Wireless Medical Technology Making Impressive Gains

Wireless medical technology. At the risk of sounding cliché, it’s the stuff of science fiction. For example, holding a small, handheld pad device up to a patient’s chest, and instantly displayed are heart rate, an electrocardiogram and temperature seems futuristic. The data is then electronically—but securely—transferred to a central location for data storage, remote diagnostic review or any number of other possible uses.

But the technology is reality and a number of companies are pioneering this new healthcare frontier. One of the challenges associated with wireless medical devices, however, is to find universally accepted protocols for manufacturers and users.

As part of its efforts to unite wireless medtech companies and create standards, CTIA, the trade association for wireless technology created a “Wireless Health Pavilion” during Medica 2011, the largest medical trade fair in the world, with more than 4,400 exhibitors and roughly 140,000 visitors from more than 110 countries.

“As the global trade organization representing the wireless industry, one of CTIA’s primary goals is to help develop new industry segments across an increasingly fertile ecosystem,” said Robert Mesirow, vice president and show director for CTIA. “By bringing mobile innovation to the largest health event in the world, CTIA hopes to stimulate the adoption of new technologies that will improve and streamline healthcare and health services now and in the future.”

The industry may be in its infancy, but it already is demonstrating very mature revenue.

Juniper Research, a United Kingdom-based wireless technology research firm, estimates that by 2014, the remote monitoring industry will be worth $1.9 billion.

Sponsors of the pavilion at Medica include founding sponsor Qualcomm Wireless Health, premier sponsor AT&T Inc.; and supporting sponsors Continue Health Alliance and the Wireless-Life Sciences Alliance. More than 20 companies participated.

Among the companies was AliveCor, a company founded by David Albert, M.D. Albert demonstrated the device during Medica.

AliveCor’s credit card-sized wireless device turns smartphones and tablets into clinical-quality, low-cost heart monitors—a mobile electrocardiogram recorder—that can be used by patients at home and by physicians and other healthcare providers in a clinical setting. Results can be sent remotely. Data can be stored and analyzed. The device Albert demonstrated at Medica looked like a beefier case for an Applie iPod (to which the device was actually attached), with sensors on the back.

In August, the Oklahoma City, Okla.-based firm secured $3 million in first-round funding from Burrill & Company and Qualcomm Inc. (acting through its venture investment arm, Qualcomm Ventures), and the Oklahoma Life Science Fund.

“AliveCor was founded on the idea that by leveraging the power of the iPhone and of Android phones we could radically decrease the cost and increase the global availability of advanced cardiac monitoring,” said Albert.

Watch a video of Albert demonstrating his device.

“The rapid rise of smartphones and tablets combined with the power of social media networks has forever changed the way we connect and engage, and it is transforming how we manage our personal health and wellness,” said G. Steven Burrill, CEO of Burrill & Company. “AliveCor’s innovative use of smartphone technologies has created a high-performance electrocardiogram recorder at a disruptive price that enables consumers to monitor their heart health anywhere at any time and provides physicians with a more comprehensive assessment of their patients.”

AliveCor used the funds to complete clinical studies currently ongoing at the Oklahoma University Health Sciences Center, pursue regulatory approvals, and gear up for commercial launch. Albert told MedicalDeviceNow, he expects CE Mark for the device in Europe by the end of the year or first quarter of next year. The company will pursue 510(k) clearance from the U.S. Food and Drug Administration (FDA) in the new year.

Clint McClellan, senior director of business development for Qualcomm’s Health and Life Sciences business in San Diego, Calif., also is president and chairman of Continua Health Alliance, a Beaverton. Ore.-based non-profit, industry organization of healthcare and high-tech companies focused on establishing systems of interoperable telehealth devices and services in three major categories: chronic disease management, aging independently, and health and physical fitness. McClellan acted as a tour guide showcasing the different technology in the wireless pavilion.

McClellan said the industry cooperation is “essential” to advancing the alliance’s goal of creating an integrated and secure system of personal connected health solutions. “It’s about improved care and outcomes,” he said. Earlier this year, Continue released designed guidelines that outline industry standards and new specifications for devices, services and communication standards to ensure interoperability.

Guidelines incorporate some of the following items:
• Bluetooth low-energy temperatures sensor device profile;
• ZigBee networking functionality extended to enable a single sensor-local area network device to communicate with multiple application hosting devices at the same time;
• Improved user identification guidance on the wide area network interface; and
• Improved consent management and non-repudiation on the health record network interface.

Another company participating company was Telcare. At the end of July this year, the firm distinguished itself in the annuls of wireless health as the first company to receive FDA approval for the world’s first cellular glucose meter.
Jonathan C. Javitt, M.D., is CEO and vice chairman at the company. On hand at Medica, he demonstrated the device, which is smaller than a flip phone.

The Telcare BGM (pictured above) automatically logs and transmits glucose readings to a secure clinical server. A private web page allows only authorized users authorize to log in, view information and recognize trends. No additional hardware or wires are required. The company’s goal is to transform the management of diabetes from a condition where patients feel cut off from their caregivers and don’t know what to do from day to day, to a model in which the patient is continually empowered to manage his or her condition through continual feedback from caregivers, family members, and even other patients.

Javitt said it only took four months for the FDA to provide clearance of the Las Vegas, Nev.-based company’s 510(k) submission.

“It helped that we included additional clinical data and submitted a very thorough application,” he said.