Now that Medical Devices Have Gone Wireless, Which Protocol to Use?

Despite the wearables boom and frequent mentions of mobile health technology in the press, the majority of patients still go to their doctor’s offices or a local hospital to have their health evaluated.

“I don’t think we are there yet for the true Quantified Self,” said Martin Kohn, MD, in a panel discussion at BIOMEDevice San Jose.

So where are we? As a culture, we have been in the mobile age for years, but it will be awhile before doctors can, say, reliably monitor their patients no matter where they are—or even know how to do so without being overloaded with data.

The next destination for patient monitoring is the home rather than, say, the hotel lobby or the cabin of an airplane. “Should we be able to monitor them when they are on vacation? Yes,” said Kohn. But the technology and infrastructure needed for that are not ready to support that on a realistic scale. The home is the next destination because “we need to start someplace,” as Kohn put it.

Still, monitoring patients in a secure and reliable fashion outside of the four walls of the hospital—no matter where it is—will require a revamped product development protocol to help navigate the chaos. While hospitals are now a well understood place in terms of wireless communications, “the rest of the places where we are going to be operating is the Wild Wild West,” said Bill Saltzstein, president and founder of Code Blue Consulting in the same BIOMEDevice San Jose panel.

Part of the chaos is the sheer volume of wireless devices used in public as well as in people’s homes. On top of that, wireless technology is changing at such a rapid clip, it becomes difficult for medical device developers to rely on a given wireless protocol for the long term. Verizon, for instance, is quietly shuttering its 2G and 3G network bands to make more room for LTE service. From a revenue perspective, cellular providers view medical device companies with their growing interest in using their wireless technology as small fish in a very big pond.

Another complication for medtech companies is the difficulty of having, say, a Class III medical device integrate with consumer-facing technologies. A medtech firm that wants to use a SIM card must persuade regulatory professionals that the software within it, which is updated by a cellular provider, is safe for clinical applications. “Imagine me telling the regulatory folks about this. I saw one guy in the fetal position literally sucking his thumb,” joked Jim Sievert, principal software engineer at Boston Scientific in a session at BIOMEDevice San Jose. The Latitude NXT remote patient management system from Boston Scientific is one such device that makes use of SIM technology now on the market. “If you have a good medical process in place, good risk analysis, and you can put mitigations in place, you should have the update problem pretty much covered. And your regulatory guys don’t have to jump off curbs.”

While designing wireless medical devices for use in the home is challenging, developing them for the hospital also requires staying ahead of the curve. While there are a range of options available, including Bluetooth, ZigBee, and other protocols, WiFi is gaining traction in hospital environments.

A post from sister publication EE Times notes that WiFi is king at Kaiser Permanente, a California-based healthcare provider with $50 billion in yearly revenue that has 1.1 million Ethernet ports.

Kaiser is also testing a cellular network but is striving to avoid putting Bluetooth devices on its crowded 2.4 GHz network. On the horizon, Shawn M. Jackman, director of wireless product management and engineering sees a potential collision of 2.4 GHz accessories. “I’m watching this wearables thing and its coming at me like a freight train,” he said in the EE times piece.

For that reason, Kaiser is skittish on using Bluetooth. “If your device is in the hospital, don’t use Bluetooth. You will get excluded from more environments than you will be allowed in. If it goes home and won’t come back into the hospital, Bluetooth is OK. Inside the hospital it’s my goal to make WiFi available to you,” Jackman said.

Medical device developers face more situations like these where they must juggle the pros and cons of continuously evolving wireless protocols while working how to make healthcare more efficient and less expensive and provide the data to back that up.

A big part of that will be figuring out how to treat patients with ever-longer lifespans and ever-more chronic conditions. Already, patients with multiple chronic disease account for 75% of medical costs, Kohn said at BIOMEDevice. “And a lot of that is avoidable.” Monitoring patients in their homes could help doctors keep tabs on patients and prevent those recently released from hospitals from being readmitted. The ultimate promise of wireless technology is that it could be used to keep patients healthy enough that they don’t have to go to the hospital in the first place. “Why focus on reducing readmissions when most people don’t want to be admitted at all?” Kohn asked.