From driving to the clinic to driving innovation: How treating patients prepared me for medical device development

My office at Abbott looks a lot different from the offices that I occupied for years as a practicing cardiologist.

But my goal — like that of doctors from all specialties around the world — remains the same: helping patients live healthier, fuller lives. Although now that I’ve moved from practice to industry, achieving that goal happens on a much larger scale.

This story starts almost 30 years ago, when I was an interventional cardiologist working in complex cardiac and vascular interventions, using a wide array of medical devices. These were the early days of coronary angioplasty for patients with cardiac chest pain and heart attacks. I started out at Duke University Medical Center and then moved to the Sanger Clinic in Charlotte, North Carolina, where I created a research team to study patient outcomes following the use of many of these new cardiac devices, mainly for opening blocked arteries of the heart. I founded the Carolinas Cardiovascular Research Foundation at the Carolinas Heart Institute, Carolinas Healthcare System (now Atrium Health), and learned a lot from the innovators I worked with throughout research, teaching and practice. While I enjoyed what I did, leaving my practice to move to industry felt like a natural decision for me.

When I was approached by Abbott to consider taking on a role that would help set the strategic direction at a company that was advancing treatments for vascular diseases, I began to consider the possibilities of making a bigger impact on medicine. Historically, many of today’s pharmaceutical and healthcare companies got their start with physicians who wanted to impact more patients and society as a whole. In fact, Abbott, where I’ve worked for the last 10 years, was founded by Dr. Wallace C. Abbott in 1888, when he started making medicines to offer more effective therapies to his patients than were available at the time.

Joining an industry that was striving to innovate in the way we treat people for various diseases, with the goal of transforming healthcare altogether, was an opportunity that I couldn’t turn down. And over the past decade, I’ve learned a number of lessons about what’s needed for success in making a transition from medical practice to industry.

Lesson 1: Everyone Must Agree on the Challenges

I often draw from my clinical experience when discussing the possibility of a new technology. The experience I had as a practicing cardiologist gives me a perspective that I share with my internal colleagues about the issues that doctors face today, and how new or different technologies could improve patient care. Prior to creating a new technology, it’s important that everyone agrees on the unmet need it will address.

For example, treating heart disease is becoming more difficult. Today, complex cases account for 70 percent of all percutaneous interventions, whereas just 10 years ago it was 30 percent of cases[i]. New treatment options must be able to address the unique needs of these patients, who present with comorbidities such as diabetes, or who may require multiple interventions. As we witnessed this increase in complex cases, we asked ourselves and the cardiology community: What do doctors need to better treat this evolving patient population? Percutaneous coronary intervention (PCI) is a procedure that has evolved dramatically over the past 30 years, from simple balloon angioplasty to drug-eluting stents; but is it time to do something differently to treat a changing patient population? We built upon those insights to create the fifth generation of our leading coronary heart stent. We engineered an enhanced version of the stent with new features that are designed to better treat these types of complex cases. And now, we are showing how new imaging techniques like optical coherence tomography (OCT) can add more precision to guiding the procedure – enabling more accurate stent sizing to the patient’s coronary arteries and ensuring an optimal final stent result.

Lesson 2: Skepticism, While Healthy, Can Hold You Back

I have a natural tendency to approach everything with some skepticism — to not always believe what I was told, be hesitant of the latest trends, and review research with a fine-tooth comb. As a practicing physician, I often responded to new pharmaceuticals or devices with cynicism, questioning and pressure testing them until I felt comfortable with the clinical data and technical utility.

Though skepticism is an important asset as a physician, but sometimes it can hold one back from using technologies that could have helped patients. When Abbott bought the startup Evalve in 2009 for its clip technology to treat mitral regurgitation, I thought the procedure to place the device via transcatheter to the heart would prove to be too difficult for most physicians to perform. It’s a minimally invasive approach to mitral valve repair, yet it’s a complex procedure and requires a definite skill set. Today, this small device has been implanted in more than 70,000 people, proving to be a successful and invaluable alternative for patients who are at increased risk for open heart surgery. It’s made even skeptical clinicians, like me, believers.

So, while a healthy dose of skepticism can be good, it’s important to recognize practice-changing technology for what it may become. Just like people didn’t realize they needed computers on their phones or lane-assist indicators and cameras on their cars, we should trust that change can be good as patients’ needs continue to evolve.

Lesson 3: Identifying the Need for a New Technology Requires a Different Mindset than Building It

One of the first things I learned in my new role at Abbott was that coming up with a solution for a complex problem required a different thought process than what I used in the clinic. In practicing medicine, doctors tend to jump in and act rapidly, basing decisions on education, expertise and experience.

The process for developing new medical devices requires a collaborative model and has many more steps. For example, in addition to calling on internal expertise and experience, Abbott also brings together experts from a wide range of fields to contribute to solutions. The process starts with a very unfiltered collecting of information – brainstorming hundreds of ideas – then testing prototypes with a “think-build-rethink” method. The last step is to research intellectual property issues, business models, and potential reimbursement and regulatory pathway considerations.

Throughout the process of developing new technologies, or improving existing ones, I now also look through the lens of a manufacturer. I ask how long the process will be from bench to patient; how hard it will be to find enough patients for a clinical trial; what the FDA will look for when considering approval and what obstacles are likely to arise.

Looking Forward

After spending nearly three decades in the clinic, the move from practice to industry proved to be immensely gratifying. I continue to learn new things, interact with former colleagues and new ones and believe our collective work has helped bring life-changing technology to many more patients than I would have otherwise treated in my practice.

What is most clear to me after moving from clinical practice to a healthcare company is that opportunities for industry and clinicians to work together to improve patient outcomes are infinite. As we at Abbott continue to develop the next breakthroughs for patients around the world, I encourage physicians to reach out to colleagues in industry positions like mine to discuss the most important challenges they face day-to-day in clinical practice. This “bridge” from the clinic to industry (or bedside to bench) can be built more efficiently through “always on” real-time communication that speeds up the evolution of medical innovation.

Charles (Chuck) Simonton, M.D., is chief medical officer and divisional vice president of Global Medical Affairs for Abbott’s vascular business. He received his medical degree from Harvard Medical School and did his internship, residency and chief residency in the Department of Internal Medicine at the University of California, San Francisco, and his Cardiology fellowship at Duke University in North Carolina.

[i] Decision Resources Group, July 2017. Data on file at Abbott.

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