Dr. Zubin J. Eapen, MD, MHS, FACC, FAHA is chief medical officer at Element Science, where he leads clinical trial and commercialization efforts for the company. Previously, Eapen served as corporate vice president of Anthem and chief medical officer of its subsidiaries CareMore Health and HealthCore. He is an adjunct associate professor of medicine at Duke University and serves on the board of visitors for Duke University School of Medicine, and is also the editor for the 14th edition of Hurst’s the Heart, the second most widely circulated cardiovascular textbook in the world.

HealthCare Business News spoke to Eapen about the significant opportunity he saw to improve the utility and the effectiveness of wearable cardioverter defibrillators to prevent sudden cardiac death.

HCB News: Please tell us about the limitations of the existing devices and why yours is surmounting those limitations.
Dr. Zubin J. Eapen: The existing wearable cardioverter defibrillators (WCDs) are removable vests and have several limitations. Traditional WCDs, which have been largely unchanged for decades, were not designed with the patient experience in mind. They are cumbersome, heavy and do not integrate well into the patient’s daily life. For instance, patients have to remove them frequently to charge the battery, clean the vest, and shower. Further, the vest is tight in order to ensure electrode contact, and that creates a feeling of being constrained. In combination with these discomforts and inconveniences, the high false alarm rate further makes the devices hard to live with. They are constant reminders to patients of their disease, which is emotionally taxing. Every time the patient takes the device off is an opportunity to not put it back on. Wear-time compliance is a significant issue and leaves patients unprotected. Our device overcomes these limitations by being wearable, comfortable, and suitable for 24/7 use, including during showers. Additionally, the machine learning algorithm minimizes false alarms, making it a more user-friendly and effective solution.

HCB News: What were the key factors that led you to innovate and develop a new form factor for a wearable defibrillator?
ZE: The idea for a new form factor emerged from the need to create a device that would be both wearable and compatible with activities of daily living. The existing wearable defibrillators were not designed to seamlessly integrate into a patient's life; the consequences of noncompliance are significant and include avoidable arrhythmic death. As a cardiologist, I could see the clear need for a more wearable solution. As an innovator in wearable devices for cardiovascular disease, I could see that trends in miniaturization, machine learning, and on-body wearables could be used to make a more patient-friendly solution.

HCB News: Can you share insights from the clinical studies you conducted and how the results impact patient outcomes and the adoption of your device?
ZE: We are very encouraged by the results from the Jewel IDE Study, which assessed the safety and effectiveness of the device in patients at risk for sudden cardiac arrest. Results from the study have been accepted as Featured Science at the AHA Annual Scientific Sessions. The data is embargoed in advance of publication so I can’t share the details, but those will be available publicly starting November 13th.

HCB News: What are your expectations for the adoption of your device among healthcare professionals, and how do you believe it will impact the standard of care for patients at risk of sudden cardiac arrest?
ZE: We anticipate strong adoption of our device among healthcare professionals, primarily because the device addresses the key limitation of compliance. Physicians have expressed confidence in the device, and many believe that it will become a first-line solution for patients at risk of sudden cardiac arrest. It can be discreetly worn, and patients are more likely to use it consistently due to its comfort and convenience. We believe that the Jewel has the potential to become a standard of care and give patients a better chance for the best possible outcome should they experience sudden cardiac arrest.

HCB News: Can you share any insights about WCDs regarding patients recovering heart function and no longer needing an ICD (implantable cardioverter-defibrillator)?
ZE: Patients who initially are at risk for sudden cardiac arrest may not need an implantable cardioverter defibrillator (ICD) in the longer term due to recovery of heart function. Today, the likelihood of this happening has increased thanks to advances in treatments for heart failure. If patients will actually wear the WCD during this initial period of higher risk,, there is the potential that we can give them the time they need to allow the healing process to progress and potentially avoid unnecessary ICD implantation. This underscores the importance of having a temporary, wearable solution that can adapt to the changing needs of patients.

HCB News: How do you envision the impact of your device on healthcare systems and the patient experience, particularly in the context of temporary risks and long-term management?
ZE: Our device has the potential to positively impact healthcare systems and patient experiences by helping health care providers offer a life-saving solution for patients at risk for sudden cardiac arrest. It offers a seamless and comfortable experience that fits into the lifestyle of patients. It empowers patients to take control of their health while maintaining a high quality of life. Some of these patients are on the path to recovery and can use our device as a temporary solution until their risk diminishes. This not only improves patient outcomes but also reduces the unnecessary burden on healthcare systems by avoiding premature ICD implantations.

HCB News: We’ve come to understand that Element Science has an ethos of diversity, and you’ve said that at the end of the day, it’s a competitive advantage and helps with a culture of innovation. Tell us about that.
ZE: Having a variety of people with different experiences and backgrounds is an essential part of the company's culture, and it has been from the outset. We choose to reflect the diverse communities we serve in our own organizational DNA, and that defines us as an organization. Bringing people with different backgrounds and perspectives together leads to better decision-making and problem-solving. At Element it’s the important driver of innovation and enables the best solutions.

HCB News: How do the scientific advisors and national investigators contribute to the company's success?
ZE: The scientific advisors and national investigators provide valuable insights and expertise that help the company refine its product and study its applications in various patient populations, thus contributing to the company's overall success.

HCB News: What is the company's long-term vision for the impact of their product on healthcare?
ZE: The company's long-term vision is to not only provide a better wearable defibrillator but to fundamentally change the experience of the patient journey from hospital to home, leveraging wearable devices powered by AI and ML to reduce healthcare disparities and improve outcomes for all.