From ‘wearables to ther-ables’

SmartDose wearable device

Unit shipments for wearable devices were expected to drive about $32 billion in revenue by 2019 — more than three times the $10 billion in revenue the market saw in 2013, according to a 2015 IHS Technology white paper on the wearables market. Beside the business applications IHS identified, it also focused on consumer possibilities in the wearables market — as fitness trackers, health data collectors and beyond.  

The potential that IHS identified is something that entrepreneurs are currently working on tapping into, and industry observers have taken note of the evolving role of wearables. Most notably, at the end of 2015, Fortune predicted that 2016 would be the year conventional thinking around wearable technology would change. The magazine predicted that this year “‘wearables’ will become ‘ther-ables.’” That is, wearables would evolve from simply tracking wellness data to actively working to keep users well.

The next generation of wearables, unlike those designed to track steps and monitor sleep — whether sold by Jawbone, Fitbit or Apple — is working to provide therapeutic value to users. Drug Store News found three companies that are at the forefront of revising what wearables can do, and how they can help users with chronic pain, those looking to quit smoking and those whose maintenance medications could use an upgrade.

Quell
Much of the buzz coming out of the annual South by Southwest festival has to do with the festival’s music and film components, but for 17 years, SXSW Interactive has celebrated innovation in various fields, including wearable technology. This year, the Waltham, Mass.-based NeuroMetrix won the top award in that category for its Quell Wearable Pain Relief Technology.

The $249 device — which sells on Quell’s website, Amazon, and hit Target.com and about 500 stores in mid-April — is worn around the calf and uses electrodes to stimulate sensory nerves, which send neural pulses to the brain, triggering a pain-relief response. Unlike TENS devices, Quell uses a different type of nerve stimulation to deliver what the company says is more powerful pain relief that customizes itself to the user through Quell’s OptiTherapy. Quell is approved by the Food and Drug Administration with indications for temporary pain relief, and management and relief of chronic pain. In clinical trials, the company has seen 81% of participants report an improvement in pain.

NeuroMetrix SVP and general manager of consumer health Frank McGillin said Quell is aimed at providing a service to a population that hasn’t been served by the current crop of wearable products.

“Today, in terms of a serious therapeutic wearable device for chronic pain, we’re pretty unique,” McGillin said. “There’s been an adoption of fitness trackers … and obviously rapid growth of those primarily around the worried well — they’re either active people trying to be even more active or they’re focused on their health. But there’s this large population of Americans suffering from chronic disease, and current devices aren’t addressing what their needs are.”

In some cases of chronic pain — which the most recent survey by the National Institute of Health says affects nearly 50 million Americans — addressing patient needs also can reduce medication use. In clinical trials, about two-thirds of participants reduced their medication use when using Quell, which McGillin said makes Quell a versatile treatment, potentially replacing medication in some cases, though he stressed that patients should consult their doctors on those matters.

“Looking at some of the big problems to be solved, chronic pain ranks up there. I think $50 billion [is] spent on the treatment of chronic pain, yet [more than] half the people are saying their pain isn’t adequately controlled. So we’re new as a technology, new as a brand, and we’re trying to both build the awareness and make Quell available to the people it’ll help,” he said.

Chrono Therapeutics
For years, the nicotine patch has been the most recognizable option to help people quit smoking, but Chrono Therapeutics’ smoking cessation solution is looking to give the nicotine patch a run for its money.

Chrono currently is developing a smoking cessation device featuring a wearable pod that acts as a nicotine delivery system. The pod will deliver nicotine to users based on when smokers have their strongest cravings. Users can even enter their typical wake-up time into pod to ensure that it begins dispensing nicotine about 90 minutes before the user wakes up, curbing their urge for a cigarette in the morning.

Chrono plans to file for FDA approval and has been working on clinical trials. Recently, the company conducted a small test to see how the device impacts nicotine cravings. Looking at 24 smokers, the test found a statistically significant reduction in cravings among the group receiving nicotine when compared with the placebo group.

“That was very encouraging to us because we had been told going into this trial that with such a small sample size of just 24 people — and also for just a 30-hour test — we might not see differences between the drug and the placebo, and the cravings might be essentially the same,” Chrono Therapeutics VP product management and marketing Jenny Hapgood said. “And yet, we did see statistically significant and clinically meaningful differences, which is giving us strong indicators that our product is more effective at helping people reduce their nicotine cravings.”

Going hand in hand with the nicotine delivery is the device’s accompanying coaching app, which looks to tackle the second challenge facing smokers — behavioral changes. The app, which Chrono hopes to have ready for user beta-testing in June, will use data collected by the pod to customize coaching and proactively remind users to power through cravings and stay on track. The app development is being partially funded by Chrono’s second Fast Tack Small Business Innovation Research grant from the National Cancer Institute.

For the Chrono team, the smoking cessation solution — whose consumer launch is anticipated in 2018 assuming regulatory approval and development are on track — also is providing a service that it believes wearables should.

“We think it’s all about this convergence where you have to have personalized therapy; you need to leverage the user’s data to impact the way that therapy works, and you need to have the digital health component because behavior change is always part of the story — whether it’s changing an addictive behavior or just being compliant with the clinical regimen you’ve been assigned,” Hapgood said. “We don’t think wearables anymore should just be tracking your data; something needs to happen. From that data, it needs to impact the therapy rather than just stop at awareness building.”

SmartDose
One of West Pharmaceutical Services’ areas of expertise is in self-injection technology, which includes the SelfDose self-injector system and the ConfiDose auto-injector system. But as medication gets more sophisticated, particularly in the case of biologic drugs, West is looking to make drug delivery more sophisticated, as well. The SmartDose electronic wearable injector is a delivery system designed to improve the patient experience and encourage medication adherence. The company is anticipating a commercial launch for SmartDose with one strategic customer later in 2016.
Patients can place the SmartDose injector on their abdomen, allowing them to be mobile during the required dosing time. It is different from some other wearables in that it does not collect data, and the first version of the SmartDose injector does not have smartphone connectivity. However, even without the bells and whistles that it expects to add in its second iteration, the device is looking to fill a therapeutic need.

“With the viscosities [of biologics] and protein concentrations going up, and thus the injected volumes going up, there really was this unmet need in the market that both us and other companies have capitalized on in the last three-plus years,” West’s VP of global innovation Chris Evans said.

Evans said the question, as the volume of biologics has gone up, is how to effectively get large doses in to patients, in something of a bolus, across multiple disease states. This led to an open-ended approach to developing the SmartDose platform used by different patient types and adaptable for use with varied molecules and treatments.

“It really opens up the doors for emerging therapies, beyond how you would traditionally think of drugs being delivered,” Evans said.

West has partnered with HealthPrize Technologies on a rewards program for patients. This means patients can earn points by scanning the barcode on their medication or otherwise “checking in” with the smartphone application and engaging with its disease-specific educational material, health tips and other content. Both of these efforts are aimed at improving adherence and keeping patients engaged with their regimen.

“It’s really not only about the delivery system and the patients’ interactions with it — it’s their interactions from the day they walk into the doctor’s office … and are prescribed something that happens to be delivered to them in a delivery system, which they now may need to inject themselves with. So, how can we help enhance that whole experience?” Evans asked. “But also from an ongoing perspective, how can you keep connected with them on a daily or weekly basis and instill confidence with self-administration?”

Beside the rewards program, West has looked to keep patients engaged by ensuring that they begin treatment and know how to properly use the delivery system. The company looks to patient onboarding and training company Noble to help patients using the SmartDose platform learn best practices for use with their medication.

“New patients with self-injectors often make errors in administration. Therefore, it is not surprising that when patients don’t have the necessary education and resources to use their self-injection system as intended, desired patient outcomes are not achieved,” Noble EVP Craig Baker said. “Research from both West and Noble revealed that patient-friendly delivery systems and comprehensive education around self-injection are needed to improve the patient experience along their journey.”

The hope is that, between personalized training and the potential for rewards, patients will be more adherent — improving outcomes and reducing the cost that nonadherence has on the entire healthcare system.

“One of the things Noble and HealthPrize helped us realize is that you also may need incentive and motivation to get people to spend the appropriate time with a trainer to maximize their learning,” Evans said. “It can all connect together if you give people the proposed value that makes it worthwhile and engaging.”

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