A new sensory system

It's not hard to imagine that a sensor as small as the size of a Band-Aid could collect information about your heart rate or temperature and then transmit that data using a wireless signal to a smartphone or another device. What might be hard to grasp is how large and transformative the market for so-called medical body area networks could be in the years ahead.

The networks collect data from sensors that can be placed at different locations on the body. The sensors wirelessly convey a wide-ranging array of physiological data to nearby hub devices, creating opportunities for healthcare providers to change the way they monitor patients at home and in the hospital.

Some technologies tap into allocated spectrum bands set aside by the Federal Communications Commission for medical use, or use device-specific networks built by hospitals. Those technologies usually require oversight from the Food and Drug Administration. Other devices, some of which are regulated by the FDA, rely on unlicensed Wi-Fi to aid consumers as they track anything from physical activity and blood glucose levels to when they take their medications.

However, the FCC last year allocated spectrum specifically for medical body area networks, or MBANs, which are expected to reduce or totally remove the need for the wires tethering a patient to a hospital bed. A sliver of that spectrum has also been set aside for monitoring patients at home.

“That's a good thing for safety,” says Dr. Eric Topol, director of the Scripps Translational Science Institute in San Diego. “Normally, in a hospital, patients are only getting checked once a shift. To have continuous monitoring–which is why a lot of people are in the intensive-care unit—that's a big plus. That could lead to lower costs and less utilization of the intensive-care unit facility. Ultimately, the bigger opportunity is just getting people out of the hospital and then doing remote monitoring.”

It could be several years before the first MBANs developed to use that spectrum come to market, but the lag is not likely to limit the development and continued adoption of wireless remote technologies that can be used to monitor and collect physiological data from patients, regardless of the care setting. Supporters say the technologies could help deliver higher quality of care and in the long term even lower costs.

Many companies have developed sensor-based technologies that are already being used in clinical settings, but proponents of the MBAN spectrum allocation say it's needed to ensure safety and prevent interference for the life-critical medical devices that monitor and track a patient's vital signs. The technologies will likely track data such as blood pressure, glucose levels and heart rhythms. However, down the line, the devices may be able to better monitor cardiac output, which may help keep heart-failure patients out of the hospital, Topol says. Other possible capabilities include fetal telemetry and predictive and early-warning systems that track changes in a patient's condition.

GE Healthcare first petitioned the FCC in 2007 to allow the spectrum to be set aside. Two other companies, Philips Healthcare and Texas Instruments, as well as the American Society for Healthcare Engineering, later joined the effort.

GE and Philips, both of which already sell patient monitoring devices that are used in care settings, say they have technologies in development that will use the MBAN spectrum. No MBAN technologies using the allocated spectrum have been brought to market yet.

However, the FDA in April granted 510(k) clearance—which does not require clinical testing—to a cableless respiration sensor that Philips developed. The chip for the technology, which will be introduced to the U.S. market later this summer, was developed to also operate in the MBAN spectrum. The company expects the technology to require additional 510(k) clearance to operate in that spectrum.

“By opening up the new spectrum, we should be able to expand who gets monitored (and) bring the price point down,” says Anthony Jones, chief marketing officer for Philips Healthcare's patient-care and clinical informatics unit. “Now it's just a matter of seeing which devices get to market and how people implement them.”

He says the company will develop products for the hospital and home markets, but sees a distinct new market opportunity for monitoring patients within their home.

“One of the things we're putting a lot of effort into is the whole hospital-to-home concept of monitoring,” Jones says. “As you get more into the home and out of the more invasive areas of monitoring, as you get farther and farther away from the hospital, the value of the MBAN technology starts to have a larger impact.”

Executives at GE and Philips declined to specify when they expect their first MBAN products to come to market.

Charles Giordano, GE Healthcare's chief technology officer, says it may occur within a few years. The company is planning to focus development of MBANs in the hospital setting, including the monitoring of heart and breathing rates, temperature and pulse oximetry.

“We're not talking about a 10-year development here,” Giordano says.

The regulatory pathway to bring these technologies to market remains incomplete. Although the FCC published the final rule in September, it has yet to name a frequency coordinator. The American Society for Healthcare Engineering currently serves as the frequency coordinator for the wireless medical telemetry service band, or WMTS, which was allocated in 2000. The organization has said it would take on the same role for MBANs.

In addition, a task force convened by the commission recommended last year that the FCC work with its counterparts in other countries on international harmonization for MBAN products. So far, however, the U.S. is the only country to have set aside spectrum for MBANs.

And, while the FCC is responsible for licensing the spectrum, it is the FDA that regulates the technologies that operate on the various spectrums. The agencies have increasingly worked together as a result of an agreement in 2010 that aligns their work supporting development of wireless medical devices.

“Medical body area networks is an exciting, emerging area of technology with many medical device implications,” an FDA spokeswoman said in an e-mail. “As it does with all medical devices, the FDA would evaluate devices that use MBAN based on the level of risk the technology might present.” The agency declined to comment further.

“It's not unusual for there to be a lag in the timing between when the FCC can make a waiver or grant spectrum … and the time they take their action and the time that the market can respond and adapt to it,” says Kerry McDermott, senior director of healthcare technology policy at the West Health Institute, a not-for-profit organization in San Diego that advocates for technologies to lower the cost of healthcare.

The FCC granted a waiver in 2011 to allow Second Sight Medical Products, a Sylmar, Calif.-based device manufacturer, to market its retinal implant system that helps restore some functional vision to the blind. The technology converts video images taken by a camera in the patient's glasses that are then wirelessly transmitted to electrodes on the surface of the retina.

The system received approval from the FDA in February, 16 months after the FCC's waiver.

“It's still very new,” McDermott says about the MBAN spectrum. “If GE and Philips actually get products in the market and begin to drive traction on this, there will be some fast followers.”

Not all manufacturers are interested in focusing their development strategy on the MBAN spectrum. Sotera Wireless, a San Diego-based start-up developer of sensor-based wireless technologies that monitor vital signs, is one example. The company believes there is more than enough evidence to reliably and securely monitor patients using a hospital's Wi-Fi network.

“We don't think it's necessary to have protected spectrum,” says Jim Welch, Sotera's vice president of quality systems, regulatory affairs and clinical affairs. “The need for dedicated MBAN just constitutes, in my opinion, a land grab.”

Monitoring technologies that use Wi-Fi allow patients to be more mobile because they are not required to stay near a hub device and are less expensive, he says. In addition, MBAN technology can be used only in the U.S., which is less than half of the total available market, he says.

Regardless of the questions about spectrum, attention to remote monitoring technologies— including sensor-based body area networks for consumers as well as medical body area networks that will use the new allocated spectrum—is on the rise. A number of mobile applications also have been developed to track health data.

Companies developing products in the remote patient monitoring space received $42 million in venture funding in the first quarter of 2013, on par with the $44 million in funding given to companies developing hospital administration technology, according to an analysis by Rock Health, an incubator for healthcare digital start-ups. Funding in the remote monitoring market during the first quarter was led by Sotera, which received $15 million.

“Remote monitoring is of intense interest,” says Malay Gandhi, Rock Health's chief strategy officer.

A Deloitte study published in 2012 estimates that the market for all wireless health monitoring devices in the U.S. will hit $22 billion by 2015, compared with the current $7 billion market. An increasingly engaged patient population, an aging baby boomer population and the evolution of payment models that reward better patient outcomes are expected to drive adoption of these technologies.

ABI Research predicts that 5 million disposable sensors will enter the market during the next five years, according to a report released this month.

GE Healthcare and Philips Healthcare, as well as the FCC in its regulatory documents, say that MBAN technology will be low-cost and will reduce costs for the broader healthcare system. An FCC official says the agency's assessment of cost comes from background provided by the companies that advocated for the spectrum allocation.

“We are also persuaded that the ready availability of chipsets and technology that can be applied to this band will promote quick development of low-cost MBAN equipment,” according to an FCC report released last year. “This, in turn, will reduce developmental expenses, encourage multiple parties to develop MBAN applications, and will promote the widespread use of beneficial MBAN technologies. Such deployment will reduce healthcare expenses, improve the quality of patient care, and could ultimately save lives.”

The high volume of the monitoring market, the disposable nature likely for many products and the success that manufacturers have already had in developing low-power, low-cost chips in other sectors are expected to keep the costs of the sensor-based MBAN technologies low.

“We want to make sure it's affordable and productive for our customers to leverage the technology because if it doesn't fit the cost model and it doesn't fit the workflow, it still won't be adopted,” GE's Giordano says.

Topol says that while development of sensors is considered inexpensive, the introduction of new medical technology usually comes with a higher price tag. “Every time there's been new technology in medicine, it's been associated with higher costs,” he says. “We're not at a point in our world where that can be tolerated.”

TAKEAWAY: The market for wireless technologies in healthcare is projected to explode, but not all manufacturers are sold on MBANs.

Follow Jaimy Lee on Twitter: @MHjlee