How a MedTech and Engineering Services Partnership Is Saving Lives with a Breakthrough Cardiac Recovery System

Sudden cardiac arrest (SCA) claims the lives of 436,000 people in the United States each year, with more than 350,000 events occurring outside the Hospital¹. When an out-of-hospital arrest (OHCA) occurs, help is needed immediately. However, without a bystander nearby or medical equipment on-hand, those at risk of SCA are left without protection. To protect those at risk of SCA, Kestra Medical Technologies introduced the ASSURE® Wearable Cardioverter Defibrillator (WCD) to help deliver lifesaving care in these critical situations.

Although the startup MedTech company held deep expertise in the development of Class III therapeutic medical devices, the company sought advanced cloud and mobile application development resources to help build the next-generation digital healthcare platform it envisioned. Kestra partnered with the product team at GlobalLogic, a Hitachi Group company, to design a uniquely data-enabled, connected platform. As a result, in 2021, the ASSURE Cardiac Recovery System was introduced. The ASSURE system is a modern approach to sudden cardiac arrest protection. It includes the ASSURE WCD, the ASSURE patient app and the Kestra CareStation™ remote patient data platform, all working together as a digital healthcare system to support and protect at-risk cardiac patients.

Since launch, the system has already benefited thousands of cardiac patients.

Data from the American Heart Association shows that nearly 74 percent of OHCAs occur at home², and according to the Cardiac Arrest Registry to Enhance Survival (CARES), almost half of all OHCAs are unwitnessed.³

The ASSURE system does not require action from the patient or bystanders to provide a lifesaving intervention. Worn outside the body, it continuously monitors and automatically detects abnormal heart rhythms. Then, if necessary, the system can autonomously deliver a therapeutic defibrillation shock to restore the heart’s normal rhythm.

“The ASSURE system fits in the healthcare system at a time that is crucial for patients — when their doctor has determined they are at elevated risk of a sudden cardiac arrest,” says Kestra Vice President of Clinical Marketing Laura Gustavson. “Taking patient and provider needs into account, we designed a WCD that is comfortable enough for 24/7 wear, an app that makes it easier for patients to participate in their own cardiac recovery process, and a data platform that gives providers valuable information to help them tailor lifesaving protection for their patients.”

The Kestra and GlobalLogic partnership supported the delivery of a next-generation system differentiated by garment comfort, algorithmic performance, and digital platform functionality.

• Breathable, lightweight garments that integrate cushioned electrocardiogram (ECG) sensors and hold defibrillation therapy pads. Easily hidden under clothing, garments come in two styles with a wide range of sizes.
• Safety and efficacy in detecting abnormal ventricular heart rhythms and providing therapeutic defibrillation. The ASSURE detection algorithm utilizes four channels of ECG and, over time, adapts to the patient’s baseline rhythms to help reduce false alarms.
• The ASSURE patient app automatically transmits data (at set intervals or when the patient chooses) to the remote data platform. Activity and usage data encourage patients to engage in their own recovery and more readily return to everyday life.
• The Kestra CareStation™ data platform lets clinicians access patient data and gain valuable insights into heart rhythms, trends and patient compliance. Reports include ventricular tachycardia, ventricular fibrillation, bradycardia, asystole, and non-sustained ventricular arrhythmia episodes, as well as WCD usage and physical activity trends. A population dashboard enables configurable notifications for clinicians and care teams.

The ASSURE system was designed to offer an array of benefits to patients and their healthcare providers, including:

• Increased patient comfort and compliance.
• Enhanced patient confidence during their recovery process.
• Clear connection and insights for improved mobile patient monitoring.
• Simplified remote patient data platform for clinicians.

To ensure regulatory specifications were met, Kestra relied on GlobalLogic’s expertise in designing integrated systems to comply with medical-device software standards and FDA quality requirements. In addition, the MedTech company also benefitted from GlobalLogic’s cloud and mobile app developer resources, as well as its strong design experience, to create a state-of-the-art system that puts the patient first.

“Finding ways to deliver better patient outcomes is at the center of everything we do,” says Kestra Senior Manager of Software Engineering Jeff Boschee. “The GlobalLogic team shared our commitment to our design approach we call Empathy Powered Design™ that focuses intensively on the experiences of the patient and those who care for them. As we continue to develop new lifesaving therapies, we know that the GlobalLogic team is fully aligned with our mission.”

In 2022, the ASSURE system was recognized as one of the winners of the Medical Design Excellence Awards.⁴ Now available in-network to more than 100 million insurance plan members across the U.S., the system is an excellent example of GlobalLogic’s contribution to digital healthcare and Hitachi’s vision of “Powering Good.”

“Digitalization and technology are moving healthcare forward at an unprecedented pace,” says GlobalLogic Software Engineering Director Stefan Blicha. “Whether it’s diagnostics, modern digital tools or doctor-patient interaction, technology constantly evolves to enable constant improvement. We expect the quality of medical care and patient quality of life to constantly improve, particularly when it comes to the prevention of diseases.”

Nitesh Banga, president and CEO of GlobalLogic, agrees that the partnership with Kestra is playing a critical role in the evolution of MedTech. “GlobalLogic’s chip-to-cloud product development competency is just one of the engineering services that helped the Kestra team develop innovative and high-quality solutions for patients and clinicians,” he says. “As a Kestra partner of nearly a decade, we’re excited to continue to support their work in evolving the product line, as well as scaling and extending into new geographies to deliver more lifesaving technologies to more people.”

As Kestra grows, the company remains committed to creating best-in-class products and platforms through active research and product development — without sacrificing safety, efficacy, ease of use, or patient and caregiver empowerment. “We’ve been able to realize our vision at scale in partnership with GlobalLogic,” says Brian Webster, president and CEO of Kestra. “In a fast-paced industry that’s always evolving, our partnership keeps us on the cutting edge of mobile technology.”

To learn how GlobalLogic can provide you with a cost-effective, scalable, highly competent and quality process-compliant software engineering product development team, visit https://www.globallogic.com/services/industries/healthcare-life-sciences/.

 

1. American Heart Association, “CPR Facts & Stats,” https://cpr.heart.org/en/resources/cpr-facts-and-stats
2. American Heart Association, “2022 Heart Disease and Stroke Statistics Update Fact Sheet,” https://www.heart.org/-/media/PHD-Files-2/Science-News/2/2022-Heart-and-Stroke-Stat-Update/2022-Stat-Update-At-a-Glance.pdf
3. Cardiac Registry to Enhance Survival (CARES), “CARES 2022 Annual Report,” 2022, https://mycares.net/sitepages/uploads/2023/2022_flipbook/index.html?page=1
4. MDDI Staff, “2022 Medical Design Excellence Awards Winners,” April 7, 2022, https://www.mddionline.com/design-engineering/2022-medical-design-excellence-awards-winners