Aaron Chatterji, Ph.D.
Professor, Duke University, Fuqua School of Business and Sanford School of Public Policy

Eric Peterson, M.D.
Fred Cobb, M.D. Professor of Medicine, Duke University, Duke Clinical Research Institute

Ann Marie Navar, M.D., Ph.D.
Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine

Neha Pagidipati, M.D., M.P.H.
Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine

Patrick Dunn, Ph.D., M.B.A., FAHA
Senior Program Manager, Connected Health, Center for Health Technology & Innovation, American Heart Association

Patrick Wayte, M.B.A.
Senior Vice President, Center for Health Technology & Innovation, American Heart Association

Purpose and Background

Cardiovascular disease (CVD) ranks as one of America’s most common and deadliest diseases. CVD is also one of the costliest to care for. Currently about 17% of the U.S. health care expenditure goes toward CVD.1 By 2030, direct medical costs of CVD are projected to triple, exceeding $1 trillion per year.

The subspecialty of cardiology has been a model for innovation. Over the last several decades, almost no area of medicine has seen such remarkable advancements as CVD. From thrombolytics to novel coronary stents, from cardiac catheterization to advanced cardiac imaging, from implantable defibrillators to cutting-edge ablation techniques, and from statins to PCSK9 inhibitors, cardiology continues to churn out discoveries. This innovation has not only changed medical practice but has also contributed to a marked decline in cardiovascular disease death and disability. Between 1973 and 2010, deaths from CVD in the U.S. declined by 61%.2

Despite such success, some fear that cardiology may have lost its innovative edge. Increasing regulatory oversight, the high cost of therapeutic clinical trials, limitations on insurers’ willingness to pay for innovation, and cultural changes in training all have been cited as factors slowing innovations in CVD care. Although venture capital investments in health care startups have been increasing (reaching nearly $18 billion in 2017), investments in cardiovascular “translational research” has slowed remarkably. Moreover, industries such as medical devices, which played a key role in previous waves of innovation, have experienced a relative decline in venture capital funding, decreasing from 13% of all deals 25 years ago to only 4% today. Furthermore, many industry experts have argued that corporate research and development is becoming less productive and that health care is experiencing an “innovation crisis.“ Regulation and reimbursement challenges continue to be significant for some technology areas, leading to concerns that red tape is curtailing future waves of innovation. Finally, the concern has also arisen that the next generation of innovators is flocking to different fields with fewer frictions, such as internet technologies, further reducing the chances of breakthrough advances in health care and in CVD in particular. Thus, understanding how cardiology was able to become such a ripe field for medical innovation and studying whether and how the field can continue to innovate are both important.

This report is designed for entrepreneurs, investors, policymakers, academics and clinical leaders interested in the factors that drive innovation in cardiovascular (CV) health. The report is divided into 10 chapters, each of which explores a different perspective on how CV innovations are developed, deployed and scaled. Through case studies and key statistics, we document how academic medical research (Chapter 1), maverick physician inventors (Chapter 2) and the patients themselves (Chapter 3) have led to significant advances in CV health. Next, we describe the ecosystem that harnesses these ideas and commercializes them into products, exploring corporate R&D (Chapter 4), venture capital (Chapter 5) and clinical/academic research organizations (Chapter 6). We then investigate how today’s regulatory (Chapter 7) and reimbursement (Chapter 8) environment is shaping the incentives to develop new ideas. Finally, we explore how the future of CVD medical innovation in fields such as digital health (Chapter 9) are being shaped by the next generation of health care innovators (Chapter 10).

Key Themes

This report articulates several broad themes that we hope to highlight in ongoing efforts by the AHA, its supporters and the broader health care ecosystem.

Several examples of innovations are included that have led to breakthroughs in the science of health and disease. Common themes appear in these examples. First, all of the examples involve a significant medical problem or a gap in care, such as elevated LDL cholesterol in patients on a statin, dissection of coronary arteries during angioplasty, or undiagnosed atrial fibrillation. Second, the initial innovation was typically a science-based solution to an important problem. Third, the innovation was able to be validated with empirical research. Fourth, the solution was disseminated and accepted broadly by clinicians, consumers and payers.

These four themes illuminate important lessons for those interested in spurring even greater innovation in CV care. First, identifying the most important problems to solve requires collaborations among scientists, clinicians, industry, regulators and patients. Chapter 1 highlights the importance of these collaborations through the story of PCSK9 therapy, where academic research identified the therapeutic targets for which industry would eventually develop biologic treatments. As the field has matured, the sources of innovation have also changed. Early advances in CV care, particularly in medical devices, came from innovative clinicians such as Tom Fogarty and Richard Stack. Innovation in CV care today is more formalized, and regulations constrain the flexibility of physicians to take risks on new ideas.

Interestingly, during the same period, patients themselves have become increasingly organized in driving innovation, as described in Chapter 3 and reflected by organizations such as the Pediatric Congenital Heart Association (PCHA) and American Sleep Apnea Association (ASAA). One key challenge will be creating an environment where we can harness the creative insights of physicians to improve care while balancing the safety, privacy and priorities of their patients.

The second insight is that science-based solutions often require “patient capital“ in the form of government grants to come to fruition. Traditional corporate R&D is facing significant challenges, as detailed in Chapter 4. New models must be created to overcome the “valleys of death” present throughout the commercialization process. Chapter 4 details one such solution, explaining the lessons from Cameron Health, which was supported by venture capitalists and industry incumbents, and their success in developing a cost-effective solution for treating patients experiencing sudden cardiac arrest.

Another potential source of innovative solutions can be found in the academic research and contract research organizations (AROs and CROs) described in Chapter 6. In an era when the rising cost of clinical trials is curbing innovative opportunities, both of these varieties of organizations are playing new roles and often collaborating. Of course, the most crucial capital of all is the human capital that will drive the next wave of medical advances. Chapter 10 discusses the Stanford Biodesign program and other similar efforts that aim to attract and train a new kind of health care innovator. These initiatives explicitly incorporate many of the themes in this report, such as a greater focus on cost-effectiveness and the need for interdisciplinary solutions, into their programs of study.

Next, the translational research gap is a critical issue to address, because the most successful innovations are empirically validated in this stage. Chapter 5 demonstrates one way to address this gap, highlighting the role of both philanthropic and venture capital funding in the advancement of CardiAQ’s percutaneous mitral valve implantation device.

Finally, even for technologies that “work,” the process of adoption is messy and unpredictable. Clinicians, consumers and payers often have differing incentives in using new technologies, creating more barriers to commercial success. Chapter 9 illustrates how digital health innovations can still succeed in this environment, documenting how AliveCor was able to receive a “breakthrough device“ designation from the Food and Drug Administration. However, this chapter details the numerous remaining barriers to digital health innovation.

Chapter 7 demonstrates the costs and benefits of the differing approaches to regulation in the case study of TAVR, a key innovation that came to market in Europe long before the U.S. With the signing of the 21st Century Cures Act in 2016 and a changing climate for reimbursement, the outlook for innovation may be brighter. Chapter 8 explains that whereas the reimbursement environment did not allow Microsoft and Google to scale their health care solutions in the early 2000s, the emerging consensus on reimbursement is becoming more favorable to innovative solutions in areas such as home-based blood- pressure monitoring.

In the subsequent chapters, this report focuses on the factors that encourage and inhibit innovation in CV health. Some chapters describe how breakthroughs occur; others recount the lessons from innovations that failed. In doing so, we hope to generate a set of insights that can guide all of those interested in promoting CV innovation. The authors represent a unique collaboration brokered by the AHA, bridging the clinical and health technology domains with those that study innovation and entrepreneurship in business schools.

The Role of the American Heart Association

The American Heart Association has been at the forefront of innovation designed to improve human health. The AHA has always aimed to solve the most pressing problems of the day, including funding critical research in the basic sciences and public health, and launching initiatives such as Get With The Guidelines, One Brave Idea and the American Heart Association Institute for Precision Cardiovascular Medicine.

The AHA’s Center for Health Technology & Innovation is focused on building and harnessing health technologies and partnerships in pursuit of innovative and scalable health care solutions.3 The AHA continues to be engaged at the exciting intersection of the traditional clinical world and the more dynamic and fast-paced consumer health portion of the market.

The AHA was fortunate to engage leading experts from Duke University and Duke Clinical Research Institute to lead this work, and we look forward to continuing to learn with and from them and to share these insights with the broader community. Our collective goal is to do further research on the drivers of innovation in CV care and how best to harness them. It is our great hope that this report is the beginning of an effort to spark yet another means of innovation in CV and even further improvements in human health.