AliveCor's Heart Monitor

Reinventing patient monitors

May 13, 2013
by Carol Ko, Staff Writer
Will sleeker, cheaper mobile devices someday change the way doctors diagnose patients? The jury’s still out, though this rapidly-growing market is already attracting considerable attention. Take the much buzzed-about AliveCor iPhone ECG heart monitor, for example. The device, which fits over the back of your iPhone, uses a biosensor to detect patient electrocardiogram readings. It was approved by the FDA in December, cleared for prescription in March and is sold for $199 on the company website.

Another svelte smartphone-centered device, Scanadu Scout, uses biosensors to measure parameters such as pulse transit time, heart rate, electrical heart activity, body temperature, heart rate variability and blood oxygenation. The device, roughly the size of a makeup compact, is expected to gain FDA clearance by late 2013.

Will such devices revolutionize health care as we know it? That’s the opinion of experts such as Dr. Eric Topol, a tireless proponent of consumer electronics who touts a leaner, cheaper health care system driven by smartphone technology. During his keynote speech at HIMSS in March, he shared apps for ear and eye exams that may one day take the place of hospital exams. Topol also claims that he hasn’t used a stethoscope in over two years. But he’s not alone.

“The decreasing cost of smartphones and its widespread adoption across the globe will enable it to be the global health care portal,” says Dr. Dave Albert, founder and chief scientific officer of Alive- Cor. According to Albert, this will pave the way for a future in which patients will be able to acquire, transmit and receive feedback on their health status anywhere, anytime.

Ultimately AliveCor’s ECG monitor gets at a larger, much-discussed trend in health care: patient self-management. And indeed, the remote health management market is growing rapidly and is set to double by 2016.

But there are several looming obstacles in the way of Albert’s vision. One of them is the question of payment. Will patients pay $200 dollars out of pocket for such a device when they’re used to a $20 co-pay? And, for that matter, will doctors pay money for such a device when they could easily use stethoscopes and other equipment provided for free by hospitals?

Such thorny questions will continue to come up as old guard products built around a thirdparty reimbursement model co-exist with sleeker, cheaper products rolled out by tech companies such as AliveCor and Scanadu.

“As they said in Ghostbusters, ‘dogs and cats living together! Mass hysteria!’” Albert says.

It may be a bit premature to start chucking regular patient monitors out the window. But that doesn’t mean manufacturers aren’t paying close attention to these startups. Dr. Albert reports that his company has already been contacted by all the major players in the industry.

And Melanie Varin, general manager of USA sales & marketing and diagnostic cardiology at GE Healthcare, confirms that some tech startups are currently in dialogue with GE to use its proprietary algorithms to improve their products. Several other manufacturers hinted that they may be strongly receptive in the future to acquisitions and partnerships with such firms, though they were reluctant to publicly disclose any information beyond that.

Going mobile
Still, there’s no question that the consumer electronics explosion is driving a major paradigm shift in health care manufacturing. Advances in semiconductor technology driven by smartphone applications are enabling medical devices to become increasingly miniaturized, portable and battery-powered.

The U.S. market for advanced wireless patient monitoring systems more than doubled from $3.9 billion in 2007 to $8.9 billion in 2011, according to a new report from Kalorama Information. Most manufacturers now offer smartphone-sized wearable patient monitors with wireless functionality.

Furthermore, consumer expectations are rapidly evolving when it comes to data access. “No one wants to walk around looking for a paper file anymore. Clinicians expect to have relevant patient data brought to them — whether at the bedside, offsite, on a PC or on a handheld device,” says Sam E. Larson, vice president of marketing, North America at Dräger Medical.

GE’s Varin agrees, citing mobility as the biggest trend of the year: “Mobility is about getting the right information
at the right location at the right time. It’s going to give health care providers a lot more freedom to practice whenever and wherever, and maybe even help them with work-life balance.”

Collaborating with a tech firm called Airstrip Technologies, GE now powers Airstrip Cardiology, an app that serves up all the data acquired on a GE ECG monitor in a smartphone format. The app enables physicians to get the same 12-grade cardiology that they’d expect to see if they were reviewing it at the ECG machine itself or at the ECG management system.

Keep it simple, stupid
The big push around EMR integration in hospitals has also had a drastic impact on the patient monitor sector, with relationships between EMR and patient monitor firms becoming increasingly interdependent. In fact, manufacturers report that health IT departments at hospitals have much more of a say in patient monitor purchasing decisions than they did just three years ago.

But developing EMR integration in a way that doesn’t sacrifice productivity is exceedingly difficult. Poorly executed EMR integration plans are common, with uncommunicative EMR or monitoring systems adding more headaches and lost productivity.

“Most facilities want to have vital signs data from devices integrated into their EMR system. But many solutions out there cost extra steps or [diverts] the workflow,” says Will Fox, director of US and Canada marketing at Welch Allyn.

Lack of interoperability is a notorious problem in the health care space. But this is expected to change soon as demand grows for better integration. Patient monitor firms without a proprietary EMR system such as Spacelabs may be poised to take advantage of this shift. “You’ll see companies have changed their tune a little bit. Everyone needs to play in the sandbox now,” says Monica Pinkernell, North American director of marketing at Spacelabs.

Data integration is a big point of discontent for doctors trying to make sense of a dizzying array of information across multiple monitors, workstations and systems. The digital age now provides doctors with more access to patient information and parameters than they’ve ever had before, but this ironically poses an added challenge for them as they try to make quick decisions treating patients amid seemingly endless—and not always useful— amounts of data.

Dr. Nikolaos Skubas, cardiac anesthesiologist at New York Presbyterian Hospital, wants a monitoring informatics system that not only integrates all patient data under one master monitor, but also simplifies information for doctors. For instance, if two contradictory readings appeared, the system would know to cancel out one of the readings using an algorithm. “We need to have a monitor that checks everything and makes sure whatever you read makes sense,” he says.

Rage against the machine
But as the conversation increasingly pivots around patient data access, management and integration, manufacturers seek to expand their product focus beyond the machines themselves, recasting themselves instead as peddlers of patient data informatics. “We’re talking less and less about patient monitors themselves and focusing instead on information: how to access it, how to move it. It’s about a total solution,” says Pinkernell.

Julia Strandberg, vice president of global marketing, patient monitoring at Covidien, predicts biosensor-driven patient data aggregation will eventually take the place of patient monitoring machines as we know it. Biometric sensors placed around the hospital would automatically record and register patients’ identities and parameters as they moved through the hospital, communicating the data to a cloud system that would aggregate and relay it back to a database that stores information on the patient.

“No longer would patients be tied to a bed or tied to a procedure, they would be organisms that flow through the hospital in a way that results in positive health outcomes,” she says.

DOTmed Registered DMBN May 2013 - Patient Monitors Companies


Names in boldface are Premium Listings.
Domestic
Kelley Mitchell, Biomedical Professional Services, AL
Andrew Schmidt, Discount Cardiology, CA
Randy Lowers, L & R Services, FL
DOTmed Certified
Ronald Tarr, MEDELCO, FL
Scott Patneaude, Sunnex, FL
Katie McAuliffe, HealthEdge Software, MA
Garret Purrington, Medical Equipment Dynamics, Inc., MA
DOTmed 100
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Eric Ebejer, Argo Surgical Repair Svcs., MI
Neil Little, USMED-EQUIP, ND
Lawrence Maroney, Integris Equipment, NY
DOTmed Certified
Bulent Buyukoglu, USmedevice, LLC, RI
DOTmed Certified
Mark Taylor, Masterfit Medical , TN
DOTmed Certified
DOTmed 100

International
Mayank Vats, ATM medicals, India
Jorge Morales Mello, BIOMET, Uruguay
Rodolfo Reyes Ingeniero, INNOVA MEDICAL, Mexico
Rick Meerkerk, Mediproma B.V., Netherlands