Failing to ultimately succeed

In the late 1950s, an engineer named Miles “Lowell” Edwards decided he wanted to develop an artificial heart. He presented the concept to Dr Albert Starr, a young surgeon at the University of Oregon Medical School, who thought the idea was too complex. Instead, Dr Starr encouraged Mr Edwards to focus first on developing an artificial heart valve.

This important partnership between an engineer and physician — which has become a hallmark of Edwards’ innovation process — led to the first Starr-Edwards heart valve being designed, developed, tested and successfully placed in a patient, within just two years. And it led to the formation of Edwards Laboratories, which set up shop in California and grew into today’s global company, Edwards Lifesciences se abre en una nueva pestaña/ventana.

In retrospect, as with later Edwards innovations that emerged over the next six decades, history has a way of making the innovation process seem continuous and linear. But the truth is that innovation in healthcare is fraught with challenge. There are so many ways to fail.

But failure can be a starting point, not a dead end.

Own your failures, learn

At the heart of Edwards’ culture is a set of guiding principles that we have deemed our “secret sauce.” We value these as unique attributes, and we routinely focus on and celebrate each of these ingredients with our employees worldwide.

We have built our patient-focused innovation culture around these pillars of innovation. Among ingredients such as “patients first,” “dream big,” “welcome surprises,” “seek diverse perspectives,” and “challenge the system” is one summarized as:

Own your failures, learn.

For innovation companies like Edwards, this permission to fail holds a lot of weight. To change the practice of medicine, the culture of an organization must not only tolerate — but also welcome — failure as a part of the learning process. As we develop life-enhancing and life-saving therapies, there are multiple points of risk, the most important being the safety and efficacy, but also including device durability, high-quality reproducibility, and the economics associated with these. And there are many smaller points along the way where failure can show up.

At the early stage of developing medical technologies, we take a lot of risk. We work to expose failure modes into the benchtop or computer modeling so that once we get into a clinical environment, we can minimize risk. We also recognize that to be a truly innovative culture, we have to go after big challenges, and that means we’ll likely fail more than we’ll succeed.

Over time at Edwards, we have experienced different versions of failure. We have had instances where the obstacles are judged as more significant than any upside, and the project or program is ultimately canceled. Even in these instances, the teams take stock of what we’ve learned and how this applies to other programs underway.

We have other instances where we have fought through the failure to overcome the challenges to ultimately succeed. While these are the experiences that may get the most attention and celebration, we know that both experiences shaped our decision-making going forward.

These are not decisions that we delegate. These decisions come from open, honest discussion with the involvement of leadership, listening with an open mind. We weigh the considerations together, take personal responsibility and ultimately reach an agreement on whether the challenges are a speed bump, or a brick wall. Should we carry on because we can overcome it, or should we stop?

Dream big

I’ll share two examples from Edwards of how understanding that embracing risk in a safe, structured way is the only way we can make progress on big ideas to impact patient care.

Many years ago, we were in development with a technology called MONARC for the minimally invasive treatment of mitral valve regurgitation. With mitral regurgitation, patients experience shortness of breath, fatigue and other symptoms that affect their quality of life. MONARC was designed with two anchors connected by a spring-like bridge that included a biodegradable element. Over a period of time after the implant in a vein near the mitral valve, the anchors would tighten, with the goal of reducing the regurgitation.

We were very excited about MONARC and its promise for patients. In a clinical study of MONARC, the investigators concluded that implantation of the device was feasible and may reduce mitral regurgitation, but cautioned that there were some instances where, over time, the device cut off coronary blood flow in patients with certain anatomical characteristics.

This was a challenge revealed through clinical study. It becomes emotional when committed innovators are learning tough lessons at this stage, and the risk is that the emotional aspect takes you into denial. If you let it, all is lost.

While this technology showed promise and proved effective in some patients, we ultimately made the tough decision to stop the program. We had approached this technology with the purpose of addressing the large unmet needs of patients with mitral regurgitation broadly, but we discovered that the MONARC technology was for a more limited group of patients. We learned that patients with mitral valve disease are not impacted in a consistent way and that their anatomy is complex and diverse. We came to understand that these patients would be better served by a “toolbox” of therapies encompassing several replacement and repair approaches, of which we had other programs underway.

The work and learnings from this program built the foundation for understanding the use of the vein near the mitral valve, the coronary sinus, for future therapies that we continue to explore today. We remain optimistic that we will ultimately achieve success with innovations that draw from the important work done years ago.

Challenge the system

In the category of pushing through challenges, we’ve had many on the pathway to developing transcatheter aortic valve replacement (TAVR) since the late 1990s. TAVR is a method of performing valve replacement without open-heart surgery.

Initially, physicians introduced the catheter system into the low-pressure venous system and followed the path of the return blood flow. This antegrade approach required complicated maneuvers, including puncturing the heart wall separating the chambers. To add to the complexity, the patients treated at the start of TAVR were very ill and elderly.

Just a few months into the clinical trial, we faced challenges that made us take pause. The procedural approach could result in damage to the mitral valve, and the early study experience had some patient complications and deaths. It was also clear the procedure was not going to be readily teachable or reproducible.

We needed to stop the trial; it was difficult but necessary. The New York Times reported on the trial suspension, and Barron’s published an article, “Headed for Heartache? se abre en una nueva pestaña/ventana” about the failures of Edwards in this study (an article I still have hanging in my office as a reminder that innovation often includes failure).

It would have been tempting to give up; instead, we went into learning mode. We had conviction that TAVR could change the practice of medicine. We knew there were patients suffering needlessly from a deadly disease that our technology could address.

Seek diverse perspectives

A Canadian physician was working with us on a different approach to TAVR. He was investigating using an approach of entering the high-pressure arterial system and advancing the catheter opposite the blood flow through the “big pipe” of the aorta and into the heart.

Using this “retrograde” approach, the procedure was teachable and it could be performed in a consistent, reproducible way.

This approach was integrated into the clinical studies and today is the preferred approach for TAVR. It would be disingenuous to say that it was all smooth sailing from there — we had many more “own your failures, learn” moments through multiple large clinical trials, generations of device advancements and learnings around everything from patient selection to procedure optimization to physician training. But we learned that challenging the commonly accepted way of approaching a therapy could result in a better experience for physicians and, ultimately, patients.

Lifelong learning

Within the next year, we expect to reach the milestone of 1 million patients worldwide who have benefitted from TAVR. The knowledge from pausing the early feasibility study in 2005 informed the technology and procedure we have today. Our extraordinary partnerships with clinicians and the advancements that come from the diverse thinking of the physicians at the bedside and the engineers on the benchtop — and bringing together their observations, ideas and solutions — continue to support an even stronger culture of innovation. We utilize our experiences to pause, listen, learn, apply the knowledge and innovate to educate and inform our employees and partners — and most importantly, understand that not everything we set out to do will succeed. That is the reality of dreaming big and going after the difficult challenges as medical innovators.

While remaining an aggressive investor in innovation, we also recognize that truly learning is about opening your mind. It is about taking a risk on thinking differently, knowing that you might be wrong. Challenge the status quo, and keep seeking answers until you find the right one. You might fail, but if you succeed, the impact could be greater than you ever imagined.

It can change your own life — and maybe the lives of countless others.