October 15, 2021
With the growing prevalence of neurological disorders, from Parkinson’s disease and chronic pain to Alzheimer’s disease, rapid innovation in neuromodulation – a medical approach to treating conditions related to the brain and nervous system – is more important than ever.
For Rafael Carbunaru, PhD, vice president of research and development for Neuromodulation at Boston Scientific, the many opportunities to improve patient care make this an exhilarating time to be a leading developer of neuromodulation therapies.
How are Carbunaru and his team driving these advancements in neuromodulation? He says that “On the most fundamental level, it’s about learning to Speak Brainish—the language of the nervous system.”
This decades-long focus on the foundational science of the nervous system ultimately led to two significant innovations in the past year: the Vercise Genus™ Deep Brain Stimulation (DBS) System to help manage the symptoms of Parkinson’s disease, and the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System that personalizes pain therapy.
Both therapies involve implanting a small device that connects to the patient’s nervous system – either the brain or spinal cord. The devices are programmed to send mild electrical pulses to interrupt or modify the signals that cause symptoms.
We asked Carbunaru about how his team translates the language of the brain to develop life-changing technologies, the role of agility in innovation, and what’s next in the world of neuromodulation.
Q: What role do physicians play in our approach to innovation?
Our mission is to transform the lives of patients through innovative solutions, and physicians are key to accessing and serving these patients. It is a truly cross-functional effort to understand and learn from physicians. Together, our teams including R&D, quality, marketing, clinical, sales and others, work in a variety of settings to learn from physicians. These settings include everything from one-on-one interactions, collaborative scientific research, advisory boards and even blinded surveys.
Receiving this information from diverse inputs allows us to uncover the most pressing clinical needs and even needs physicians may not know they have. From there, we work to combine the perspectives of physicians with our unique expertise in the science and technology to advance the features and capabilities of our products and develop new solutions and therapies.
Q: How do you develop the agility to remain competitive in the short term while creating new and exciting ideas for the future?
I think of “agility” as if Boston Scientific were a car. Our company’s agility is its get-up-and-go, its ability to change speed and direction as needed to advance. It starts with our culture. To be successful in a fast-paced field like neuromodulation, we’ve evolved a cross-functional culture that can adapt and improve and jump into different opportunities with agility. For example, every week our senior management team reviews R&D project portfolios. We aren’t micromanaging the development process; we’re working to identify where to focus, deploy resources, course correct or make adjustments to the portfolio, without losing time.
In the past year, we had a record number of launches, and I think this was only possible because of our culture. We prioritize flexibility and a forward-looking perspective without sacrificing quality.
Q: Can you reference us a particular product that illustrates this approach?
A recent example is the launch of the Alpha and Genus Systems. We challenged ourselves to deliver two new SCS and DBS systems at the same time. Up to that point, we would sequence that development, completing a system about every two years. Both SCS and DBS systems send mild electric pulses to specific areas of the nervous system to reduce symptoms while minimizing side effects. But beyond that, these two types of systems have specific needs for each indication.
Our solution was to organize ourselves early on to focus on common core development for both indications, which created efficiency. We dedicated another team to develop the customizations needed to create excellent SCS and DBS systems simultaneously.
The result was two major launches within a few weeks of one another. Getting both innovative systems across the finish line is a testament to our cross functional teams' agility, perseverance, deep understanding of the clinical need and winning spirit.
Q. What is one of the biggest clinical challenges you face?
Patient access. Even though we have products and therapies for chronic pain management and deep brain stimulation, there is a large proportion of people that do not have access to them, even in the U.S. and Europe. Why? Because they are unaware these solutions exist, and their physicians do not specialize in providing them.
So, a patient can spend many years in a frustrating cycle of using therapies that are not ideal for them, without realizing there are specialized alternatives that could literally transform their lives.
This is particularly true for pain patients. People live with chronic pain thinking, “this is just the way it is, and I must deal with it for the rest of my life.” It’s just not true – we have so many options right now for treating different kinds of pain. Sometimes we hear of patients who have suffered from chronic pain for 10 years, taking opioids, getting surgeries, without getting adequate relief, and then they try WaveWriter Alpha and suddenly the pain is gone, and their lives are transformed.
We’re trying to educate physicians and patients about our therapies so they can make informed decisions.
Q: What’s next in neuromodulation?
The future is exciting. We’re moving towards treatments for more indications, patient monitoring and management, and having an even better understanding of how to interface with the nervous system. These things will keep us busy for a while, but we’ll also be able to transform a lot more lives.
As far as indications are concerned, the number one cause for long-term disabilities are neurological diseases, such as stroke, depression, and so on. Millions of people need transformative solutions that do not exist today, not just for our business and for Boston Scientific, but for society.
I’m very excited about our ability to monitor and manage people with chronic diseases in ways that were previously impossible. If a patient has a fluctuating chronic disease, and they go to the doctor once every six months, it’s difficult for a physician to properly understand how the patient’s condition shifts. Imagine what you could do if you could follow that patient throughout the entire six months? You could optimize therapy and help them manage their condition much better. We are creating programs to monitor and manage patients and give doctors actionable information about their patient’s current state. The therapy can be optimized for each patient based on artificial intelligence and advanced analytics tools. I think this will have a very big impact.
I’m also very excited about the progress in our ability to continue to learn to Speak Brainish. It’s just short of miraculous sometimes what we do for some patients because we have a better understanding of how to interface with the nervous system.