Medical Device Monitor

Sure, They're Cool, but Will Smart Wearables Ever Live Up to Their Potential?


Katherine T. Adams

There’s value in giving patients real-time health data, but getting them to act on the information is another thing. And what happens when the novelty wears off?

Automation is hitting a world where the population is aging dramatically. So intones Price­waterhouseCoopers in its report, “21st Century Pharmaceutical Collaboration: The Value Convergence.” By 2020, the authors point out, there will be more people in the world over the age of 65 than those under 5. Moreover, as people age, they will face larger out-of-pocket costs for medications. Biopharmaceutical companies, PwC argues, must take advantage of digital health opportunities to understand how patients respond to drug interventions, to keep costs down, and to remain profitable.

Google understands the problem and is expanding its reach into wearable health devices. Google Life Sciences, a subsidiary of Google’s parent company, Alphabet, is teaming with Sanofi on a diabetes-monitoring collaboration to find better ways to collect, analyze, and process diabetes-related information to develop technologies that improve outcomes. That means creating devices that would combine multiple parts of diabetes monitoring into a single system, with sensor devices and information on medication regimens, blood glucose levels, and patient-reported data.

One of Google Life Sciences’ newest entrants in health-tracking devices is a wristband that measures pulse, heart rhythm, and skin temperature, and also gauges environmental factors like light and noise exposure. The data would give a patient’s physician or researchers minute-by-­minute data on the patient’s physical state. The health-tracking wristband, says Google Life Sciences, will be marketed as a medical device that could be prescribed to patients and used in clinical trials.

“That sounds all very well and good,” says Chanin Wendling, director of Geisinger in Motion at Geisinger Health System in Pennsylvania. “Everybody thinks these smartwatches are neat. But how do you get a couch potato to get up and start using one? Pennsylvania has a large population of obese people, and there are a lot of medical issues connected to that. Getting a person like that to use a smartwatch is problematic.”

Wendling’s point gets to the heart of issues payers face with wearable medical devices. Most devices are used by young people who like technology, but challenges exist in educating older patients about the value of using smart wearables to monitor health issues. Adherence, too, is an issue.

“They are kind of cool—and being able to look at your data is kind of cool—but 75% of [users] may not be wearing their smartwatch after six months or so,” says Wendling. Consumer reviews by Argus, the auditing network, suggest that most users lose interest in their fitness bands after about six months.

Even so, Wendling concedes, there is value in devices that target chronic conditions with the aim of, say, helping a patient keep blood pressure or glucose levels in a tolerable range. “If we can apply technology and spend $500 up front to avoid $2,500 in health costs down the road, then these devices may be worth the effort.”

Cancer test developments

Patients with colorectal cancer who could benefit from targeted therapies may be more readily identified through Biocept’s Target Selector assay. Launched August 5, the assay uses a blood sample to identify KRAS mutations. Other tests now available to detect the presence of a mutation rely mainly on a tumor tissue sample. Biocept says the test can help to identify these patients in an earlier stage of disease, and also can be used to monitor treatment response and disease progression.

Myriad Genetics’ Prolaris prostate cancer screening test is now ­Medicare-covered for determining the aggressiveness of prostate cancer in patients with localized tumors. The local coverage determination is effective Oct. 15, 2015.

Pump controls diabetes

Over one year, patients using Intarcia’s ITCA 650, a GLP-1 receptor agonist delivered through a subdermal pump, experienced greater reductions in HbA1c and weight than patients taking oral sitagliptin (Januvia) (1.5 vs. 0.8 percentage-­point HbA1c reduction and 9 pounds versus 3 pounds). Implanted under the skin, the matchstick-sized pump delivers exenatide and eliminates the need for injections, potentially reducing adherence issues in people taking oral and injectable diabetes medications. Intarcia will present details from its FREEDOM-2 study at major medical meetings in the coming months.

Leadless pacemaker safety

Data from the LEADLESS II study confirmed the safety and efficacy of the Nanostim leadless pacemaker for patients who need a single-chamber ventricular pacemaker. Nanostim is the first pacemaker without leads and resides in the heart rather than in a surgical pocket. Common pacemaker complications include pocket infections or problems related to their leads.

About 7% of those who received the Nanostim device experienced serious adverse events—approximately half of historical incidence with conventional pacemakers. St. Jude Medical presented the results at the European Society of Cardiology Congress and published them in the New England Journal of Medicine.

Devices slow to reach patients

When it comes to life-saving medical devices, approvals are unnecessarily slow, according Ariel Dora Stern, who published her research in Harvard Business School’s Working Knowledge. “Instead of speeding innovative, first-mover products to market… the FDA’s regulatory approval process appears to delay approvals,” Stern argues. Devices, she explains, can differ in any number of ways, which forces the FDA to make ad hoc rules for testing each new device. In other words, she says, administrative and classification matters can delay device approval.

Selected FDA medical device approvals, July 3–Sept. 2, 2015
Date Manufacturer Device name Use and notes
July 10 Qiagen Therascreen EGFR RCQ PCR kit New FDA-approved use as a companion diagnostic for patients who may be prescribed gefitinib (Iressa). The test determines exon 19 deletions and exon 21 mutations of the EGFR gene in non–small-cell lung cancer tumor tissue. The FDA approved the kit as a companion diagnostic for afatinib (Gilotrif) in 2013.
July 20 Abbott Laboratories iDesign Advanced Wave Scan Takes more than 1,200 microreadings of the eye in a 3-second scan, identifying cornea shape and curvature and potentially expanding lasik treatment population. Approved for adults with higher astigmatism levels, nearsightedness, and a wider range of pupil sizes.
July 27 Minerva Surgical Endometrial Ablation System Approved for use in premenopausal women with menorrhagia due to benign causes in whom childbearing is complete. Approval is contingent on submission of postmarketing, single-arm, nonrandomized studies providing 2- and 3-year outcomes.
July 28 ReShape Medical Integrated Dual Balloon System Intended to facilitate weight loss in people with BMI 30–40 kg/m2. Delivered into the stomach through the mouth, the balloon is filled with a sterile solution that takes up room in the stomach. Intended for people who have not succeeded at weight loss through diet and exercise and do not want or do not qualify for bariatric surgery. Approval based on outcomes of the REDUCE trial, published in Surgery for Obesity and Related Diseases.
Aug. 19 Boston Scientific Innova Vascular Self-Expanding Stent System Minimally invasive treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery, which can cause peripheral artery disease. Approved as a class 3 (high-risk) device.
Aug. 24 Dexcom Sapien 3 Transcatheter Heart Valve (THV) First fully mobile system for monitoring blood glucose in real time, this prescription-only device sends glucose data to an IOS-enabled smartphone. User can designate up to five people to receive data. Approved for use in patients 2 years and older.
Sources: FDA, Fierce Medical Devices, manufacturers’ news releases, and Mobile Health News.

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