and timely insights and nudges delivered to our members to help them stay healthier,” says the company on its website. In fact, when glucose readings are out of range, a Livongo “diabetes response specialist” may call or text the member to alert them to take action.
“Our smartwatch integration allows us to capture information from our Members, add it to our AI+AI engine, and return actionable, personalized, and timely information back to them,” said Livongo President Jennifer Schneider, M.D., M.S., in a press release. “By offering another way to access personalized health insights, we are able to more easily influence positive behavior change, which we know can lead to better health.”
Companies are coming hard and fast into the wearables arena. Here are a few of the more recent entrees.
| Company | Product | Dollars/cents |
| AliveCor (Mountain View, California) | KardiaMobile 6L, six-lead personal ECG device. FDA clearance May 2019 | Patient purchases bundle from AliveCor when setting up the Kardia app. (One-year connection.) Physician practice bills insurance every 30 days for remote patient monitoring. |
| Bloomlife (San Francisco, California) | Smart Pregnancy Tracker (launched in 2017) for contraction tracking. Company intends to submit an enhanced product, Bloomlife Plus, for regulatory approval in late 2019. Bloomlife Plus would detect early labor onset. | Smart Pregnancy Tracker is available by weekly subscription ($20). Bloomlife Plus has not been submitted to FDA yet. |
| Empatica, Cambridge, Massachusetts | Embrace2: FDA-cleared wristband detects patterns associated with tonic-clonic epileptic seizures in patients 6 years and over. Prescription necessary. | $249 plus subscription plan (starting at $9.90 per month and rising based on number of caregivers who receive alerts). |
| EnLiSense, Allen, Texas | SWEATSENSER Dx platform technologies: Uses sweat to detect early warning of changes to body’s physiological state (infection). | Not available |
| Nemaura Medical (Loughborough, England) | SugarBEAT® continuous glucose monitor; FDA De Novo application filed July 2019 | Will be subscription-based. Company says daily price is expected to be comparable to cost of using glucose meters and strips.
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| Omron Healthcare (Lake Forest, Illinois) | HeartGuide™ wristwatch: Wearable oscillometric wrist blood pressure monitor. Cleared by FDA December 2018. | List price: $499. Complimentary access to HeartAdvisor, corresponding mobile app. |
| Verily (South San Francisco, California) | Study Watch: FDA cleared as Class II medical device (Jan 2019) for its on-demand ECG feature. Prescription only. | Not available |
| VivaLNK (Campbell, California) | Vital Scout: ECG monitoring device | Wellness monitor $149 (online). Four adhesives: $5.99. |
| VivaQuant (St. Paul, Minnesota) | RX-1 identifies and reports cardiac arrhythmias. FDA clearance April 2019. | Not available |