Every corner of the health care industry has had to refocus efforts in some way this year. There are no exceptions.
Edwards Lifesciences, a $4 billion, Irvine, California-based med tech company, is a shining example of this sudden shift. Most of the discussions surrounding COVID-19 and the med tech industry are about what you’d expect. Health care’s need for ventilators, PPE, and other medical supplies.
However, Edwards Lifesciences, focused primarily on the heart valve space, didn’t just sit on its collective hands during the last few months, waiting for elective surgeries to resume. The company has taken on a number of initiatives in response to the pandemic, CEO Mike Mussallem told Health Evolution. For example, it teamed up with UPS to supply necessary ICU monitoring equipment to hospitals and provided grants to more than 20 partner organizations providing safety-net support.
As with everyone else, it has been a difficult, last few months for Edwards. The pandemic has forced the company to pause enrollment in clinical trials related to its technology and reduced revenue guidance for the year. But Mussallem, who has been at the helm of Edwards since 2000, is inspired and encouraged from the response he’s seen at his company and the industry at large. He spoke with Health Evolution about COVID-19, the company’s innovative culture and more.
Health Evolution: What was the response to COVID-19 from your team at Edwards Lifesciences?
Mussallem: Over the last several months, we have had dedicated resources to closely monitoring the fast-changing environment and developing policies to strike a balance to ensure employee safety while also maintaining patient care and global supply. Our employees have been incredible. The unwavering commitment of our global employees, including those in our global supply chain organization, meant that structural heart patients with urgent needs continued to be treated, and the increased number of critically ill patients were closely monitored at a time when they needed it most. Our teams have also provided their support in health care facilities around the world, living our Credo: Helping Patients is Our Life’s Work, and Life is Now.
The response has been unbelievable. Many of our charitable partners also quickly mobilized to address the most urgent community needs, and we are very proud to support them and many others in their efforts. [Our non-profit foundation] immediately issued grants to more than 20 partner organizations providing safety-net support in the communities where Edwards’ employees live and work around the world. We have also provided donations of critical care technologies during the crisis to help in the care of underserved patients as well as donations of our global team’s time to address other needs.
Health Evolution: How do you envision the med tech industry will have to adjust, strategically, to the impact of the virus – not just from a clinical perspective but a business one as well?
Mussallem: Our industry came together as leaders through the [Advanced Medical Technology Association] so that we could work together to be a part of the solution to the immense challenges facing our health care community worldwide. We prioritized several issues and formed cross-industry teams to address each challenge.
One is focused on the tremendous and urgent need for high quality diagnostic tests, and the need for transparency with government and policymakers on the progress there.
Another is focused on trying to help patients and health systems return to doing what some might call elective, or less urgent, procedures, not only for the well-being of patients but also to protect the economic integrity of the health care system and hospitals.
A third is focused on helping fragile, small med tech companies and innovators secure the necessary resources to continue their important work of innovating to address patient needs. The work by these teams on recovery and rebuilding is continuing.
Health Evolution: Can you share an example of how Edwards has partnered with organizations during this crisis?
Mussallem: One partnership in particular that stands out to me is the incredible effort put forth by our team in Australia along with our supply chain professionals to ensure the continued supply of the bovine pericardial tissue utilized in our life-saving heart valve technologies. The transport of the bovine pericardial tissue from Australian cattle was disrupted when almost all commercial air travel between Australia and the U.S. was upended by the pandemic. Faced with this challenge, Edwards’ teams worked with the Australian and U.S. government authorities to help them understand the urgency in delivering this product. Capacity was made available on two flights leaving Australia to ensure the cargo would arrive in the U.S. in time for its use in Edwards’ critical manufacturing operations.
Health Evolution: What were some of the COVID-19 lessons learned from your perspective?
Mussallem: Whatever we may have thought or assumed in the early days, we soon learned was wrong. New information has come routinely, and it has necessitated an agile approach to decision-making. For some of our decisions, we have turned to and relied on science, and in other areas, we rely on policies of local or federal governments or hospital systems. Our solutions need to accommodate not only scientific information coming from trusted sources, but also the policy decisions from others that we respect. This is a unique situation that we have never faced before.
Health Evolution: What was the biggest challenge you have encountered?
Mussallem: The biggest challenge we’re facing is the concern we have for many patients in the areas we serve, such as those affected by heart valve disease, that are not getting treated. The reasons are varied and include fear of seeking treatment because of risk of COVID-19 in their communities, inability to get treated because procedures are being cancelled due to the strain on hospital resources or for personal economic reasons, such as job loss or lack of insurance coverage.
We know that COVID-19 is deadly and has created tremendous strain on the health care system globally. But, sadly, we expect that because of this strain and associated treatment delays, some valve disease patients will worsen and not survive the delay, given the deadly nature of these chronic conditions. This is a very difficult time for structural heart patients and their doctors as they weigh the risk of COVID-19 versus the underlying progressive disease.
Health Evolution: Switching topics, how do you instill an innovative culture into strategy at Edwards?
Mussallem: I have always dismissed the notion that big companies cannot innovate. Edwards has invested a great deal to understand the innovation process and we have integrated three key, important ingredients into the company: a culture of innovation, innovation-focused business processes and generous, continuous funding. Our culture of innovation is embodied through both tangibles and intangibles, whether we think about how we structure our physical spaces to encourage collaboration, how we organize the company to create focused teams or how we embrace risk-taking and a learning culture that understands the role of failure in the innovation process. Our business processes focus on funding tied to achievement of milestones and rewarding our teams on innovation success and patient impact.
Today, we spend well above the industry norm on R&D as a percentage of sales, and this is a practice for Edwards that has endured for many years. We create meaningful value by transforming patient care, and we can do that with bold innovation as a core piece of our strategy, along with focus and leadership.
Health Evolution: What are some of the major advancements in your core areas of heart disease and critical care medicine that you are working on?
Mussallem: We continue to invest significantly in research and development and clinical evidence. In transcatheter aortic valve replacement, we continue to look for opportunities to make the procedure and technology better, but we also recognize that there are many patients that remain untreated. Likewise, mitral and tricuspid valve disease patients are tremendously under‐served today. These diseases are diverse and complex, and treatment is challenging. We believe we can make tremendous change in these areas, and we think it’s an unbelievable opportunity to help patients with multiple treatment opportunities under development across a broad product portfolio.
In critical care, the advent of artificial intelligence is going to advance our monitoring technologies further. These technologies have always been best‐in‐class with a focus on accuracy, and the incorporation of advanced technologies will make it a more powerful tool in decision‐making in the future. We’re going to be able to use artificial intelligence to help give clinicians better insights, so that they can make high‐quality decisions while caring for patients that are critically ill or in very serious surgery.
Health Evolution: Has COVID disrupted any of these future timelines?
Mussallem: The pandemic has necessitated a delay in enrollment of certain clinical trials to ensure the research is high quality in consideration of the urgent COVID-19 response around the globe. We are coordinating closely with the trials’ clinical investigators to resume enrollments when clinicians’ and patients’ needs can be better served.
Health Evolution: With the health care industry in flux, what kind of leadership advice can you share with your fellow CEOs?
Mussallem: We are not alone in this within the global health care community. My best advice is to always keep the patient at the center, and no matter what chaos or uncertainty is around you, letting the needs of patients guide your decisions will provide remarkable clarity.