Posted: 09 Feb. 2023 6 min. read

Medtech company gets to ‘the heart’ of data, cloud, RWE

8 questions for heart-pump manufacturer, Abiomed

By Karla Feghali, senior manager, head of ConvergeHEALTH Services, Deloitte Consulting, LLP

It has been almost 60 years since President Lyndon B. Johnson designated February as American Heart Month—a month-long opportunity to highlight best practices and innovations in detecting and treating cardiovascular disease.1 Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups.2 In the US, a person dies every 34 seconds from cardiovascular disease, which accounts for about one in every five deaths (nearly 700,000 people a year). The global cardiovascular devices market is projected to grow from $54.08 billion in 2021 to $86.27 billion by 2028.3

Abiomed, Inc., a medical device technology company that develops and manufactures the world’s smallest heart pumps, was recently acquired by Johnson & Johnson's Medtech Segment. Abiomed was founded in 1981 with the goal of developing the world’s first artificial heart.4 Over the years, the mission evolved into a commitment to develop new approaches to help heart patients recover from cardiovascular diseases. Abiomed manufactures the Impella(R) platform of temporary mechanical circulatory support devices for both the right and left sides of the heart.

I recently had an opportunity to talk with Dawn Bardot, Ph.D., general manager of Global Service and Cloud Product at Abiomed, about her company’s technologies and the role real-world evidence, artificial intelligence, and cloud technology plays. Here’s an excerpt from that conversation:

Karla: Can you explain how your heart pumps work and what makes them unique?

Dawn: Our patients tend to be very sick and are often being treated for cardiogenic shock or advanced cardiac disease. The heart pump allows the patient’s heart to rest and recover. It ensures the flow of blood to the patient’s organs so the doctors can evaluate the patient, perform therapies, place stents, and revascularize the patient. The patient might be too sick for such an intervention without a heart pump. We have pumps that can support either the left or right side of the heart, depending on the patient’s specific need. We want patients to go home with their native heart. What makes our pump innovation unique is our evidence-development strategy, our cloud platform, and our use of data and analytics. We have almost two decades of knowledge and data.

Karla: How is cloud technology used in these devices?

Dawn: Our cloud capabilities allow us to see 95% of our deployed devices. With this technology, a doctor might be at home but still able to securely monitor the patient who is in the hospital. It can also make it possible for a consulting physician to collaborate remotely. We have a 24/7 clinical support center that keeps an eye on all of the pumps in use. During the [first year of the] pandemic, being able to connect everything in the cloud meant the physician, the heart team, and our clinical care team could monitor the pumps remotely. Physicians could also provide updates to the patient’s family and explain what to watch for during the recovery.

Karla: Your devices generate a lot of data. How is that information used?

Dawn: Device-generated data is typically used for post-market surveillance and compliance management. We use it more exponentially. Along with conducting post-market surveillance on every device, we use the data to perform predictive analytics. We can combine hemodynamic data from the pump with physiologic information from the patient’s EMR [electronic medical record], which is all deidentified, to build predictive analytics that will, for example, give indications of probability of heart recovery. We have pump data on more than 250,000 patients in what we call our IQ database, which is our Impella Quality assurance database that, among other things, helps us track health outcomes for all of the patients we have treated. About 95% of our patients are monitored through our cloud technology, which was implemented about two and a half years ago. Data from over 60,000 pumps have now been collected via our cloud platform.

Karla: What role does artificial intelligence (AI) play in patient management?

Dawn: AI is the future of patient management. These incredibly sick patients are on a very specialized device, and AI means the care team has access to our combined best knowledge and experience. The information they use to make decisions is tailored to that specific patient based upon the outcomes of all the patients that came before. That's the opportunity that AI offers. Combining AI with the sensors in the pump and predictive analytics creates a data stream that can be highly predictive. For example, it can determine when the patient is likely to become hypotensive or develop other issues while the device is in use. This can give the physician time to prepare for that event and help ensure the patient gets the right therapy at the right time. We also use AI to help identify patients for clinical studies, which can increase access for diverse participation.

Karla: There are a lot of medical devices generating tremendous amounts of health data. But there generally is not much interoperability between devices. What will it take for digital health data to reach its potential?

Dawn: About three years ago, we ran our first clinical study on our flagship heart pump transmitting data to the cloud. Today, over 1,500 US hospitals and another 450 outside of the US are on this cloud platform. That’s an exponential change. Now the hospitals would like to pull data generated by the pump and stream it into the patient’s EMR with no human intervention. This enables streamlining data collection and reduces the burden on clinicians. In this space, interoperability is definitely a challenge. We are still very much in the early days. We are working with a handful of hospitals to integrate data from our devices into their clinical setting either through an EMR or some other tools. Right now, we have to build this one hospital at a time, and that is not a scalable path.

Karla: How do you identify patients to participate in your clinical trials?

Dawn: This is incredibly important to Abiomed. When we think about clinical-trial participation, we consider two buckets—the patient side and the provider side. We want to make sure that we can identify the patients who are most appropriate for a study. Patients often find out about a study through word of mouth or from their physician. We also find patients by mining real world data. This type of tool can open the patient-access window much wider. On the provider side, we know that participating in clinical studies can be burdensome. Physicians from small hospitals might not have the resources they need to participate. Our newest real world evidence initiative—Long-term Outcome and Quality Indicator (LOQI) can automatically transfer data from the EMR into the electronic data capture (EDC) using the Fast Healthcare Interoperability Resources (FHIR) standard. This reduces the effort needed for physicians who want to participate in our clinical studies, which means we can include smaller and rural sites as clinical study partners and as a result capture greater patient diversity. Efforts like these will help fill a gap in data that has long-plagued clinical trials and registries, which is the lack of representation of these rural and community centers in large data sets. We know our demographics and we use various diversity measures in our clinical studies. We think a diversity of information is important in the labeling of our device for transparency and for physicians and patients to understand how the device performs in various populations.

Karla: What role did real world evidence (RWE) play in the development of your heart pumps?

Dawn: Abiomed has always valued RWE, which we use to identify best practices and protocols, and to support the highest possible survival rate for native heart recovery. We don't limit the use of RWE to regulatory decisions. In 2021, the Food and Drug Administration (FDA) published 90 examples of RWE used in medtech device regulatory decisions. Abiomed was included in four of those examples. I think that gives gravatas to the importance of RWE to us and to regulators. RWE in medical devices can be challenging because devices generally don’t have billing codes. It is important that we design our studies to measure the outcomes that we're looking for. Device-generated data represents a huge wealth of potential real-world evidence. But we are just scratching the surface. We really have to figure out how to combine this data with other types of patient data to create a whole-patient view.

Karla: What advice do you have for medtech companies that are just beginning to use device generated data and RWE?

Dawn: We generate terabytes of data that can provide us with a continuous stream of information on novel metrics that doctors might never have seen before. But with new data comes new challenges. A company needs to determine if the data is truly fit-for-purpose or if it is confounding. It is only after the evidence has been vetted that we can determine if the quality is high enough and reproducible. Then we know we have something that can be used as evidence. The right data can be a fundamental differentiator for any medical device manufacturer. We have knowledge that is second to none…but I always want more.


1 American Heart Month: Be Prepared to Save a Life, American Red Cross

2 Heart Disease Facts, Centers for Disease Control and Prevention, October 14, 2022

3 Global Cardiovascular Devices Market to Offer Growth, SkyQuest Technology Consulting, November 1, 2022

4 Abiomed: Our story

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