Supposing Stanford were to name a chief heart gadgeteer, it might be Michael McConnell, MD, a cardiologist with degrees from MIT in electrical engineering and bioengineering. McConnell, tall and fit with laser-blue eyes, isn’t wearing a physician’s white coat on the day he escorts two young Silicon Valley fitness app developers out of his office. Dressed in black from head to foot, he is among a new breed of physician-engineers, fluent in both medicine and technology.

This year, in addition to caring for heart patients, McConnell is trying to figure out how to integrate a new wave of heart- and fitness-monitoring devices into the medical system.

Traditional heart-monitoring equipment lives in hospitals. The equipment is utilitarian, safe and ugly, hooked up to wires, electrodes and monitors. A new generation of portable heart gadgets has the potential to leapfrog these old approaches. Looking more like fashion accessories than medical equipment, these gadgets leverage advances in smartphones, sensors and digital video, and, in many cases, perform their functions better and faster than the old equipment — for a fraction of the price.

Yet the medical establishment isn’t quite ready for them. So the heart gadgeteers are working overtime to address the regulatory hurdles, funding issues and institutional inertia keeping these devices out of mainstream medical use.

 

The integrator

“I knew I wanted to study the heart before I knew I wanted to go to medical school,” says McConnell. “It represents the best of engineering — fluids, electrical and mechanical — all in one organ.”

In his roles as director of cardiovascular health innovation and co-director of the preventive cardiology clinic, he tries to figure out how to get more of his heart patients to use wearable fitness devices, to encourage them to exercise more and eat right.

“Eighty percent of heart disease, particularly coronary artery disease, is preventable through diet and exercise,” he says. “The problem is that the current system only reimburses physicians after someone has heart problems.”

Today the U.S. health-care system largely operates on a fee-per-service model, in which health-care providers receive payments for each service, test or procedure performed. This structure encourages physicians to order more tests and treatments than may be necessary because there is no penalty, only additional profit, in adding extra charges. Government-run, single-payer health programs, on the other hand, compensate physicians with fixed annual salaries and all-in-one fees based on a patient’s health problem. This financially motivates providers to order services more wisely, coordinate care between specialists and look for ways to prevent expensive health problems down the road.

The U.S. structure is slowly evolving for the better with changes launched under the 2010 Patient Protection and Affordable Care Act. The new law offers carrots and sticks to motivate health-care providers to become more efficient, less fragmented and more accountable. There are incentives for cost reductions, disease prevention and quality improvement, including bonuses for hospitals that show improved outcomes for heart failure, pneumonia and surgery. And there are billions in government grants for funding comparative-effectiveness research, studies that identify which treatment options are the most effective for any given condition. McConnell is using these and private funds to gather evidence on the effectiveness of these new devices.

“We want to prevent patients from having heart attacks by making them more cognizant of the effects of diet and exercise on their heart.”

As a start, McConnell and his colleagues are pilot testing a number of off-the-shelf, wearable fitness monitors — Nike, Fitbit, Jawbone and Lark, to name a few.

He’s already witnessed dramatic results when patients with strong personal motivations to improve their health are given tools to help them reach their goals. For example, when one of his patients with worsening diabetes was given parenting responsibility for a grandchild, he started using a pedometer to track his progress in trying to walk at least 10,000 steps a day.

“The patient’s weight, blood sugar and blood pressure all came down, and he was able to go off medications,” said McConnell. “A dramatic result to be sure, but regular physical activity is a critical factor for health and longevity.”

McConnell and his cardiology colleagues are also in the planning stages of integrating data feeds from consumer health tools and prescription heart devices into a unified, heart-health web-based dashboard. The first phase of this initiative will focus on patients who’ve had heart attacks, allowing them and their physicians to track recovery, activity, diet and medication adherence through smartphone-based tools and a website that links patient and physician. (Recent studies show that heart patients are bad at taking their prescribed pills: After hospitalization for a serious cardiac event, one in three patients stop taking at least one of their heart-related medications after a month, according to Michael Ho, MD, at the Denver VA Medical Center.)

In addition to helping heart attack patients, Stanford Hospital and Stanford University are giving employees at risk of developing diabetes tools to encourage them to exercise more and eat healthier foods. Using an online program created by Omada Health, these patients get coaching and social support as well as wearable fitness monitors and scales with wireless Internet connections that help them track diet, weight and exercise goals.

The hospital also has hired a former Jawbone information technology expert to link this data from wearable devices and mobile apps into the patients’ electronic medical records.

Some insurers are following suit. Aetna, one of the largest health insurance providers in the United States, recently launched CarePass, a program that offers customers a free iPhone app and access to a website that integrates patient medical records with data from fitness-monitoring devices from Fitbit, Jawbone and Withings. United Health Care has a similar program, called OptumizeMe. While these insurers don’t pay for the wearable devices, Fitbit and Jawbone offer volume discounts to corporations.

 

The innovator

When a medical gadget crosses the line from personal health monitoring to diagnosing medical conditions in the United States, it must be approved by the Food and Drug Administration and can be prescribed only by physicians. For heart devices, the additional time and expenses required for clinical testing, regulatory approval processes, insurance reimbursement approvals and physician acceptance can significantly slow the movement of newer, better technologies into the medical system.

One expert on these processes is Uday Kumar, MD, an entrepreneur-in-residence in the San Francisco office of Third Rock Ventures. Kumar, a cardiac electrophysiologist by training, typically dresses in the de facto uniform of Silicon Valley entrepreneurs: open-collared shirts and jeans. He has founded or co-founded four medical and information technology companies and is a consulting associate professor of bioengineering and the fellowship director of Stanford’s Global Biodesign Program, which trains technology innovators to address medical needs in developing regions.

In 2006, while a Stanford Biodesign fellow himself, Kumar co-invented a radically improved heart device, the Zio Patch, a translucent, silver, wearable sensor that detects intermittent, irregular heartbeats, called arrhythmias. This device and information service, marketed through iRhythm Technologies Inc., which Kumar founded, is a good case study on the difficulties startups face in getting their inventions into the hands of physicians. (Disclosure: Stanford University has financial ties to this company.)

FOLLOW YOUR HEART - Uday Kumar co-invented the Zio Patch to improve detection of irregular heartbeat rhythms.

The old standard for detecting arrhythmias, designed 60 years ago, is the Holter monitor, a boxy device worn around the neck or on a belt, with electrode wires that have to be positioned in multiple locations across the chest. Unlike the Zio Patch, the Holter device typically records only a day or two of heartbeats. It is uncomfortable to sleep in and it can’t get wet.

Zio Patch users, on the other hand, adhere a 2-by-5-inch sensor on the chest over the heart, where it continuously records all heart activity for up to 14 days. Users tap a button on the device to flag when they feel symptoms, so that the specific heartbeat activity at that time is highlighted on the physician’s report. After the monitoring period, patients mail the patch back to iRhythm’s data center. The heart data is analyzed and a report is prepared for electronic review by a physician.

Evidence says that patients who use the Zio Patch find it easier to wear over long periods of time, so it is more likely to record an arrhythmia and lead to an early, lifesaving intervention, such as a pacemaker. It can be prescribed by primary care physicians, so it could save on the cost of referrals to specialists. And it speeds the time to diagnosis and treatment, potentially reducing the expenses of hospitalization and surgery. These results were published in a study led by prominent Scripps Health cardiologist Eric Topol, MD, published online Jan. 3, 2013, in the American Journal of Medicine.

Despite the fact that the Zio Patch was cleared by the FDA in 2009, and patients and physicians prefer it to the Holter monitor, adoption has hit some snags because not all regional Medicare and Medicaid programs reimburse it fully. This affects people with private insurance as well, as many private insurers are slow to reimburse for a new device unless it’s also fully covered by Medicare.

 

Getting on these reimbursement lists and being compensated fairly for creating paradigm-busting devices is difficult. Rather than having free-market, supply-and-demand forces determine the retail price of new devices, prices are set annually by a committee from the Centers for Medicare and Medicaid Services. The quickest route for a device to get on the government list is to be assigned an established reimbursement code used by older devices, and sometimes the company can apply for a new technology “add-on” reimbursement that will help cover the additional value and cost of the new device. Or a company can apply for a temporary code for the initial deployment of the device or service.

Either way the manufacturer must gather further evidence to prove that its device or service provides additional features and benefits. But, often by the time this evidence is gathered, the submission windows have closed and the manufacturer has to wait another year to go before the coding and price-setting review committees. In the meantime, insurance claims are denied because of “insufficient evidence of clinical improvement.”

Herein lies a Catch-22 of launching new heart gadgets: Care providers rarely prescribe devices that aren’t on the reimbursement lists, and cash-strapped startups often have trouble financing the large, evidence-gathering studies required to gain acceptance by the FDA, insurers and physicians. Because of this, the mortality rate of new device companies is high.

“Between the requirements of FDA regulation and reimbursement, the U.S. seems to be doing its best to starve the innovation ecosystem in medtech,” says Paul Yock, MD, director of the Stanford Biodesign Program. “We are being as adaptive as we can in this new environment, but we are facing the most challenging set of conditions we have experienced for many decades.”

Despite this, Kumar is hopeful: “If the problem being addressed is important and the idea truly has merit and is beneficial to patients, providers and the health-care systems as a whole, companies can make it through, even though it may be slow going at first and require a company to raise significant capital to get through this.” 

 

The persuader

Marie Guion-Johnson, CEO of AUM Cardiovascular, is on the money trail. She needs to raise a second round of capital by the end of the year to finish the clinical trials required to get her new heart device through the FDA-approval process.

This device, called the CADence, detects blocked arteries from the surface of the chest. The device, a sleek, palm-sized unit that looks a bit like an air hockey paddle, is placed at several locations on a person’s chest, where it digitally records signals of blood flowing through arteries. Proprietary software identifies the noisy signals of blood turbulence associated with arterial blockages, then generates a report to help physicians with diagnosis and treatment plans.

Guion-Johnson, a bioengineering PhD, adjunct professor of biomedical engineering at the University of Minnesota and former Stanford Biodesign fellow, founded her company in 2009 for personal reasons — she wanted to create a heart device that could’ve saved her first husband’s life. At age 41, he died unexpectedly of a blockage in the left anterior descending coronary artery, nicknamed “the widow maker” for its frequent involvement in sudden cardiac deaths.

Her early research into using acoustics for detecting coronary artery disease took her all over the world during a stressful time of her life.

“In 2004 I moved to Turin, Italy, to study coronary hemodynamics with a professor at the Politecnico di Torino,” says Guion-Johnson. “The people around me thought I had lost my mind. I didn’t know Italian, my son was 2 years old and my daughter was a first grader. I was a single mom without a clothes dryer or a car in a foreign country. At the time I thought I’d never make it but here I am.”

Because no similar devices exist to detect obstructive artery disease the FDA considers the CADence novel, and this makes its road to approval for use and insurance reimbursement more complex, time-consuming and expensive.

After FDA approval, she says her next big hurdle will be physician acceptance. And she believes that one of the quickest ways to get doctors to try a new class of device is to gather safety and efficacy data in a clinical trial, then have her participating cardiologists publish the results in high-profile medical journals. A trial is under way.

“You can see the obvious benefits [of CADence],” says Robert Wilson, MD, a cardiology professor at the University of Minnesota and the former chair of the CADence clinical trial. “There is absolutely no risk, and the cost is substantially less than a heart stress test, both to the health-care system and to the patient.” 

LISTENING IN - Marie Guion-Johnson created the CADence to identify blocked arteries inexpensively and without risk to patients.

Sometime during the fourth quarter of this year, the company will analyze the results of the CADence FDA “pivotal clinical trial,” which is being run at 13 research institutions, including the Mayo Clinic, University of Minnesota and UCLA Medical Center. Guion-Johnson is hoping that these results will show that her device, which is expected to cost around $120 a test, will reduce the need for expensive nuclear heart tests, where patients are injected with radioactive tracer and their heart is photographed with special cameras. A nuclear stress test can cost $900 or more.

“This disruptive technology has the potential to save thousands of lives a year,” says Guion-Johnson. “Getting this idea to market has been more difficult than I ever imagined, but I know it’ll be worth it.”

 

The bridge builders

Back at his office inside Stanford Hospital, McConnell sits at a desk that offers a visual reminder of the chasm between the dream and the reality of new heart gadgets. On one side of his desk is the “big picture” — a colorful architectural rendering of a planned heart-gadget information center. Styled after Apple’s genius bar, it includes demonstration units of heart- and fitness-monitoring devices, posters and experts to help educate consumers on the latest offerings.

On the other side of his desk are tall stacks of old-fashioned patient folders. McConnell points to one stack in the corner of his office. “Those are some Zio Patch reports waiting to be reviewed,” he says. Though Zio Patch reports are electronically available, in the short term, the hospital still uses the old Holter-era process of printing readouts on paper, primarily so that it’s easier to work with the community physicians who lack access to electronic medical records or prefer paper reports.

This illustrates an important point brought up by both McConnell and Kumar — whatever new heart devices come along, someone has to make it easy to integrate them into health-care providers’ electronic medical record systems and physicians’ daily work flow. Bridging this divide means device developers also have to become systems integrators and software developers.

Early in the development of Zio Patch, Kumar realized that iRhythm had to become more than a device company.

“We had to provide a complete solution that enabled the use of the Zio Patch,” he says. “So that meant spending a few years and significant resources building a sophisticated algorithm to analyze the heartbeats. We also had to create a completely new way of presenting all of this data in a report, so it could be usable by all types of physicians, from super-specialists to generalists. And then we had to provide all of the back-end logistics regarding processing devices and reports. In the end, I like to think of iRhythm as an information technology company enabled by a novel device supported by a service.” The company’s total solution costs about four times more than a Holter monitor per patient, but collects seven to 14 times more heart data. The hope, says Kumar, is that the Zio Patch will result in cost savings to the medical system over time. So far it has been prescribed to more than 150,000 patients.

 

The heart gadgeteers are a special breed. Part visionary and part bulldog, they know that medical device development is not a get-rich-quick business. It’s a passion that drives them to get up every morning for years, and, one by one, knock off the 10,000 steps required to get an innovative new medical device into the hands of physicians and patients.

There’s a lot at stake as the nation struggles to improve overall health while reducing medical costs. But by moving these heart devices into the mainstream, the gadgeteers know they can significantly reduce the physical, financial and emotional impacts of cardiovascular disease, the leading cause of death in the United States. SM

 

Contact Kris Newby