Millions of Americans with irregular heart rhythms are leading full lives today, thanks to Medtronic implanted cardiac devices and remote monitoring capabilities — including implantable cardioverter defibrillators (ICDs), which Carol Malnati was instrumental in developing as a product development engineer earlier in her career.

An active and honored member of the Society of Women Engineers, today Malnati is vice president, Cardiac Implantables Technology Development Center at Medtronic, where she leads R&D and engineering efforts for the Cardiac Rhythm businesses. Medtronic is among the world's largest medical technology, services, and solutions companies — alleviating pain, restoring health, and extending life for millions.

In 2020, we saw a flood of medical news on the growing use of telemedicine — and more specifically, how cardiac arrhythmia patients were relying on remote monitoring technologies during the pandemic. Was the pandemic a catalyst for this technology?

We saw a dramatic jump in usage of our remote monitoring solutions for cardiac devices. The majority of our implantable electronic heart devices are supported by advanced Internet-based remote monitoring technology. And, our remote monitoring capabilities were a game changer for patients and healthcare providers during the global pandemic because these solutions enabled routine device checks to be completed remotely from the patients’ homes rather than requiring them to come into the clinic and potentially be exposed to the coronavirus.

Specifically, in 2020, we saw a 116 percent increase in CareLink Express mobile placements. CareLink Express mobile uses a tablet to check a patient’s cardiac device in a variety of healthcare settings (e.g., emergency rooms, operating rooms, procedural areas, hospital nursing floors). The COVID-19 pandemic created a skyrocketing usage of remote monitoring, with more than 1,700 new patients being added to our CareLink Internet-based remote monitoring network each day.

We saw this as a moment — for physicians and patients — that underscored the value of digital healthcare. In the case of remote cardiac monitoring, it meant being able to record timely device and physiologic data — and to send that data securely over the Internet to the patient’s healthcare team. It not only kept countless cardiac patients out of the ER and helped them avoid in-person clinic visits, but it also helped limit use of personal protective equipment (PPE) and freed up hospital beds for critical-care patients.

Today, not only can we receive data on patients’ cardiac functions, but we can actually reprogram some device settings from afar, such as for patients who are undergoing MRI scans, as well as remotely reprogramming our newest insertable cardiac monitor (ICM), called LINQ II™. This means we can provide technical support without having our field personnel in the same room — again, reducing exposure and saving valuable time for patients and healthcare providers.

From the perspective of a product development engineer, would you say it’s been a steady evolution of the technology design and applications to get to this point?

Looking back on the past few decades of our development process, it seems inevitable that we’d have remote monitoring systems that are this functional, intuitive, and reliable today. But you could say there were three primary make-or-break technology developments that paved the way: 1) access to the internet and eventual cloud connectivity, 2) the proliferation of consumer electronics and Bluetooth communication technology, and 3) advances in sensors and diagnostic technology.

In parallel with these advances, we also benefited from refinements in microelectronic circuitry, increased speed of data transmission, and a recognition of the importance of user-experience design. Medtronic continuously fueled progress by investing in specialized engineering expertise in systems architecture, software design, and human factors.

The first technology enabler — the Internet — allowed patients’ devices to be remotely monitored. And even in the 1990s, long before Google was a household name, we had a bold vision of managing cardiac device patients utilizing the Internet. We began working with the FCC in 1999 to dedicate a frequency band for medical device transmissions, known as MICS in the U.S. and MICS/MEDS elsewhere in the world. We also built a secure back-end system to protect patient health information, clinician-facing websites and in-home patient monitors.

By 2002, we had launched our first cardiac remote monitoring system in the U.S., called the CareLink network, and within a few years began seeing significant gains in patient adherence and health outcomes.

The second technology advance was around the proliferation of consumer electronics, which meant we could finally meet patients where they were — instead of requiring them to come to the clinic or hospital. Bluetooth® technology and modern mobile consumer electronics were still in development when we identified the need to pivot from our proprietary telemetry to an open, but protected, platform.

But the first iteration of Bluetooth wasn’t well-suited to medical applications; it didn’t meet our security standards, and it drained batteries too quickly. That prompted our engineers to develop something we called BlueSync™, which uses a low-energy form of Bluetooth and solved both of those problems.

After rigorous testing for reliability and security in real-world conditions, we implemented BlueSync across our entire family of implantable devices, which required a complete changeout in electronics and firmware and a whole new mechanical package. Now more than 365,000 patients across 35 countries experience the ease of BlueSync monitoring.

What direction are you seeing in remote monitoring technology today?

It was a huge breakthrough for patients in 2017 when we could monitor their pacemakers via smartphone, instead of a bedside monitor. Today, 25 percent of patients use their smartphones and a Medtronic app as their heart monitor. And with app-based monitoring comes significant increases in patient adherence to their doctor’s guidelines — we saw an increase from 77 percent to 95 percent when they switched to the mobile app from bedside monitors.

Because smartphone technology is constantly advancing — along with consumer expectations for simpler, more convenient, more intuitive experiences — we are continuously upgrading our patient mobile app. Now the app-based monitoring is available to patients across the entire cardiac device portfolio.

And the third technology milestone for remote cardiac monitoring was the development of a new generation of sensors, data, and diagnostics. Our investments in research, technology, and product development allowed us to develop new physiologic sensors and apply predictive analytics.

In 2014, we launched our first miniaturized insertable cardiac monitor, the Reveal LINQ™ICM. Now in its fifth generation, this device is inserted under the skin and monitors the heartbeat. Medtronic ICMs leverage a sophisticated, precise atrial fibrillation detection algorithm, deep miniaturization, and link to a mobile management and monitoring service. The advanced technology is producing more exact data – patients are 4.3 times more likely to reach a suspected atrial fibrillation diagnosis with a Medtronic ICM in 12 months compared to a one-time 30-day monitor.

Can you sum up what these engineering advances mean to the average cardiac device user today?

In a word, this technology means freedom. Freedom for patients to get on with their lives, knowing they can have remote connectivity of their pacemaker or defibrillator’s operation to their healthcare provider through these technologies. The patient has basic visibility to their device just by checking an app on their smartphone, for example. With advanced technology widely available — more than 1.5 million patients monitored — patients can expect this type of freedom in their healthcare experiences. Beyond that, the precision, reliability, and personalization of these remote monitoring devices means greater peace of mind — so reassuring to heart patients.

Does the current technology ecosystem give any clues as to what’s next for remote cardiac monitoring?

We’re seeing a wider variety of remote monitoring technology — from wearables to new smartphone apps — now available to monitor, diagnose and/or treat diverse health conditions, due to COVID-19. Likewise, I’m confident we’ll see increasingly convenient and personalized solutions for more people with a variety of heart conditions — solutions that are integrated across patient and physician platforms and devices, for more meaningful and accessible insights into a range of physiologic factors.

Along the way, our growing mastery of user-experience and patient-centric focus design will continue to simplify and improve the way we interact with these devices as well. And finally, as our predictive analytics grow, these technologies should be able to better forecast potential heart health problems. And with our rapidly aging population — and heart disease now the #2 cause of death in the U.S. after COVID-19 — that could be life-changing for millions.

Sherrie Trigg

Editor and Director of Medical Content


Medical Design Briefs Magazine

This article first appeared in the July, 2021 issue of Medical Design Briefs Magazine.

Read more articles from this issue here.

Read more articles from the archives here.